Folic acid supplementation in postmenopausal women with hot flushes: phase III randomised double-blind placebo-controlled trial

Ayman A A Ewies, Ikhlaaq Ahmed, Farook Al-Azzawi, Joan Pitkin, Pratima Gupta, Mojca Persic, Banchhita Sahu, Alaa El-Ghobashy, Lisa Barraclough, Jacqueline Woodman, Jaspreet Babrah, Sarah Bowden, Deborah Stocken, Lucinda Billingham, Sudha Sundar, Daniel Rea

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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.

Original languageEnglish
JournalBJOG: An International Journal of Obstetrics & Gynaecology
Early online date13 May 2021
DOIs
Publication statusE-pub ahead of print - 13 May 2021

Bibliographical note

Funding Information:
SB has reported grants from National Institute of Health Research (NIHR) Research for Patient Benefit during the conduct of the study. DR has reported personal fees from Pfizer, personal fees from Novartis, personal fees from Roche, personal fees from Daiiachi‐Sankyo, personal fees from Lily, grants from Roche, grants from Biotheranostics and grants from RNA diagnostics. All of these are outside the submitted work. No potential conflicts of interest were reported by the other authors. The trial was funded by a grant from ‘Research for Patient Benefit’, Ref: PB‐PG‐1111‐26094. The funder and the manufacturers had no role in the design of the study, in the collection, analysis or interpretation of the data, or in the writing of the report.

Publisher Copyright:
© 2021 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.

Keywords

  • Folic acid
  • hot flushes

ASJC Scopus subject areas

  • Obstetrics and Gynaecology

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