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Summary   Background  In routine practice, irritable bowel syndrome ( IBS ) symptoms are often difficult to be relieved and impair significantly patients’ quality of life (QoL). A randomised, double‐blind, placebo‐controlled study has shown the efficacy of alverine citrate/simeticone ( ACS ) combination for  IBS  symptom relief.    Aim  As  IBS  symptoms are often intermittent, this pragmatic study was designed to compare the efficacy of an on‐demand  ACS  treatment vs. that of usual treatments.    Methods  Rome  III IBS  patients were enrolled by 87 general practitioners who were randomly allocated to one of two therapeutic strategies: on‐demand  ACS  or usual treatment chosen by the physician. The primary outcome measure was the improvement of the  IBSQ oL score between inclusion and month 6.    Results  A total of 436 patients (mean age: 54.4 years; women: 73.4%) were included, 222 in the  ACS  arm and 214 patients in the usual treatment arm, which was mainly antispasmodics. At 6 months, improvement of  IBSQ oL was greater with  ACS  than with the usual treatment group (13.8 vs. 8.4; p &lt; 0.0008). The  IBS ‐severity symptom score ( IBS ‐ SSS ) was lower with  ACS  than in the usual treatment arm with a mean ( SE ) decrease of 170.0 (6.6) vs. 110.7 (6.7), respectively (p = 0.0001). An  IBS ‐ SSS  &lt; 75 was more frequent in the  ACS  group (37.7% vs. 16.0%; p &lt; 0.0001). Improvement of both abdominal pain and bloating severity was also greater with the on‐demand  ACS  treatment, which was associated with both lower direct and indirect costs.    Conclusions  After 6 months, on‐demand  ACS  treatment led to a greater improvement of QoL, reduced the burden of the disease and was more effective for  IBS  symptom relief than usual treatments.

international journal of clinical practice

On‐demand treatment with alverine citrate/simeticone compared with standard treatments for irritable bowel syndrome: results of a randomised pragmatic study