Efficacy of Hop (Humulus Lupulus L.) in treating early Menopausal Symptoms: A Randomized Controlled Clinical Trial.

Abstract

Abstract: Background: One of the treatments that have been suggested for menopausal symptoms is hormone replacement therapy. However, its side effects and risks are made concerns for clinician and patients. Nowadays, phytoestrogens have been considered in treatment of menopausal symptoms and researches have been conducted in this regard. Hop is an herb that contains phytoestrogen compounds. But, its effect on early menopausal symptoms hasn’t been investigates. Thus, the present study aimed to assess the efficacy of Hop (Humulus Lupulus L.) in treating early menopausal symptoms and hot flashes (primary outcomes) that performed in Tabriz, 2013 -2014. Materials and Methods: This randomized, double –blind, placebo controlled trial, have been conducted on 60 post –menopausal and 60 peri –menopausal women. Data were collected by using Greene scale and daily hot flushes checklist before the intervention, and 4, 8 and 12 weeks after intervention. Subjects were allocated into two groups with ratio of 1:1 by stratified (according to menopausal status) block randomization. The intervention group tool 500 mg hop tablets and the control group took 500 mg placebo tablets for 90 days. Descriptive and analytical statistics including ANCOVA were used for data analysis. Results: There was no loss to follow –up during the 12 weeks of intervention. The Greene total score in the Hop Group was significantly lower than that in the placebo group at 4 (adjusted difference: -10.0, 95% confidence interval: -11.1 to -8.9), 8(-18.6, -20.1 to -17.1) and 12 (-23.4, -25.1 to -21.6) weeks after intervention. The intervention group also improved significantly in all aspects of Greene (mental, physical, vasomotor and sexual symptoms) compared with the control group (p<0.001). The hot flushes number in the Hop group was significantly lower than that in the placebo group during 4 (-8.4, -9.8 to -7.1), 8 (-14.6, -19.3 to -14.9) and 12 (-23.8, -26.4 to -21.1) weeks after intervention. In the premenopausal group, the Greene total score in the Hop group was significantly lower than that in the placebo group at 4 (-8.3, -9.7 to -6.9), 8(-14.6, -16.5 to -12.7) and 12 (-18.2, -20.5 to -16.0) weeks after intervention. Also, the number of hot flushes was significantly lower in the hop group than that in the placebo group during 4 (-8.8, -10.3 to -7.0), 8(-17.0, -20.0 to -13.9) and 12(-22.0, -25.9 to -18.0) weeks after the intervention. In the postmenopausal group, the Greene total score in the Hop group was significantly lower than that in the placebo group at 4 (-11.7, -13.6 to -9.9), 8(-23.6, -25.5 to -21.7) and 12(-29.9, -31.7 to -28.1) weeks after the intervention. Also, the number of hot flushes was significantly lower in the hop groups than that in the placebo group during 4 (-7.4, -9.2 to -5.6), 8 (-16.1, -18.9 to -13.2) and 12 (-24.5, -27.4 to -21.5) weeks after the intervention. Conclusion: According to the results of this study, the use of 500 mg hope tablets daily for 4, 8 and 12 weeks has significant effect on the number of hot flushes and early menopausal symptoms. Thus, use of this herbal drug could be recommended for menopausal women due to high acceptance, convenient to use and no side effect. Through this transcription, we can promote the women's efficiency and quality of life in this important period of life.