scholarly journals Comparison of Second-Line Quadruple Therapies with or without Bismuth forHelicobacter pyloriInfection

2015 ◽  
Vol 2015 ◽  
pp. 1-6 ◽  
Author(s):  
Guang-Hong Jheng ◽  
I-Chen Wu ◽  
Hsiang-Yao Shih ◽  
Meng-Chieh Wu ◽  
Fu-Chen Kuo ◽  
...  
Keyword(s):  
Eradication Rate ◽  
Rescue Therapy ◽  
Controlled Trial ◽  
Second Line ◽  
Second Line Therapy ◽  
Quadruple Therapy ◽  
Intention To Treat ◽  
Bismuth Subcitrate ◽  
Acceptable Side ◽  
Treat Analysis

The bismuth-based quadruple regimen has been applied inHelicobacter pylorirescue therapy worldwide. The non-bismuth-based quadruple therapy or “concomitant therapy” is an alternative option in first-line eradication but has not been used in second-line therapy. Discovering a valid regimen for rescue therapy in bismuth-unavailable countries is important. We conducted a randomized controlled trial to compare the efficacies of the standard quadruple therapy and a modified concomitant regimen. One hundred and twenty-four patients were randomly assigned into two groups: RBTM (rabeprozole 20 mg bid., bismuth subcitrate 120 mg qid, tetracycline 500 mg qid, and metronidazole 250 mg qid) and RATM (rabeprozole 20 mg bid., amoxicillin 1 g bid., tetracycline 500 mg qid, and metronidazole 250 mg qid) for 10 days. The eradication rate of the RBTM and RATM regimen was 92.1% and 90.2%, respectively, in intention-to-treat analysis. Patients in both groups had good compliance (~96%). The overall incidence of adverse events was higher in the RATM group (42.6% versus 22.2%,P=0.02), but only seven patients (11.5%) experienced grades 2-3 events. In conclusion, both regimens had good efficacy, compliance, and acceptable side effects. The 10-day RATM treatment could be an alternative rescue therapy in bismuth-unavailable countries.

scholarly journals Empiric “Three-in-One” Bismuth Quadruple Therapy for Second-Line Helicobacter pylori Eradication: An Intervention Study in Southern Italy

Antibiotics ◽  
2022 ◽  
Vol 11 (1) ◽  
pp. 78
Author(s):  
Giuseppe Losurdo ◽  
Ilaria Lacavalla ◽  
Francesco Russo ◽  
Giuseppe Riezzo ◽  
Irene Vita Brescia ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Adverse Events ◽  
Eradication Rate ◽  
Sequential Therapy ◽  
Second Line ◽  
Capsule Formulation ◽  
Second Line Therapy ◽  
Quadruple Therapy ◽  
Intention To Treat ◽  
Line Therapy

The eradication of Helicobacter pylori (H. pylori) may be difficult due to antibiotic resistance. Indeed, after one failure, a second-line therapy is needed and a bismuth containing quadruple therapy (BQT) with a three-in-one capsule formulation is becoming very popular. Therefore, we aimed to evaluate effectiveness and safety of BQT as a second-line therapy. We recruited consecutive patients with one therapy failure. For ten days patients received the three-in-one BQT Pylera® therapy, in combination with a proton-pump inhibitor (PPI), decided at the choice of the investigator, at full dose bid. The eradication rate was calculated by intention-to-treat (ITT) and per-protocol (PP)analyses and 95% confidence intervals (CI) were calculated. Seventy-three patients were recruited, 41 females and 32 males (mean age 53.0±13.1 years). Fifty-five patients failed triple therapy with amoxicillin and clarithromycin and the remaining 18 received sequential therapy. Seventy-two patients consumed at least 90% of the capsules, while only one did not complete the therapy due to adverse events (nausea and diarrhea). By ITT analysis, BQT was successful in 62 subjects (eradication rate 84.9%, 95%CI 76.7–93.1%). By PP analysis, the eradication rate was 86.1% (95%CI 78.1–94.1%).Adverse events were observed in 14 subjects (20.5%).In conclusion, our report confirmed that BQT is effective as an empiric second-line regimen.

scholarly journals Fourteen-Day Sequential Therapy Containing Rabeprazole Versus 10 And 14-Day Concomitant Therapy in The First Line Treatment of Helicobacter Pylori Infection: A Randomized, Open-Label Clinical Trial

2021 ◽  
Author(s):  
Hassan Seddik ◽  
Hanae Boutallaka ◽  
Sanaa Berrag ◽  
Samir Mrabti ◽  
Khaoula Loubaris ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Adverse Effects ◽  
Eradication Rate ◽  
Cost Effective ◽  
Sequential Therapy ◽  
Open Label ◽  
Quadruple Therapy ◽  
Intention To Treat ◽  
13C Urea Breath Test ◽  
Treat Analysis

Abstract Aims:To compare an optimized sequential therapy to 10 and 14-day non-Bismuth quadruple therapies currently recommended, in terms of efficacy, incidence of adverse effects and cost.Patients and methods:This open-label prospective study randomized patients with confirmed Helicobacter pylori (H.Pylori) infection to 3 groups (1:1:1): The first group received quadruple therapy of twice-daily (bid) Omeprazole 20mg, Amoxicillin 1g, Clarithromycin 500mg and Metronidazole 500mg for 10days (QT-10), the second group received a 14 day quadruple therapy following the same regimen (QT-14), and the third received an optimized sequential therapy consisting on a bid Rabeprazole 20 mg plus amoxicillin 1g for 7 days, followed by bid Rabeprazole 20 mg, clarithromycin 500 mg and metronidazole 500mg for the next 7 days (OST-14). Adverse events (AEs) were recorded throughout the study, and the H.Pylori eradication rate was determined 4 to 6 weeks after treatment using the 13C urea breath test.Results:In intention to treat analysis, eradication rate was 85,5%, 91,8% and 95,4% respectively in QT-10, QT-14 and OST-14 groups (p=0,03). In the per protocol analysis, the eradication rate was significantly higher in the OST- 14 group compared to the QT-14 and QT-10 groups (98,1%, 94,4% and 89,5% respectively, p=0,02).The overall incidence of AEs was significantly lower in the OST-14 group (p=0,01). Furthermore, the OST-14 was the most cost-effective among the three groups.Conclusion:14-day optimized sequential therapy is a safe and effective alternative that allows a higher eradication rate compared to 10 and 14-days quadruple therapies while causing less adverse effects and allowing a gain in term of cost.

scholarly journals Efficacy of H. pylori eradication depending on genetic polymorphism of CYP2C19, MDR1 and IL-1β

2019 ◽  
Vol 91 (8) ◽  
pp. 34-40 ◽  
Author(s):  
N V Bakulina ◽  
I V Maev ◽  
I V Savilova ◽  
I G Bakulin ◽  
T A Il'chishina ◽  
...  
Keyword(s):  
Eradication Rate ◽  
Standard Dose ◽  
High Dose ◽  
Independent Factor ◽  
Cure Rate ◽  
Intention To Treat ◽  
Associated Diseases ◽  
Bismuth Subcitrate ◽  
H Pylori ◽  
Treat Analysis

Aim. To evaluate an association of genetic polymorphisms CYP2C19, MDR1, and IL-1β on the eradication rate by 10-day modified therapy in patients with H. pylori - associated diseases. Materials and methods. In this study was conducted a prospective, randomized trial, included 89 patients with H. pylori - associated diseases. They were divided into 2 groups depending on therapy: clarithromycin 500 mg, b.i.d., amoxicillin 1000 mg, b.i.d., bismuth subcitrate 240 mg, b.i.d. rabeprazole 20 mg or 40 mg, b.i.d. for 10 days. All subjects underwent pharmacogenetic testing of CYP2C19, MDR1, and IL-1β. Results and discussion. Per - protocol (PP) eradication rates in group with rabeprazole 40 mg were 97.6% (41/42; 95% CI 87.7-99.6), in group with rabeprazole 20 mg were 82.1% (32/39; 95% CI 67.3-91.0). Intention - to - treat analysis in group with rabeprazole 40 mg eradication rates were 89.1% (41/46; 95% CI 77.0-95.3), in group with standard dose rabeprazole - 74.4% (32/43; 95% CI 59.8-85.1). No significant differences in eradication rates between the groups of ultrarapid, rapid, normal and intermediate CYP2C19 metabolizers (PP: 93.5%/90.3%/84.6% respectively; χ2=0.87, p=0.65). Eradication rates in group with IL-1β CC genotype there was no difference among the IL-1β CT and TT genotype groups (PP: 92.9%/85.7%/94.7% respectively; χ2=1.34; p=0.51). The cure rate among MDR1 TT genotype was significantly lower than among subjects in the MDR1 CC/CT genotype groups (PP: 76.2% vs 96.3%: χ2=5.04; p=0.025; OR=8.13). Conclusion. Ten - day modified triple therapy with high dose rabeprazole significantly high eradication rates in patients with H. pylori - associated diseases. Independent factor for treatment failure is MDR1 CC/CT genotype status.

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.

2020 ◽  
Author(s):  
Marouf Muhammad Alhalabi ◽  
Mohammed Waleed Alassi ◽  
Khaled Cheha
Keyword(s):  
Helicobacter Pylori ◽  
Odds Ratio ◽  
Eradication Rate ◽  
Protocol Analysis ◽  
Controlled Trial ◽  
First Line ◽  
Serious Adverse Events ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Treat Analysis

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).

scholarly journals Second-Line Bismuth-Containing Quadruple Therapy for Helicobacterpylori Infection: A 12-Year Study of Annual Eradication Rates

2021 ◽  
Vol 10 (15) ◽  
pp. 3273
Author(s):  
Kiwon Shin ◽  
Min-Jae Cho ◽  
Jung-Hwan Oh ◽  
Chul-Hyun Lim
Keyword(s):  
Adverse Events ◽  
Gastrointestinal Symptoms ◽  
Long Term Results ◽  
Second Line ◽  
Second Line Therapy ◽  
Quadruple Therapy ◽  
Intention To Treat ◽  
Line Therapy ◽  
Standard Triple Therapy ◽  
H Pylori

Background: Bismuth-containing quadruple therapy (BQT) consisting of a proton-pump inhibitor (PPI), bismuth, metronidazole and tetracycline is recommended as a second-line treatment for Helicobacter pylori (H. pylori) infection when PPI-based standard triple therapy (STT) consisting of a PPI, amoxicillin and clarithromycin is unsuccessful. The purpose of this study was to analyze the long-term results of BQT as a second-line therapy to determine its effectiveness. Methods: This study included 643 subjects who failed first-line STT and received 7 or 10–14 days of BQT as a second-line therapy. We retrospectively analyzed the annual H. pylori eradication rates, demographic factors and adverse events. Results: The overall eradication rates by intention-to-treat (ITT) and per-protocol (PP) analyses were 80.7% (519/643) and 93.3% (519/556), respectively. By PP analysis, the eradication rates for 2008–2011, 2012–2015, and 2016–2019 were 93.3%, 91.0%, and 96.4%, respectively (p = 0.145). There were no significant differences between the 7-day group and the 10–14-day group in both the ITT (79.7% vs. 86.0%, p = 0.148) and the PP analyses (92.7% vs. 96.6%, p = 0.187). A multivariate analysis showed that current smoking was associated with eradication failure. Eighty-nine subjects (16.0%) suffered adverse events, mainly gastrointestinal symptoms, but only six cases were severe. Conclusions: BQT as a second-line therapy is an effective treatment for H. pylori. Treatment for 10–14 days showed a higher eradication rate compared with a 7-day regimen, but not significantly.

Roxadustat for anemia in patients with end-stage renal disease incident to dialysis

2021 ◽  
Author(s):  
Robert Provenzano ◽  
Evgeny Shutov ◽  
Liubov Eremeeva ◽  
Svitlana Korneyeva ◽  
Lona Poole ◽  
...  
Keyword(s):  
Rescue Therapy ◽  
Controlled Trial ◽  
Epoetin Alfa ◽  
Open Label ◽  
Treatment Groups ◽  
Intention To Treat ◽  
Primary Endpoints ◽  
Stage Renal Disease ◽  
End Stage ◽  
Event Rates

Abstract Background We evaluated the efficacy and safety of roxadustat vs. epoetin alfa for the treatment of chronic kidney disease (CKD) related anemia in patients new to dialysis. Methods This was a phase 3, open-label, epoetin alfa-controlled trial. Eligible adults were on hemodialysis/peritoneal dialysis for ≥2 weeks and ≤4 months before randomization and had mean hemoglobin ≤10.0 g/dL. Primary endpoints were mean hemoglobin (g/dL) change from baseline averaged over weeks 28–52 regardless of rescue therapy (non-inferiority criterion: lower limit of 95% CI for treatment difference > −0.75) and percentage of patients achieving a hemoglobin response between weeks 1–24 censored for rescue therapy (non-inferiority margin for between-group difference: −15%). Adverse events were monitored. Results The intention-to-treat population included patients randomized to roxadustat (n = 522) or epoetin alfa (n = 521). Mean (SD) hemoglobin changes from baseline averaged over weeks 28–52 were 2.57 (1.27) and 2.36 (1.21) in the roxadustat and epoetin alfa groups. Roxadustat was non-inferior (least-squares mean difference: 0.18 [95% CI: 0.08, 0.29]) to epoetin alfa. Percentages of patients with a hemoglobin response were 88.2% and 84.4% in the roxadustat and epoetin alfa groups. Roxadustat was non-inferior to epoetin alfa (treatment-group difference: 3.5% [95% CI: −0.7%, 7.7%]). Adverse event rates were comparable between treatment groups. Conclusions Roxadustat was efficacious for correcting and maintaining hemoglobin levels compared to epoetin alfa. Roxadustat had an acceptable safety profile.

scholarly journals Efficacy of and Resistance to Rifaximin-based Quadruple Therapy in Helicobacter pylori Eradication

2020 ◽  
Vol 20 (3) ◽  
pp. 218-224
Author(s):  
Hyun Soo Kim ◽  
Hyuk Yoon ◽  
Dong Woo Shin ◽  
Dong Jun Oh ◽  
Mingu Kwon ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Rescue Therapy ◽  
Treatment Options ◽  
Treatment Protocol ◽  
Resistance Rate ◽  
Quadruple Therapy ◽  
Minimal Inhibitory Concentrations ◽  
Intention To Treat ◽  
H Pylori ◽  
Triple Regimen

Background/Aims: The treatment options for Helicobacter pylori (<i>H. pylori</i>) infection are in a state of flux: traditional triple therapies have started to fail, and new treatments are unable to achieve optimal eradication rates. Rifaximin and rifabutin are new antibiotics. The aim of this study was to evaluate the efficacy and safety of adding rifaximin to the standard triple regimen and of a rifabutin-based triple regimen as a rescue therapy for <i>H. pylori</i> eradication.Materials and Methods: We enrolled 27 <i>H. pylori</i>-positive patients who were treated with a proton pump inhibitor, amoxicillin, clarithromycin, and rifaximin for 14 days. <i>H. pylori</i> eradication was assessed by a <sup>13</sup>C-urea breath test performed 4 weeks after therapy completion. The efficacy of the therapy was based on intention-to-treat (ITT) and per-protocol (PP) analysis. We also investigated the resistance rate, compliance, and side effects associated with rifaximin therapy. Minimal inhibitory concentrations and resistance to rifabutin were evaluated using the agar dilution method.Results: Of the 27 patients, 22 completed the treatment protocol with 100% compliance; five patients withdrew. The ITT and PP eradication rates for the rifaximin-containing quadruple therapy were 70.4% (19/27) and 86.3% (19/22), respectively. Adverse events were observed in five of 22 patients (22.7%). The resistance rates to rifaximin and rifabutin were 66.7% (2/3) and 0% (0/3), respectively.Conclusions: The findings of this study show the limitations of rifaximin-based quadruple therapy and suggest the benefits of a rifabutin-based rescue regimen in South Korea.

scholarly journals Effect of manual therapy in patients with hemophilia and ankle arthropathy: a randomized clinical trial

2019 ◽  
Vol 34 (1) ◽  
pp. 111-119 ◽  
Author(s):  
Elena Donoso-Úbeda ◽  
Javier Meroño-Gallut ◽  
José Antonio López-Pina ◽  
Rubén Cuesta-Barriuso
Keyword(s):  
Manual Therapy ◽  
Joint Pain ◽  
Controlled Trial ◽  
Control Group ◽  
Load Bearing ◽  
Intention To Treat ◽  
Joint Health ◽  
Experimental Group ◽  
Treat Analysis

Objective: The aim of this study was to evaluate the effects of a manual therapy using fascial therapy on joint bleeding, joint pain and joint function in patients with hemophilic ankle arthropathy. Setting: Hemophilia patient associations. Design: Randomized, controlled trial, multicenter and intention-to-treat analysis. Participants: A total of 65 patients with hemophilic ankle arthropathy. Intervention: The experimental group ( n = 33) received one fascial therapy session per week for three weeks. The control group ( n = 32) received no treatment. Outcome measure: The primary outcome was frequency of joint bleeding measured using self-reporting. Secondary outcomes were joint pain (under load-bearing and non-load-bearing conditions) measured using the visual analog scale; joint condition was measured using the Hemophilia Joint Health Score. Outcomes were measured at baseline, posttreatment and after five months of follow-up. Results: Improvements in the frequency joint bleeding at T0, T1 and T2 were significantly higher in the experimental group (T0: mean (SD) = 1.56 (1.30); T1: mean (SD) = 0.00 (0.00); T2: mean (SD) = 0.27 (0.57)) compared to the control group (T0: mean (SD) = 1.70 (1.78); T1: mean (SD) = 0.05 (0.21); T2: mean (SD) = 0.58 (0.85)). Mean improvement of joint state after the study period was 1.74 points (±1.66) for patients in the experimental group, while the control group exhibited a joint deterioration with 0.43 points (±0.85). Ankle joint pain under load-bearing and non-load-bearing conditions improved in the experimental group with −1.72 (±1.86) and −0.50 (±1.39) points, respectively. Conclusion: The study showed that fascial therapy is favorable for patients with hemophilic ankle arthropathy.

Sign in / Sign up

Export Citation Format

Share Document