OBJECTIVES:Gut-directed hypnotherapy (GHT) in individual sessions is highly effective in the treatment of irritable bowel syndrome (IBS). This study aimed to assess the long-term effect of GHT in group sessions for refractory IBS.METHODS:A total of 164 patients with IBS (Rome-III-criteria) were screened, and 100 refractory to usual treatment were randomized 1:1 either to supportive talks with medical treatment (SMT) or to SMT with GHT (10 weekly sessions within 12 weeks). The primary end point was a clinically important improvement on several dimensions of daily life (assessed by IBS impact scale) after treatment and 12-month follow-up. The secondary end point was improvement in general quality of life (QOL; Medical Outcome Study Short-Form-36), psychological status (Hospital Anxiety Depression Scale) and reduction of single IBS symptoms. Analysis was by intention to treat.RESULTS:A total of 90 patients received allocated intervention. After treatment, 28 (60.8%) out of 46 GHT patients and 18 (40.9%) out of 44 SMTs improved (absolute difference 20.0%; 95% confidence interval (CI): 0-40.2%; P=0.046); over 15 months, 54.3% of GHT patients and 25.0% of controls improved (absolute difference 29.4%; 95% CI 10.1-48.6%; P=0.004). GHT with SMT improved physical and psychological well being significantly more than SMT alone (P<0.001). Gender, age, disease duration and IBS type did not have an influence on the long-term success of GHT.CONCLUSIONS:GHT improves IBS-related QOL, is superior to SMT alone, and shows a long-term effect even in refractory IBS. © 2013 by the American College of Gastroenterology.