OBJECTIVE: Although hormone replacement therapy (HRT) improves menopausal depressive symptoms, women unresponsive to HRT need an antidepressant drug as an effective adjunctive therapy. The aim of this study was to assess whether the herbal medicine Unkei-to has an impact on HRT-resistant menopausal depressive symptoms as an effective adjunctive therapy combined with HRT. METHODS:Twenty-four HRT-resistant menopausal depressive women were randomly assigned to group 1 (n = 12) or group 2 (n = 12). Subjects in group 1 were accessioned into 6 months of open treatment with Unkei-to as an adjunctive therapy and changed to Toki-shakuyaku-san for 6 months following a 1-month washout period. Group 2 started with Toki-shakuyaku-san for 6 months and then changed to Unkei-to for 6 months following a 1-month washout period. RESULTS: Three months' treatment with Unkei-to as an adjunctive therapy significantly improved Zung's Self-Rating Depression Scale (ZSDS) scores, State-Anxiety (STAI-1) scores, and Trait-Anxiety (STAI-2) scores noted before treatment, and this effect continued at 6 months. Treatment with Unkei-to was also significantly effective in reduction of ZSDS scores, STAI-1 scores, and STAI-2 scores at 3 months compared with Toki-shakuyaku-san treatment, and this effect continued at 6 months. CONCLUSIONS: Unkei-to is another option as an adjunctive herbal therapy in HRT-resistant menopausal depressive women.
RCT Entities:
OBJECTIVE: Although hormone replacement therapy (HRT) improves menopausal depressive symptoms, women unresponsive to HRT need an antidepressant drug as an effective adjunctive therapy. The aim of this study was to assess whether the herbal medicine Unkei-to has an impact on HRT-resistant menopausal depressive symptoms as an effective adjunctive therapy combined with HRT. METHODS: Twenty-four HRT-resistant menopausal depressivewomen were randomly assigned to group 1 (n = 12) or group 2 (n = 12). Subjects in group 1 were accessioned into 6 months of open treatment with Unkei-to as an adjunctive therapy and changed to Toki-shakuyaku-san for 6 months following a 1-month washout period. Group 2 started with Toki-shakuyaku-san for 6 months and then changed to Unkei-to for 6 months following a 1-month washout period. RESULTS: Three months' treatment with Unkei-to as an adjunctive therapy significantly improved Zung's Self-Rating Depression Scale (ZSDS) scores, State-Anxiety (STAI-1) scores, and Trait-Anxiety (STAI-2) scores noted before treatment, and this effect continued at 6 months. Treatment with Unkei-to was also significantly effective in reduction of ZSDS scores, STAI-1 scores, and STAI-2 scores at 3 months compared with Toki-shakuyaku-san treatment, and this effect continued at 6 months. CONCLUSIONS: Unkei-to is another option as an adjunctive herbal therapy in HRT-resistant menopausal depressivewomen.