Meta-analysis of the effect of placebo on the outcome of medically treated reflux esophagitis.
BACKGROUND
To ascertain the placebo-induced effect in the treatment of reflux esophagitis, we reviewed all the English-language literature concerning the results of placebo-controlled trials of erosive/ulcerative esophagitis from 1976 to 1990. Twenty-two studies fulfilled our meta-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 healing of esophagitis, with a pooled rate difference (PRD) of 0.22 in favor of the active drug, an odds ratio (OR) of 2.57 (confidence interval (CI) = 2.0-3.3). Pooled mean healing rate (+/- SD) with the active drug 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 response, complete disappearance of symptoms was observed in an average of 31.6% active-treated patients and in 11.8% of placebo-treated patients, 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.


CONCLUSIONS
Placebo is a relatively inactive drug in the short-term treatment of erosive ulcerative reflux and does not appear to change the natural history of the disease.
Pace
F
F
Gastrointestinal Unit, L. Sacco Hospital, Milan, Italy.
Maconi
G
G
Molteni
P
P
Minguzzi
M
M
Bianchi Porro
G
G
D000897:Anti-Ulcer Agents / Q000627:therapeutic use; D004942:Esophagitis, Peptic / Q000188:drug therapy*; D006635:Histamine H2 Antagonists / Q000627:therapeutic use; D006801:Humans; D015990:Placebo Effect; D013997:Time Factors; D016896:Treatment Outcome; D014945:Wound Healing
D000897:Anti-Ulcer Agents; D006635:Histamine H2 Antagonists