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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.
J Altern Complement Med. 2021 Nov; 27(11):959-967.JA

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.

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Authors+Show Affiliations

Kim HI
Department of Obstetrics and Gynecology, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
Kim MK
Institute of Women's Life Medical Science, CHA University School of Medicine, Seoul, Republic of Korea.
Lee I
Department of Obstetrics and Gynecology, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
Yun J
Department of Obstetrics and Gynecology, National Health Insurance Service Ilsan Hospital, Goyang, Republic of Korea.
Kim EH
Department of Obstetrics and Gynecology, National Health Insurance Service Ilsan Hospital, Goyang, Republic of Korea.
Seo SK
Department of Obstetrics and Gynecology, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.

MeSH

Double-Blind MethodFemaleHot FlashesHumansHumulusIsoflavonesMenopausePhytotherapyPlant ExtractsSoybeans

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

34399063

Citation

Kim, Hye In, et al. "Efficacy and Safety of a Standardized Soy and Hop Extract On Menopausal Symptoms: a 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial." Journal of Alternative and Complementary Medicine (New York, N.Y.), vol. 27, no. 11, 2021, pp. 959-967.
Kim HI, Kim MK, Lee I, et al. Efficacy and Safety of a Standardized Soy and Hop Extract on Menopausal Symptoms: A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial. J Altern Complement Med. 2021;27(11):959-967.
Kim, H. I., Kim, M. K., Lee, I., Yun, J., Kim, E. H., & Seo, S. K. (2021). Efficacy and Safety of a Standardized Soy and Hop Extract on Menopausal Symptoms: A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Journal of Alternative and Complementary Medicine (New York, N.Y.), 27(11), 959-967. https://doi.org/10.1089/acm.2021.0027
Kim HI, et al. Efficacy and Safety of a Standardized Soy and Hop Extract On Menopausal Symptoms: a 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial. J Altern Complement Med. 2021;27(11):959-967. PubMed PMID: 34399063.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and Safety of a Standardized Soy and Hop Extract on Menopausal Symptoms: A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial. AU - Kim,Hye In, AU - Kim,Min Kyoung, AU - Lee,Inha, AU - Yun,Jisun, AU - Kim,Eui Hyeok, AU - Seo,Seok Kyo, Y1 - 2021/08/16/ PY - 2021/8/17/pubmed PY - 2021/11/9/medline PY - 2021/8/16/entrez KW - hop KW - hot flush KW - isoflavones KW - menopause KW - soy SP - 959 EP - 967 JF - Journal of alternative and complementary medicine (New York, N.Y.) JO - J Altern Complement Med VL - 27 IS - 11 N2 - 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. SN - 1557-7708 UR - https://www.unboundmedicine.com/medline/citation/34399063/Efficacy_and_Safety_of_a_Standardized_Soy_and_Hop_Extract_on_Menopausal_Symptoms:_A_12_Week_Multicenter_Randomized_Double_Blind_Placebo_Controlled_Clinical_Trial_ DB - PRIME DP - Unbound Medicine ER -