JGH open : an open access journal of gastroenterology and hepatology · 2026
A Multicenter, Prospective Real-World Study of Simethicone-Activated Charcoal in Patients With Persistent Dyspeptic Symptoms Despite Acid Suppression (SIMAC Study).
СтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Kumar Ashish, Sreenivas D V, Behera Sambit Kumar, Rao Guduru Raghavendra Srinivas, Kumar G S Sameer, Chatterjee Jaya Ghosh, Choudhary Nalini Kant, Bagepally Ravi Shankar, Puri Shekhar, Rizvi S M A, Pathak Rahul, Pal Shruti
Аннотация
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. Full adherence was 87.1% at Day 14 and 83.6% at Day 28, with no serious clinical events.
CONCLUSION: In patients with persistent gas-predominant dyspepsia despite PPI therapy, simethicone-activated charcoal was associated with significant short-term symptomatic improvement. Controlled trials are warranted to confirm treatment effect.
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. Full adherence was 87.1% at Day 14 and 83.6% at Day 28, with no serious clinical events.
CONCLUSION: In patients with persistent gas-predominant dyspepsia despite PPI therapy, simethicone-activated charcoal was associated with significant short-term symptomatic improvement. Controlled trials are warranted to confirm treatment effect.