One of the most difficult problems practitioners of traditional medical systems face in the Western world-and particularly in the United States-is the skepticism of many of our Western medical colleagues. Not only do our practices come from a radically different world view and set of theoretical assumptions, but we also suffer from what the U.S. scientific community often calls lack of "credible scientific evidence," despite having thousands of years of empirical clinical experience to support our claims.
Numerous complaints have been made about inadequate methodology in acupuncture clinical trials, the lack of replicability of study design, the fact that most clinical trials are too short and without adequate follow-up, and the impossibility of conducting a true double-blind acupuncture study. Serious problems have occurred when attempting to create a "placebo" for acupuncture, although such objections have not so far been voiced for dietary and herbal studies or for Qi Gong. Another major objection is the lack of adequate numbers of clinical trial subjects to justify general conclusions regarding the efficacy of acupuncture and Oriental medicine.
This paper contains the preliminary proposal for a large-scale (4,000-subject), random, multi-center, multi-factorial study of two conditions that TCM may consider related but Western medicine does not. The purpose of linking these problems is to see how well they correlate to TCM, dietary and energetic (Reiki and Qi Gong) treatment, and to screen out other presentations that Western medicine would consider in the same categories but that TCM does not. The use of healthy volunteers further prevents false results due to other drugs in the subjects' systems. Suggestions for funding such a study are also addressed, since this would otherwise be an impediment to implementation of a study of this size. By placing 500 subjects in each factorial group, the problem of number of subjects should also be greatly diminshed. Subjects would all be 50 or older, since these conditions affect older people with increasing frequency-which should make the funding of this study more attractive as life-expectancy increases and greater numbers of people suffer from these difficulties.
History and Development of the ProblemsOne of the most difficult problems practitioners of traditional medical systems face in the Western world-and particularly in the United States-is the skepticism of many of our Western medical colleagues. The myriad truths that we have become convinced of clinically through centuries of empirical trial are often dismissed by Western-style clinicians primarily because they come out of a different set of theoretical assumptions and world view, using a very different vocabulary than that of Twentieth-Century Western science. One additional barrier preventing our ability to communicate our enthusiasm for the healing arts we practice with the Western medical establishment is the lack of what has often been called "credible scientific evidence" using clinical trials whose methodology will satisfy rigorous scientific scrutiny [1,2]
Although published clinical trials of disciplines like acupuncture, Oriental medicine, Qi Gong and dietary therapy are numerous in countries like China, the medical profession in the United States is unwilling to accept the validity of their conclusions.[3-5] This is hardly surprising, because it is also unwilling to accept the results of clinical drug trials for what might be called "Western-style" pharmaceuticals conducted outside the borders of the United States. So we are left with a situation in which medical researchers in the United States need to translate Oriental medical concepts into Western scientific terms and generally try one or two or a few acupuncture points to treat specific diseases as defined by Western medicine.[5-7] This very situation explains why clinical trials of Pericardium 6 and auricular acupuncture, with its emphasis on specific internal organs-as opposed to the more traditional Oriental concepts of meridians and Qi flow-have been so comparatively popular here. Of the some 2,302 acupuncture studies recently cited in a new 158-page bibliography published by the National Institutes of Health in the United States, at least 133 of them (judging by the titles of the journal articles, as listed) concerned the use of auricular acupuncture in addiction and 81 directly to the use of Pericardium (Neiguan) to prevent nausea and vomiting.[1] This is just a sample of the studies available in Western languages, since the database MedLine, when its pre-1966 listings are included, yields over 6,000 articles in the category "acupuncture" alone.
Objections that have so far been raised to clinical trials that have already been conducted include the following: Studies do not include an adequate number of subjects to justify widespread application of their conclusions. Studies are not long enough in duration and do not contain adequate provision for follow-ups. Study design is not replicable for any of a number of reasons: First, there is the undisputed fact that no acupuncture study can truly be double-blind, since acupuncturists always know that they are performing acupuncture and are equally well aware when they are administering placebo treatments. Individualization of treatment to suit individual patients-in both acupuncture and herbal medicine- is another problem. Studies by traditional practitioners of Rehmannia 6 (liu wei di huang wan) or Rehmannia 8 (ba wei di huang wan), for example, contain within them the implicit assumption that the formula will be modified to suit each set of presenting symptoms. [1,2,4,5,8-10] Often, also, no acupuncture points are mentioned in the published study, which regardless of the conclusions reached by the investigators makes the trial essentially not replicable by other researchers and therefore invalid from a scientific point of view.
Other major problems with acupuncture and Qi Gong clinical trials have been the many available systems of both disciplines in use. It is rare in Western clinical acupuncture literature, when seeing a published report of a clinical trial that describes using needles to tonify a particular point, that we can tell how the tonification was accomplished. Was the needle inserted with the flow of the meridian, with a clockwise twist of the needle, etc.? The same problem exists in Qi Gong, where the many schools of practice sometimes prevent a clear understanding of exactly what technique was used and how even the most spectacular results were accomplished. Again, the basic problem of replicability using identical techniques and procedures, so fundamental to credibility from a Western scientific point of view, remains elusive. [1,2,11]
A penultimate problem with the acceptability of studies of acupuncture and Oriental medicine published in China and elsewhere in the Orient is that-except for those clinical trials dealing with animal studies or basic science-it is generally of a different order than that conducted in the United States. What do I mean by this statement? Whereas in the Orient, and indeed in some Western TCM publications, articles often describe the degrees of efficacy of a single treatment used on all human subjects or of head-to-head comparisons of two different Oriental medical treatments, in the West the emphasis is still on the double-blind, placebo-controlled study.[4,5,7,9,10,12] In other words, we here in the United States are still stuck at a lower level of reality, trying to prove such basic concepts as "acupuncture can work, although from a modern, Western, scientific point-of-view we are still not certain why" and "using traditional herbal formulas may not make a given condition worse and may even help it." [13-16] Centuries of experience with the efficacy of these treatments have permitted our colleagues in the Orient to move far beyond this level of conceptualization in developing sophisticated experimental protocols.
It has become a widely accepted concept in China during the past half-century that Western medicine and Oriental medicine and acupuncture and Qi Gong belong together. A practitioner, it is believed, ought to be trained in both TCM and Western medicine to be fully effective. In the context of the long Chinese history of the use of these techniques, this concept-however currently useful-does not truly reflect centuries of earlier practice. While accepting completely the usefulness of this concept in China, for cultural reasons the field has not developed that way in the United States. Although the collegiality between medical doctors and TCM practitioners seen in China-where TCM practitioners can also treat major medical problems such as stroke and coma- would be extremely desirable here, this is far from the case currently. Even recently-founded clinic and alternative-health maintenance organizations explicitly state that serious conditions are for Western medicine and functional disorders and chronic pain are the primary domain of TCM practitioners. [17]
An increasing number of states within the United States are developing requirements that Western medical practitioners have at least 220 hours of training in acupuncture per se before attempting to practice it, that they practice acupuncture only within their medical specialty, and even sometimes that they refrain from calling themselves "acupuncturists." Some states, however, still require no training at all in acupuncture on the part of medical doctors in order to practice this healing art.[18,19]
In the rest of the Western world, most countries require 200-300 hours of study by medical doctors before they can call themselves acupuncturists and bar any but medical doctors from practicing acupuncture and Oriental medicine.[20] However, it is clear to all TCM practitioners that 100, 200 or even 300 hours of training (of which one-third to one-half of are generally devoted to theory and the rest to practice) do not begin to permit the practitioner to learn much about what s/he is doing. Is it any wonder that clinical trials designed by Western practitioners are often invalid from a TCM point of view or that these medical doctors practice what is commonly called "cookbook acupuncture"?
Some Western practitioners of acupuncture and Oriental medicine, after examining the often unsatisfactory, inconclusive and sometimes negative results of Western acupuncture clinical trials have suggested that we in the United States dispense with various aspects of the current double-blind, placebo-controlled model for clinical trials of acupuncture and oriental medicine. Instead, they suggest forms of patient-tracking systems for use in clinics, hospitals and other institutions.[21] This approach, although immensely practicial from an Oriental medical point of view, might make it even more difficult to convince skeptics of the clinical efficacy of these treatment methods unless large numbers of clinical subjects are used.
One Possible Clinical-Trial Solution
Following are suggested point-by-point solutions to the problems listed above, with reference to a hypothetical multi-factorial, multi-center clinical trial designed to study two chronic conditions prevalent in adults over 50-mild, persistent tinnitus, and insomnia characterized by difficulty falling asleep-neither of which is, in itself, life-threatening. They are not considered related disorders from the point of view of Western medicine but often are part of a symptom patterns associated with Deficient Yin and/or Blood from an Oriental medical point of view. Both have both been acknowledged by the NIH and various other research organizations as being major quality-of-life issues to the aging population.[22-25] As more and more members of the "baby-boom" generation born in the 1940s reach the age of 60, therefore, and the general life expectancy in the United States increases, a larger percentage of the population will be older, and it is reasonable to assume that an ever-greater percentage of the population will be afflicted with these ills.[26]
The choice of these disorders will permit at least theoretical equipoise, since neither disorder responds longterm to any known Western treatment that is without side effects, and some may pose drug dependency problems to the patient.[27] Acupuncture studies of tinnitus conducted by western medical doctors have been either inconclusive or negative for acupuncture, but have always been based on small numbers of subjects.[28-31] A few provocative insomnia studies have been conducted in the West, but again the number of subjects did not permit conclusive findings.[32-35]
My proposal calls for a study of 4,000 otherwise healthy volunteers (screened for both physical and mental health), age 50 or older, living in retirement communities in different parts of the United States. All would have had mild, persistent tinnitus and difficulty falling asleep for a minimum of three months.They would be screened and monitored to be certain they are taking no other medications that might interfere or interact adversely with the possible herbal or acupuncture protocol [36-37] and to insure that thee subjects's food is cooked for them by a staff, a fact which will help to standardize their diets to insure compliance in this area.
Subjects would be assessed at the beginning of the trial as well as once a month during it using a SOAP (Subjective/Objective Assessment Protocol). This would be administered by objective outside physicians not aware of the the nature of the clinical study in progress who would only be permitted to ask questions pertaining directly to the symptoms under study and not to the protocols being used. Study subjects would be instructed to speak with these physicians only about their symptoms and not about the methods they are using during the trial. The study would be divided into eight randomly-chosen factorial groups comprised of 500 subjects each:
1) A control group receiving a standard treatment for both tinnitus and insomnia
2) A group receiving acupuncture only
3) A group receiving herbs only
4) A group receiving Qi Gong instruction only
5) A group receiving dietary modification only
6) A group receiving a form of external energy administration known as Reiki
7) A group receiving all of the above treatments
8) A group receiving no treatment at all
In order to standardize the treatments in the interest of making the trial more reproducible, the same Western medical treatment should be chosen for the group receiving the drug therapy, the same acupuncture points and needling method(s) chosen for the acupuncture subjects, the same herbal formula (perhaps Liu Wei di Huang Wan; Six Ingredient Pill with Rehmannia) for all members of the herbal group, the same type of Qi Gong instruction for all members of that group, the same procedure of standard Reiki administration for all subjects in that group[38], and the same dietary modifications for all in that group. Acupuncture and Reiki should be administered three times a week during the first two weeks, twice a week for next six weeks and once a week thereafter., or until the conditions no longer trouble the subjects (as determined by a SOAP examination).
Members of the dietary group must be pre-screened for allergies or religious objections to certain of the foods that might be in the dietary program, and only those who can fully participate in the dietary program should be admitted to that aspect of the trial. Naturally, in the combined group (Group 7), all the treatments would be added together, which would be very time-consuming for the subjects. It is here also proposed that standardized herbal tinctures be used in order to increase the bio-availability of the formula and to simplify the administration of the preparations, in accordance with the TCM principle that digestion tends to weaken with age. Also, in the United States, many people consider herbal formulas difficult to prepare and this often limits subjects compliance.[39]
For the Qi Gong classes, I propose that the teaching be done by practitioners certified by the Healing Tao Instructors Association [40-41], primarily because the teaching there is standardized and, therefore, it satisfies the criteria for replicability. Reiki, being a non-invasive, passive form of energy administration, [38] would provide an opportunity to examine the benefits of active vs. passive energy application. In both cases. Frequency would be as above. Dietary and herbal programs would follow standard TCM methods.
The group receiving no treatment might either be told that they are receiving subliminal therapy piped into their rooms during the night or they might be given an inert preparation that resembles the tincture as a placebo. This should also help to account for any placebo reaction within the confines of the trial, so that all factorial treatments in the study have equal placebo value.
Some consideration was given to proposing that this be made a cross-over study, since neither tinnitus nor insomnia is amenable to medical cure and the drug protocols that exist may have serious potential side effects. In this age group, survivability might also be an issue, and so it was decided not to propose this alternative, since the duration of the study, I believe, should be a minimum of 6-8 months, with follow-ups at 1 year and 18 months. Also, the likelihood of participants developing one or more medical conditions that require medication is said to increase with age, and for this reason also the duration of the study should be kept to a minimum and the groups run parallel rather than in a cross-over fashion. In my opinion, given previous studies showing that analgesics and antibiotics limit response to acupuncture[22-26], it would be ideal if all such drugs could be witheld for the duration of the trial. If this is not practical for medical reasons, any deviation from the norm of no Western medications in the acupuncture and Oriental modalities group, whether prescription or over-the-counter, should be duly noted so that proper statistics can be kept to prevent any patients using such drugs from improperly influencing the statistics and conclusions based on the responses to the clinical trial for their group.
Problems Inherent in This Design
Among the problems related to this proposed clinical trial are those related to its scope. To my knowledge, no published research approximating the size of this study has ever been conducted in Chinese traditional medicine within the United States utilizing these age-related criteria. Certainly no controlled study of this size has been attempted to demonstrate the efficacy of Reiki. One reason for this situation in the case of acupuncture is the recent "legitimization" of acupuncture as a clinical modality by the National Institutes of Health, which only officially occurred in the United States in 1996 and 1997.[1] Chinese herbs, Qi Gong and Reiki as treatment modalities have not yet been so officially recognized, although several studies have been funded within the past 4 years by the OAM (Office of Alternative Medicine) concerning the efficacy of diet, certain herbal medicines and various aspects of Qi Gong, some of which have already produced encouraging results.[42,43]
Again, due to the current proposed clinical trial's scope, there is a problem of the administrative costs involved. A study of this size would require the coordination of a large number of people over an extended period of time, and all national, state, local and institutional requirements for informed consent and patient confidentiality would need to be satisfactorily addressed. It is likely that only a committee could satisfactorily address such an administrative issue. Each institution involved in the clinical trial would need to have a part-time coordinator. Given the number of individual coordinators in different locations, it would be imperative to have at least one full-time administrator to oversee the entire process.
With a study of this size, the only viable method of keeping patient records would be by computer, which would mean expensive computer time and a tie-line from each institution to the administering center for the purpose of central record-keeping. Despite the many millions spent annually in the United States on researching new medical drugs and devices, most grants given by the Office of Alternative Medicine (except for the establishment of individual study centers) do not generally exceed $30,000.[42,43] It is clear that the budget of this proposed study would far exceed that figure. Therefore, it would be necessary to find substantial funding elsewhere. Researchers concerned with alternative medicine in the United States have often complained that the problem with finding funding for clinical trials in this field is that the results of clinical trials involving traditional medicine are not patentable and therefore attract neither drug company money nor the interest of medical equipment manufacturers-two of the most lucrative sources of research and development money outside of the government avenues of funding. A drug company might easily spend $10,000,000 or more on developing a new, patentable drug, but would have no ultimate financial incentive to give $1,000,000 to a study of the type described above. This, in turn, would mean organizers would have to be extremely creative in searching for research money.
What solution might there be to this puzzle? Perhaps a coalition comprised of acupuncture schools and organizations, health maintenance organizations serving senior citizens , organizations promoting Qi Gong and Reiki, non-medical corporations that might be willing to help with donations of computer-related equipment and services and private individuals and foundations might be able to underwrite a study such as the one proposed above. This is not the way money for medical research is normally raised in the United States, but it appears to be the only way to obtain substantial funding under current circumstances.
Given the complaints Western medical specialists in the United States have expressed with regard to the inadequate number of subjects taking part in previous acupuncture and Oriental medicine clinical trials, it would be logical to address these problems directly at this point in order to answer the questions of critics and ultimately prove to the satisfaction of the the Western medical community what all of us who practice Oriental medicine and other traditional healing arts already know empirically from our own clinical experience-that these techniques work.
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41. A list of books that support the teaching of this sequence is available at URL http://www. peinet.pe.ca/people/JMcconne/books.html
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