0 1991 Raven Press, Ltd., New York
J CIin Gastroenterol 1991; 13 (Siippl. I ) : S149-Sl54, 1991
Duodenal Ulcer Therapy with Low-Dose Antacids: A Multicenter Trial Christian Nauert,
M.D.,
and W. F. Caspary,
M.D.
During the last century, antacids have been used for the treatment of diseases of the upper gastrointestinal tract (1-3). With the introduction of Hz-antagonists more than 10 years ago, their principle of reduction of gastric acidity for the treatment of upper gastrointestinal diseases was confirmed. Even after the introduction of very potent inhibitors of gastric acid secretion such as omeprazol and the H2-antagonists, antacids are the most commonly used self-medications for relieving peptic ulcer symptoms. High-dose antacids have been shown to accelerate the healing of peptic ulcerations (2-4) but recently low-dose antacid treatment (e.g., 1 antacid tablet four times a day) (5-7) has been found to be effective in healing ulcer. Moreover, this low-dose antacid therapy with a low neutralizing capacity (120-200 mEq/day) appears to be as effective as the much higher (five- to sixfold) acid neutralizing capacity used 10 years ago. Prostaglandins of the E series, such as misoprostol, inhibit gastric secretion of acid and pepsin (8,9) and in reasonably large doses are as effective as HZantagonists in the treatment of gastric and duodenal ulcerations. In a dose of 200 pg four times daily or 400 pg twice daily, misoprostol effectively accelerates the healing of duodenal ulcerations (10). To date, there have been no studies comparing directly the effectiveness of low-dose antacids and prostaglandins in healing of duodenal ulcer. Therefore, the present study was aimed at determining the efficacy of a new aluminum-magnesium hydroxide-containing antacid tablet in duodenal ulcer therapy and to compare it to misoprostol. Since aluminum hydroxide-containing antacids have been reported to exert their antiulcerative effects not only by acid neutralization but also by other actions on the gastric mucosa (e.g., cytoprotective action) (1 1,121, it seemed reasonable
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) o r misoprostol (MS, Cytotec, 400 p.g p.0. 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. Key Words: Duodenal ulcer-Antacids-MisoprostolAluminum hydroxide-Magnesium hydroxide-Low dose-Clinical trial.
From the Clinical Research Department, Rh6ne-Poulenc Rorer (C.N.), Koln, and Department of Gastroenterology, University of Frankfurt (W.F.C.), Frankfurt, F.R.G. Address correspondence and reprint requests to Dr. C. Nauert at Clinical Research Department, RhBne-Poulenc Rorer, Nattermannalee 1 , D-5000 Koln 30, Federal Republic of Germany.
S149
J CIin Gastroenterol 1991; 13 (Siippl. I ) : S149-Sl54, 1991
Duodenal Ulcer Therapy with Low-Dose Antacids: A Multicenter Trial Christian Nauert,
M.D.,
and W. F. Caspary,
M.D.
During the last century, antacids have been used for the treatment of diseases of the upper gastrointestinal tract (1-3). With the introduction of Hz-antagonists more than 10 years ago, their principle of reduction of gastric acidity for the treatment of upper gastrointestinal diseases was confirmed. Even after the introduction of very potent inhibitors of gastric acid secretion such as omeprazol and the H2-antagonists, antacids are the most commonly used self-medications for relieving peptic ulcer symptoms. High-dose antacids have been shown to accelerate the healing of peptic ulcerations (2-4) but recently low-dose antacid treatment (e.g., 1 antacid tablet four times a day) (5-7) has been found to be effective in healing ulcer. Moreover, this low-dose antacid therapy with a low neutralizing capacity (120-200 mEq/day) appears to be as effective as the much higher (five- to sixfold) acid neutralizing capacity used 10 years ago. Prostaglandins of the E series, such as misoprostol, inhibit gastric secretion of acid and pepsin (8,9) and in reasonably large doses are as effective as HZantagonists in the treatment of gastric and duodenal ulcerations. In a dose of 200 pg four times daily or 400 pg twice daily, misoprostol effectively accelerates the healing of duodenal ulcerations (10). To date, there have been no studies comparing directly the effectiveness of low-dose antacids and prostaglandins in healing of duodenal ulcer. Therefore, the present study was aimed at determining the efficacy of a new aluminum-magnesium hydroxide-containing antacid tablet in duodenal ulcer therapy and to compare it to misoprostol. Since aluminum hydroxide-containing antacids have been reported to exert their antiulcerative effects not only by acid neutralization but also by other actions on the gastric mucosa (e.g., cytoprotective action) (1 1,121, it seemed reasonable
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) o r misoprostol (MS, Cytotec, 400 p.g p.0. 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. Key Words: Duodenal ulcer-Antacids-MisoprostolAluminum hydroxide-Magnesium hydroxide-Low dose-Clinical trial.
From the Clinical Research Department, Rh6ne-Poulenc Rorer (C.N.), Koln, and Department of Gastroenterology, University of Frankfurt (W.F.C.), Frankfurt, F.R.G. Address correspondence and reprint requests to Dr. C. Nauert at Clinical Research Department, RhBne-Poulenc Rorer, Nattermannalee 1 , D-5000 Koln 30, Federal Republic of Germany.
S149
