Folic acid supplementation in postmenopausal women with hot flushes: phase III randomised double-blind placebo-controlled trial.
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Authors
El-Ghobashy, Alaa
Issue Date
2021-11-01
Journal
Type
Article
Peer-Reviewed Publication
Peer-Reviewed Publication
Keywords
Clinical trial
Dietary supplements
Double-blind methods
England
Female
Folic acid
Hot flushes
Multicentre study
Postmenopausal women
Postmenopause
Randomised controlled trial
Treatment outcome
Dietary supplements
Double-blind methods
England
Female
Folic acid
Hot flushes
Multicentre study
Postmenopausal women
Postmenopause
Randomised controlled trial
Treatment outcome
Journal Title
BJOG: An International Journal of Obstetrics and Gynaecology
Volume
128
Issue
12
Begin page
2024
End page
2033
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.
Citation
Ewies AAA, Ahmed I, Al-Azzawi F, Pitkin J, Gupta P, Persic M, Sahu B, El-Ghobashy A, Barraclough L, Woodman J, Babrah J, Bowden S, Stocken D, Billingham L, Sundar S, Rea D. Folic Acid Supplementation in Postmenopausal Women with Hot Flushes: Phase III Randomised Double-Blind Placebo-Controlled Trial. BJOG. 2021 May 13. doi: 10.1111/1471-0528.16739. Epub ahead of print. PMID: 33982872.