Efficacy of Helicobacter pylori eradication regimens in Rwanda: a randomized controlled trial.
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 regimen...
| Publicado en: | BMC Gastroenterology Vol. 18; no. 1 |
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| Autores principales: | , , , , , , , , , |
| Formato: | research randomized controlled trial Journal Article |
| Publicado: |
BioMed Central
8/30/2018
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=131509182&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 131509182 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 1471230X 1CHO jtl: BMC Gastroenterology issn: 1471230X maglogo: N pubinfo: dt: 8/30/2018 vid: 18 iid: 1 pid: 24147 pub: BioMed Central artinfo: ui: 131509182 131509182 NLM30165823 131509182 10.1186/s12876-018-0863-2 NLM30165823 131509182 ppct: 1 formats: tig: atl: Efficacy of Helicobacter pylori eradication regimens in Rwanda: a randomized controlled trial. aug: au: Kabakambira, Jean Damascene Hategeka, Celestin Page, Cameron Ntirenganya, Cyprien Dusabejambo, Vincent Ndoli, Jules Ngabonziza, Francois Hale, DeVon Bayingana, Claude Walker, Tim affil: Kigali University Teaching Hospital (CHUK), Kigali, Rwanda sug: subj: Helicobacter Pylori Drug Effects Antibiotics Therapeutic Use Helicobacter Infections Drug Therapy Human Male Amoxicillin Therapeutic Use Helicobacter Infections Microbiology Ciprofloxacin Adverse Effects Disease Eradication Doxycycline Therapeutic Use Metronidazole Therapeutic Use Ciprofloxacin Therapeutic Use Doxycycline Adverse Effects Treatment Failure Amoxicillin Adverse Effects Female Middle Age Drug Therapy, Combination Quality of Life Omeprazole Therapeutic Use Omeprazole Adverse Effects Metronidazole Adverse Effects Adult Clarithromycin Adverse Effects Clarithromycin Therapeutic Use Antibiotics Adverse Effects Rwanda Validation Studies Comparative Studies Evaluation Research Multicenter Studies Randomized Controlled Trials Scales Middle Aged: 45-64 years Adult: 19-44 years Male Female ab: 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. pubtype: Academic Journal doctype: research randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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