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A double blind clinical evaluation of cimetidine on peptic ulcer 2. duodenal ulcer



A double blind clinical evaluation of cimetidine on peptic ulcer 2. duodenal ulcer



Japanese Archives of Internal Medicine 27(3): 80-90



The therapeutic efficacy and safety of cimetidine (800 mg/day) was compared against gefarnate (300 mg/day) in a 6 wk outpatient-based study by a double-blind, group-to-group comparison. Patients (203) with endoscopically proven active-stage round duodenal ulcer were studied. Of these, 151, i.e., 73 allotted to cimetidine and 78 to gefarnate, met the requirements of the study. Background factors did not differ significantly between the 2 drug groups. For analysis of side effects, all 203 patients served as subjects. The final global improvement rating (FGIR) differed significantly between the 2 drugs, and responders to cimetidine vastly outnumbered responders to gefarnate, as evidenced by the number and percent of the subjects falling in each of the following 5 point scales: cimetidine.sbd.markedly improved, 50 (69%); moderately improved, 11 (15%); slightly improved, 8 (11%); unchanged, 3 (4%) and aggravated, 1 (1%); gefarnate.sbd.33 (42%), 15 (19%), 20 (26%), 7 (9%) and 3 (4%), respectively. The rating for healing of endoscopically proven duodenal ulcer lesions was in favor of cimetidine. The difference in the rating between the 2 drugs did not reach statistical significance 3 wk after beginning treatment, i.e., 30 (41%) for cimetidine and 23 (30%) for gefarnate, attained statistical significance (P < 0.001) at 6 wk, as shown by the figures of 60 (82%) for cimetidine and 42 (54%) for gefarnate. The overall improvement rating of subjective symptoms also differed significantly between the 2 drugs (P < 0.001). Acid symptoms, i.e., heartburn and belching, showed the most striking improvement among subjective symptoms that responded more favorably to cimetidine than to gefarnate. Overall safety, in terms of the frequency of complaints of side effects attributable to the drug, nearly equaled 3/91 for cimetidine and 5/97 for gefarnate. No severe side effects were recorded. The therapeutic usefulness rate of cimetidine proved to be well over that of gefarnate (P < 0.001), as shown by the pronounced difference in the pattern of distribution of responders and nonresponders on a 5-point rating table: cimetidine.sbd.strikingly useful, 49 (67%); very useful, 12 (16%); useful, 6 (8%); probably not, 5 (7%) and harmful, 1 (1%); gefarnate.sbd.30 (39%), 13 (17%), 21 (27%), 12 (15%) and 2 (3%), respectively.

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Accession: 004571947

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