RESUMEN
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).