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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

Authors
 Hye In Kim  ;  Min Kyoung Kim  ;  Inha Lee  ;  Jisun Yun  ;  Eui Hyeok Kim  ;  Seok Kyo Seo 
Citation
 JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE, Vol.27(11) : 959-967, 2021-11 
Journal Title
JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE
ISSN
 1075-5535 
Issue Date
2021-11
MeSH
Double-Blind Method ; Female ; Hot Flashes* / drug therapy ; Humans ; Humulus ; Isoflavones* / therapeutic use ; Menopause ; Phytotherapy* ; Plant Extracts* / therapeutic use ; Soybeans
Keywords
hop ; hot flush ; isoflavones ; menopause ; soy
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.
Full Text
https://www.liebertpub.com/doi/10.1089/acm.2021.0027
DOI
10.1089/acm.2021.0027
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Obstetrics and Gynecology (산부인과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Hye In(김혜인) ORCID logo https://orcid.org/0000-0001-7961-5988
Seo, Seok Kyo(서석교) ORCID logo https://orcid.org/0000-0003-3404-0484
Lee, Inha(이인하) ORCID logo https://orcid.org/0000-0003-4869-6281
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/187163
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