USE OF THE ANTACID HYDROTALCITE TO TREAT GASTRODUODENAL LESIONS INDUCED BY NONSTEROIDAL ANTIINFLAMMATORY DRUGS - A MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

Objectives: Gastrointestinal side effects have been reported for most of the non-steroidal anti-inflammatory drugs (NSAID) in widespread cli nical use. The purpose of the present multicentre trial was to define the effects of hydrotalcite on NSAID-induced dyspepsia and gastroduode nal lesions. In addition, we investigated possible connections between the kind of NSAID and the severity and location of the mucosal damage , and connections between efficacy of the study medication and the con sumption of coffee, tobacco and alcohol. Design and methods: Fifteen c entres took part in a randomly allocated double-blind trial. A total o f 170 arthritic patients with a minimum of 4 weeks of NSAID treatment and endoscopically proven mucosal injury were randomly divided into tw o groups. While still taking NSAID, each patient also took two tablets of either hydrotalcite or a placebo four times a day. Results: Data f rom follow-up endoscopy were obtained in 150 patients. After 6 weeks, the mucosal damage had healed in 88% of the patients taking hydrotalci te, and in 66.7% of those taking placebo (P<0.001). Hydrotalcite clear ly diminished the abdominal diurnal and nocturnal pain. Endoscopy reve aled that most of the lesions were in the antrum, but no differences i n NSAID ulcerogenicity were found. In regular coffee drinkers, the hea ling process of gastric, but not duodenal, lesions was retarded. Howev er, no correlation was established between the efficacy of the study m edication and smoking or alcohol consumption; the latter even improved healing rates. Conclusions: These data emphasize the efficacy of hydr otalcite in the treatment of NSAID-induced gastroduodenal lesions and associated abdominal pain.