Sucralfate versus ranitidine in the treatment of gastric ulcer. Randomized clinical results in short-term and maintenance therapy.
This clinical study compared the healing capacities of sucralfate and ranitidine in the treatment of gastric ulcer. Sixty patients were assigned at random to treatment with either sucralfate (1 g four times per day) or ranitidine (150 mg twice per day). The patients underwent endoscopy before inclusion in the study, after four weeks, and after eight weeks if the ulcers had not completely healed after the fourth week (phase I). Patients whose ulcers had healed were invited to participate in phase II, consisting of maintenance treatment for one year. The dosage was 1 g sucralfate twice per day or 150 mg ranitidine before going to bed. The patients underwent a clinical examination every three months and endoscopy every six months, and whenever symptoms suggested a relapse. After four weeks, the ulcers in 53 percent of the sucralfate-treated patients (16 of 30) had healed, compared with 56 percent of the ranitidine-treated patients (17 of 30). After eight weeks, the cumulative healing rates were 83 percent (25 of 30) and 86 percent (26 of 30), respectively. At the six-month follow-up visit, the relapse rates were seven of 21 (33.3 percent) in the sucralfate group and nine of 18 (50 percent) in the ranitidine group. After 12 months, the accumulative relapse rates were eight of 18 (44.4 percent) and nine of 18 (50.0 percent). The only side effects worth noting were mild constipation in four patients treated with sucralfate. One patient in the ranitidine group had myalgia and one reported headache in phase I. In conclusion, sucralfate appears to be as effective as ranitidine in the short-term treatment of gastric ulcers and in relapse prophylaxis.
Herrerias-Gutierrez
J M
JM
Gastroenterology Department, University Hospital of Sevilla, Spain.
Pardo
L
L
Segu
J L
JL
D000328:Adult; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011897:Random Allocation; D011899:Ranitidine / Q000008:administration & dosage / Q000627:therapeutic use*; D012008:Recurrence; D013276:Stomach Ulcer / Q000188:drug therapy* / Q000473:pathology; D013392:Sucralfate / Q000008:administration & dosage / Q000627:therapeutic use*
D013392:Sucralfate; D011899:Ranitidine