Relationship between Sakita endoscopic stage and duration of treatment for duodenal ulcer healing.

1. Endoscopic staging of peptic ulcer lesions according to Sakita will be a methodological improvement in therapeutic trials provided that the correlation between stages and the time spent in treatment is proved valid. 2. We describe a double-blind controlled randomized trial carried out to determine the efficacy of cimetidine in patients with duodenal ulcer in the H stage of Sakita endoscopic staging. Fifty-two patients with duodenal ulcer (H stage) were randomly allocated to receive either 400 mg cimetidine twice daily (N = 26), or placebo (N = 26) for two weeks; patients with unhealed ulcers continued the same treatment for an additional week. 3. Of the cimetidine-treated patients, 19 (73%) were healed after two weeks and 23 (88.5%) after three weeks of treatment, and of the placebo-treated patients, 8 (31%) were healed after two and 13 (50%) after three weeks. 4. These differences indicate a natural tendency of the H stage lesions to heal faster than reported for the active (stage A) lesions and still faster if treated with cimetidine. These findings, by establishing a relationship between the ulcer stage and the time spent in treatment, may help the physician to treat duodenal ulcer patients and will enable the adoption of an important, uniform criterion for selection of duodenal ulcer patients for therapeutic trials, especially in multicenter trials.