The effect of combined herbal capsules (Menohelp®) on early symptoms of menopause: a randomized double-blind placebo-controlled trial

Introduction: Early symptoms of menopause are very common and often very bothersome. Considering the increasing number of women experiencing these symptoms in the world and Iran, there is a growing need to use methods to reduce these symptoms. Therefore, this study was performed with aim to determine the effect of the combined herbal capsules (Menohelp) on reducing the early symptoms of menopause, number and intensity of hot flashes (primary outcomes), and improving sleep quality and quality of life (secondary outcomes) in menopausal women. Methods: In this double-blind trial in Tabriz, 100 women aged 50 to 59 years suffering from early symptoms of menopause were randomly assigned into two groups of receiving capsules of either Menohelp or placebo. The randomization was done using blocked randomization stratifying by duration of menopause with allocation ratio of 1:1. The outcomes were assessed using the Green Climacteric Scale, a checklist including the number and severity of hot flashes, Pittsburgh sleep quality and the Menopause-Specific Quality of Life (MENQOL). Data were analyzed by SPSS statistical software (version 21) and repeated measures ANOVA, ANCOVA and Mann-Whitney U. P<0.05 was considered statistically significant. Results: There were no statistically significant differences between the two groups in terms of mean score of Green at 4 and 12 weeks of intervention (adjusted mean difference 0.60, 95% CI -2.9 to 4.0), but, mean rank number (p = 0.003 and p = 0.008, respectively) and mean intensity (0.59, 0.3 to 0.9) of hot flashes were higher in the Menohelp group than the placebo group. The mean rank score of Pittsburgh (p = 0.29) at 4 weeks and mean score of MENQOL (p = 0.64) at 12 weeks of intervention were not significantly different between the two groups. Conclusion: The results of the present study could show the positive effects of Menohelp herbal capsule on improving the early symptoms of menopause.