The methodology flaws in Hinman's acupuncture clinical trial, part I: design and results interpretation.

In the October 2014 edition of JAMA, Dr. Hinman and her colleagues published an acupuncture clinical trial entitled “Acupuncture for Chronic Knee Pain: A Randomized Clinical Trial” and 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”. The author strongly disagrees with this conclusion, as there were serious flaws in the trial design, the statistical analysis of the data and in the interpretation of the results of this study. This commentary is prepared in two parts. In Part I, the study design, acupuncture dose and interpretation of results will be investigated. In Part II, the Zelen design and dilution effect will be discussed.