Background: Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder that affects at least 20% of the general population. There is a significant predominance of IBS in females, with a female: male ratio of 2:1, especially in western countries. In contrary Eastern countries, some studies report that men with IBS are 4 times more affected than their female counterparts.Differences have been found in the clinical manifestations and there has been evidence of differences in the appropriate treatment efficacy for IBS in both genders. Hormonal and psychosocial factors have been proposed to explain this difference in prevalence. Men also tend to experience more interpersonal problems than women as a result of their IBS and are less likely to seek medical attention than women. The purpose of this study was to evaluate the representation of male participants in enrolled in IBS clinical trials
Methods: In this descriptive, retrospective study, we searched MEDLINE and ClinicalTrials.gov from January 2000 to April 2022 for publications on randomized clinical trials in IBS. Number ofparticipants in clinical trials, their gender, race, the country where the trial was conducted, year of publication were recorded and descriptive statistical analysis of all the variables was performed.
Results: We identified 65 studies comprising 28477 individuals with different subtypes of IBS. All of the randomized clinical trials (RCT) were performed between 2008 and 2022. Of the total RCT, 22.3% of the patients were male and 77.6% were female. 86% of the studies were performed in the United States, 8% in Western Europe, 3% in Canada, and the remaining in China and South Africa. 46% (n:30) of the RCT included ethnical information, having Caucasians (81.4%) majority and African descendants (13.3%) as the bigger racial groups.
Conclusions: Our retrospective study confirmed relatively few male percentage participants are enrolled in the most relevant clinical trials that are published in the last two decades. A more sex-gender-oriented approach in the medical care setting could improve the understanding of heterogeneous patients suffering from IBS. Equal representation in trials can facilitate better design treatment of irritable bowel syndrome in both genders which can lead to better outcomes. Further work is needed to improve the representation of minorities and underrepresented groups in medical research by identifying and addressing the barriers.