Original article
Pretreatment antimicrobial susceptibility testing is cost saving in the eradication of Helicobacter pylori

https://doi.org/10.1016/S1542-3565(03)00131-9Get rights and content

Abstract

Background & Aims:

The major obstacle to 100% effective eradication of Helicobacter pylori infection is represented by antimicrobial-resistant H. pylori strains. This randomized study was designed to evaluate whether regimens based on pretreatment susceptibility testing were more effective and cost saving compared with standard nonsusceptibility testing-based therapy in the eradication of H. pylori infection.

Methods:

We studied 150 consecutive H. pylori-infected dyspeptic subjects. Patients were randomly assigned to omeprazole 20 mg twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 7 days or to omeprazole 20 mg twice daily and 2 antimicrobials chosen based on susceptibility testing. H. pylori status was reevaluated 12 weeks after the end of treatment by the 13C-urea breath test.

Results:

Susceptibility testing-based regimens led to the following results. (1) Eradication rates were 97.3% (95% confidence interval [CI], 91.2%–99.5%) (71 of 73) and 94.6% (95% CI, 87.6%–98.3%) (71 of 75) in the per-protocol and intention-to-treat analysis, respectively. These were significantly higher (P < 0.005) than eradication rates obtained without susceptibility testing, that is, 79.4% (95% CI, 69.1%–87.6%) (58 of 73) and 77.3% (95% CI, 66.9%–85.7%) (58 of 75) in the per-protocol and intention-to-treat analyses, respectively. (2) There were savings of approximately $5 U.S. per patient compared with standard triple therapy.

Conclusions:

Pretreatment antimicrobial susceptibility testing is more effective and cost saving and, in health systems that confirm cost advantage, microbial susceptibility testing should be routinely used for eradication of H. pylori infection.

Section snippets

Patients and study protocol

We studied 150 consecutive H. pylori-infected patients with dyspeptic symptoms and without previous H. pylori eradication treatment. These patients were referred to our endoscopy unit from general practitioners because of a positive serology and/or 13C-urea breath test for H. pylori. Patients were randomized according to a predetermined randomization schedule to receive standard triple therapy or susceptibility testing-based therapy. Patients were randomly assigned with equal allocation to the

Results

A total of 150 patients were enrolled into the randomized parallel-group study, with 75 patients in the susceptibility test group and 75 patients in the standard triple therapy group. Two patients in each group discontinued therapy because of side effects (diarrhea, nausea, and vomiting) and were therefore excluded from analysis. The rate of culture and testing for resistance was 72 of 75 (96%). A second endoscopy was performed in 3 patients, and the success rate for culture and testing was 3

Discussion

H. pylori infection is a chronic, transmissible infectious disease that causes gastritis and peptic ulcer and is implicated in the development of carcinoma of the distal stomach.13, 14 Successful therapy requires a combination of drugs that prevents the emergence of resistance and reaches the bacteria within its various niches. The ideal eradication regimen would be one that is simple (e.g., few medications and short duration) and essentially 100% effective. Regimens that have been proven

Acknowledgements

The authors thank Mr. A. Piccolo (endoscopy nurse) for assistance.

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Supported in part by grants from Ministero per la Istruzione, Università e Ricerca, Consiglio Nazionale delle Ricerche, and C.I.R.A.N.A.D., Seconda Università di Napoli.

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