The efficacy of a pectin-based raft-forming anti-reflux agent in endoscopy-negative reflux disease.
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.


CONCLUSIONS
Aflurax reduces heartburn in patients with endoscopy-negative GORD.
Havelund
T
T
Dept. of Medical Gastroenterology S, Odense University Hospital, Denmark.
Aalykke
C
C
D000328:Adult; D000368:Aged; D000863:Antacids / Q000008:administration & dosage; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005764:Gastroesophageal Reflux / Q000175:diagnosis / Q000188:drug therapy*; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D005773:Gastroscopy; D006356:Heartburn / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D010368:Pectins / Q000627:therapeutic use*; D016896:Treatment Outcome
D000863:Antacids; D004338:Drug Combinations; D005765:Gastrointestinal Agents; C109521:idoflux; D010368:Pectins