A randomized controlled trial comparing sequential with triple therapy for Helicobacter pylori in an Aboriginal community in the Canadian North

• Published in: Canadian journal of gastroenterology 2013-12, Vol.27 (12), p.701-706
• Main Authors: Morse, Amy L, Goodman, Karen J, Munday, Rachel, Chang, Hsiu-Ju, Morse, John Wi, Keelan, Monika, Geary, Janis, Sander, Veldhuyzen van Zanten
• Format: Article
• Language: English
• Subjects: Adult; Amoxicillin - administration & dosage; Anti-Bacterial Agents - administration & dosage; Bacterial infections; Breath Tests; Clarithromycin - administration & dosage; Clinical trials; Drug Resistance, Bacterial; Drug therapy; Drug Therapy, Combination; Female; Gastroenterology; Gram-negative bacteria; Helicobacter Infections - diagnosis; Helicobacter Infections - drug therapy; Helicobacter pylori; Humans; Inuits; Male; Medication Adherence; Metronidazole - administration & dosage; Middle Aged; Native North Americans; Northwest Territories; Original; Proton Pump Inhibitors - administration & dosage; Rabeprazole - administration & dosage
• ISSN: 0835-7900; 2291-2789; 1916-7237; 2291-2797
• DOI: 10.1155/2013/143047

Helicobacter pylori infection occurs more frequently in Arctic Aboriginal settings than elsewhere in North America and Europe. Research aimed at reducing health risks from H pylori infection has been conducted in the Aboriginal community of Aklavik, Northwest Territories. To compare the effectiveness of the Canadian standard therapy with an alternative therapy for eliminating H pylori infection in Aklavik. Treatment-naive H pylori-positive individuals were randomly assigned to a 10-day regimen (oral twice-daily doses) with rabeprazole (20 mg): standard triple therapy (proton pump inhibitor, added clarithromycin [500 mg] and amoxicillin [1 g] [PPI-CA]); sequential therapy (ST) added amoxicillin (1 g) on days 1 to 5, and metronidazole (500 mg) and clarithromycin (500 mg) on days 6 to 10. Participants with clarithromycin-resistant H pylori were randomly assigned to ST or quadruple therapy. Treatment effectiveness was estimated as per cent (95% CI) with a negative urea breath test at least 10 weeks after treatment. Of 104 (53 PPI-CA, 51 ST) randomized participants, 89 (49 PPI-CA, 40 ST) had post-treatment results. Per-protocol treatment effectiveness was 59% (95% CI 45% to 73%) for PPI-CA and 73% (95% CI 58% to 87%) for ST. Based on intention to treat, effectiveness was 55% (95% CI 41% to 69%) for PPI-CA and 57% (95% CI 43% to 71%) for ST. Of 77 participants (43 PPI-CA, 34 ST) with 100% adherence, effectiveness was 63% (95% CI 43% to 82%) for PPI-CA and 81% (95% CI 63% to 99%) for ST. While additional evidence is needed to confirm that ST is more effective for Arctic Aboriginal communities than the Canadian standard H pylori treatment, these results show standard PPI-CA treatment to be inadequate for communities such as Aklavik.