[Intermittent treatment or preventive treatment of recurrence in duodenal ulcer disease? A controlled, double-blind study with 150 mg ranitidine daily for one year].
This 1-year study compared two pragmatic strategies in long-term management of duodenal ulcer: continuous treatment with ranitidine 150 mg after dinner and treatment of duodenal ulcer attacks with ranitidine 300 mg and placebo in the interval. A multicentric, randomized double-blind study was conducted in 399 patients, 197 in the ranitidine group and 202 in the placebo group. Efficacy was judged by the prevalence of ulcer-pain recurrences; secondary criteria were the prevalence of endoscopic recurrences, complications and the number of facultative visits, hospitalizations and days off work related to duodenal ulcer disease. Both groups were similar with regard to main epidemiologic features and number of drop-outs (10.5 percent). Fifty-two patients were withdrawn for symptomatic or endoscopic relapses: 6 in the ranitidine group, 46 in the placebo group (p less than 0.05). Sixty-six percent of the patients remained asymptomatic at one year in the ranitidine group versus 33 percent in the placebo group (p less than 0.001). Seventeen patients with ranitidine (8.6 percent) and 59 with placebo (29.2 percent) experienced at least one endoscopic recurrence (p less than 0.05). In the placebo group, 8 complications were observed (bleeding = 5, duodenal stenosis = 3), and none in the ranitidine group (p less than 0.005). Patients with ranitidine had significantly less facultative visits and endoscopies, number of days off work, and hospitalizations (p less than 0.05). Tolerance was good (5 percent side-effects, all minor) and identical in the two groups.(ABSTRACT TRUNCATED AT 250 WORDS)
Mignon
M
M
Service d'Hépato-Gastroentérologie, Hôpital Bichat, Paris.
Ruszniewski
P
P
Pappo
M
M
Alberola
B
B
Georges
D
D
D000328:Adult; D004311:Double-Blind Method; D004381:Duodenal Ulcer / Q000150:complications / Q000188:drug therapy*; D016145:Endoscopy, Digestive System; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D010146:Pain / Q000209:etiology; D010438:Peptic Ulcer Hemorrhage / Q000209:etiology; D016032:Randomized Controlled Trials as Topic; D011899:Ranitidine / Q000008:administration & dosage / Q000627:therapeutic use*; D012008:Recurrence
D011899:Ranitidine
Traitement des poussées ou traitement préventif des récidives dans la maladie ulcéreuse duodénale? Etude contrôlée en double aveugle d'une prise quotidienne de ranitidine 150 mg pendant un an.