In a double-blind study 83 patients with duodenal ulcers, initially healed after treatment with either 1 g cimetidine daily or 50 mg trimipramine daily, were allocated by randomization to maintenance treatment with either 400 mg cimetidine daily, 25 mg trimipramine daily, or placebo for 6 months. Monthly clinical interviews were carried out and endoscopy performed whenever the symptoms suggested ulcer relapse. After 6 months the treatment was discontinued, and the patients were observed similarly for another 6-month period. After 6 months of maintenance treatment 88% in the cimetidine group versus 55% in the trimipramine group and 53% in the placebo group remained in symptomatic remission, yielding a significant difference between the cimetidine-treated patients and the two other groups (P less than 0.05). After a further 6 months of drug-free follow-up study, the percentages were 48% versus 29% and 29% in the cimetidine, trimipramine, and placebo groups, respectively (P less than 0.05). Thus maintenance treatment with trimipramine proved no better than placebo in preventing relapses of duodenal ulcers. Second, maintenance treatment with 400 mg cimetidine daily did prevent ulcer relapse, and, third, maintenance treatment with cimetidine for 6 months did not alter the long-term course of the duodenal ulcer disease.
ABSTRACT. Becker U, Lindorff K, Andersen C, Ranløv PJ (Department of Internal Medicine B, Central Hospital, Hillerød, Denmark). Antacid treatment of duodenal ulcer. Acta Med Scand 1987; 221:95–101.
Sixty‐seven consecutive outpatients with endoscopically verified duodenal ulcer were randomised to a double‐blind treatment with either 10 ml of an antacid suspension (buffering capacity 85 mmol/10 ml, packed in single dosage pads) 1 and 3 h after each meal and at bedtime or cimetidine 400 mg b.i.d. The double‐dummy technique was employed. Endoscopy was performed after 4 weeks treatment and, if the ulcer had not healed, after 8 weeks treatment. When ulcer healing had occurred, the patient entered a 1 year follow‐up study. The cumulative healing rates after 4 and 8 weeks treatment were 83 and 97% vs. 69 and 94% in the antacid and cimetidine groups respectively. No significant differences were observed between the treatment groups regarding ulcer healing, symptom relief or compliance. Adverse reactions were few and only 3 (9%) patients in the antacid group had to discontinue the treatment due to diarrhoea. Of the cimetidine treated patients, 61% had symptomatic relapse during the 1 year follow‐up compared to 71% of the antacid treated patients. There were no significant differences in recurrence rate or time to relapse. The moderate dose antacid treatment used here is efficient, well tolerated, safe, convenient and is a good alternative treatment of the duodenal ulcer patient.
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