Introduction:
The primary treatment aim for irritable bowel syndrome (IBS) is to relieve overall symptoms which can significantly impair
the patient’s quality of life (QOL); however, it generally requires a
high pill burden that may be improved by administration of combinatorial
formulations. Thus, the effectiveness of alverine citrate and simeticone
combination (ACS) for global symptom relief for IBS was investigated in this
non-interventional study. Patients and Methods: ROME III IBS patients (n = 640;
52.3% male: mean age: 43.6 ± 12.5 years) with abdominal pain and discomfort
≥60 of 0-100 visual analogue scale (VAS) were included in a prospective,
multicenter, non-interventional study at 26 Chinese sites from December 2010 to
January 2012. Patients received alverine citrate (60 mg) with simeticone (300
mg) (ACS) 3× daily for 4 weeks. Pain/discomfort and bloating/distension were
assessed by VAS. Global symptoms and QOL were assessed by 7-point and 5-point
Likert scales, respectively. Post-treatment bowel function was assessed by
Bristol Stool Form Scale (BSFS) and treatment-related adverse events (AEs) were
recorded. Results: Of 640 patients, 540 (84.4%) completed the study, and 100
(15.6%) withdrew. In total, 87.5% reported bloating at baseline. After 4-week
ACS treatment, 89.1% reported global symptom improvement. Furthermore, 4-week
ACS treatment reduced pain and bloated VAS scores significantly from 78.4 ± 9.9
to 32.1 ± 21.0 and from 63.2 ± 27.2 to 22.6 ± 20.9, respectively (both p < 0.001),
decreased diarrhea or constipation occurrence from 67.2% to 10.2% (p <
0.001), and reduced IBS impact on QOL with only 2 treatment-related AEs. Conclusion: Routine clinical administration of ACS for IBS over a 4-week period
provides effective relief of IBS symptoms and improves QOL in IBS patients.
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