Sacral nerve modulation for irritable bowel syndrome: A randomized, double-blinded, placebo-controlled crossover study

Background Irritable bowel syndrome (IBS) is among the most common gastrointestinal disorders, and a substantial proportion of patients have an insufficient response to treatment. In a single-blinded study, sacral nerve modulation (SNM) significantly reduced symptoms of IBS. The aim of the present double-blinded, randomized, placebo-controlled study was to evaluate the effect of SNM for IBS. Methods We included patients with diarrhea-predominant or mixed IBS and a minimum baseline IBS-specific symptom score of 40 points (Gastrointestinal Symptom Rating Scale-IBS version). Patients underwent a 6-week period of SNM. In the first 4 weeks, the patients were randomized 1:1 to have the neurostimulator set subsensory or OFF for 2 weeks and then the opposite for another 2 weeks. Patients and investigators were blinded to settings. In the remaining 2 weeks, the stimulation was set suprasensory. IBS-specific symptoms and quality of life were assessed with validated questionnaires and bowel diaries. Key Results Twenty-one patients were randomized and eligible for analysis. The IBS-specific symptom score was reduced with borderline significance during stimulation (subsensory-OFF median change -1 (-26, 9), OFF-subsensory median change 8 (-11, 36); P = 0.0572). Pain was significantly reduced during stimulation (subsensory-OFF median change -1.5 (-4, 1), OFF-subsensory median change 1 (-4, 3); P = 0.0188), along with the number of daily bowel movements (subsensory-OFF median change 0 (-1.8, 0.2), OFF-subsensory median change 0.2 (-0.5, 1.1); P = 0.0373). The median placebo effect was 14% (0, 55). Conclusion and Inferences Sacral nerve modulation for IBS seems promising but should be considered experimental until larger multicenter studies have been performed.