A randomized trial of standard-dose versus half-dose rabeprazole, clarithromycin, and amoxicillin in the treatment of Helicobacter pylori infection

Mansour, Nabil; Hashash, Jana G.; El-Halabi, Mustapha; Ghaith, Ola; Maasri, Karim; Sukkarieh, Ismail; Malli, Ahmad; Sharara, Ala I.

doi:10.1097/meg.0b013e3283496502

Cited by 11 publications

(16 citation statements)

References 27 publications

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Section: Triple Therapymentioning

confidence: 99%

“…Increasing efficacy by prolongation of therapy was also noted in Greek patients, with eradication rates of 74.5% for 7 days, 80.6% for 10 days, and 90.2% for 14 days of therapy [4]. Another study showed that efficacy could be maintained when lower doses of medications were given, which reduced costs and side effects with cure rates of 77.2% for 10 mg rabeprazole, 500 mg amoxicillin, and 250 mg clarithromycin vs 78.9% for the standard 20 mg, 1 g, and 500 mg doses of these drugs [5].Regardless of the type of therapy used, study from Canada showed widespread failure to comply with test and treat in up to 10% of cases and a failure to confirm eradication in 32% [6]. This illustrates that efficacious first-line therapy will always depend on adherence to guidelines by physicians and compliance with therapy by patients.…”

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Treatment of Helicobacter pylori infection 2012

et al. 2012

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Helicobacter pylori resistance rates to antibiotics vary in different countries and even in different regions of the same country. Choice of treatment is strongly dependent on antibiotic resistance rates. In some countries, triple therapy with a proton-pump inhibitor, amoxicillin, and clarithromycin is still the best option, but eradication results fall short of what would be desired (90-95%) in countries with clarithromycin resistance >20%, bismuth-containing quadruple therapy, or nonbismuth sequential or concomitant therapies may then be the preferred option. Newer antibiotic regimens are awaited. Vaccination would be the best option, especially for developing countries, but little progress has been made in designing a vaccine.A considerable amount of work has been conducted over the last year assessing many issues around Helicobacter pylori eradication therapy. These focussed primarily on assessing the efficacy of current standard triple therapy and exploring new first-line treatments. There was also progress in investigating antibiotic resistance rates, and the rescue therapies required to deal with ensuing treatment failures. There has also been an evolution in the use of adjunctive therapies. This article will address the published literature over the last year pertaining to these topics. Triple TherapyNumerous studies over the last year have assessed the efficacy of standard triple therapy with amoxicillin, clarithromycin, and a proton-pump inhibitor for the eradication of H. pylori, which have been perceived to be in decline in recent years. One such study looked at cure rates reported in all published literature from Spain between 1997 and 2008 and found that while cure rates have in fact been stable over that period, they remain inadequate with a mean cure rate of 80% by intention-to-treat and 83% by per-protocol [1]. Similar results were obtained from a multicenter study in Japan that revealed an eradication rate of 80.7% with an incidence of adverse drug reactions of 4.4% [2]. Other studies have looked at whether the efficacy of triple therapy can be improved by prolonging the course of therapy. In China, a study of shorter regimens showed eradication rates of 76, 89, and 91% for 3-day, 5-day, and 7-day regimens, respectively [3]. Increasing efficacy by prolongation of therapy was also noted in Greek patients, with eradication rates of 74.5% for 7 days, 80.6% for 10 days, and 90.2% for 14 days of therapy [4]. Another study showed that efficacy could be maintained when lower doses of medications were given, which reduced costs and side effects with cure rates of 77.2% for 10 mg rabeprazole, 500 mg amoxicillin, and 250 mg clarithromycin vs 78.9% for the standard 20 mg, 1 g, and 500 mg doses of these drugs [5].Regardless of the type of therapy used, study from Canada showed widespread failure to comply with test and treat in up to 10% of cases and a failure to confirm eradication in 32% [6]. This illustrates that efficacious first-line therapy will always depend on adherence to guidelines by phy...

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Section: Triple Therapymentioning

confidence: 99%

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confidence: 99%

Treatment of Helicobacter pylori infection 2012

et al. 2012

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“…To date, three randomized controlled trials, involving a total of 475 patients, have examined the value of 50% reduction in the dose of all administered antibiotics for H. pylori (two STT and the current concomitant NBQT) and have all confirmed similar eradication rates to the standard-dose comparator (Table 4), with a reduction in adverse events and cost. 13,33 This concept is attractive and challenges the prevailing dogma in the treatment of H. pylori. One theoretical concern, however, is that these low-dose regimens may produce prolonged sub-minimum inhibitory concentration effects which may, in turn, contribute to development of resistant strains.…”

Section: Discussionmentioning

confidence: 99%

“…The overall eradication rate was, however, suboptimal (77.6% with standard-dose therapy and 77.2% with half-dose triple therapy on ITT), signalling a 13.8% decline in eradication rate of the exact standard-dose regimen over a 6-year period within the same geographic area and institution. 13,14 Based on the reported superiority of NBQT and the promising concept of reduced-dose combination therapy, this study was designed to investigate the efficacy and safety of 7-day standard-dose vs. half-dose concomitant NBQT regimen for the eradication of H. pylori infection.…”

Section: Introductionmentioning

confidence: 99%

Challenging the dogma: a randomized trial of standard vs. half‐dose concomitant nonbismuth quadruple therapy for Helicobacter pylori infection

et al. 2014

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Background: Current treatment of Helicobacter pylori consists of three or four drugs for 7-14 days with important associated cost and adverse events. Aims: This study compared efficacy and safety of standard dose vs. half-dose concomitant nonbismuth quadruple therapy (NBQT) for 7 days. The standard dose consisted of twice daily rabeprazole 20 mg, amoxicillin 1 g, metronidazole 500 mg, and clarithromycin 500 mg. Methods: This was a prospective randomized trial.14 C-urea breath test was performed !4 weeks after treatment and !2 weeks off acid suppressive therapy. Compliance and adverse events were monitored during treatment. Results: A total of 200 consecutive treatment-naïve patients were enrolled. Baseline characteristics were similar between groups, with 15.5% of subjects reporting prior macrolide use. Eradication occurred in 78% (95% CI 68.6-85.7%) in both groups on intention-to-treat analysis. Per-protocol rates were 82.1 vs. 83.9% for standard-dose patients vs. half-dose patients, respectively (p ¼ NS). Adverse events (only mild) were reported in 57 vs. 41% of standard-dose patients vs. half-dose patients (p ¼ 0.024), with metallic taste and nausea notably less frequent in the latter (36 vs. 12% and 18 vs. 7%, respectively; p < 0.05 for both). Overall, eradication failed in 38.7% of prior macrolide users vs. 18.9% without such exposure (p ¼ 0.019). On multivariate logistic regression, prior macrolide exposure was the only factor associated with failed eradication (OR 2.60, 95% CI 1.06-6.39; p ¼ 0.038). Treatment was cheaper with the half-dose regimen. Interpretation: A 50% reduction in antibiotic dosage does not diminish efficacy of concomitant nonbismuth quadruple therapy but leads to significant reduction in cost and adverse events. Seven-day concomitant NBQT is suboptimal for H. pylori independent of prior macrolide exposure.

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“…elicobacter pylori is a significant cause of chronic active gastritis, peptic ulcer disease, and gastric cancer (1). Several strategies have been proposed for eradication of H. pylori, including the standard first-line treatment (standard triple therapy [STT]) and quadruple, sequential, and concomitant treatments (2).…”

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Efficacy and Pharmacological Mechanism of Pronase-Enhanced Low-Dose Antibiotics for Helicobacter pylori Eradication

Liu

et al. 2014

Antimicrob Agents Chemother

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bThis study examined the efficacy and pharmacological mechanism of pronase-assisted low-dose antibiotics for eradication of Helicobacter pylori. Mongolian gerbils infected with H. pylori received 7-day treatment (omeprazole, different concentrations of pronase, amoxicillin, and clarithromycin), and the efficacy was assessed using the eradication rate and the colonization of H. pylori. In Mongolian gerbils orally administered pronase, the thickness of the gastric mucous layer (GML) was examined using immunohistochemical and alcian blue staining, and the concentrations of amoxicillin in gastric tissue and serum were detected using high-performance liquid chromatography (HPLC). The eradication rates were 80.0% (12/15) in the high-pronase quadruple group (HPQG) and 86.7% (13/15) in the high-antibiotic group (HAG) (P ‫؍‬ 1.000). The antibiotic dose in the HPQG was only 1/20 that in the HAG. Thirty minutes after oral treatment with pronase, the sticky protein of the GML was hydrolyzed, and the GML became thinner. Higher amoxicillin concentrations in both the gastric tissue and serum were observed in the pronase group than in the Am10 group. The concentration of amoxicillin in the Am10-plus-Pr108 group in gastric tissue was 3.8 times higher than in the Am10 group in 5 min. Together, these data suggest that pronase significantly reduced the dose of antibiotics used in H. pylori eradication. The pharmacological mechanism is likely pronase removal of the mucus layer, promoting chemical factor (i.e., gastric acid and pepsinogen) distribution and increasing the antibiotic concentrations in the deep GML, which acted on H. pylori collectively. Thus, pronase may enhance the level of antibiotics for eradication of H. pylori in the clinic.

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A randomized trial of standard-dose versus half-dose rabeprazole, clarithromycin, and amoxicillin in the treatment of Helicobacter pylori infection

Cited by 11 publications

References 27 publications

Treatment of Helicobacter pylori infection 2012

Treatment of Helicobacter pylori infection 2012

Challenging the dogma: a randomized trial of standard vs. half‐dose concomitant nonbismuth quadruple therapy for Helicobacter pylori infection

Efficacy and Pharmacological Mechanism of Pronase-Enhanced Low-Dose Antibiotics for Helicobacter pylori Eradication

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