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Sequential therapy versus standard triple-drug therapy for Helicobacter pylori eradication: a randomized trial.

Abstract

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.

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  • Authors+Show Affiliations

    ,

    University of Bologna, Bologna, Italy. vairadin@med.unibo.it

    , , , , , , , ,

    Source

    Annals of internal medicine 146:8 2007 Apr 17 pg 556-63

    MeSH

    Adult
    Aged
    Anti-Bacterial Agents
    Anti-Ulcer Agents
    Double-Blind Method
    Drug Administration Schedule
    Drug Resistance, Bacterial
    Drug Therapy, Combination
    Dyspepsia
    Female
    Helicobacter Infections
    Helicobacter pylori
    Humans
    Male
    Middle Aged
    Peptic Ulcer
    Prospective Studies

    Pub Type(s)

    Journal Article
    Multicenter Study
    Randomized Controlled Trial

    Language

    eng

    PubMed ID

    17438314

    Citation

    Vaira, Dino, et al. "Sequential Therapy Versus Standard Triple-drug Therapy for Helicobacter Pylori Eradication: a Randomized Trial." Annals of Internal Medicine, vol. 146, no. 8, 2007, pp. 556-63.
    Vaira D, Zullo A, Vakil N, et al. Sequential therapy versus standard triple-drug therapy for Helicobacter pylori eradication: a randomized trial. Ann Intern Med. 2007;146(8):556-63.
    Vaira, D., Zullo, A., Vakil, N., Gatta, L., Ricci, C., Perna, F., ... Morini, S. (2007). Sequential therapy versus standard triple-drug therapy for Helicobacter pylori eradication: a randomized trial. Annals of Internal Medicine, 146(8), pp. 556-63.
    Vaira D, et al. Sequential Therapy Versus Standard Triple-drug Therapy for Helicobacter Pylori Eradication: a Randomized Trial. Ann Intern Med. 2007 Apr 17;146(8):556-63. PubMed PMID: 17438314.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Sequential therapy versus standard triple-drug therapy for Helicobacter pylori eradication: a randomized trial. AU - Vaira,Dino, AU - Zullo,Angelo, AU - Vakil,Nimish, AU - Gatta,Luigi, AU - Ricci,Chiara, AU - Perna,Federico, AU - Hassan,Cesare, AU - Bernabucci,Veronica, AU - Tampieri,Andrea, AU - Morini,Sergio, PY - 2007/4/18/pubmed PY - 2007/4/26/medline PY - 2007/4/18/entrez SP - 556 EP - 63 JF - Annals of internal medicine JO - Ann. Intern. Med. VL - 146 IS - 8 N2 - 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. SN - 1539-3704 UR - https://www.unboundmedicine.com/medline/citation/17438314/Sequential_therapy_versus_standard_triple_drug_therapy_for_Helicobacter_pylori_eradication:_a_randomized_trial_ L2 - https://www.annals.org/article.aspx?volume=146&issue=8&page=556 DB - PRIME DP - Unbound Medicine ER -