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On-demand treatment with alverine citrate/simeticone compared with standard treatments for irritable bowel syndrome: results of a randomised pragmatic study.
Int J Clin Pract. 2014 Feb; 68(2):245-54.IJ

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.

Authors+Show Affiliations

Department of Gastroenterology, UMR 1073, Rouen University Hospital, University of Rouen, Rouen, France.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Pragmatic Clinical Trial
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24147869

Citation

Ducrotte, P, et al. "On-demand Treatment With Alverine Citrate/simeticone Compared With Standard Treatments for Irritable Bowel Syndrome: Results of a Randomised Pragmatic Study." International Journal of Clinical Practice, vol. 68, no. 2, 2014, pp. 245-54.
Ducrotte P, Grimaud JC, Dapoigny M, et al. On-demand treatment with alverine citrate/simeticone compared with standard treatments for irritable bowel syndrome: results of a randomised pragmatic study. Int J Clin Pract. 2014;68(2):245-54.
Ducrotte, P., Grimaud, J. C., Dapoigny, M., Personnic, S., O'Mahony, V., & Andro-Delestrain, M. C. (2014). On-demand treatment with alverine citrate/simeticone compared with standard treatments for irritable bowel syndrome: results of a randomised pragmatic study. International Journal of Clinical Practice, 68(2), 245-54. https://doi.org/10.1111/ijcp.12333
Ducrotte P, et al. On-demand Treatment With Alverine Citrate/simeticone Compared With Standard Treatments for Irritable Bowel Syndrome: Results of a Randomised Pragmatic Study. Int J Clin Pract. 2014;68(2):245-54. PubMed PMID: 24147869.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - On-demand treatment with alverine citrate/simeticone compared with standard treatments for irritable bowel syndrome: results of a randomised pragmatic study. AU - Ducrotte,P, AU - Grimaud,J C, AU - Dapoigny,M, AU - Personnic,S, AU - O'Mahony,V, AU - Andro-Delestrain,M C, Y1 - 2013/10/21/ PY - 2013/07/12/received PY - 2013/09/22/accepted PY - 2013/10/24/entrez PY - 2013/10/24/pubmed PY - 2015/4/7/medline SP - 245 EP - 54 JF - International journal of clinical practice JO - Int J Clin Pract VL - 68 IS - 2 N2 - 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. SN - 1742-1241 UR - https://www.unboundmedicine.com/medline/citation/24147869/On_demand_treatment_with_alverine_citrate/simeticone_compared_with_standard_treatments_for_irritable_bowel_syndrome:_results_of_a_randomised_pragmatic_study_ L2 - https://doi.org/10.1111/ijcp.12333 DB - PRIME DP - Unbound Medicine ER -