A pilot study of acupuncture augmentation therapy in antidepressant partial and non-responders with major depressive disorder

Background: Acupuncture is widely used for treating major depressive disorder (MDD). There is evidence supporting acupuncture as an antidepressant monotherapy, but its efficacy as augmentation in antidepressant partial and non-responders has not been well-investigated. Methods: Thirty subjects (47% female, mean age 48 +/- 11 years) with a history of SCID-diagnosed MDD and partial or non-response after 8 weeks of antidepressant therapy were assigned 8 weeks of standardized 30-min open acupuncture augmentation sessions on a weekly (n = 24) or twice-weekly (n = 6) basis. Change in the Hamilton-D-17 score was the primary outcome measure, and response rates (based on HAM-D-17 score improvement of >= 50%) the secondary outcome. Results: Twenty subjects (40% female: 18 in weekly and 2 in twice-weekly treatment) completed the study. In the intent-to-treat (ITT) sample (N = 30), HAM-D-17 scores decreased from 18.5 +/- 3.8 to 11.2 +/- 5.3 in the weekly group (p < 0.001), and from 18.5 +/- 3.3 to 11.8 +/- 4.8 in the twice-weekly group (p = 0.03). Improvement did not differ significantly between treatment arms (p = 0.76). Response rates were 47% for all ITT subjects, 50% for the weekly group and 33% for the twice-weekly group (p =0.66). The most common side effects included soreness/pain (n = 7), bruising (n = 4), and mild bleeding (n = 1) at the needle site. One subject discontinued because of side effects (pain). Limitations: Open design, small sample, polypharmacy with antidepressants. Conclusions: Once or twice-weekly acupuncture augmentation was safe, well-tolerated and effective in antidepressant partial and non-responders, suggesting good feasibility in outpatient settings. Replication in controlled trials is warranted. (C) 2010 Elsevier B.V. All rights reserved.