Cost-effectiveness of mifepristone and misoprostol versus misoprostol alone for the management of missed miscarriage: an economic evaluation based on the MifeMiso Trial (2021)

Type of publication:
Journal article

Author(s):
Okeke Ogwulu, C B; Williams, E V; Chu, J J; Devall, A J; Beeson, L E; Hardy, P; Cheed, V; Yongzhong, S; Jones, L L; La Fontaine Papadopoulos, J H; Bender-Atik, R; Brewin, J; Hinshaw, K; Choudhary, M; Ahmed, A; Naftalin, J; Nunes, N; Oliver, A; Izzat, F; Bhatia, K; Hassan, I; Jeve, Y; Hamilton, J; Deb, S; Bottomley, C; Ross, J; Watkins, L; *Underwood, M; Cheong, Y; Kumar, C S; Gupta, P; Small, R; Pringle, S; Hodge, F S; Shahid, A; Horne, A W; Quenby, S; Gallos, I D; Coomarasamy, A; Roberts, T E

Citation:
BJOG : an international journal of obstetrics and gynaecology; May 2021 [epub ahead of print]

Abstract:
OBJECTIVE To assess the cost-effectiveness of mifepristone and misoprostol (MifeMiso) compared with misoprostol only for the medical management of a missed miscarriage. DESIGN Within-trial economic evaluation and model-based analysis to set the findings in the context of the wider economic evidence for a range of comparators. Incremental costs and outcomes were calculated using non-parametric bootstrapping and reported using cost-effectiveness acceptability curves. Analyses were performed from the NHS perspective.SETTING28 UK NHS early pregnancy units.PARTICIPANTS711 women aged 16-39 years with ultrasound evidence of a missed miscarriage. INTERVENTIONS Mifepristone and misoprostol or matched placebo and misoprostol tablets. MAIN OUTCOME MEASURES Cost per additional successfully managed miscarriage and QALYs. RESULTS For the within-trial analysis, MifeMiso intervention resulted in an absolute effect difference of 6.6% (95% CI: 0.7% to 12.5%) per successfully managed miscarriage and QALYs difference of 0.04% (95% CI: -0.01% to 0.1%). The average cost per successfully managed miscarriage was lower in the MifeMiso arm than in the placebo and misoprostol arm, with a cost-saving of £182 (95% CI: £26 to £338). Hence, MifeMiso intervention dominated the use of misoprostol alone. The model-based analysis showed that MifeMiso intervention is dominant compared to expectant management and the current medical management strategy. However, the model-based evidence suggests that the intervention is a less effective but less costly strategy than surgical management. CONCLUSIONS The within-trial analysis found that based on cost-effectiveness grounds, MifeMiso intervention is likely to be recommended by decision-makers for the medical management of women presenting with a missed miscarriage.

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Postpartum haemorrhage and risk of long-term hypertension and cardiovascular disease: an English population-based longitudinal study using linked primary and secondary care databases (2021)

Type of publication:
Journal article

Author(s):
*Parry-Smith, William; Šumilo, Dana; Subramanian, Anuradhaa; Gokhale, Krishna; Okoth, Kelvin; Gallos, Ioannis; Coomarasamy, Arri; Nirantharakumar, Krishnarajah

Citation:
BMJ Open; May 2021; vol. 11 (no. 5); p. e041566

Abstract:
OBJECTIVE To investigate the long-term risk of developing hypertension and cardiovascular disease (CVD) among those women who suffered a postpartum haemorrhage (PPH) compared with those women who did not. DESIGN Population-based longitudinal open cohort study. SETTING English primary care (The Health Improvement Network (THIN)) and secondary care (Hospital Episode Statistics (HES)) databases. POPULATION Women exposed to PPH during the study period matched for age and date of delivery, and unexposed. METHODS We conducted an open cohort study using linked primary care THIN and HES Databases, from 1 January 1997 to 31 January 2018. A total of 42 327 women were included: 14 109 of them exposed to PPH during the study period and 28 218 matched for age and date of delivery, and unexposed to PPH. HRs for cardiovascular outcomes among women who had and did not have PPH were estimated after controlling for covariates using multivariate Cox regression models. OUTCOME MEASURES Risk of hypertensive disease, ischaemic heart disease, heart failure, stroke or transient ischaemic attack. RESULTS During a median follow-up of over 4 years, there was no significant difference in the risk of hypertensive disease after adjustment for covariates (adjusted HR (aHR): 1.03 (95% CI: 0.87 to 1.22); p=0.71). We also did not observe a statistically significant difference in the risk of composite CVD (ischaemic heart disease, heart failure, stroke or transient ischaemic attack) between the exposed and the unexposed cohort (aHR: 0.86 (95% CI: 0.52 to 1.43; p=0.57). CONCLUSION Over a median follow-up of 4 years, we did not observe an association between PPH and hypertension or CVD.

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Postpartum haemorrhage and risk of mental ill health: A population-based longitudinal study using linked primary and secondary care databases (2021)

Type of publication:
Journal article

Author(s):
*Parry-Smith W.; Coomarasamy A.; Nirantharakumar K.; Okoth K.; Subramanian A.; Gokhale K.M.; Chandan J.S.; Sumilo D.; Humpston C.

Citation:
Journal of Psychiatric Research; May 2021; vol. 137 ; p. 419-425

Abstract:
There is a gap in the literature investigating the impact of obstetric complications on subsequent mental ill health outcomes. The aim of this study was to establish the association between post-partum haemorrhage (PPH) and mental ill health. We conducted a retrospective open cohort study utilizing linked primary care (The Health Improvement Network (THIN)) and English secondary care (Hospital Episode Statistics (HES)) databases, from January 1, 1990 to January 31, 2018. A total of 42,327 women were included: 14,109 of them were exposed to PPH during the study period and 28,218 unexposed controls were matched for age and date of delivery. Hazard ratios (HRs) for mental illness among women with and without exposure to PPH were estimated after controlling for covariates. Women who had had PPH were at an increased risk of developing postnatal depression (adjusted HR: 1.10, 95%CI: 1.01-1.21) and post-traumatic stress disorder (PTSD) (adjusted HR: 1.17, 95%CI: 0.73-1.89) compared to women unexposed to PPH. When restricting the follow-up to the first year after childbirth, the adjusted HR for PTSD was 3.44 (95% CI 1.31-9.03). No increase in the overall risk was observed for other mental illnesses, including depression (adjusted HR: 0.94, 95%CI: 0.87-1.01), severe mental illness (adjusted HR: 0.65, 95%CI: 0.40-1.08, p = 0.239) and anxiety (adjusted HR: 0.99, 95%CI: 0.90-1.09). PPH is associated with a significant increase in the risk of developing postnatal depression and PTSD in the first year after delivery. Active monitoring for mental illness should form an integral part of the follow-up in women who suffered a PPH.

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Reflective writing: Training and assessment (2016)

Type of publication:
Conference abstract

Author(s):
*Sizer, A; Chivers, C; Hayes, K; Khan, R

Citation:
Volume 123, Issue S2. Special Issue: Top Scoring Abstracts of the RCOG World Congress 2016, 20–22 June 2016, ICC Birmingham, United Kingdom

Abstract:
Reflective writing is a mandatory component of the annual review of competence progression (ARCP) for UK trainees in Obstetrics & Gynaecology.

It is often commented at ARCP panels that the quality of reflective writing is poor, but if challenged, consultants often find it difficult to say why.

It has been commented the reflection is not an intuitive process for doctors and is a skill that needs to be learnt. However, there is no clear learning process in the curriculum and an internet search revealed no course or training session that was available in the UK.

A reflective writing workshop was developed in the West Midlands Deanery. This was part of the monthly Symposium teaching for trainees at ST3‐5 level. Prior to the workshop, trainees were asked to submit a representative piece of reflective writing from their ePortfolio that had been submitted in the past 6 months so that the particular case or situation that they had reflected on was still fresh in their memory.

The workshop took the following format:

  • Trainees were split into small groups with a facilitator. They were given three pre-written reflective pieces to discuss, one poor, one average and one good. Following the small group work there was feedback to the entire group.
  • The lead facilitator then gave a presentation on reflective writing and models of reflection, particularly focussing on Gibbs reflective cycle and Rolfe's framework of reflection.
  • Trainees were then asked to work on writing a reflective piece in small groups on a mock scenario using a reflective model. There was further feedback and analysis by the whole group.
  • For the final session each trainee was asked to rewrite the reflection that they had previously submitted.
  • In order to assess the reflections pre- and post- workshop we devised a simple scoring system to take into account the key points of the reflective process, namely structure (ie was any particular model followed), length of the descriptive component, and then a subjective assessment of the descriptive and analytical components as well as the action plan. This gave a score of 10 for each reflective piece.
  • The workshop was very well received by the trainees. Interestingly, feedback from the trainees suggested that consultants needed to develop skills in the assessment of reflection.
    Data will be presented on the workshop and scoring system, including qualitative feedback data.

Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis (2020)

Type of publication:
Systematic Review

Author(s):
*Parry Smith, William R; Papadopoulou, Argyro; Thomas, Eleanor; Tobias, Aurelio; Price, Malcolm J; Meher, Shireen; Alfirevic, Zarko; Weeks, Andrew D; Hofmeyr, G Justus; Gülmezoglu, Ahmet Metin; Widmer, Mariana; Oladapo, Olufemi T; Vogel, Joshua P; Althabe, Fernando; Coomarasamy, Arri; Gallos, Ioannis D

Citation:
The Cochrane Database of Systematic Reviews; Nov 2020; vol. 11 ; p. CD012754

Abstract:
BACKGROUND Postpartum haemorrhage (PPH), defined as a blood loss of 500 mL or more after birth, is the leading cause of maternal death worldwide. The World Health Organization (WHO) recommends that all women giving birth should receive a prophylactic uterotonic agent. Despite the routine administration of a uterotonic agent for prevention, PPH remains a common complication causing one-quarter of all maternal deaths globally. When prevention fails and PPH occurs, further administration of uterotonic agents as 'first-line' treatment is recommended. However, there is uncertainty about which uterotonic agent is best for the 'first-line' treatment of PPH. OBJECTIVES To identify the most effective uterotonic agent(s) with the least side-effects for PPH treatment, and generate a meaningful ranking among all available agents according to their relative effectiveness and side-effect profile.SEARCH METHODSWe searched the Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (5 May 2020), and the reference lists of all retrieved studies. SELECTION CRITERIA All randomised controlled trials or cluster-randomised trials comparing the effectiveness and safety of uterotonic agents with other uterotonic agents for the treatment of PPH were eligible for inclusion.DATA COLLECTION AND ANALYSIS Two review authors independently assessed all trials for inclusion, extracted data and assessed each trial for risk of bias. Our primary outcomes were additional blood loss of 500 mL or more after recruitment to the trial until cessation of active bleeding and the composite outcome of maternal death or severe morbidity. Secondary outcomes included blood loss-related outcomes, morbidity outcomes, and patient-reported outcomes. We performed pairwise meta-analyses and indirect comparisons, where possible, but due to the limited number of included studies, we were unable to conduct the planned network meta-analysis. We used the GRADE approach to assess the certainty of evidence.MAIN RESULTS Seven trials, involving 3738 women in 10 countries, were included in this review. All trials were conducted in hospital settings. Randomised women gave birth vaginally, except in one small trial, where women gave birth either vaginally or by caesarean section. Across the seven trials (14 trial arms) the following agents were used: six trial arms used oxytocin alone; four trial arms used misoprostol plus oxytocin; three trial arms used misoprostol; one trial arm used Syntometrine® (oxytocin and ergometrine fixed-dose combination) plus oxytocin infusion. Pairwise meta-analysis of two trials (1787 participants), suggests that misoprostol, as first-line treatment uterotonic agent, probably increases the risk of blood transfusion (risk ratio (RR) 1.47, 95% confidence interval (CI) 1.02 to 2.14, moderate-certainty) compared with oxytocin. Low-certainty evidence suggests that misoprostol administration may increase the incidence of additional blood loss of 1000 mL or more (RR 2.57, 95% CI 1.00 to 6.64). The data comparing misoprostol with oxytocin is imprecise, with a wide range of treatment effects for the additional blood loss of 500 mL or more (RR 1.66, 95% CI 0.69 to 4.02, low-certainty), maternal death or severe morbidity (RR 1.98, 95% CI 0.36 to 10.72, low-certainty, based on one study n = 809 participants, as the second study had zero events), and the use of additional uterotonics (RR 1.30, 95% CI 0.57 to 2.94, low-certainty). The risk of side-effects may be increased with the use of misoprostol compared with oxytocin: vomiting (2 trials, 1787 participants, RR 2.47, 95% CI 1.37 to 4.47, high-certainty) and fever (2 trials, 1787 participants, RR 3.43, 95% CI 0.65 to 18.18, low-certainty). According to pairwise meta-analysis of four trials (1881 participants) generating high-certainty evidence, misoprostol plus oxytocin makes little or no difference to the use of additional uterotonics (RR 0.99, 95% CI 0.94 to 1.05) and to blood transfusion (RR 0.95, 95% CI 0.77 to 1.17) compared with oxytocin. We cannot rule out an important benefit of using the misoprostol plus oxytocin combination over oxytocin alone, for additional blood loss of 500 mL or more (RR 0.84, 95% CI 0.66 to 1.06, moderate-certainty). We also cannot rule out important benefits or harms for additional blood loss of 1000 mL or more (RR 0.76, 95% CI 0.43 to 1.34, moderate-certainty, 3 trials, 1814 participants, one study reported zero events), and maternal mortality or severe morbidity (RR 1.09, 95% CI 0.35 to 3.39, moderate-certainty). Misoprostol plus oxytocin increases the incidence of fever (4 trials, 1866 participants, RR 3.07, 95% CI 2.62 to 3.61, high-certainty), and vomiting (2 trials, 1482 participants, RR 1.85, 95% CI 1.16 to 2.95, high-certainty) compared with oxytocin alone. For all outcomes of interest, the available evidence on the misoprostol versus Syntometrine® plus oxytocin combination was of very low-certainty and these effects remain unclear. Although network meta-analysis was not performed, we were able to compare the misoprostol plus oxytocin combination with misoprostol alone through the common comparator of oxytocin. This indirect comparison suggests that the misoprostol plus oxytocin combination probably reduces the risk of blood transfusion (RR 0.65, 95% CI 0.42 to 0.99, moderate-certainty) and may reduce the risk of additional blood loss of 1000 mL or more (RR 0.30, 95% CI 0.10 to 0.89, low-certainty) compared with misoprostol alone. The combination makes little or no difference to vomiting (RR 0.75, 95% CI 0.35 to 1.59, high-certainty) compared with misoprostol alone. Misoprostol plus oxytocin compared to misoprostol alone are compatible with a wide range of treatment effects for additional blood loss of 500 mL or more (RR 0.51, 95% CI 0.20 to 1.26, low-certainty), maternal mortality or severe morbidity (RR 0.55, 95% CI 0.07 to 4.24, low-certainty), use of additional uterotonics (RR 0.76, 95% CI 0.33 to 1.73, low-certainty), and fever (RR 0.90, 95% CI 0.17 to 4.77, low-certainty). AUTHORS' CONCLUSIONS The available evidence suggests that oxytocin used as first-line treatment of PPH probably is more effective than misoprostol with less side-effects. Adding misoprostol to the conventional treatment of oxytocin probably makes little or no difference to effectiveness outcomes, and is also associated with more side-effects. The evidence for most uterotonic agents used as first-line treatment of PPH is limited, with no evidence found for commonly used agents, such as injectable prostaglandins, ergometrine, and Syntometrine®.

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Babies in occiput posterior position are significantly more likely to require an emergency cesarean birth compared with babies in occiput transverse position in the second stage of labor: A prospective observational study (2020)

Type of publication:
Journal article

Author(s):
Tempest, Nicola; Lane, Steven; Hapangama, Dharani; UK Audit Ressearch Trainee Collaborative in Obstetrics, Gynecology (UK-ARCOG) (*William Parry-Smith is a core committee member of UK-ARCOG)

Citation:
Acta Obstetricia et Gynecologica Scandinavica; Apr 2020; vol. 99 (no. 4); p. 537-545

Abstract:
INTRODUCTION Malposition complicates 2-13% of births at delivery, leading to increased obstetric interventions (cesarean section and instrumental delivery) and higher rates of adverse fetal and maternal outcomes. Limited data are available regarding the likely rates of obstetric intervention and subsequent neonatal and maternal outcomes of births with babies in persistent occiput posterior position vs those in persistent occiput transverse position. The UK Audit and Research trainee Collaborative in Obstetrics and Gynecology (UK-ARCOG) network set out to collect data prospectively at delivery on final mode of delivery and immediate outcomes.MATERIAL AND METHODS The UK-ARCOG network collected data on all births with malposition of the fetal head complicating the second stage of labor (n = 838) (occiput posterior/occiput transverse) requiring rotational vaginal operative birth or emergency cesarean to expedite delivery across 66 participating UK National Health Service maternity units over a 1-month period. The outcomes considered were the need for emergency cesarean section without a trial of instrumental delivery, success of the first method of delivery employed in achieving a vaginal delivery and neonatal/maternal outcomes.RESULTS Obstetricians regarded assistance with an operative vaginal delivery method to be unsafe in 15% of babies in occiput posterior position and 6.1% of babies in occiput transverse position, and they were delivered by primary emergency cesarean section. When vaginal delivery was deemed safe (defined as attempted assisted vaginal rotational delivery), the first instrument attempted was successful in 74.4% of occiput posterior babies and 79.3% of occiput transverse babies.CONCLUSIONS Our data facilitates decision making by obstetricians to increase safety of assisted rotational operative delivery of a malpositioned baby at initial assessment and in counseling women. Until data from a well-designed randomized controlled trial of instrumental delivery vs emergency cesarean section are available, this manuscript provides contemporaneous national data from a high resource setting within a structured training program, to assist the selection of an appropriate instrument/method for the delivery of a malpositioned baby.

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The FAST-M complex intervention for the detection and management of maternal sepsis in low-resource settings: a multi-site evaluation (2021)

Type of publication:
Journal article

Author(s):
Cheshire, James; Jones, Laura; Munthali, Laura; Kamphinga, Christopher; Liyaya, Harry; Phiri, Tarcizius; *Parry-Smith, William; Dunlop, Catherine; Makwenda, Charles; Devall, Adam James; Tobias, Aurelio; Nambiar, Bejoy; Merriel, Abi; Williams, Helen Marie; Gallos, Ioannis; Wilson, Amie; Coomarasamy, Arri; Lissauer, David

Citation:
BJOG : an international journal of obstetrics and gynaecology; Jul;128(8):1324-1333

Abstract:
OBJECTIVE To evaluate whether the implementation of the FAST-M complex intervention was feasible and improved the recognition and management of maternal sepsis in a low-resource setting.DESIGNA before and after design.SETTINGFifteen government healthcare facilities in Malawi.POPULATION Women suspected of having maternal sepsis.METHODS The FAST-M complex intervention consisted of the following components: i) the FAST-M maternal sepsis treatment bundle and ii) the FAST-M implementation programme. Performance of selected process outcomes were compared between a two month baseline phase and six month intervention phase with compliance used as a proxy measure of feasibility.MAIN OUTCOME RESULT Compliance with vital sign recording and use of the FAST-M maternal sepsis bundle.RESULTS Following implementation of the FAST-M intervention, women were more likely to have a complete set of vital signs taken on admission to the wards (0/163 (0%) vs. 169/252 (67.1%), p<0.001). Recognition of suspected maternal sepsis improved with more cases identified following the intervention (12/106 (11.3%) vs. 107/166 (64.5%), p<0.001). Sepsis management improved, with women more likely to receive all components of the FAST-M treatment bundle within one hour of recognition (0/12 (0%) vs. 21/107 (19.6%), p=0.091). In particular women were more likely to receive antibiotics (3/12 (25.0%) vs. 72/107 (67.3%), p=0.004) within one hour of recognition of suspected sepsis.CONCLUSION Implementation of the FAST-M complex intervention was feasible and led to the improved recognition and management of suspected maternal sepsis in a low-resource setting such as Malawi.

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Obstetric and gynaecology trainees’ knowledge of paediatric and adolescent gynaecology services in the UK: A national qualitative thematic analysis (2019)

Type of publication:
Journal article

Author(s):
*Ritchie, J K; *Sahu, B; Wood, P L

Citation:
European Journal of Obstetrics, Gynecology, and Reproductive Biology; Apr 2019; vol. 235 ; p. 30-35

Abstract:
BACKGROUND: The British Society of Paediatric and Adolescent Gynaecology (BritSPAG) was created in 2000 with specific aims to include raising the profile of paediatric and adolescent gynaecology (PAG) within the United Kingdom (UK). The Society has since developed a set of clinical standards for all acute hospitals providing gynaecological services to enable successful provision of paediatric and adolescent gynaecology care.AIMSTo determine the depth of knowledge that obstetric and gynaecology trainees have with regards to the PAG services provided at their Hospital, reflecting how widely PAG services have had an impact on trainees.METHOD: The national survey was distributed to all deaneries in the UK for circulation to all their trainees via e mail during Nov 2017-March 2018.RESULTS: 28% of the trainees said there was a PAG clinic at their hospital, 46.9% did not have a clinic and 24.7% were unsure. 41.6% of the respondents were aware of BritSPAG, however only 10.4% were aware of the BritSPAG clinical standards for service planning with regards to PAG clinics. Nearly half were aware of the PAG specialist centre for their region but only 6.5% were aware of the BritSPAG UK map of services. A large majority (93.24%) didn't believe that trainees in O&G received adequate exposure to PAG in their training.CONCLUSION: This study represents the largest and first national survey to seek obstetric and gynaecology trainees' thoughts on the provision of PAG training in the UK today. Given that only 28% of trainees answering said that they were aware of a PAG clinic at their hospital, this indicates not only that many hospitals did not have a dedicated PAG clinic but more worryingly five of the trainees were not aware of the existence of a confirmed PAG clinic at their hospital, and therefore are potentially losing out on training opportunities. Disappointingly the results of our survey reveal that trainees in Obstetrics and Gynaecology still have very little experience or exposure to PAG during their training despite there being opportunities to do so.

Sinecatechins ointment as a potential novel treatment for usual type vulval intraepithelial neoplasia: a single-centre double-blind randomised control study (2021)

Type of publication:
Randomised controlled trial

Author(s):
Jason Yap, Daniel Slade, Harriet Goddard, Christopher Dawson, Raji Ganesan, Shireen Velangi, *Banchhita Sahu, Baljit Kaur, Ana Hughes, David Luesley

Citation:
BJOG 2021 May;128(6):1047-1055

Abstract:
Objective To compare the safety and efficacy of Veregen® ointment against placebo in the treatment of usual type vulvar intraepithelial neoplasia (uVIN). Design A Phase II randomised control trial. Setting A tertiary gynaecological oncology referral center. Population All women diagnosed with primary and recurrence uVIN. Methods Eligible patients were randomised to receive either Veregen® or placebo ointment (applied 3 times daily for 16 weeks), and were followed up at 2, 4, 8, 16, 32 and 52 weeks. Main outcome measures Outcome measures, recorded at 16 and 32 weeks, were histological (HR) and clinical (CR) response (as measured by ≥30% reduction in the sum of the longest diameter of all lesions when compared to baseline), toxicity and changes in quality of life and pain scores. Results 26 patients were randomised and all 13 patients who received Veregen® showed either complete (n=5) or partial (n=8) CR with a trend towards an improvement in baseline symptoms. In placebo group, 3 patients had complete CR, 2 had partial CR and 6 had stable disease. Patients in the Veregen® group showed a significant improvement in CR as compared to the placebo group (P=0.0026). There was no evidence of difference in HR and toxicity reported in both groups. Conclusion Our study indicates that Veregen application is safe and leads to at least a partial clinical resolution of uVIN lesions and symptoms improvement, thus warranting a phase III multi-centre RCT.

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Folic Acid Supplementation in Postmenopausal Women with Hot Flushes: Phase III Randomised Double-Blind Placebo-Controlled Trial (2021)

Type of publication:
Randomised controlled trial

Author(s):
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

Citation:
BJOG; November 2021; Volume128, Issue12, Pages 2024-2033

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) 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.

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