Treatment of reflux oesophagitis with a carbenoxolone/antacid/alginate preparation. A double-blind controlled trial.

Twenty-nine patients were treated with a carbenoxolone/antacid/alginate preparation (Pyrogastrone) and 30 with antacid/alginate alone four times each day for 8 weeks, in a double-blind study, to ascertain the value of carbenoxolone in the treatment of patients with endoscopically confirmed reflux oesophagitis. Symptom review every 2 weeks and endoscopic findings every 4 weeks were converted to a 6-point grading system to facilitate statistical comparison, using a stochastic model for predicting the rate of change in grades during treatment. Carbenoxolone-treated patients showed an 82% improvement in symptom grades over 8 weeks and improved 50% faster (P less than 0.01) than did control patients, who showed a 63% improvement. Endoscopic improvement was not significantly different in the first 4 weeks, although healing was better maintained in carbenoxolone-treated patients during the second 4 weeks (P less than 0.05). At the low doses used (5 X 20 mg daily) no significant side effects of carbenoxolone were encountered. Pyrogastrone should be considered as a therapeutic alternative in patients who fail to respond to routine management with antacids.

RCT Entities:   Population Interventions Outcomes