Sequential therapy versus standard triple-drug therapy for Helicobacter pylori eradication: a randomized trial.
Background: Antimicrobial resistance has decreased eradication rates for Helicobacter pylori infection worldwide.Objective: To determine whether sequential treatment eradicates H. pylori infection better than standard triple-drug therapy for adults with dyspepsia or peptic ulcers.Design: Randomized,...
| Publicado en: | Annals of Internal Medicine Vol. 146; no. 8; pp. 556 - 564 |
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| Autores principales: | , , , , , , , , , , , , , , , , , , , |
| Formato: | clinical trial consumer/patient teaching materials research tables/charts Journal Article |
| Publicado: |
American College of Physicians
4/17/2007
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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=106301940&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 106301940 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00034819 AIM jtl: Annals of Internal Medicine issn: 00034819 maglogo: N pubinfo: dt: 4/17/2007 vid: 146 iid: 8 pid: 1652 pub: American College of Physicians place: Philadelphia, Pennsylvania artinfo: ui: 106301940 106301940 NLM17438314 2009563573 10.7326/0003-4819-146-8-200704170-00006 NLM17438314 106301940 ppf: 556 ppct: 8 formats: tig: atl: Sequential therapy versus standard triple-drug therapy for Helicobacter pylori eradication: a randomized trial. aug: au: Vaira D Zullo A Vakil N Gatta L Ricci C Perna F Hassan C Bernabucci V Tampieri A Morini S Vaira, Dino Zullo, Angelo Vakil, Nimish Gatta, Luigi Ricci, Chiara Perna, Federico Hassan, Cesare Bernabucci, Veronica Tampieri, Andrea Morini, Sergio affil: University of Bologna, Bologna, Italy sug: subj: Antibiotics Administration and Dosage Dyspepsia Drug Therapy Helicobacter Infections Drug Therapy Peptic Ulcer Drug Therapy Proton Pump Inhibitors Administration and Dosage Adult Aged Chi Square Test Clinical Trials Confidence Intervals Data Analysis Software Double-Blind Studies Drug Administration Schedule Drug Resistance, Microbial Drug Therapy, Combination Dyspepsia Microbiology Female Fisher's Exact Test Funding Source Male Middle Age Patient Education Peptic Ulcer Microbiology Sample Size Human Adult: 19-44 years Aged: 65+ years Middle Aged: 45-64 years Female Male ab: Background: Antimicrobial resistance has decreased eradication rates for Helicobacter pylori infection worldwide.Objective: To determine whether sequential treatment eradicates H. pylori infection better than standard triple-drug therapy for adults with dyspepsia or peptic ulcers.Design: Randomized, double-blind, placebo-controlled trial.Setting: Two Italian hospitals between September 2003 and April 2006.Patients: 300 patients with dyspepsia or peptic ulcers.Measurements: (13)C-urea breath test, upper endoscopy, histologic evaluation, rapid urease test, bacterial culture, and assessment of antibiotic resistance.Intervention: A 10-day sequential regimen (40 mg of pantoprazole, 1 g of amoxicillin, and placebo, each administered twice daily for the first 5 days, followed by 40 mg of pantoprazole, 500 mg of clarithromycin, and 500 mg of tinidazole, each administered twice daily for the remaining 5 days) or standard 10-day therapy (40 mg of pantoprazole, 500 mg of clarithromycin, and 1 g of amoxicillin, each administered twice daily).Results: The eradication rate achieved with the sequential regimen was significantly greater than that obtained with the standard treatment in the intention-to-treat analysis (89% vs. 77%; P = 0.0134; difference, 12% [95% CI, 3% to 20%]), the modified intention-to-treat analysis (91% vs. 78%; P = 0.0022; difference, 13% [CI, 5% to 21%]), and the per-protocol analysis (93% vs. 79%; P = 0.0013; difference, 14% [CI, 6% to 21%]). Sequential therapy was significantly more effective in patients with clarithromycin-resistant strains (89% vs. 29%; P = 0.0034). The incidence of major and minor side effects did not differ between therapy groups (17% in both groups). One patient (0.7%) in the standard therapy group discontinued treatment because of side effects.Limitations: Follow-up was incomplete in 4.6% and 2.7% patients in the sequential therapy and standard therapy groups, respectively. The results may not be generalizable to other countries. Sequential therapy may be more effective because it includes 1 additional antibiotic (tinidazole) that is not contained in standard therapy.Conclusions: Sequential therapy is statistically significant compared with standard therapy for eradicating H. pylori infection and is statistically significantly more effective in patients with clarithromycin-resistant strains. Side effects are similar with both treatment regimens and are rarely severe enough to cause discontinuation of therapy. ClinicalTrials.gov registration number: NCT00403364. pubtype: Academic Journal doctype: clinical trial consumer/patient teaching materials research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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