TAMPA, Fla.--(BUSINESS WIRE)--In five letters to the editor published in the latest issue of JAMA, the Journal of the American Medical Association, acupuncture clinicians and researchers around the world point to key flaws that call into question the validity and research methods used in a randomized clinical trial published in JAMA in October of 2014. The Australian study, Acupuncture for chronic knee pain: a randomized clinical trial, by Hinman, et al., concluded, “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.” Many American acupuncturists were outraged when the October 2014 article was published in JAMA and have called for a review of the study’s design and protocols.
Yong Ming Li, MD, Ph.D., of New Jersey challenges that the researchers altered the aims and hypotheses of the study after the data was collected and the trial was closed. According to the original aims and hypotheses submitted to the official clinical trials registry in 2009 the objective of the study was not to evaluate the effectiveness of traditional needle acupuncture against sham laser acupuncture, but to evaluate laser acupuncture against sham laser acupuncture with needle acupuncture serving as a positive control for laser acupuncture. Protocols originally filed with the registry as well as the authors' baseline publication do not describe sham laser acupuncture as being a control for needle acupuncture. Dr. Li's letter furthermore debates the validity of using sham laser acupuncture as a control for needle acupuncture, as it is not generally accepted as a valid control for needle acupuncture.
Hongjian He, AP, Ph.D., of Florida also questions design choices: she specifically points to the use of non-standardized point selection for chronic knee pain. Also some patients received treatments once a week, while others got treated twice a week. This lack of consistency throws into question the validity of the statistics extrapolated from the data collected during the study.
David Baxter, TD, DPhil, MBA, and Steve Tumilty, Ph.D., questioned in their letters why the researchers chose to use laser dosages below the threshold necessary to have a therapeutic effect and why they failed to specify wavelength used in the study and why those levels were chosen.
Lixing Lao, Ph.D., MB, and Dr. Wing-Fai Yeung, BCM, Ph.D., point out in their letter that patients were assessed after 12 weeks and then again after one year, but that without treatment for chronic knee pain after one year, the condition naturally will deteriorate, so that the findings after a year are irrelevant. With these key flaws revealed the conclusion of this randomized clinical trial is clearly undermined.
No group has been more involved in this issue than the Traditional Chinese Medicine American Alumni Association (TCMAAA). Through its broad social media in the USA and around the world, TCMAAA has orchestrated a series of professional forums and discussions on research ethics and design for acupuncture studies after the Australian study was published in JAMA.
“This collection of letters represents a merging of licensed acupuncturists and integrative medicine practitioners who demand the same gold standards of ethics and design quality for clinical acupuncture research as conventional medical studies,” stated Haihe Tian, Ph.D., AP., the President of TCMAAA.
Even with the challenges acupuncture poses in gold-standard randomized clinical trials this valuable treatment method should not be overlooked. With properly designed and well-thought-out studies acupuncture can be evaluated fairly and thoroughly, with conclusions founded upon careful reasoning, accepted controls, and irrefutable evidence.
About TCMAAA:
Registered in Florida, TCMAAA (website: www.tcmaaa.org) is a nonprofit organization with one thousand members of licensed acupuncture practitioners formally trained in accredited medical education institutions in China. As a leading organization among Chinese Medicine practitioners, TCMAAA continues to support its members’ professional growth across the United States.
