[A clinical trial on the effect of aluminum containing antacids on the course of duodenal ulcer healing and morphology of the gastric mucosa]. / Badania kliniczne nad wplywem glinowych leków alkalizujacych na przebieg gojenia wrzodu dwunastnicy i stan blony sluzowej zoladka.

ABSTRACT

We carried out the controlled, double-blind clinical study on the effect of antacids containing aluminium on the healing of duodenal ulcer (DU) and the morphology of gastric mucosa in 153 patients with duodenal ulcer disease. The patients were treated for 4 weeks with either dihydroxyaluminium-sodium carbonate (Alugastrin) or aluminium and magnesium hydroxides (Alumag) and for comparison with ranitidine or placebo. The clinical usefulness of antacids were assessed according to the following criteria ulcer healing ratio, disappearance of ulcer pain, drug tolerance both subjective and objective (biochemical analyses) and drug effect on the gastric mucosa (endoscopy, histology and morphometry). The results were compared with results obtained from ranitidine treated patients. We have shown that both antacids speed up the DU healing similarly to ranitidine (71%, 75% and 79% respectively) and significantly better than placebo (47% of cases). All administered drugs diminished subjective symptoms of patients and were well tolerated. Dihydroxyaluminium-sodium carbonate and aluminium and magnesium hydroxides as well as ranitidine were without any trophic effects on the gastric mucosa. Thus, despite differences in the pharmacological action (antacids are gastroprotective drugs, ranitidine inhibits HCl secretion), antacids are similarly effective to ranitidine in the treatment of DU patients. However, ranitidine is more comfortable for the patients and better accepted in the long-term treatment.