Combination of Acupuncture and Fluoxetine for Depression: A Randomized, Double-Blind, Sham-Controlled Trial

Background and objective: The current pharmacological management of depression remains limited. The aim of this study was to assess the efficacy and safety of acupuncture in combination with fluoxetine as an intervention for major depressive disorder (MDD). Subjects and interventions: A total of 80 patients with MDD (DSM-IV) were randomized to two groups: VA group received verum acupuncture, 10 mg/day fluoxetine and placebo; SA group received sham acupuncture and 20-30mg/day fluoxetine. Acupuncture was applied 5 times a week over a period of 6 weeks. Design and settings: A randomized, double-blind, double-dummy, sham-controlled trial was conducted in Dehong Prefecture Traditional Chinese Medicine Hospital. Outcome measures: All subjects were assessed in a double-blind fashion at four time points (i.e., baseline, the end of the second, fourth, and sixth week of treatment. The primary outcome measure was the therapeutic response rate based on the rate of total score change in the 17-item Hamilton Rating Scale for Depression (HRSD). Anxious symptoms, antidepressant side-effects, and acupuncture adverse effects were also measured additionally. Results: At the end of the treatment period, the therapeutic response rates were not statistically significant between groups (80.0% for the VA group and 77.5% for the SA group, respectively). No statistical significance was found between the 2 groups in the rate of HRSD score change (z = 1.80, p = 0.07), but patients in the VA group showed better improvement than the SA group in symptoms of anxiety and side-effects of antidepressant (z = 2.60, p = 0.01 and z = 23.60, p < 0.001, respectively). The overall rate of adverse events due to acupuncture was 8.75%. Conclusions: Additionally applied standardized acupuncture to low-dose fluoxetine for depression is as effective as a recommended dose of fluoxetine treatment. Depressive patients with severe anxious symptoms and/or intolerable side-effects of antidepressants can benefit from it.