A Randomized, Controlled Clinical Trial of Combining Therapy with Traditional Chinese Medicine-Based Psychotherapy and Chinese Herbal Medicine for Menopausal Women with Moderate to Serious Mood Disorder

Objective. To comparatively examine the effectiveness and safety of the combination therapy of traditional Chinese medicine formula Bushen-Shugan granule and psychotherapy (BSSG-P) and Chinese herbal medicine Bushen-Shugan granule (BSSG) alone in the treatment of moderate to serious mood disorder in menopausal women. Methods. In our previous clinical studies, BSSG-P had been proved to be superior to BSSG, psychological treatment, and placebo in improving mild mood disorder in menopausal women. In this study, we analyzed the efficacy of BSSG-P and BSSG in the treatment of moderate to serious mood disorder. Eighty-five eligible participants, who were diagnosed as menopausal women with moderate to serious mood disorder and categorized as kidney deficiency and liver-qi stagnation pattern, were randomly assigned into two groups and treated with BSSG-P or BSSG. They were subjected to an 8-week treatment period and a 4-week follow-up study. The primary outcome instrument was the Greene Climacteric Scale, Self-Rating Depression Scale (SDS), and Self-Rating Anxiety Scale (SAS), respectively. Results. When comparing all time points with baseline, both BSSG-P and BSSG markedly decreased the t