Abstract

This multicenter, randomized, controlled clinical study was designed to address the effectiveness of combined traditional-Chinese-medicine- (TCM-) based psychotherapy and Chinese herbal medicine (CHM) in the treatment of menopausal syndrome. Altogether 424 eligible women diagnosed as menopausal syndrome and categorized as Kidney-Yin/Kidney-Yang deficiency pattern in TCM were randomly assigned into 4 groups and accepted TCM-based psychotherapy (PSY), CHM, PSY + CHM, or placebo therapies, respectively, for 12 weeks, and another 12 weeks were taken as the followup. Kupperman Index (KI) and the Menopause-Specific Quality of Life (MENQOL) with its four subscales (vasomotor, physical, psychosocial, and sexual) were employed for efficacy assessment. Results showed that 400 participants completed 12-week treatment, of which 380 finished the record of KI and MENQOF at week 24. The average adjusted number of KI score decreased between baseline and 12 weeks in all groups. Statistically significant differences were detected in the average adjusted change between the PSY + CHM group and placebo at overall time points (P < 0.05). No severe adverse events occurred in each group and no significant differences were indicated between any of the three groups and placebo in adverse event proportion. We concluded that TCM psychotherapy combined with CHM has a favorable outcome in treating menopausal syndrome.

Highlights

  • Menopause is the phase of life when a woman transitions, both mentally and physically, from sexual maturity to old age

  • 920 cases diagnosed with menopausal syndrome were screened in the study; 424 eligible women participated in the trial and were randomly assigned as follows: PSY + Chinese herbal medicine (CHM) group (n = 105); PSY group (n = 104); CHM group (n = 111); placebo group (n = 104)

  • Baseline characteristics were similar among all groups, with the exceptions of menopausal statuses, Kupperman index scores and psychosocial subscale scores (Table 1)

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Summary

Introduction

Menopause is the phase of life when a woman transitions, both mentally and physically, from sexual maturity to old age In this phase, many females suffer from a considerable variety of symptoms; these can include hot flashes, night sweats, menstrual irregularities, vaginal dryness, depression, nervous tension, palpitations, and others [1]. Many females suffer from a considerable variety of symptoms; these can include hot flashes, night sweats, menstrual irregularities, vaginal dryness, depression, nervous tension, palpitations, and others [1] Such symptoms are frequently considered part of menopausal syndrome. Researchers have documented the occurrence of certain psychological and somatic symptoms in specific clusters [4] Some of these symptom clusters, such as vasomotor symptoms and sexual difficulties, were best predicted solely by menopausal status [1] and can be more effectively controlled by hormonal interventions than placebo [5]. Women who seek medical help for menopausal problems tend to report more physical and psychological problems in general [6], and women with more negative attitudes towards menopause in general report more symptoms during the menopausal

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