[Sulpiride in the management of gastroduodenal ulcers. A comparative double-blind study].

UNLABELLED

Sulpiride (Dogmatil) is a new type of drug acting on the hypothalamus resulting in a physiological increase in amplitude and frequency of gastric motor activity, reduction of signs of abnormal activity and pyloric spasm and an increase in the rate of gastric emptying. Gastric secretion is for all practical purposes unchanged, either in quantity or in acid content. The effects of Sulpiride on the duodenum are similar through some hypotony may be seen. The motor effects of Sulpiride do not relate to its effectiveness in treatment of gastroduodenal ulceration and experiments have shown that this activity can be explained by the reduction of capillary vaso-constriction in local blood circulation at the site of experimentally-induced ulcers, producing a vaso-dilatation assisting healing. This study objectively evaluates the activity of Sulpiride in gastro-duodenal ulcers. 64 patients were studied under strict criteria and acute hemorragic, multiple or abnormally situated ulcers as well as those associated with other infections were eliminated. The dosage was uniform, two ampoules daily of 100 mgs i.m. of Sulpiride or placebo for 12 days, followed by 3 capsules daily of 50 mgs of Sulpiride or placebo for 48 days. No other treatment was given and no dietery restrictions were imposed, though alcohol and Aspirin and similar drugs were restricted. Of the 64 patients, 26 (18 men, 8 women, aged from 21 to 80 years) had gastric ulcers, 14 were treated with Sulpiride, 12 with placebo. 38 cases (29 men and 9 women, aged between 21 and 70 years) had duodenal ulcers, 18 were treated with Sulpiride, 20 with placebo. Full clinical, biological, radiological and endoscopic tests were carried out and a full questionnaire was completed.

RESULTS

Highly significant differences in favour of Sulpiride were shown in both gastric and duodenal ulcer cases, maximum from the 20th day than less significative radiological results appeared. Similar remarks apply to endoscopic results. Sulpiride was extremely well tolerated, though amenorrhea (1) or galactorrhea (2) were noted without causing inconvenience to the patient. The author believes that the clinical effectiveness of Sulpiride in the treatment of gastro-duodenal ulcers is incontestable showing maximum results in ambulatory patients from the 20th day. A large number of patients would probably have produced statistically significant differences in radiological and endoscopic evidence of healing.