Factors affecting duodenal ulcer healing. Four double-blind trials in 193 patients.

An analysis of four double-blind endoscopically controlled trials carried out in 1978 -1980 is presented. Drugs utilized were (patient numbers in brackets): a new histamine H2-receptor antagonist ranitidine (25) v. placebo (22), the colloidal bismuth ulcer-coating preparation bicitropeptide (24) v. cimetidine (26), the tricyclic antidepressant trimipramine (20) v. placebo (19), and the disaccharide coating preparation sucralfate (29) v. placebo (28). Factors analysed were smoking, alcohol consumption, age, length of history, sex and race. The prevalence of smoking and alcohol use, age and length of history varied in the four trials. Pronouncements regarding these factors based on small trials are therefore unreliable. There were no overall diffeences in healing rates whether the patient smoked, consumed alcohol, was above or below 40 years of age, or had a history shorter or longer than 1 year. Comparison of drug and placebo responses revealed that the differences between these were most significant in: non-smokers (P=0,0010) compared with smokers (P=0,0288); teetotallers (P<0,005) compared with alcohol consumers (NS); history under 1 year (P<0,005) compared with over 1 year (P<0,025); males (<0,01) compared with females (NS); and Indians (P<0,005) compared with Blacks (NS).

RCT Entities:   Population Interventions Outcomes