title: A controlled multicentre therapeutic trial to determine the efficacy of a novel antacid (AI-Mg-hydroxy-carbonate) in duodenal ulcer.
abstract: 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.
authors.affiliation: First Department of Medicine, University Medical School, Pécs, Hungary.
authors.forename: L
authors.initials: L
authors.lastname: Nagy
authors.forename: G
authors.initials: G
authors.lastname: Nagy
authors.forename: I
authors.initials: I
authors.lastname: Rácz
authors.forename: L
authors.initials: L
authors.lastname: Simon
authors.forename: I
authors.initials: I
authors.lastname: Solt
authors.forename: I
authors.initials: I
authors.lastname: Patty
authors.forename: F
authors.initials: F
authors.lastname: Tárnok
authors.forename: G
authors.initials: G
authors.lastname: Mózsik
authors.forename: T
authors.initials: T
authors.lastname: Jávor
mesh_terms: 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
chemical_list: D000863:Antacids; D013535:Suspensions; D013607:Tablets; D000536:Aluminum Hydroxide