Omeprazole in the long-term treatment of gastro-oesophageal reflux disease. A double-blind randomized dose-finding study.
BACKGROUND
Omeprazole is effective in the treatment of reflux oesophagitis, and it is important to determine the lower dose limit with still appropriate clinical efficacy.


METHODS
Patients with endoscopic oesophagitis grade 1-4 (N = 220) were randomized to double-blind treatment with 20 mg or 40 mg omeprazole daily for 4-8 weeks. Those healed after this initial treatment phase were re-randomized to double-blind treatment with 20 mg omeprazole daily (n = 67), 10 mg omeprazole daily (n = 68), or placebo (n = 33) for 6 months. Remission was defined as the absence of any endoscopic sign of oesophagitis.


RESULTS
Healing rates were increased with 40 mg omeprazole, the therapeutic gain compared with the 20-mg dose being 15% after 4 and 8 weeks. The proportion of patients in remission after 6 months was 59% with 20 mg omeprazole, 35% with 10 mg omeprazole, and 0% with placebo.


CONCLUSIONS
Maintenance treatment with 10 mg omeprazole can prevent recurrence of oesophagitis in about one-third of patients with all grades of oesophagitis, and 20 mg omeprazole in about twice as many.
Laursen
L S
LS
Dept. of Medical Gastroenterology, Odense University Hospital, Denmark.
Havelund
T
T
Bondesen
S
S
Hansen
J
J
Sanchez
G
G
Sebelin
E
E
Fenger
C
C
Lauritsen
K
K
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000897:Anti-Ulcer Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004942:Esophagitis, Peptic / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications / Q000188:drug therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage* / Q000627:therapeutic use; D012008:Recurrence; D012044:Regression Analysis; D016896:Treatment Outcome
D000897:Anti-Ulcer Agents; D009853:Omeprazole