Ranitidine bismuth citrate with clarithromycin given twice daily effectively eradicates Helicobacter pylori and heals duodenal ulcers

• Published in: The American journal of gastroenterology Vol. 93; no. 3; pp. 380 - 385
• Main Authors: BARDHAN, K. D, WURZER, H, MARCELINO, M, JAHNSEN, J, LOTAY, N, ROBERTS, P. M
• Format: Journal Article
• Language: English
• Published: Oxford Blackwell Publishing 01.03.1998
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - adverse effects; Anti-Bacterial Agents - therapeutic use; Antibiotics; Antitrichomonal Agents - administration & dosage; Antitrichomonal Agents - adverse effects; Biological and medical sciences; Bismuth - administration & dosage; Bismuth - adverse effects; Bismuth - therapeutic use; Clarithromycin - administration & dosage; Clarithromycin - adverse effects; Clarithromycin - therapeutic use; Digestive system; Double-Blind Method; Drug Therapy, Combination; Duodenal Ulcer - drug therapy; Female; Helicobacter Infections - drug therapy; Helicobacter pylori; Histamine H2 Antagonists - administration & dosage; Histamine H2 Antagonists - adverse effects; Histamine H2 Antagonists - therapeutic use; Humans; Male; Medical sciences; Metronidazole - administration & dosage; Metronidazole - adverse effects; Middle Aged; Pharmacology. Drug treatments; Ranitidine - administration & dosage; Ranitidine - adverse effects; Ranitidine - analogs & derivatives; Ranitidine - therapeutic use; Treatment Outcome; Human; Evaluation; Bismuth compound; Clarithromycin; Duodenum; Controlled therapeutic trial; Antiulcer agent; Eradication; Antihistaminic; Macrolide; Antibiotic; Association; Ranitidine; Digestive diseases; Intestinal disease; Ulcer; Antagonist; Antibacterial agent; Effectiveness factor; H2 Histamine receptor
• ISSN: 0002-9270; 1572-0241
• DOI: 10.1111/j.1572-0241.1998.00380.x

Ranitidine bismuth citrate (RBC) b.i.d. with clarithromycin q.i.d. eradicates Helicobacter pylori (H. pylori) in 82-94% of patients, and heals duodenal ulcers in 88-90% of patients. This double blind, placebo-controlled study examines the efficacy of a simpler b.i.d. treatment regimen, and examines the potential benefit of including a second antibiotic, metronidazole, to the b.i.d. treatment regimen. A total of 648 patients with active duodenal ulcer received RBC 400 mg b.i.d. for 4 wk, coprescribed with clarithromycin 250 mg q.i.d., clarithromycin 500 mg b.i.d., or clarithromycin 500 mg b.i.d. with metronidazole 400 mg b.i.d. for the first 2 wk of treatment. Endoscopies were performed prestudy, after 4 wk of treatment, and at least 4 wk posttreatment. H. pylori status was assessed by CLOtest, 13C-urea breath test (UBT), and histology prestudy, and by UBT and histology at least 4 wk posttreatment. Adverse events were recorded at each visit. All three regimens were highly effective and well tolerated. H. pylori eradication rates were 84-94% and duodenal ulcer healing rates were 92-96% (observed data). Highest H. pylori eradication and ulcer healing rates were achieved with RBC 400 mg b.i.d. with clarithromycin 500 mg b.i.d. Ranitidine bismuth citrate with clarithromycin 500 mg b.i.d. provides an effective, simple and well tolerated regimen for the eradication of H. pylori and healing of duodenal ulcers.