Dear Editors,I was intrigued to see the recent trial of Liu et al reporting the benefits of exenatide over metformin in terms of weight loss and pregnancy rate in women with polycystic ovary syndrome. I am writing to clarify the discrepancies between the trial as registered and the trial as reported in the manuscript. According to the trial registration on the Chinese Clinical Trial Registration Site (ChiCTR‐IIR‐16008084), the trial was a three‐armed trial for exenatide, metformin or spironolactone. The study as reported only includes two arms, one with exenatide with eventual crossover to metformin the second to metformin alone. What happened to the spironolactone arm and where did the crossover design originate? The authors also report clinical pregnancy rates on treatment. This is not listed as one of the objectives of the study on the clinical trial registration site. Similarly, the inclusion and exclusion criteria as listed on the registration site make no mention of patients seeking pregnancy or screening for fertility factors in the patient or couple. In fact one of the exclusion criteria reads “Also exclude patients who could not take effective contraceptive measures through the study,” The method of randomization and the means to maintain allocation concealment are not noted in the published manuscript. Providing these would help external reviewers assess the quality of the trial. Finally, I note that the trial was registered after recruitment had begun. Can the authors provide an explanation for this lapse? Thank you very much for clarification of these questions.REFERENCELiu X, Zhang Y, Zheng S‐Y, et al. Efficacy of exenatide on weight loss, metabolic parameters and pregnancy in overweight/obese polycystic ovary syndrome. Clin Endocrinol. (Oxf). 2017;87:767–774. https://doi.org/10.1111/cen.13454.
Clinical Endocrinology – Wiley
Published: Jan 1, 2018
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