A controlled multicentre therapeutic trial to determine the efficacy of a novel antacid (AI-Mg-hydroxy-carbonate) in duodenal ulcer.
Tisacid (a new, modern Hungarian AI-containing antacid) with a high acid-neutralizing capacity (greater than 26.8 mmol/g) also enhances gastric mucosal defense mechanisms (prostaglandin-dependent gastroprotection). A simple-blind, prospective, randomized, parallel multicentre clinical trial has been performed on both the clinical efficacy and possible side-effects of Tisacid monotherapy (AI-Mg-hydroxy-carbonate) on informed patients suffering from active duodenal ulcers. The four study groups were as follows: Group A: 3 g/day of Tisacid (acid-neutralizing capacity = 78 mmol, n = 85), Group B: 6 g/day of Tisacid (acid-neutralizing capacity = 156 mmol, n = 88), Group C: 12 g/day of Tisacid (acid-neutralizing capacity = 312 mmol, n = 68), Group D (as control): 1.0 g/day cimetidine (n = 91). The total number of patients was 332. It was found that the new Hungarian antacid compound (both tablet and suspension) can essentially accelerate the healing rate of duodenal ulcers; the cumulative healing rate of ulcers and the decrease of complaints can be achieved equally by relatively low doses of Tisacid monotherapy and cimetidine alone; and there were no essential differences between the clinical potency and side-effects of Tisacid tablets or the suspension.
Nagy
L
L
First Department of Medicine, University Medical School, Pécs, Hungary.
Nagy
G
G
Rácz
I
I
Simon
L
L
Solt
I
I
Patty
I
I
Tárnok
F
F
Mózsik
G
G
Jávor
T
T
D000293:Adolescent; D000328:Adult; D000368:Aged; D000536:Aluminum Hydroxide / Q000627:therapeutic use*; D000863:Antacids / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004381:Duodenal Ulcer / Q000188:drug therapy*; D005260:Female; D006801:Humans; D006814:Hungary; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011897:Random Allocation; D013535:Suspensions; D013607:Tablets
D000863:Antacids; D013535:Suspensions; D013607:Tablets; D000536:Aluminum Hydroxide