EFFICACY OF A PECTIN-BASED ANTIREFLUX AGENT ON ACID REFLUX AND RECURRENCE OF SYMPTOMS AND ESOPHAGITIS IN GASTROESOPHAGEAL REFLUX DISEASE

Objective: Gastro-oesophageal reflux disease may be treated with a dru g forming a floating neutral raft in the stomach. The pectin-based raf t-forming anti-reflux agent Aflurax(R) (Idoflux(R)) was examined, firs t regarding reduction of oesophageal acid exposure, and next as to its efficacy as maintenance treatment in patients with healed oesophagiti s. Design: Double-blind, placebo-controlled randomized clinical trials . Setting: Open access endoscopy unit. Participants: Fourteen patients with erosive oesophagitis had measurement of acid exposure. Eighty-ei ght patients with healed erosive/ulcerative oesophagitis and relief of heartburn after pre-treatment with omeprazole received maintenance tr eatment. Interventions: Crossover 12-h oesophageal pH monitoring durin g Aflurax/placebo treatment. Maintenance treatment for up to 6 months with two tablets of Aflurax 1200 mg or placebo four times daily. Main outcome measures: Percentage time pH less than 4 in 6 plus 6 h (uprigh t + supine). Time to recurrence of moderate or severe heartburn (life table analysis). Results: The median (interquartile range) acid exposu re times in the upright position were: 3.1% (1.6-13.0%) on Aflurax ver sus 6.7% (2.5-14.9%) on placebo (P = 0.10). In the supine position no difference was found (Aflurax 13.7%, placebo 13.2%). The time to recur rence of heartburn with Aflurax treatment was prolonged significantly; after 6 months the life table estimates were 48% of patients in remis sion on Aflurax versus 8% on placebo (P = 0.01). Following treatment, erosive oesophagitis was found in 17/34 on Aflurax versus 28/38 on pla cebo (P < 0.05). Conclusion: Aflurax significantly delays recurrence o f moderate or severe heartburn and erosive oesophagitis, when used as maintenance treatment. The acid exposure was not significantly reduced with pH monitoring.