Safety and Efficacy of Almagate and Simethicone Combination in Symptomatic Management of GERD: Post-marketing Observational TRIALMA Study
| Autor: | Sunit Arora, Rakesh P. Patel, Tariq A Patel, Jagjit Singh, K Rajagopalan, Satyajit Ray, Aftab S Shaik, Monil Patel |
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| Rok vydání: | 2020 |
| Předmět: |
heartburn
medicine.medical_specialty Almagate business.industry lcsh:R Clinical Biochemistry lcsh:Medicine Simethicone dyspepsia regurgitation General Medicine medicine.disease digestive system diseases chemistry.chemical_compound chemistry GERD medicine Observational study business Intensive care medicine medicine.drug |
| Zdroj: | Journal of Clinical and Diagnostic Research, Vol 14, Iss 3, Pp OC01-OC04 (2020) |
| ISSN: | 2249-782X |
| DOI: | 10.7860/jcdr/2020/42934.13562 |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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