Duodenal ulcer therapy with low-dose antacids: a multicenter trial.
One hundred outpatients with endoscopically verified duodenal ulcer were treated in a double-blind, randomized, multicenter trial with either low-dose antacid (AA, Supralox, 1 tablet three times a day 1 h a.c. and 2 tablets at bedtime, with acid binding capacity of 225 mEq) or misoprostol (MS, Cytotec, 400 micrograms p.o. b.i.d.). Patients were treated up to 4 weeks and underwent endoscopic and clinical evaluation at 2 and 4 weeks. Clinical symptoms were recorded at the beginning and at 2 and 4 weeks. Ninety-eight patients completed the study. After 4 weeks of treatment, the healing rate in the AA group was 79.6% compared with 74.4% in the MS group. The difference in healing rates between these two groups was statistically not significant. The effect on clinical symptoms assessed as percentage improvement during the therapy was similar under both medications. However, the relief of night pain was significantly higher during the first 2 weeks of AA therapy. The side effects of both treatments were minimal, with a higher rate of side effects (especially diarrhea) in the MS group. Thus, a low-dose antacid tablet regimen is safe and effective therapy for duodenal ulcer patients.
Clinical Research Department, Rhône-Poulenc Rorer, Köln, F.R.G.
C
C
Nauert
W F
WF
Caspary
D000293:Adolescent; D000328:Adult; D000368:Aged; D000536:Aluminum Hydroxide / Q000008:administration & dosage*; D000863:Antacids / Q000008:administration & dosage*; D004311:Double-Blind Method; D004338:Drug Combinations; D004381:Duodenal Ulcer / Q000188:drug therapy*; D004384:Duodenoscopy; D005260:Female; D006801:Humans; D008276:Magnesium Hydroxide / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D016595:Misoprostol / Q000627:therapeutic use*; D010147:Pain Measurement
D000863:Antacids; D004338:Drug Combinations; D016595:Misoprostol; C013591:aluminum hydroxide, magnesium hydroxide, drug combination; D000536:Aluminum Hydroxide; D008276:Magnesium Hydroxide