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硫胺素补充剂对多囊卵巢综合征女性总体健康及不孕治疗结局的影响:一项三盲随机安慰剂对照临床试验

The Effects of Thiamine Supplementation on General Health and Infertility Treatment Outcomes in Women with Polycystic Ovary Syndrome: A Triple-Blinded Randomized Placebo-Controlled Clinical Trial.

作者信息

Moti Mahtab, Amini Leila, Haghani Hamid, Nateghi Mohammad Reza

机构信息

School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.

Department of Midwifery, Reproductive Health, and Pregnancy, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.

出版信息

Int J Fertil Steril. 2024 Feb 2;18(2):128-134. doi: 10.22074/ijfs.2023.1972708.1398.

Abstract

BACKGROUND

The aim of this study was to evaluate the effects of thiamine (vitamin B1) on general health and infertility treatment outcomes in women with polycystic ovary syndrome (PCOS).

MATERIALS AND METHODS

The study is a triple-blinded, randomized, placebo-controlled clinical trial performed on 64 infertile women with PCOS referred to Sarem Hospital in Tehran, Iran. The primary outcomes of the study were general health and infertility treatment outcomes. Eligible women were randomly assigned to the vitamin B1 group (n=32, vitamin B1 tablet at a dose of 300 mg/day for 4 weeks) or the placebo group (n=32, placebo tablet daily for 4 weeks). A general health questionnaire was completed before and after the intervention by both groups, and treatment success was evaluated at the end of the study. Data were analyzed using SPSS software ver.16 P<0.05 was considered statistically significant.

RESULTS

The mean age of participants in the vitamin B1 (VB1) group was 30.4 ± 3.27 years and in the placebo (Pl) group was 29.1 ± 2.66 years with the mean duration of marriage 12.7 ± 3.01 and 13.2 ± 2.97 years respectively. Our results showed that there were significant differences between the two groups in overall score (P<0.001) and scores for all domains of the general health questionnaire including somatic symptoms (P<0.001), anxiety and insomnia (P<0.001), social dysfunction (P=0.028), and severe depression (P<0.001) after the intervention. Four weeks consumption of vitamin B1 also resulted in higher numbers of positive pregnancy tests (P=0.006), although the number of fetuses was not significantly different between the two groups after the intervention.

CONCLUSION

The results of the current study support a possible favourable effect of vitamin B1 on improving general health, infertility treatment outcome, and retrieved follicle count without changing the number of fetuses in women with polycystic ovary syndrome (registration number: IRCT201510266917N3).

摘要

背景

本研究旨在评估硫胺素(维生素B1)对多囊卵巢综合征(PCOS)女性总体健康状况及不孕治疗结局的影响。

材料与方法

本研究为三盲、随机、安慰剂对照临床试验,对转诊至伊朗德黑兰萨雷姆医院的64例PCOS不孕女性进行。研究的主要结局为总体健康状况及不孕治疗结局。符合条件的女性被随机分为维生素B1组(n = 32,服用剂量为300 mg/天的维生素B1片,共4周)或安慰剂组(n = 32,每天服用安慰剂片,共4周)。两组在干预前后均完成一份总体健康问卷,并在研究结束时评估治疗成功率。使用SPSS软件版本16进行数据分析,P < 0.05被认为具有统计学意义。

结果

维生素B1(VB1)组参与者的平均年龄为30.4 ± 3.27岁,安慰剂(Pl)组为29.1 ± 2.66岁,平均结婚年限分别为12.7 ± 3.01年和13.2 ± 2.97年。我们的结果显示,干预后两组在总体评分(P < 0.001)以及总体健康问卷所有领域的评分上存在显著差异,包括躯体症状(P < 0.00l)、焦虑和失眠(P < 0.001)、社会功能障碍(P = 0.028)以及重度抑郁(P < 0.001)。服用4周维生素B1后,尿妊娠试验阳性的人数也更多(P = 0.006),尽管干预后两组的胎儿数量无显著差异。

结论

本研究结果支持维生素B1可能对改善多囊卵巢综合征女性的总体健康状况、不孕治疗结局及回收卵泡数量具有有益作用,且不改变胎儿数量(注册号:IRCT201510266917N3)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/063d/10875311/6d2a13dda915/Int-J-Fertil-Steril-18-128-g01.jpg

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