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We randomly assigned 159 patients with non-ulcer dyspepsia, defined as chronic or recurrent epigastric pain without concomitant symptoms of the irritable bowel syndrome and with no evidence of organic disease, to treatment for three weeks with an antacid suspension one and three hours after meals, 400 mg of cimetidine twice a day, or placebo, according to a double-blind, double-dummy model. The intensity and duration of epigastric pain were recorded by the patients four times daily during a one-week period without therapy and during the three weeks of treatment. The mean reduction in pain intensity after three weeks in the placebo group was 25 percent. Neither antacid nor cimetidine treatment resulted in more than a 4 percent better effect. The reduction of pain was statistically significant (P less than 0.01) in all three groups. The time course of the pain scores in the groups receiving active drugs followed closely those in the placebo group, and there were no significant differences between the groups at any stage of the treatment. We conclude that the neutralization or suppression of gastric acid is of no clinical value in patients with this syndrome.

Over a 15-month period, 75 critically ill patients at risk of acute gastrointestinal bleeding were randomized into two groups: one group (38 patients) received the H2-blocker cimetidine intravenously at an initial dosage of 300 mg every six hours, and the other group (37 patients) received antacid (Mylanta II) through a nasogastric tube at an intial dosage of 30 ml every hour. Gastric pH was measured hourly and titrated above 3.5. Upper-gastrointestinal-tract bleeding occurred in seven of 38 cimetidine-treated patients but in none of 37 antacid-treated patients (P less than 0.01). When antacid titration was added to the cimetidine regimen in four of seven patients with bleeding, all four stopped bleeding. Renal failure, sepsis, peritonitis, hypotension, respiratory failure, jaundice, multiple trauma, and major operative procedures were associated with an increased incidence of bleeding. Cimetidine does not adequately protect seriously ill patients from acute upper-gastrointestinal-tract bleeding. Antacid is better for this purpose.

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 of absence of an ulcer crater. We conclude that cimetidine significantly hastens the healing of benign gastric ulcer.

To determine whether a large-dose antacid regimen is effective in promoting healing of duodenal ulcer, 74 patients with endoscopically proved duodenal ulcer completed a 28-day double-blind clinical trial comparing such a regimen with an inert placebo. The ulcer healed completely in 28 of the 36 antacid-treated as compared to 17 of the 38 placebo-treated patients (P less than 0.005). The antacid regimen was not more effective than placebo in relieving ulcer symptoms. Presence or absence of symptoms during the fourth treatment week was a poor predictor of presence or absence of an ulcer crater. Ulcers of placebo-treated patients who smoked cigarettes were less likely to heal than those of nonsmokers (P = 0.03). Except for mild diarrhea, no side effects of the antacid regimen were observed. We conclude that a large-dose antacid regimen hastens the healing of duodenal ulcer.