Efficacy and safety of non-hormonal agents for vasomotor symptoms of menopause: A prospective, double-blind, placebo-controlled study

Abstract

Aim. To assess the safety and efficacy of non-hormonal agents for mild vasomotor symptoms of menopause. Materials and methods. The study included 173 females aged 4855 with mild vasomotor symptoms during the early postmenopausal period. Patients in the study cohort were stratified into two groups by the double-blind method. In group 1 (study), the patients took the homeopathic agent Neoclimsal 1 tablet 4 times a day sublingually until completely dissolved for 4 weeks (n=86). In group 2 (n=87), the patient received a placebo (30 mg of microcrystalline cellulose) in a regimen mimicking the study treatment. Twenty-three patients withdrew from the study due to protocol violation or revoked their consents for reasons not related to medication. At the end of the study, 75 patients remained in both groups. The therapeutic efficacy was assessed based on the Greene and MENQOL scores change. The SF-36 questionnaire was used to evaluate patients' quality of life, and the average rate of falling asleep was calculated to assess the change in sleep disturbance. The change of M-echo and mammography results were reviewed using the BI-RADS scale 12 months after the start of the treatment to assess the agent's safety. Study design: A prospective, double-blind, placebo-controlled study. Results. The course of Neoclimsal, sublingual tablets, reduced the severity of vasomotor symptoms by 2.3 times, the severity of depression by half (p0.001), and at the end of treatment after 12 weeks of observation, the therapeutic effect not only persisted but tended to increase (p0.001). Improvement in the quality of life of patients treated with Neoclimsal was confirmed by an improvement in the MENQOL score by 1.4 times a month after the start of therapy while maintaining the achieved result after 12 weeks of observation (p0.001). The drug's safety is confirmed by the absence of adverse side effects and allergic reactions, the absence of endometrial thickness change within 3 months after the start of treatment, and mammography results using the BI-RADS scale at 12 months. Conclusion. The results indicate the effectiveness of non-hormonal therapy in relieving vasomotor symptoms of mild postmenopause with a high safety profile. The drug has a beneficial effect on sleep disorders, reducing the severity of mental distress and improving the general quality of life.