METAANALYSIS OF THE EFFECT OF PLACEBO ON THE OUTCOME OF MEDICALLY TREATED REFLUX ESOPHAGITIS

Background: To ascertain the placebo-induced effect in the treatment o f reflux esophagitis, we reviewed all the English-language literature concerning the results of placebo-controlled trials of erosive/ulcerat ive esophagitis from 1976 to 1990. Twenty-two studies fulfilled our me ta-analytic criteria. Results: After 4 to 8 weeks of treatment, active drugs (cimetidine, ranitidine, nizatidine, omeprazole, metoclopramide , sucralfate) were significantly more effective than placebo in the he aling of esophagitis, with a pooled rate difference (PRD) of 0.22 in f avor of the active drug, an adds ratio (OR) of 2.57 (confidence interv al (CI) = 2.0-3.3). Pooled mean healing rate (+/-SD) with the active d rug was 47.3 +/- 24.0%, as compared with 26.8 +/- 18.0% obtained with placebo after 4 to 8 weeks of treatment. With regard to symptomatic re sponse, complete disappearance of symptoms was observed in an average of 31.6% active-treated patients and in 11.8% of placebo-treated patie nts, respectively. The PRD was 0.20, and the OR 2.25 (CI = 1.65-3.06). The incidence of side effects was not statistically different for the two treatment groups. Conclusion: placebo is a relatively inactive dr ug in the short-term treatment of erosive ulcerative reflux and does n ot appear to change the natural history of the disease.