Journal of Clinical and Diagnostic Research (Mar 2020)

Safety and Efficacy of Almagate and Simethicone Combination in Symptomatic Management of GERD: Post-marketing Observational TRIALMA Study

  • Tariq A Patel,
  • Monil Patel,
  • K Rajagopalan,
  • Rakesh Patel,
  • Aftab S Shaikh,
  • Satyajit Ray,
  • Sunit Arora,
  • Jagjit Singh

DOI
https://doi.org/10.7860/JCDR/2020/42934.13562
Journal volume & issue
Vol. 14, no. 3
pp. OC01 – OC04

Abstract

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Introduction: Gastroesophageal Reflux Disease (GERD) is one of the most common conditions worldwide with a significant impact on quality of life. Almagate and simethicone act as antacid and antiflatulent agents, respectively and aid in relief of GERD symptoms. Aim: To evaluate the safety and efficacy of almagate and simethicone combination in symptomatic management of GERD. Materials and Methods: A prospective, post-marketing observational, multicenter study was conducted between January 2019 and May 2019. Patients aged between 18 and 65 years, with uncomplicated symptomatic GERD, frequent episodes of heartburn, regurgitation or dyspepsia symptoms, and those who required add-on antacid therapy were included. Patients received a suspension of almagate plus simethicone during their initial visit (5-10 mL thrice-a-day for 15 days). The intensity of heartburn, regurgitation, and dyspepsia was recorded using visual analog scale of 0 (no symptoms) to 10 (severe symptoms) at baseline and after 15 days. Overall, patient satisfaction score (0-5) was assessed and adverse events were recorded. Descriptive statistics and Mann-whitney U test was used for statistical analysis. Results: Out of the 1812 patients enrolled in the study, 1767 patients continued and completed the 15-day treatment. The mean age of patients was 43.59 years {male: 793 (44.9%); female: 974 (55.1%)}. The mean symptoms score for heartburn, regurgitation, and dyspepsia was significantly reduced after treatment compared with baseline (p<0.01). Post-treatment, around half of the patients (46%) had an overall satisfaction score of 4 followed by a satisfaction score of 5 (43%) and 3 (11%). The mean overall satisfaction score was 4.31 and 38 patients (2.15%) reported adverse events. All the adverse events were mild and were resolved within a week. Conclusion: The combination of almagate and simethicone was efficacious in relieving severe symptoms of heartburn, regurgitation, and dyspepsia and was well tolerated in patients with symptomatic GERD.

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