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ABSTRACT
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.
Conflict of interest The authors report no conflicts of interest. The authors alone are responsible for the content and writing of this paper.
Source of funding This study was partially financed by the Servicio de Salud Metropolitano Oriente de Santiago-Chile and the School of Medicine of the University of Chile. We thank Saval Laboratories Chile for providing the drugs used in this study.