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

P Ducrotte, J C Grimaud, M Dapoigny, S Personnic, V O'Mahony, M C Andro-Delestrain, P Ducrotte, J C Grimaud, M Dapoigny, S Personnic, V O'Mahony, M C Andro-Delestrain

Abstract

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 IBSQoL 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 IBSQoL was greater with ACS than with the usual treatment group (13.8 vs. 8.4; p < 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 < 75 was more frequent in the ACS group (37.7% vs. 16.0%; p < 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.

© 2013 The Authors International Journal of Clinical Practice Published by John Wiley & Sons Ltd.

Figures

Figure 1
Figure 1
Flow chart. *These patients were excluded of the ITT population
Figure 2
Figure 2
Mean changes in Irritable Bowel Syndrome Quality of Life (IBSQoL) questionnaire scores from baseline to month 6
Figure 3
Figure 3
Evolution of IBS symptoms according to treatment strategy (mean IBS-SSS score)
Figure 4
Figure 4
Improvement of IBS SSS score according to IBS subtypes

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Source: PubMed

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