期刊
BJOG-AN INTERNATIONAL JOURNAL OF OBSTETRICS AND GYNAECOLOGY
卷 128, 期 12, 页码 2024-2033出版社
WILEY
DOI: 10.1111/1471-0528.16739
关键词
Folic acid; hot flushes
资金
- Research for Patient Benefit [PB-PG-1111-26094]
- National Institutes of Health Research (NIHR) [PB-PG-1111-26094] Funding Source: National Institutes of Health Research (NIHR)
The study did not show a statistically significant difference in reducing Hot Flush Score over 12 weeks between folic acid and placebo groups in postmenopausal women. However, there was an increased benefit in the folic acid group regarding changes in total and emotional UQoL scores at week 8 compared with placebo.
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.
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