Sa1158 The Number of Drug Side Effects Is Associated With Greater Efficacy in IBS Clinical Trials: The Potential Influence of Unblinding

Abstract

and after cholecystectomy were used as surrogate measure for resource utilization. RESULTS: Within the time frame of the study, 419 patients (79.4% women; age 42.4±0.7 years) were diagnosed with biliary dyskinesia, with all but 24 (94.3%) undergoing cholecystectomy. The mean duration of symptoms was 19.8±7.5 months; in 129 (30.8%) patients, symptoms had started less than 3 months prior to evaluation. Functional gallbladder imaging revealed a mean gallbladder ejection fraction of 22.4±1.0%, with 66 (15.8%) patients having normal results. Patients completed 3.2±0.1 diagnostic tests prior to being scheduled for cholecystectomy. Appropriate follow up data were available for 209 patients. Within the 12 months interval, ER visit and hospitalizations decreased from 1.0±0.1 to 0.7±0.2 (P=0.07) and from 0.3±0.04 to 0.26±0.06 (P=0.69), respectively. In univariate analyses, age, shorter disease duration, normal gallbladder ejection fraction, a history of chronic back pain and use of prescription opioids were associated with ongoing resource utilization after surgery. Using a multiple nonlinear regression model, younger age (OR 3.2; 95% CI: 1.2-8.2) and use of opioid analgesics (OR 3.7; 95% CI: 1.3-10.2) were independent predictors of ongoing resource utilization. CONCLUSIONS: Our data demonstrate a lowered threshold for cholecystectomy, as more than one third of the patients did not meet current consensus criteria for biliary dyskinesia. While we did not address the impact of surgery on symptoms, surgery has a marginal effect on resource utilization. The impact of coexisting disorders and opioid use on ongoing healthcare needs points at the role of non-gastrointestinal factors and argues against surgical approaches.