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.


OBJECTIVE
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.


METHODS
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.
Holtmeier
Wolfgang
W
Department of Gastroenterology, Med. Klinik I, J.W. Goethe Universität, Frankfurt, Australia. W.Holtmeier@em.uni-frankfurt.de
Holtmann
Gerald
G
Caspary
Wolfgang F
WF
Weingärtner
Ulrike
U
D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D000536:Aluminum Hydroxide / Q000627:therapeutic use*; D000863:Antacids / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D015738:Famotidine / Q000627:therapeutic use*; D005260:Female; D006356:Heartburn / Q000188:drug therapy*; D006635:Histamine H2 Antagonists / Q000627:therapeutic use*; D006801:Humans; D008276:Magnesium Hydroxide / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000863:Antacids; D006635:Histamine H2 Antagonists; C010467:hydrotalcite; D000536:Aluminum Hydroxide; D015738:Famotidine; D008276:Magnesium Hydroxide