A comparative prospective study to assess the clinical efficacy and safety of pantoprazole monotherapy versus pantoprazole and itopride dual therapy in patients with gastroesophageal reflux disease in a tertiary care hospital

Background: Gastroesophageal reflux disease (GERD) is a common chronic, relapsing condition that carries a risk of significant morbidity and potential mortality from resultant complications. Proton pump inhibitors (PPIs) remained as the main stay in the therapy of GERD but they do not have any role in increasing the tone of lower esophageal sphincter which is the main pathophysiology of GERD. In this regard addition of prokinetic agent like Itopride may be beneficial in improving the symptoms associated with GERD. So the present study has been taken to compare the healing rates of esophagitis and reduction in symptom scores associated with GERD between Pantoprazole monotherapy and Pantoprazole plus Itopride combination.Methods: 100 patients diagnosed with GERD were randomly assigned into two groups, Group A and Group B. Group A received tablet Pantoprazole 40 mg twice daily alone and group B received tablet Pantoprazole 40 mg twice daily and tablet Itopride 50 mg thrice daily 30 minutes before food for 4 weeks. The patients were followed up at the end of 4 weeks and were given the questionnaire to assess the FSSG scores. Endoscopy and FSSG scores were recorded and then the percentage of responders in both groups was compared.Results: Endoscopic evidence of healing of esophagitis was similar in both the groups, 72% in Group A and 74% in Group B. The symptom relief was significantly more in Pantaprozole plus Itopride group 74.5% (4.2±1.6) than Pantaprozole alone 62.5% (6.4±1.1) after 4 weeks (p < 0.001).The occurrence of side effects was less in group B compared to group A (22% vs 30%, p= 0.172).Conclusions: Pantoprazole and combination of Pantoprazole plus Itopride provide more effective endoscopic healing of esophagitis. Pantoprazole and Itopride combination is more efficacious in ameliorating the symptoms of GERD than Pantoprazole alone