|TCMAAA Fan AY Hinman Trial’s Flaws Part I-design and results interpretation|
|February 27, 2015 | Arthur Yin Fan | J Integr Med 2015; 13 (2) : 65–68|
|ABSTRACT | FULL TEXT | PDF|
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.
Hinman’s acupuncture RCT has too many methodology flaws and misleading
As an independent researcher and practitioner in Acupuncture and Chinese medicine for thirty years, I strongly disagrees with Hinman’s 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. I published a commentary recently [Fan A. The methodology flaws in Hinman’s acupuncture clinical trial, Part I: Design and results interpretation. J Integr Med. 2015; 13(2): 65–68.]http://www.jcimjournal.com/articles/publishArticles/pdf/S2095-4964(15)60170-4.pdf
The major concerns are:
(1)There is a major mistake in the primary testing factor in this RCT: the laser acupuncture should be the primary testing factor, not the needle acupuncture;
(2)The interpretation of the results was misleading;
(3)The “under-dosed” acupuncture treatments diluted the potential real effectiveness of acupuncture;
(4)Laser acupuncture and acupuncture would be effective in Hinman’s RCT, if the statistics were re-analyzed after re-adjusting the data.
(5)It is improper to test two different testing factors in one RCT with so small sample size;
(6)Laser acupuncture is not one kind of acupuncture, the author intentionally mixes it with acupuncture;
(7)Acupuncture did have significant effectiveness (p<0.05 in week 12), compared to the control (this is a primary control). However, the author intentionally does not interpreter this important result into the conclusion, instead, she concludes acupuncture is not effective and says her findings do not support acupuncture for patients.
I feel the author, somehow, intentionally misleads readers by testing acupuncture as a major intervention in this RCT-There was no significance between the positive control and the naïve control (i.e., acupuncture and control groups). Therefore, we can only conclude that the positive control, acupuncture was under-dosed or the study was otherwise flawed. That the positive control shows significance is a basic sign of the success of a clinical trial. From this perspective, Hinman’s trial was a failed clinical trial for laser acupuncture. As it would be unethical to publish an astonishing article, with a group of almost scrapped data and confusing logic, that misleads the readers, including the general public, medical society and policy makers, the researchers should have re-adjusted or re-designed their study instead of publishing it.