Abstract
BackgroundFrom previous reviews, there still have been controversies over the effect of metformin (MET) on reproductive function in PCOS patients. The reasons for the inconsistent findings especially lie in the transparency and accuracy of randomized controlled trials (RCTs) reports. However, we could find no data about the quality of RCTs reporting in MET for PCOS. Thus, a retrospective survey related to the quality of reporting in MET for PCOS was conducted.MethodsA retrospective survey was conducted by two investigators. Two investigators assessed the quality of overall reporting and key methodological factors reporting using items from the CONSORT 2010 statement.ResultsA total of 39 RCTs were included in full text. The median overall quality score was 9, with a minimum of 2 and a maximum of 13. Good or general reporting existed in 11 items with positive rate of more than or equal to 50%. The median score of key methodological items was 4 with a minimum of 0 and a maximum of 5. Randomization, allocation concealment, blinding, baseline characteristics and intention-to-treat (ITT) analysis were reported in 26 (67%), 19 (49%), 20 (51%), 38 (97%) and 17 (44%) of the 39 RCTs, respectively. After adjustment, the mean overall score increased by about 1.71 for manuscripts with funding source (95% CI, 0.18 to 3.24), while it increased by about 3.51 for manuscripts published in one year increment (95% CI, 1.82 to 5.19). There was a relatively close, significant correlation (r = 0.589, P < 0.001) between the score of overall reporting quality and year of publication.ConclusionAlthough the overall reporting quality of RCTs in MET for PCOS has improved over time, reporting of key methodological items remains poor. Reporting of RCTs on MET for PCOS should keep up with the standards of the CONSORT statement.
Highlights
From previous reviews, there still have been controversies over the effect of metformin (MET) on reproductive function in Polycystic ovary syndrome (PCOS) patients
The aim of this study was to assess the overall quality of published articles of randomized trials in MET for PCOS with a special focus on the key methodological items that safeguard against biases, namely appropriate randomization, allocation concealment, blinding, baseline characteristics and analysis according to intention-to-treat (ITT) principle
This study demonstrated that the quality of reporting in randomized controlled trials (RCTs) on MET for PCOS was suboptimal especially in key methodological items
Summary
There still have been controversies over the effect of metformin (MET) on reproductive function in PCOS patients. Several systematic reviews and meta-analyses [6,7,8,9,10,11,12,13] have evaluated the efficacy of metformin in the treatment of anovulation because of PCOS. Most of these reviews concluded that metformin monotherapy represented a safe and valid therapeutic option for improving ovulation in PCOS patients. Description of trial design (such as parallel, factorial) including allocation ratio
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