Beschreibung:
<jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Key Results</jats:title><jats:p>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); <jats:italic>P</jats:italic> = 0.0572). Pain was significantly reduced during stimulation (subsensory‐OFF median change −1.5 (−4, 1), OFF‐subsensory median change 1 (−4, 3); <jats:italic>P</jats:italic> = 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); <jats:italic>P</jats:italic> = 0.0373). The median placebo effect was 14% (0, 55).</jats:p></jats:sec><jats:sec><jats:title>Conclusion and Inferences</jats:title><jats:p>Sacral nerve modulation for IBS seems promising but should be considered experimental until larger multicenter studies have been performed.</jats:p></jats:sec>