A Randomized Control Trial of Acupuncture in The Treatment of Depression: How to Bridge the Gap between Flexibility of Treatment and Standardization. Rosa N. Schnyer, L.Ac. University of Arizona
One of the main challenges when designing acupuncture research studies is
finding a way for staying true to the fundamental principles of Chinese medicine, while at
the same time holding the projects to the highest standards of treatment research.
Acupuncture is not a heterogeneous discipline and therefore, there is not a universal
standard of acupuncture treatment care. If one is to draw from the rich diversity of the
profession, it is often impossible to extract from the academic literature one established
protocol to treat a specific condition, or to get a representative treatment approach by
consulting just one practitioner. Established research methods aim at controlling all
variables and rely on treatment standardization to minimize the effects of bias, chance
variation, and confounding, and to assure replicability. Acupuncture does not aim at
treating biomedically defined diseases and in fact, it is based on a sound theoretical
framework of its own, that aims at including all possible variables to understand diverse
clinical presentations in order to provide individualized treatment. Although, much
controversy remains on the use of RCT’s in acupuncture clinical trials, RCT’s are still
considered the gold-standard for investigating treatment efficacy, and are the expected
The question arises then, is it possible to use research strategies developed in a
biomedical context to investigate a medical system that is based on another world view?
How do we determine treatment efficacy while maintaining fidelity of treatment? How do
we address the question of blinding and “tease apart” the placebo response? It is
inappropriate to conduct acupuncture treatment research by depriving the discipline of its
greatest strengths: differential diagnosis and individualized treatment, yet the idea of
individualized treatment seems to conflict with a standardized treatment approach. It is
feasible, however, to deliver replicable, and standardized treatments that are tailored to
the individual. By developing a treatment manual that promotes the systematic
articulation of the theoretical framework (s) chosen, it is possible to attain standardization
and maintain replicability, while at the same time allowing for individualized treatment.
In collaboration with Dr. John Allen at the University of Arizona, and Dr. Rachel
Manber at Stanford University, we have conducted several clinical trails using a manual
based treatment approach to acupuncture, while investigating the issues of blinding,
placebo, and expectations. We are currently conducting a full-scale clinical trial to
investigate the efficacy of acupuncture in the treatment of depression in men and women
ages 18-65 (U of A); a study to investigate acupuncture as a treatment for depression
during pregnancy, and a study to look at the comparative efficacy of acupuncture and
paxil in the acute and continuation treatment of depression (Stanford).
The design, methods and results will be presented of a preliminary RCT to
determine the efficacy of acupuncture in the treatment of unipolar depression in women
ages 18-45 (funded in 1992 by the former Office of Alternative Medicine of the NIH --
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