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

Background

Pharmacological treatment of geriatric depression is often ineffectivebecause patients cannot tolerate adequate doses of antidepressantmedications.

Aim

Examine the efficacy and safety of shuganjieyu – the first Chinese herbalmedicine approved for the treatment of depression by China’s drug regulatoryagency -- with and without adjunctive treatment with repetitive transcranialmagnetic stimulation (rTMS) in the treatment of geriatric depression.

Methods

Sixty-five inpatients 60 or older who met ICD-10 criteria for depression wererandomly assigned to an experimental group (shuganjieyu + rTMS) (n=36) or acontrol group (shuganjieyu + sham rTMS)(n=29). All participants received 4capsules of shuganjieyu daily for 6 weeks. rTMS (or sham rTMS) wasadministered 20 minutes daily, five days a week for 4 weeks. Blinded ratersused the Hamilton Rating Scale for Depression (HAMD-17) and the TreatmentEmergent Symptom Scale to assess clinical efficacy and safety at baselineand 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 fromthe control group.

Results

None of the patients had serious side effects, but 40% in the experimentalgroup and 50% in the control group experienced minor side effects that allresolved spontaneously. Both groups showed substantial stepwise improvementin depressive symptoms over the 6 weeks. Repeated measures ANOVA found nodifferences between the two groups. After 6 weeks, 97% of the experimentalgroup had experienced a 25% or greater drop in the level of depression, butonly 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 weresome minor, non-significant differences in the onset of the treatment effectbetween the different types of depressive symptoms, but by the second weekof treatment all five HAMD-17 subscale scores had improved significantly inboth groups

Conclusion

The Chinese herbal medicine shuganjieyu is effective and safe in thetreatment of geriatric depression, but only a minority of patients havegreater than 50% improvement in their depressive symptoms after 6 weeks oftreatment. Adjunctive use of rTMS with shuganjieyu does not improve theoverall outcome and does not significantly speed up the onset of action ofshuganjieyu.