51. Efficacy and Safety of a Standardized Soy and Hop Extract on Menopausal Symptoms: A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.
- Author
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Kim, Hye In, Kim, Min Kyoung, Lee, Inha, Yun, Jisun, Kim, Eui Hyeok, and Seo, Seok Kyo
- Subjects
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PERIMENOPAUSE , *DRUG efficacy , *BIOMARKERS , *COMBINATION drug therapy , *MYALGIA , *SELF-evaluation , *CLINICS , *TERTIARY care , *PARESTHESIA , *JOINT pain , *SOYBEAN , *HOPS , *RANDOMIZED controlled trials , *TREATMENT effectiveness , *BLIND experiment , *DESCRIPTIVE statistics , *RESEARCH funding , *PLANT extracts , *PATIENT compliance , *FATIGUE (Physiology) , *DATA analysis software , *STATISTICAL sampling , *PATIENT safety , *LONGITUDINAL method - 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 results suggest that 190 mg of combined soy and hop extract is safe and effective for improvement of menopausal symptoms. CRIS No.: KCT0006019. [ABSTRACT FROM AUTHOR]
- Published
- 2021
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