The methodology flaws in Hinman's acupuncture clinical trial, Part III: Sample size calculation.

In the October 2014 publication of JAMA, Dr. Hinman and colleagues published the study “Acupuncture for Chronic Knee Pain: A Randomized Clinical Trial,” in which the authors concluded that “in patients older than 50 years with moderate or severe chronic knee pain, neither laser nor needle acupuncture conferred benefit over sham for pain or function. Our findings do not support acupuncture for these patients”. We strongly disagree with such a conclusion. As pointed out in my former articles, serious flaws exist in the trial design, statistics, interpretation of the results, as well as the use of Zelen study design itself, as reported by Hinman et al. In Part II of the critique I discussed problems in sample size calculation of the Hinman study due to the variance introduced by multiple groups, multiple therapists, as well as the characteristics of intervention therapies. In this article, I discuss these aspects in more detail.