Abstract
BackgroundSuccessful H. pylori treatment requires the knowledge of local antimicrobial resistance. Data on the efficacy of H. pylori eradication regimens available in sub-Saharan Africa are scant, hence the optimal treatment is unknown.Our goals were to determine the efficacy of available regimens in Rwanda as well as evaluate the effect of treatment on health-related quality of life (HRQoL) in patients undergoing esophagogastroduodenoscopy.MethodsThis is a randomized controlled trial conducted from November 2015 to October 2016 at a tertiary hospital in Rwanda. Enrollees were 299 patients (35% male, age 42 ± 16 years (mean ± SD)) who had a positive modified rapid urease test on endoscopic biopsies. After a fecal antigen test (FAT) and HRQoL assessment by the Short Form Nepean Dyspepsia Index (SF-NDI) questionnaire, patients were randomized 1:1:1:1 to either a triple therapy combining omeprazole, amoxicillin and one of clarithromycin/ciprofloxacin/metronidazole or a quadruple therapy combining omeprazole, amoxicillin, ciprofloxacin and doxycycline. All therapies were given for a duration of 10 days. The outcome measures were the persistence of positive FAT (treatment failure) 4 to 6 weeks after treatment and change in HRQoL scores.ResultsThe treatment success rate was 80% in the total population and 78% in patients with a history of prior triple therapy. Significant improvement in HRQoL in the total group (HRQoL mean scores before and after treatment respectively: 76 ± 11 and 32 ± 11, p < 0.001) and the group with functional dyspepsia (HRQoL mean scores before and after treatment respectively: 73 ± 11 and 30 ± 9, P < 0.001) was observed across all treatment groups.Using clarithromycin based triple therapy (standard of care) as a reference, the group treated with metronidazole had worse HRQoL (p = 0.012) and had a trend towards worse treatment outcome (p = 0.086) compared to the ciprofloxacin based combination therapies.ConclusionClarithromycin and ciprofloxacin based combination therapies are effective and safe to use alternatively for H. pylori eradication and improve HRQoL. Among the regimens studied, metronidazole based triple therapy is likely to be clinically inferior.Trial registrationThe clinical trial was retrospectively registered (PACTR201804003257400) with the Pan African Clinical Trial Registry database, on April 6th, 2018 in South Africa.
Highlights
Successful H. pylori treatment requires the knowledge of local antimicrobial resistance
The current study examines the efficacy of ciprofloxacin and metronidazole based H. pylori eradication therapies compared with clarithromycin based triple therapy, and the observed impact on health-related quality of life (HRQoL), among patients referred for endoscopy
Previous medication use was very common among the study population: 77% had used Proton Pump Inhibitors (PPI) or histamine (H2) receptor antagonists, 17% had taken triple therapy before and 14% reported using antibiotics for other illnesses
Summary
Successful H. pylori treatment requires the knowledge of local antimicrobial resistance. Data on the efficacy of H. pylori eradication regimens available in sub-Saharan Africa are scant, the optimal treatment is unknown. For successful eradication policies in any country, there is need for accurate diagnostic tests and treatment tailored to local antibiotic resistance patterns. The choice of a diagnostic test is influenced by the pretest probability of infection, cost, availability, population prevalence of infection and factors such as the previous use of proton pump inhibitors (PPIs) and antibiotics that may alter test results. The urea breath test which is the best option to document eradication is not available in most resource limited countries. No laboratory in Rwanda cultures H. pylori reliably at present, and resistance testing is not available
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