Ewies, AAA, Ahmed, I, Al‐Azzawi, F et al. (13 more authors) (2021) Folic acid supplementation in postmenopausal women with hot flushes: phase III randomised double-blind placebo-controlled trial. BJOG: An International Journal of Obstetrics & Gynaecology. ISSN 1470-0328
Abstract
Objective
To assess whether folic acid supplementation ameliorates hot flushes.
Design
Double-blind, placebo-controlled randomised trial.
Setting
Nine hospitals in England.
Population
Postmenopausal women experiencing ≥50 hot flushes weekly.
Methods
Women (n = 164) were randomly assigned in a 1:1 ratio to receive folic acid 5 mg tablet or placebo daily for 12 weeks. Participants recorded frequency and severity of hot flushes in a Sloan Diary daily and completed Greene Climacteric and Utian Quality of Life (UQoL) Scales at 4-week intervals.
Main outcome measures
The change in daily Hot Flush Score at week 12 from randomisation based on Sloan Diary Composite Score B calculation.
Results
Data of 143 (87%) women were available for the primary outcome. The mean change (SD) in Hot Flush Score at week 12 was −6.98 (10.30) and −4.57 (9.46) for folic acid and placebo group, respectively. The difference between groups in the mean change was −2.41 (95% CI −5.68 to 0.87) (P = 0.149) and in the adjusted mean change −2.61 (95% CI −5.72 to 0.49) (P = 0.098). Analysis of secondary outcomes indicated an increased benefit in the folic acid group regarding changes in total and emotional UQoL scores at week 8 when compared with placebo. The difference in the mean change from baseline was 5.22 (95% CI 1.16–9.28) and 1.88 (95% CI 0.23–3.52) for total and emotional score, respectively.
Conclusions
The study was not able to demonstrate that folic acid had a statistically significant greater benefit in reducing Hot Flush Score over 12 weeks in postmenopausal women when compared with placebo.
Tweetable abstract
Folic acid may ameliorate hot flushes in postmenopausal women but confirmation is required from a larger study.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2021 The Authors. This is an open access article under the terms of the Creative Commons Attribution 4.0 International License (CC BY 4.0) (https://creativecommons.org/licenses/by/4.0/) |
Keywords: | Folic acid, hot flushes |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Inst of Clinical Trials Research (LICTR) (Leeds) |
Depositing User: | Symplectic Publications |
Date Deposited: | 30 Jun 2021 10:42 |
Last Modified: | 30 Jun 2021 10:42 |
Status: | Published online |
Publisher: | Wiley |
Identification Number: | 10.1111/1471-0528.16739 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:175647 |