Amy R. Hausman, L.Ac, Dipl. OM. (NCCAOM)
As a licensed acupuncturist, it’s empowering to see your profession cast in an approving light, especially when it’s reviewed by a well respected medical journal. However, since I have witnessed the effectiveness of acupuncture for a myriad of disorders, I am always curious as to why its efficacy is not positively portrayed in more clinical trials. Having reviewed this study for Dr. Park, I now know why.
The purpose of this study was to investigate the efficacy of acupuncture in the treatment of moderate obstructive sleep apnea syndrome (OSAS). It was a randomized, placebo-controlled, single-blinded study, with blinded evaluation of 36 patients presenting with an apnea/hypopnea index (AHI) of 15-30/hour. The patients were divided into 3 groups: an experimental group of 12 people receiving acupuncture once a week for 10 weeks, a sham group of 12 patients who received “fake” acupuncture once a week for 10 weeks, and a control group of 12 patients who received no treatment. The results showed that out of the 26 patients who completed the study, there were significant changes for those in the experimental group that received acupuncture. Not only did the number of respiratory events (or number of obstructions) decrease in the acupuncture group, but there were also marked improvements in the outcome measures as displayed by the SF-36 and Epworth questionnaires. The investigating team concluded that acupuncture is more effective than sham acupuncture in relieving the respiratory events of patients presenting with moderate OSAS.
SHAM VERSUS REAL LIFE RESULTS
My first question regarding this study has to do with the conclusion made by the investigating team. While the research showed that acupuncture is more effective than sham acupuncture in relieving respiratory events in moderate OSAS, there was no mention of a comparison of the experimental group (those receiving acupuncture) to the control group (those not receiving acupuncture).
Granted, real acupuncture versus “sham” acupuncture may prove that there is such as thing as a “good” treatment versus a “bad” treatment. Especially as the research team here utilizes the sham group in the same way that a pharmaceutical company would compare those who were taking “placebos” to those who were taking the “controlled substance” in question. However, some TCM (Traditional Chinese Medicine) practitioners may disagree with the
study’s conclusion citing faults in its design.
EASTERN VERSUS WESTERN STUDY DESIGN
The study noted that there were some improvements in the sham group over those in the control group. This implies that even though no real acupuncture points were used on specific meridians, there was some sensation or response that provoked an outcome for the patient. This can lead to conflicting ideas as to whether the sham acupuncture is in fact a real treatment or if it is truly placebo acupuncture as it is meant to be. For this reason, a future study with only 2 study arms, an experimental group and a control group, omitting a sham group altogether in favor of simply comparing the results of acupuncture to no acupuncture may be better from a TCM perspective.
Furthermore, if it is true that a clinical trial must show a certain reliability and reproducibility in order for it to be deemed valid, this same criteria makes it difficult to assay the full impact of acupuncture and other forms of TCM for the treatment of illnesses confined within a Westernized paradigm of disease and health.
DIFFERENT PARADIGMS, DIFFERENT PERSPECTIVES
When I was in graduate school, I was part of a research team that put together a proposal for studying the effects of acupuncture in post-stroke rehabilitation. Our analysis of previous studies addressing the use of acupuncture revealed several fundamental difficulties in the assessment of an ancient Eastern medical paradigm within the framework of modern Western medical research protocols. These difficulties occurred primarily when attempting to apply scientific demands of reliability and validity to the TCM treatment approach based on individual presentation and pattern diagnosis.
TCM sees each person as an individual with a unique set of patterns and presentations regardless of the disease diagnosis. That being said, 5 people presenting with OSAS to a TCM practitioner may be diagnosed with 5 different TCM disease patterns and therefore treated with different acupuncture point prescriptions. While some of the points may be the same, as noted in this pilot study being reviewed, there may be other points specific to each individual that addresses the root of his/her sleep apnea syndrome. Treating the root of the disorder or what is considered the underlying cause is a fundamental treatment principle in TCM. Not only can such a treatment reduce the severity of the symptoms, but it may also reduce the occurrence or recurrence of such disorders altogether. Therefore, it would be interesting to note the long-term effects of using the same point protocol on different patients and whether or not further evaluation at a later date would show more variance in results. Unfortunately, there is no mention in the original article of the different TCM disease patterns used to come up with their acupuncture point prescription or if that was even taken into consideration.
In essence, the basic differences in approach may make a true study of TCM impossible within a Western medical framework. Thus, trying to adhere to strict TCM protocols usually results in studies being conducted with discrepancies in design, intervention and control procedures—all things that in a more statistical evaluation like the study mentioned would compromise the scientific relevance and validity of their results.
Perhaps the future of clinical trials investigating the efficacy of acupuncture lies within a setting that allows for both a TCM approach of customized treatment along with a Western standardization that will be statistically measurable, reproducible, and scientifically valid. While the efficacy of acupuncture has been seen for thousands of years, it seems the progress of acupuncture research is
slow indeed, and the gap between TCM and Western medicine may be the sticking point when trying to conduct a valid clinical study using acupuncture.
Amy R. Hausman, L.Ac, Dipl. OM. (NCCAOM) is board-certified in Chinese Medicine. As the founder of Co-Creative Healing Arts and Acupuncture, Amy brings her experience as a licensed acupuncturist and psycho-spiritual counselor to those suffering from anxiety/depression,reproductive issues, sleep disorders, pain management, addictions, chronic sinusitis, migraines, and other acute and chronic illnesses.
Focusing on the body as a whole rather than only the part that is sick is a key to healing all types of disorders. It is this subtle yet powerful approach that Amy integrates using her background in both Chinese medicine and Integrative Energy Medicine in order to help initiate the person’s own healing process.
For a limited time, mention this article and receive $50 off your first consultation and treatment. You can contact her directly at: 917-334-8907.
*Treatment of Moderate Obstructive Sleep Apnea Syndrome with Acupuncture: A randomized, placebo-controlled pilot trial Anaflavia O. Freire, Gisele C.M. Sugai, Fernanda Silveira Chrispin, Sonia Maria Togeiro, Ysao Yamamura, Luiz Eugenio Mello, Sergio Tufik: Sleep Medicine, 2006, xx(xxxx), 1-8, © Elsevier