TY - JOUR
T1 - Healing of Benign Gastric Ulcer with Low-Dose Antacid or Cimetidine
T2 - A Double-Blind, Randomized, Placebo-Controlled Trial
AU - Isenberg, J. I.
AU - Peterson, W. L.
AU - Elashoff, J. D.
AU - Sandersfeld, M. A.
AU - Reedy, T. J.
AU - Ippoliti, A. F.
AU - Van Deventer, G. M.
AU - Frankl, H.
AU - Longstreth, G. F.
AU - Anderson, D. S.
PY - 1983/6/2
Y1 - 1983/6/2
N2 - We conducted a 12-week, double-blind, randomized, placebo-controlled trial to determine whether cimetidine (300 mg with meals and at bedtime) or a convenient, liquid aluminum–magnesium antacid regimen (15 ml one hour after meals and at bedtime) would expedite healing or relief of symptoms in patients with benign gastric ulcer. Of the 101 patients who completed the trial according to protocol, 32 received the antacid, 36 cimetidine, and 33 placebo. At 4, 8, and 12 weeks after entry, ulcers had healed in a larger percentage of patients treated with cimetidine than of those treated with placebo: 53, 86, and 89 per cent of the cimetidine group versus 26, 58, and 70 per cent of the placebo group (P = 0.02, 0.01, 0.05), respectively. Healing at the three intervals had occurred in 38,70, and 84 per cent, respectively, of the antacid-treated patients. Neither cimetidine nor antacid was more effective than placebo in relieving symptoms. The presence or absence of symptoms during the fourth and eighth treatment weeks was a poor predictor of the presence or absence of an ulcer crater. We conclude that cimetidine significantly hastens the healing of benign gastric ulcer. (N Engl J Med 1983; 308:1319–24.) The majority of studies evaluating cimetidine or antacid have shown these drugs to be superior to placebo in promoting the endoscopic healing of duodenal ulcer.1 2 3 4 5 6 However, there is no clear consensus that either antacid7,8 or cimetidine9 10 11 12 13 hastens healing of gastric ulcer. For example, although two placebo-controlled trials have reported improvements in gastric-ulcer healing with cimetidine,9,10 three others have not.11 12 13 One large study showed that gastriculcer healing was similar with a regimen of “highdose” liquid antacid or cimetidine,14 but because no placebo group was included, it was not clear that either treatment was superior to placebo. This study was designed to.
AB - We conducted a 12-week, double-blind, randomized, placebo-controlled trial to determine whether cimetidine (300 mg with meals and at bedtime) or a convenient, liquid aluminum–magnesium antacid regimen (15 ml one hour after meals and at bedtime) would expedite healing or relief of symptoms in patients with benign gastric ulcer. Of the 101 patients who completed the trial according to protocol, 32 received the antacid, 36 cimetidine, and 33 placebo. At 4, 8, and 12 weeks after entry, ulcers had healed in a larger percentage of patients treated with cimetidine than of those treated with placebo: 53, 86, and 89 per cent of the cimetidine group versus 26, 58, and 70 per cent of the placebo group (P = 0.02, 0.01, 0.05), respectively. Healing at the three intervals had occurred in 38,70, and 84 per cent, respectively, of the antacid-treated patients. Neither cimetidine nor antacid was more effective than placebo in relieving symptoms. The presence or absence of symptoms during the fourth and eighth treatment weeks was a poor predictor of the presence or absence of an ulcer crater. We conclude that cimetidine significantly hastens the healing of benign gastric ulcer. (N Engl J Med 1983; 308:1319–24.) The majority of studies evaluating cimetidine or antacid have shown these drugs to be superior to placebo in promoting the endoscopic healing of duodenal ulcer.1 2 3 4 5 6 However, there is no clear consensus that either antacid7,8 or cimetidine9 10 11 12 13 hastens healing of gastric ulcer. For example, although two placebo-controlled trials have reported improvements in gastric-ulcer healing with cimetidine,9,10 three others have not.11 12 13 One large study showed that gastriculcer healing was similar with a regimen of “highdose” liquid antacid or cimetidine,14 but because no placebo group was included, it was not clear that either treatment was superior to placebo. This study was designed to.
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U2 - 10.1056/NEJM198306023082203
DO - 10.1056/NEJM198306023082203
M3 - Article
C2 - 6341844
AN - SCOPUS:0020581879
SN - 0028-4793
VL - 308
SP - 1319
EP - 1324
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 22
ER -