Sex Difference in the Treatment of Dupuytren's Disease: A Systematic Review and Meta-Analysis of Clinical Trials.

Abstract

Purpose: The aim of this study was to assess the sex differences in enrollment into clinical trials for Dupuytren's disease (DD), treatment efficacy, and complications. Methods: Three databases were searched; Ovid MEDLINE, Ovid EMBASE, and EBSCO CINAHL. Included studies were clinical trials on adult patients with DD. Exclusion criteria were non-English studies and other study designs. Two independent reviewers completed abstract screening, full-text review, and data extraction. The number and percentage of studies that reported ad hoc analyses for sex differences in treatment efficacy, tolerability, and complications were reported. A meta-analysis was performed on the proportion of female participants enrolled in clinical trials for DD. Results: A total of 3172 references were screened, and 59 studies were identified for full-text review. We identified 28 clinical trials for DD of which none reported secondary analyses for sex differences. Only 2 trials discussed sex differences in complications, and one trial reported sex differences in tolerability. The proportion of female participants in the meta-analysis was 19.5% [95% CI: 16.1-23.0%]. Conclusion: Sex differences in the clinical trials for DD are not widely considered in clinical trials despite their critical role. Males and females do not have equal representation in clinical trials for DD. Future studies should account for sex differences in the design and the analysis of clinical trials.