: Effect of Menohelp herbal combination on early menopausal symptoms: a randomized double-blind placebo-controlled clinical trial.

Abstract

Introduction: Average life expectancy has increased globally and in Iran, and women spend a significant portion of their lives after menopause. Therefore, it is more important to use evidence-based methods to treat menopausal problems. According to the production of Menohelp herbal composition for the treatment of early menopause symptoms and the lack of sufficient scientific evidence about its effectiveness, this study aimed to assess the effectiveness of Menohelp, a herbal composition produced by a herbal drug company, on early menopausal symptoms. Methods: This double-blind superiority trial was conducted on 100 menopausal women aged to 59 covered by public health centers in Tabriz city, who were suffering from early menopausal symptoms. Eligible women, after a breast exam to ensure of no palpable mass, was randomized into two groups receiving capsule of Menohelp or placebo, once a day for 12 weeks. The randomization was done using stratified (based on the duration of menopause 3 years or less and more than 3 years) block randomization with a block size of 4 and allocation ratio of 1:1. Primary outcomes were menopausal symptoms, and the number and severity of hot flashes. Secondary outcomes include quality of life and sleep quality. We collected the outcomes using Green menopausal symptom scale, and a checklist including the number and severity of hot flashes (at baseline, 4 and 12 weeks of intervention), quality of life of menopausal women (MENQOL) (at baseline and 12 weeks of intervention) and Pittsburgh sleep quality (at 4 of intervention). Also, blood sample was checked to assess levels of ALT, AST, AIK at baseline and 12 weeks of intervention. Independent t, Mann-Whitney U, repeated measures ANOVA, ANCOVA were used to compare the outcomes between the groups. Results: There was no statistically significant difference between the groups in terms of baseline characteristics (p > 0.05, except for the variable of marital satisfaction (p = 0.03)). At the 4 weeks of intervention, there were no statistically significant differences in terms of Green scale scores (p = 0.92), and Pittsburgh sleep quality (p = 0.29) between the two groups, but the number (p = 0.003) and intensity (p = 0.007) of hot flashes were higher and overall perceived improvement of menopausal symptoms (p = 0.04) was lower in the Menohelp group compared to the placebo group. At the 12 weeks of intervention, there was no statistically significant difference in terms of the scores of the Green scale (p = 0.63), MENQOL (p = 0.64) and the level of liver enzymes (p > 0.05) between the two intervention and control groups, but the number (p = 0.008) and intensity (p = 0.007) of hot flashes were higher and overall perceived improvement of menopausal symptoms (p = 0.002) was lower in the Menohelp group compared to the placebo group