Efficacy and safety of the Chinese herbal medicine shuganjieyu with and without adjunctive repetitive transcranial magnetic stimulation (rTMS) for geriatric depression: a randomized controlled trial.

Abstract

BACKGROUND: Pharmacological treatment of geriatric depression is often ineffective because patients cannot tolerate adequate doses of antidepressant medications. AIM: Examine the efficacy and safety of shuganjieyu - the first Chinese herbal medicine approved for the treatment of depression by China's drug regulatory agency -- with and without adjunctive treatment with repetitive transcranial magnetic stimulation (rTMS) in the treatment of geriatric depression. METHODS: Sixty-five inpatients 60 or older who met ICD-10 criteria for depression were randomly assigned to an experimental group (shuganjieyu + rTMS) (n=36) or a control group (shuganjieyu + sham rTMS)(n=29). All participants received 4 capsules of shuganjieyu daily for 6 weeks. rTMS (or sham rTMS) was administered 20 minutes daily, five days a week for 4 weeks. Blinded raters used the Hamilton Rating Scale for Depression (HAMD-17) and the Treatment Emergent Symptom Scale to assess clinical efficacy and safety at baseline and 1, 2, 4, and 6 weeks after starting treatment. Over the six-week trial, there was only one dropout from the experimental group and two dropouts from the control group. RESULTS: None of the patients had serious side effects, but 40% in the experimental group and 50% in the control group experienced minor side effects that all resolved spontaneously. Both groups showed substantial stepwise improvement in depressive symptoms over the 6 weeks. Repeated measures ANOVA found no differences between the two groups. After 6 weeks, 97% of the experimental group had experienced a 25% or greater drop in the level of depression, but only 20% had experience a 50% or greater drop in the level of depression; the corresponding values in the control group were 96% and 19%. There were some minor, non-significant differences in the onset of the treatment effect between the different types of depressive symptoms, but by the second week of treatment all five HAMD-17 subscale scores had improved significantly in both groups. CONCLUSION: The Chinese herbal medicine shuganjieyu is effective and safe in the treatment of geriatric depression, but only a minority of patients have greater than 50% improvement in their depressive symptoms after 6 weeks of treatment. Adjunctive use of rTMS with shuganjieyu does not improve the overall outcome and does not significantly speed up the onset of action of shuganjieyu.