Methodological changes in the evaluation of complementary and alternative medicine: issues raised by Sherman et al. and Hawk et al.
نویسنده
چکیده
5 The quest for methodologies appropriate for evaluating complementary and alternative medicine (CAM) continues to challenge the research community. Two papers in this issue, Sherman et al.’s “Description and Validation of a Noninvasive Placebo Acupuncture Procedure,” (pp. 11–19) and Hawk et al.’s “Issues in Planning a Placebo-Controlled Trial of Manual Methods: Results of a Pilot Study,” (pp. 21–32) demonstrate efforts by thoughtful investigators to develop legitimate placebo interventions and to address standardization of delivery. Sherman et al. show great ingenuity in their use of a toothpick and a plastic insertion tube to mimic acupuncture needling. In their first experiment, the toothpick insertions were perceived as slightly more like real needling than the real needling itself; in the second, a still impressive 53% of those receiving the simulated needling believed it “definitely” or “probably” was real acupuncture, compared to 65% of those receiving actual acupuncture. Further supporting the legitimacy of this method as a placebo or control is the difference in reported therapeutic response: 33% of subjects receiving real acupuncture reported significant improvement in their back pain compared to only 4% receiving imitation acupuncture. Yet questions remain. The ideal placebo should be therapeutically inert; a reasonable placebo should be reasonably inert. But the authors note that noninsertive needling is actually practiced as part of some styles of acupuncture and that the effects of gentle stimulation are not well understood at this time. Therefore, they suggest that the toothpick method be considered a “minimal sham treatment,” which should not be assumed to be inert. Nonetheless, based on the efficacy of patient blinding and the differences in therapeutic response to toothpick versus acupuncture needling, they recommend their method as a “reasonable control treatment for acupuncture-naïve individuals in randomized controlled trials assessing the efficacy of acupuncture for low-back pain.” Although Sherman and colleagues are clearly conscious of the subtleties in these distinctions among placebos, shams, and minimal shams, other investigators using this method in the future may lack this awareness or fail to convey it to consumers of their research. Unless a clear disclaimer to the contrary is noted in the abstract as well as the text of an article, most readers assume that methods used as placebos, controls, or shams are actually inert. A broader context for interpretation may be achieved by including a “no treatment” and/or a conventionally treated group along with the minimal sham and real acupuncture groups. In the Hawk et al. trial, a multidisciplinary team of researchers began with the assumption that fundamental differences exist between the administration of medications and the application of manual procedures. They designed a multisite pilot study on chiropractic care for women with chronic pelvic pain, seeking to address the methodological challenges inherent in these differences. They also hoped to lay the groundwork for a larger randomized controlled trial (RCT).
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ورودعنوان ژورنال:
- Journal of alternative and complementary medicine
دوره 8 1 شماره
صفحات -
تاریخ انتشار 2002