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Effects of a standardised extract of Trifolium pratense (Promensil) at a dosage of 80mg in the treatment of menopausal hot flushes: A systematic review and meta-analysis.
Phytomedicine. 2017 Jan 15; 24:141-147.P

Abstract

OBJECTIVE

To critically assess the evidence for a specific standardised extract of Trifolium pratense isoflavones (Promensil) at a dosage of 80mg/day in the treatment of menopausal hot flushes.

DATA SOURCES

Systematic literature searches were performed in Medline, Scopus, CINAHL Plus, Cochrane, AMED and InforRMIT and citations obtained from 1996 to March 2016. Reference lists were checked; corresponding authors contacted and the grey literature searched for additional publications.

REVIEW METHODS

Studies were selected according to predefined inclusion and exclusion criteria. All randomised clinical trials of a specific standardised extract of Trifolium pratense isoflavones (Promensil) used as a mono-component at 80mg/day and measuring vasomotor symptoms were included. The data extraction and quality assessment were performed independently by one reviewer and validated by a second with any disagreements being settled by discussion. Weighted mean differences and 95% confidence intervals were calculated for continuous data using the fixed-effects model.

RESULTS

Twenty potentially relevant papers were identified, with only five studies meeting the inclusion criteria. The meta-analysis demonstrated a statistical and clinically relevant reduction in hot flush frequency in the active treatment group compared to placebo. Weighted mean difference 3.63 hot flushes per day: [95% CI 2.70-4.56]; p˂0.00001). Due to a lack of homogeneity a priori defined sub-group analyses were performed demonstrating a substantive difference between cross-over and parallel-arm clinical trial designs.

CONCLUSION

There is evidence for a statistical and clinically significant benefit for using a specific standardised extract of red clover isoflavones (Promensil) at 80mg/day for treating hot flushes in menopausal women across the 3 studies included in the meta-analysis. The preparation was safe over the short-term duration of the studies (3 months).

Authors+Show Affiliations

NatMed-Research Unit, Division of Research, Southern Cross University, Military Rd., Lismore, NSW 2480, Australia. Electronic address: stephen.myers@scu.edu.au.NatMed-Research Unit, Division of Research, Southern Cross University, Military Rd., Lismore, NSW 2480, Australia.

Pub Type(s)

Journal Article
Meta-Analysis
Review
Systematic Review

Language

eng

PubMed ID

28160855

Citation

Myers, S P., and V Vigar. "Effects of a Standardised Extract of Trifolium Pratense (Promensil) at a Dosage of 80mg in the Treatment of Menopausal Hot Flushes: a Systematic Review and Meta-analysis." Phytomedicine : International Journal of Phytotherapy and Phytopharmacology, vol. 24, 2017, pp. 141-147.
Myers SP, Vigar V. Effects of a standardised extract of Trifolium pratense (Promensil) at a dosage of 80mg in the treatment of menopausal hot flushes: A systematic review and meta-analysis. Phytomedicine. 2017;24:141-147.
Myers, S. P., & Vigar, V. (2017). Effects of a standardised extract of Trifolium pratense (Promensil) at a dosage of 80mg in the treatment of menopausal hot flushes: A systematic review and meta-analysis. Phytomedicine : International Journal of Phytotherapy and Phytopharmacology, 24, 141-147. https://doi.org/10.1016/j.phymed.2016.12.003
Myers SP, Vigar V. Effects of a Standardised Extract of Trifolium Pratense (Promensil) at a Dosage of 80mg in the Treatment of Menopausal Hot Flushes: a Systematic Review and Meta-analysis. Phytomedicine. 2017 Jan 15;24:141-147. PubMed PMID: 28160855.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of a standardised extract of Trifolium pratense (Promensil) at a dosage of 80mg in the treatment of menopausal hot flushes: A systematic review and meta-analysis. AU - Myers,S P, AU - Vigar,V, Y1 - 2016/12/12/ PY - 2016/05/13/received PY - 2016/11/14/revised PY - 2016/12/11/accepted PY - 2017/2/6/entrez PY - 2017/2/6/pubmed PY - 2017/4/25/medline KW - Hot flushes KW - Isoflavones KW - Menopause KW - Red clover KW - Standardisation KW - Trifolium pratense SP - 141 EP - 147 JF - Phytomedicine : international journal of phytotherapy and phytopharmacology JO - Phytomedicine VL - 24 N2 - OBJECTIVE: To critically assess the evidence for a specific standardised extract of Trifolium pratense isoflavones (Promensil) at a dosage of 80mg/day in the treatment of menopausal hot flushes. DATA SOURCES: Systematic literature searches were performed in Medline, Scopus, CINAHL Plus, Cochrane, AMED and InforRMIT and citations obtained from 1996 to March 2016. Reference lists were checked; corresponding authors contacted and the grey literature searched for additional publications. REVIEW METHODS: Studies were selected according to predefined inclusion and exclusion criteria. All randomised clinical trials of a specific standardised extract of Trifolium pratense isoflavones (Promensil) used as a mono-component at 80mg/day and measuring vasomotor symptoms were included. The data extraction and quality assessment were performed independently by one reviewer and validated by a second with any disagreements being settled by discussion. Weighted mean differences and 95% confidence intervals were calculated for continuous data using the fixed-effects model. RESULTS: Twenty potentially relevant papers were identified, with only five studies meeting the inclusion criteria. The meta-analysis demonstrated a statistical and clinically relevant reduction in hot flush frequency in the active treatment group compared to placebo. Weighted mean difference 3.63 hot flushes per day: [95% CI 2.70-4.56]; p˂0.00001). Due to a lack of homogeneity a priori defined sub-group analyses were performed demonstrating a substantive difference between cross-over and parallel-arm clinical trial designs. CONCLUSION: There is evidence for a statistical and clinically significant benefit for using a specific standardised extract of red clover isoflavones (Promensil) at 80mg/day for treating hot flushes in menopausal women across the 3 studies included in the meta-analysis. The preparation was safe over the short-term duration of the studies (3 months). SN - 1618-095X UR - https://www.unboundmedicine.com/medline/citation/28160855/Effects_of_a_standardised_extract_of_Trifolium_pratense__Promensil__at_a_dosage_of_80mg_in_the_treatment_of_menopausal_hot_flushes:_A_systematic_review_and_meta_analysis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0944-7113(16)30250-1 DB - PRIME DP - Unbound Medicine ER -