Jiawei Xiaoyao capsule treatment for mild to moderate major depression with anxiety symptoms: a randomized, double-blind, double-dummy, controlled, multicenter, parallel-treatment trial

OBJECTIVE: To assess the efficacy and safety of Jiawei Xiaoyao (JWXY) capsules on mild to moderate depression with anxiety symptoms, a randomized, double-blind, double-dummy controlled, multicenter, parallel-treatment trial was carried out among 210 outpatients with mild to moderate depression and anxiety symptoms from three hospitals in Beijing China. METHODS: Participants were randomized into the JWXY group or the sertraline group. Each group received JWXY treatment and sertraline placebo, or sertraline and JWXY placebo for 8 weeks. Main outcomes were measured using the Hamilton Depression Rating Scale (HAMD), Hamilton Anxiety Rating Scale (HAMA) and the Clinical Global Impression Scale. RESULTS: JWXY and sertraline had the equivalent effect on HAMD at every interview point. JWXY was more effective at reducing the HAMA scores at the 2nd and 12th week, HAMD sleep disturbance subscale scores at the 8th and 12th week, and HAMA somatic anxiety subscale scores at the 12th week. The rate of adverse events in the two groups was the same. CONCLUSION: For mild to moderate depression with anxiety symptoms, JWXY could be as effective as sertraline in alleviating depressive symptoms. For anxiety symptoms, JWXY may be effective more quickly and with longer lasting effects than sertraline. In particular, it may also improve quality of sleep and somatic anxiety symptoms. JWXY is safe and cheaper than conventional antidepressants, and may be the first alternative choice for depression with anxiety symptoms. (C) 2019 JTCM. All rights reserved.