Brief reportA pilot study of acupuncture augmentation therapy in antidepressant partial and non-responders with major depressive disorder
Introduction
Acupuncture is a popular complementary/alternative therapy that has been in use for thousands of years for the treatment of various medical and psychiatric conditions (Yeung et al., 2008). Although many depressed individuals seek out acupuncture, there are as of yet few rigorously designed studies to provide empirical support for the effectiveness of acupuncture in treating major depressive disorder (MDD) (Yeung et al., 2008), and various reviews of the existing literature have concluded that evidence for acupuncture as a potential antidepressant, while promising, remains preliminary (Mukaino et al., 2005, Leo and Ligot, 2007, Smith et al., 2010). Clinical trials of acupuncture have been limited by small samples, inconsistent results, and limited generalizability due to the use of different acupuncture styles, needling techniques, and acupoints (Yeung et al., 2008).
Acupuncture researchers are faced with the challenge of using a treatment approach that is uniform enough to be readily adaptable into a randomized controlled trial (RCT) format, while also respecting Traditional Chinese Medicine (TCM), which prescribes individualized and variable acupuncture treatments depending on TCM-specific diagnostic factors (Schnyer and Allen, 2001a, Yeung et al., 2008). In the recent years, efforts have been made to develop protocols that can be more easily studied in clinical trial settings (Schnyer and Allen, 2001b, Schnyer and Allen, 2002), and better quality, rigorous studies of acupuncture monotherapy for depression have been emerging (Allen et al., 2006). However, acupuncture remains sorely understudied as an augmentation for antidepressant partial or non-responders (Smith et al., 2010). Given the well-established tolerability and safety of acupuncture (Ernst and White, 2001, Vincent, 2001) and the lack of adverse interactions with antidepressants, it could, if effective, be a valuable addition when a pre-existing antidepressant regimen has been of limited benefit.
In view of the foregoing, we designed an open pilot study to determine the efficacy and safety of a standardized, uniform acupuncture protocol as augmentation therapy in patients with major depressive disorder (MDD) who were partial- or non-responders to standard antidepressants. Given the variability of the recommended number and frequency of treatment visits for different conditions, we also wished to examine differences in effectiveness depending on whether treatment was administered weekly or twice-weekly. The findings of this study, if positive, would be used to inform the design of a larger scale, double-blind controlled trial.
We hypothesized that acupuncture treatment would be associated with a response rate of at least 50%, as defined by a 50% or greater reduction in score on the 17-item Hamilton-D (HAM-D-17) Scale (Hamilton, 1960), and that the response would be more robust in subjects receiving twice-weekly treatment. As a secondary hypothesis, we predicted that acupuncture treatment would be associated with minimal side effects, as determined clinically by the subject and the study doctors.
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Patient recruitment and inclusion/exclusion criteria
The study was performed at the Depression Clinical and Research Program (DCRP) of the Massachusetts General Hospital. Participants were recruited by clinician referral and advertisements in local newspapers, radio, and television. Two of the study authors (AY and DM), who are accredited medical acupuncturists, provided the treatment.
At the screening visit (the patient's first visit to the clinic) the patients signed an informed consent approved by our Institutional Review Board (IRB) and were
Results
Thirty-four patients were screened and admitted to the study. Four chose not to begin treatment after the screening visit, and 30 subjects (47% female, mean age 48 ± 11 years; 24 in weekly and 6 in twice-weekly therapy) comprised the intent-to-treat (ITT) sample, based on having at least one follow-up visit after initiating acupuncture treatment. Three subjects met criteria for MDD in partial remission, and the rest met criteria for a current major depressive episode per the SCID mood module. One
Discussion
Acupuncturists usually base their diagnosis and treatment selection on the TCM framework, often resulting in individually-tailored treatments for specific constellations of symptoms. Research-wise, this approach can be troublesome, because it limits the rigorousness of clinical trials and the generalizability of their findings. In this study, we tested a uniform diagnostic and treatment approach, basing study eligibility exclusively on the diagnosis of DSM-IV MDD, and selecting a uniform set of
Role of funding source
This study was supported by the MGH Depression Clinical and Research Program's clinical practice revenues. Only the authors of the manuscript were involved in the study design, collection, analysis and interpretation of data, writing of the report, and the decision to submit the paper for publication.
Conflict of interest
Dr. Fava has received research support from Abbott Laboratories, Alkermes, Aspect Medical Systems, Astra–Zeneca, BioResearch, BrainCells, Inc., Bristol–Myers–Squibb Company, Cephalon, Clinical Trial Solutions,LLC, Eli Lilly & Company, EnVivo Pharmaceuticals, Inc., Forest Pharmaceuticals Inc., Ganeden, GlaxoSmithKline, J & J Pharmaceuticals, Lichtwer Pharma GmbH, Lorex Pharmaceuticals, NARSAD, NCCAM, NIDA, NIMH, Novartis, Organon Inc., PamLab, LLC, Pfizer Inc, Pharmavite, Roche, Sanofi–Aventis,
Acknowledgments
The authors thank Rosa Schnyer, L.Ac., Jing Liu, M.D., Katherine Hui, M.D., and Ming Lee, L.Ac., for their helpful insight regarding the selection of acupoints for the study.
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