scholarly journals Modified quadruple therapy versus bismuth-containing quadruple therapy in first-line treatment of Helicobacter pylori infection in Korea; rationale and design of an open-label, multicenter, randomized controlled trial

Medicine ◽  
2018 ◽  
Vol 97 (46) ◽  
pp. e13245 ◽  
Author(s):  
Hyun Lim ◽  
Chang Seok Bang ◽  
Woon Geon Shin ◽  
Jae Ho Choi ◽  
Jae Seung Soh ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Helicobacter Pylori ◽  
Controlled Trial ◽  
Line Treatment ◽  
First Line ◽  
Open Label ◽  
Quadruple Therapy ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
First Line Treatment

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

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).

scholarly journals Comparing The Efficacy of Two-Week Therapy With Modified Bismuth Quadruple Versus Modified Levofloxacin Concomitant Regimen for Helicobacter Pylori Infection in Syrian Patients. A Randomized Controlled Trial.

2021 ◽  
Author(s):  
Marouf Muhammad Alhalabi ◽  
Mohammed Waleed Alassi ◽  
Kamal Alaa Eddin ◽  
Khaled Cheha
Keyword(s):  
Randomized Controlled Trial ◽  
Helicobacter Pylori ◽  
Confidence Interval ◽  
Odds Ratio ◽  
Controlled Trial ◽  
Line Treatment ◽  
First Line ◽  
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. 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).

scholarly journals Efficacy of Two-Week Therapy With Bismuth Quadruple Versus Levofloxacin Concomitant for Helicobacter Pylori Infection: A Prospective Single-Center Randomized Controlled Trial.

2021 ◽  
Author(s):  
Marouf Alhalabi ◽  
Mohammed Waleed Alassi ◽  
Kamal Alaa Eddin ◽  
Khaled Cheha
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
P Value ◽  
Line Treatment ◽  
First Line ◽  
Open Label ◽  
Stool Antigen Test ◽  
Randomized Controlled ◽  
Syrian Population ◽  
First Line Treatment

Abstract Antibiotic-resistance reduces the efficacy of conventional therapy for H.pylori infection worldwide, which necessitates using various protocols according to location. This was an open‑label randomized controlled trial. We used two modified protocols, bismuth quadruple and concomitant levofloxacin. The aim was to compare the eradication rates of previous protocols as empirical first-line treatment to cure H.pylori infection in intention-to-treat (ITT) and per-protocol analyses (PPA) in Syrian population. We assigned seventy-eight eligible naïve patients, with a 1:1 ratio to receive two-week therapy of (bismuth subsalicylate 524 mg four times daily, doxycycline 100 mg, tinidazole 500 mg, and esomeprazole 20 mg, each twice daily) (B-group), or (levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg, each twice daily) (L-group). We confirmed H.Pylori eradication by stool antigen test at eight weeks. According to IIT, the eradication rates were 76.92%, and 82.05%, for the B-group and L-group respectively. According to PPA, the eradication rates were 78.9%, and 82.1% for the B-group and L-group respectively. P-value was 078. We didn’t report serious adverse effects. The eradication rates in both regimens were fair. Further trials are required to identify the preferred first-line treatment for H.pylori infection in the Syrian population.

scholarly journals Comparing the efficacy of two-week therapy with bismuth quadruple versus levofloxacin concomitant regimen for Helicobacter Pylori infection in Syrian patients. A randomized controlled trial.

2021 ◽  
Author(s):  
Marouf Muhammad Alhalabi ◽  
Mohammed Waleed Alassi ◽  
Kamal Alaa Eddin ◽  
Khaled Cheha
Keyword(s):  
Randomized Controlled Trial ◽  
Helicobacter Pylori ◽  
Confidence Interval ◽  
Odds Ratio ◽  
Controlled Trial ◽  
Line Treatment ◽  
First Line ◽  
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. 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 trials are intended to help select the right 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).

Sign in / Sign up

Export Citation Format

Share Document