Abstract
There is a resurgence of interest in the management of peptic ulceration because of the advent of endoscopy, which permits ulcers to be diagnosed accurately and their healing assessed, and because of the introduction of drugs that accelerate healing. Evaluation of treatments for peptic ulcer requires carefully planned clini cal trials in which patients are randomly allocated to treatment groups, preferably in a double-blind fashion. The design of the trial and interpreta tion of the results must take into consideration the normal course of peptic ulcer disease. Gastric and duodenal ulcers probably heal at approximately the same rate (1), and so the time taken to attain complete healing depends on the initial size of the ulcer. The duration of a trial must be sufficient to allow measurement of the healing rate by successive endoscopic measure ments. Early differences between placebo and treatment groups may be obscured if endoscopic assessment is made only at the end of a trial, because ulcers tend to heal naturally regardless of the treatment. In recent clinical trials data on relapse rates in patients receiving placebo preparations suggest that relapse occurs more rapidly and more frequently than clinical assess ment or radiological studies had previously estimated. Relapse rates of 65-80% within six months and 80-100% within one year have been found in these trials for both duodenal and gastric ulcers (2-4). Endoscopy has also shown that approximately one fifth of ulcers recur in the absence of symptoms (5). Randomized clinical trials performed on duodenal ulcer patients between 1964 and 1974 have been analyzed (6) and these data, together with more recent trials, particularly of cimetidine, are discussed in this review.
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