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

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.

[Efficacy of alverina citrate and simethicone combination in abdominal pain and discomfort of irritable bowel syndrome].

UNLABELLED: The alverina citrate and simethicone combination (ACS-Meteospazmil) is used for irritable bowel syndrome (IBS) for almost 20 years, but the supporting scientific evidence for efficacy is limited. OBJECTIVE: to evaluate the effectiveness of ACS in patients with abdominal pain and discomfort at IBS. METHODS: In a double-blind, randomized, placebo-controlled study enrolled 412 patients with IBS conform to Rome criteria III. Selection criterion in the study was to evaluate the intensity of abdominal pain or discomfort during the 2-week run-in period without medication, which according to analog scale (VAS) was to be 60-100 mm. With the help of an interactive voice communication system (IVCS), patients were randomized to treatment with either alverin citrate 60 mg with Simethicone 300 mg three times daily or corresponding placebo for 4 weeks. RESULTS: For analyze of the results of the study were selected 409 patients. After 4 weeks, patients treated with ACS, was observed lower scores in the VAS assessment of abdominal pain or discomfort compared to placebo (mean--40 and 50 mm, p = 0.047) and a higher level of response to treatment (46.8% and 34.3%, respectively). Recorded side effects were similar in both groups. CONCLUSION: The combination of ACS was significantly more effective in patients with IBS compared to placebo in reducing abdominal pain or discomfort.

Clinical trial: the efficacy of alverine citrate/simeticone combination on abdominal pain/discomfort in irritable bowel syndrome--a randomized, double-blind, placebo-controlled study.

BACKGROUND: Alverine citrate and simeticone combination has been used for almost 20 years in irritable bowel syndrome (IBS), but supportive scientific evidence of efficacy was limited. AIM: To evaluate the efficacy of alverine citrate and simeticone combination in patients with IBS-related abdominal pain/discomfort. 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: Alverine citrate/simeticone combination was significantly more effective than placebo in relieving abdominal pain/discomfort in patients with IBS.