Treatment of duodenal ulcer with omeprazole or ranitidine in a Brazilian population: a multicenter double-blind, parallel group study.
Two hundred and forty-one patients with at least one ulcer at stage A1 or A2, measuring at least 5 mm in its larger diameter, were included in this Brazilian double-blind randomized study. Patients received omeprazole 20 mg in the morning (n = 120) or ranitidine 300 mg at night (n = 121) for 2 wk; unhealed ulcers were treated for an additional 2 wk. At the end of 4 wk, unhealed ulcers were treated openly with omeprazole 20 mg o.m. for 4 wk. Healing rates at 2 and 4 wk were 67.3% and 92.9% for omeprazole and 39.8% and 82.0% for ranitidine (per protocol analysis). Results were similar when analyzed as intention to treat (p significant in favor of omeprazole). Epigastric day-time pain was the most common of all symptoms (89.2%), but only heartburn at day 15 showed a significantly better response to omeprazole than to ranitidine. A multivariate analysis (logit analysis) showed that the odds in favor of healing were greater for small ulcers, nonsmokers, and omeprazole treatment.
Zaterka
S
S
Department of Clinical Gastroenterology, Hospital das Clínicas da F.M.U.S.P., Brazil.
Massuda
H
H
Chinzon
D
D
Eisig
J N
JN
Miszputen
S
S
Kendo
M
M
Silva
A E
AE
Ferrari Júnior
A P
AP
Castro
L P
LP
Castro
F J
FJ
D000328:Adult; D001938:Brazil / Q000453:epidemiology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004381:Duodenal Ulcer / Q000188:drug therapy* / Q000453:epidemiology; D005260:Female; D006801:Humans; D008297:Male; D015999:Multivariate Analysis; D009853:Omeprazole / Q000627:therapeutic use*; D011899:Ranitidine / Q000627:therapeutic use*; D012307:Risk Factors; D013997:Time Factors
D011899:Ranitidine; D009853:Omeprazole