Objective: To evaluate the efficacy of sertraline versus placebo in the management of somatic and psychological complaints of the climacteric syndrome.
Methods: We conducted a randomized, double-blind, placebo-controlled trial. A total of 44 women with moderate to severe complaints, defined as 16 or more points according to the Menopause Rating Scale (MRS) considering only the psychological and somatic domains, were incorporated into the trial and randomized to receive either sertraline (50 mg/day) or placebo. Both groups were evaluated at baseline and after 45 and 90 days of treatment. A reduction of 50% or more in the score was considered as a successful response.
Results: Thirty-three patients finished the trial (16 in the sertraline group and 17 in the placebo group), showing an odds ratio of 7.94 (95% confidence interval 1.3-57.3), p = 0.0038 for the sertraline group, in spite of the prominent effect of placebo.
Conclusions: Sertraline was more effective than placebo in the management of the somatic and psychological complaints of the climacteric syndrome.