Tu2083 A Randomized Controlled Trial Comparing the First-Line Eradication Rate Using Vonoprazan or PPI for Helicobacter pylori Infectious Gastritis

2016 ◽  
Vol 150 (4) ◽  
pp. S1269 ◽  
Author(s):  
Masafumi Maruyama ◽  
Daisuke Kubota ◽  
Masayuki Miyajima ◽  
Takefumi Kimura ◽  
Koujiro Tokutake ◽  
...  
2017 ◽  
Vol 30 (3) ◽  
pp. 185 ◽  
Author(s):  
Pedro Boal Carvalho ◽  
Joana Magalhães ◽  
Francisca Dias de Castro ◽  
Bruno Rosa ◽  
José Cotter

Introduction: Helicobacter pylori eradication has become increasingly difficult as resistances to several antibiotics develop. We aimed to compare Helicobacter pylori eradication rates between triple therapy and sequential therapy in a naive Portuguese population.Material and Methods: Prospective randomized trial including consecutive patients referred for first-line Helicobacter pylori eradication treatment. Exclusion criteria: previous gastric surgery/neoplasia, pregnancy/lactancy, allergy to any of the drugs. The compared eradication regimens were triple therapy (pantoprazol, amoxicillin and clarithromycin 12/12 hours, 14 days) and sequential therapy (pantoprazol 12/12 hours for 10 days, amoxicillin 12/12 hours for days 1 - 5 and clarithromycin plus metronidazol 12/12 hours during days 6 - 10). Eradication success was confirmed with urea breath test. Statistical analysis was performed with SPSS v21.0 and a p-value < 0.05 was considered statistically significant.Results: Included 60 patients, 39 (65%) female with mean age 52 years (SD ± 14.3). Treatment groups were homogeneous for gender, age, indication for treatment and smoking status. No statistical differences were encountered between sequential and triple therapy eradication rates (86.2% vs 77.4%, p = 0.379), global eradication rate was 82%. Tobacco consumption was associated with a significantly lower eradication success (54.5 vs 87.8%, p = 0.022).Discussion: In this randomized controlled trial in a naive Portuguese population, we found a satisfactory global Helicobacter pylori eradication rate of 82%, with no statistical differences observed in the efficacy of the treatment between triple and sequential regimens.Conclusion: These results support the use of either therapy for the first-line eradication of Helicobacter pylori.


2020 ◽  
Author(s):  
Marouf Muhammad Alhalabi ◽  
Mohammed Waleed Alassi ◽  
Kamal Alaa Eddin ◽  
Khaled Cheha

Abstract Introduction: Antibiotic-resistant reduces the efficacy of conventional triple therapy for Helicobacter Pylori infections worldwide, lead to varying treatment protocols according to locations.Aim: Primary outcome was eradication rates of bismuth quadruple (BQ) and levofloxacin concomitant (LC) as empirical first-line treatment by intention to treat (ITT) in a referral hospital in Syria.Design: an open‑label parallel blind randomized controlled trial.Materials and Methods: We randomly assigned seventy-eight naïve who tested positive for Helicobacter Pylori gastric infection, with a 1:1 ratio to receive either BQ (bismuth subsalicylate 524 mg four times daily, doxycycline 100 mg, tinidazole 500 mg, and esomeprazole 20 mg, each twice daily for two weeks), or LC (levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice daily for two weeks). We confirmed Helicobacter Pylori eradication by stool antigen test by eight weeks.Results: Thirty-nine patients were allocated in each group. In the BQ group, thirty-eight patients completed the follow-up, thirty patients were cured. While in the LC group, thirty-nine completed the follow-up, thirty-two patients were cured. The ITT eradication rates of the BQ and LC groups were 76.92%, and 82.05%, respectively. Odds ratio with 95% confidence interval according to ITT was 1.371 [0.454-4.146]. We didn’t report serious adverse effects.Conclusions:Both therapy regimens had acceptable rates of eradication. we suggest using both regimens as empirical first-line therapy in the treatment of Helicobacter Pylori infection in the Syrian population.Clinicaltrial.gov, NCT04348786


2021 ◽  
Author(s):  
Marouf Muhammad Alhalabi ◽  
Mohammed Waleed Alassi ◽  
Kamal Alaa Eddin ◽  
Khaled Cheha

Abstract Background: Antibiotic-resistant reduces the efficacy of conventional triple therapy for Helicobacter Pylori infections worldwide, lead to varying treatment protocols according to locations. The primary outcome of this research is to estimate the eradication rates of modified bismuth quadruple versus modified levofloxacin concomitant as empirical first-line treatment by intention to treat analysis (ITT) and per-protocol analysis (PPA) in a referral hospital in Syria.Settings and Design: an open‑label parallel blind randomized controlled trial.Methods: We randomly assigned seventy-eight naïve who tested positive for Helicobacter Pylori gastric infection, with a 1:1 ratio to (B-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 B- 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 B-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 82.1% for the B-group and L-groups 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 help select 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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