To detect vascular variability anomalies (VVAs), a blood pressure and heart rate profile around the clock for at least 7 days is a start. As a minimum, measurement every 60 or preferably 30 minutes for a week is needed, to be continued if abnormality is found, to assess the about 24-hour (circadian) variability that exists in all individuals. As a first dividend, one then also obtains a glimpse of 2 of the very many longer-than-circadian periodicities, the biological half-week and week. Certainly if we can have sensors and computer chips in our cars that continuously monitor the pressure over a tire’s life, we should be able to do the same job for ourselves for diagnostic and therapeutic decisions. Healthcare today emphasizes wellness with recommendations for exercise and a proper diet, yet these evaluations may not be adequate. BP may be measured at a visit to the doctor or before an exercise session, along with measuring body weight and performing a physical exam. The seeds of disease are planted long before they are visible, and what appears to be normal from a conventional point of view may in fact be abnormal. Hidden alterations of physiological function, masked by the body’s remarkable adaptive capabilities, may become visible through a new diagnostic and therapeutic realm—chronobiology—that reveals hitherto unseen abnormalities. The tools of chronobiology may yield additional dividends, such as the detection of physiological “loads” related to stress and stress relief and the undesirable effects of space weather upon personal events such as sudden cardiac death, societal events like terrorism and war, and natural disasters. Chronobiologically interpreted automatic ambulatory BP and heart rate (HR) monitoring (C-ABPM) may detect the antecedents of these types of events. C-ABPM is of interest in preventive cardiology, since it reveals new diagnoses as vascular variability anomalies (VVAs) and renders previous conventional diagnoses more reliable, such as that of an elevated BP. These VVAs include MESOR (midline-estimating statistic of rhythm)-hypertension, an elevation of the MESOR, which is diagnosed, like all other VVAs, only after 1 or preferably several replications of 7-day around-the-clock BP monitoring with available, affordable, and unobtrusive instrumentation. The recommendation for continuous C-ABPM recognizes several principles that constitute inseparably intertwined contributors to severe cardio-, cerebro- and renovascular diesase. C-ABPM gauges wear and tear of genetics, physical loads, and in particular mental stress placed upon individuals from “womb to tomb” by daily life, including weather in extraterrestrial space as well as that on earth, as a continuous surveillance paradigm preventing us from flying blind to a change from less than 5% to near 100% in the risk of a stroke within 6 years.
对于血压等看似简单的问题，仅 仅衡量药物乃至饮食和运动的影 响是不够的：而需要至少 7 天昼 夜不停地仔细衡量，以准确描述 众多个体身上出现的 24 小时（ 全天）变化。由此带来的首要好 处是，可以简要了解很多超过一 个昼夜时长的两个时段（即生物 半周和生物周）的情况。当然， 既然我们的汽车可以装传感器和 电脑芯片，在轮胎寿命期内对轮 胎压力进行持续监测，那么我们 自己应该也能采取相同的做法， 以作出诊断和治疗决定。如今的 医疗注重建议运动和合理饮食以 保持健康，但仅有这些要素或许 不够。可在就医时或在运动课程 之前测量血压，同时称体重并进 行体检。疾病在显现之前很久便 已埋下种子，而传统观点所认为 的正常情况实际上可能并不正 常。生理机能的隐性变化被身体 强大的适应能力掩盖，但可由新 的时间生物学诊断和治疗方法揭 示，从而展现可能隐藏的异常情 况。时间生物学工具还可能带来 其他好处，例如检测与压力和压 力释放有关的生理“负荷”，及 太空天气对个人事件（如心脏猝 死）、社会事件（如恐怖主义和 战争）以及自然灾害的不利影 响。从时间生物学角度解释的动 态血压 (BP) 和心率 (heart rate, HR) 监测 (C-ABPM) 可能会查出 这些事件的前因。C-ABPM 有助于 预防心脏病，因为其可显示血管 变异异常 (vascular variability anomalies, VVA) 等新诊断，并使 先前的传统诊断（如血压 (BP) 升高）更加可靠。VVA 包括高血 压 MESOR（midline-estimating statistic of rhythm，即调整中值）， 即 MESOR 升高，如同其他所有 VVA 一样，其仅可通过使用价格 合理且普通可用的测量仪器进行 7 天昼夜不停的血压 (BP) 测， 得到一次或（最好是）几次证实 后作出诊断。关于持续 C-ABPM 的建议确认了几项要素，这些要 素紧密结合并互相作用，促成心 脏、大脑和肾血管疾病。包括日 常生活在个体的整个一生中对个 体基因、身体负荷和精神压力的 损耗，其中包括地球以外空间及 地球上的天气。
La mejor medición de los efectos de los fármacos e incluso de la dieta y del ejercicio físico en algo aparentemente tan simple como la presión arterial no es suficiente: necesita medirse prestando atención detenida al tiempo, durante las 24 horas al menos 7 días, para caracterizar de forma precisa la variabilidad durante 24 horas (circadiana), que existe en muchas personas. Como primer resultado, se vislumbran también dos de los muchos periodos largos circadianos, el biológico de media semana y el de una semana. Ciertamente, si nuestros coches pueden tener sensores y chips informáticos, que monitorizan continuamente la presión de los neumáticos, deberíamos ser capaces de conseguir lo mismo con respecto a las decisiones diagnósticas y terapéuticas. La atención médica actual enfatiza el bienestar con recomendaciones de practicar ejercicio físico y llevar una dieta apropiada, aunque estas valoraciones puede que no sean las adecuadas. La presión arterial puede medirse cuando se visita al médico o antes de una sesión de ejercicio, conjuntamente con el peso corporal y un examen físico. Las semillas de las enfermedades se plantan mucho antes del momento en que las enfermedades se hacen visibles y lo que parece normal desde un punto de vista convencional puede que sea, en realidad, anormal. Las alteraciones ocultas de la función fisiológica, enmascaradas por la notable capacidad adaptativa del cuerpo, pueden hacerse visibles mediante un nuevo entorno diagnóstico y terapéutico (de modo cronobiológico), lo que puede revelar anomalías que podrían estar ocultas. Los instrumentos de cronobiología podrían reportar beneficios adicionales, tales como la detección de “cargas” fisiológicas relacionadas con el estrés y la liberación de estrés, así como los efectos indeseables asociados al tiempo espacial en los acontecimientos personales, como la muerte súbita cardiaca, los acontecimientos sociales, como el terrorismo y la guerra, y los desastres naturales. El control (chronobiologically interpreted automatic ambulatory blood pressure monitoring, C-ABPM) automático y ambulatorio de la presión arterial (PA) y la frecuencia cardiaca (FC) interpretados de forma cronobiológica podría detectar los antecedentes de este tipo de acontecimientos. El C-ABPM es interesante en la cardiología preventiva, ya que revela nuevos diagnósticos, como las anomalías de la variabilidad vascular (vascular variability anomalies, VVA), y convierte los diagnósticos convencionales anteriores en más fiables, tales como los que muestran una PA elevada. Estas VVA incluyen la hipertensión de estimación de línea media estadística del ritmo (midline-estimating statistic of rhythm, MESOR), una elevación de MESOR, que se diagnostica, como el resto de las VVA, solamente después de una o preferiblemente varias réplicas del control constante de la PA las 24 horas del día durante 7 días mediante instrumentos que estén disponibles, sean asequibles y no causen molestias. La recomendación para un continuo C-ABPM reconoce varios principios, los cuales constituyen factores entrelazados e inseparables que contribuyen a las enfermedades graves cardiovasculares, cerebrovasculares y renovasculares. Estos incluyen el desgaste genético, las cargas físicas y el estrés mental, que soportan las personas continuamente en la vida diaria, incluido el tiempo en el espacio extraterrestre, así como en la tierra.
Healthcare stakeholders are slowly beginning to realize that the current costly, disease-oriented health service provided to an individual after the onset of disease can be complemented by programs for “wellness” with self help–based care utilizing ongoing surveillance and early actions whenever warranted. A cost-effective C-ABPM system (around the clock at 30-min intervals for all ages) is immediately available, worldwide, on a small scale. It is provided with free analyses for all from a project on The BIOsphere and the COSmos, BIOCOS. This project constitutes a validation test for an international website (www.2011.geocataclysm.org) recommended by a World Forum on “Natural Cataclysms and Global Problems of the Modern Civilization,” held September 19-21, 2011, in Istanbul, Turkey, that extended the scope of prior consensus conferences. Thus, responses to Sir William Osler’s “wear and tear,” putative harbingers of severe disease,1–4 are detected as gauges of loads,4–8 prompting preventive action. Eventually, this task can be implemented on a large scale by an international multilingual analytical and educative website (Figure 1)1,4 on a larger than the currently ongoing small-scale endeavor. The emphasis on wellness can be augmented when prevention is desired. We need no longer fly blind, ignorant to the circadian and the many other variabilities within us and around us, as soon as we have in this generation a system instituted where such a service can be offered freely, such as in community libraries or pharmacies. In the next generation, everyone can be trained in self-monitoring in earliest schooling.9 Today, we have a Zeo Sleep Coach that monitors the brain’s electrical waves, the Fitbit that tracks the number of steps you take each day (you need 10 000 steps a day), body scales that measure your weight and body-fat readings and send them to your computer, blood pressure (BP) monitor jacks into your smart phones, and motion sensors that allow you to track how often you brush your teeth or how many times a day you use the bathroom or open the refrigerator door. C-ABPM is no longer out of the ordinary.
What Can Be Done Today
In a forthcoming book for the lay public advising patients found to have a BP that is too high or too low, a colleague asked the authors whether he could reproduce Figure 2, published in 198410 as an example of interindividual differences among 24-hour profiles. At the time of the original publication, we had not yet formulated VVAs or VVDs (Figure 3, pp 70-71) that are not generally known, a long series of consensus meetings notwithstanding1–4 and of course had no reference values for them. Mostly not implemented as yet is the detection of circadian and approximately 7-day (circa-septan) BP periodicities documented over a century ago that is immediately available for diagnostic and therapeutic use in 2012. As to diagnosis, let us start by asking this question: Who in Figure 2 is at the greater risk of a cerebral stroke or other severe cardiovascular disease? The important answer, contrary to current worldwide practice, is this: We can’t tell; the record is too short. We need a 7-day record as a start and must continue to monitor if it shows abnormality (Figure 4, p 71).
In looking at Figure 2 in 2012, some readers who rely on current official guidelines11 may infer that CH, the 60-year-old man, had a larger swing in BP and may be the healthier of the 2. Many more may recognize CH, the subject whose data are shown on the left of Figure 2, as an excessive “dipper,” a very common diagnosis based on a single 24-hour profile associated with undesirable outcomes, on a population basis.12–15 This majority in turn should not only question a record length of 24 hours as a basis of a diagnosis (Figure 2)5,16–18 but can compare the utility of a classification of dipping with the chronobio-logic diagnosis: eg, of a circadian overswing, CHAT (short for circadian hyper-amplitude-tension; Figure 3)4,19 associated with a high risk of stroke (Figures 5A–5C, pp 72-73).4 It must be realized that a diagnosis based on the single measurement of BP (Figures 6A–6C, pp 74-75), like that relying on a single 24-hour record, as in the case of Figure 2 and others, is a spotcheck rather than a platinum standard (Figure 7, p 75).2
Urgency and Feasibility of Lifelong Monitoring, Starting at the Diagnosis of Blood Pressure Abnormalitya
In 1904, Theodore C. Janeway of Johns Hopkins University,20 then the opinion leader, did not wish to see a patient before collecting sufficient data to assess periodicities. (The plural was justified since by 1880 and 1881, Ignaz Zadek in Berlin had collected sufficiently long time series to document 24-h, 84-h, and 168-h rhythms [Figure 8, p 76].)21,22 In 1974, Frederic C. Bartter, of Bartter syndrome fame, then head of the Hypertension-Endocrine Branch at the US National Institutes of Health (NIH) and later the director of the Clinical Center at the NIH,b recognized that the reason his patient was diagnosed differently by 2 physicians who saw him at different times of day stemmed from circadian changes in BP (Figure 9A, p 76). His foresight was later illustrated in the abstract (Figure 9B, p 77), with additional evidence accumulating since the availability of automatic BP monitoring (Figure 9C, p 77).
By conventional standards, this patient is clearly normotensive every morning. Yet the BP determined each day at 6 in the afternoon provides especially convincing evidence that this patient is a hypertensive…. My plea today, first made in 1974, is that information contained in such curves[cosinor fits; see Figures 2 and and3:3: our addition] become a routine minimal amount of information accepted for the description of a patient’s blood pressure. The analysis of this information by cosinor should become a routine. It is essential that enough information be collected to allow objective characterization of a periodic phenomenon, to wit, an estimate of M [the time structure or chronome-adjusted mean, or MESOR] … an estimate of [the amplitude] A itself, and finally an estimate of acrophase,φ[a measure of timing, Figure 10A, p 78: our addition24]. In this way, a patient can be compared with himself at another time[Figure 10B, p 79: our addition25], or under another treatment, and the patient can be compared with a normal [Figure 2: our addition] or with another patient.23
What to do With 24-hour CHAT or With Other Records Covering a Single Cycle
Turning back to Figure 2, by using “clinically” healthy in its title rather than just “healthy” in 1984, we implied that we had no outcome data on the subjects investigated but were not aware of any abnormality. We still lack outcomes for CH, but have (we emphasize tentative) gender- and age-specified reference standards (RS) for whites, among others.26 We can make a diagnosis of 24-hour CHAT27 specifically in the light of now-available acceptability limits for the 24-hour amplitude, still to be improved by restriction to long-lived disease-free individuals. Having diagnosed 24-hour CHAT, we must realize the limitations of the record’s brevity.5,16–18 Taking a 24-hour profile to assess a single circadian cycle being equivalent to taking the pulse for 1 second to gauge just a single cardiac cycle was recognized long ago.27,a The analogy of taking the pulse for only 1 second as assessing only a single cycle can now be extended to the physiological counterparts of a half-year and of the seasons and to periods shorter than 6 months, the cis-half-year (on this side of the period = cis) or longer than 12 months, the transyear (beyond = trans). Like the 11-year (undecennian) or decadal period of the sunspots, they are all reflected in the human circulation (Figures 11A–11C, pp 80-82).28–30 Whether it is normal or abnormal, neither a 24-hour nor a single 10- or 11-year record can eventually remain the basis of a diagnostic, therapeutic, or etiologic decision. In any case, the need remains for further lifelong C-ABPM and for continued epidemiological data collection and analysis, the purpose of the website. When the 24-hour record happens to be abnormal, it constitutes no more than an indication of the urgency of C-ABPM to assess a possibly acceptable physiological response. Reliance on data covering less than a solar cycle length has led to controversy31,32 and has retarded recognition of heliobiology in the West (Figures 12A–12D, pp 83-85).32,33
A record of the beating heart for a minute or 2 may be compatible with diagnosing death vs life, but it is hardly recommended when a full 24-hour record can fail to reveal abnormality that is present during each of 11 subsequent days and of course vice versa.
A 1-Week CHAT
A diagnosis of 24-hour CHAT, of an excessive circadian swing, can be physiologically associated in certain individuals, with events such as the arrival of welcome visitors (Figure 13, p 85)5 or any other pleasant tasks (not necessarily loads) such as giving a party5 or discussing important-seeming topics with a friend or even with a dear family member or without any obvious reason but perhaps one hidden in space weather.34,35 When a 24-hour cosine curve is fitted to a 7-day series as a whole (rather than to a 24-hour profile, as in Figure 2), a few days of CHAT may be smoothed out and the record as a whole may be acceptable (Figure 14A, p 86) or at least the number of weeks with CHAT is reduced (Figure 14B, p 87).36 On a population basis, the high risk of severe events associated with CHAT (Figures 5A–5C) and more so with coexisting VVDs is clearly demonstrated (Figures 15A and 15B, pp 88-90).4 A VVA for a single day should invariably prompt, as a follow-up, at least an added 7-day C-ABPM. In a case of fulminating CHAT (Figure 10B, p 79),25 this recommendation was not fully implemented, albeit a second short record was even more abnormal than the first. The patient took a conventional stress test instead, which was normal, and hence nothing else was done. Some months later, he returned asking for an implanted BP sensor. We asked why, and he told us that in the interim he had had a myocardial infarction.25 C-ABPM was also ignored in a single case of CHAT during pregnancy (but not in other cases with this diagnosis in the same investigation). In that case, the systolic BP average (MESOR) was 115 mmHg (Figure 16, p 91)4 and the cost of ignoring variability approximated $1 million US for the case of a very premature baby.
A chronobiologic approach works when a dipping classification can fail19,37,38 or dipping misleads39 on a small-group basis. It seems the more important to realize that dipping cannot be recommended for the diagnosis of individuals, even for 7-day records because it is not equivalent to C-ABPM,4,40,41 in keeping with Einstein’s admonition to “make everything as simple as possible but no simpler.” Dipping is “simpler.”
When the diagnosis of MESOR-hypertension is made, the dose prescribed is preferably varied, starting with a time preceding the peak by several hours. Hence, the circadian acrophase of BP as a marker preceded by an interval whose length depends on the chronopharmaceutics of the drug(s) involved is a procedure that has yielded a faster desired response, with fewer side effects compared to traditional therapy (Figure 17, p 91) in the hands of Rina Zaslavskaya, MD, the leading chronocardiologist.42,43 If needed, the timing of the drug can next be varied empirically to find the optimum (Figures 18A and 18B, p 92).44 This is the more important since the same dose of the same drug in the same patient tested at 6 different circadian stages, for approximately 1 month at each time (at clock hours after awakening 3 h apart) can induce or enhance an existing CHAT at 1 test time or at another remove CHAT and lower BP, as intended (Figure 19, p 93).45,46 Sometimes, a single change in the timing of a medication can correct abnormality (Figure 20, p 94).2 Continued surveillance is indicated (Figure 21, p 95).2 The many millions receiving hypotensive drugs need not fly blind, concerning risks in Figures 9A and and9B9B (pp 76-77), while for security on the road we routinely automatically measure the pressure in automotive tires. Moreover, if we monitor ourselves continuously and automatically, we may learn about a new world of infradian rhythms that reflect physical environmental counterparts and relate to sudden cardiac death (Figure 22, p 96), suicide (Figures 23A–23D, pp 97-99), homicide (Figure 24, p 100), and terrorism (Figures 25 and and26,26, pp 100-101). We may even find, on a population basis, the antecedents (Figure 27, p 102)30,47 as well as the consequences48 of a tsunami accompanying an earthquake at some distance from its epicenter.
Multiple Circadian Rhythms and beyond
Time series collected and accumulating for the goal of self-surveillance, once aligned with physical environmental time series, enlarge the scope of Vladimir Ivanovich Vernadsky’s noösphere,49,50 the sphere of the human mind by a chronosphere, a trans-disciplinary spectrum of cycles congruent insofar as their periods in us and around us have overlapping confidence intervals (CIs 95%) (Figures 28A–28H, pp103-109).51–54 Our inclusion of the moon in Figure 28B (p 104) is in keeping with studies on his own heart55 by Miroslav Mikulecky, emeritus head of internal medicine and professor of statistics at Comenius University in Bratislava, Slovakia, and organizer of meetings on this and related topics.56–60 It is here prompted by the first patient encountered by us who shows the double period of tides61 averaging 24.8 hours, repeatedly in the computer output (not input) of analyses of time series.
JF is a woman, 61 years of age, at start of a years-long around-the-clock study, including C-ABPM, with a 20-year history of twice-yearly adynamic depression, each lasting 2 to 3 months. During “downtimes,” JF is unable to get out of bed and to keep synchronized with a 24-hour periodic sleep-wake schedule. Her sleep pattern scans the hours of the day during her episodes. She self-rated vigor-wellness while claiming sensitivity to the moon. In the first months of the first two adynamic episodes investigated, we found a double tidal period of 24.8 hours supporting her impression of selenosensitivity. JF self-measured BP and HR for 5 initial months and for >16 months thereafter (Figure 28D, p 106). At least 2 circadian periods coexist most of the time (Figure 28E, p 107). She also collected saliva at 4-hour intervals around the clock for the determination, in 11 702 assays, of cortisol, aldosterone, dehydroepiandrosterone, estradiol, testosterone, and melatonin (Figure 28F, p 107), showing multiple recurring circadian endocrine as well as vascular ecfrequentia. Several circadian periods were also present in her outside downtimes during relative wellness,62 suggesting a “wrangling” of the tides with society and natural and artificial light. We may speculate whether the tides act via gravity and magnetism, a view shared with physicist-chemist Dr Vladimir Evstafyev63 and Prof Mikulecky (their personal communications), acting by mechanisms considered by Friedemann Freund.64 In any event, in JF, this tug of war yields (compromise?) periods between 24.0 and 24.8 hours except that during some of the first months of an adynamic desynchronized episode, a precise average double-tidal period prevails. The diagnosis in JF of dysfrequentia, visualized by a comparison with an age- and gender-matched control in Figures 28G and 28H (pp 108-109) can be made by C-ABPM (but not by self-measurement, a highly motivated JF notwithstanding, in keeping with earlier results65).
Cycles in us, such as the physiological week, among others, led to natural geomagnetic near-weeks (Figures 29A and 29B, p 110).51 Reports of new cycles by physicists prompted our discovery of coperiodic biospheric signatures of the cosmos such as approximately 5 or 16 months long (Figures 30A–30C, pp 111-112)34 and other cycles (Figures 31A–31C, pp 113-115).53,54 There are further cross-spectral coherences54,66–68 and phase synchronizations68 between endpoints around us, such as Bz, Kp, Wolf number, or coronal mass ejection or cosmic rays and urinary variables or the decades-long monitored BP of individuals. Associations are also seen from cross-wavelets and coherence between myocardial infarctions of populations or the incidence of terrorism on the one hand and space weather on the other hand (Figures 32A–32D, pp 115-117). We trust that with Figures 33 and and3434 (pp 118-119), among others, a chronouspherea emerges, consisting of many infradians with periods longer than 28 hours up to myriadennians.69,70 For some of the infra-dian pairs of periods, the disappearance or reappearance of the environmental (eg, solar) or interplanetary component entails corresponding biospheric consequences (Figures 34–36, pp 119-121).44,61,62 The approach by removal of a gland and replacement of its hormone started endocrinology and eventually chronobiology.71 Investigation seems indicated not only by mapping51,54,71–74 but also by the subtraction and/or addition approach44,75 (or preferably by the remove-and-replace approach implemented by the sun), notably for those in healthcare interested in the effects of space weather.34
In confronting congruent cycles in us and around us, the biospheric cycles when they are coded in our genes may reflect what goes on and went on outside us from the origins of living matter more reliably than the relatively recently recorded corresponding physical cycles. The dynamics of the cosmos almost certainly went on for a very long time and have left their mark in our makeup. We have just begun to scratch the surface of measurement. A record of polar lights and sunspots traces only a millennium or less; time series of sun-related, interplanetary, lunar, or geomagnetic variables cover a much shorter span; recordings by satellites of interplanetary, solar, and cosmic variables are still more recent. None of them, however, matches in density or length the dynamic information provided by cycles in living matter.
In this context, the cycles of the biosphere, mimicking those of the cosmos, constitute another novel way of dating and certainly serve to validate, as magnetometers or cosmometers, the relatively recent physical counterparts.52 This dating by mapping reveals a set of transdisciplinary cycles pervading all disciplines, each a sphere of the human mind (also Attic Greek nous) yielding a novel time structure. We can get much information about such a chronousphere by monitoring ourselves with repeated passes over the accumulating data as a whole (globally) and in sections of varying lengths (locally)—that is glocally in time and glocally in space, eventually from the womb to the tomb in the individual and in the population.
In the first issue of Global Advances in Health and Medicine, McCraty et al,76 and in another journal, McCraty and Childre,77 presented the Global Coherence Initiative aimed at a shift from “competition” to “greater cooperation” in a coherent planetary standing wave. The “increased power of connected intention and consciousness,” also a topic of interest in Michael Persinger’s78,79 and Hans Wendt’s80 research already explored at atomic and quantum81 levels, should all prompt attempts to seek better measures of coherence beyond those used herein from macroscopic physics and time series analysis. Perhaps the language of frequencies within them and far outside Schumann’s resonances is pertinent, that yielded Figure 23 and remove-and-replace approaches in arriving at Figures 24 to to2626 constitute a step in that direction.
It seems the more important to assess the status quo of information measured as tangible “coherence,” the topic of this paper. From this viewpoint, C-ABPM, while worth implementing for immediate health benefit, once it is aligned with physical environmental monitoring provides marker rhythm information concerning both environmental magnetism and other nonphotic factors competing with oscillations in the visible range.
The findings herein of a largely novel spectrum of transdisciplinary components—the chronosphere and its entry into the noösphere (ie, the chronousphere)—constitute a complement to work by a great many others.82–89 Most pertinent are Alexander Leonidovich Chizhevsky’s heliobiology and Vladimir Ivanovich Vernadsky’s even broader noösphere. Bernhard and Traute Düll,90 Harlan True Stetson,91 Alexander P. Dubrov,84 Frank A. Brown Jr,85 and Rutger Wever86 pioneered in the field, as did Sergei M. Chibisov87 and Tamara Breus,88 contributing a review of the status quo in Russia.89
Many tasks remain to reach two goals: (1) a miniaturized, unobtrusive, and ambulatorily functional C-ABPM device that is affordable to all and communicates with (2) an also automated, manned website providing analyses of several kinds of incoming data flows such as (a) physiological, to start with of BPs and HRs; (b) epidemiological, to start with of natality, morbidity, and mortality; and (c) sociological, to start with military, political, and criminological (time series). The feasibility of a device costing less than $100 has been demonstrated,92 as well as the ability of glocal analyses in space and time of all 3 kinds of time series (a, b, c) as steps in concept validation and feasibility demonstration.4,53 For the epidemiological data analyses, which should be ongoing as natality, morbidity, and mortality data accumulate, state health departments constitute a major hurdle: a few offer to sell these data or just refuse to provide them in the United States, as was the case in 45 of 48 states to which requests for data were sent. The time has come for realizing that replacing baselines for all statistics with mapped cycles is the mandate of the health department, of the World Health Organization and of the United Nations; analyses of epidemiological data are their job. Here, governmental action is required to place as a minimum the data into the public domain and as an optimum to have health departments realize the need for retrospective and ongoing analyses. The biggest hurdle, however, is the attitude of well-meaning teachers currently prevailing in medical schools, where the majority are unaware that continued reliance on a single BP measurement or a single 24-hour profile will leave many people who need treatment untreated, and equally regrettable, many people who may not need treatment will be treated. The proposition that it would be best to perhaps give an antihypertensive drug to everybody reaching a certain age is the best documentation of the fact that concern about “do no harm” is forgotten and the need to diagnose variability disorders leading to personal severe disease (such as stroke) and to other social disasters (such as crime or terrorism) or to natural cataclysms (such as earthquakes) is ignored. An alternative is available in the project on The BIOsphere and the COSmos, BIOCOS.
The BP cuff in the healthcare provider’s office must go for the moment to the homes of each individual. In the 1960s and 1970s, it seemed worthwhile to plead, as Frederic C. Bartter also did, for moving the BP cuff from the providers’ offices to everybody’s (including his own) office by day and home by night. This recommendation holds until a system of C-ABPM becomes affordably available to everybody. Bartter advocated this as head of the Hypertension-Endocrine Branch at the US National Institutes of Health (NIH) and later as head of the NIH’s Clinical Center. In 2012, self-measurements at home have detected an effect of the great earthquake in Japan, proving their value.48 They confirmed, if not the finding of antecedents30,47 at least the consequences of the same quake found on a small scale yet worldwide in a de facto validation test of an ongoing C-ABPM system, serving for cost-free analyses of self-surveillance data by all comers.
aDr Howard Levine, the late head of medical education at the New Britain (Connecticut) General Hospital and professor of medicine at the University of Connecticut, implemented self-measurements of blood pressure, heart rate, and other performance variables, including grip strength, around the clock from the time of a chronobiologic diagnosis of MESOR-hypertension until the end of his life from amyotrophic lateral sclerosis, his weakness notwithstanding.
bDr Bartter also self-measured BP around the clock from the time of diagnosis until a fatal stroke.
aHalberg et al wrote in 1997, “Even a single heartbeat, however faint, will rule in at least a glimmer of life. The taking of the pulse for only a second or two then provides valuable information as to the merits of further efforts in resuscitation. But if the pulse were routinely taken for only a second or so, a bradycardic athlete in the best of health might be presumed dead!”27
aFrom Greek chronos, time; Attic Greek nous, mind; and Greek sphairos, globe. We used nous in the portmanteau’d chronousphere to credit Vladimir Ivanovich Vernadsky, Pierre Teilhard de Chardin, and Edouard le Roy, who used the derivation of noosphere from noos, recognizing the need for a sphere of the human creative mind or broader culture, courageously extrapolating beyond the sphere of available data (criticized by Hagemeister M. In: Rosenthal BG, editor. The occult in russian and Soviet culture. Ithaca: Cornell University Press; 1997. p. 185-202, yet endorsed with extensive study by Ertel S. Stud Psychol. 1996;38:3-22). Cosmism’s pioneers as yet did not have the means (computers and satellites) for detecting and documenting the pervading transdisciplinary spectrum of solar, interplanetary, geopheric, and biospheric cycles and the consequences in the human mind of the aeolian disappearance and/or reappearance of nonphotic rhythms.
Franz Halberg, Franz Halberg, MD, Dr hc mult, is professor of laboratory medicine and Pathology at the Halberg Chronobiology Center at the University of Minnesota, Minneapolis.
Germaine Cornélissen, Germaine Cornélissen, PhD, is professor of integrative biology and physiology and director at the Halberg Chronobiology Center at the University of Minnesota, Minneapolis.
Dewayne Hillman, Dewayne Hillman, PhD, is a consultant at the Halberg Chronobiology Center at the University of Minnesota, Minneapolis.
Larry A. Beaty, Larry A. Beaty, BS, is the senior member of the Phoenix Study Group, composed of volunteering members of the Twin Cities chapter (Minneapolis) of the Institute of Electrical and Electronics Engineers.
Shiyu Hong, Shiyu Hong is a student of statistics at the Halberg Chronobiology Center at the University of Minnesota, Minneapolis.
Othild Schwartzkopff, Othild Schwartzkopff, MD, FAAP, is an assistant clinical professor of pediatrics at the Halberg Chronobiology Center at the University of Minnesota, Minneapolis.
Yoshihiko Watanabe, Yoshihiko Watanabe, MD, is an associate professor and cardiologist at Tokyo Women’s Medical University, Medical Center East, Japan.
Kuniaki Otsuka, Kuniaki Otsuka, MD, is a professor and hospital president at Tokyo Women’s Medical University, Medical Center East, Japan.
Jarmila Siegelova, Jarmila Siegelova, MD, is professor and head of the Department of Functional Physiology and Rehabilitation, St Anna Hospital, Masaryk University, Brno, Czech Republic.
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Accessed April 4, 2012
We report on the safety of non-insertive acupuncture (NIA) in 54 newborns diagnosed with neonatal abstinence syndrome (NAS) in a busy inner-city hospital.
For this case series, a retrospective chart review was conducted. Data on participant demographics, number of NIA treatments, provider referrals, and outcomes of interest (sleeping, feeding, and adverse events) were collected.
Of the 54 newborns receiving NIA, 86% were non-Hispanic white; 87% were on Medicaid, and gestational age ranged from 33.2 to 42.1 weeks. Out of 54 chart reviews, a total of 92 NIA sessions were documented ranging from 1 to 6 sessions per infant. Of the total number of treatments (n = 92), 73% were requested by a physician. Chart reviews reported that restless infants calmed down during NIA, babies slept through or fell asleep immediately following NIA, and better feeding was noted following NIA. There were no adverse events noted in the medical records.
This retrospective chart review shows potential for the use of NIA as an adjunctive treatment in newborns with NAS symptoms during hospitalization. More research is necessary to study whether the incorporation of NIA can result in positive outcomes in newborns withdrawing from narcotics.
目标：我们对患者较多的市中心 医院内被诊断患有初生儿脱瘾综 合征 (neonatal abstinence syndrome, NAS) 的 54 名初生儿 接受非插入式针刺疗法 (non-insertive acupuncture, NIA) 的安全性提出报告。
方法：对于此病案系列，执行回 顾性图表分析。收集与参与者的 人口统计、NIA 治疗次数、提供者 转诊介绍，及关注结果（睡眠、 进食和不良事件）有关的数据。
效果：接受 NIA 的 54 名初生儿 中，86% 是非西班牙裔白种 人；87% 接受医疗补助，孕龄从 33.2 至 42.1 周。在 54 次图表 分析中，共记录 92 次 NIA 疗 程，每名婴儿接受 1 次到 6 次 疗程的治疗。在总治疗次数中 (n = 92)，73% 由医生安排执行。图 表分析表明，烦躁的婴儿在接受 NIA 期间平静下来，婴儿入睡或 在接受 NIA 后立即入睡，并且接 受 NIA 后进食情况有所改善。病 历卡未记录不良事件。
结论：此回顾性图表分析说明 NIA 用作住院治疗期间出现 NAS 症状的初生儿的辅助治疗的可能 性。需要进行更多研究，以确定 使用 NIA 是否对中断使用麻醉药 的初生儿具有较好的疗效。
Informamos sobre la seguridad de la acupuntura sin inserción de agujas (non-insertive acupuncture, NIA) en 54 neonatos diagnosticados con síndrome de abstinencia neonatal (SAN) en un concurrido hospital urbano.
Para esta serie de casos, se realizó una revisión retrospectiva de las historias clínicas. Se recopilaron datos sobre las características demográficas de los participantes, el número de tratamientos con NIA, las derivaciones de los médicos y los resultados de interés (sueño, aliment-ación y acontecimientos adversos).
De los 54 neonatos que recibieron NIA, el 86 % eran blancos no hispanos; el 87 % estaban afiliados a Medicaid, y la edad gestacional estuvo comprendida entre las 33,2 y las 42,1 semanas. De las 54 revisiones de las historias clínicas, se documentaron un total de 92 sesiones de NIA, con un intervalo de entre 1 y 6 sesiones por recién nacido. Del número total de tratamientos (n = 92), el 73 % lo solicitó un médico. Según las revisiones de las historias clínicas, los lactantes inquietos se tranquilizaron durante la NIA, los bebés se durmieron durante o inmediatamente después de la NIA y se detectó una mejora de la alimentación tras la NIA. No se notificaron acontecimientos adversos en las historias clínicas.
Esta revisión retrospectiva de historias clínicas muestra el potencial de uso de la NIA como tratamiento complementario en neonatos con síntomas de SAN durante la hospitalización. Es necesario seguir investigando para estudiar si la incorporación de la NIA puede ofrecer resultados positivos para el retiro de narcóticos en neonatos.
A chart abstraction form was used to collect information on both mother and newborn, including demographics, sex of newborn, type of delivery, gestational age, birth weight, discharge weight, days of hospitalization, and feeding style. Information on number of NIA sessions, tolerance of NIA, and safety information came from chart notes that provided qualitative and quantitative data. These were documented by the acupuncturist following treatment. Data collection and analysis were conducted by a research assistant who received a list of newborns from the acupuncturists. Nursing and nutrition notes provided information about behavior and feeding patterns. This review was approved by the Institutional Review Board at BMC.
The records of 54 newborns were identified for the specified time period and were included in the data abstraction. There were 157 newborns diagnosed with NAS during the time period; however, NESA students rounded once per week, accounting for many newborns not receiving the NIA. Characteristics of the babies receiving NIA are listed in the Table. A total of 92 NIA treatments were documented. The number of NIA treatments on each baby ranged from 1 to 6 sessions and depended on the length of stay and acupuncturist availability. Thirty-one newborns received 1 NIA session, 13 received 2 NIA sessions, 7 received 3 sessions, 2 received 4 sessions, and 1 received 6 NIA sessions. Of the total number of treatments, 67 (73%) sessions documented the request of a physician; 2 (2%) sessions documented that the nursing staff requested NIA. Twenty-three (25%) sessions did not indicate who requested the session. In addition, 2 mothers inquired about NIA to hospital clinicians.
The average maternal age was 28.1 years; the range was between 19 and 43 years. More than half of all mothers identified as non-Hispanic white. The vast majority (81%) of mothers were from Massachusetts, primarily from Boston and nearby suburbs. Lastly, 87% of the mothers were on Medicaid assistance.
|Category||N = 54 (%)|
|Sex of newborn|
|Type of delivery|
|Gestational age (wk)|
|Median (range)||38.6 (33.2–42.1)|
|Birth weight (g)|
|Median (range)||2995 (1315–4195)|
|Days of hospitalization|
|Median (range)||20 (4–53)|
|Formula feeding||52 (96)|
|Not documented||2 (4)|
|Age of mother|
|Mean (Range)||28.1 (19–43)|
|Race of mother|
|Non-Hispanic white||46 (86)|
|Country of origin|
|United States, Massachusetts||44 (81)|
|United States, other states||5 (9)|
|Outside United States||2 (4)|
|Not specified||3 (6)|
|Not available||1 (2)|
Prescribed maternal medications included metha-done and subutex, both used for narcotic dependence, psychiatric medications (benzodiazepines), and bronchodilators. Nonprescribed drugs mothers used during pregnancy were heroin, cocaine, marijuana, and nicotine (cigarettes).
Chart reviews revealed no reported adverse events (eg, change in vitals, bruising, rash) as a result of the NIA treatments. There were 3 recurring themes found in the observations of the newborns following treatments. First, 28 records documented that babies slept through the treatment or fell asleep immediately after treatment. For those who were already sleeping, 1 record revealed a deeper sleep following NIA. Second, the relaxing effects of NIA were especially prominent in babies who were agitated prior to treatment. Thirteen sessions done on restless babies documented a noticeable release of tension during treatment. These charts previously noted that the babies were difficult to console and irritable. Lastly, in nursing and nutrition notes, 8 records revealed babies had better feedings following NIA and had higher caloric intake in the days following. For 1 baby, the treatment resulted in a cessation of hiccups. Two other records noted babies with slower, more even breathing during and immediately following the treatment.
Results suggest the feasibility of having this modality available to NAS babies; physicians, nurses, and other clinical staff readily made referrals. Because treatment was done at the bedside, took a short amount of time, and was seemingly acceptable to staff members and parents, it seems feasible to add NIA as an adjunctive treatment to usual care. Mothers who were approached by the acupuncturists also seem to find the method acceptable.
Babies presenting with NAS require specialized care focused on alleviating symptoms of withdrawal. Very little is known about the use of NIA in newborns with NAS. Our retrospective chart review is the first to report on the use of NIA in a busy inner-city hospital. We present data that needs further rigorous study to demonstrate the safety and efficacy of NIA with newborns with NAS. This chart review is the first step to developing a study of feasibility, acceptability, and safety of NIA.
Although the literature on the use of NIA in newborns is scant, there is another case report that documented acupuncture ear points in a newborn with NAS.14 The same authors also examined the use of auricular acupuncture in a sample of 5 newborns with NAS.15 Furthermore, a randomized trial studied the use of ear seeds to deliver acupressure to newborns with NAS.9
There are clinical data on acupressure combined with massage for newborns. Chen et al used massage with acupressure treatments in 40 premature infants.16 The benefit from this touch therapy was better digestion and increased weight gain. The goal was to influence nurses and parents to consider infant massage and acupressure treatments after discharge. Though the babies in this study were not diagnosed with NAS, prematurity is often observed in babies with NAS. In addition, poor gastric motility is a common observation in NAS. Newborn demographics revealed that the treatments were well tolerated by premature newborns and babies of small gestational age.
Restlessness, poor feeding, and irritability frequently are observed in babies going through drug withdrawal. In our chart review, we found that 8 records reported better feeding, 28 records documented that babies slept through or fell asleep after NIA, and 13 records revealed more relaxed babies after NIA. Similar results are reported in a randomized control trial that found that newborns with colic receiving acupuncture had shorter periods of crying and less fussing overall compared to controls.11 The demonstrated successful use of acupuncture for reducing irritability and as a digestive aid may present a plausible mechanism of action for NAS babies who often display hyperactivity and poor feeding. These studies are important in establishing the efficacy of acupuncture for neonates. More research is necessary to determine whether the incorporation of NIA can result in positive outcomes such as better sleeping, feeding, and, in turn, easier withdrawal from NAS.
During the NIA sessions, 2 parents inquired about NIA for the baby and several parents were taught the NIA points. Including parents in the treatment process has the potential to positively impact bonding, particularly since inability to console the newborn combined with insecurity about ability as a parent can inhibit the bonding process.17 Studies have shown that touch therapy has been useful in the clinical setting to encourage bonding between parent and newborn as well as to reduce time spent in hospitals.17 NIA also can incorporate nursing and medical staff members to provide additional support to parents and families and strengthen clinician-parent relationships and parent-newborn relationships.
Acupuncture has been shown to carry a low risk of adverse effects when used correctly in the clinical setting.18 The medical records of the newborns in this review did not reveal any signs of adverse effects. The literature estimates the rate of adverse events following acupuncture at 14/10 000 treatments for adults.19 A recent systematic review of acupuncture for children found that acupuncture is safe in a pediatric population when done by trained and licensed acupuncturists. Reported adverse events were minor, often resulting from poor delivery of acupuncture.20 Our chart review reveals the safety and feasibility of incorporating NIA into clinical practice for neonates. It is important to emphasize these facts to parents and providers who are considering using acupuncture for their newborns, as safety is a serious concern.
Costs for additional or extra treatments are always an issue. NESA students provided the NIA treatments during their rotation time in the pediatric unit so that there was no additional time or cost burden to the staff. Development of a protocol including NIA during hospitalization for NAS should include costs as well as determination of most efficacious dosage of the therapy.
There are several limitations in the findings of this case series. First, the information available in the medical record for each mother and baby varied in terms of detail of the NIA session and NAS symptoms. That our review did not reveal any adverse events related to the treatment does not eliminate the possibility of undocumented adverse events. Second, the acupuncturists were there only 1 day a week, therefore limiting access to NIA. Having an acupuncturist available 1 day per week resulted in some newborns being treated early in their hospital stay, while others who were hospitalized for an extended period of time may have received the treatment after a long duration of pharmacological interventions. Those who had longer lengths of stay had a greater chance of receiving the treatment more than once. In addition, although NAS scoring information was collected, there were missing data on the scores and inconsistency in reporting scores. The main goal of pharmacological therapy is to reduce the symptoms and subsequent scoring. It is unclear what role the NIA played in reducing the symptoms because the babies were on medications while receiving NIA. Clinicians hope that scores decrease with each day of life, but some charts noted a difficult day for the newborn, resulting in higher scores. Records of many of the babies receiving NIA noted decreased scoring between the day before treatment and the day after, but this could be due to a combination of pharmacological management and NIA. More research is needed to assess how NIA impacts NAS scoring.
Future research includes a prospective case control series to address potential limitations such as sample size and confounders. A larger randomized controlled study might also enable deeper exploration into variables such as a length of stay, potential cost savings, and birth weight. Future studies might examine whether mother-delivered NIA could be a facilitator of mother-newborn bonding.
Findings from this study provide preliminary data supporting the need for future research on the efficacy and safety of NIA in the newborn population. The feasibility of NIA in healthcare settings depends on the patient population served. In areas with a high prevalence of drug use, the availability of NIA for the newborn population exposed to drugs in utero could enhance the care delivered to these patients long term. By recognizing the enriching capacity of NIA for the newborn population with NAS, healthcare providers can continue to improve the specialized care these patients need.
Dr Gardiner is the recipient of an NIH K K07 AT00546301A1 grant.
Amanda C. Filippelli, Amanda C. Filippelli, MA, MPH, is a research assistant in the Department of Family Medicine, Boston Medical Center, Massachusetts.
Laura F. White, Laura F. White, PhD, is an associate professor in the Department of Biostatistics, Boston University School of Public Health.
Lisa W. Spellman, Lisa W. Spellman, LAc, is an adjunct clinical instructor in the Department of Family Medicine, Boston Medical Center, and an instructor in the New England School of Acupuncture, Newton, Massachusetts.
Maria Broderick, Maria Broderick, EdD, LAc, is a clinical faculty member at the New England School of Acupuncture.
Ellen Silver Highfield, Ellen Silver Highfield, LAc, is an assistant professor in the Department of Family Medicine, Boston Medical Center.
Elizabeth Sommers, Elizabeth Sommers, PhD, MPH, LAc, is the director of Research and Education at Pathways to Wellness/AIDS Care Project, Boston, and a faculty member in the Department of Health Policy and Management, Boston University School of Public Health.
Paula Gardiner, Paula Gardiner MD, MPH, is an assistant professor in the Department of Family Medicine, Boston Medical Center.
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Strong international mobilization and political will drove a golden decade for global health. Key initiatives over the last decade include setting of health-related Millennium Development Goals; the Commission on Macroeconomics and Health; the creation of the Global Fund to Fight AIDS, Tuberculosis and Malaria; the Doha Declaration on the TRIPS Agreement and Public Health affirming countries’ rights to protect public health when implementing patent rules; and the creation of product development partnerships to address neglected areas of research and development. Significant progress was made in reducing the incidence of and morbidity and mortality from human immunodeficiency virus (HIV), tuberculosis (TB), and malaria, with a major impact made through increased access to medicines. Antiretroviral treatment for HIV was expanded to 6.6 million people, and medication prices were reduced significantly through generic competition. However, donor support has started to decline at a time when many patients still wait for treatment and the prices of needed newer medicines are on the increase due to patent protection. TB incidence has started to decrease, but progress in diagnosis and treatment of multi-drug-resistant TB has been slow due to complexity of treatment and high drug costs. Promising new TB drugs in development need to be introduced rapidly and appropriately while treatment is being expanded. The introduction of more affordable artemisinin combination therapies for malaria contributed to significantly reducing malaria incidence and mortality, but challenges remain in ensuring that the latest recommendations for treating severe malaria are implemented. Looking to the next decade, there is a worrisome mismatch between additional health priorities accompanied by shifting burdens of disease that need to be addressed and dwindling political attention and financial support. Difficulties in producing and guaranteeing access to affordable medicines are expected from a changing pharmaceutical market where an appropriate balance between trade and health has not been found. Systematic changes through a global framework for research and development and access are needed to support increased innovation and access to the health tools of the next decade.
大的国际动员和政治引导，将催 生出全球健康事业的一个黄金十 年。在过去的十年中，主要的初 步行动包括设立联合国千年发展 目标；建立宏观经济学和卫生委 员会；创建抗击艾滋病、肺结核 与疟疾全球基金；TRIPS协定多哈 宣言，确认在保护专利实施细则 时，保护公共健康的国家权力； 以及建立产品开发合作关系，促 进被忽视的研发领域的发展。通 过提高药物供应水平，在降低 HIV、肺结核和疟疾的发病率和死 亡率方面取得了显著进展。HIV抗 逆转录病毒疗法已经覆盖了660万 人，并且通过非专利药品竞争， 使得医疗价格显著降低。然而， 随着更多的患者需要治疗，且患 者所需的新药价格由于专利保护 而上涨，捐赠者支持力度开始下 降。肺结核的发病率已经开始下 降，然而多药抗药性肺结核的诊 断和治疗进展缓慢，其原因是治 疗的复杂性和较高的药物花费。 当前，随着治疗范围的扩大，需 要在恰当时机迅速引入的新药物 正在研发之中。青蒿素组合治疗 是一种更廉价的疗法，该疗法的 引入显著降低了疟疾的发病率和 死亡率，但是在保证实施最新的 治疗严重性疟疾的卫生计划方针 方面，仍面临挑战。展望下一个 十年，我们看到一个令人担忧的 情况，那就是伴随着疾病负担转 移的附加卫生工作重点，与政策 注意力和资金支持减弱之间的矛 盾。随着药物市场的变化，可以 预见到在生产和保证廉价药物供 应方面的困难，当前的市场贸易 和卫生状况之间尚未建立起恰当 的平衡。全球框架内药物研发和 供应的系统变化，需要支持增加 创新的要求，并为下一个十年提 供健康工具。
Una sólida movilización internacional y política generará una década dorada para la salud mundial. Las iniciativas fundamentales de la última década incluyen la propuesta de Objetivos de Desarrollo del Milenio relacionados con la salud; la Comisión sobre Macroeconomía y Salud; la creación de un Fondo mun-dial de lucha contra el SIDA, la tuberculosis y la malaria; la Declaración de Doha relativa al acuerdo sobre los ADPIC y la salud pública, en el que se reconocen los derechos de los países de proteger la salud pública cuando se implementen las leyes de patentes; y la creación de asociaciones para el desarrollo de productos con el fin de tratar las áreas descuidadas de investigación y desarrollo. Se logró un progreso importante en la reducción del índice de mortalidad causada por el VIH y su incidencia, la tuberculosis (TB) y la malaria, debido al aumento de las posibilidades de acceso a los medicamentos para tratar estas enfermedades. El tratamiento antirretroviral para el VIH fue tornó más accesible y benefició a 6,6 millones de personas. Además, los precios de los medicamentos se redujeron en forma significativa a raíz de la competencia con los genéricos. Sin embargo, el apoyo de los donantes comenzó a disminuir en el momento en que los pacientes más necesitan el tratamiento y los precios de los nuevos medicamentos están en aumento a causa de la protección de patentes. La incidencia de la TB comenzó a disminuir, aunque el progreso en el diagnóstico y el tratamiento de pacientes con cepas de TB resistentes a una variedad de fármacos ha sido lento debido a la complejidad del mismo y al alto costo de los fármacos. Se están desarrollando nuevos fármacos con efectos prometedores que deben ser introducidos con rapidez, pero de manera adecuada, mientras se amplía el tratamien-to. La introducción de terapias combinadas a base de artemisinina más asequibles para tratar la malaria contribuyó en la reducción significativa de la incidencia y tasa de mortalidad de esta enfermedad; no obstante, el desafío sigue siendo garantizar que se implementen las últimas recomendaciones para el tratamiento de la malaria grave. Para la próxima década, se prevé un desajuste preocupante entre las prioridades adicionales en materia de salud, así como un costo variable de la enfermedad que se debe tratar y la atención política y apoyo económico cada vez más escasos. Se prevén dificultades para producir y garantizar el acceso a medicamentos asequibles en un mercado farmacéutico cambiante, en el que se no se ha podido encontrar un equilibrio adecuado entre el comercio y la salud. Es necesario hacer cambios sistemáticos a partir de un marco global para la investigación, el desarrollo y el acceso a los medicamentos para sustentar la cantidad de innovaciones cada vez más alta y el acceso a las herramientas de salud de la próxima década.
Thirty-four million people are living with HIV today, more than ever before. But during the last decades, new infections were reduced from 3.1 to 2.7 million and AIDS deaths from 2 to 1.8 million per year.13
Ten years ago, just a few thousand patients were on antiretroviral treatment (ART) in developing countries, a number that has now reached more than 6.6 million.13 Though this is a major achievement that seemed unthinkable 10 years ago, it still means that only half of those in need today have access to treatment.
A decade ago, ART was considered too expensive and too complex for developing countries. The considerable decrease in the price of HIV medicines driven by generic competition—from %10 000 per patient per year a decade ago to %61 today14—the simplification of drug regimens and monitoring needs, and the elaboration of strategies to simplify treatment provision and overcome human resources shortages by shifting medical tasks away from doctors to other healthcare workers were all key to breaking the deadlock. Civil society mobilization played an essential role in each of these aspects.15
Substantial international political commitment and funding was necessary as countries suffering from the world’s highest burden of HIV could not have afforded the resources necessary to drive an appropriate response alone. The GFATM is widely recognized as one of two main funding mechanisms that have helped countries to increase prevention of HIV, TB, and malaria and expand treatment of and care for people with those diseases and is an example of what can be achieved through international solidarity with a clear focus on patients. GFATM ensured ART for 3.3 million people by the end of 2011 alone and aims to support 7.3 million by 2016.16 The US President’s Emergency Plan for AIDS Relief, launched in 2003, is the second important pillar of international support to AIDS prevention and treatment, supporting 3.9 million people on ART by the end of September 2011 and with a new target of 6 million people on treatment by the end of 2013.17
Until now, GFATM has been unique in adopting a “demand-driven” approach that relies on mobilizing sufficient resources to support all reasonable proposals for funding from affected countries. Proposals prepared at country level by Country Coordinating Mechanisms bringing together representatives from government, aid agencies, and non-governmental organizations, and people living with the diseases have promoted local ownership and participatory decision making in determining needs and overseeing implementation. Yet despite an impressive track record, the GFATM faces significant financial shortfalls, forcing it to cancel for the first time in its 10-year history its annual funding round.17 Affected countries now effectively have no new funding opportunities until 2014. Though a transition mechanism is being put in place to prevent interruption of programs, the funding crisis will significantly slow the expansion of life-saving treatment for the 3 diseases. It will also make it hard to make important improvements in the quality of care through, for example, earlier initiation of ART and better treatment regimens and monitoring.
Decreased financial support for global health in general, and HIV/AIDS in particular, occurs despite political commitments to have 15 million people on treatment by 201519 and at a time when there is evidence that the epidemic can be reversed. A landmark study in 2011 showed that ART not only reduces mortality and morbidity but also can substantially reduce HIV transmission.20 This makes ART provision the most effective biomedical prevention tool for HIV/AIDS we currently have21 and means that scaling up ART access makes good financial sense as well.22
With funding for AIDS decreasing,13 ensuring that medicines remain affordable is as important as ever. But all key generic-producing countries including India (which supplies more than 80% of ARVs in developing countries23), China, and Brazil protect patents, so generic production of new medicines generally is blocked.
Newer ARVs, such as raltegravir and etravirine, to which patients will eventually need to switch, exist only as originator products and cost (US)%675 and (US)%913 per year, respectively (to which the price of 2 or more other drugs need to be added to form a complete treatment regimen).14 Unless these prices are reduced, treatment providers are effectively facing a treatment time bomb, as more and more patients will need to be switched to more expensive regimens.24
For most of the past decade, AIDS has been fuel-ling the TB epidemic in Africa, and TB remains the second leading cause of death from an infectious disease after HIV, with up to 1.5 million deaths per year. Progress in bringing TB under control has been slow, and global TB incidence only started decreasing modestly in 2006.25
The GFATM has played an important role, having funded 8.6 million TB treatments since its inception and providing about %0.5 billion per year, mainly to the poorest countries. With an affordable treatment regimen and the biggest health burden in some of the emerging economies like China and India, TB control may at first sight seem less vulnerable to dwindling international support than HIV, with 86% of financing coming from the high-burden countries themselves.25
Yet countries are struggling with the growing and costly challenge of multidrug-resistant (MDR) and extensively drug-resistant TB,26 as the usefulness of the WHO-recommended 6-month treatment regimen becomes increasingly limited. The number of MDR-TB cases is growing every year in Eastern Europe, Central Asia, and Africa, with Belarus currently topping the list with 26% of new TB cases and 60% of retreatment cases being MDR-TB.25
Considerable efforts by civil society organizations helped make MDR-TB a public health priority. As with HIV, it required challenging notions that MDR-TB was untreatable in resource-limited settings and that it would divert attention and resources from treating drug-susceptible TB.27 Although MDR-TB is now an international priority with an agreed-upon global plan to universal access to treatment,28 too little practical progress has been made over the last decade. Only 46 000 people are diagnosed and treated out of an estimated 440 000 new cases every year.25
The cost of second-line drugs remains high at around %4500 on average per patient. Currently, the DR-TB drug market is too small and fragmented and barely attracts manufacturers. Price reductions from economies of scale will be realized only when more patients are put on treatment, but the vicious circle of high costs dissuading countries from addressing MDRTB—meaning limited patient numbers keep prices high—needs to be overcome.29
The complexity of treatment is an additional barrier to scale up. Diagnosis is complex and expensive and even in high-prevalence settings is not yet routinely offered. A new automated molecular test offers a much faster diagnosis but costs %17 per test. In addition, to obtain an individualized picture of drug resistance and determine treatment options, full culture and drug sensitivity testing are still required.30 MDR-TB treatment lasts for 18 to 24 months and is highly complex, with drugs inducing many side effects. As a result, treatment outcomes are poor (around 60% treatment success) and defaulter rates high.31 Nevertheless, it has been demonstrated that good outcomes can be achieved in resource-limited settings supported by clinical or community-based models.32,33 Despite the difficulties, treatment expansion is feasible.
But the financial situation of the GFATM is threatening initiatives to expand treatment for MDR-TB. Some high-burden countries that finally recognize the severity of the problem may be able to finance at least part of the response with their own resources: India, which produces a quarter of the world’s MDR-TB cases, plans to diagnose and treat 30 000 new patients per year by 2014.
Improving the treatment regimen to make it more efficacious, of shorter duration, and more affordable will be an essential part of the path toward rapid and large expansion of MDR-TB treatment. Though the problem of drug resistance has been driven by irrational drug use and prescribing, with over-the-counter availability of TB drugs in many countries (which remains unaddressed), it also has been a predictable crisis, as no new TB drugs have reached the market since the 1960s.
Three PDPs were founded to address the research gaps in TB: the Global Alliance for TB drug development, the Foundation for Innovative New Diagnostics, and Aeras, for vaccines. In addition, some drug companies have restarted limited investment into TB drug development, often as a goodwill gesture. After decades of inactivity, there is again a pipeline of TB drugs in development, although this pipeline is not nearly as robust as those for more profitable diseases.12
Two new drugs, bedaquiline and delamanid, are the most advanced in clinical development. Both are being tested in MDR-TB patients, and approval by the US Food and Drug Administration is expected as early as 2012. However, additional studies will be needed not only to add these drugs to existing regimens but also to determine if a better and shorter regimen for MDR-TB can be defined, removing at least some of the old drugs. There is so far insufficient interest in and funding for such studies and few research sites with adequate capacity to carry them out.
Market introduction of the new drugs is another challenge: they should be available to all those in need but only through appropriate programs and adequately skilled health workers in order to avoid the rapid development of resistance. Price should not be a barrier and should not be used as a way to restrict use.
Ultimately, a completely new regimen, effective against both current drug-sensitive and drug-resistant TB, is needed. This still is some way off, at least for a universal regimen that will not require sophisticated tests before treatment can be started.
Progress in malaria control over the past decade has been significant. Global malaria incidence decreased by 17% and malaria-specific mortality by 26% since 2000. Yet malaria still takes a heavy toll, with an estimated 216 million episodes of malaria and 655 000 deaths occurring in 2010. Of these, 91%were in Africa, and 86% of global malaria deaths were in children under 5 years of age.34 More recent estimates suggest that the disease burden is even higher, putting the number of deaths from malaria in 2010 at 1.24 million.35
Three tools were the essential ingredients of progress during the past decade: artemisinin-based combination therapies (ACTs), impregnated bednets (including long-lasting insecticide-treated nets), and malaria rapid diagnostic tests (RDTs), which enable the confirmation of malaria even in the most remote areas where microscopy is not available.36
Artemisinin, a natural compound of Artemisia annua, an herb described as “a true gift from old Chinese medicine,” has been used as a traditional treatment for malaria and fever for more than 2 millennia and became more widely recognized and studied in the 1960s to 1990s.37 WHO first stated that ACTs should be introduced in 2001, after studies had long shown widespread and high-level resistance to the older drugs and in particular choloroquine, which has been in use since the 1940s.38 It took repeated, often redundant resistance studies in many countries and much mobilization over the following years to convince African governments to change national protocols.39
From the beginning, with ACTs being considerably more expensive than older, increasingly ineffective treatments such as chloroquine and sulfadoxine-pyrimethamine, cost was a major barrier. With international funding necessary for their large-scale introduction, the GFATM became the main funding source, supporting 230 million malaria treatments to date. Since 2005, the US President’s Malaria Initiative (PMI) has acted as a second pillar of international support to malaria control.
In parallel, important price reductions were achieved thanks to generic competition. In 2001, WHO negotiated an agreement with Novartis (Basel, Switzerland), the manufacturer of one of the main ACT treatments, to lower the cost the company was charging the public sector from %4 to %2.40 per adult treatment. The company at the time claimed that %2.40 was its cost, implying it could go no lower. But competition from multiple producers has since lowered the price to under %1, illustrating again how market competition acts as a greater catalyst to price reductions than negotiated discounts with pharmaceutical companies.40
Reducing the price of ACTs until they reach a level similar to the average chloroquine price of less than %0.10 will not be feasible, as the production of the raw material through plant extraction is too costly. A semisynthetic artemisinin will reach the market in 2012 but with limited production capacity and only modest cost advantages initially.41
A scheme was developed in 2004 to subsidize the cost of ACTs in order to make the medicines more affordable in the private sector. This concept is currently being piloted through the Affordable Medicine Facility— malaria (AMFm) in 7 countries, starting in 2011.42 Many questions remain about the scheme. Mark-ups by middlemen add significantly to the end price, and some question whether scarce donor money shouldn’t be used to expand access to free care through the public sector rather than subsidizing the private sector, particularly given the funding crisis currently affecting global health. The AMFm got off to a troubled start as it allowed orders from wholesalers to increase so rapidly that they disrupted the global raw material market, contributing to a tripling of the raw material price in 2011.43
More recently, WHO also has changed its recommendations to countries for the treatment of severe malaria—from quinine injections to injectable artesunate. Severe malaria occurs less frequently than uncomplicated malaria but is often fatal. Injectable artesunate is safer and easier to use, and it reduces mortality by 39% in adults and 24% in children, compared to quinine.44 It is also more expensive, but a global treatment switch would only cost an additional %31.8 million per year—a small investment within the billion dollar budgets of the GFATM and PMI even in the current financial climate.45
After initial difficulties, the uptake of ACTs has been encouraging in the last 5 years, with annual sales of ACTs approximately matching the annual number of malaria cases. But the concern remains that malaria treatments are still widely used based on fever symptoms alone. As diagnosis is not always confirmed through microscopy or the use of RDTs, there is significant overtreatment. An increased use of RDTs to confirm malaria diagnosis is needed as is now recommended by WHO.46
The emergence of drug resistance is a threat because of the continued availability of artesunate monotherapy, low-quality drugs and potentially because of overuse (as with chloroquine previously). Suspected resistance to artemisinin has now been identified in 4 countries in Southeast Asia.34 It would be a tragedy to lose “the gift of Chinese medicine” within a couple of decades of WHO’s recommending its introduction and after it has been used for millennia.
It will also be very hard to replace. Malaria drug research has been revived through the product development partnership’s Medicines for Malaria Venture, but most of the drugs in the pipeline are artemisinin-like molecules, and a different drug class is at least 5 years away.
Ambitious targets have been set to eliminate malaria in a range of countries.36 This may be feasible in all but the countries with the highest transmission rates. It seems more urgent, therefore, to control malaria and reduce deaths in the 42 countries in Africa that are not ready yet for elimination.
LOOKING TO THE NEXT DECADE
The past decade has been a golden decade for global health, driven by strong international mobilization and political will to address priority health problems of the poorest. It has resulted in significant progress in expanding access to treatment and reducing mortality from and incidence of the main infectious diseases. Nevertheless, major needs remain, including those outlined below.
Competing Health Priorities
The “vertical” approach to HIV, TB, and malaria is criticized by some as a distraction from the need to support health systems more broadly or by those who contend that the scope of the GFATM should be expanded; for example, to finance the health-related Millennium Development Goals.47,48 Other health challenges such as mother and child health received comparatively less investment. However, one of the strengths of the GFATM has been its clear focus on patients and its prioritization of 3 diseases. Whatever approach is adopted as a means to address a broader set of health priorities in an integrated way, it will need to build on, and not backpedal on, the progress being made for major infectious diseases.
Shifting Burdens of Disease
Additional health challenges have increased in importance during the past decade: many developing countries now face the double burden of infectious diseases and noncommunicable diseases. Addressing noncommunicable diseases will require both a focus on prevention and basic interventions but also the access to treatment for complex diseases including cancers. Policy discussions have so far only focused on the first; lessons need to be learned from HIV, another chronic disease, from the past decade.49
Dwindling Political Attention and Financial Shortfalls
Current financing is insufficient to even adequately address HIV, TB, and malaria, and there is a risk of backtracking on progress. International funding for global health has become more difficult to mobilize, and the time of large financial commitments made at annual G8 meetings is over. The financial crisis has made the leading economies more inward looking. Affected countries need to increase their investment in health, but the need for global solidarity will not go away. Major emerging countries like Brazil, Russia, India, China, and South Africa (collectively called the “BRICS”) do not appear ready to become significant international donors. The health challenges in BRICS countries are significant, and they are only just being weaned off international donor support. Least-developed countries have exceeded in total health expenditure the recommendations of the Macroeconomics and Health Commission (personal communication with Dr David Evans, World Health Organization, December 16, 2011). Significant additional and predictable funding for global health solidarity is therefore needed. An example of how innovative financing can benefit health already exists: a tax on airline tickets implemented by France and a number of other countries generates revenues that flow to UNITAID, a multilateral organization that funds medicines and diagnostics for HIV, TB, and malaria.50 Additional resources could be generated by creating a financial transaction tax (FTT), such as the one currently being debated in Europe, and dedicating a portion of the proceeds to healthcare.51 As the idea of a Eurozone FTT becomes a firmer political possibility, no leaders have yet committed a portion of the expected revenue to support global health.
Increasing Difficulties in Producing and Providing Access to Affordable Medicines
Increased intellectual property protection that prevents production of newer medicines in key generic-producing countries such as India, Brazil, and China will continue to be fiercely debated in the coming decade. In the future, it should be assumed that all new medicines that are true innovations (and not minor modifications to existing drugs) will be widely patented.
The need to ensure affordability will require political will to enforce strict patentability criteria, allow for patent opposition, routinely issue compulsory licenses, and resist pressure by rich countries to further increase monopoly protections. Although the Doha Declaration continues to play an important role, it is increasingly being eroded. Under international trade regulations, countries are free to determine patentability criteria or to issue compulsory licenses to overcome patents, but few countries have implemented these flexibilities into national legislation, and fewer still have made use of them—with the notable exception of India, Thailand and Brazil.52 This is a reflection of the considerable political pressure from industry and rich countries not to use them.
A better balance between health and trade is needed as the importance of reining in drug costs becomes ever more acute. Increasingly, use of these flexibilities has been constrained through bilateral trade agreements. Both the European Union–India Free Trade Agreement and the European Free Trade Association-India deal currently being negotiated pose a threat to access to medicines by introducing, for example, intellectual property enforcement measures. The United States is negotiating the Transpacific Partnership Agreement with a number of Asian and Latin American countries, which it considers the blueprint for future US-led free trade agreements where significant threats to access to medicines exist.53
The overall trend is that a system of affordable medicine production for resource-limited countries is continuously eroding and nothing adequate is being proposed to replace it. Though health groups have been fighting a defensive battle to maintain the possibility of generic production for as long as possible, it may now be time to call for revision of the TRIPS Agreement itself to ensure that it is consistent with access to medicine as a key aspect of the right to health.
Evolving Strategies From Drug Companies
Pharmaceutical companies continue to affirm that concerns around the price of medicines can be resolved through tiered pricing policies—where developing countries are offered price discounts, with the least-developed countries paying the least. There is evidence, however, that lower-middle income countries are squeezed out of standardized price discounts and face increasing prices.23 While tiered pricing reduces the cost burden, it is in most cases significantly less efficient than generic competition in reducing prices.54
Some patent-holding pharmaceutical companies have entered into voluntary license agreements to authorize generic manufacturers to produce generic versions of their medications. The terms of such licenses are typically secret and have many restrictions, on geographical scope in particular. Voluntary licenses can be part of the solution if they are used in a way that responds to medical needs, as pioneered by the recently created Medicines Patent Pool.10 Experience with voluntary licenses to date is that companies will need to be under greater pressure before they allow access in all countries; the inherent limitation lies in the voluntary nature of this approach.
In addition, the decade ahead will see changes in the pharmaceutical industry—including Indian generic companies being bought by multinational companies and generic companies entering into research and development—that are of concern for the future capacity of generic competition for newer drugs. Profit expectations on one hand and access challenges on the other for noncommunicable diseases will likely crystallize the fight for access to medicines.
A Global Framework for Research and Development
A decade after the establishment of PDPs, there is today a range of products in the pipeline that can be expected to reach patients in the coming years. This is significant progress. But at the same time, PDPs are only a very limited effort to address large research and development needs not comparable to investments made into more profitable areas like cardiovascular diseases or even hepatitis C. The TB Alliance’s goal to develop a completely new treatment regimen that works for all TB patients, for example, remains many years away. Beyond HIV, TB, and malaria and certain neglected tropical diseases, significant innovation needs remain unaddressed. The PDPs also face considerable funding challenges, with public funding having decreased since onset of the financial crises and philanthropic funding, on which the PDPs are still heavily dependent, not being easily expanded.55
Intense policy discussions have taken place at the intergovernmental level during the past decade recognizing that more systematic changes to the current research and development system are needed to ensure that research and development is driven toward major public health needs and the specific requirements of resource-limited settings and that its fruits are affordable.56,57 A key concept that has emerged is a need to separate the cost of research and development from the price of products. This means that research and development should be funded with grants or innovation rewards (or prizes)58 rather than relying on high prices protected by drug monopolies to recoup investments made into medical research and drug development. This separation would allow research and development to be steered toward areas of greatest medical need, and not only as in the current patent-driven model, toward areas of high commercial return. At the same time, such an approach would overcome the problem of high product prices that leads to the exclusion of patients who cannot afford them.
A WHO Consultative Expert Working Group on Research and Development: Financing and Coordination has further examined the available options and recommends to the World Health Assembly in May 2012 to start negotiation of a research and development convention as a binding legal instrument to ensure adequate funding toward agreed health priorities and access to the fruits of this research.59
This is the type of long-term solution that countries need to support to ensure that future innovation is driven in a way that it meets health needs, products are priced affordably, and the access to medicine struggles of the past decade are not condemned to be repeated.
Tido von Schoen-Angerer, Tido von Schoen-Angerer, MD, MSc, is the executive director of the Médecins Sans Frontières Access Campaign, Geneva, Switzerland.
Nathan Ford, Nathan Ford, PhD, MPH, is the medical coordinator of the Médecins Sans Frontières Access Campaign and a research associate at the Centre for Infectious Disease Epidemiology and Research, University of Cape Town, South Africa.
James Arkinstall, James Arkinstall, MA, is the head of communications at the Médecins Sans Frontières Access Campaign.
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Chronically ill people are frequent users of complementary and alternative medicine (CAM). Some patients experience great benefits from their use of CAM, like patient “XX” in this case report. XX was diagnosed with secondary progressive multiple sclerosis in 2004 and has reported a “best case” after the use of Dr Birgitta Brunes’ unconventional treatment. The patient reports that many of her symptoms that, according to her neurologist, were irreversible are gone or have been greatly reduced. Such patient-defined “best cases” related to the use of CAM should be further explored to optimize and safeguard patients’ treatment decisions and treatment outcomes.
性硬化症，而在接受Birgi t t a
Las personas que padecen enfermedades crónicas son usuarios frecuentes de la medicina complementaria y alternativa (CMA, por sus siglas en inglés). Algunos pacientes experimentan grandes beneficios a partir del uso de CAM, como es el caso de la paciente “XX” que se analiza en este caso clínico. Dicha paciente fue diagnosticada con esclerosis múltiple secundaria progresiva en el año 2004 y fue registrada como el “mejor caso”, luego de recibir el tratamiento no convencional de la Dra. Birgitta Brunes. La paciente reconoció que muchos de sus síntomas, que según su neurólogo eran irreversibles, desaparecieron o se redujeron en gran medida. Dicha paciente, catalogada como el “mejor caso” relacionado con el uso de CAM, debe ser sujeta a análisis más profundos para optimizar y resguardar las decisiones que toman los pacientes sobre el tratamiento y los resultados del mismo.
THE REGISTRY OF EXCEPTIONAL COURSES OF DISEASE
This case report was selected from the Registry of Exceptional Courses of Disease (hereafter referred to as “the Registry”). The Registry includes Scandinavian patient-defined, self-reported positive and negative exceptional courses of disease related to the use of CAM. To be included, the patients must have or have had a disease or health problem, must have experienced what they perceive to be exceptionally positive or exceptionally negative health effects, and must relate these health effects to the use of CAM. In a “best case,” the patient experiences reduced disease symptoms or full recovery.a,11–13
As of October 1, 2011, 72 patients diagnosed with MS were included in the Registry, all reporting “best cases.” Acupuncture, nutritional therapy, reflexology, herbs and food supplements, homeopathy, massage/aromatherapy, and spiritual healing were the most frequently used CAM modalities among these patients.
Context and Goal
We here present a self-defined “best case” of MS. The presentation is based on the Registry questionnaire, medical records, a medical assessment, and an in-depth interview. The goal is to describe a patient-defined “exceptionally positive” course of MS as seen from both a patient and medical perspective.
Medical, Social, and Family History
“XX” is a 46-year-old married Norwegian woman with several children. She is a university graduate who had been working full time for some time after being diagnosed but is now on a 100%-disability pension. Approximately 28 years ago, she had a facial paralysis on her right side from which she fully recovered after 1 to 2 months. About 15 years ago, she experienced 2 episodes of herpes zoster (shingles). She has otherwise been healthy. Several of XX’s close relatives also have been diagnosed with MS.
When she was in her 20s, XX was diagnosed with probable MS but was not herself informed of the diagnosis. A few years later, she experienced partial loss of sensation in her legs and was finally officially diagnosed with secondary progressive MS at the age of 41 years. Her main symptoms were fatigue, problems with leg coordination after experiencing strain for some time, periodical memory problems, and urge-characterized urination. Subsequently, XX experienced severe fatigue and reduced sensation in her feet, legs, and fingers. She even found brushing her teeth exhausting. She continued to have problems holding and emptying the bladder and also experienced depression.
No conventional treatment was provided by doctors within the conventional healthcare system. Within a year after being diagnosed, XX discovered the treatment given by Birgitta Brunes (BB), MD, and decided to participate in one of BB’s courses.
BB is a Swedish medical doctor who herself suffers from MS and who has worked with treatment and rehabilitation of MS patients since 1994. She has developed a systematic approach to symptom alleviation, which she presented in a book14 published in the Scandinavian countries. With her colleagues, she gives courses for MS patients that usually last 4 days and focus on psychological factors (emotions, stress, etc), social factors, and medical treatment. These elements are combined in a treatment plan individually adapted for each patient.
BB does not consider her treatment as CAM per se.15 Her theory is based on conventional medical knowledge and practical experience from many years of working as a general practitioner. The treatment is only considered alternative in relation to the prevailing medical understanding of the cause and treatment of MS. The intention is not to heal MS but to alleviate MS symptoms.
The treatment rests on 3 pillars:
Neurotransmitters (noradrenaline, dopamine, acetylcholine, serotonin), vitamin B12, and amino acids adjusted according to individual need;
Psychotherapeutic treatment of basic psychological traits.
XX’s Individualized Treatment
Use and Adjustment of Medication and Supplements. After careful self-testing, XX has found the suitable dosage for the different medications, and she is making necessary adjustments as time passes. Her current intake of medication and supplements include lofepramine (a tricyclic antidepressant) plus tablets containing norepinephrine to prevent urge incontinence. She asserts that these drugs also give her energy. She also takes acetylcholine and anticholinesterase in addition to phosphatidylcholine and lecithin from the health food store, which she contends create “heat” and help her empty the bladder and intestines. The intake of serotonin tablets and 5-hydroxytryptophan (5-HTP) from the health food store help her keep a brighter outlook on life and to be positive, sleep well, and not worry about the future and her illness. At the same time, she takes specially adapted amino acids for MS patients that attend to the muscles while she is not using them.
Detoxification. XX had her 8 amalgam fillings removed over a period of 2 years. To be able to tolerate the discomfort related to the removal of the fillings, she took large doses of cortisone for 3 weeks each time.
Psychotherapeutic Treatment. For almost 4 years, XX has rested systematically. Meditation and rest in the form of mental control and relaxation have been important. This has gradually helped her get better because according to her, “the body has economized on the neurotransmitters which the nerves are supposed to bring to the muscles.” XX did not want to stop working, even though she understood that the job drained her of the little energy she had. The realization that she had to spend all her energy on herself in order to have a chance of getting better has been very important for her. Now she spends most of her time with her family. She is able to make herself and her own health a priority without feeling guilty.
Other Measures. In consultation with BB, XX has changed her diet according to advice from the MS center at a Norwegian hospital. She first omitted red meat, fat, and dairy products and later omitted sugar and yeast, artificial sweeteners, and natural sugars.
MS and cancer cases in the Registry are assessed by medical doctors. Medically exceptional courses of disease are defined as courses occurring with less than 1% probability after the given conventional treatment based on current medical knowledge. The assessment of this case concluded, “Interesting description of Dr. Brunes’ treatment and the experienced effects of this. This is, however, not a medically exceptional course of disease.”
XX thinks that the CAM treatment consisting of vita-mins and minerals from the health food store along with “mind control” in the form of meditation and positive thinking support the conventional medical treatment included in BBs’ treatment model. The patient writes,
The supplements administer my immune system and the rest of my physical health, which again makes me stronger and helps me handle my MS better…. The reason why I experience my MS-course as exceptionally positive is that many of my symptoms that according to my neurologist were irreversible, now are gone or have been greatly reduced. I have a sense of touch in all fingers and toes and under the whole soles of my feet. Four years ago I was numb to my knees and sometimes all the way to my chest. I have more energy, can do more things myself, and I do not need to rest the whole day. I have much more control of the bladder. Going to the bathroom 13 to 16 times per 24 hours has now been reduced to about half of this. I have also learnt to handle the disease and to have a positive outlook on life. I am no longer melancholic. I actually feel that my life has never been as good as it is now, in spite of the many limitations caused by the disease.
XX can contact BB by phone whenever she feels the need for follow-up care.
Confidentiality and Informed Consent
The Regional Committee for Medical and Health Research Ethics and the Norwegian Data Inspectorate have approved the Registry. The patients have given their informed consent. Information that could identify the patient in this case report has been avoided. The patient has read and approved the case report.
BB and her treatment model have been criticized because the treatment is unconventional and expensive and the outcomes have not been validated through clinical studies.16 BB’s treatment model includes a holistic and psychosocial medical approach to MS treatment. Many arguments have been raised for a more patient-centered and biopsychosocial medicine to optimize and safeguard modern patients’ treatment decisions and treatment outcomes.17,18 A qualitative study of patients’ experiences and reflections with regard to their reported “best cases” of MS in the Registry found that these patients, independently of treatment systems, changed over time their position from passive recipients of conventional health care to explorers of healthcare. The concept of “explorer” implies action and entails all the social, cultural, and economical capital19 needed by the patients to take responsibility for and cope with their situations. As explorers, the patients, like XX in this case report, influence how an intervention is chosen and used. CAM facilitates the patients’ own efforts that patients believe are needed for improved health and well-being in their lives with MS.13
A holistic and psychosocial medical approach to MS treatment, including hope and the ability for the patient to cope, was of vital importance to XX’s positive outcome of the MS treatment presented in this case report. The patient-experienced benefits of CAM reported in “best cases” so far generate unexplored and complex questions worthy of further research.
a For more information on the Registry, see pages 70–75 of this issue.
Anita Salamonsen, Anita Salamonsen, MSc, is a researcher of The National Research Center in Complementary and Alternative Medicine (NAFKAM), Department of Community Medicine, University of Tromsø, Norway.
Brit J. Drageset, Brit J. Drageset, BSc, is a consultant of The National Research Center in Complementary and Alternative Medicine (NAFKAM), Department of Community Medicine, University of Tromsø, Norway.
Vinjar Fønnebø, Vinjar Fønnebø, PhD, is professor of preventive medicine and director of The National Research Center in Complementary and Alternative Medicine (NAFKAM), Department of Community Medicine, University of Tromsø, Norway.
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A 6-year-old patient with cerebral palsy was treated with Chinese scalp acupuncture. The Speech I, Speech II, Motor, Foot motor and sensory, and Balance areas were stimulated once a week, then every other week for 15 sessions. His dysarthria, ataxia, and weakness of legs, arms, and hands showed significant improvement from each scalp acupuncture treatment, and after 15 sessions, the patient had recovered completely. This case report demonstrates that Chinese scalp acupuncture can satisfactorily treat a child with cerebral palsy. More research and clinical trials are needed so that the potential of scalp acupuncture to treat cerebral palsy can be fully explored and utilized.
Se aplicó acupuntura china en el cuero cabelludo para tratar a un paciente de 6 años de edad que sufría de parálisis cerebral. Una vez a la semana se estimularon el Habla I, Habla II, la función motora, la función motora del pie y funciones sensoriales, y las áreas que regulan el equilibrio. Luego, se repitió el procedimiento cada dos semanas durante 15 sesiones. La disartria, ataxia y debilidad en las piernas, brazos y manos que padecía el paciente mostró una mejoría considerable luego de recibir este tipo de tratamiento con acupuntura. Transcurridas las 15 sesiones, el paciente se había recuperado por completo. El análisis de este caso demuestra que esta técnica de acupuntura china puede ser efectiva en el tratamiento de los niños que sufren parálisis cerebral. Se necesitarán realizar más investigaciones y ensayos clínicos para que los beneficios potenciales de la acupuntura en el cuero cabelludo, como técnica de tratamiento de la parálisis cerebral, sea plenamente analizada y aplicada.
MEDICAL HISTORY AND PRESENTING CONDITION
Michael, a 6-year-old with cerebral palsy, came from Amarillo, Texas, with his parents to our clinic in Albuquerque, New Mexico, on March 10, 2011. His mother reported that he had never spoken an understandable English sentence and had almost no coordination in his upper or lower extremities. For example, his hands were so weak that he could not make an observable mark on paper with a pencil. He had become passive and initiated little or no communication. His low functional level had resulted in his being diagnosed with mental retardation and learned helplessness.
Multiple medical doctors, including neurologists and ear, nose, and throat specialists, evaluated Michael, and the diagnosis was stroke in utero. Michael had been receiving speech therapy and physical therapy for several years with no noticeable improvement and had been a passive participant in kindergarten for 2 years because of his inability to write, speak, or take part in physical activities.
The examination at our clinic showed no abnormal findings of his physical development or hearing. It was hard to understand him when he said his name, age, and birthday or when he counted aloud. His coordination was severely impacted. He could not point to his nose, touch his index fingers together, or kick his legs. His tongue was red with a thin white coating, and his pulses were wiry and slippery.
Chinese scalp acupuncture and ear acupuncture were used to treat this patient. Primary scalp areas were Speech I and Speech III (Figure 2). The secondary scalp locations were Foot motor and sensory area, Motor area, and Balance area (Figures 2–4). The needles were rotated at least 200 times per minute with thumb and index finger for several minutes.4 Foot motor and sensory area, Motor area, or Balance area was selected according to Michael’s symptoms. The ear point “Shenmen” was selected for the first needle in order to help Michael relax and reduce his sensitivity to scalp acupuncture. The needles were kept in place for 15 to 30 minutes. Although Michael was afraid of needles before beginning the treatment, he was quiet and cooperative and did not cry while the needles were inserted. He did not notice that there was a needle inserted in his ear and showed no negative reaction at all. Next, 4 needles were put on the Speech I area and the Foot motor and sensory area of his scalp. The needles were stimulated slightly.
Outcome and Follow-up Treatments
Michael showed improvement in his speech during and at the end of his first treatment. It was easier to understand him when he said his name and age, and when he counted, most of the numbers were clearer after the treatment than they were before the treatment.
During the second session, Michael was not afraid. The new toy his mother showed him as the last needle was inserted diminished any tension he may have experienced. He tried very hard to make clear sounds in order to get the new toy. Michael attempted to repeat the words and sentences the doctor and his parents were saying and continued to say many clear words that could be understood. He seemed very happy when he found he was able to kick his legs and stand on one leg without difficulty.
Prior to the third session, his mother reported that Michael had started to talk in clearer sentences, some of which she could understand. She had found him already dressed when she went to wake him up to come to the acupuncture clinic. The fourth treatment was similar to the third, and 4 needles were inserted without any pain. During this treatment, Michael was able to speak like a normal child, sing a song clearly, and laugh.
By the fifth session, his parents said he was more physically active and had less trouble speaking. His fear and anxiety both at school and at home had diminished. Michael was playing with other children and based on his teacher’s report, had made some improvement in his schoolwork. Examination showed that he could speak more clearly and could write or paint like a normal child. His physical activities, such as jumping, kicking, running, and standing on one leg, showed no restriction at all. The redness of his tongue was now only on the tip. His treatments were extended to once every other week.
After the 10th session, Michael’s speech and grades in school, as well as speech and physical activities at home, had significantly improved. He still had trouble saying some words, primarily those beginning with s or r. He improved so quickly that his treatments were extended from twice a month to once a month. After his 15th session, Michael had become a happy, communicative, and physically active boy who could say whatever he wanted, express his feelings with clear words, and move his body and limbs as he wished. He had no restriction of any of his mental and physical activities. His parents were happy to report that his math and reading scores had progressed by a grade level and he was moved to first grade. Our final examination at the clinic showed that his tongue was a little red with a thin white coating and his pulses were soft.
Chinese scalp acupuncture has been found to have good results in children with cerebral palsy including paralysis, ataxia, hypotonia or hypertonia, apraxia, dysarthria (trouble speaking), dysphasia, and mental retardation. With advanced brain research and imaging technology, scientists continue to understand better how the brain can adapt after damage and even regain its ability to function.5 It is now apparent that a child’s brain is not fully developed until about the age of 8 years and has the ability to reorganize, adapt, and reroute signals if it is stimulated properly.6 Brain cells not only can change in function and shape but also can take over the functions of nearby damaged cells.7 Based on these abilities, scalp acupuncture is geared toward stimulating and restoring affected brain tissue, as well as retraining unaffected brain tissue to compensate for the lost functions of damaged tissue.
Cerebral palsy may occur in children in utero, during childbirth, or after birth up to about the age of 3 years.8 The majority of children with cerebral palsy are born with it, although it may not be detected until months or years later. The brain damage often is caused by genetic abnormalities, stroke, maternal infections and fevers, or fetal injury. In this case, the patient appeared to have a stroke in utero.
The United Cerebral Palsy Foundation estimates that nearly 500 000 children and adults in the United States are living with one or more of the symptoms of cerebral palsy.9 According to the Centers for Disease Control and Prevention, about 10 000 babies born in the United States each year will develop cerebral palsy.10 Conventional Western medicine offers no cure for cerebral palsy, holding that the damage is not repairable and the disabilities that result are permanent.11 The diagnosis of cerebral palsy has historically relied upon the patient’s history and physical examination. Once a child is diagnosed with cerebral palsy, further diagnostic tests are optional. In Western medicine, treatment for cerebral palsy is a lifelong multidimensional process focused on overcoming developmental disabilities or learning new ways to accomplish challenging tasks.12
The incidence of dysarthria is estimated to range from 31% to 88%.13 To treat children with dysarthria, the needles are inserted bilaterally in Speech Areas I or III. The thinnest needles that can be inserted into the scalp should be selected. One needle should be inserted on the “Shenmen” point on the ear to help young patients relax and to reduce sensitivity to needle insertion and stimulation of the scalp. The least number of needles possible should be used in the scalp in the initial treatment, and the needles should be rotated at least 200 times per minute with thumb and index finger for 1 minute. The needles should be twirled as gently as possible so that the child can tolerate the sensation, and the stimulation should be repeated every 10 minutes. The practitioner should select Foot motor and sensory area and Motor area or Balance areas accordingly to which symptoms and signs the child has.
Verbal communication with children and their parents during treatment helps to reduce their fear and anxiety. At the same time, it can be important to encourage a child with aphasia to talk, count, or sing in order to exercise the power of speech. During treatment, some patients may have some or all of the following sensations: hot, cold, tingling, numbness, heaviness, distension, and the sensation of water or electricity moving along their spine, legs, or arms.14 The practitioner should tell the parents and child that those sensations are normal and that patients who experience some or all of these sensations usually respond and improve more quickly. However, those who do not have such sensations could still have immediate positive results.
To treat motor dysfunction, the acupuncturist places the needles in Motor areas. Generally speaking, weakness of limbs or a paralyzed extremity is treated by choosing the opposite side of the Motor area on the scalp.15 For instance, for a patient with weakness in the right leg and foot, the left side of the Motor area on the scalp should be needled. The Upper one-fifth region is used to treat contralateral dysfunctional movement of the lower extremity, trunk, spinal cord, and neck. The Middle two-fifths region is used to treat contralateral dysfunctional movement of the upper extremity. The Lower two-fifths region is used to treat bilateral dysfunctional movement of the face and head.16
To treat patients with coordination and balance problems, the acupuncturist inserts and stimulates needles in the Balance area bilaterally. It is important to have patients move the affected limb actively as well as passively. Initially, the patient should be treated 2 to 3 times a week until major improvements are achieved. Then treatment is once weekly, then every 2 weeks, and then scheduled as indicated by the patient’s condition. A therapeutic course consists of 10 treatments.
There are several different acupuncture techniques to treat weakness of limbs or paralysis. Although scalp acupuncture has the best and fastest response, other techniques are necessary for a fuller recovery. According to the individual’s condition, regular body acupuncture, electric acupuncture, and moxibustion, as well as physical therapy and massage, can be combined with scalp acupuncture to speed recovery.
Electrical stimulation may be helpful if the practitioner has difficulty performing the rotation of the needles more than 200 times per minute. It is suggested that only 1 to 2 pairs of the scalp needles be stimulated at any one session or the brain can become too confused to respond. Moxibustion can enhance the therapeutic results of scalp acupuncture, especially in weaker patients. The timeframe for patients with cerebral palsy to be treated by scalp acupuncture is crucial. Parents should have their child receive acupuncture treatment as soon as his or her condition is diagnosed. The earlier the child receives treatment, the better the prognosis will be.
Western medical science so far has not found a proven explanation for the success of Chinese scalp acupuncture in treating central nervous system disorders and specifically with treating cerebral palsy. There is a growing amount of clinical evidence that scalp acupuncture can improve or remove symptoms in patients with cerebral palsy. In China, there are many clinical and research studies showing the excellent results obtained from treating cerebral palsy with scalp acupuncture.17–19 Therefore, there is an urgent need for Chinese scalp acupuncture to be studied and perfected using modern Western science and technology. More case reports, case series, and clinical trials of Chinese scalp acupuncture in the treatment of cerebral palsy are needed so that its potential can be fully explored and utilized.
Jason Jishun Hao, Jason Jishun Hao, DOM, MTCM, MBA, is president, International Academy of Scalp Acupuncture, Santa Fe, New Mexico.
Sun Zhongren, Sun Zhongren, PhD, is professor at Heilongjiang University of Chinese Medicine, Harbin, China.
Shi Xian, Shi Xian, PhD, is an associate professor at General Hospital of the Chinese People’s Liberation Army, Beijing, China.
Yang Tiansong, Yang Tiansong is a doctoral candidate at Heilongjiang University of Chinese Medicine.
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The goal of science is truth through knowledge. But medicine’s truth is not altogether the same as science’s truth.
Science works with ideas, imagination and intuition, but essentially has to do with facts. Medicine has also to deal with meaning.
This is not an argument for less science in medicine, but for more and better science; better in the sense of better attuned to ‘the rest of life’.
Truthfulness is a core principle of medical practice and medical science.
But a kind of untruthfulness is common in day-to-day clinical practice.
The fundamental untruth is the illusion of certainty.
The inexcusable untruth is to reduce the patient’s problem to it to its narrow biomedical parameters and to allow the patient as a person to vanish from our gaze.
Science fails medicine by the narrowness of the scope of things it is willing to investigate. Important areas of medicine have been neglected as a consequence.
The medical research culture must change if it is to promote science for understanding alongside science for manipulation. We need to be unsparingly critical of the distinction between useful science and wasteful science.
“Medical knowledge is not knowledge acquired primarily for its own sake (but) for a specific purpose—the care of the sick.”1
William James (1842–1910) was an American psychologist and philosopher best known for the series of Gifford lectures delivered in Edinburgh in 1901 and later published as The Varieties of Religious Experience. His work was reviewed in the BBC Radio 4 programme ‘In our time’ on the 13th of May 2010, when he was judged by one expert to have been the greatest philosopher ever! He did not draw any firm conclusions about the existence of God from his research, whose purpose was psychological rather than theological, and he was open to the possibility that some or all of those varieties of experience might be eruptions from the individual’s subconscious. But he was insistent that they should be taken seriously, and was critical of the scientific attitude towards such phenomena, though he was primarily a Darwinian scientist himself who turned to philosophy in later life.
One of his criticisms is particularly pertinent to the problem of science in relation to medicine. He said that the worst thing about science is ‘the religion of scientificism’—which induces a kind of fear. He said his fellow scientists crippled themselves by the fear of doing something that might be regarded as unscientific, and so they closed their minds. This is reflected in quotations from Kuhn and Polanyi in Chapter 11. James’s view, consistent with Darwin’s open-minded scientific attitude, was that we have to be open to the thought that what seems intellectually absolutely unavoidable today may seem really stupid to us tomorrow. So we should never close down on any intellectual possibilities whatsoever. The quotation from George Engel that introduces Chapter 6 that the scientific attitude can permit no restrictions as to the category of natural phenomena investigated echoes the same conviction. The discussion on the radio went on to reflect on the ascendancy of Bertrand Russell’s philosophy, and the triumph of what James would have regarded as an over-investment in logic and a lack of interest in the diversity of human experience. This sentiment is echoed in the quotation from Mary Midgeley at the end of Chapter 6, which concludes, “We do not need to esteem science less. What we need is to esteem it in the right way. Especially we need to stop isolating it from the rest of life”.2 One of the speakers on the radio suggested that James’ continuing importance is that he represents a struggle in his period and our own to reconcile naturalism, the understanding that human beings are the product of nature, with humanism; the struggle to find a place for human values in a world of nature. Which today might be represented as the question—in a world of particles, what place is there for values?
SCIENTIFIC TRUTH IN MEDICINE
The good internal to the practice of research is truth, an understanding of what is really real about some aspect of the world we inhabit.1
The goal of science is truth through knowledge. Thus, the role of science in medicine is to get at the truth. But medicine’s truth is not altogether the same as science’s truth. Science works with ideas, imagination and intuition, but essentially has to do with facts. Medicine has also to deal with meaning. In this, medicine comes close to theology. Science and theology are both exploring reality; different but inseparable aspects of reality. Medicine somehow has to accommodate the patient’s whole reality. The truth we seek is “to understand things as they really are, knowing that in its fullness it will always be beyond us”.3 But if we abandon it we abandon our patient. And medicine’s truth has to accommodate the diversity of human experience that an over-investment in logic may disregard. It has to accommodate ‘the rest of life’ of which our biomedical condition is only a part and a reflection. It has to accommodate the values that give meaning to the particles.
Medicine’s problem with science has been a recurring theme through- out this book—a problem born out of success. The programme on William James also touched upon the fate of movements, of the spirit or of the mind, that become codified and institutionalised and suffer a loss of the life that inspired and motivated them. This is true of medical science to the extent that it has become increasingly concerned with manipulation rather than understanding; increasingly focused on the particles, and less on the rest of life. Our gratitude for the success of medical science in what it has been able to do for us need not be diminished by suggesting that it is seeking increasingly sophisticated answers to the wrong questions. Or rather that it is failing to address the right questions with the same degree of sophistication and commitment.
This is not an argument for less science. On the contrary, it is the same argument that David Horrobin made 30 years ago for more and better science.4 That does not mean ‘better’ in the sense of more skilled or sophisticated, but in the sense of better attuned to ‘the rest of life’. In Horrobin’s terms it means making science more humane; more concerned, as he puts it, with the extraordinary potency of the control mechanisms that maintain the constancy of our physico-chemical equilibrium, without which we would never remain well. He is highlighting medical science’s surprising lack of interest in this ‘evolutionary imperative’; its preoccupation with learning to control the processes that go wrong at the expense of learning to enable the processes that help to put things right. And its lack of interest in learning to exploit them; even though they are integral and indispensable to every therapeutic process.
This is an argument that medical science needs to be better directed; better attuned to the humanistic rather than the mechanistic goals of medicine. It is a huge challenge to the culture of medical science; and to the culture of medicine in general. And to the culture of the society that medicine serves and helps to shape, and in turn is shaped by.
The wider cultural implications, such as medicine’s role in creating the kinder, more imaginative, more generous world’, ‘the more just and sustainable world’ envisioned in the quotations in Chapter 4, are employed in Chapter 17. The essential cultural reorientation that is required of medical science is that it should ‘frame its understanding of the world to understand the world truly rather than in order to control the world easily and cheaply.’ That is a crude paraphrase of a quotation from an essay on medical knowledge by HT Engelhardt that is used by David Greaves in his analysis of the problem with science in Mystery in Western Medicine, which I warmly recommend.5 The quotation is crude not only in the way I have rephrased it, but in the aspersion it casts on the goals of medical science; whose application in the real world is in any case seldom easy or cheap. But it makes the point yet again that the role of science is to understand the world truly.
Truthfulness, I have suggested, is a core principle of medical practice and medical science, and I outline my reasons in Chapter 10. But in fact, untruthfulness is common in day-to-day clinical practice.6 It arises when medicine only acknowledges part of ‘the story of sickness’. A diagnosis, for example, is only part of the story; a description of what is going on, rarely an explanation of why a thing is as it is, but often presented as if it defines the whole problem.7 Untruthfulness arises when a doctor gives an antibiotic for a self-limiting illness, or another inappropriate prescription (though possibly with significant ‘placebo’ effect); or offers a diagnosis when the truth is ‘I don’t know’; or tells an ill patient there is nothing wrong because the tests are all normal.
Untruth is introduced when “the dogma of technological medicine ignores the therapeutic effect of the doctor and the self-healing powers of the patient”8 when “doctors expect to find an answer to every problem if only they look hard enough with the right instruments.”9 It happens because although technology allows us to practise with ever greater precision and is a powerful tool for understanding, it also creates powerful misunderstanding when unwisely applied.10
In a great deal of medical practice, often with the best of intentions and to good effect, there is an element of deceit. This inherent untruthfulness is not necessarily to be condemned so much as to be acknowledged and reflected upon; sometimes to be corrected, sometimes to be accepted when there are mitigating circumstances.11 Deceit and consent to deceit are inevitable in medical practice whenever we imply, and quite possibly believe, that we know the truth of the matter when all we really know are some of the facts of the matter. We are victims of the success of biomedicine because of the expectation it encourages that we have the answers; whereas we are always dealing with a high degree of complexity and uncertainty. The inherent truth of the patient’s experience will often be beyond us. But that does not absolve us from the responsibility to be open to it, and faithful to it—as best we can be and as fully as the patient invites us to be.
The fundamental untruth is the illusion of certainty. The inexcusable untruth is to reduce the problem and our response to it to its narrow biomedical parameters and to allow the patient as a person to vanish from our gaze. We can have no certainty about all that determines the course of illness and healing in any individual. We have to explore constantly and courageously that penumbra of uncertainty that surrounds our presumed certainties. This attitude does not displace, but assumes and comprehends proper respect for evidence and scientific method, clinical knowledge and skill. But it leaves room for the flexibility of mind that is essential if we are to know the world truly; especially if we are to open to the inherent truth of the patient’s experience. This flexibility is not scientific laissez-fair but an honest acknowledgement that, to paraphrase John Polkinghorne, on the one hand the physical world is too surprising to allow any a priori concept of what is reasonable, and on the other, the actual character of our encounter with reality must be allowed to shape our knowledge and our thought.12
THE LIMITATIONS OF SCIENCE
Science fails medicine not through lack of competence—it is able to do and to discover amazing things, but through lack of vision. Not for want of curiosity, but for the limit of things it is curious about. Not for any lack of the ability to investigate, but for the narrowness of the scope of things it is willing to investigate. The weaknesses of science are its strengths: its preoccupation with the things it does well and with the tools it knows how to use best. The opportunities of science to explore novel conceptions that do not sit comfortably with its contemporary paradigm seem to be regarded almost as threats; stifled by the fear that once a new framework is accepted it will lead to conclusions that have been hitherto, rightly or wrongly, abhorred (to paraphrase the quotation from Polanyi in Chapter 11); stifled by the quasi-religious fear of William James’s ‘scientificism’.
In short, science must be true to its traditional vocation to the systematic pursuit of knowledge that permits no restriction as to the category of natural phenomena investigated. The cultural and structural problems that contribute to this loss of vision are explored in the Introduction and in Chapters 10 and 11. The areas of medicine that have been neglected as a consequence, though not quite ignored, include the following:
We know a great deal about the causes of disease and the mechanism of the body’s response to insult and disorder of various kinds; causes as precise as our genetic susceptibility; mechanisms analysed down to the cellular and intracellular level. We know a great deal about the detailed mechanics of bodily self-regulation. We know a certain amount about the influence of psychological and environmental factors on these processes. We can describe the healing of a wound by first and second ‘intention’, the restoration of biochemical measurements to ‘the normal range’, the change in certain pathognomonic symptoms (symptoms characteristic of a specific disease). But our understanding of the correlation of these factors with the well-being of the person as a whole is more uncertain. Remember the quotation from Roy Porter:
In myriad ways, medicine continues to advance, new treatments appear, surgery works marvels, and (partly as a result) people live longer. Yet few people today feel confident, either about their personal health or about doctors, healthcare delivery and the medical profession in general.13
For example, we know perfectly well that the ‘placebo’ effect and contextual healing happen. We know that various factors can promote these effects. And we know that they account for a significant part of even the specific efficacy of treatments demonstrated in controlled trials, as well as their actual effectiveness in practice. But we have a very poor understanding of these fundamental dynamics of healing processes; let alone how to make best use of them.
We know very little about the natural history of these effects in the person as a whole. We know that placebo can induce relief of presenting symptoms, measurable physiological changes, and changes in brain chemistry. But the more general effect of these reactions in the person as a whole, and the effects over time are not known. We do not know anything much about the time scale of onset or duration of placebo responses, or their permanence or transience. We do not know to what extent they are usually limited to the target symptom or condition. We do not know whether and to what extent they have incidental effects on aspects of well-being other than the presenting problem. Bearing in mind that ‘placebo’ responses ‘work’ by mobilising resources for self-regulation and self-healing, we do not know whether these resources are thereafter enhanced to the benefit of longer term healthfulness. The only context I know, and to which I can find reference, in which detailed observations of this kind are made is the homeopathic method that I describe in Chapter 14 and Appendix 14.1.
A piece of research begging to be attempted, for example, is suggested by the short notes on ‘Healing processes’ in that chapter. The detailed observation of changes in response to treatment by the homeopathic method provides a well documented account of the dynamics of self-regulation and self-healing across a wide range of morbidity. These clinical observations, described in the appendix, are valid whether the agent of the healing process is the contextual or ‘placebo’ effect of the method, or the homeopathic prescription itself, or a combination of the two. A similarly detailed and documented account of placebo responses, in conventional trial situations perhaps, would permit comparison between the two sets of observations. Firstly, both would be descriptions of ‘natural healing’, providing invaluable insight into that process, because whatever they do homeopathic medicines cannot have pharmacological effects. And secondly the comparison would cast light on the similarity or difference of the process in the two clinical situations, allowing us to draw inferences about the similarities or differences between the effect of the homeopathic medicines and the inert placebo agents used in trials.
We know a great deal about disease processes, but we do not know much about the poorly defined state that we call illness, and out of which disease arises; or from which medicine has to ‘create’ a disease in order to explain it. Actually, that is not quite true. It is more accurate to say that we do know a fair amount about the things that make us ill, but we can’t do much about it, unless and until it becomes a disease, or unless we can turn it into a disease we do know how to treat, or at least how to control. We know, for example, that exams, bereavement and moving house, and other critical or traumatic situations in life affect our immune system and our adrenal function. We know that poverty and social deprivation make us ill; not only when there is actual lack of essential food, accommodation, hygiene, education, etc., but also where there is relative lack of material well-being compared to wealthier sections of society. And the medical and social sciences do develop or advocate the means to remedy or mitigate such problems. But there is an inevitable element of mystery to personal illness, and to the challenge of meeting the needs of a particular individual who is ill.
It may be beyond the scope of science to analyse every facet of the mystery of personal illness. But at least it must not encourage us to neglect the mysterious in favour of the measurable—the McNamara fallacy again (Chapter 10). The science that permits us to define illness in terms of precise biological disorder must not distract us from the importance of the biographical diagnosis, the story of the sickness. But more importantly it must take account of that broader diagnostic perspective, explore it, and help us to understand and manage it.
However, there are questions that may shed light on aspects of the mystery that medical science can, and to a limited extent does answer:
‘Why me?’ Why do/did I become ill when others in similar circumstances did not?
‘Why this?’ Why did I develop this illness/disease? Why do I react to anxiety/hot weather/a virus with headache, when X gets diarrhoea and Y gets eczema?
‘Why now/then?’ Why did it happen when it did—not six months ago, or next week? What were the factors/circumstances that determined the time of onset?
The limited extent of medical science’s exploration of these questions is illustrated by contrast with the particularly detailed case taking necessarily employed by doctors using the homeopathic method. This is a clinical process of a wholly conventional if unusually comprehensive kind that yields an unusually versatile and comprehensive synthesis of biological and biographical data from which, by contrast with a more conventional approach, a more complete understanding both of the evolution of the illness in that person (the story of sickness), and of what needs to be healed as well as treated can emerge.14 This not only facilitates the therapeutic process, but also reveals the possible scope of detailed epidemiological enquiry.
TREATMENT—THE BLACK BOX
For a period during my GP career my surgery was in our home. My consulting room was our sitting room out of hours. Patients would often sit on the sofa. The waiting room was a small room immediately adjacent where the receptionist sat with the patients, and the atmosphere was intimate, welcoming and cheerful. The sound of laughter filtering through the door into the consulting room, unusual in the average doctors’ waiting room, was not uncommon. I provided routine fifteen minute appointments, but the patients were often and evidently feeling better by the time they came in to me because of the warmth of their ‘reception’. They did then get the benefit of my repertoire of clinical skills, and whatever personal qualities I brought to the relationship. This, at the time, was my therapeutic ‘black box’. It would be quite difficult to itemise all of its component parts. And impossible to be sure which component made what contribution to the patient’s subsequent well-being and clinical outcome. A GP colleague of mine identified 35 separate components of the therapeutic encounter.
All treatment, every medical encounter is a therapeutic black box. The workings of the black box in conventional practice, we like to think, are less of a mystery because we know what the specific component, the drug or procedure is meant to do. The workings of the black box in complementary medicine are often represented as a sort of confidence trick because we are sceptical that it has a specific component that does anything at all. In either case the result may be effective or ineffective, safe or unsafe. But the medical model justifies the use of the black box only if it has a specific component whose efficacy can be ‘proved’.
One approach to the black box is to unpack it, isolate that specific component, and submit it to ‘destructive analysis’. Another approach is to say that we must not attempt to unpack the black box because to try may destroy it, and deprive it of its practical effectiveness.
Science has a dual responsibility towards the understanding of human wholeness and the healing vocation that is expressed beautifully in an essay by George Orwell on The Meaning of a Poem:
I have tried to analyse this poem as well as I can in a short period, but nothing I have said can explain, or explain away, the pleasure I take in it. That is finally in explicable, and it is just because it is inexplicable that detailed criticism is worthwhile. Men of science can study the life-processes of a flower, or they can split it up into its component elements, but any scientist will tell you that a flower does not become less wonderful, it becomes more wonderful, if you know all about it.15
Science must combine a humility and sense of awe in the face of the wonderful and inexplicable, and in the face of irreducible uncertainty, with a scientific passion and insatiable curiosity to know all about it. It will never fully explain, and must never seek to explain away, the mystery of life, but the mystery itself makes critical analysis worthwhile.
Medical science must accept that there is always a black box that operates between every practitioner and every patient in every therapeutic encounter. It has many components and many dimensions, and the permutation of these will vary from one encounter to another. The complete and precise operation of the black box, the outcome of its operation, its effectiveness, the human consequences, will always, ultimately defy analysis. That finally is inexplicable, and it is just because it is inexplicable that detailed criticism is worthwhile.
Medical science must not make the mistake of confusing the question whether the black box ‘works’, with the question how it does it. Both are valid questions, and both have valid answers. Both are worth exploring. But the answer to one does not depend upon the answer to the other. We would like to know how our black boxes ‘work’, and we will try to find out. But what matters more is that they do work. If we are honest, and admit, as research into placebo effects increasingly reveals, that all our therapeutic activities are effectively black box operations; and if we were to abandon all treatments in which we do not fully understand how the black box works, we would give up medical practice altogether.
USEFUL SCIENCE AND WASTEFUL SCIENCE
Useful science enables us to do things that are really worth doing. The question of what is really worth doing is an ethical and cultural question that is profoundly important to our conception of the goals of medicine and the model we devise to serve those goals. But we have seen in Chapter 9, when exploring the crisis of cost in the health service, that when challenged to reduce cost there is a considerable number of activities that clinicians consider are not worth doing. Medical science has made it possible to do them and provided the technology to do them. This bears out Lyng’s suggestion quoted in the earlier discussion of the problems of technology in Chapter 11, that technology encourages ‘the interventionist thrust’ of modern medicine. This appetite for and tacit dependence on the necessary ‘instrumentation’ is fed by medical science, and rather than serving the goals of medicine simply ‘creates the space for possible medical events.’16 David Horrobin characterised this over-use of technology as “The application of a technique to a situation, without any critical consideration of whether the outcome is likely to be favourable or not”.4 We might restate David Haslam’s observation that “We use the medical model because the medical is what we use, even though it may not be appropriate”,17 as ‘We use medical technology because medical technology is what we use, even though it may not be appropriate.’
Science wastefully applied, because it is not really useful, is of course science harmfully applied. Every intervention carries some risk; is potentially iatrogenic. An intervention that is not really useful is one kind of medical untruth. And a wasteful intervention costs money that could be better spent.
In May 2010 the British Medical Journal published a ‘head to head’ debate, ‘Is modern genetics a blind alley?’18 “Yes”, says James le Fanu. “Modern genetics has become the largest single research field in the history of biology, driven forward by the expectation that ‘like a mechanical army (it will) destroy ignorance … promising unprecedented opportunities for science and medicine’. And yet for all this cornucopia of new facts and knowledge, its influence on everyday medical practice remains scarcely detectable.” He quotes the chief executive of Genentech as saying that all this effort amounts to “the largest money losing industry in the history of mankind.” He speculates that the complexities of those methodologies might explain in part the paucity of original ideas in medicine, diverting attention and resources from more fruitful forms of clinical research. Le Fanu regards it as “highly improbable that the future of medicine might lie in understanding disease at (this) most fundamental reductionist level.”
D.J. Weatherall argues that on the contrary genetic research promises real benefits and is already delivering some. He points out that genetic research is a young discipline and that it would be short sighted to view it as a blind alley, considering the complexity of the subject it has to explore. But his contribution to the debate does not inspire confidence. He acknowledges the extraordinary complexity of biological function in health and disease that modern genetics continues to unearth. He compares this phase of its exploration to the endless, and some might argue similarly fruitless search in modern physics for a grand unifying theory. He acknowledges that most common diseases “seem to reflect the action of many different genes with small effects, presumably combined with environmental factors and the biology of ageing.”
Research like this is presumably driven by scientific passion, and does increase our wonder at the beautiful intricacy of life, even if ultimately what makes us tick remains inexplicable. But having read this debate, I wonder to what extent the research will prove to be practically useful. Nevertheless, it is reassuring that this debate, and the ethical debates about embryo research and the like, are happening.
But science has a huge responsibility to be sure that its passion and the seductive power of what it can do, do not lead us up blind alleys, at the end of which nothing really useful is achieved; particularly if our essential humanity and wholeness is diminished in the process.
Perhaps the most serious revolution that remodelling medicine requires is in medical research. There are many challenges (see Box 18.1). The pre- dominant thrust of research programmes is to isolate a problem from its ‘confounding variables’ (all the other things in life that bear upon the health and well-being of the afflicted person), and then to reduce the problem to its most fundamental biological component (genetic, biochemical, functional, anatomical) so that this can be managed or manipulated. The test of the ability of any treatment that results from this process to do what is expected of it (its efficacy) requires that the measurement of this outcome is similarly isolated from the effect of confounding variables.
BOX 18.1. Research Challenges
The dynamics of illness.
Context and meaning.
‘Subtle’ therapeutic effects.
The therapeutic ‘black box.
This is a generalisation that is not true of all research methods, but it does represent the principal focus and predominant thrust of medical research. It is brilliantly successful in what it sets out to do. It does make it possible to manage or manipulate particular components of disease processes. But it provides a very partial solution to the whole complex spectrum of illness-disease-sickness. I have hyphenated the three words to emphasise that medicine is concerned with a complex phenomenon of which the pathology, which is what we usually mean by disease, is only a part. The illness-disease-sickness triad, whose various meanings are discussed at the beginning of Chapter 8, involves the person as a whole and is contingent upon a multiplicity of circumstances in the person’s life. What is more any medical intervention affects the person as a whole, not just the part that it acts directly upon, and has consequences for the circumstances of the person’s life. And lastly, no actual medical intervention is simple or circumscribed. As we have seen it is always a ‘black box’ procedure.
The narrow focus of biomedical research, for all its achievements, cannot do justice to this complexity. In fact it really has nothing to say about it. This is not to disparage biomedical science. It is not an argument to esteem science less, but ‘to esteem it in the right way’, in Mary Midgeley’s words; ‘especially to stop isolating it from the rest of life’. As Iris Bell and colleagues put it in a discussion of the research relevant to a new model for primary health care: “The reductionist approach to science is valuable (but) it fails to reflect the way the real world operates”.19 Which is perhaps why as Roy Porter reflected in the quotation in Chapter 3, despite the myriad ways in which science continues to advance, “Few people today feel confident, either about their personal health or about doctors, health-care delivery and the medical profession in general”.13
The medical research culture must change if it is to promote science for understanding alongside science for manipulation. Medical scientists might argue that the myriad advances in science do allow us to understand; to understand what goes wrong when disease affects us, and what to do about it. But it is probably fair, and more accurate to say that science allows us to describe what goes wrong so that we may do something about it, but not necessarily to understand it. It allows us to know what to do to correct the fault, but it does not help us to understand the mixed dynamics of the illness-disease-sickness process, nor of the healing process.
A change in the medical research culture that promotes this level of understanding and the health care practices that it permits will not come easily. The biomedical paradigm is so powerful and the model so successful that it is almost impervious to change. The plausibility construct or world view that sustains them is not conducive to change. Its materialist perspective encourages mechanistic solutions. “World views and the values placed on different health outcomes are closely related. Thus the values that underlie medical care shape the scientific questions that researchers ask, the health outcomes they measure, and the interpretation of the results”—Iris Bell and colleagues again, reflecting the discussion in Chapters 10 and 11.
To develop research methods that study health-care processes that are holistic and integrative is even more difficult than studying diseases and treatments that are isolated from the rest of life. This is because, by definition they concern illness-disease-sickness that has multiple determinants (predisposing and causative factors), that affects the person as a whole (all aspects of their well-being), that has multiple outcomes (physical, psycho- logical and social), and that involves a number of interventions (either as ingredients of the ‘black box’ or as separate and distinctive processes), which are individualised to the needs of the patient.
It is obvious from this scenario that research of this kind is asking far more profound questions than ‘what is wrong?’, and ‘what works?’ It is asking questions about the whole phenomenon of illness-disease-sickness within the narrative of human experience, of life. It is exploring new ways of thinking about disease and therapeutics. This may sound idealistic and impossibly challenging. It is challenging, but it is not impossible. And to a limited extent the challenge is being met, the methods are being explored, and it is beginning to happen.
This is too big a subject for me to do more than offer a few examples to illustrate it. General readers who do not have an interest in research may find the next few pages heavy going, and may prefer to skip to the Conclusion at the end of the chapter.
1. RESEARCH POLICY
Based on work by Trisha Greenhalgh, Professor of Primary Care Research, University College, London, writing in the British Medical Journal20:
The narrow focus of research policy and research commissioning is manifestly inadequate and inappropriate to health care in the real world: “Research policy is currently powerfully shaped and constrained by talk of the knowledge based economy and the contribution of high technology innovation to UK plc. This discourse has repositioned the core business of primary care research as running a ‘population laboratory’ for large scale epidemiological studies, preferably with a pharmacological component. Such studies are important but they are not the whole story.” Research initiative in general practice (which might reveal more of the story) is burdened by “the creeping institutionalisation and regulation of research. Epidemiology’s unanswered questions demand large scale collaborative studies that can be undertaken only within a complex research infrastructure. Non-epidemiological questions relevant to primary care (for example, on the humanistic and social dimensions of illness and healing) are currently defined as a lesser form of science for which only B-list funding and publication outlets are available.”
2. EXPLORING ILLNESS: INTERPRETIVE MEDICINE
These quotations are taken from a paper by Joanne Reeve proposing ‘interpretive medicine’ as a better framework for the generalist care that must be the foundation of good clinical practice. It is “the critical, thoughtful, professional use of an appropriate range of knowledge in the dynamic, shared exploration and interpretation of individual illness experience, in order to support the creative capacity of individuals in maintaining their daily lives.”21
The holistic and integrative ideal in medicine is best, if imperfectly, represented by general practice. Other disciplines, such as geriatric medicine and palliative care and some aspects of mental health care, also represent this generalist ideal. But it is threatened by the evidence based approach which has strayed from its founders’ intention that evidence should be submitted to the judgement of clinical relevance, and become focused on “hierarchies of evidence (that) privilege knowledge from what some consider to be a narrow methodological perspective.” The effect of this is to narrow the scope of the generalist’s perception of the patient. “The disadvantages of constrained protocol-driven care are recognised by the profession; but still form a new formative normative framework for clinical practice.” This militates against generalism, which “is more than disease-focused care delivered in a community setting. It is a different approach to understanding and addressing health and illness. (It) describes a philosophy of practice which is person, not disease, centred; continuous, not episodic; integrates biotechnical and biographical perspectives; and views health as a resource for living and not an end in itself.” The generalist approach is essential to address growing concerns about the inefficiency, ineffectiveness and inequity of fragmented health care, and to promote an understanding of “specific events in their broader context, integrating biomedical evidence with a reflexive and interpretive approach that acknowledges, the complexity of individual human experience.”
3. SETTING RESEARCH PRIORITIES: A LAYMAN’S EXPERIENCE
This is a personal view published in the British Medical Journal.22 The author, Lester Firkins, is a former banker who became involved in the world of medical research, specifically clinical trials, because of his role in a patients’ charity concerned with Creutzfeldt-Jakob Disease (CJD) which had claimed the life of his son. When he attended a consumer workshop on clinical trials for CJD he “assumed that this was what always happened in planning clinical research; it seemed natural and made sense.” He was surprised to discover however, that “the views of patients, their families and even clinicians are rarely sought when research priorities are being decided,” and that his later involvement as co-chairman on the steering committee for a CJD research project was “an example of ‘cutting edge’ involvement of lay people in clinical research.” Whereas to him it had seemed “a normal and sensible thing to do: who else other than someone closely involved with the disease could help with some important elements in the design of the trial?” In banking an attempt would automatically be made to research customers’ needs before packaging a new product.
His experience taught him that unpleasant competition for academic status and fiefdoms must not be allowed to override patients’ interests in research planning and funding: and that involvement of patients and their professional and lay carers should be normal and welcome in the shaping of clinical research, and knowledge about and participation in good clinical trials should be a normal feature of citizenship.
4. A CIRCULAR MODEL FOR RESEARCH
Presumably the kind of participation described above would be a component of the circular model of evaluation of complex interventions recommended by Harald Walach and colleagues.23 This is proposed as an alternative to, and an improvement upon the ‘hierarchical’ method for evaluating complex interventions. All medical interventions when they are applied in the real world are in effect, as we have seen, complex interventions; if only because they inevitably include contextual and placebo effects, even when they involve only one specific procedure, which is seldom the case anyway. The hierarchical research model has at its base descriptive case studies, but at its apex, and as the final arbiter of efficacy, the blinded randomised controlled trial. This depends upon the assumption that only the specific effects of a treatment or procedure, attributable to an understandable mechanism are of clinical value. This we know to be a false assumption.
The circular model described in that paper is derived from the evolution of evaluation methodology in the social sciences “which has reached the consensus that only a multiplicity of methods used in a complementary fashion will eventually give a realistic estimate of the effectiveness and safety of an intervention. Rather than postulating a single ‘best method’ this view acknowledges that there are optimal methods for answering specific questions, and that a composite of all methods constitutes best scientific evidence. Experimental methods that test specifically for efficacy have to be complemented by observational, non-experimental methods that are more descriptive in nature and describe real-life effects and applicability.” The authors quote the synthesis of different ways of knowing described by Gabbay and le May as the ‘mindlines’ used in decision making by general practitioners, as an empirical example and justification for this model.24 (See Chapter 10, ‘Ways of knowing’.) “Many patients recover because of complex, synergistic or idiosyncratic reasons that cannot be isolated in controlled environments (trials)…. By conceptualising evidence as circular we can highlight the fact that sometimes the ‘best’ evidence may not be attributional, objective, additive or even clinical.”
5. EVALUATING LARGE SCALE AND COMPLEX INTERVENTIONS
In fact it is not unusual that large scale healthcare interventions are introduced without clear evidence that benefits outweigh costs and harms. This was pointed out in a debate about the merits or otherwise of such a process in the British Medical Journal.25 Bernard Crump argues that it can be appropriate to do so when explicit evidence is hard to come by; particularly in complex interventions that involve the behaviour of people and systems and that are just not susceptible to evaluation by the yardsticks that have been developed for narrower biomedical interventions. He, too, argues, as do Walach and colleagues vis-à-vis the social sciences, “We need to learn from other scientific sectors to broaden our understanding of evidence.” He is not suggesting an uncritical approach to such interventions, far from it, but a process for developing programmes of improvement that “builds on feedback on intermediate outcomes and will allow for adjustment of the intervention as the implementation takes place.” He recommends combining this with the ‘generative’ approach that takes account of the mixed dynamics of the therapeutic process and requires a deep appreciation of contextual factors, using a combination of qualitative methods (descriptive, observational, narrative) and quantitative methods (measuring what it is possible and appropriate to measure).
The other protagonist to this debate, Seth Landefeld, argues that on the contrary the evidence should be compelling if well intended interventions are not to fail, perhaps cause harm, and cost dearly. He is doubtful that observational studies provide sufficient justification. But he warns that evidence should only be accepted, and interventions put into practice “carefully, because the effects of interventions may vary among patients, providers, and medical care environments, which often differ from those in studies that establish efficacy.” Which actually seems like an argument for the circular, iterative and generative approaches that others recommend.
6. MULTI-DISCIPLINARY INTEGRATIVE CARE
In a study from Denmark five conventional practitioners (neurologist, occupational therapist, physical therapist, psychologist and nurse) and five complementary practitioners (acupuncture, nutritional therapy, classical homeopathy, craniosacral therapy and reflexology) explored the possibilities of collaboration in the care of patients with multiple sclerosis (MS).26
The project’s core question was—‘Is it possible to improve treatment outcomes in people with MS by developing a model for bridge-building between conventional and alternative practitioners, and thereby facilitate and integrative treatment process at the patient level?’ The study is particularly interesting, and ambitious, because it brings together practitioners with, effectively, ten different theoretical and practical approaches to patient care. The basis for the dialogue (IMCO) was the four parameters—Intervention (what does the practitioner do together with the patient?), Mechanism (how do the process and context of treatment achieve the outcome?), Context (the motivation, attitudes, personal resources, insights and expectations that the patient brings to the process), and Outcomes (what physical, emotional, psychological and social benefits are expected and achieved by the intervention?). The definitions in parenthesis are my paraphrase.
The study did not set out to evaluate the outcome of multidisciplinary integrative care of this kind, but to explore its feasibility and the means by which it can be achieved. The study process (four seminars with preparatory work) was not easy, and common objectives in terms of outcomes were very difficult to agree. But eventually the ten practitioners “developed a mutual understanding of the different treatment models; began to think as a team; developed a mutual communication platform based on trust; and developed a platform for collaboration with the researchers.”
The authors conclude, “Creating bridges between fundamentally different ways of conceptualising diseases, curing and healing, simply takes time. However, collaboration is possible when focusing less on singular treatments and more on the primary target of optimising the treatment of each unique individual.”
7. INVESTIGATING ‘WHOLE PERSON’ APPROACHES
Iris Bell and colleagues emphasise as I have done that Integrative Medicine is not the same thing as complementary medicine (CAM) but “a comprehensive primary care system that emphasises wellness and healing of the whole person”.19 Nevertheless, they go on to say that, “As it evolves, truly integrative medicine also depends for its philosophical foundation and patient-centred approach on systems of CAM that emphasise healing the person as a whole (e.g., Traditional Chinese Medicine, Ayurvedic Medicine, and classical homeopathy). These CAM systems diverge the most in philosophy, diagnosis and treatment from conventional medicine, and thus remain marginalised. As a result, clinicians and researchers often break off parts of these CAM systems from their original contexts to fit a few of the smaller pieces into the dominant model of conventional care and medical research. For example, numerous studies have investigated the efficacy of acupuncture for various Western disorders, but virtually no studies examine the effectiveness of the sum total of Chinese medicine as practiced. It is a testable hypothesis that the effect sizes of the full treatment program could be much larger and more clinically significant if the entire Chinese medicine treatment program were studied as used.”
A THOUGHT EXPERIMENT
Only two of these examples of lateral thinking around the subject of research are directly related to complementary medicine (CAM), but they are all relevant to the particular challenge that is presented by the role of CAM, and any expanded role for CAM, within integrative health care. Here is a thought experiment that supposes the large scale introduction of a potential health care improvement for which there is not compelling evidence (example 5), but which could generate, or of course fail to generate such evidence.
The 2010 UK coalition government proposed that an ¤80 billion (₡94 billion, %124 billion) budget should be entrusted to general practitioners to commission services from other health care providers. Suppose that all 500 of the GP consortia expected to manage this budget, if it is equally distributed, were required to commit 0.1% of their share of the budget to integrating complementary medicine into primary and secondary care. Or if that seems too extreme, suppose that 0.0002% of the total budget is allocated to a 20% cohort of consortia, 100 of them, for that purpose. In either case each consortium committed to the task would have ¤160 000 (₡187 000, %247 000) to spend per year. The object of the exercise is to improve the health and well-being of their patients and to reduce the burden (of time, cost and stress) on themselves and their practices and the other services they would normally commission by the informed and discriminating use of complementary medicine; a similar exercise to that undertaken in the Glastonbury Project (Chapter 16). It would be a new exercise in interprofessional care. It would require consortia:
Get to know the complementary practices in their area.
Understand and appraise their potential contribution to patient care—but not to learn their therapeutic methods (example 6).
Learn from patients’ experience of using complementary medicine (example 3).
Select therapists (Chapter 19).
Learn to collaborate (Chapter 19).
Establish proper communication and continuity.
Audit the process and its outcomes.
Apply all appropriate ways of knowing (Chapter 10) to inform and develop their practice ‘mindlines’.
Incorporate research from formal trials with these other sources of knowledge in a circular process of evaluation (example 4) that comprehends the effectiveness of the complementary approaches as a whole rather than isolated bits of their respective black box (example 7).
This need not actually be a hugely time consuming or demanding task. It might even be enjoyable and liberating.
Medical knowledge is not knowledge acquired primarily for its own sake (but) for a specific purpose – the care of the sick.1
Medical science and the study of health care delivery are already developing methods of enquiry and suggesting outcomes that justify a radical reappraisal of medical thought and practice. Subtle therapeutic methods that stimulate self-regulation and self-healing, and the contextual and ‘meta-organic’ factors that contribute to these have already achieved significance and importance in our understanding of the dynamics of health care. And their application is a widespread and insistent reality of contemporary medicine. Wider and more formal and systematic adoption and integration of these methods and of the precepts they exemplify promise health gains and economic benefits that are too great to ignore. If the promise is to be fulfilled, and it must certainly be tested to be sure that it can be, medical science must redirect its biomedical gaze towards these more holistic horizons. And that redirection of its gaze will require that it is more willing to adopt ways of looking at illness-disease-sickness, and at health care and healing that are far more flexible and versatile than the ‘hierarchy’ of evidence has hitherto permitted. Medical science must acknowledge that there are ways of knowing and things to be known that exceed the scope of its presently dominant paradigm. The examples given in these pages point the way.
Science, the systematically organised expression of our desire to know the world truly, admits to no boundaries. But medical science is an applied science. As a doctor I am guided in my practice as much by an awareness of what I should not do as of what I should do. There are questions that I must ask, and questions that I must not ask unless the patient invites them, at least implicitly. There are insights that I must not offer unless and until the patient is ready to receive them; things I must not say because they would be inappropriate, impertinent or unkind. There are procedures I must not perform without the patient’s consent; prescriptions I must not make unless they are really needed and will be tolerated. This often requires great sensitivity, discretion and restraint. In other words I have a repertoire of knowledge and skills, and personal attributes, which must always be subordinated to my compassionate understanding of the person in my care and the context of that particular therapeutic encounter. It must be appropriately applied.
The application of science in medicine must be similarly discriminating, and always have a person in its gaze, even when it is a molecule that is the precise focus of attention. This is a shared responsibility between the clinician and the scientist. Scientists must fully understand the implications that the application of their science will have for the therapeutic process, the healing relationship. They must not promote its application simply out of their scientific enthusiasm for its possibilities, just as I must not impose some treatment on a patient simply because of my enthusiasm for that particular drug or procedure, or therapeutic theory. And the clinician must not adopt a scientific advance just because it becomes available. It must never be true, to misquote David Haslam again, that we use the medical science because the medical science is what we use. We must never be tempted to use a laboratory test just because it has become a cheaper and easier way of managing a patient if it does not help us to understand that patient’s predicament truly; particularly if it becomes a substitute for listening to the patient carefully. And I mean carefully. Clinicians must never succumb to the lust described by D.H. Lawrence and quoted by David Horrobin4:
When I went to the scientific doctor
I realised what lust there was in him to wreak his
so-called science on me
and reduce me to the level of a thing.
So I said: Good morning! And left him.
There must be a dialogue between clinicians and scientists that ensures that what clinicians really need to know, or really need to have available to them, is translated into an agenda for the scientists. And that what scientists have to offer can be really usefully applied in clinical practice. The same principle applies to other fields of applied science, of course. And it begs the question—When should this dialogue begin? I suspect that to be truly fruitful it must begin at quite an early stage in a common educational pathway.
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This work reports the results of an evaluation study to assess the efficacy of the Early HeartSmarts (EHS) program in schools of the Salt Lake City, Utah, School District. The EHS program is designed to guide teachers with methods that support young children (3–6 y old) in learning emotion self-regulation and key age-appropriate socioemotional competencies with the goal of facilitating their emotional, social, and cognitive development. The study was conducted over one school year using a quasiexperimental longitudinal field research design with 3 measurement points (baseline, preintervention, and postintervention) using The Creative Curriculum Assessment (TCCA), a teacher-scored, 50-item instrument measuring students growth in 4 areas of development: social/emotional, physical, cognitive, and language development. Children in 19 preschool classrooms in the Salt Lake City School District were divided into intervention and control group samples (n = 66 and n = 309, respectively; mean age = 3.6 y). The intervention classes were specifically selected to target children of lower socioeconomic and ethnic minority backgrounds. Overall, there is compelling evidence of the efficacy of the EHS program in increasing total psychosocial development and each of the 4 development areas measured by the TCCA: the results of a series of analyses of covariance found a strong, consistent pattern of large, significant differences on the development measures favoring preschool children who received the EHS program over those in the control group.
Este trabajo informa los resultados de un estudio de evaluación de la eficacia del programa Early Heartsmarts (EHS) en las escuelas del Distrito Escolar de Salt Lake City, Utah. El programa EHS está diseñado para orientar a los maestros respecto de métodos de asistencia a niños pequeños (entre 3 y 6 años de edad) en el aprendizaje de técnicas de autorregulación emocional y competencias socioemocionales fundamentales, adecuadas para su edad, con el fin de favorecer su desarrollo emocional, social y cognitivo. Este estudio se realizó durante un año escolar, conforme un diseño de investigación de campo cuasi experimental y longitudinal, diseñada con tres puntos de medición (punto de partida, intervención previa e intervención posterior), en la que se utilizó una Evaluación del Currículo Creativo (TCCA, por sus siglas en inglés), un instrumento calificado por el maestro de 50 puntos para medir el crecimiento de los estudiantes en 4 áreas del desarrollo: social y emocional, físico, cognitivo y desarrollo del lenguaje. Los niños de los 19 salones de clase de nivel preescolar en el Distrito Escolar de Salt Lake City, se analizaron de manera fraccionada según muestras de intervención y de control de grupo (n=66 y n=309, respectivamente; edad promedio=3 a 6 años). Las clases de intervención fueron seleccionadas específicamente para examinar a niños de bajo nivel socioeconómico y pertenecientes a minorías étnicas. En general, existen pruebas convincentes de la eficacia del programa EHS para fomentar el desarrollo psicosocial total. Respecto de cada una de las 4 áreas de desarrollo que fueron medidas por la TCCA: los resultados de una serie de análisis de la covarianza mostraron un patrón sólido y consistente de diferencias notorias y significativas en las medidas de desarrollo que favorecen a los niños de preescolar que recibieron el programa EHS, respecto de aquellos del grupo de control.
EARLY HEARTSMARTS PROGRAM
The EHS program was designed to facilitate emotional awareness and psychosocial development in young children 3 to 6 years of age. To achieve this goal, the EHS program provides teachers with a curriculum to guide and support young children in learning several key emotional and social competencies known to facilitate psychosocial development (Table 1):
|The core of the Early HeartSmarts program (Institute of HeartMath, 2008) is teaching young children key social and emotional competencies known to facilitate their psychosocial growth and development:
|How the program Is Organized|
|Each of these skills builds successively through the main sections of the program.
|Shift and Shine Technique
|Heart Warmer Technique
how to recognize and better understand basic emotional states,
how to self-regulate emotions,
ways to strengthen the expression of positive feelings,
ways to improve peer relations, and
skills for developing problem-solving.
Key among these competencies are two simple emotion shifting tools: “Shift and Shine” and “Heart Warmer.” These tools were specifically adapted from the HeartMath system of emotional management tools to facilitate young children’s learning of emotion self-regulation skills.
Psychophysiology of Emotion Regulation
Research has shown that the positive emotion-focused tools and techniques that form the foundation of the EHS program can facilitate emotional self-regulation by teaching individuals, including children, the ability to make an intentional shift to a specific psychophysiological state, termed psychophysiological coherence (described below). This state has been shown to be associated with optimal psychosocial growth, learning, and performance.39–41 The basis of this ability to make such a shift lies in the fundamental role the heart plays in the emotional system and the critical communication link between the heart and the brain.
It is now known that heart’s pattern of rhythmic activity is directly responsive to changes in emotional states, as can be seen in the real-time example shown in Figure 1.40,41 During the experience of stress and negative emotions such as anger, frustration, and anxiety, heart rhythms become more erratic and disordered—incoherent. In such states, the corresponding patterns of afferent neurological signals sent from the heart to the brain produce an inhibition of higher cognitive functions (Figure 2), impeding brain processes necessary for functions such as attention, memory recall, abstract reasoning, problem solving, creativity, and the self-regulation of emotion and behavior. This cardiac neurological input also interacts with the brain’s emotional centers, where it acts to reinforce feelings of emotional stress and instability.47,48 Thus, when students come to school in a negative emotional state, the “inner noise” produced by such psychophysiological incoherence impairs the very cognitive resources needed for learning, academic performance, and prosocial behavior.43,45
Conversely, the experience of positive emotions, such as love or appreciation, is associated with a highly ordered, smooth, sine wavelike pattern of heart rhythm activity—heart rhythm coherence (Figure 1). In such positive affective states, the heart transmits an ordered and harmonious signal to the higher brain centers (Figure 2), facilitating cognitive and emotion regulation abilities and typically producing increased emotional stability and enhanced attention, memory recall, comprehension, reasoning ability, creativity, and task performance (see research reviewed in McCraty et al, 2009).15 This is a particularly important point in understanding the operative mechanism of the HeartMath techniques taught in the EHS program.
Furthermore, sustained positive emotions induce a system-wide shift to psychophysiological coherence,15,41 a state in which the brain, nervous system, and entire body operate with increased synchronization and harmony (Figure 3). Physiological correlates of the coherence state include increased synchronization between the 2 branches of the autonomic nervous system; a shift in autonomic balance toward increased parasympathetic activity; increased vascular system resonance; increased heart-brain synchronization (the brain’s α rhythms exhibit greater synchronicity with the heartbeat); and entrainment between the heart rhythm and other physiological oscillatory systems. The coherence state is also marked by reduced perceptions of emotional stress, enhanced positive emotional experience, and improved cognitive function and task performance.15,41 Moreover, studies have shown that psychophysiological states such as coherence that naturally enhance para-sympathetic activity play an important role in facilitating children’s development of effective emotion regulation, prosocial behavior, and cognitive function.49,50
A pioneering discovery was that the psychophysiological coherence state can be intentionally generated. This shift to coherence can be achieved by using a positive emotion-based system of easy-to-use tools and techniques.51,52(See Figure 1 for a real-time example of this shift.) Briefly, these techniques couple an intentional shift in attention to the physical area of the heart with the self-activation of a positive emotion like love or appreciation. This rapidly initiates a distinct shift to increased coherence in the heart’s pattern of rhythmic activity. In turn, this produces a change in the pattern of afferent cardiac signals sent to the brain, which reinforces the self-generated positive emotional shift and makes it easier to sustain.
Typically, the shift to coherence induces enhancements in perception and cognition that enable more effective memory, reasoning, decision making, and action when confronted with stressful or challenging situations. Furthermore, with regular practice, these physiological, emotional, and cognitive patterns become increasingly familiar to the brain, ultimately establishing a new set point by which the system then strives to maintain these upgraded, healthier patterns of psycho-physiological function. The occurrence of such a psychophysiological “repatterning” process facilitated by the HeartMath system of coherence-building techniques is supported by studies conducted in diverse populations, documenting enduring improvements in health, emotional well-being, attitudes, behaviors, and relationships in individuals who practiced these techniques over several months’ time.53–56
Research also supports the efficacy of this approach in educational settings, where the introduction of programs incorporating coherence-building tools and techniques at the elementary, middle school, high school, college, and graduate levels has been demonstrated to improve emotional disposition, psychosocial functioning, learning, test anxiety management, and academic performance.43,45,46,53,57 Controlled laboratory experiments using electrophysiological measures have also shown that both middle school and high school students can acquire the ability to self-activate the coherence state by using the HeartMath emotion self-regulation tools and that they are able to effectively apply this skill during a stressful or challenging situation.46,53
RESEARCH DESIGN AND METHODS
The study evolved informally as a research opportunity resulting from discussions between IHM’s education division staff and officials in the Salt Lake City, Utah, School District. The study was conducted in the 2006–2007 school year on all preschool classes in the district and employed a quasi-experimental, longitudinal field research design with intervention and control groups. The Creative Curriculum Assessment instrument (TCCA) was administered by teachers, who evaluated each child on 50 items measuring student growth on 4 development dimensions—social/emotional, physical, cognitive, and language development58—at 3 measurement moments over the course of the school year. There were a total of 19 schools in the study, each with one preschool class. Students in the preschool classes were divided into intervention and control group samples, in which classes in the former were specifically selected to target children of lower socioeconomic and ethnic minority family backgrounds. Three preschool classes constituted the intervention group to which the EHS program was provided; the total student count for these classes was 66 preschoolers.a Sixteen preschool classes from the remaining schools constituted the control group, which had a total student count of 309.
The study hypothesis was that, relative to the control group, children in the intervention group would exhibit an increased level of development along the 4 TCCA development dimensions of psychosocial growth—social and emotional, physical, cognitive, and language development—following exposure to the EHS program over the school year study period.
In late January 2007, two members of IHM’s Education Division conducted a 1-day training for teachers selected to introduce the EHS program into their preschool classes. The goal of the training was to provide the teachers with a working familiarity with the scientific foundation of the HeartMath System as well as the EHS concepts, tools, techniques, and materials prior to their beginning classroom instruction. Teachers then delivered the EHS program (presented in summary form in Table 1) to their students throughout the rest of the school year through the end of May 2007.
TCCA instrument has been psychometrically validated as an assessment instrument and is widely used in schools throughout the United States. It was adopted by the Salt Lake City School District as a standardized means of systematically assessing the psychosocial development of all preschool students in the 19 schools in the district.
The TCCA is organized into 4 distinct dimensions covering the social/emotional, physical, cognitive, and language areas of a child’s development. Each dimension is divided into subcategories and then measurement items on which the teacher evaluates and scores each child. Altogether, there are 50 measurement items—13 in social/emotional development, 8 in physical development, 16 in cognitive development, and 13 in language development. For each item, the teachers assessed and scored each child’s development on a 4-point competency/proficiency rating scale: 0 = Forerunners; 1 = Step I; 2 = Step II; 3 = Step III.b Over the 2006–2007 school year, the teachers completed the TCCA 3 times: the first (baseline measurement) in October, 2006; the second (preintervention measurement) in early January, 2007; and the third (postintervention measurement) at the end of April, 2007.
Table 2 shows the breakdown of the study population in terms of sociodemographic characteristics. Aggregated across the 3 intervention and 16 control schools, there were a total of 375 children in the study’s sample population, ranging from 2.8 to 4.7 years of age. Of these, 66 (17.6%) were in the intervention group and 309 (82.4%) were in the control group. The 2 samples were comparable on both age and gender, with a mean age of 3.6 years each and with a nearly even division on gender: 48% male and 52% female for the intervention group and 49% male and 51% female for the control group. Reflecting sample selection, there is a difference in family socioeconomic status in that while almost two-thirds (64%) of the intervention group received a free lunch from the school district, only half (48%) of the children in the control group did so. Also, there are notable differences in ethnic composition: there was a greater proportion of Hispanic children in the intervention group (65% vs 51%) and a much lower proportion of white children (8% vs 33%, respectively). Finally, there was a greater range in class size in the control group (11–28 children vs 18–26, respectively), and the mean class size was slightly smaller in the intervention group (19.31 vs 22.00).
|All students (n = 375)||Intervention Group (n = 66)||Control Group (n = 309)|
|Mean Age ± SD, y (Range 2.8 – 4.7)||3.6 ± 0.32||3.6 ± 0.31||3.6 ± 0.33|
|Gender, % male||49||48||49|
|Free lunch, %||51||64||48|
|No. of classes||19||3||16|
|Class size, mean (range)||19.7 (11–28)||19.3 (18–26)||22.0 (11–28)|
Abbreviations: NA, not available; SD, standard deviation.
For each development dimension, a child’s scores on the items involved were aggregated to construct a scale score for that dimension and then aggregated again across all 50 items to construct a total development scale score. Students were scored on each of the 50 items using the values on the 4-point rating scale. Since the lowest point value on the rating scale was 0, the maximum score for any item was 3 points, which, summed over the 50 items, yields a total possible development scale score of 150 points.
Using the whole sample, we conducted an item analysis and a validity and reliability of measurement analysis of the TCCA instrumentation—development scales, subcomponents, and individual items (results available in Bradley et al, 2009).59 Starting with the item analysis, the range of the point-biserial order correlation (pbs [.rho]) over the 50 items across the 3 measurement moments was 0.26 to 0.82. There were no items with a 0 or negative pbs [.rho], so all items met the minimum criteria for technically acceptable measurement and indicate an adequate level of discrimination between high- and low-performing children on the assessment. The standard error of measurement (SEM) for the total development score was ff1.05, ff1.29, and ff1.20 points for time 1 (T1), time 2 (T2), and time 3 (T3), respectively, and ranged from ff0.15 to 0.44 for the 4 development dimensions over all 3 measurement moments—all well within psychometrically acceptable limits.
Turning to the results of the validity and reliability of measurement for the total development score, the T1, T2, and T3 Cronbach’s α reliability coefficients were all high (0.97, 0.98, and 0.98, respectively). With the exception of somewhat lower α coefficients for physical development (0.80, 0.86, and 0.86), high α coefficients also were observed on the other 3 development dimensions (ranging from 0.92 to 0.95). Though lower α coefficients were observed for the subcomponents within each of the 4 development dimensions (ranging from 0.71 to 0.93), they were, with 3 exceptions (gross motor, T1, and fine motor, T1, and T2), all above 0.80. Overall, the results indicate a high degree of internal consistency.
We also conducted a factor analysis with varimax rotation to evaluate the degree of convergent and discriminant validity in the EHS study data. Though there were some exceptions, the factors and loadings and item classifications are generally consistent with the results of the original validation study. In short, the results of these analyses indicate that the baseline, preintervention, and postintervention measures appear to have psychometric integrity as measurement constructs.
The line graph in Figure 4 plots the results of these measurement procedures for the whole study population’s mean total development score and mean scores for the 4 development dimensions at the 3 moments of measurement. Clearly evident is a strong upward trend in development on all 5 measures over the 3 time points. Thus, the mean total development score rose from 47.71 at baseline to 90.71 at the preintervention moment to 124.15 at the postintervention measurement moment: a T1-to-T3 increase of 160.22%. For the development dimensions, the greatest increase in mean score observed was for cognitive development, 13.90 to 38.79 (an increase of 179.06%) whereas the lowest increase was for physical development (9.29 to 21.56, an increase of 132.08%).
Baseline (Time 1) Results
Table 3 presents the results of a 1-way analysis of variance (ANOVA) of differences in mean score by intervention status on the 5 development scales at baseline broken down by gender, ethnicity, and socioeconomic status. Starting with the results for intervention status, significant differences on all 5 scales (P < .01) with a moderate or large effect size (ES,c 0.41–0.66) were observed between the control group and the intervention group. Though there are no differences by gender, there are significant differences mostly in the moderate effect size range (0.30–49) favoring white children over those with Hispanic or other ethnic affiliation on all development scales (P < .001) except physical development. A similar pattern is observed on the indicator of socioeconomic status: the non–free lunch children had significantly higher development scores than the free-lunch children on all scales (P < .05) except that for physical development.
|Mean||SD||SEM||Mean||SD||SEM||Mean||SD||SEM||ANOVA between Groups
|Mean Sq||F||ES||P <|
|Intervention Group (N=66)||Control Group (N=309)|
|Total Development Score||39.47||16.20||1.99||49.47||19.34||1.10||5434.40||15.33||0.56||.001|
|Social/Emotional Development Score||9.62||4.45||0.55||12.83||5.32||0.30||558.30||20.83||0.66||.001|
|Physical Development Score||8.33||2.19||0.27||9.49||2.93||0.17||73.00||9.23||0.45||.01|
|Cognitive Development Score||11.71||5.85||0.72||14.36||7.09||0.40||382.01||8.05||0.41||.01|
|Language Development Score||9.80||5.48||0.67||12.79||5.99||0.34||484.05||13.91||0.52||.001|
|Male (N=178)||Female (N=189)|
|Total Development Score||47.25||19.62||1.47||48.01||18.93||1.38||52.68||0.14||0.04||ns|
|Social/Emotional Development Score||11.98||5.40||0.40||12.46||5.30||0.39||20.87||0.73||0.09||ns|
|Physical Development Score||9.31||3.01||0.23||9.29||2.72||0.20||0.08||0.01||0.01||ns|
|Cognitive Development Score||13.92||7.15||0.54||13.78||6.79||0.49||1.89||0.04||0.02||ns|
|Language Development Score||12.03||6.17||0.46||12.48||5.86||0.43||18.84||0.52||0.08||ns|
|Hispanic (N=202)||White (N=108)||Other (N=65)|
|Total Development Score||43.34||15.87||1.12||56.70||20.95||2.02||46.34||20.66||2.56||6360.78||18.94||0.47||.001|
|Social/Emotional Development Score||11.49||4.65||0.33||13.94||5.86||0.56||11.88||5.72||0.71||216.17||7.94||0.30||.001|
|Physical Development Score||9.13||2.46||0.17||9.78||3.20||0.31||8.97||3.25||0.40||18.82||2.35||0.18||ns|
|Cognitive Development Score||12.25||5.70||0.40||17.28||7.84||0.75||13.38||7.03||0.87||898.88||20.54||0.49||.001|
|Language Development Score||10.47||4.97||0.35||15.71||6.08||0.58||12.11||6.37||0.79||969.89||31.30||0.60||.001|
|Non–Free Lunch (N=184)||Free Lunch (N=191)|
|Total Development Score||50.98||20.88||1.54||44.55||16.86||1.22||3879.50||10.82||0.34||.01|
|Social/Emotional Development Score||12.93||5.67||0.42||11.61||4.88||0.35||163.84||5.88||0.25||.05|
|Physical Development Score||9.49||3.12||0.23||9.09||2.54||0.18||15.41||1.91||0.14||ns|
|Cognitive Development Score||15.22||7.46||0.55||12.62||6.18||0.45||635.98||13.60||0.38||.001|
|Language Development Score||13.33||6.47||0.48||11.23||5.33||0.39||413.75||11.82||0.36||.001|
Abbreviations: ANOVA, analysis of variance; ES, effect size; F, ANOVA test statistic; NS, not significant; SEM, standard error of measurement; Sq, square.
Two points emerge from these results: first, that the intervention and control groups were not well matched at baseline on the 5 development scales; second, that in the analysis that follows, it was necessary to control for the effects of ethnicity and free-lunch status in the event that pre-to-postintervention differences in development are observed between the intervention and control groups.
In the analysis of the effects of the EHS intervention, we conducted 2 analyses. The first—a within-groups analysis—was conducted on the intervention and control groups separately in order to investigate the degree of pre-post change in development within each group. The second—a between-groups analysis— was conducted to identify changes in development in the intervention group that could be attributed to any observed effects of the EHS intervention by comparing the differences in pre-post changes in development between the 2 groups.
For the within-groups analysis, we employed a within-subjects repeated measures procedure on the 5 development scales to investigate the changes in development in the 2 periods up to and then following the EHS intervention—T1 to T2 and T2 to T3, respectively. Though a lower rate of development in the preintervention period (T1 to T2) was expected in the intervention group relative to the control group, given the former’s disadvantaged status on the baseline measures, a higher rate was expected following exposure to the EHS intervention. However, as shown in Table 4, a different pattern of results was observed.
||Time 1 vs Time 2
||Time 2 vs Time 3
|Mean||SD||Mean||SD||Mean||SD||Mean sq||F||ES||P <||Mean sq||F||ES||P <|
|Within-subjects Repeated Measures, Intervention Group|
|Within-subjects Repeated Measures, Control Group|
Abbreviations: ES, effect size; SD, standard deviation; Sq, square.
Across all 5 development scales, though a significant increase in mean score (P < .001, on all measures) of an extremely large ES (ES ranges from 1.17–2.81 over all measures) was observed in both time periods for each group, the greatest increase in development occurred in the first period, T1 to T2. This pattern is typified by the total development data. Thus, the results for the intervention group show that the greatest increase in development occurred in the first period, before the EHS intervention (T1-T2 D mean score = 53.15 points, ES 2.73; T2-T3 D mean score = 38.69 points, ES 1.84). Although somewhat smaller in magnitude, a similar pattern was observed for the control group (T1-T2 D mean score = 40.64 points, ES = 1.91; T2-T3 D mean score = 32.42 points, ES = 1.43).
There are 2 points of interest here. One is that this pattern is similar in both groups. This suggests some underlying commonality, such as the initial novelty of children first entering a new, stimulating social environment, the preschool class. It could be expected that after the children experience an accelerated growth rate, they then adapt as the school environment becomes more familiar. The second point is that although the pattern is similar in both groups, there is a more elevated growth in the intervention group during the first period both in relation to the control group in the first period and also in relation to the intervention group’s rate of growth in the second period. A plausible explanation is that this pattern in the intervention group children may have resulted from an even more novel experience of a nurturing, growth-promoting teacher and the psychosocially stimulating preschool environment relative to the disadvantaged circumstances of an ethnic minority and/or lower socioeconomic family background characteristic of most children in this group. An alternative explanation for the pattern is the possibility of a Hawthorne effect: namely, that the intervention group teachers may have (consciously or unconsciously) inflated the ratings of their students in the preintervention period. Unfortunately, there were insufficient cases with the required combination of ethnosocioeconomic characteristics to investigate the first explanation posited above for the elevated rate of development observed. However, we were able to investigate the question of a potential Hawthorne effect, the results of which are presented below.
Even with this pattern, the smaller degree of change in the second period was still very large (ES range 1.17–1.99) and highly significant (P < .001) across the 5 measures in both groups. Determining how much of this increase in development in the intervention group is attributable to the effects of the EHS program requires a between-groups comparison of the 2 groups, in which any differences in the measures of development at the baseline (T1) and preintervention (T2) moments are statistically controlled. We turn to this all-important question next.
The primary statistical analysis technique used to investigate pre-post changes in development was analysis of covariance (ANCOVA). An important advantage of ANCOVA is that the baseline (T1) and preintervention (T2) differences on the development measures between the intervention and control groups are statistically adjusted to make them comparable before the change effects are estimated. This is accomplished by treating them as covariates in the statistical model. We begin with the results by intervention status before moving to the breakdowns by gender, ethnicity, and family socioeconomic background.
Figure 5 and Table 5 present the results for the 5 development scales and the 10 subcomponents by intervention status. Clearly evident is the strong consistent pattern of moderate to large, significant differences on all 15 measures of development, favoring the intervention group over the control group. On 10 of the 15 measures, including 4 of the 5 development scales, the magnitude of the difference was large and highly significant (ES > 0.60, P < .001). More specifically, from the adjusted means on the 5 development scales, a significant difference with a large ES was observed favoring the intervention group on the total development scale (130.96 vs 122.79, respectively; ES 0.81, P < .001) and on each of the social/emotional development (34.95 vs 31.90, ES 0.97, P < .001), physical development (22.59 vs 21.35, ES 0.79, P < .001), cognitive development (40.58 vs 38.41, ES 0.55, P < .01), and language development (33.74 vs 30.99, ES 0.73 P < .001) scales. At the subcomponent level, 6 of the 10 constructs had differences favoring the intervention group that were large in terms of ES and highly significant: sense of self, ES 1.05, P < .001; responsibility for self and others, ES 0.61, P < .001; prosocial behavior, ES 0.94, P < .001; fine motor, ES 0.68, P < .001; learning and problem solving, ES 0.65, P < .001; and reading and writing, ES 0.84, P < .001.
|Spring Post-study Between-Group Effects
|Intervention Group (n = 65)
||Control Group (n = 301)
|Adj Mean||SEM||Lower 95% CI||Upper 95% CI||Adj Mean||SEM||Lower 95% CI||Upper 95% CI||Mean Sq||F|
|Total Development Score||130.96||1.72||127.57||134.35||122.79||0.77||121.27||124.31||3200.92||18.13||0.81||.001|
|Social/Emotional Development Score||34.95||0.54||33.89||36.02||31.90||0.24||31.42||32.38||446.46||25.69||0.97||.001|
|Physical Development Score||22.59||0.27||22.07||23.12||21.35||0.12||21.12||21.59||77.74||17.60||0.79||.001|
|Cognitive Development Score||40.58||0.68||39.25||41.92||38.41||0.31||37.81||39.02||235.35||8.33||0.55||.01|
|Language Development Score||33.47||0.58||32.34||34.61||30.99||0.26||30.48||31.51||303.67||14.99||0.73||.001|
|Sense of Self||11.09||0.19||10.71||11.46||9.92||0.09||9.75||10.08||63.73||29.98||1.05||.001|
|Responsibility for Self and Others||13.24||0.26||12.72||13.75||12.29||0.12||12.06||12.53||43.52||10.40||0.61||.001|
|Learning and Problem Solving||12.45||0.27||11.92||12.97||11.42||0.12||11.18||11.66||53.38||12.00||0.65||.001|
|Representation and Symbolic Thinking||8.26||0.17||7.93||8.60||7.78||0.08||7.63||7.94||11.15||6.38||0.48||.05|
|Listening and Speaking||15.64||0.28||15.08||16.19||14.81||0.13||14.56||15.06||32.68||6.91||0.50||.01|
|Reading and Writing||17.89||0.33||17.24||18.55||16.25||0.15||15.95||16.55||138.65||20.23||0.84||.001|
Abbreviations: Adj, adjusted; CI, confidence interval; ES, effect size; F, ANOVA test statistic; SEM, standard error of measurement; Sq, square.
To investigate the degree to which these observed differences in development were not mediated by one or more intervening sociodemographic factors identified as significant at baseline, an ANOVA was conducted on the 5 development scales controlling for gender, ethnic status, and socioeconomic family background (free-lunch status). The results are presented in Table 6.
|Spring Post-study Between-Group Effects
|Dependent Variable||n||Adj Mean||SEM||Lower 95% CI||Upper 95% CI||N||Adj Mean||SEM||Lower 95% CI||Upper 95% CI||Mean Sq||F||ES||P <|
Abbreviations: CI, confidence interval; F, ANOVA test statistic; ES, effect size; NS, not significant; SEM, standard error of measurement.
Beginning with the results (adjusted means) for the total development scale, a consistent pattern of moderate to large, significant differences is observed favoring the intervention over the control group: for boys (128.10 vs 121.35, ES 0.47, P < .05), girls (133.876 vs 124.42, ES 0.65, P < .001), Hispanic children (129.60 vs 121.22, ES 0.63, P < .001), white children (130.62 vs 121.87, ES 0.44, P < .05), free-lunch recipients (131.61 vs 125.29, ES 0.56, P < .01), and non–free lunch recipients (130.09 vs 120.33, ES 0.57, P < .01). These results suggest a markedly greater level of development for children with these characteristics who were exposed to the EHS program than those who were not.
Moving to the 4 development scales, for girls, Hispanic children, and free lunch students, there is a pattern of a significantly greater increase in development in the intervention group compared to the control group on all 4 scales. With the exception of the cognitive development scale, the same pattern is observed for boys and non–free lunch students. For white students, though, this difference is evident only on 2 dimensions—physical development and language development.
We conducted another ANCOVA to investigate the degree to which the observed differences between the 2 groups of children were not confounded by an underlying difference in class size (results not shown; available in Bradley et al, 2009).59 To conduct the study, we constructed a matched-group comparison by selecting classes from the control group sample that were close to or within the class size range (18–24 children) of the 3 classes in the intervention group. There were 4 classes in the control group (total n = 90) with a class size of between 17 and 26 children, and we selected these for the matched-group comparison. Coincidentally, these 7 classes also were within the same range on mean baseline total development score (35.78–42.71 points). This enabled us to simultaneously control for the effects of baseline differences between the intervention and control group on both class size and total development, providing for a somewhat more rigorous matched-groups analysis. As previously, to control for any differences in development between the 2 groups in the preintervention period, development scores at T1 and T2 were deployed as covariates in the statistical model.
A notable, significant difference in the pre-post increase in the mean total development score is observed for the intervention group over the matched-group sample from the control group (123.68 vs 115.93, respectively, ES 0.61, P < .001). A similar difference is evident for 3 of the 4 development dimensions: social/emotional development (33.14 vs 29.53, ES 0.81, P < .001); physical development (21.86 vs 20.74, ES 0.55, P < .01), and language development (31.43 vs 28.60, ES 0.63 P < .001). In short, when baseline differences in class size and total development are controlled, there is still compelling evidence of markedly greater development in the children who participated in the EHS program than in those who did not.
Split-half Sample Analysis
As the final step in the primary analysis, we conducted a split-half sample analysis (results not shown; available in Bradley et al, 2009).59 In a typical application, the procedure involves randomly dividing the study sample population into halves and then repeating the analysis separately on each half-sample. This enables a check on the statistical integrity of nonrandom samples and also provides some indication of the likely generalizability of results.
To conduct this analysis, we randomly divided the intervention and control groups into 2 approximately equal subgroups each and then repeated the pre-post ANCOVA comparison on each of the two half-sample pairings, accordingly: viz, random split (RS) 1: first intervention subgroup vs 1st control subgroup; RS2: second intervention subgroup vs second control subgroup. As an extra precaution, we not only conducted the analysis on the 5 development scales and but also included the 10 subcomponents of the 4 development dimensions as well.
Beginning with the 5 development scales, a comparison of the results for RS1 to those for RS2 found that, with one exception (cognitive development scale), a pattern of moderate to large, significant differences favoring the intervention group on the other 4 development measures was evident in both ANCOVAs. This suggests that the intervention results on the total development scale and the social/emotional, physical, and language development scales appear to be robust, are unlikely to be the result of sample bias, and are probably generalizable to children with similar characteristics.
To investigate the key question of a pre-postintervention effect, we used a rigorous multivariate procedure—ANCOVA—in order to be statistically confident that any observed pre-postintervention differences could not be the result of differences at baseline between the 2 groups. This procedure revealed a strong pattern of differences favoring the intervention group children on the 5 development dimension scales as well as on the 10 subcomponents. This intervention effect also was observed on the total development scale for each of the sociodemographic categories examinedd (male, female, Hispanic, white, free lunch, and non–free lunch) and also for female, Hispanic, and free-lunch on all 4 development dimension scales and for whites on the physical development and language development scales. These results are consistent with the findings of prior studies on the implementation of programs using similar emotion self-regulation techniques in elementary, middle, and high schools and tertiary education.43,45,46,53,57
The strong evidence of an EHS intervention effect appears robust. Both the matched-groups analysis (in which we controlled for baseline differences in class size and total development score) and the random split-half sample analysis found essentially the same prepostintervention differences in development favoring the intervention group on the total development scale, and also on 3 of the 4 development dimension scales— social/emotional development, physical development, and language development. The random split-half sample results are noteworthy in that they suggest that on these development measures, it is unlikely that the differences between the 2 groups are due to sample bias and are probably generalizable to children with similar characteristics and in similar educational contexts as those in the intervention group.
Overall, the strong, consistent pattern of positive pre-to-postintervention results provides compelling evidence of the efficacy of the EHS program in promoting greater development across the 5 primary measures—total development, social/emotional development, physical development, cognitive development, and language development.
The study evolved as an adjunct investigation to the research already being conducted on the development of preschoolers in all schools in the Salt Lake City School District. Some limitations came with this research strategy.
One limitation concerns the generalizability of the study’s results. There are 2 potential issues: (1) the lack of randomization in sample selection and intervention/control group assignment and (2) the degree to which the study population is broadly representative of the population of preschoolers in the United States as a whole. Though the lack of randomization for sample selection is not an issue, because all 19 schools in the Salt Lake City School District were included, it is a limitation of the criterion-reference procedure used to assign intervention or control group status. Even so, the results from the random split-half sample analysis suggest, in broad terms, that the primary findings appear to be generalizable to preschool children in similar sociogeographic contexts and with similar sociodemographic characteristics. Concerning the second issue, further research will be necessary on samples that are more representative of US preschool children as a whole in order to confirm the efficacy of the EHS program in promoting growth and development more broadly.
Another limitation was that the teachers were not completely blinded to the study’s goals and desired outcomes and therefore could have consciously or unconsciously acted to affect the results. Although we found little evidence of scoring bias in the teachers’ ratings, we cannot definitively rule out such an artifact.
A final limitation is that the children’s scores are all based on observation, evaluation, and rating from a single source: their teachers. Although we were mostly able to address the basic psychometric issues of rating consistency, measurement validity, reliability, and discrimination in the item analysis we performed, future studies should be conducted using at least 2 independent observers to rate each child’s development on the measurement items.
Of the key socioemotional competencies in early childhood that lay the foundation for future development and the potential for adult psychosocial growth, well-being, and accomplishment, emotional self-regulation is core.16,17 Yet as noted at the outset, a disturbing proportion of preschool children, especially those from ethnic minority and low socioeconomic family backgrounds, lack the fundamental socioemotional skills needed to learn and function effectively at school. Although the EHS program was developed with the broader goal of enhancing the psychosocial development of all preschool children, it was expected that the program would have particular application in facilitating development in children from disadvantaged family backgrounds and circumstances.
Despite the limitations noted above, the results are striking in that there is strong evidence of an intervention effect. First, across all of the analyses performed, a consistent pattern of large, significant differences in growth on the primary development constructs—total development scale, social/emotional development scale, physical development scale, cognitive development scale, and language development scale, plus their 10 subcomponents (all but 2 subcomponents had a large effect size)—is evident for the children receiving the EHS intervention relative to those in the control group who did not. The magnitude of development observed for the intervention-group children is particularly striking, as they started the study with a significant development handicap relative to their peers in the control group. Yet after participating in the EHS program, they had surpassed the latter’s development growth by the end of the study.
A second important finding is the consistent pattern of pre-to-postintervention differences in total development score between the 2 groups for all of the sociodemographic categories investigated. Importantly, given the study’s targeting of ethnic-minority and low– socioeconomic status students, the evidence shows that the EHS program was effective in boosting the development of boys (with the exception of cognitive development), girls, Hispanic children, and free-lunch students in the intervention group on the 4 development dimensions—social/emotional, physical, cognitive, and language—beyond that of their peers in the control group. And it was effective for non–free lunch and white students in the intervention group, with the exception of cognitive development and language development scores, respectively.
A series of additional analyses found that these differences do not appear to be mediated by classroom size or explained by baseline differences in development between the 2 groups of children. Further, the evidence from a random split-half sample analysis corroborates the results for the whole intervention and control group samples and indicates that the findings for all but 1 of the 5 development scales (cognitive development) are robust and likely generalizable to children of comparable sociodemographic characteristics.
In sum, the strong, consistent pattern of positive results observed across all analyses is compelling evidence of the efficacy of the EHS program in significantly facilitating a marked growth in development in preschool children.
An important point to emphasize is that these results are for very young preschool children, 96% of whom were between 3 and 4 years old. It is both striking and remarkable that children as young as 3 years can begin to learn and practice the emotion self-regulation skills they were taught in the EHS program, which appears to facilitate their psychosocial development. Given that the age range from 3 to 6 years is a period of accelerated neurological growth and psychosocial development, it is likely that the learning and sustained use of these competencies and skills during this important developmental period will readily instantiate a new set point in the young child’s nervous system for an optimal pattern of psychophysio-logical function and thereby significantly boost the development trajectory of future psychosocial growth.
Establishing this key set point early in the child’s life, when neural connectivity is still highly malleable, and then sustaining it throughout the whole educational process with programs building on these foundational skills sets the child on a thriving life course of health, well-being, achievement, and social responsibility. Correspondingly, the integration of programs designed to foster socioemotional competence into educational curricula—beginning in preschool— should help prevent manifestation of much of the psychosocial dysfunction and pathology that not only robs individuals of a fulfilling life but also results in an enormous cost to our society.
Development of the Early HeartSmarts (EHS) program was made possible by a generous grant from the Kalliopeia Foundation, San Rafael, California. We are grateful to the Salt Lake City School District personnel for their willingness to sponsor and implement the EHS evaluation, in particular Dr Patrick Galvin and Ms Donna Anderson for their roles in designing and carrying out data collection for the study. We also thank the teachers in the study, especially those who taught the classes included in the intervention group, and we extend our appreciation to all the children who participated in the study. Jeffrey Goelitz of Institute of HeartMath (IHM) coordinated all aspects of the study with the Salt Lake City School District. We are indebted to Drs Karl H. Pribram and Allan N. Schore for providing helpful comments on an earlier draft of this report. Finally, it should be noted that Dr Raymond Bradley and Dana Tomasino are independent research consultants to IHM, whose involvement in the EHS study began in 2009 after the data were collected.
|Items, no.||Cases, no.||Point Bi-serial Correlation
|Fall Pre-study Score (Time 1)|
|Sense of Self||4||353||0.63||0.66||3.86||1.88||0.10||0.82|
|Responsibility for Self and Others||5||366||0.52||0.72||4.95||2.12||0.11||0.85|
|Learning and Problem Solving||5||365||0.63||0.77||4.26||2.25||0.12||0.87|
|Representation and Symbolic Thinking||3||367||0.63||0.70||2.93||1.35||0.07||0.81|
|Listening and Speaking||6||355||0.47||0.81||6.87||3.03||0.16||0.88|
|Reading and Writing||7||353||0.46||0.72||5.80||3.12||0.17||0.85|
|Winter pre-study score (time 2)|
|Sense of Self||4||362||0.71||0.76||7.54||2.36||0.12||0.87|
|Responsibility for Self and Others||5||363||0.63||0.81||9.07||2.80||0.15||0.90|
|Learning and Problem Solving||5||362||0.72||0.79||8.33||2.79||0.15||0.90|
|Representation and Symbolic Thinking||3||362||0.65||0.77||5.68||1.72||0.09||0.84|
|Listening and Speaking||6||357||0.57||0.83||11.39||3.67||0.19||0.91|
|Reading and Writing||7||364||0.55||0.79||11.45||3.97||0.21||0.90|
|spring post-study score (time 3)|
|Sense of Self||4||365||0.61||0.76||10.20||2.02||0.11||0.84|
|Responsibility for Self and Others||5||372||0.65||0.82||12.46||2.84||0.15||0.91|
|Learning and Problem Solving||5||373||0.73||0.79||11.58||2.86||0.15||0.91|
|Representation and Symbolic Thinking||3||374||0.71||0.81||7.87||1.55||0.08||0.87|
|Listening and Speaking||6||371||0.62||0.83||15.01||3.19||0.17||0.90|
|Reading and Writing||7||371||0.64||0.83||16.53||4.05||0.21||0.92|
Abbreviations: Min, minimum; max, maximum; SD, standard deviation; SEM, standard error of measurement.
aThe selection of intervention group schools was made by members of the Salt Lake City School District staff.
bThe rating process requires the teacher to identify the developmental level of each child for each item using a 4-point scale. The proficiency requirements for each item (Table 1) are phrased in terms of specific behaviors and functional areas (with exemplars) anchored to each level of the rating scale. The Forerunner level represents behaviors that may indicate a developmental delay or that a child has not previously been exposed to that skill and is scored to emphasize the child’s strengths upon which future development and instruction can build. While Step III represents complete mastery of a particular goal, Step I and Step II represent distinct successive phases of development a child moves through on the way to mastery.
cEffect size (ES) was computed by dividing the mean difference by the pooled standard deviation. Following Cohen’s (1988) guidelines for interpreting the meaning of the ES coefficient’s magnitude: < 0.10 trivial effect; 0.10–0.29 small effect; 0.30–0.49 moderate effect; ≥ 0.50 large effect.
dThere were too few cases in the intervention group’s “Ethnicity-other” category (n = 5) for this analysis.
Raymond Trevor Bradley, Raymond Trevor Bradley, PhD, is director of the Institute for Whole Social Science, Capitola, California.
Patrick Galvin, Patrick Galvin, PhD, is a research consultant and former director of research and evaluation, Salt Lake City School District, Salt Lake City, Utah.
Mike Atkinson, Mike Atkinson is laboratory manager at the Institute of HeartMath, Boulder Creek, California.
Dana Tomasino, Dana Tomasino is a research assistant at the Institute for Whole Social Science.
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As part of its efforts to disseminate the results of Cochrane reviews to a wider audience, the Cochrane Complementary and Alternative Medicine (CAM) Field develops Summary of Findings (SoF) tables and then uses these tables as a basis for its Plain Language Summaries. In each SoF table, the most important outcomes of the review, the effect of the intervention on each outcome, and the quality of the evidence for each outcome are presented. The process of developing the SoF table involves deciding which outcomes to present for which time points and evaluating the strength and quality of the evidence for the outcomes. The Cochrane CAM Field contacted the authors of this review to request clarification on any points that are not understood in the Cochrane review and also to request their review of the SoF. In this article, review authors in the Cochrane Collaboration reviewed the effects of horse chestnut seed extract for chronic venous insufficiency.
CHRONIC VENOUS INSUFFICIENCY AND HORSE CHESTNUT SEED EXTRACT
Chronic venous insufficiency (CVI) is characterized by a chronic inability of veins in the lower leg to transport blood back toward the heart due to damage to the one-way valves within the leg veins. This damage is caused by blood clots (deep vein thromboses) or other factors, such as congenital disorders. This results in venous hypertension, an increase in pressure within the veins in the leg.
The signs of CVI include swelling of the leg, feelings of tired and painful legs, dry scaly skin, varicose veins, hardening of the skin, and leg ulcers (open wounds on the lower legs that do not heal after 6 weeks). CVI severity is often graded into 3 categories: stage I, swelling (edema); stage II, swelling (edema) plus skin changes; stage III, the presence of open or healed leg ulcers. Stage III is considered the most severe stage of CVI. About 10% to 15% of adult men and 20% to 25% of adult women present signs and symptoms consistent with a diagnosis of CVI, and the prevalence increases with age.
The horse chestnut (Aesculus hippocastanum L) is a large tree growing to about 25 to 30 m in height. The seed of the horse chestnut is a small brown nut. Unprocessed horse chestnut seeds contain a toxin called esculin (also spelled aesculin). This toxin may increase the risk of bleeding due to its ability to prevent blood clots from forming. The unprocessed seeds are poisonous, and symptoms associated with horse chestnut seed poisoning include vomiting, diarrhea, headache, confusion, weakness, muscle twitching, poor coordination, coma, and paralysis. Horse chestnut seeds are therefore processed to remove the toxic component, resulting in purified horse chestnut seed extract (HCSE).
The active component of HCSE is called escin (also spelled aescin). Escin appears to promote blood circulation through the veins and thereby reduce swelling and inflammation of the legs. It is not exactly clear how escin works, but theories include that it works by “sealing” leaking capillaries, improving the elastic strength of veins, preventing the release of enzymes that damage the blood vessels, and blocking other various physiological events that lead to vein damage.
The most common dosage of horse chestnut is 300 mg HCSE twice daily, standardized to contain 50 mg escin per dose, for a total daily dose of 100 mg escin.
In theory, horse chestnut may increase the risk of bleeding. In addition, animal studies suggest that HCSE may cause lowered blood sugar.
WHAT DOES THE RESEARCH SAY?
Not all research provides the same quality of evidence. The higher the quality, the more certain we are about what the research says about an effect. The words will (high-quality evidence), probably (moderate-quality evidence), and may (low-quality evidence) describe how certain we are about the effect.
After searching for all relevant studies, the review authors found 17 studies that they included in the review. Ten of these studies were placebo-controlled trials. The trials showed that for people with chronic venous insufficiency, horse chestnut seed extract
probably reduces lower-leg volume,
may reduce circumference at ankle, and
may reduce circumference at calf.
We are uncertain of the effect of HCSE on leg pain and edema because the quality of the evidence is very low.
In general, side effects are poorly documented, and it is difficult to provide precise information. In these trials, some participants experienced gastrointestinal complaints, dizziness, nausea, headache, and itching.
WHERE DOES THIS INFORMATION COME FROM?
The Cochrane Collaboration is an independent global network of volunteers dedicated to summarizing research about healthcare.
A new search for studies and updated content was published in Issue 9, 2010 (no change to conclusions).
This article was prepared on behalf of the Cochrane Complementary and Alternative Medicine Field and with funding from the US National Center for Complementary and Alternative Medicine of the US National Institutes of Health (grant number R24 AT001293).
Vigdis Underland, Vigdis Underland, MS, Nordic Cochrane Centre’s Norwegian branch, Norwegian Knowledge Centre for Health Services, Oslo, Norway.
Ingvil Sæterdal, Ingvil Sæterdal, PhD; Nordic Cochrane Centre’s Norwegian branch, Norwegian Knowledge Centre for Health Services, Oslo, Norway.
Mysterious Disease Devastates Pacific Coast of Central America
A mysterious epidemic has killed more than 24 000 people in El Salvador and Nicaragua since 2000 and stricken thousands of others with chronic kidney disease at rates unseen almost anywhere else. Some suggest that agricultural chemicals are the cause, but others contend that the grueling nature of the work and dehydration are to blame. Dr Richard J. Johnson, a kidney specialist at the University of Colorado, Denver, and other researchers who are working to discover the cause of the disease suspect chronic dehydration.
To read the full article, click here. (Source: seattlepi.com)
Health Affairs Study Says Electronic Health Records May Not Cut Health Costs; Health IT Leaders Disagree
A study published this month in Health Affairs found that doctors using computers to track tests such as x-rays and magnetic resonance imaging ordered substantially more tests than doctors who relied on paper records.
A number of experts have suggested that electronic health records (EHRs) will help reduce unnecessary and redundant tests by giving doctors more comprehensive and timely information when making diagnoses, but this study showed the opposite: doctors with computerized access to a patient’s previous image results ordered tests on 18% of the visits, whereas those using paper records ordered tests on 12.9% of visits. In other words, physicians using electronic technology ordered 40% more image testing than those without the tracking technology.
Health information technology (IT) leaders are now voicing their disagreement with this contention. In a blog post soon after the study’s results were featured on numerous websites, Dr Farzad Mostashari, national coordinator for health information technology, said that the study’s results “tell us little” about whether electronic health records will help to reduce costs. Dr Mostashari cites several problems with the study authors’ analysis, a major one of which is that reducing test orders is not the way in which EHRs are intended to reduce costs.
Read the full article about the Health Affairs study here. (Source: The New York Times)
Read Dr Mostashari’s blog post here. (Source: US Department of Health and Human Services’ HealthITBuzz)
Study: Malaria During Pregnancy Stunts Fetal Growth
The results of a large-scale study conducted along the Thai-Burmese border indicate that malaria infection during the early months of pregnancy stunts fetal growth even when the mothers do not have any symptoms of malaria. The study, conducted by the Shoklo Malaria Research Unit, tracked 3779 women’s pregnancies from 2001 to 2010.
Pregnancy reduces a woman’s immunity, making pregnant women more vulnerable to malaria infections and increasing the risk of illness and death, according to the World Health Organization (WHO).
Though the potential effects of malaria on later stages of pregnancy and birth weight—including spontaneous abortion, stillbirth, and premature delivery—are well documented, the study by SMRU is among the first to show the effects of malaria on early fetal growth, even in areas where malaria infections are not nearly as prevalent as they once were.
Read more about the study’s results here. (Source: AsianScientist)
Urgent Humanitarian Aid Needed For 80 000 Sudanese Refugees
Only a short window of opportunity remains before the rainy season severely inhibits the urgent provision of humanitarian assistance to tens of thousands of Sudanese refugees in South Sudan, the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) warned recently.
Since November 2011, 80 000 refugees have fled violence in Sudan’s Blue Nile State, seeking shelter in the Doro and Jamam refugee camps. The camps are located in a remote and barren region of South Sudan, where humanitarian organizations confront massive logistic challenges to access and assist refugees. At the onset of rains in late April, the region will be even more inaccessible, likely becoming a vast swamp with small islands of dry ground. Over the coming weeks, all organizations providing assistance in the camps must transition to an emergency footing to ensure that refugees can survive the coming months, MSF said.
Newly arriving refugees speak of ongoing bombing and fighting in Sudan’s Blue Nile State. While people have sought safety in the Doro and Jamam camps, they have encountered a harsh environment where their ability to survive is stretched to the breaking point.
Serious gaps in assistance mean that the most basic needs are not adequately covered. Less than 8 liters of clean water per person per day is being provided, far below the recommended minimum standards of 15 to 20 liters per day in refugee camps. In its clinics, MSF witnesses the direct consequences of the lack of water; rising cases of diarrhea constitute 1 in 4 medical consultations.
The full press release is available here. (Source: Médecins Sans Frontières)
Environmental Exposure to PCBs Linked to Infertility
High levels of polychlorinated biphenyls (PCBs) and p,p’-DDE, a breakdown product of DDT, have been linked to an excessive number of sex chromosomes in sperm, according to a recent study published in Environmental Health Perspectives.
Men with higher levels of PCBs and p,p’-DDE in their blood were more likely than those with lower levels to have a higher percentage of sperm sex-chromosome disomy, the greatest known cause of failed pregnancies.
In the study of 341 men from subfertile couples, researchers found that exposure to p,p’-DDE may be associated with increased rates of XX, XY, and total sex-chromosome disomy, and exposure to PCBs may be associated with increased rates of YY, XY, and total sex chromosome disomy.
Read the study here.
Camel Milk May Improve Autism Symptoms
Emerging reports suggest that camel milk, the drink of nomadic peoples from Mongolia to India, may have a healing effect on various diseases.
Parents worldwide who have been experimenting with camel milk in their children with autism spectrum disorder (ASD) are reporting reduced symptoms and increased skills in their children. Improvements cited in Internet posts include better sleep, increased motor planning abilities and spatial awareness, more eye contact, better language, and fewer gastrointestinal problems.
Though autism is defined as a developmental disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM), studies have shown that inflammation, a condition common to many human diseases, may be a factor.
Veteran Israeli camel expert Dr Reuven Yagil, who first described the use of camel milk to treat autism, contends that autism is an autoimmune disease afflicting primarily the intestines. American-Israeli scientist Dr Amnon Gonenne says that there is an active inflammatory component particularly in cases of autism that exhibit allergic symptoms.
Eyal Lifshitz, manager of a camel milk research center and owner of Milk From Eden camel farm, and Dr Gonenne believe that one of camel milk’s beneficial effects is the calming of inflammation.
Read the full article here. (Source: The Autism File)
USAID Launches New Gender Policy To Ensure Gender Equality and Female Empowerment
During a recent White House event, Dr Rajiv Shah, Administrator for the United States Agency for International Development (USAID), launched the Agency’s new Policy on Gender Equality and Female Empowerment.
This policy comes at a critical time as global efforts to reduce gender gaps have met only partial success. Across every development priority worldwide—from education to economic inclusion—gender inequality remains a significant challenge. For example, according to the United Nations Food and Agriculture Association, if women had equal access to the same productive resources as men, they could increase yields on their farms by 20% to 30%, which could reduce the number of hungry people in the world by up to 150 million people.
The goal of the policy is to improve the lives of citizens around the world by advancing equality between females and males, and empowering women and girls to participate fully in and benefit from the development of their societies.
More information, including the specific goals of the policy, is available here. (Source: USAID)
Millennium Development Goal Drinking Water Target Met
The world has met the Millennium Development Goal (MDG) target of halving the proportion of people without sustainable access to safe drinking water well in advance of the MDG’s 2015 deadline, according to a report issued recently by UNICEF and the World Health Organization (WHO). Between 1990 and 2010, more than 2 billion people gained access to improved drinking water sources, such as piped supplies and protected wells.
The report, Progress on Drinking Water and Sanitation 2012, by the WHO/UNICEF Joint Monitoring Programme for Water Supply and Sanitation, says that at the end of 2010, 89% of the world’s population, or 6.1 billion people, used improved drinking water sources. This is 1% more than the 88% MDG target. The report estimates that by 2015, 92% of the global population will have access to improved drinking water.
But there is still considerable work to be done in this area. Read about it here. (Source: World Health Organization)