Double-blind comparison of liquid antacid and placebo in the treatment of symptomatic reflux esophagitis.

Abstract

Although antacids have been the mainstay of pharmacologic therapy for reflux esophagitis, their effectiveness has not been tested in a placebo-controlled double-blind trial. We report a double-blind comparison of liquid antacid vs placebo in the treatment of reflux esophagitis in 32 patients with chronic heartburn. Entry criteria included the presence of symptomatic gastroesophageal reflux confirmed by both an acid perfusion (Bernstein) test and by intraesophageal pH probe. Drug treatment consisted of 15 ml (80 mEq) doses of antacid (Maalox Therapeutic Concentration, William H. Rorer) or placebo taken 7 times daily, ie, 1 and 3 hr after meals and at bedtime. Both groups showed significant improvement (P less than 0.05) in both frequency and severity of heartburn. The time to reproduce heartburn with the timed Bernstein test was increased with both active drug and placebo therapy. The mean increase was 402% (41 +/- 20 sec to 169 +/- 66 sec) for the placebo group and 286% (42 +/- 16 to 120 +/- 57 sec) in the antacid group. Both the antacid and placebo groups showed improvement in the degree of esophagitis as assessed endoscopically. The current study asked: does regular antacid therapy have a favorable influence on the natural history of symptomatic reflux esophagitis, ie, does therapy heal or otherwise change esophagitis so that painful episodes are either less frequent, less severe, or both? We found that the natural history of symptomatic reflux esophagitis was to improve with either antacid or placebo. There was no significant difference in antacid or placebo on the (short-term) natural history of the disease.