title: Rational Helicobacter pylori therapy: evidence-based medicine rather than medicine-based evidence.
abstract: Data are available such that choice of Helicobacter pylori therapy for an individual patient can be reliably predicted. Here, treatment success is defined as a cure rate of 90% or greater. Treatment outcome in a population or a patient can be calculated based on the effectiveness of a regimen for infections with susceptible and with resistant strains coupled with the knowledge of the prevalence of resistance (ie, based on formal measurement, clinical experience, or both). We provide the formula for predicting outcome and we illustrate the calculations. Because clarithromycin-containing triple therapy and 10-day sequential therapy are now only effective in special populations, they are considered obsolete; neither should continue to be used as empiric therapies (ie, 7- and 14-day triple therapies fail when clarithromycin resistance exceeds 5% and 15%, respectively, and 10-day sequential therapy fails when metronidazole resistance exceeds 20%). Therapy should be individualized based on prior history and whether the patient is in a high-risk group for resistance. The preferred choices for Western countries are 14-day concomitant therapy, 14-day bismuth quadruple therapy, and 14-day hybrid sequential-concomitant therapy. We also provide details regarding the successful use of fluoroquinolone-, rifabutin-, and furazolidone-containing therapies. Finally, we provide recommendations for the efficient development (ie, identification and optimization) of new regimens, as well as how to prevent or minimize failures. The trial-and-error approach for identifying and testing regimens frequently resulted in poor treatment success. The described approach allows outcome to be predicted and should simplify treatment and drug development.
authors.affiliation: Department of Medicine, Michael E. DeBakey VA Medical Center, and Baylor College of Medicine, Houston, Texas. Electronic address: dgraham@bcm.edu.
authors.forename: David Y
authors.initials: DY
authors.lastname: Graham
authors.affiliation: Department of Internal Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan.
authors.forename: Yi-Chia
authors.initials: YC
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan.
authors.forename: Ming-Shiang
authors.initials: MS
authors.lastname: Wu
mesh_terms: D000658:Amoxicillin / Q000008:administration & dosage; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D001729:Bismuth / Q000008:administration & dosage; D017291:Clarithromycin / Q000008:administration & dosage; D024881:Drug Resistance, Bacterial; D004359:Drug Therapy, Combination; D019317:Evidence-Based Medicine; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008795:Metronidazole / Q000008:administration & dosage; D017211:Treatment Failure
chemical_list: D000900:Anti-Bacterial Agents; D008795:Metronidazole; D000658:Amoxicillin; D017291:Clarithromycin; D001729:Bismuth
keywords: Amoxicillin; Bismuth; Clarithromycin; Concomitant Therapy; Evidence Based; Helicobacter pylori; ITT; MITT; Metronidazole; PP; PPI; Proton Pump Inhibitors; Quadruple Therapy; Review; Sequential Therapy; Tetracycline; Treatment; Treatment Success; intention to treat; modified intention to treat; per protocol; proton pump inhibitor