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Folic Acid Supplementation in Postmenopausal Women with Hot Flushes: Phase III Randomised Double-Blind Placebo-Controlled Trial
  • +13
  • Ayman Ewies,
  • Ikhlaq Ahmed,
  • Farook Alazzawi,
  • Joan Pitkin,
  • Pratima Gupta,
  • Mojca Persic,
  • Banchhita Sahu,
  • Alaa El-Ghobashy,
  • Lisa Barraclough,
  • Jacqueline Woodman,
  • Jaspreet Babrah,
  • Sarah Bowdem,
  • Deborah Stocken ,
  • Lucinda Billingham,
  • Sudha Sundar,
  • Daniel Rea
Ayman Ewies
Sandwell and West Birmingham Hospitals NHS Trust
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Ikhlaq Ahmed
University of Birmingham Edgbaston Campus
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Farook Alazzawi
University Hospitals of Leicester NHS Trust
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Joan Pitkin
Northwest University Healthcare NHS Trust
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Pratima Gupta
University Hospitals Birmingham NHS Foundation Trust
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Mojca Persic
Royal Derby Hospital
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Banchhita Sahu
Princess Royal Hospital
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Alaa El-Ghobashy
Royal Wolverhampton Hospitals NHS Trust
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Lisa Barraclough
The Christie NHS Foundation Trust
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Jacqueline Woodman
University Hospital Coventry
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Jaspreet Babrah
University of Birmingham Edgbaston Campus
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Sarah Bowdem
University of Birmingham Edgbaston Campus
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Deborah Stocken
University of Leeds
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Lucinda Billingham
University of Birmingham Edgbaston Campus
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Sudha Sundar
University of Birmingham Edgbaston Campus
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Daniel Rea
University of Birmingham Edgbaston Campus
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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 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) with p=0.098. There was 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: Folic acid had a greater benefit in reducing Hot Flush Score over 12 weeks in postmenopausal women when compared with placebo; however, the difference did not reach statistical significance. Definitive evidence of benefit requires a larger study.

Peer review status:UNDER REVIEW

24 Jul 2020Submitted to BJOG: An International Journal of Obstetrics and Gynaecology
24 Jul 2020Assigned to Editor
24 Jul 2020Submission Checks Completed
09 Aug 2020Reviewer(s) Assigned
22 Sep 2020Review(s) Completed, Editorial Evaluation Pending