A Multicenter, Prospective Real-World Study of Simethicone-Activated Charcoal in Patients With Persistent Dyspeptic Symptoms Despite Acid Suppression (SIMAC Study)
Abstract
Background: Persistent gas-predominant dyspeptic symptoms affect many patients despite adequate proton pump inhibitor (PPI) therapy, reflecting mechanisms beyond acid secretion. We evaluated the real-world effectiveness and safety of simethicone (80 mg) plus activated charcoal (250 mg) in adults with persistent symptoms despite prior PPI therapy.
Methods: In this prospective, multicenter observational study across nine Indian sites, adults with persistent gas-related symptoms despite ≥ 2 weeks of standard-dose PPI therapy received the combination thrice daily for 28 days. Severity across 11 gastrointestinal domains was assessed using a modified Visual Analog Severity scale at baseline, Day-14, and 28. The primary outcome was change in symptom severity from baseline to Day 28, analyzed using Friedman testing with Bonferroni-adjusted Wilcoxon post hoc comparisons. A global symptom score (mean of all 11 domains) was used for exploratory subgroup analyses; secondary outcomes included adherence and safety.
Results: All 183 participants completed follow-up, with significant reductions across all 11 symptoms (all p < 0.001). Belching decreased from 46.3 ± 26.4 to 10.9 ± 19.5, epigastric burning from 48.1 ± 27.3 to 10.7 ± 17.9, and bloating from 44.2 ± 29.1 to 12.9 ± 18.6. Improvements were evident by Day-14 and sustained to Day-28. The median global symptom score reduction was 25.0 units (95% CI: 22.7-27.3), with consistent improvement across demographic and clinical subgroups.…
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