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A randomized, double-blind, placebo-controlled, cross-over pilot study on the use of a standardized hop extract to alleviate menopausal discomforts.
Phytomedicine. 2010 May; 17(6):389-96.P

Abstract

OBJECTIVES

To examine the efficacy of a hop extract (standardized at 100mug 8-prenylnaringenin per day) for relief of menopausal discomforts.

METHODS

A 16-week randomized, double-blind, placebo-controlled, cross-over study was conducted with 36 menopausal women. The participants were randomly allocated to either placebo or active treatment (hop extract) for a period of eight weeks after which treatments were switched for another eight weeks. The Kupperman Index (KI), the Menopause Rating Scale (MRS) and a multifactorial Visual Analogue Scale (VAS) were assessed at baseline, and after eight and sixteen weeks.

RESULTS

After 8 weeks, both active treatment and placebo significantly improved all outcome measures when compared to baseline with somewhat higher average reductions for placebo than for the active treatment. After 16 weeks only the active treatment after placebo further reduced all outcome measures, whereas placebo after active treatment resulted in an increase for all outcome measures. Although, the overall estimates of treatment efficacy (active treatment-placebo) based on linear mixed models do not show a significant effect, time-specific estimates of treatment efficacy indicate significant reductions for KI (P = 0.02) and VAS (P = 0.03) and a marginally significant reduction (P = 0.06) for MRS after 16 weeks.

CONCLUSIONS

Whereas the first treatment period resulted in similar reductions in menopausal discomforts in both treatment groups, results from the second treatment period suggest superiority of the standardized hop extract over placebo. Thus, phytoestrogen preparations containing this standardized hop extract may provide an interesting alternative to women seeking relief of mild vasomotor symptoms.

Links

Publisher Full Text

Authors+Show Affiliations

Erkkola R
Department of Obstetrics and Gynecology, Turku University Central Hospital, 20521 Turku, Finland.
Vervarcke S
No affiliation info available
Vansteelandt S
No affiliation info available
Rompotti P
No affiliation info available
De Keukeleire D
No affiliation info available
Heyerick A
No affiliation info available

MeSH

Cross-Over StudiesDouble-Blind MethodFemaleFlavanonesHumansHumulusMenopauseMiddle AgedPain MeasurementPhytoestrogensPhytotherapyPilot ProjectsPlant ExtractsReference StandardsTreatment Outcome

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20167461

Citation

Erkkola, R, et al. "A Randomized, Double-blind, Placebo-controlled, Cross-over Pilot Study On the Use of a Standardized Hop Extract to Alleviate Menopausal Discomforts." Phytomedicine : International Journal of Phytotherapy and Phytopharmacology, vol. 17, no. 6, 2010, pp. 389-96.
Erkkola R, Vervarcke S, Vansteelandt S, et al. A randomized, double-blind, placebo-controlled, cross-over pilot study on the use of a standardized hop extract to alleviate menopausal discomforts. Phytomedicine. 2010;17(6):389-96.
Erkkola, R., Vervarcke, S., Vansteelandt, S., Rompotti, P., De Keukeleire, D., & Heyerick, A. (2010). A randomized, double-blind, placebo-controlled, cross-over pilot study on the use of a standardized hop extract to alleviate menopausal discomforts. Phytomedicine : International Journal of Phytotherapy and Phytopharmacology, 17(6), 389-96. https://doi.org/10.1016/j.phymed.2010.01.007
Erkkola R, et al. A Randomized, Double-blind, Placebo-controlled, Cross-over Pilot Study On the Use of a Standardized Hop Extract to Alleviate Menopausal Discomforts. Phytomedicine. 2010;17(6):389-96. PubMed PMID: 20167461.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, double-blind, placebo-controlled, cross-over pilot study on the use of a standardized hop extract to alleviate menopausal discomforts. AU - Erkkola,R, AU - Vervarcke,S, AU - Vansteelandt,S, AU - Rompotti,P, AU - De Keukeleire,D, AU - Heyerick,A, Y1 - 2010/02/18/ PY - 2009/09/21/received PY - 2010/01/05/revised PY - 2010/01/18/accepted PY - 2010/2/20/entrez PY - 2010/2/20/pubmed PY - 2010/10/6/medline SP - 389 EP - 96 JF - Phytomedicine : international journal of phytotherapy and phytopharmacology JO - Phytomedicine VL - 17 IS - 6 N2 - OBJECTIVES: To examine the efficacy of a hop extract (standardized at 100mug 8-prenylnaringenin per day) for relief of menopausal discomforts. METHODS: A 16-week randomized, double-blind, placebo-controlled, cross-over study was conducted with 36 menopausal women. The participants were randomly allocated to either placebo or active treatment (hop extract) for a period of eight weeks after which treatments were switched for another eight weeks. The Kupperman Index (KI), the Menopause Rating Scale (MRS) and a multifactorial Visual Analogue Scale (VAS) were assessed at baseline, and after eight and sixteen weeks. RESULTS: After 8 weeks, both active treatment and placebo significantly improved all outcome measures when compared to baseline with somewhat higher average reductions for placebo than for the active treatment. After 16 weeks only the active treatment after placebo further reduced all outcome measures, whereas placebo after active treatment resulted in an increase for all outcome measures. Although, the overall estimates of treatment efficacy (active treatment-placebo) based on linear mixed models do not show a significant effect, time-specific estimates of treatment efficacy indicate significant reductions for KI (P = 0.02) and VAS (P = 0.03) and a marginally significant reduction (P = 0.06) for MRS after 16 weeks. CONCLUSIONS: Whereas the first treatment period resulted in similar reductions in menopausal discomforts in both treatment groups, results from the second treatment period suggest superiority of the standardized hop extract over placebo. Thus, phytoestrogen preparations containing this standardized hop extract may provide an interesting alternative to women seeking relief of mild vasomotor symptoms. SN - 1618-095X UR - https://www.unboundmedicine.com/medline/citation/20167461/A_randomized_double_blind_placebo_controlled_cross_over_pilot_study_on_the_use_of_a_standardized_hop_extract_to_alleviate_menopausal_discomforts_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0944-7113(10)00023-1 DB - PRIME DP - Unbound Medicine ER -