Cimetidine versus antacid in scleroderma with reflux esophagitis. A randomized double-blind controlled study.

The effectiveness of cimetidine vs. antacid in the treatment of patients with scleroderma and symptomatic reflux esophagitis was studied in a double-blind cross-over controlled trial. Fifteen patients were initially randomized to either cimetidine (300 mg four times daily) with placebo antacid, or placebo tablet (1 four times daily) with Mylanta II (30 ml four times daily and PRN). After 8 wk of therapy on the initial regimen, each patient was crossed over to the alternate regimen for an additional 8 wk of therapy. The severity of symptoms during each treatment period was estimated by patient interviews and changes in esophagitis were evaluated endoscopically. Cimetidine gave significantly greater relief of heartburn than antacid regardless of the initial randomization. Cimetidine also resulted in significant endoscopic improvement of the esophageal mucosa whereas antacid was without effect. Neither cimetidine nor antacid produced any improvement in esophageal stricture size or lower esophageal sphincter pressure. Cimetidine was without toxicity whereas antacid therapy frequently produced diarrhea.

RCT Entities:   Population Interventions Outcomes