On-demand treatment of acute heartburn with the antacid hydrotalcite compared with famotidine and placebo: randomized double-blind cross-over study.

BACKGROUND

Antacids are widely used in the self-treatment of gastroesophageal reflux-induced complaints, but respective studies are lacking.

GOALS

To compare the efficacy and safety of hydrotalcite with the H2 receptor antagonist famotidine and placebo in the on-demand treatment of acute heartburn under daily practice conditions.

STUDY

Five hundred sixty-two individuals in 4 centers were randomized in a double-blind, double-dummy, 3-fold cross-over study to single-dose treatments of 1000 mg hydrotalcite, 10 mg famotidine, or placebo. Heartburn severity and relief was measured with numerical and visual rating scales.

RESULTS

A significantly better heartburn relief score was achieved 60 minutes after administration of hydrotalcite compared with placebo (primary end point, P<0.0001). Better efficacy was also observed 30 minutes and 3 hours after the intake of hydrotalcite in comparison with famotidine or placebo. A significant decrease in heartburn severity compared with placebo occurred within 10 minutes for hydrotalcite and was faster compared with both controls.

CONCLUSIONS

For subjects self-administering antacids for episodic heartburn, antacid hydrotalcite provides symptom relief significantly faster and, within the first 3 hours postdosing, more effective than famotidine or placebo. These results suggest that on-demand treatment of hydrotalcite is an effective and well-tolerated therapy for heartburn.