Long term behaviour of healed duodenal ulcer with and without maintenance therapy

Seventy six patients who showed complete ulcer healing at endoscopy were treated within 48 hr with either placebo (41 patients) or cimetidine 400 mg nocte (35 patients) as a maintenance therapy for a period of one year in a double blind controlled study. Patients were reviewed every month and an endoscopy was performed every 3 months after starting the treatment or earlier if there was recurrence of symptoms. During the first three months of treatment the relapse rate in the two treatment groups were similar. The difference between the two first became obvious at 4 mo, but statistically significant difference appeared only at 6 mo: 70.7% in the placebo group suffered a relapse compared to 42.9% in the cimetidine group (x2 = 6.01; p less than 0.02). The difference remained significant until the 10th mo (78.1% vs 48.6%; x2 = 7.16; p less than 0.01). At 12 mo, the difference was not significant (80.5% vs 62.9%; x2 = 2.93). The age, sex, duration of illness, previous treatment and blood group status did not influence ulcer relapse. However, two factors had an influence on the relapse rate: a) in patients receiving placebo the relapse rate was significantly greater in smokers compared to non smokers; no such difference was observed in the cimetidine group. Moreover, smokers on cimetidine had a significantly lower relapse rate at 6.9 and 12 mo compared to smokers on placebo (50% vs 88.9%, 50% vs 94.4% and 53.3% vs 94.4%; p less than 0.01 for each).(ABSTRACT TRUNCATED AT 250 WORDS)