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

Research output: Contribution to journalArticlepeer-review

Authors

  • Ayman A A Ewies
  • Farook Al-Azzawi
  • Joan Pitkin
  • Pratima Gupta
  • Mojca Persic
  • Banchhita Sahu
  • Alaa El-Ghobashy
  • Lisa Barraclough
  • Jacqueline Woodman
  • Jaspreet Babrah
  • Deborah Stocken

External organisations

  • Sandwell and West Birmingham Hospitals NHS Trust
  • Leicester General Hospital, University Hospitals Leicester NHS Trust Leicester UK
  • London Northwest University Healthcare NHS Trust
  • University of Nottingham, Royal Derby Hospital Centre, Derby, UK.
  • Princess Royal Hospital
  • Gynaecological Oncology Surgery
  • The Christie NHS Foundation Trust
  • University Hospital Coventry and Warwickshire NHS Trust, Coventry, UK.
  • University of Leeds
  • Imperial College London
  • University Hospitals Birmingham NHS Foundation Trust

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 5mg tablet or placebo daily for 12 weeks. Participants recorded frequency and severity of hot flushes in Sloan Diary daily and completed Greene Climacteric and Utian Quality of Life (UQoL) Scales at 4-weekly 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 was 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, 0.87), p=0.149 and in the adjusted mean change was -2.61 (95% CI: -5.72, 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.

Bibliographic note

Final Version of Record not yet available as of 25/05/2021.

Details

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

Keywords

  • Folic acid, Hot Flushes