RESUMEN
OBJECTIVES: This study aimed to compare the effects of true and sham acupuncture in relieving symptoms of irritable bowel syndrome (IBS). METHODS: A total of 230 adult IBS patients (75 % females, average age: 38.4 years) were randomly assigned to 3 weeks of true or sham acupuncture (6 treatments) after a 3-week "run-in" with sham acupuncture in an "augmented" or "limited" patient-practitioner interaction. A third arm of the study included a waitlist control group. The primary outcome was the IBS Global Improvement Scale (IBS-GIS) (range: 1 - 7); secondary outcomes included the IBS Symptom Severity Scale (IBS-SSS), the IBS Adequate Relief (IBS-AR), and the IBS Quality of Life (IBS-QOL). RESULTS: Although there was no statistically significant difference between acupuncture and sham acupuncture on the IBS-GIS (41 vs. 32 % , P = 0.25), both groups improved significantly compared with the waitlist control group (37 vs. 4 % , P = 0.001). Similarly, small differences that were not statistically significant favored acupuncture over the other three outcomes: IBS-AR(59 vs. 57 % , P = 0.83), IBS-SSS (31 vs. 21 % , P = 0.18), and IBS-QOL (17 vs. 13 % , P = 0.56). Eliminating responders during the run-in period did not substantively change the results. Side effects were generally mild and only slightly greater in the acupuncture group. CONCLUSIONS: This study did not find evidence to support the superiority of acupuncture compared with sham acupuncture in the treatment of IBS.