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Efficacy and Safety of a Standardized Soy and Hop Extract on Menopausal Symptoms: A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.
- Source :
-
Journal of Alternative & Complementary Medicine . Nov2021, Vol. 27 Issue 11, p959-967. 9p. - Publication Year :
- 2021
-
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]
- Subjects :
- *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
Subjects
Details
- Language :
- English
- ISSN :
- 10755535
- Volume :
- 27
- Issue :
- 11
- Database :
- Academic Search Index
- Journal :
- Journal of Alternative & Complementary Medicine
- Publication Type :
- Academic Journal
- Accession number :
- 153410394
- Full Text :
- https://doi.org/10.1089/acm.2021.0027