Effect of the Mixed Herbal Medicines Extract (Fennel, Chamomile, and Saffron) on Menopause Syndrome: a Randomized Controlled Clinical Trial

Abstract

Introduction: Menopause is the transition from the reproductive phase of a woman to the non-reproductive. It may impair quality of life. The study aims to determine the effectiveness of mixed herbal medicines on menopause symptoms

Methods: A randomized, triple-blind, clinical trial and placebo-controlled study on 120 peri-menopausal women aged 45-65 years for 12 weeks. All participants took herbal extracts drops orally daily and randomly allocated into four groups: placebo (C), A (250 mg chamomile, 30 mg fennel, 15 mg saffron), B (1000 mg, 120 mg, 60 mg), and D (500 mg, 60 mg, 30 mg). Primary outcome was the mean change in scores of the menopause rating scale that evaluates 11 symptoms.

Results: The median (IQR) physical score significantly reduced from 8.5(4) to 2(3), in psych score reduced from 12(4) to 2 (2) and in urogenital score reduced from 6.5(3) to 3(2) in group B. In group D physical score decreased from 12(6) to 8(4), in psychological score reduced from12 (3) to 8(4) and urogenital score reduced from 7.5 (3) to 8(3) at week 12. No significant differences in group A and C. With comparison the scores of physical, psych and urogenital domain of MRS questionnaire in 1th ,6th and 12th, no significant difference within group A and C were seen, but statistically significant difference was within group B (p<0.001) and D (p<0.001) in all weeks. The effect size was 0.92.

Conclusion: A 12 weeks extracts treatment, there were significant improvement in physical, psychological and urogenital domains in group B.