Resolving Paradoxes in Acupuncture Research: A Roundtable Discussion

Abstract

Peter M. Wayne: We’re going to be discussing the workshop that we held at the North American Research Conference on Complementary and Integrative Medicine (NARCCIM) in May 2009. The workshop was designed to present the findings from a Society for Acupuncture Research (SAR) board retreat, which focused on ‘‘Paradoxes in Acupuncture Research: Strategies for Moving Forward.’’ The paradoxes, in turn, had emerged during the 2007 SAR International Conference that reviewed the progress in our field in the decade since the 1997 NIH Consensus Development Conference on Acupuncture. The conference was a great success, with more than 300 attendees and support from the National Institutes of Health (NIH), conventional medical schools, schools of acupuncture and Oriental medicine, and a variety of other national and international organizations. The conference concluded that the field of acupuncture research had made great progress since 1997. Many rigorous phase II and III randomized controlled trials were completed for acupuncture treatment of a wide variety of medical conditions, and some very strong basic research was performed with state-of-the-art tools to examine biochemical and physiologic correlates of acupuncture. Important progress was also made with respect to control procedures and other aspects of clinical research design. Summaries of the conference have been published in the Journal of Alternative and Complementary Medicine. But in putting together this work, we identified two paradoxes. Paradox One is that an increasing number of large clinical trials have reported that true acupuncture does not significantly outperform sham acupuncture, a finding apparently at odds with traditional theories regarding acupuncture point specificity and needling techniques. Paradox Two is that while many studies with animal and human experimental models have reported physiologic effects that vary as a function of needling parameters, the extent to which these parameters influence therapeutic outcomes in clinical trials is unclear. As the SAR board prepared a White Paper to highlight these paradoxes and discuss research directions to resolve them, the opportunity arose to present our thinking at the NARCCIM conference. Richard Hammerschlag: That gives us a good sense of where we’re at: How we came to focus on these paradoxes, our work in clarifying them, and the research we’re proposing as necessary to resolve them. Regarding the first paradox, many people, and especially practitioners, were quite disturbed after the 2007 SAR Conference by the conclusion, especially on the basis of the largescale German trials that were presented, that it either doesn’t matter where we place acupuncture needles or that something is amiss with the research design of such studies. As researchers, we need to be open to exploring both possibilities. For me, the question with regard to this paradox is twofold. First, sham needling is not inert and appears to produce a level of benefit that is procedure related. Second, inclusion of a sham-treatment arm in a randomized controlled trial may reduce the level of effectiveness of the active-treatment arm (by reducing patient expectancy of receiving an effective treatment from 100% to 50%). My concern is that by utilizing a control procedure that has treatment benefit and by following a research design that may decrease the effectiveness of a verum or active treatment, we’re generating type II errors and getting false-negative results. For example, sham needling—especially if it’s invasive—may induce microtrauma through local physiologic changes in microcirculation or cytokines that promote healing in the body. A recent review indicates that in acupuncture trials that have had both a sham arm and a nontreatment arm in addition to the active-treatment arm, the difference between the sham and nontreatment arms seems to have been greater than that between the placebo and nontreatment arms in conventional pharmaceutical trials. So this again raises a possibility that sham treatment is not inert, and that some