[Sulpiride in the management of gastroduodenal ulcers. A comparative double-blind study]. 1975

M Molle

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.

UI MeSH Term Description Entries
D007031 Hypothalamus Ventral part of the DIENCEPHALON extending from the region of the OPTIC CHIASM to the caudal border of the MAMMILLARY BODIES and forming the inferior and lateral walls of the THIRD VENTRICLE. Lamina Terminalis,Preoptico-Hypothalamic Area,Area, Preoptico-Hypothalamic,Areas, Preoptico-Hypothalamic,Preoptico Hypothalamic Area,Preoptico-Hypothalamic Areas
D007273 Injections, Intramuscular Forceful administration into a muscle of liquid medication, nutrient, or other fluid through a hollow needle piercing the muscle and any tissue covering it. Intramuscular Injections,Injection, Intramuscular,Intramuscular Injection
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D010437 Peptic Ulcer Ulcer that occurs in the regions of the GASTROINTESTINAL TRACT which come into contact with GASTRIC JUICE containing PEPSIN and GASTRIC ACID. It occurs when there are defects in the MUCOSA barrier. The common forms of peptic ulcers are associated with HELICOBACTER PYLORI and the consumption of nonsteroidal anti-inflammatory drugs (NSAIDS). Gastroduodenal Ulcer,Marginal Ulcer,Gastroduodenal Ulcers,Marginal Ulcers,Peptic Ulcers,Ulcer, Gastroduodenal,Ulcer, Marginal,Ulcer, Peptic,Ulcers, Gastroduodenal,Ulcers, Marginal,Ulcers, Peptic
D010919 Placebos Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol. Sham Treatment
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D004381 Duodenal Ulcer A PEPTIC ULCER located in the DUODENUM. Curling's Ulcer,Curling Ulcer,Curlings Ulcer,Duodenal Ulcers,Ulcer, Curling,Ulcer, Duodenal,Ulcers, Duodenal
D005260 Female Females
D005769 Gastrointestinal Motility The motor activity of the GASTROINTESTINAL TRACT. Intestinal Motility,Gastrointestinal Motilities,Intestinal Motilities,Motilities, Gastrointestinal,Motilities, Intestinal,Motility, Gastrointestinal,Motility, Intestinal

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