Randomised clinical trial comparing sequential and concomitant therapies for<i>Helicobacter pylori</i>eradication in routine clinical practice

McNicholl, Adrián G.; Marín, Alicia C; Molina–Infante, Javier; Castro, Manuel; Barrio, Jesús; Ducóns, Julio; Calvet, Xavier; Coba, Cristóbal De la; Montoro, Miguel; Bory, Felipe; Pérez-Aísa, Ángeles; Forné, Montserrat

doi:10.1136/gutjnl-2013-304820

Cited by 115 publications

(83 citation statements)

References 29 publications

(30 reference statements)

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“…11 More recently, multiple trials of concomitant NBQT have confirmed an ITT eradication rate of 75-96.4% (per-protocol rates consistently superior to 80%) with a possible advantage for longer treatment duration (Table 3). 15,16,[21][22][23][24][25][26][27][28][29][30][31][32] The results of this randomized trial appear to confirm our earlier observation 13 that reduced-dose regimens (down to 50% posology) performs similarly to standard-dose regimens with the added benefit of reduced cost and adverse events. 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.…”

Section: Discussionsupporting

confidence: 80%

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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Section: Discussionsupporting

confidence: 80%

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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“…Several studies showed that both ST and QT were highly effective and no difference in the eradication rate [36,37]. In addition, this study showed that eradication rates of QT and ST therapies were similar, too.…”

Section: Discussionsupporting

confidence: 59%

Comparison of three different regimens against Helicobacter pylori as a first-line treatment: A randomized clinical trial

Kefeli

Başyiğit

Yeniova

et al. 2015

Bosn J of Basic Med Sci

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Treatments with bismuth-containing quadruple therapy (QT), sequential therapy (ST), or concomitant therapy (CT) have been proposed as empirical first-line regimens for Helicobacter pylori. We compared the efficacy and tolerability of 10 days bismuth-containing quadruple QT, 10 days ST, and 10 days CT with as first-line treatments for H. pylori in a randomized crossover study. The subjects were randomly divided into three groups. The first 130 patients were treated with rabeprazole, bismuth potassium citrate, metronidazole, and tetracycline for 10 days. The second 130 patients in the sequential group were treated with rabeprazole and amoxicillin for 5 days, and then rabeprazole, clarithromycin, and metronidazole for an additional 5 days. The last 130 patients in the concomitant group were treated with rabeprazole, amoxicillin, clarithromycin, and metronidazole for 10 days. H. pylori eradication was confirmed by urea breath test at 6 weeks. The primary outcome was eradication rates of first-line treatment by intention to treat and per protocol (PP) analyzes. There was no difference between the average ages and the male/female ratio of the groups. The PP analysis was performed on 121, 119, and 118 patients in the QT, ST, and CT groups, respectively. In the PP analysis, the successful eradication 94.2% (114/121), 95.0% (113/119), and 95.8% (113/118) the QT, ST, and CT groups, respectively. There was no significant difference among the three groups (p = 0.86). 10 days QT, ST, and CT are highly effective as empirical first-line therapies for H. pylori in the region with high clarithromycin resistance.

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“…In studies published in South Korea, the eradication rate for concomitant therapy was considerably higher than that for sequential therapy [100,101] . However, several other studies have reported no difference in eradication rates between sequential and the concomitant therapy [102][103][104] .…”

Section: Are There Suitable Sequential and Concomitant Therapy Alternmentioning

confidence: 93%

Antibiotic treatment forHelicobacter pylori: Is the end coming?

Kim

Choi

Chung

2015

WJGPT

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Infection with the Gram-negative pathogen Helicobacter pylori (H. pylori ) has been associated with gastroduodenal disease and the importance of H. pylori eradication is underscored by its designation as a group I carcinogen. The standard triple therapy consists of a proton pump inhibitor, amoxicillin and clarithromycin, although many other regimens are used, including quadruple, sequential and concomitant therapy regimens supplemented with metronidazole, clarithromycin and levofloxacin. Despite these efforts, current therapeutic regimens lack efficacy in eradication due to antibiotic resistance, drug compliance and antibiotic degradation by the acidic stomach environment. Core tip: This article reviews the recent literature describing antibiotic resistance and trends in Helicobacter pylori (H. pylori ) treatment. As there is no effective conventional therapy, new treatments are being developed and bismuth quadruple, sequential, concomitant therapies are recommended as a first-line regimen in regions with high levels of clarithromycin resistance. Quinolones have also been used for H. pylori treatment, although the cure rate has gradually reduced with this approach. New therapeutic directions include probiotic supplementation, tailored therapy, novel agents, and nanotechnology.

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Randomised clinical trial comparing sequential and concomitant therapies forHelicobacter pylorieradication in routine clinical practice

Abstract: Concomitant therapy led to a non-statistically significant advantage (5%) over sequential therapy, coming closer to 90% cure rates. Both therapies showed an acceptable safety profile. ClincialTrials.gov: NCT01273441.

Cited by 115 publications

References 29 publications

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

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

Comparison of three different regimens against Helicobacter pylori as a first-line treatment: A randomized clinical trial

Antibiotic treatment forHelicobacter pylori: Is the end coming?

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