Efficacy and Safety of a Standardized Soy and Hop Extract on Menopausal Symptoms: A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Abstract
Objectives: Soy and hop extracts have been investigated as alternatives for hormone replacement therapy. However, their combined efficacy is not known. We investigated the efficacy and safety of a combined soy and hop extract on postmenopausal symptoms. Design: Double-blinded, randomized controlled trial. Settings/Location: Gynecological outpatient clinic of tertiary hospital. Subjects: Seventy-eight women with moderate or severe menopausal symptoms assessed as modified Kupperman Menopoausal Index (KMI) scores >20. Interventions: They received either a combined soy and hop extract (n = 38) or placebo (n = 40). Outcome measures: Menopausal symptoms were evaluated through self-reporting of modified Kupperman Menopausal Index (KMI) scores at baseline and after 6 and 12 weeks. We assessed serum levels of bone metabolism biomarkers, ultrasonographic parameters, hormone profiles, compliance, and safety. Results: After 12 weeks of the treatment, treatment group scores decreased by 20.61 points compared with 14.80 points in the placebo group (p < 0.05). Fatigue, paresthesia, arthralgia, and myalgia, palpitation and vaginal dryness significantly improved more in the treatment group compared with the placebo group after 12 weeks (p < 0.05). Urine N-telopeptide in participants ≥50 years in the treatment group showed a reduced increase. Endometrial thickness and hormonal profiles did not show significant changes in either group. No serious adverse events were reported. Conclusion: The…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 40 participants or records.
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