Efficacy of a pectin-based anti-reflux agent on acid reflux and recurrence of symptoms and oesophagitis in gastro-oesophageal reflux disease.
OBJECTIVE
Gastro-oesophageal reflux disease may be treated with a drug forming a floating neutral raft in the stomach. The pectin-based raft-forming anti-reflux agent Aflurax (Idoflux) was examined, first regarding reduction of oesophageal acid exposure, and next as to its efficacy as maintenance treatment in patients with healed oesophagitis.


METHODS
Double-blind, placebo-controlled randomized clinical trials.


METHODS
Open access endoscopy unit.


METHODS
Fourteen patients with erosive oesophagitis had measurement of acid exposure. Eighty-eight patients with healed erosive/ulcerative oesophagitis and relief of heartburn after pre-treatment with omeprazole received maintenance treatment.


METHODS
Crossover 12-h oesophageal pH monitoring during Aflurax/placebo treatment. Maintenance treatment for up to 6 months with two tablets of Aflurax 1200 mg or placebo four times daily.


METHODS
Percentage time pH less than 4 in 6 plus 6 h (upright + supine). Time to recurrence of moderate or severe heartburn (life table analysis).


RESULTS
The median (interquartile range) acid exposure times in the upright position were: 3.1% (1.6-13.0%) on Aflurax versus 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 recurrence of heartburn with Aflurax treatment was prolonged significantly; after 6 months the life table estimates were 48% of patients in remission on Aflurax versus 8% on placebo (P = 0.01). Following treatment, erosive oesophagitis was found in 17/34 on Aflurax versus 28/38 on placebo (P < 0.05).


CONCLUSIONS
Aflurax significantly delays recurrence of moderate or severe heartburn and erosive oesophagitis, when used as maintenance treatment. The acid exposure was not significantly reduced with pH monitoring.
Havelund
T
T
Department of Medical Gastroenterology, Odense University Hospital, Denmark.
Aalykke
C
C
Rasmussen
L
L
D000368:Aged; D000897:Anti-Ulcer Agents / Q000627:therapeutic use; D000930:Antidiarrheals / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D016145:Endoscopy, Digestive System; D004941:Esophagitis / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D005260:Female; D005500:Follow-Up Studies; D005744:Gastric Acid / Q000378:metabolism*; D005764:Gastroesophageal Reflux / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D006356:Heartburn / Q000188:drug therapy / Q000378:metabolism; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use; D010368:Pectins / Q000627:therapeutic use*; D012008:Recurrence; D012449:Safety; D016896:Treatment Outcome
D000897:Anti-Ulcer Agents; D000930:Antidiarrheals; D010368:Pectins; D009853:Omeprazole