Folic Acid Supplementation in Postmenopausal Women with Hot Flushes: Phase III Randomised Double-Blind Placebo-Controlled Trial

Abstract

Where a licence is displayed above, please note the terms and conditions of the licence govern your use of this document.When citing, please reference the published version. Take down policyWhile the University of Birmingham exercises care and attention in making items available there are rare occasions when an item has been uploaded in error or has been deemed to be commercially or otherwise sensitive.

Effect of Folic Acid Versus Placebo on Hot Flashes in Menopausal Women Attending a Rural Family Practice Centre: A randomized controlled clinical

“…We found in our study there is statistical signi cance difference between the two groups in the fourth week regarding mean hot ash score where (p < 0.002). Matching to our study, the randomized control trial in England by Ewies et al 2020 showed that folic acid gave greater bene t in reducing the hot ash score in postmenopausal women when compared with placebo. However; the difference between two groups did not reach statistical signi cance which is inconsistent with this study result which revealed statistically signi cant difference in the fourth week severity after treatment [17].…”

“…Matching to our study, the randomized control trial in England by Ewies et al 2020 showed that folic acid gave greater bene t in reducing the hot ash score in postmenopausal women when compared with placebo. However; the difference between two groups did not reach statistical signi cance which is inconsistent with this study result which revealed statistically signi cant difference in the fourth week severity after treatment [17]. Also, this study is not consistent with the study of El-Ghobashy et al, 2021 which was not able to demonstrate that folic acid had a greater bene t in reducing hot ash score over 12 weeks in postmenopausal women when compared with placebo [13].…”

“…Another study, examined the effect of 5 mg folic acid supplementation versus no treatment for 4 weeks found that, by the 4th week of treatment the folic acid group demonstrated an average of 57% reduction in hot ushes frequency while the control group showed no change [18]. A randomized controlled trial by Ewies et al was unable to show that folic acid was signi cantly superior to placebo in lowering the Hot Flush Score over a 12-week period in postmenopausal women which may be due to a greater than expected response to placebo [17]. The effectiveness of hormone therapy was clearly demonstrated in a Cochrane review of 9 placebo-controlled trials of oral oestrogen therapy for menopausal hot ashes, but it also revealed that those receiving placebo treatment experienced a mean reduction of 58% in hot ash frequency [19].…”

“…Studies have reported that folic acid increased serotonin activity and reduced noradrenaline secretion. In rodents treated with folic acid, an antidepressant effect was observed through the regulation of the noradrenergic receptors (α1 and α2) and serotonergic receptors (5-HT1A and 5-HT2A/2C) [17].…”

“…The current study found that there was no statistically signi cant difference between interventional and control group regarding their MENQOL domains after treatment. In England a study by Ewies et al 2020 investigated the effect of folic acid supplementation in reducing hot ashes; it found that according to Greene Climacteric Scale, folic acid had a greater bene t in ameliorating menopausal symptoms compared with placebo; however, the difference wasn't statistical signi cant further according to Utian QOL Score, the scores were similar for both groups and there was no statistically signi cant difference for any subscale score with the exception of the total score and emotional score at the 8th week. The mean differences from baseline in total score and emotional score were statistically signi cantly greater for folic acid group compared to placebo [17].…”