246 10-day Sequential Versus 10-day Bismuth-Containing Quadruple Therapy As Empirical First-Line Treatment for Helicobacter pylori: An Open Label Randomized Crossover Trial

Abstract Background This randomized, open-label trial aimed to compare the efficacy of 10-day bismuth-containing quadruple therapy (BQT) with 7-day proton-pump inhibitor-clarithromycin containing standard triple therapy (STT) as an empirical first-line Helicobacter pylori therapy. Methods Participants with H. pylori infection were randomly assigned to either 10-day BQT (daily doses of bismuth 300 mg, four times; lansoprazole 30 mg, twice; metronidazole 500 mg, three times; and tetracycline 500 mg, four times) or 7-day STT (lansoprazole 30 mg; amoxicillin 1,000 mg; and clarithromycin 500 mg; each given twice daily). Participants who failed initial therapy were crossed over to the alternative treatment regimen. Primary outcome was the eradication rates of first-line treatment by intention-to-treat analysis. Results Study participants (n = 352) were randomized to receive either 10-day BQT (n = 175) or 7-day STT (n = 177). The BQT-group achieved a significantly higher eradication rate than the STT-group in the intention-to-treat analysis (74.3% vs 57.1%, respectively; P = 0.001), modified intention-to-analysis (87.2% [130/149] vs 68.7% [101/147], respectively; P < 0.001) and per-protocol analysis (92.9% [105/113] vs 70.1% [94/134], respectively; P < 0.001). Although there was no serious adverse event, the compliance was lower with BQT than STT as a higher proportion of participants in the BQT-group discontinued therapy because of adverse events than those in the STT-group (23.1% vs 9.1%, respectively; P = 0.001) Conclusions Ten-day BQT had higher eradication rates compared to that of the 7-day STT as an empirical first-line treatment for H. pylori eradication in Korea. Trial registration: ClinicalTrials.gov, NCT02557932. Registered 23 September 2015, https://clinicaltrials.gov/ct2/show/NCT02557932?term=NCT02557932&draw=2&rank=1.

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Faculty Opinions recommendation of Sequential versus triple therapy for the first-line treatment of Helicobacter pylori: a multicentre, open-label, randomised trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.717964930.793468200 ◽

2012 ◽

Author(s):

Yoshio Yamaoka ◽

Seiji Shiota

Keyword(s):

Helicobacter Pylori ◽

Triple Therapy ◽

Randomised Trial ◽

Line Treatment ◽

First Line ◽

Open Label ◽

First Line Treatment

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Efficacy of Bismuth-Containing Quadruple Therapy as First-line Treatment for Helicobacter pylori Infection

Euroasian Journal of Hepato-Gastroenterology ◽

10.5005/jp-journals-10018-1041 ◽

2012 ◽

Vol 2 (2) ◽

pp. 90-93

Author(s):

Metin Küçükazman ◽

Ayse Kefeli ◽

Sebahat Basyigit ◽

Abdullah Özgür Yeniova ◽

Yasar Nazligül ◽

...

Keyword(s):

Helicobacter Pylori ◽

Helicobacter Pylori Infection ◽

Line Treatment ◽

First Line ◽

Quadruple Therapy ◽

First Line Treatment

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Efficacy of Two-Week Therapy with Doxycycline-Based Quadruple Versus Levofloxacin Concomitant for Helicobacter Pylori Infection: A Prospective Single-Center Randomized Controlled Trial.

10.21203/rs.3.rs-457018/v1 ◽

2021 ◽

Author(s):

Marouf Alhalabi ◽

Waleed Alassi ◽

Kamal Alaa Eddin ◽

Khaled Cheha

Keyword(s):

Helicobacter Pylori ◽

Odds Ratio ◽

Controlled Trial ◽

Helicobacter Pylori Infection ◽

Line Treatment ◽

First Line ◽

Open Label ◽

Randomized Controlled ◽

First Line Treatment

Abstract Background: Antibiotic-resistant reduces the efficacy of conventional triple therapy for Helicobacter Pylori infections worldwide, lead to varying treatment protocols according to locations. This was an open‑label randomized controlled trial. We used two protocols, doxycycline-based quadruple and concomitant levofloxacin regimens. The aim was to compare the eradication rates of previous protocols as empirical first-line treatment to cure Helicobacter Pylori infection in intention-to-treat (ITT) and per-protocol analyses (PPA) in Syrian population.Settings and Design: an open‑label parallel randomized controlled trial.Methods: We randomly assigned seventy-eight naïve who tested positive for Helicobacter Pylori gastric infection, with a 1:1 ratio to (D-group ) which receive (bismuth subsalicylate 524 mg four times daily, doxycycline 100 mg, tinidazole 500 mg, and esomeprazole 20 mg, each twice per day for two weeks), or (L-group) which receive (levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for two weeks). We confirmed Helicobacter Pylori eradication by stool antigen test at eight weeks. Results: Thirty-nine patients were allocated in each group. In the D-group, thirty-eight patients completed the follow-up, thirty patients were cured. While in the L-group, thirty-nine completed the follow-up, thirty-two patients were cured. According to ITT, the eradication rates were 76.92%, and 82.05%, for the D-group and L-group respectively. Odds ratio with 95% confidence interval was 1.371 [0.454-4.146]. According to PPA, the eradication rates were 78.9 %, and 82.05% for the D-group and L-group respectively. The odds ratio with 95% confidence interval was 1.219 [0.394-3.774]. We didn’t report serious adverse effects. Conclusions: The eradication rates in both therapy regimes were fair. Further researches are required to identify the optimum first-line treatment for Helicobacter-Pylori Infection in the Syrian population.Trial registration: We register this study as a standard randomized clinical trial (Clinicaltrial.gov, identifier‑NCT04348786, date:29-January-2020, https://clinicaltrials.gov/ct2/show/NCT04348786).

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