How Useful Are Randomized Placebo-Controlled
Clinical Trials To Acupuncturists?
Agatha P. Colbert, MD
Despite an increasing number of randomized controlled trials (RCTs) of acupuncture in the past 5 years, little knowledge has been disseminated that is of practical use to clinicians. Acupuncture, a practitioner-dependent, complex modality, involves individualized patient treatments, the application of appropriate cointerventions, and a deliberate eliciting of the placebo response. The pharmaceutical RCT model is inadequate to assess this therapeutic intervention. Pragmatic clinical outcome trials (PCTs) are more likely to give useful information to clinicians. It is suggested that proportionately more resources, financial as well as intellectual, be assigned to designing and conducting PCTs and basic mechanistic studies than to RCTs.
Acupuncture, Randomized Placebo-Controlled Trials, Pragmatic Controlled Trials, Placebo Response
The establishment of the National Institutes of Health (NIH) Office of Alternative Medicine in 1992, the NIH Acupuncture Consensus Conference in 1997, and the authorization of the National Center for Complementary and Alternative Medicine (NCCAM) in 1998 have been driving forces in the quest for more rigorous research on acupuncture's efficacy, safety, and underlying mechanisms. A recent review1 of 147 randomized controlled trials (RCTs) performed in the 5-year period after the NIH Consensus Conference showed a marked increase in the number of acupuncture RCTs being published. The quality of reporting in these publications, as judged by the combined CONSORT2 and STRICTA3 standards, is also improving. Despite these advances, many acupuncturists question the relevance of this type of research to actual clinical practice.
Most acupuncturists agree that acupuncture RCTs with positive outcomes will inevitably help to mainstream the profession by validating its effectiveness to patients, the biomedical community, legislators, health care reimbursement agencies, and research funding sources.
Clinicians often cite these suppositions: (1) acupuncture has been a successful medical therapy for several thousand years; (2) acupuncturists know from observation and personal experience that acupuncture is effective and will continue practicing acupuncture regardless of negative (or positive) research results; and (3) patients will persist in seeking acupuncture treatments because they often derive therapeutic benefits.
It is presumed that a steady flow of new patients will continue to seek acupuncture as they hear reports from friends and family members who have been helped. Acupuncture will likely be able to treat new diseases because, rather than creating a drug for a specific biomedical diagnosis, acupuncture works not only by remediating symptoms but by identifying and treating the physiological/emotional/psychological and spiritual imbalances that give rise to a particular disease process in a given individual.
Why do practitioners find RCT research not as useful as it might be? Astute clinicians know that a successful course of treatment depends as much on the art as the science of medicine. The pharmaceutical model for evaluating the efficacy of a single drug is, at its core, inadequate for assessing acupuncture's therapeutic benefits; it is difficult to develop an appropriate sham needle, find sham acupuncture points, and/or to recruit a sham practitioner. This model also does not fit acupuncture research because the practice of acupuncture encompasses far more than inserting needles at preassigned points on the body as part of a formula to treat a specific biomedical diagnosis.
Medical acupuncturists, when asked what would make RCTs useful to real-world practice, emphasized the need for detailed descriptions of the acupuncture treatments provided.4 Flexibility of point selection is essential to the clinician. The choice of acupuncture points is determined after a comprehensive evaluation of the patient's root imbalances (a concept not recognized in the biomedical model), and frequently modified during subsequent treatment sessions depending on the patient's response and his/her unique clinical presentation on a particular day.
By necessity, placebo-based RCTs must assign specific constellations of acupuncture points for treating the disease in question. Such RCTs can allow no accommodation for managing the unique evolving levels of imbalance that emerge once the therapeutic effect begins its process.
In addition, the success of an acupuncture treatment is highly practitioner-dependent. Of little or no importance in drug trials is the experience and skill of the person dispensing the medication. Just as the manual dexterity of a surgeon and the interaction skills of a psychotherapist substantially influence outcomes of a specific encounter, so do the finely developed palpatory skills of the acupuncturist and his/her conscious intention and intuitive ability to connect at the heart level with patients enhance or diminish the benefits of an acupuncture treatment.
The goal of a pharmaceutical trial is to define the beneficial effect(s) of a single pharmaceutical agent. Acupuncture needling is almost never provided as an isolated treatment. Rather, it is combined with modalities such as herbs, tuina, moxa, magnets, meditation, physical therapy, relaxation exercises, psychotherapy, and a variety of other self-help interventions. The patients and their practitioners recognize the synergistic effects of these approaches as to the whole of the treatment. Not only would it be impossible to separate the effect of each cointervention, but it would perhaps be detrimental to the therapeutic process to apply these modalities separately.
Probably the largest mismatch between the pharmaceutical research model and acupuncture practice are the conflicting attitudes toward placebo effect. To preclude any spurious enhancement of treatment consequence, drug studies scrupulously attempt to avoid the potential benefits that patients derive simply from the attention awarded by participation in a clinical trial. Research designs sometimes even include ways of intentionally creating a nocebo effect to counter any possibility of the patient's belief system positively influencing the study's outcome.
Conversely, CAM practitioners attempt to instruct the patient about the powerful force that is the body-mind connection to facilitate the patient's ability to self-heal. How individuals think and feel has a bearing on the quality of life and the ability to deal with illness.
So if the pharmaceutical paradigm, in its search for the intrinsic power of a single drug, is unsatisfactory for investigating a complex therapeutic intervention like acupuncture, what are the alternatives? Hammerschlag5 has called for an approach that assesses whole systems and compares real-world treatment options with standard care. In the UK, Thomas et al6 and MacPherson7 are paving the way for such pragmatic clinical trials (PCTs) of acupuncture. In a recent JAMA article, the authors demonstrated a high level of interest by health care policy makers in this type of clinical research.8
Paralleling the PCTs, which will help to inform health care decision makers and provide more clinically useful knowledge to practitioners, researchers can continue to explore the how's and why's of acupuncture through different types of mechanistic studies. The distal effects of perturbing the acupuncture network are being evaluated through the use of functional magnetic resonance imaging9 and other optical imaging. New technology is also helping to quantify previously ill-defined electrophysiological and anatomical correlations of acupuncture points and meridians.10,11
RCTs, by necessity, break down acupuncture into its component parts (the sum of which is less than the whole) and often provide little useful information to practitioners. Conversely, PCTs can supply practical information and have far greater potential for evaluating the place of acupuncture in the current health care system. Perhaps it is time to commit proportionately more of our scientific rigor, painstaking efforts, and dollars to PCTs and less to RCTs.
- Hammerschlag RH, Milley R, Colbert AP, Yohalem B, Weih J. Randomized controlled trials of acupuncture, 1997-2002: pilot test of a CONSORT and STRICTA quality of reporting instrument. In: Proceedings of the 10th Annual Symposium of the Society for Acupuncture Research. Cambridge, Mass: Society for Acupuncture Research; 2003.
- Altman DG, Schulz KF, Mohler D, et al, for the CONSORT Group. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001;134:663-694.
- MacPherson H, White A, Cummings M, Jobst K, Rose K, Niemtzow R. Standards for reporting interventions in controlled trials of acupuncture: the STRICTA recommendations. Clin Acup Oriental Med. 2002;3:6-9.
- Claraco AE, Fargas-Babjak A, Hanna SE. The reporting of clinical acupuncture research: what do clinicians need to know? J Altern Complement Med. 2003;9:143-149.
- Hammerschlag R. Acupuncture: on what should its evidence base be based? Altern Ther Health Med. 2003;9:34.
- Thomas KJ, Fitter M, Brazier J, et al. Longer term clinical and economic benefits of offering acupuncture to patients with chronic low back pain assessed as suitable for primary care management. Complement Ther Med. 1999;7:91-100.
- MacPherson H. Out of the laboratory and into the clinic: acupuncture research in the real world. Clin Acup Oriental Med. 2000;1:97-100.
- Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003;290:1624-1632.
- Zhang WT, Jin Z, Cui GH, et al. Relations between brain network activation and analgesic effect induced by low vs. high frequency electrical acupoint stimulation in different subjects: a functional magnetic resonance imaging study. Brain Res. 2003;982:168-178.
- Kwok G, Cohen M, Cosic I. Mapping acupuncture points using multi channel device. Australas Phys Eng Sci Med. 1998;21:68-72.
- Langevin HM, Yandow JA. Relationship of acupuncture points and meridians to connective tissue planes. Anat Rec. 2002;268:257-265.
Dr Agatha P. Colbert is a postdoctoral Research Fellow at the Oregon Center for Complementary Medicine in Portland, Oregon.
Agatha P. Colbert, MD*
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