Abstract
Purpose: Treatment failure for Helicobacter Pylori is due to antimicrobial resistance, and recrudescence. This study utilizes shorter regimen for better compliance and efficacy. Methods: 75 (N=75)-naïve dyspeptic patients underwent upper endoscopy with biopsies with positive DNA PCR H. pylori and stool H. pylori antigen. All were randomized into three arms: DeMAND Group (n=25): Oral Dexlansoprozole 60 mg, Moxifloxacin 400 mg, Amoxicillin 1 gram; Doxycycline 100 mg once, and Nitazoxanide 500 mg twice daily for four days; LOAD Group (n=25) oral: Levofloxacin 250 mg, Omeprazole 40 mg, and Doxycycline 100 mg once a day, with Alinia 500 mg twice daily for seven days; LAC Group (n=25) with traditional regimen of lansoprazole 15 mg, Amoxicillin I gram, Clarithromycin 500 mg twice daily for seven days. Exclusion: active bleeding, pregnancy, antimicrobial hypersensitivity, and use of antisecretory and antimicrobials within eight weeks. Results: 68 patients (90.7%) completed with seven (9%) total dropouts. Side events were minor rash, dizziness, diarrhea and palpitations. 30 days post-therapy stool antigen test of H. pylori was negative in 19/25 patients (76%-ITT analysis) in Group A, 22/25 (88%) in LOAD Group, and 18/25 (72%) in LAC Group, with no significant difference in eradication rate amongst all arms (χ2=2.1, p=0.36). Per-protocol analysis revealed no difference (χ2=2.4, p=0.30) in eradication rate amongst DeMAND (19/23=82.6%), LOAD (22/23=95%), LAC (18/22=81%). Conclusion: The 4-day DeMAND regimen is safe and as effective as the LOAD and LAC therapy for eradicating H. pylori, with shorter length and comparable cost benefits. Larger trial warrants validation.
Published Version
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