Puneet Rijhwani1, C. M. Agarwal2, Mohammed Shoaib3, Prerna Upadhyaya4, Pradeep Agarwal5
ABSTRACT: BACKGROUND: Gastroesophageal reflux disease (GERD) is a chronic symptom of mucosal damage caused by stomach acid coming up from the stomach into the esophagus. Pathophysiological evidences point towards disordered motility as the main cause of GERD rather than acid hyper secretion. Cinitapride hydrogen tartrate is a 5-HT2-receptor antagonist and 5-HT4-receptor agonist activity. OBJECTIVE: The present study was planned to assess the efficacy and safety of Cinitapride hydrogen tartarate 1 mg tablets in gastro oesophageal reflux disease. MATERIAL AND METHODS: 35 adult patients (›20 years old), both genders from the outpatient clinic in private practices with diagnosis of gastroesophageal reflux were enrolled. One patient left the study due to an adverse reaction. 34 patients were analyzed. All patients received cinitapride 1 mg three times a day for four weeks. Patients were also supplied antacid tablets, which could be taken as a rescue medication during the course of the study. RESULTS: Total 29 male patients and 6 female patients enrolled in the study. There was a significant reduction in the mean overall symptoms intensity score from 8.4±1.4 (range: 6-11) at baseline to 0.3±1.1 (range: 0-6) at the end of week 4. There was also a significant reduction in the mean intensity score of the individual symptoms i.e. feeling of gastric fullness, upper abdominal pain, anorexia, heartburn and nausea & vomiting from at the end of the study. All the patients enrolled into the study required antacid tablets as rescue medication initially but the mean number of antacid tablets consumed declined drastically from 7.1±3.4 (range: 2-14) at baseline to 0.5±1.4 (range: 0-6) at the end of the study. 29 of the 34 patients (85.3%) were rated to have an “excellent” efficacy to the study drug, 4 patients (11.8%) were rated to have a “good” efficacy and 1 patient (2.9%) was rated to have a “fair” efficacy to the study drug at the end of the study. 4 patients developed adverse events during the course of the study –diarrhea, drowsiness, increased passage of flatus and lethargy. CONCLUSION: Cinitapride is effective and well tolerated in the treatment of adult patients with gastroesophageal reflux.
