A randomized, placebo-controlled, crossover study of tibolone (Livial) on menopause symptoms, psychological well-being, and dyadic relationship of postmenopausal Chinese women and their spouses

Objective: To investigate the effects of 6-month treatment of tibolone on menopause symptoms, psychological well-being, and the dyadic relationship of postmenopausal Chinese women and their spouses. Design: A randomized, double-blind, crossover study was conducted in 100 postmenopausal Hong Kong Chinese women who received tibolone (2.5mg/day) and placebo. At baseline, 6-month and 13-month visits, the women filled in the Greene Climacteric Scale (GCS), 12-item General Health Questionnaire (GHQ) and Dyadic Adjustment Scale (DAS), and their spouses completed GHQ and DAS. Results: Both tibolone and placebo treatment were associated with a significant reduction in the GCS total scores after the first 6-month interventional period (95% CI: -8.0 to -2.5 for tibolone, and -5.7 to -0.7 for placebo). After the correction for placebo response, tibolone treatment was associated with a significant reduction in the GCS somatic subscore (-1.1 ± 0.4 for tibolone group versus 0.6 ± 0.5 for placebo group, P < 0.05). There were no significant changes in the GHQ and DAS total scores of the women and their spouses after tibolone treatment, both with and without the correction for placebo response. Conclusions: Tibolone treatment had a significant beneficial effect on the somatic menopause symptoms but had no effect on the psychological well-being or marital relationship of the postmenopausal Chinese women and their spouses.