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

Journal of Clinical Gastroenterology

Volumn 41, Issue 6, 2007, Pages 564-570

  Holtmeier, Wolfgang ^a   Holtmann, Gerald ^c   Caspary, Wolfgang F ^a   Weingärtner, Ulrike ^b  

^a GOETHE UNIVERSITY   (Germany)

^b BAYER AG   (Germany)

^c ROYAL ADELAIDE HOSPITAL   (Australia)

Author keywords

Antacid; Gastroesophageal reflux disease; Heartburn; On demand treatment; Symptom relief

Indexed keywords

FAMOTIDINE; HISTAMINE H2 RECEPTOR ANTAGONIST; HYDROTALCITE; PLACEBO;

ABDOMINAL DISTENSION; ADULT; AGED; ARTICLE; ASTHMA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIARRHEA; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HEARTBURN; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; PRIORITY JOURNAL; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; SINGLE DRUG DOSE; VISUAL ANALOG SCALE;

ACUTE DISEASE; ADOLESCENT; ADULT; AGED; ALUMINUM HYDROXIDE; ANTACIDS; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; FAMOTIDINE; FEMALE; HEARTBURN; HISTAMINE H2 ANTAGONISTS; HUMANS; MAGNESIUM HYDROXIDE; MALE; MIDDLE AGED; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 34250710056     PISSN: 01920790     EISSN: None     Source Type: Journal    
DOI: 10.1097/MCG.0b013e31802e7efb     Document Type: Article

References (43)

1. Holtmann G, Maldonado-Lopez E, Haag S. Heartburn in primary care: problems below the surface. J Gastroenterol. 2004;39: 1027-1034.
2. Barlow WJ, Orlando RC. The pathogenesis of heartburn in nonerosive reflux disease: a unifying hypothesis. Gastroenterology. 2005;128:771-778.
3. Dickman R, Fass R. Functional heartburn. Curr Treat Options Gastroenterol. 2005;8:285-291.
4. Kennedy T, Jones R. The prevalence of gastro-oesophageal reflux symptoms in a UK population and the consultation behaviour of patients with these symptoms. Aliment Pharmacol Ther. 2000;14: 1589-1594.
5. Haque M, Wyeth JW, Stace NH, et al. Prevalence, severity and associated features of gastro-oesophageal reflux and dyspepsia: a population-based study. N Z Med J. 2000;113:178-181.
6. Jones R, Horbach S, Sander P, et al. Heartburn in patients with gastro-oesophageal reflux disease in Germany and Sweden: a study on patients' burden of disease. Pharmacoeconomics. 2003;21: 1091-1102.
7. Revicki DA, Wood M, Maton PN, et al. The impact of gastroesophageal reflux disease on health-related quality of life. Am J Med. 1998;104:252-258.
8. Dimenas E. Methodological aspects of evaluation of Quality of Life in upper gastrointestinal diseases. Scand J Gastroenterol Suppl. 1993;199:18-21.
9. DeVault KR, Castell DO. Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease. Am J Gastroenterol. 2005;100:190-200.
10. Inadomi JM, Fendrick AM. PPI use in the OTC era: who to treat, with what, and for how long? Clin Gastroenterol Hepatol. 2005;3: 208-215.
11. Hydrotalcite (altacite). Drug Ther Bull. 1975;13:71.
12. Mendelsohn D, Mendelsohn L. Hydrogen ion, pepsin and bile acid binding properties of hydrotalcite. S Afr Med J. 1975;49:1011-1014.
13. Watters KJ, Murphy GM, Tomkin GH, et al. An evaluation of the bile acid binding and antacid properties of hydrotalcite in hiatus hernia and peptic ulceration. Curr Med Res Opin. 1979;6:85-87.
14. Staß H. Hydrotalcite. Physicochemical characteristics of a layer-lattice antacid. Series title: Advances in Medicine. Munich: Urban & Vogel; 1988.
15. Dreyer M, Marwinski D, Wolf N, et al. Acidity profile in humans after multiple oral administration of hydrotalcite. Arzneimittelforschung. 1991;41:738-741.
16. Miederer S, Wirtz M, Fladung B. Acid neutralization and bile acid binding capacity of hydrotalcite compared with other antacids: an in vitro study. Chin J Digest Dis. 2003;4:140-146.
17. Decktor DL, Robinson M, Maton PN, et al. Effects of aluminum/ magnesium hydroxide and calcium carbonate on esophageal and gastric pH in subjects with heartburn. Am J Ther. 1995;2:546-552.
18. Holtermüller K, Liszkay M, Bernard I, et al. Therapy of benign gastric ulcer with low dose antacid hydrotalcite vs. ranitidine. Results of a double-blind, randomized multicenter trial. Z Gastroenterol. 1992;30:717-721.
19. Schmassmann A, Tarnawski A, Gerber HA, et al. Antacid provides better restoration of glandular structures within the gastric ulcer scar than omeprazole. Gut. 1994;35:896-904.
20. Tarnawski AS, Tomikawa M, Ohta M, et al. Antacid talcid activates in gastric mucosa genes encoding for EGF and its receptor. The molecular basis for its ulcer healing action. J Physiol Paris. 2000;94: 93-98.
21. Schwarz J, Wachenhausen H. Einbeziehung von Call-Centern in die Patientenrekrutierung bei klinischen Prüfungen. Pharm Ind. 2004;66:953-960.
22. Food and Drug Administration. FDA guidance for Industry: Guidelines for the clinical evaluation of gastric secretory depressant (GSD) drugs. USA: FDR CDER Rockville; 1997.
23. Simon TJ, Berlin RG, Gardner AH, et al. Self-Directed Treatment of Intermittent Heartburn: a randomized, multicenter, double-blind, placebo-controlled evaluation of antacid and low doses of an H(2)-receptor antagonist (famotidine). Am J Ther. 1995;2:304-313.
24. Pappa KA, Gooch WM, Buaron K, et al. Low-dose ranitidine for the relief of heartburn. Aliment Pharmacol Ther. 1999;13:459-465.
25. Paul K, Redman CM, Chen M. Effectiveness and safety of nizatidine, 75 mg, for the relief of episodic heartburn. Aliment Pharmacol Ther. 2001;15:1571-1577.
26. Max M, Portenoy R, Laska E. The design of analgesic clinical trials. New York: Raven Press; 1991.
27. Maton PN, Burton ME. Antacids revisited: a review of their clinical pharmacology and recommended therapeutic use. Drugs. 1999;57:855-870.
28. Decktor DL, Robinson M, Gottlieb S. Comparative Effects of Liquid Antacids on Esophageal and Gastric pH in Patients with Heartburn. Am J Ther. 1995;2:481-486.
29. Robinson M, Rodriguez-Stanley S, Miner PB, et al. Effects of antacid formulation on postprandial oesophageal acidity in patients with a history of episodic heartburn. Aliment Pharmacol Ther. 2002;16:435-443.
30. Laskin OL, Patterson PM, Shingo S, et al. Pharmacodynamics and dose-response relationship of famotidine: a double-blind randomized placebo-controlled trial. J Clin Pharmacol. 1993;33:636-639.
31. Feldman M. Comparison of the effects of over-the-counter famotidine and calcium carbonate antacid on postprandial gastric acid. A randomized controlled trial. JAMA. 1996;275:1428-1431.
32. Mann SG, Cottrell J, Murakami A, et al. Prevention of heartburn relapse by low-dose famotidine: a test meal model for duration of symptom control. Aliment Pharmacol Ther. 1997;11:121-127.
33. Robinson M, Rodriguez-Stanley S, Ciociola AA, et al. Synergy between low-dose ranitidine and antacid in decreasing gastric and oesophageal acidity and relieving meal-induced heartburn. Aliment Pharmacol Ther. 2001;15:1365-1374.
34. Weihrauch TR, Gauler TC. Placebo-efficacy and adverse effects in controlled clinical trials. Arzneimittelforschung. 1999;49:385-393.
35. Galmiche JP, Letessier E, Scarpignato C. Fortnightly review: treatment of gastro-oesophageal reflux disease in adults. BMJ. 1998;316:1720-1723.
36. Talley NJ, Lauritsen K. The potential role of acid suppression in functional dyspepsia: the BOND, OPERA, PILOT, and ENCORE studies. Gut. 2002;50(suppl 4):iv36-iv41.
37. Faaij RA, Van Gerven JM, Jolivet-Landreau I, et al. Onset of action during on-demand treatment with maalox suspension or low-dose ranitidine for heartburn. Aliment Pharmacol Ther. 1999;13: 1605-1610.
38. Houcke P, Maffioli C, Corallo J, et al. Comparison of the effects of Rocgel and anti-H2 on the symptomatology of gastroesophageal reflux without esophagitis. Ann Gastroenterol Hepatol (Paris). 1995;31:264-267.
39. Lanza FL, Smith V, Page-Castell JA, et al. Effectiveness of foaming antacid in relieving induced heartburn. South Med J. 1986;79: 327-330.
40. Weberg R, Berstad A. Symptomatic effect of a low-dose antacid regimen in reflux oesophagitis. Scand J Gastroenterol. 1989;24:401-406.
41. Graham DY, Patterson DJ. Double-blind comparison of liquid antacid and placebo in the treatment of symptomatic reflux esophagitis. Dig Dis Sci. 1983;28:559-563.
42. Koop H, Classen M, Liebe S, et al. Topic complex III: therapy of nonerosive reflux disease (NERD). Z Gastroenterol. 2005;43:176-179.
43. Zacny J, Zamakhshary M, Sketris I, et al. Systematic review: the efficacy of intermittent and on-demand therapy with histamine H2-receptor antagonists or proton pump inhibitors for gastro-oesophageal reflux disease patients. Aliment Pharmacol Ther. 2005;21: 1299-1312.