Abstract / Summary
Objective Irritable bowel syndrome (IBS) is characterized by recurring gastrointestinal symptoms and substantial psychosocial burden. Despite the wide range of therapeutic options, no approach is consistently superior across patients. To address the heterogeneity of patients with IBS, the present study investigated the feasibility of assigning a personalized therapy based on symptom dynamics. Methods In the PIONEER-IBS randomized controlled trial (RCT), participants initially completed symptom diaries daily for 7 weeks. Based on individual symptom patterns, eye movement desensitization and reprocessing (EMDR) or gut-directed hypnotherapy (GDH) were assigned in a personalized or a reverse personalized manner; a control group received optimized treatment as usual (TAU). The primary outcome was the feasibility of the study protocol. Secondary outcomes included changes in gastrointestinal and psychosocial measures after the interventions (T2) and at a three-month follow-up (T3). Results Of the 79 randomized patients, 58 (73.4%) completed their assigned intervention with at least 5/7 sessions. Baseline symptom burden was high (IBS-SSS at baseline: 314.19, STD ± 81.21). No significant differences in secondary outcomes were observed between personalized and reverse-personalized therapy at T2 and T3. Pre–post change scores within randomization groups revealed an improvement in somatic symptom burden in both intervention groups (SSS-8: p = 0.0027 personalized therapy; p = 0.05 reverse-personalized therapy) at T2. Conclusion In this study, novel concepts of personalizing therapy were demonstrated. However, the benefit of treatment allocation based on individual symptom dynamics, the validity of personalization approaches and the efficacy of EMDR in specific IBS subgroups represent distinct but intertwined questions that require further evaluation.