The cover story on acupuncture and the treatment of fibromyalgia raises many questions related to the basics of experimental design. Unfortunately, the trial as presented in January/February’s issue of the BCMJ (2004;46:21-23) does not appear to be a valid test of the effectiveness of acupuncture. Several serious, indeed fatal, flaws render this trial useless from a scientific perspective:
1. While the article is very readable, it gives the gloss of science where none exists. For example, the patients were all un-blinded volunteers who were interested in acupuncture. “Expectant realization” tends to make those who believe in a treatment perceive symptomatic benefit.
2. Indeed, volunteer bias (where motivated subjects tend to perceive improvement) could alone account for the vague findings presented.
3. The people administering the acupuncture were likely committed advocates of that therapy and, being un-blinded, could well have conveyed any number of nonspecific social and psychological cues (e.g., “norms of social reciprocity,” “please-the-therapist bias,” etc.) that would induce patients to perceive (or report) symptomatic relief.
4. There was no control group to see if perhaps the simple act of being in a study or getting mind-body counseling could cheer people up. Thus, the Hawthorne effect could account for the results obtained.
5. We are not told what the scoring system was, nor is it clear that it was validated.
6. Multiple non-standardized interventions were in play (e.g., mind-body maneuvers and moxibustion) which could have their own attendant placebo effects.
In short, the type of setup used (non-blinded volunteers, rated subjectively) virtually guarantees that the treatment on offer will be perceived as beneficial just by placebo effects alone. One could well substitute massage, energy healing, or crystals into this trial and get the same results so long as those entering were already believers and no objective outcomes were measured.
The publication of papers devoid of scientific merit does not help doctors decide on the validity of novel therapies, and giving front-page status to such articles may give credit where it is not due.
—Lloyd Oppel, MD
Above is the information needed to cite this article in your paper or presentation. The International Committee
of Medical Journal Editors (ICMJE) recommends the following citation style, which is the now nearly universally
accepted citation style for scientific papers:
Halpern SD, Ubel PA, Caplan AL, Marion DW, Palmer AM, Schiding JK, et al. Solid-organ transplantation in HIV-infected patients. N Engl J Med. 2002;347:284-7.
About the ICMJE and citation styles
The ICMJE is small group of editors of general medical journals who first met informally in Vancouver, British Columbia, in 1978 to establish guidelines for the format of manuscripts submitted to their journals. The group became known as the Vancouver Group. Its requirements for manuscripts, including formats for bibliographic references developed by the U.S. National Library of Medicine (NLM), were first published in 1979. The Vancouver Group expanded and evolved into the International Committee of Medical Journal Editors (ICMJE), which meets annually. The ICMJE created the Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals to help authors and editors create and distribute accurate, clear, easily accessible reports of biomedical studies.
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