T Havelund1, C Aalykke. 1. Dept. of Medical Gastroenterology S, Odense University Hospital, Denmark.
Abstract
BACKGROUND:Patients with heartburn as their main complaint but normal oesophageal mucosa at endoscopy are classified as having endoscopy-negative gastro-oesophageal reflux disease (GORD). They have mainly postprandial reflux and low total acid exposure and could possibly be managed with a non-systemic drug. In such patients we examined the effect of a pectin-based raft-forming anti-reflux agent (Aflurax (Idoflux)) on the severity of heartburn. METHODS:Patients with heartburn but with normal/erythematous oesophageal mucosa (n = 65) were randomized to double-blind treatment with two 1200-mg tablets of Aflurax or two placebo tablets four times daily for 4 weeks. The main outcome measure was heartburn severity on day 15 and day 29. RESULTS: The number of patients scoring heartburn severity on day 15 as none, mild, moderate, and severe were 6, 14, 8, and 3, respectively, with Aflurax versus 2, 6, 13, and 11 with placebo (P < 0.05). No further treatment effect was found on day 29. CONCLUSION:Aflurax reduces heartburn in patients with endoscopy-negative GORD.
RCT Entities:
BACKGROUND:Patients with heartburn as their main complaint but normal oesophageal mucosa at endoscopy are classified as having endoscopy-negative gastro-oesophageal reflux disease (GORD). They have mainly postprandial reflux and low total acid exposure and could possibly be managed with a non-systemic drug. In such patients we examined the effect of a pectin-based raft-forming anti-reflux agent (Aflurax (Idoflux)) on the severity of heartburn. METHODS:Patients with heartburn but with normal/erythematous oesophageal mucosa (n = 65) were randomized to double-blind treatment with two 1200-mg tablets of Aflurax or two placebo tablets four times daily for 4 weeks. The main outcome measure was heartburn severity on day 15 and day 29. RESULTS: The number of patients scoring heartburn severity on day 15 as none, mild, moderate, and severe were 6, 14, 8, and 3, respectively, with Aflurax versus 2, 6, 13, and 11 with placebo (P < 0.05). No further treatment effect was found on day 29. CONCLUSION:Aflurax reduces heartburn in patients with endoscopy-negative GORD.