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.

Abstract Background: The eradication rate of Helicobacter Pylori infection with standard triple therapy either clarithromycin or levofloxacin has declined due to antimicrobial resistance. The aim of this research was to estimate the eradication rate of bismuth quadruple and levofloxacin concomitant regimens as empirical first-line regimens in a referral hospital in Syria.Settings and Design: an open‑label parallel blind randomized controlled trial.Methods: Researchers randomly assigned naïve patients with H pylori infection with a 1:1 ratio into two groups. We give group A (bismuth subsalicylate 524 mg four times a day, and doxycycline 100 mg tinidazole 500 mg and esomeprazole 20 mg, each twice daily for 14 days). We give group B (levofloxacin 500 mg every day, tinidazole 500 mg, amoxicillin 1000 mg and esomeprazole 20 mg each twice daily for 14 days). Researchers used a computer program to generate randomized numbers. We concealed the sequence in an opaque envelope until the intervention was assigned. medical laboratory doctors were blinded to treatment allocation. Statistical analysis: chi-square test for categorical variables, t-test for continuous data.Results: Researchers allocated seventy-eight patients. Thirty-eight patients completed the follow‑up in bismuth regimen, and thirty-nine patients in concomitant levofloxacin. Thirty patients in the bismuth regimen were cured, the eradication rate was 78.94% according to per-protocol analysis, and 76.92% according to intention‑to‑treat analysis. While in concomitant levofloxacin thirty-two patients were cured, the eradication rate was 82.05% according to intention‑to‑treat analysis (P = 0.780). Researchers didn’t report serious adverse events in both groups. Odds ratio with 95% confidence interval according to the intention‑to‑treat analysis was 1.371 [0.454-4.146]. While the odds ratio with a 95% confidence interval according to per-protocol analysis was 1.22 [0.394-3.774].Conclusions: Both treatment regimens had acceptable eradication rates. Researchers suggest using both regimens as empirical first-line therapy in treating Helicobacter Pylori gastric infection in the Syrian population. No serious adverse events were recorded.Trial registration: Researchers This study was registered as a standard randomized clinical trial (Clinicaltrial.gov, identifier‑NCT04348786, date:29-January-2020, https://clinicaltrials.gov/ct2/show/NCT04348786).

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

Gastroenterology ◽

10.1016/s0016-5085(16)34288-3 ◽

2016 ◽

Vol 150 (4) ◽

pp. S1269 ◽

Cited By ~ 2

Author(s):

Masafumi Maruyama ◽

Daisuke Kubota ◽

Masayuki Miyajima ◽

Takefumi Kimura ◽

Koujiro Tokutake ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Helicobacter Pylori ◽

Eradication Rate ◽

Controlled Trial ◽

First Line ◽

Randomized Controlled

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Randomized Controlled Trial for Helicobacter pylori Eradication in a Naive Portuguese Population: Is Sequential Treatment Superior to Triple Therapy in Real World Clinical Setting?

Acta Médica Portuguesa ◽

10.20344/amp.8072 ◽

2017 ◽

Vol 30 (3) ◽

pp. 185 ◽

Cited By ~ 2

Author(s):

Pedro Boal Carvalho ◽

Joana Magalhães ◽

Francisca Dias de Castro ◽

Bruno Rosa ◽

José Cotter

Keyword(s):

Randomized Controlled Trial ◽

Helicobacter Pylori ◽

Triple Therapy ◽

Eradication Rate ◽

Controlled Trial ◽

Sequential Therapy ◽

First Line ◽

Portuguese Population ◽

Helicobacter Pylori Eradication ◽

Randomized Controlled

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.

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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.

10.21203/rs.3.rs-250381/v1 ◽

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).

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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.

10.21203/rs.3.rs-80097/v3 ◽

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).

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Efficacy of two-week therapy with doxycycline-based quadruple regimen versus levofloxacin concomitant regimen for helicobacter pylori infection: a prospective single-center randomized controlled trial

BMC Infectious Diseases ◽

10.1186/s12879-021-06356-5 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Marouf Alhalabi ◽

Mohammed Waleed Alassi ◽

Kamal Alaa Eddin ◽

Khaled Cheha

Keyword(s):

Clinical Trial ◽

Helicobacter Pylori ◽

Confidence Interval ◽

Odds Ratio ◽

Controlled Trial ◽

Helicobacter Pylori Infection ◽

First Line ◽

Link Type ◽

Syrian Population

Abstract Background Antibiotic-resistance reduces the efficacy of conventional triple therapy for Helicobacter Pylori infections worldwide, which necessitates using various treatment protocols. We used two protocols, doxycycline-based quadruple regimen and concomitant levofloxacin regimen. The aim was to assess the effectiveness of doxycycline-based quadruple regimen for treating Helicobacter Pylori infections compared with levofloxacin concomitant regimen as empirical first-line therapy based on intention-to-treat (ITT) and per-protocol analyses (PPA) in Syrian population. Settings and design An open-label, randomised, parallel, superiority clinical trial. Methods We randomly assigned 78 naïve patients who tested positive for Helicobacter Pylori gastric infection, with a 1:1 ratio to (D-group) which received (bismuth subsalicylate 524 mg four times daily, doxycycline 100 mg, tinidazole 500 mg, and esomeprazole 20 mg, each twice per day for 2 weeks), or (L-group) which received (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 8 weeks after completing the treatment. Results Thirty-nine patients were allocated in each group. In the D-group, 38 patients completed the follow-up, 30 patients were cured. While in the L-group, 39 completed the follow-up, 32patients 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 Levofloxacin concomitant therapy wasn’t superior to doxycycline based quadruple therapy. Further researches are required to identify the optimal first-line treatment for Helicobacter-Pylori Infection in the Syrian population. Trial registration We registered this study as a standard randomized clinical trial (Clinicaltrial.gov, identifier-NCT04348786, date:29-January-2020).

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A 14-Day Course of Triple Therapy is Superior to a 10-Day Course for the Eradication ofHelicobacter pylori: A Canadian Study Conducted in a ‘Real World’ Setting

Canadian Journal of Gastroenterology and Hepatology ◽

10.1155/2015/659390 ◽

2015 ◽

Vol 29 (8) ◽

pp. e7-e10 ◽

Cited By ~ 6

Author(s):

Yen-I Chen ◽

Carlo A Fallone

Keyword(s):

Triple Therapy ◽

Eradication Rate ◽

Day Treatment ◽

Office Visit ◽

First Line ◽

Intention To Treat ◽

Treatment Naïve ◽

Gastric Biopsies ◽

H Pylori ◽

Treat Analysis

BACKGROUND: SuccessfulHelicobacter pylorieradication with the traditional seven-day course of proton pump inhibitor (PPI) triple therapy is declining. Prolonging therapy to either 10 or 14 days is associated with better eradications rates.OBJECTIVE: To compare the effectiveness of 14-day course of triple therapy versus a 10-day course in the treatment ofH pyloriin Canada.METHODS: Consecutive treatment-naive patients with clinical indications forH pylorieradication underwent either a 10-day course or a 14-day course of traditional PPI triple therapy depending on the date of the office visit (an odd date received the 10-day course, whereas an even date received the 14-day treatment).H pylorieradication was ascertained via urea breath test or gastric biopsies performed ≥4 weeks after completion of therapy. Analyses were by both intention to treat and per-protocol.RESULTS: A total of 83 patients were included in the study (31 in the 10-day group and 52 in the 14-day group). In the intention-to-treat analysis, eradication rates were 82.7% (95% CI 70% to 92%) versus 45.2% (95% CI 27% to 64%), favouring the 14-day treatment (P<0.001). Similarly, in the per-protocol analysis, eradication rates were 91.5% (95% CI 80% to 98%) versus 63.6% (95% CI 41% to 83%), favouring the 14-day arm (P=0.01). Adverse events and compliance were not significantly different between the two groups.CONCLUSION: A 14-day course of standard PPI triple therapy was superior to a shorter-duration therapy and should be included as a first-line regimen forH pylorieradication in Canada. The 10-day course of treatment did not achieve an acceptable eradication rate and should no longer be used in this country.

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Vonoprazan-Based Regimen Is More Useful than PPI-Based One as a First-LineHelicobacter pyloriEradication: A Randomized Controlled Trial

Canadian Journal of Gastroenterology and Hepatology ◽

10.1155/2017/4385161 ◽

2017 ◽

Vol 2017 ◽

pp. 1-7 ◽

Cited By ~ 17

Author(s):

Masafumi Maruyama ◽

Naoki Tanaka ◽

Daisuke Kubota ◽

Masayuki Miyajima ◽

Takefumi Kimura ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Adverse Events ◽

Eradication Rate ◽

Controlled Trial ◽

Eradication Therapy ◽

Group Versus ◽

Intention To Treat ◽

Randomized Controlled ◽

Primary Endpoints ◽

H Pylori

Background. A new agent, potassium-competitive acid blocker vonoprazan (VPZ) has potent acid-inhibitory effects and may offer advantages over conventionalH. pylorieradication therapies. We aimed to compare the eradication rate between VPZ-based treatment and PPI-based one.Methods. This randomized controlled trial was designed to assign 141 patients withH. pylori-positive gastritis to VPZ group (VPZ 20 mg, amoxicillin 750 mg, and clarithromycin 200 or 400 mg twice daily for 7 days) or PPI group (rabeprazole 20 mg or lansoprazole 30 mg, amoxicillin 750 mg, and clarithromycin 200 or 400 mg twice daily for 7 days). Primary endpoints were eradication rates and adverse events.Results. Seventy of 72 patients in VPZ group and 63 of 69 patients in PPI group completed the treatment after 7 days. The eradication rate was significantly higher in VPZ group than PPI group by intention-to-treat analysis (95.8% versus 69.6%,P=0.00003, 95% confidence interval [CI] 88.3-99.1% versus 57.3-80.1%) and per-protocol analysis (95.7% versus 71.4%,P=0.0002, 95% CI 88.0-99.1% versus 58.7-82.1%). The incidence of adverse events was not different between the groups (26.3% in VPZ group versus 37.7% in PPI group,P=0.15).Conclusion. VPZ-based regimen is more useful than that PPI-based regimen as a first-lineH. pylorieradication therapy.

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Adding Bismuth to Rabeprazole-Based First-Line Triple Therapy Does Not Improve the Eradication of Helicobacter pylori

Gastroenterology Research and Practice ◽

10.1155/2017/5320180 ◽

2017 ◽

Vol 2017 ◽

pp. 1-6 ◽

Cited By ~ 1

Author(s):

Meng-Chieh Wu ◽

Yao-Kuang Wang ◽

Chung-Jung Liu ◽

Fang-Jung Yu ◽

Fu-Chen Kuo ◽

...

Keyword(s):

Helicobacter Pylori ◽

Triple Therapy ◽

Eradication Rate ◽

Therapy Group ◽

Resistance Rate ◽

Controlled Study ◽

First Line ◽

Intention To Treat ◽

Bismuth Subcitrate

This randomized controlled study aimed to evaluate whether adding bismuth to the standard first-line triple therapy could improve the eradication rate of Helicobacter pylori. A total of 162 patients with Helicobacter pylori infection were randomly assigned to either the 7-day triple therapy group (RAK regimen: rabeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg bid; n=81) or the bismuth plus triple therapy group (n=81). In the RBAK group, bismuth subcitrate 360 mg twice daily was added to the RAK regimen. A follow-up endoscopy or urea breath test was performed at least 4 weeks after eradication to confirm the treatment efficacy. Comparable compliance and Helicobacter pylori eradication rates were observed in both groups in either intention-to-treat [RAK 72.8% (59/81) versus RBAK 77.8% (63/81); p=0.47] or per protocol analysis [RAK 74.7% (59/79) versus RBAK 81.8% (63/77); p=0.26]. Adverse effects were commonly reported (50.6% for both groups) although most of these did not cause cessation of treatment. The resistance rate was 27.2% for metronidazole and 12.3% for clarithromycin. Adding bismuth to the standard 7-day triple therapy did not substantially increase the eradication rate. Further study is needed clarifying whether extending the duration of RBAK regimen to 10–14 days can lead to a better result.

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