A Randomized Clinical Trial to Determine the Efficacy of Regimens Containing Clarithromycin, Metronidazole, and Amoxicillin Among Histologic Subgroups for Helicobacter pylori Eradication in a Developing Country

• Published in: Helicobacter (Cambridge, Mass.) Mass.), 2009-04, Vol.14 (2), p.100-108
• Main Authors: Fischbach, Lori Ann, Bravo, Luis Eduardo, Zarama, Guillermo Rosero, Bravo, Juan Carlos, Ojha, Priyadarshi Rohit, Priest, Elisa Lynne, Collazos, Tito, Casabon, Lucy Alba, Guerrero, Lorena Zambrano, Singh, P. Karan, Correa, Pelayo
• Format: Article
• Language: English
• Subjects: Adult; Aged; amoxicillin; Amoxicillin - administration & dosage; Amoxicillin - adverse effects; Anti-Bacterial Agents - administration & dosage; clarithromycin; Clarithromycin - administration & dosage; Clarithromycin - adverse effects; Clinical trial; Cohort Studies; Colombia; Developing Countries; Drug Therapy, Combination; Female; Gastritis, Atrophic - drug therapy; Gastritis, Atrophic - pathology; Helicobacter Infections - drug therapy; Helicobacter Infections - pathology; Helicobacter pylori; Helicobacter pylori - drug effects; Helicobacter pylori eradication; Humans; Male; metronidazole; Metronidazole - administration & dosage; Metronidazole - adverse effects; Middle Aged; proton pump inhibitor; Single-Blind Method; South America; Treatment Outcome
• ISSN: 1083-4389; 1523-5378
• DOI: 10.1111/j.1523-5378.2009.00667.x

Background: Most treatments deemed effective for Helicobacter pylori eradication in developed countries are less effective in developing countries. Regimens containing clarithromycin, metronidazole, and amoxicillin seem efficacious despite antibiotic resistance, and may be a viable option in developing countries. Materials and Methods:  We evaluated the efficacy of a 14‐day regimen with 500 mg clarithromycin b.i.d., 500 mg metronidazole t.i.d., and 500 mg amoxicillin t.i.d. (with and without a proton pump inhibitor), and a 10‐day regimen containing 500 mg clarithromycin b.i.d., 1 g amoxicillin b.i.d., and 20 mg omeprazole b.i.d. in Pasto, Colombia, using a randomized, single‐blind design stratified by presence of atrophic gastritis. Results: H. pylori was eradicated in 86.8% and 85.3% of the participants randomized to a clarithromycin‐metronidazole‐amoxicillin and clarithromycin‐amoxicillin‐omeprazole regimens, respectively (p = .79). Per‐protocol analyses indicated greater efficacy for the clarithromycin‐metronidazole‐amoxicillin regimen (97%) versus the clarithromycin‐amoxicillin‐omeprazole regimen (86%) (p = .04), particularly for participants with atrophic gastritis (clarithromycin‐metronidazole‐amoxicillin = 100%, clarithromycin‐amoxicillin‐omeprazole = 81%; p = .02). Adverse events were mild, but adverse event‐related non‐compliance was reported more often for regimens containing clarithromycin, metronidazole, and amoxicillin. Conclusions: Our results suggest that an eradication rate of > 85% can be achieved with 14‐day clarithromycin, metronidazole, and amoxicillin and 10‐day clarithromycin, amoxicillin, and omeprazole regimens in Pasto, Colombia. The regimens containing clarithromycin, metronidazole, and amoxicillin appear to be superior to the clarithromycin, amoxicillin, and omeprazole regimen for compliant participants and those with atrophic gastritis. Our findings provide treatment options for a population in a developing country with a high prevalence of H. pylori infections and antibiotic resistance.