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      Efficacy of Helicobacter pylori eradication regimens in Rwanda: a randomized controlled trial

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          Abstract

          Background

          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, 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 .

          Methods

          This 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.

          Results

          The 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.

          Conclusion

          Clarithromycin 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 registration

          The clinical trial was retrospectively registered ( PACTR201804003257400) with the Pan African Clinical Trial Registry database, on April 6th, 2018 in South Africa.

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          Most cited references25

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          Helicobacter pylori eradication therapy for functional dyspepsia: Systematic review and meta-analysis.

          To evaluate whether Helicobacter pylori (H. pylori) eradication therapy benefits patients with functional dyspepsia (FD).
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            Quality of life in functional dyspepsia: responsiveness of the Nepean Dyspepsia Index and development of a new 10-item short form.

            The Nepean Dyspepsia Index is a reliable and valid measure of quality of life in functional dyspepsia, but responsiveness has been little studied. The Nepean Dyspepsia Index originally contained 42 items designed to measure impairment of a subject's ability to engage in relevant aspects of their life because of dyspepsia, and their enjoyment of these aspects; in addition, the individual importance of areas was assessed. It was subsequently shortened to 25 items, yielding five sub-scales. To test the Nepean Dyspepsia Index's responsiveness and develop a responsive, very short form. A randomized, double-blind controlled trial was performed in 589 patients with documented functional dyspepsia. Symptoms and quality of life were measured at baseline, 2 and 4 weeks. Responsiveness of the Nepean Dyspepsia Index quality-of-life section was evaluated by correlation with symptom scores and calculation of standardized changes in scores. Two items from each sub-scale which best represented the area of life (by factor loadings) were selected to create the 10-item short form (SF; short form-Nepean Dyspepsia Index). Internal consistency was assessed by Cronbach's alpha and responsiveness was assessed as above. The Nepean Dyspepsia Index quality-of-life scales demonstrated excellent responsiveness to change in both the active and placebo arms (standardized response means all > 1.0). The Nepean Dyspepsia Index accounted for only 8% of the variance in percentage change in symptoms (by visual analogue scales), indicating that it was evaluating areas of life not covered by symptoms. The 10-item short form had adequate internal consistency (all scales > or = 0.70) and all strongly (and significantly) correlated with the long form sub-scales; it was also highly responsive. The Nepean Dyspepsia Index is a responsive disease-specific quality-of-life measure; the 10-item short form can be applied in clinical trials of functional dyspepsia.
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              Meta-analysis: the efficacy, adverse events, and adherence related to first-line anti-Helicobacter pylori quadruple therapies.

              Owing to rising drug-resistant Helicobacter pylori infections, currently recommended proton-pump inhibitor-based triple therapies are losing their efficacy, and regimens efficacious in the presence of drug resistance are needed. To summarize the efficacy, safety and adherence of first-line quadruple H. pylori therapies in adults. Meta-regression models identified factors explaining variation in the efficacy of first-line quadruple therapies from 145 treatment arms. Estimates of average efficacy were calculated within homogeneous groups. Quadruple therapy containing a gastric acid inhibitor, bismuth, metronidazole and tetracycline was enhanced when omeprazole was included, treatment duration lasted 10-14 days, and when therapy took place in the Netherlands, Hong Kong and Australia. Treatment efficacy decreased as the prevalence of metronidazole resistance increased. Even in areas with a high prevalence of metronidazole resistance, this quadruple regimen eradicated more than 85% of H. pylori infections when it contained omeprazole and was given for 10-14 days. Furthermore, in the presence of clarithromycin resistance, this quadruple regimen eradicated 90-100% of H. pylori infections, while the currently recommended triple therapy containing clarithromycin, amoxicillin and a proton-pump inhibitor eradicated only 25-61% (P < 0.001). Adherence and adverse events for quadruple therapy were similar to currently recommended triple therapies. Guidelines should include quadruple therapy with a proton-pump inhibitor, a bismuth compound, metronidazole and tetracycline among recommended first-line anti-H. pylori therapies.
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                Author and article information

                Contributors
                damaskabakambira@gmail.com
                celestin.hategeka@gmail.com
                cameron.page@gmail.com
                cyprien.dr@gmail.com
                drdusabevincent1@gmail.com
                jndoli1971@gmail.com
                Fngabo2001@yahoo.fr
                devonchale@gmail.com
                cbayrw2000@yahoo.fr
                timwalkerd@gmail.com
                Journal
                BMC Gastroenterol
                BMC Gastroenterol
                BMC Gastroenterology
                BioMed Central (London )
                1471-230X
                30 August 2018
                30 August 2018
                2018
                : 18
                : 134
                Affiliations
                [1 ]ISNI 0000 0004 0647 8603, GRID grid.418074.e, Kigali University Teaching Hospital (CHUK), ; Kigali, Rwanda
                [2 ]ISNI 0000 0001 2288 9830, GRID grid.17091.3e, Centre for Health Services and Policy Research, School of Population and Public Health, Faculty of Medicine, , University of British Columbia, ; Vancouver, BC Canada
                [3 ]ISNI 0000 0001 2288 9830, GRID grid.17091.3e, Collaboration for Outcomes Research and Evaluation, Faculty of Pharmaceutical Sciences, , University of British Columbia, ; Vancouver, BC Canada
                [4 ]Department of Medicine, University Hospital of Brooklyn, New York, USA
                [5 ]Butare University Teaching Hospital (CHUB), Huye, Rwanda
                [6 ]ISNI 0000 0001 2193 0096, GRID grid.223827.e, Department of Medicine, , University of Utah School of Medicine, ; Salt Lake City, UT USA
                [7 ]ISNI 0000 0000 8831 109X, GRID grid.266842.c, School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, ; Newcastle, Australia
                Author information
                http://orcid.org/0000-0003-2697-3081
                Article
                863
                10.1186/s12876-018-0863-2
                6117961
                30165823
                ba0e28f4-cf2a-40ae-b5ac-504573009caa
                © The Author(s). 2018

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 12 July 2018
                : 20 August 2018
                Funding
                Funded by: Butare University Teaching Hospital
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2018

                Gastroenterology & Hepatology
                h. pylori eradication,dyspepsia,clinical trial,rwanda
                Gastroenterology & Hepatology
                h. pylori eradication, dyspepsia, clinical trial, rwanda

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