Helicobacter pylori eradication with a capsule containing bismuth subcitrate potassium, metronidazole, and tetracycline given with omeprazole versus clarithromycin-based triple therapy: a randomised, open-label, non-inferiority, phase 3 trial

Malfertheiner, Peter; Bazzoli, Franco; Delchier, Jean‐Charles; Celiński, Krzysztof; Giguere, Monique; Rivière, Marc; Mégraud, Françis

doi:10.1016/s0140-6736(11)60020-2

Cited by 467 publications

(386 citation statements)

References 37 publications

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“…This finding is in line with the results of previous important studies [8,20], and is a valid alternative to standard 14-day PPI-clarithromycin-based triple treatment or 10-day sequential therapy or 10-day concomitant therapy [13].…”

Section: Discussionsupporting

confidence: 91%

“…Of note, clarithromycin resistance is J Gastrointestin Liver Dis, June 2017 Vol. 26 No 2: 129-137 rapidly increasing worldwide [6] and this trend undermines the efficacy of the standard first-line triple (proton pump inhibitor -PPI, amoxicillin, clarithromycin) therapy, yielding a low eradication rate (<80%) [7][8][9]. Other first-line regimens included the "sequential" (PPI, amoxicillin followed by clarithromicin and tinidazole) therapy [9][10][11].…”

Section: Introductionmentioning

confidence: 99%

“…when first-line therapy fails) therapeutic approaches contain PPI plus amoxicillin plus levofloxacin [12]. More recently, a combination of tetracycline hydrochloride, metronidazole, and bismuth subcitrate potassium (Pylera®) has been developed as either the first-and second-line regimen [5,8,13]. Pylera entered the Italian market in March 2016.…”

Section: Introductionmentioning

confidence: 99%

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Eradication Rates in Italian Subjects Heterogeneously Managed for Helicobacter pylori Infection. Time to Abandon Empiric Treatments in Southern Europe

Ciaula

Scaccianoce

Venerito

et al. 2017

JGLD

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Background & Aims: H. pylori eradication is strongly affected by various factors, including the ongoing antibiotic resistance. We describe a “real life” scenario in patients managed for H. pylori-related conditions, living in a southern Italian region (Apulia), an area with clarithromycin resistance >15%.Methods: 2,224 subjects were studied in two tertiary referral centers in Apulia. Analyses included: reason for referral, H. pylori infection rates (13C-urea breath test – UBT or upper endoscopy), and eradication rates following distinct regimens previously prescribed or prospectively prescribed (such as the bismuth-based quadruple therapy Pylera®, recently marketed in Italy).Results. Over 80% of the patients were referred by family physicians (60% naïve subjects). The overall infection rate was 32.5% and it was similar in asymptomatic patients (31.1%) or with H. pylori-related symptoms/clinical conditions (34.3%). In the 987 H. pylori+ve patients receiving therapy, the overall eradication rate was 80.2% (ITT). Observed eradication rate varied greatly across different regimens: 57.1% (2nd line levofloxacin), 59.6% (unconventional), 70.7% (7-day triple), 73.2% (7-day undefined), 89% (10-day sequential) and 96.9% (ITT, 10 day Pylera®, 1st to 5th line regimens given to 227 patients).Conclusions. A heterogeneous “real life” scenario in Southern Europe shows that H. pylori+ve patients are put at risk of poor outcomes and points to the need of a susceptibility-based therapy according to guidelines and local microbial resistance. In the present setting (i.e. high clarithromycin resistance), despite the high observed eradication rate, sequential therapy should not be recommended (absent in guidelines, unneeded antibiotic). Bismuth-based quadruple treatment (1st, 2nd or subsequent lines) yields the highest eradication rates.Abbreviations: ALT: Altamura; BA: Bari; EGDS: esophagogastroduodenoscopy; GERD: gastro-esophageal reflux disease; H. pylori: Helicobacter pylori; ITT: intention-to-treat; PP: per-protocol; PPI: proton pump inhibitor; UBT: urea breath test.

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Section: Discussionsupporting

confidence: 91%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Eradication Rates in Italian Subjects Heterogeneously Managed for Helicobacter pylori Infection. Time to Abandon Empiric Treatments in Southern Europe

Ciaula

Scaccianoce

Venerito

et al. 2017

JGLD

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“…Several studies were conducted to evaluate the most effective therapeutic regimen for improving the eradication rate of H. pylori infection and obtaining higher healing efficacy [17][18][19][20][21]. This study is another attempt in this respect, though at a smaller scale, which might be (at least to best knowledge) the first attempt to evaluate the efficacy of curcumin as an adjuvant to the standard triple H. pylori eradication therapy.…”

Section: Discussionmentioning

confidence: 99%

Potential Benefit of Curcumin Adjuvant Therapy to the Standard H. Pylori Eradication Therapy in Patients With Peptic Ulcer Disease

Abdulridha¹,

Abbas

Najeb

2017

Asian J Pharm Clin Res

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Objective: This study was designed to explore the benefit of curcumin as adjuvant therapy to the standard Helicobacter pylori eradication triple therapy in both duodenal and gastric ulcers patients.Methods: The present study enrolled 40 patients newly diagnosed endoscopically with peptic ulcer disease to be allocated into group 1 treated with standard H. pylori eradication triple therapy, and group 2 patients treated with curcumin (500 mg) capsules three times daily for 14 days as an adjuvant to standard triple therapy. Stool antigen test, immunoglobulin M serology test, tumor necrosis factor-alpha (TNF-α), interleukin 1 beta (IL-1β), and total antioxidant capacity (T-AOC) are measured at the baseline and after 6 weeks of treatment. Results:The result showed that the use of curcumin as adjuvant therapy produced highly significant improvement in healing efficacy which was significantly distinguished in duodenal ulcer patients compared to gastric ulcer groups 2 patients (p<0.05), along with a highly significant reduction in pro-inflammatory IL-1β level in group 2 patients (p<0.01). After 6 weeks of treatment, there was a highly significant elevation in the level of TNF-α in groups 1 (p<0.01), though group 2 patients presented with non-significant elevation in TNF-α level. Moreover, the T-AOC was improved with curcumin adjuvant therapy, though non-significant, compared to group 1 patients who showed a reduction in T-AOC. Conclusion:This study revealed that addition of curcumin as adjuvant therapy produced improvement in ulcer healing efficacy, and controlled the inflammatory and oxidative stress process induced by H. pylori infection.

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“…Eradication rates were 55% for the triple scheme and 80% for the quadruple scheme (P<0.0001). It is noteworthy that 70% of the strains were resistant to metronidazole and 20% to clarithromycin (131) . Recent meta-analysis showed that quadruple therapy provides eradication rates similar to those observed with classical triple therapy (127) .…”

Section: Statement 29mentioning

confidence: 99%

3rd BRAZILIAN CONSENSUS ON Helicobacter pylori

Coelho

Maguinilk

Zaterka³

et al. 2013

Arq. Gastroenterol.

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Significant progress has been obtained since the Second Brazilian Consensus Conference on Helicobacter pylori Infection held in 2004, in São Paulo, SP, Brazil, and justify a third meeting to establish updated guidelines on the current management of H. pylori infection. The Third Brazilian Consensus Conference on H pylori Infection was organized by the Brazilian Nucleus for the Study of Helicobacter, a Department of the Brazilian Federation of Gastroenterology and took place on April 12-15, 2011, in Bento Gonçalves, RS, Brazil. Thirty-one delegates coming from the five Brazilian regions and one international guest, including gastroenterologists, pathologists, epidemiologists, and pediatricians undertook the meeting. The participants were allocated in one of the five main topics of the meeting: H pylori, functional dyspepsia and diagnosis; H pylori and gastric cancer; H pylori and other associated disorders; H pylori treatment and retreatment; and, epidemiology of H pylori infection in Brazil. The results of each subgroup were submitted to a final consensus voting to all participants. Relevant data were presented, and the quality of evidence, strength of recommendation, and level of consensus were graded. Seventy per cent and more votes were considered as acceptance for the final statement. This article presents the main recommendations and conclusions to guide Brazilian doctors involved in the management of H pylori infection.

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Helicobacter pylori eradication with a capsule containing bismuth subcitrate potassium, metronidazole, and tetracycline given with omeprazole versus clarithromycin-based triple therapy: a randomised, open-label, non-inferiority, phase 3 trial

Cited by 467 publications

References 37 publications

Eradication Rates in Italian Subjects Heterogeneously Managed for Helicobacter pylori Infection. Time to Abandon Empiric Treatments in Southern Europe

Eradication Rates in Italian Subjects Heterogeneously Managed for Helicobacter pylori Infection. Time to Abandon Empiric Treatments in Southern Europe

Potential Benefit of Curcumin Adjuvant Therapy to the Standard H. Pylori Eradication Therapy in Patients With Peptic Ulcer Disease

3rd BRAZILIAN CONSENSUS ON Helicobacter pylori

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