Abstract | BACKGROUND: AIM: METHODS: A total of 412 IBS patients meeting ROME III criteria were included in this double-blind randomized placebo-controlled study if their abdominal pain/discomfort intensity was at least 60 mm on a 0-100 mm visual analogue scale (VAS) during a 2-week run-in treatment-free period. Patients were randomly assigned through the use of Interactive Voice Response System to receive either alverine citrate 60 mg with simeticone 300 mg three times daily or matching placebo for 4 weeks. RESULTS: The full analysis set included 409 patients (71.4% female: mean age: 46.2 +/- 13.9 years). At week 4, alverine citrate and simeticone group had lower VAS scores of abdominal pain/discomfort (median: 40 mm vs. 50 mm, P = 0.047) and higher responder rate (46.8% vs. 34.3%, OR = 1.3; P = 0.01) as compared with placebo group. Patient receiving alverine citrate and simeticone reported greater global symptom improvement compared with those receiving placebo (P = 0.0001). Reported adverse events were similar in both groups. CONCLUSION:
|
Authors | T Wittmann, L Paradowski, P Ducrotté, L Bueno, M-C Andro Delestrain |
Journal | Alimentary pharmacology & therapeutics
(Aliment Pharmacol Ther)
Vol. 31
Issue 6
Pg. 615-24
(Mar 2010)
ISSN: 1365-2036 [Electronic] England |
PMID | 20003095
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Antifoaming Agents
- Drug Combinations
- Parasympatholytics
- Propylamines
- alverine
- Simethicone
|
Topics |
- Abdominal Pain
(drug therapy)
- Adolescent
- Adult
- Aged
- Antifoaming Agents
(therapeutic use)
- Double-Blind Method
- Drug Combinations
- Female
- Humans
- Irritable Bowel Syndrome
(drug therapy)
- Male
- Middle Aged
- Parasympatholytics
(therapeutic use)
- Propylamines
(therapeutic use)
- Simethicone
(therapeutic use)
- Treatment Outcome
|