Non-bismuth Quadruple Therapy Research Articles

14-day tailored PCR-guided triple therapy versus 14-day non-Bismuth concomitant quadruple therapy for Helicobacter pylori eradication: A multicenter, open-label randomized noninferiority controlled trial.

The systematic use of susceptibility testing and tailored first-line treatment for Helicobacter pylori eradication has yet to be established. To compare 14-day tailored PCR-guided triple therapy to 14-day non-Bismuth concomitant quadruple therapy for first-line Helicobacter pylori eradication. We performed a multicenter, parallel-group, randomized noninferiority controlled trial. Naive adult patients with Helicobacter pylori infection were treated with 14-day tailored PCR-guided triple therapy (esomeprazole 40 mg and amoxicillin 1000 mg b.d. plus clarithromycin 500 mg or levofloxacin 500 mg b.d. according to clarithromycin susceptibility) or 14-day non-Bismuth concomitant quadruple therapy (esomeprazole 40 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and metronidazole 500 mg b.d.). The primary endpoint was H. pylori eradication. We screened 991 patients for eligibility and randomized 241 patients. The first-line eradication rate was 99.2% in the tailored PCR-guided group and 95.9% in the control group (ITT population; absolute difference of +3.30%, with a lower bound of CI at -0.68%). Both first-line therapies were well tolerated, with a formally significant difference in favor of the tailored PCR-guided group (61.4% vs. 41.2%, p = 0.003). Economic analyses revealed a lower cost of the tailored PCR-guided arm, with a 92% chance of being jointly more effective and less expensive than the control arm in the ITT population. In a country with a high level of clarithromycin resistance, the results of our study demonstrated the noninferiority of 14-day tailored PCR-guided triple therapy as a first-line H. pylori eradication therapy compared to 14-day non-Bismuth quadruple therapy (ClinicalTrials.gov NCT02576236).

Intraluminal Therapy for Helicobacter pylori Infection—Comparison of Medicament Containing Tetracycline, Metronidazole, and Bismuth versus Amoxicillin, Metronidazole, and Clarithromycin: A Randomized Controlled Study

Helicobacter pylori (H. pylori) can be eradicated immediately via local application of single-dose medicament on endoscopic examination. In our previous report, "the eradication rate of intraluminal therapy for H. pylori infection (ILTHPI) is 53.7% (51/95) using medicament containing amoxicillin, metronidazole, and clarithromycin". We aimed to evaluate the efficacy and adverse events of medicament containing tetracycline, metronidazole, and bismuth and to improve the efficacy of stomach acid control before ILTHPI. After usage of dexlansoprazole (60 mg b.i.d.) or vonoprazan (20 mg q.d.) for 3 days before ILTHPI, 103 of 104 (99.1%) symptomatic H. pylori-infected treatment-naïve patients achieved levels of stomach pH ≥ 6. Patients were randomized to receive ILTHPI with medicaments containing tetracycline, metronidazole, and bismuth (Group A, n = 52) or amoxicillin, metronidazole, and clarithromycin (Group B, n = 52). The eradication rate of ILTHPI was similar between Group A (76.5%; 39/51) and Group B (84.6%, 44/52) (p = 0.427) and the adverse event was mild diarrhea (2.9%; 3/104). The eradication rate significantly increased from 53.7% (51/95) to 84.6% (44/52) after acid control (p = 0.0004) for Group B patients. The overall eradication rates of successful ILTHPI plus 7-day non-bismuth (Group A) or 7-day bismuth (Group B) oral quadruple therapy for ILTHPI failure patients were both excellent (96.1% for Group A and 98.1% for Group B).

Efficacy and Safety of 7-Day Non-Bismuth Concomitant Quadruple Therapy for First-Line Helicobacter pylori Eradication in the Elderly.

Aging may affect the efficacy of Helicobacter pylori eradication. The aim of our study was to assess the efficacy and safety of 7-day non-bismuth concomitant quadruple therapy as a first-line H. pylori infection eradication regimen in elderly individuals. We retrospectively analyzed a cohort with prospectively collected data from January 2013 to December 2019 at Chang Gung Memorial Hospital in Kaohsiung. There were 408 naive infected subjects aged 20 years or older who were treated with 7 days of concomitant therapy as a first-line H. pylori eradication regimen. We divided the patients into an elderly group (aged ≥ 65 years) and a control group (aged < 65 years). Two patients were lost during follow-up in the elderly group and 29 patients were lost in the control group, resulting in 56 in the ≥ 65-year age group and 321 in the control group. The patients were asked to perform urea breath tests 8 weeks later. The eradication rates for the elderly and control groups were 93.1% (95% confidence interval (CI): 83.3-98.1) and 84.0% (95% CI 79.7-87.7) (p = 0.070), respectively, in the intention-to-treat analysis, and 96.4% (95% CI 87.6-99.6) and 91.6% (95% CI 88.0-94.4) (p = 0.210), respectively, in the per-protocol (PP) analysis. The adverse event rates were 8.9% in the elderly group and 12.8% in the control group (p = 0.417). The compliance was 100% in both groups. No significant difference was seen in antibiotic resistance in either group. Multivariate analysis revealed that metronidazole resistance (odds ratio (OR) 6.870, 95% CI 1.182-39.919, p = 0.032) and dual-therapy resistance (OR 7.188, 95% CI 1.326-38.952, p = 0.022) were independent factors for eradication failure. The efficacy of non-bismuth concomitant quadruple therapy in the elderly cohort was comparable with that in the non-elderly cohort for first-line H. pylori eradication with acceptable adverse effects.

Helicobacter pylori resistance to clarithromycin and quinolones in patients with dyspepsia in Tuzla Canton, Bosnia and Herzegovina.

Aim To evaluate Helicobacter pylori (H. pylori) resistance to clarithromycin and quinolones in patients with dyspepsia in Tuzla Canton, Bosnia and Herzegovina, a region with no data on clarithromycin or quinolones resistance. Methods A prospective cross-sectional study was conducted at the Department of Gastroenterology and Hepatology at University Clinical Centre Tuzla between January 2021 and June 2022. The study included 99 patients who underwent esophagogastroduodenoscopy (EGDS) due to dyspepsia. In all patients biopsies were taken for rapid urease test (RUT) and histology findings, concomitantly with blood samples for IgG serology. All RUT positive patient samples were tested for clarithromycin and quinolones susceptibility with GenoType HelicoDr, a PCR method which detects point mutations in 23S rRNA and mutations in the gyrA gene. Results Out of 99 dyspeptic patients, 67 (67.7%) were serologically positive to H. pylori, 46 (46.4.%) were RUT positive, and 19 (19.2 %) had a positive histology finding. Antibiotic (AB) resistance was tested in the total of 46/99 (46.4%) patients. Resistance to clarithromycin was detected in 28.26% (13/46), quinolones resistance in 36.96% (17/46) , and resistance to both AB was detected in 8.69% (4/46) tested biopsies. Conclusions Due to high clarithromycin and quinolones resistance rates, we recommend the use of bismuth quadruple or non-bismuth concomitant quadruple therapy for H. pylori eradication in Tuzla Canton, Bosnia and Herzegovina.

Current Trends in the Management of Helicobacter pylori Infection in Serbia: Preliminary Results from the European Registry on H. pylori Management

Background: Helicobacter pylori (H. pylori) is the most common chronic bacterial infection. Treatment effectiveness remains a subject of debate considering bacterial antimicrobial resistance. Our aim was to analyze the diagnostic methods and eradication treatments for H. pylori infection in Serbia. Methods: An observational multicenter prospective study was conducted in Serbia, as part of the European Registry on H. pylori Management (Hp-EuReg). Demographics, treatment indication, diagnostic methods, previous eradication attempts, and treatment were collected at AEG-REDCap e-CRF. Modified intention-to-treat (mITT) and per-protocol (PP) effectiveness analyses were performed. Safety, compliance, and bacterial antimicrobial resistance rates were reported. Data were quality checked. Results: Overall, 283 patients were included, with a mean age of 55 ± 15 years. Dyspepsia (n = 214, 77%) was the most frequent treatment indication, and histology (n = 144, 51%) was the most used diagnostic method. Overall eradication rate was 95% (PP) and 94% (mITT). Most prevalent first-line therapy was quadruple PPI + clarithromycin + amoxicillin + metronidazole, with a 96% effectiveness (p < 0.001). Second-line main treatment choice was triple amoxicillin + levofloxacin, with a 95% effectiveness (p < 0.05). Single-capsule Pylera® was the most prescribed third-line therapy, with 100% effectiveness (p < 0.05). Longer treatment duration was associated with a higher eradication rate in first-line therapy (p < 0.05). Clarithromycin and quinolone resistance rates in first-line were 24% and 8.3%, respectively. The overall adverse events’ incidence rate was 13.4%, and therapy compliance was 97%. Conclusions: Considering the high eradication rate, 14-day non-bismuth quadruple concomitant therapy is a reasonable first-line choice, while quinolone-based therapy and single-capsule Pylera® should be considered as rescue therapy options.

Comparison of Efficacy of Conventional Triple Therapy and Non Bismuth Quadruple Therapy for Helicobacter Pylori Eradication

Objective: To compare the efficacy of conventional triple therapy and non bismuth quadruple therapy for helicobacter pylori eradication. Setting: Gastroenterology Department, Lady Reading Hospital Peshawar. Study Design: Randomized control trial. Duration: 6 months 15th August, 2018 to 15th February 2019. Materials and Methods: In this study a total of 111 patients were observed. Patients were put in two groups, group A triple Helicobacter pylori eradication therapy and group B non-bismuth quadruple Helicobacter pylori eradication therapy. Randomization of patients to either treatment group was done through lottery method. All patients were worked up with detailed history and clinical examination to look for any known allergy to drugs used in this study, to document any comorbidity and to exclude alarm features, baseline investigations including complete blood count, Random blood sugar, liver function tests and renal function tests. H pylori stool antigen was reported from Lady Reading Hospital laboratory at time of inclusion and four weeks after completion of therapy. The purpose and benefits of study was explained to patients and written consent for participation in study was obtained. Patients were asked on follow up about adherence to the treatment. Results: In this study mean age in Group A was 44 years with SD ± 2.77. Whereas mean age in Group B was 42 years with SD ± 3.12. In Group A 55% patients were male and 45% patients were female. Where as in Group B 58% patients were male and 42% patients were female. More over Group A (triple Helicobacter pylori eradication therapy) was effective in 75% patients. Where as Group B (non-bismuth quadruple Helicobacter pylori eradication therapy) was effective in 94% patients and was not effective in 6% patients. Conclusion: Our study concludes that non bismuth quadruple therapy is more effective than triple therapy in the treatment of Helicobacter pylori eradication. Keywords: Conventional triple therapy, Non-bismuth quadruple therapy, Helicobacter pylori eradication

Efficacy and safety of high-dose esomeprazole-amoxicillin dual therapy for Helicobacter pylori rescue treatment: a multicenter, prospective, randomized, controlled trial.

Background:High-dose dual therapy (HDDT) with proton pump inhibitors (PPIs) and amoxicillin has attracted widespread attention due to its favorable efficacy in eradicating Helicobacter pylori (H. pylori). This study aimed to compare the efficacy and safety of high-dose PPI–amoxicillin dual therapy and bismuth-containing quadruple therapy for H. pylori rescue treatment.Methods:This was a prospective, randomized, multicenter, non-inferiority trial. Patients recruited from eight centers who had failed previous treatment were randomly (1:1) allocated to two eradication groups: HDDT (esomeprazole 40 mg and amoxicillin 1000 mg three times daily; the HDDT group) and bismuth-containing quadruple therapy (esomeprazole 40 mg, bismuth potassium citrate 220 mg, and furazolidone 100 mg twice daily, combined with tetracycline 500 mg three times daily; the tetracycline, furazolidone, esomeprazole, and bismuth [TFEB] group) for 14 days. The primary endpoint was the H. pylori eradication rate. The secondary endpoints were adverse effects, symptom improvement rates, and patient compliance.Results:A total of 658 patients who met the criteria were enrolled in this study. The HDDT group achieved eradication rates of 75.4% (248/329), 81.0% (248/306), and 81.3% (248/305) asdetermined by the intention-to-treat (ITT), modified intention-to-treat (MITT), and per-protocol (PP) analyses, respectively. The eradication rates were similar to those in the TFEB group: 78.1% (257/329), 84.2% (257/305), and 85.1% (257/302). The lower 95% confidence interval boundary (−9.19% in the ITT analysis, − 9.21% in the MITT analysis, and −9.73% in the PP analysis) was greater than the predefined non-inferiority margin of −10%, establishing a non-inferiority of the HDDT group vs. the TFEB group. The incidence of adverse events in the HDDT group was significantly lower than that in the TFEB group (11.1% vs. 26.8%, P < 0.001). Symptom improvement rates and patients’ compliance were similar between the two groups.Conclusions:Fourteen-day HDDT is non-inferior to bismuth-containing quadruple therapy, with fewer adverse effects and good treatment compliance, suggesting HDDT as an alternative for H. pylori rescue treatment in the local region.Trial registration:Clinicaltrials.gov, NCT04678492.

The efficacy of culture-guided versus empirical therapy with high-dose proton pump inhibitor as third-line treatment of Helicobacter pylori infection: A real-world clinical experience.

Most consensuses recommend culture-guided therapy as third-line Helicobacter pylori treatment. This study aimed to investigate the efficacies of culture-guided therapy and empirical therapy with high-dose proton pump inhibitor (PPI) in the H. pylori third-line treatment. Between August 2012 and October 2021, H. pylori-infected patients with at least two failed eradication attempts received anti-H. pylori therapy according to the results of antimicrobial sensitivity tests plus high-dose rabeprazole and/or bismuth. They were categorized into three groups: patients who had positive results of culture with equal to or more than three susceptible antibiotics were treated by culture-guided non-bismuth quadruple therapy, patients who had positive results of culture with one or two susceptible antibiotics were treated by culture-guided bismuth-containing therapy, and patients who had a negative result of culture were treated by an empirical therapy with high-dose rabeprazole plus amoxicillin, tetracycline and levofloxacin. A post-treatment assessment was conducted at week 8. We recruited 126 patients. The eradication rates of culture-guided non-bismuth quadruple therapy (n=50), culture-guided bismuth-containing therapy (n=46) and empirical therapy (n=30) were 84.0%, 87.0%, and 66.7% (95% confidence interval: 73.8-94.2%, 77.3-96.7%, and 49.8-83.6%), respectively. Overall, culture-guided therapy achieved a higher eradication rate than empirical therapy (85.4% vs 66.7%; 95% confidence interval, 0.4% to 37.0%, P=0.022). Culture-guided therapy with high-dose PPI achieves a higher eradication rate than empirical therapy with high-dose PPI in the third-line treatment of H. pylori infection. The eradication rate of rescue therapy with bismuth plus two susceptible antibiotics is not inferior to that with three susceptible antibiotics.

Tailored eradication strategy vs concomitant therapy for Helicobacter pylori eradication treatment in Korean patients.

BACKGROUNDAntibiotic resistance to Helicobacter pylori (H. pylori) infection, which ultimately results in eradication failure, has been an emerging issue in the clinical field. Recently, to overcome this problem, an antibiotic sensitivity-based tailored therapy (TT) for H. pylori infection has received attention. AIMTo investigate the efficacy and safety profiles of TT for H. pylori infection treatment compared to a non-bismuth quadruple therapy, concomitant therapy (CT) regimen. METHODSWe included patients (> 18 years) with an H. pylori infection and without a history of Helicobacter eradication who visited the Gil Medical Center between March 2016 and October 2020. After being randomly assigned to either the TT or CT treatment group in 1 to 1 manner, patient compliance, eradication success rate (ESR), and patient-reported side effects profiles were assessed and compared between the two groups. H. pylori infection was diagnosed using a rapid urease test, Giemsa stain, or dual priming oligonucleotide polymerase chain reaction (DPO-PCR). Tailored eradication strategy based through the presence of a 23S ribosomal RNA point mutation. For the TT group, a DPO-PCR test, which detected A2142G and/or A2143G point mutations, and a clarithromycin resistance test were performed. Patients in the clarithromycin-resistant group were treated with a bismuth-containing quadruple combination therapy, while those with sensitive results were treated with the standard triple regimen. RESULTSOf the 217 patients with a treatment naive H. pylori infection, 110 patients [mean age: 58.66 ± 13.03, men, n = 55 (50%)] were treated with TT, and 107 patients [mean age: 56.67 ± 10.88, men, n = 52 (48.60%)] were treated with CT. The compliance (TT vs CT, 100% vs 98.13%, P = 0.30), and follow-up loss rates (8.18% vs 9.35%, P = 0.95) were not significantly different between the groups. The ESR after treatment was also not statistically different between the groups (TT vs CT, 82.73% vs 82.24%, P = 0.95). However, the treatment-related and patient-reported side effects were significantly lower in the TT group than in the CT group (22.77% vs 50.52%, P < 0.001).CONCLUSIONThe DPO-based TT regimen shows promising results in efficacy and safety profiles as a first-line Helicobacter eradication regimen in Korea, especially when physicians are confronted with increased antibiotic resistance rates.

Single Capsule Bismuth Quadruple Therapy for Eradication of H. pylori Infection: A Real-Life Study.

Background and aim: Bismuth quadruple therapy (BQT) or non-bismuth quadruple therapy (i.e., concomitant therapy) (CT) is the first-line regimens to eradicate H. pylori infection in areas with high prevalence of clarithromycin (CLA) resistance. Guidelines suggest that in areas of high prevalence of H. pylori strains with double resistance (i.e., CLA + metronidazole), BQT should be preferred to CT. The aim of this study was to evaluate the efficacy and safety of BQT administered through the three-in-one pill (Pylera) formulation in a large series of H. pylori–infected patients, naive to treatment in a region with high CLA and dual resistance. Patients and methods: We treated 250 patients (148 F and 102 M, mean age 48.6 years) with H. pylori infection naïve to treatment. Patients received esomeprazole 40 mg bid and Pylera 3 tablets qid for 10 days. Diagnosis of H. pylori infection was through 13C urea breath test (13C UBT), or stool antigen test or histology, as appropriate. The evaluation of eradication was through 13C UBT at least 45 days after the end of therapy. Incidence of treatment-related adverse events (TRAEs) was assessed through a questionnaire at the end of treatment. Compliance was considered good if at least 90% of medication had been taken. Statistical analysis was per intention-to-treat e per protocol (PP). 95% confidence intervals (CIs) were calculated. Results: 1) 13 patients (5.2%) discontinued therapy due to side effects; 2) eradication rates in ITT and PP were 227/250 (90.8%; 95% CI 86.3–93.7%) and 226/237 (95.3%; 95% CI 91–99%), respectively; 3) the prevalence of TRAEs was 26.8%; and 4) adherence to treatment was good with compliance greater than 90%. Conclusion: In this real-life study, we demonstrate that in an area with a high prevalence of H. pylori strains with CLA or CLA + metronidazole resistance, BQT using Pylera is an effective therapeutic strategy with ITT eradication rates higher than 90%; this therapy is associated with good compliance and low incidence of side effects.

Effcacy of quadruple therapy for the treatment of H. pylori infection at Gia Dinh people’s hospital

Helicobacter pylori (H. pylori) infection is one of the most common chronic bacterial infections in the world. For the purpose of eradicating H. pylori, quadruple therapies are widely prescribed in patients infected with H. pylori. According to the Maastricht V Consensus Conference, in regions where the rate of resistance of H. pylori to CLR and MTZ is high such as Viet Nam, bismuth quadruple therapy is the first choice. However, bismuth also causes many side efects. The aim of this study was to assess the effectiveness of quadruple therapies on H. pylori infection at Gia Dinh people’s hospital. Seventy-one patients aged 18 years old and older diagnosed with H. pylori infection at the Gastroenterology Unit of Gia Dinh People’s hospital were enrolled in this descriptive cross–sectional study. The efficacy and frequency of side effects of bismuth and non-bismuth quadruple therapies for H. pylori eradication were evaluated and the total rate of H. pylori eradication with both therapies was reported to be 70.4%. The success rate of bismuth quadruple therapy was 80.0%, significantly higher than that of non bismuth quadruple therapy (47.6%). Additionally, the frequency of side effects encountered by bismuth quadruple therapy was insignificantly higher than non-bismuth quadruple therapy (p &gt; 0.05). In conclusion, the effectiveness of treatment with bismuth quadruple therapy was higher than that with non-bismuth quadruple therapy.

Comparison between Hybrid, Reverse Hybrid, and Non-Bismuth Levofloxacin Quadruple Regimens for Helicobacter Pylori Infection in Egypt: A Randomized Trial.

BACKGROUND The prevalence of Helicobacter pylori (H. pylori) in developing countries is 50.8%, with the highest occurrence presented in Africa (79.1%). It increases the risk of chronic gastritis, peptic ulcer, cancer of the stomach, and lymphoma. The effect of standard treatment for H. pylori eradication is below 80%, and evaluation of alternative lines of treatment is needed. We aimed to compare the hybrid, reverse hybrid, and levofloxacin quadruple therapies as first-line therapy in Egypt. METHODS This was a randomized interventional trial done in the clinics affiliated with the Internal Medicine Department. 330 individuals were selected according to the inclusion criteria. They were divided into three groups: group 1 (110 subjects who received a reverse hybrid regimen), group 2 (110 subjects who received a hybrid regimen), and group 3 (110 subjects who received a non-bismuth levofloxacin quadruple regimen). RESULTS Group 3 had a significantly lower eradication rate of 82.7% versus 92.7% and 91.8% in groups 1 and 2, respectively. There were non-significant differences in the incidence rates of adverse events among the three groups. CONCLUSION Both the reverse hybrid and hybrid groups had good eradication rates in the Egyptian population, but non-bismuth levofloxacin quadruple therapy did not obtain a sufficient eradication rate.

Treatment of Refractory Helicobacter pylori Infection-Tailored or Empirical Therapy.

The treatment of refractory Helicobacter pylori remains challenging in clinical practice. Factors that should be considered in the treatment of refractory H. pylori infection include treatment length, dosage of antibiotics and proton pump inhibitors (PPIs), number of drugs, and the selection of appropriate antibiotics. Extending the treatment length of triple therapy and non-bismuth quadruple therapy to 14 days may increase the eradication rate compared with a shorter period (7 or 10 days). The use of a higher dose of PPIs or vonoprazan may also increase the efficacy of triple therapy. Four-drug therapy, including bismuth or non-bismuth quadruple therapies, usually achieve higher eradication rates than triple therapy. The addition of bismuth or metronidazole to levofloxacin-amoxicillin-PPI therapy may also increase the eradication rate. Therefore, four-drug therapies containing a higher dose of PPIs for 14 days are recommended in the third-line treatment setting for refractory H. pylori infection. The selection of appropriate antibiotics may be guided by susceptibility testing or empirically by medication history. Tailored therapy guided by susceptibility testing or genotypic resistance is recommended whenever possible. However, properly designed empirical therapy based on prior medication history (i.e., avoid the reuse of clarithromycin or levofloxacin empirically) is an acceptable alternative to tailored therapy after considering accessibility, cost, and the preference of the patient.

Eradication Rates for Esomeprazole and Lansoprazole-Based 7-Day Non-Bismuth Concomitant Quadruple Therapy for First-Line Anti-Helicobacter pylori Treatment in Real World Clinical Practice.

PurposeNon-bismuth concomitant quadruple therapy is commonly administered in Taiwan, achieving an acceptable efficacy as a first-line anti-Helicobacter pylori treatment. This study compared the eradication rates between esomeprazole- and lansoprazole-based non-bismuth concomitant quadruple therapy for first-line anti-H. pylori treatment.Patients and MethodsThis study included 206 H. pylori-infected naïve patients between July 2016 and February 2019. The patients were prescribed with either a 7-day non-bismuth containing quadruple therapy (esomeprazole, 40 mg twice daily; amoxicillin, 1 g twice daily; and metronidazole, 500 mg twice daily; and clarithromycin, 500 mg twice daily for 7 days [EACM group]; lansoprazole, 30 mg twice daily; amoxicillin, 1 g twice daily; metronidazole, 500 mg twice daily; and clarithromycin, 500 mg twice daily [LACM group]). Then, the patients were asked to perform urea breath tests 8 weeks later.ResultsThe eradication rates in the EACM group were 86.1% (95% confidence interval [CI], 77.8%–92.2%) and 90.6% (95% CI, 82.9%–95.6%) in the intention-to-treat (ITT) and the per-protocol (PP) analyses, respectively. Moreover, the eradication rates in the LACM group were 90.1% (95% CI, 82.6%–95.2%) and 92.6% (95% CI, 85.5%–96.9%) in the ITT and the PP analyses, respectively. Consequently, the LACM group exhibited more diarrhea patients than the EACM group (7.1% versus 1.0%, p = 0.029), but all symptoms were mild. Univariate analysis in this study showed that metronidazole-resistant strains were the clinical factor affecting the eradications (95.3% versus 78.9%, p = 0.044). Moreover, a trend was observed in dual clarithromycin- and metronidazole-resistant strains (91.5% versus 66.7%, p = 0.155).ConclusionThe eradication rates between esomeprazole and lansoprazole-based non-bismuth concomitant quadruple therapy for first-line H. pylori treatment were similar in this study. Both could achieve a > 90% report card in the PP analysis.

Consistency of Helicobacter pylori eradication rates of first-line concomitant and sequential therapies in Korea: A nationwide multicenter retrospective study for the last 10years.

Eradication rate of standard triple therapy for H.pylori has declined to unacceptable level, and alternative regimens such as concomitant and sequential therapy have been introduced. We aimed to assess the consistency of eradication rates of concomitant and sequential therapies as for the first-line H.pylori eradication in Korea. A nationwide multicenter retrospective study was conducted including 18 medical centers from January 2008 to December 2017. We included 3,800 adults who had test to confirm H.pylori eradication within 1year after concomitant or sequential therapy. Concomitant and sequential therapy were prescribed for 2508 and 1292 patients, respectively. The overall eradication rate of concomitant therapy was significantly higher than that of sequential therapy (91.8% vs. 86.1%, p<.001). In time trend analysis, the eradication rates of concomitant therapy were 90.2%, 88.2%, 92.1%, 94.3%, 91.1%, and 93.4% for each year from 2012 to 2017 with an increasing trend (p=.0146), while those of ST showed no significant trend (p=.0873). Among 263 patients with second-line therapy, bismuth quadruple therapy showed significantly higher eradication rate than quinolone-based triple therapy (73.9% vs. 51.5% in ITT analysis, p=.001; 82.7% vs. 63.0% in PP analysis, p=.002). Concomitant therapy is the best regimen for the first-line H.pylori eradication showing consistently higher eradication rate with an increasing trend for the last 10years in Korea. Bismuth quadruple therapy should be considered for second-line therapy after eradication failure using non-bismuth quadruple therapy.

Salvage Regimens after Failure of Previous Helicobacter pylori Eradication Therapy: A Systematic Review and Meta-analysis

Background/Aims: As antibiotic resistance increases and new first-line therapies emerge, salvage therapies for &lt;i&gt;Helicobacter pylori&lt;/i&gt; (&lt;i&gt;H. pylori&lt;/i&gt;) eradication failures are becoming more common and complicated. This study aimed to systematically review overall salvage regimens after previous failure of &lt;i&gt;H. pylori&lt;/i&gt; eradication.Materials and Methods: A systematic review of randomized clinical trials evaluating salvage therapies after previous &lt;i&gt;H. pylori&lt;/i&gt; eradication failure was performed. A meta-analysis was conducted when an adequate number of studies suitable for grouping was found.Results: Overall, 36 studies with 77 treatment arms were identified, and they were highly heterogeneous regarding previously failed regimens and salvage regimens under comparison. Bismuth quadruple therapy after failure of standard triple therapy showed a pooled intention-to-treat (ITT) eradication rate of 75.5% (95% CI, 71.6~79.1%), and the rates were significantly higher with 14-day therapy than 7-day therapy by 9% (95% CI, 2~15%). Levofloxacin triple therapy after failure of standard triple therapy demonstrated a pooled ITT eradication rate of 73.3% (95% CI, 68.4~77.3%). In direct comparison, the two regimens were not significantly different in eradication rates. No study evaluated salvage regimens after the failure of bismuth or non-bismuth quadruple therapy.Conclusions: The current studies regarding salvage regimens are highly heterogeneous. Bismuth quadruple therapy and levofloxacin triple therapy may be a reliable option after failure of standard triple therapy, but the regional profile of antibiotic resistance should be considered. Further studies are needed for salvage regimens after failure of non-bismuth or bismuth quadruple therapy.

Non-Bismuth Quadruple Therapy, Sequential Therapy or High-Dose Esomeprazole and Amoxicillin Dual Therapy for First-Line Helicobacter pylori Eradication: A Prospective Randomized Study.

Aim: The study aims were to evaluate and compare the effectiveness and safety of non-bismuth quadruple therapy with sequential therapy and dual therapy with high dose esomeprazole and amoxicillin as an empirical first-line approach to eradicate Helicobacter pylori infection.Patients and methods: Prospective randomized trial included 393 patients infected with H. pylori naïve to eradication therapy, randomized to receive a 10-day non-bismuth quadruple or concomitant (CT) therapy, 10-day sequential therapy (SQ), or 14-day high-dose esomeprazole and amoxicillin (BT). Treatment outcome was assessed by C13-urea breath test at least six weeks after therapy. Adverse events and compliance were assessed with questionnaires and residual medication count.Results: The baseline demographic clinical and endoscopic characteristics were similar among the three groups. The intention to treat (ITT) analysis was performed in 130, 132, and 131 patients in the BT, SQ, and CT groups, respectively. The eradication rates in ITT were 64.6%, 83.1%, and 92.3%, respectively, in the BT, SQ and CT groups (p = 0.0001). The eradication rates per protocol were 67.7%, 88.5%, and 95.3% (p = 0.0001), respectively, in the BT, SQ, and CT groups. The CT and SQ groups were higher than the BT group (p = 0,0001) but no significant results were seen in the eradication rate between CT and SQ, both in PP analysis and in ITT analysis (p = 0.09). The prevalence of the side effects following the non-bismuth quadruple therapy was 38.2%, significantly higher (p = 0.001) than the BT group (13.80%) and SQ group (22%). There were no significant differences in compliance among the three therapies (p = 0.16).Conclusion: This study found that non-bismuth quadruple therapy yielded a higher H. pylori eradication rate over sequential regimen as a first-line treatment in Morocco, with no statistical difference between the two protocols studied, while the eradication rate of dual high-dose of esomeprazole and amoxicillin did not exceed 60%. All three therapy schemes showed excellent compliance. However, the prevalence of side events was more important and significantly higher with non-bismuth quadruple therapy.

Comparative efficacy and safety of high-dose dual therapy, bismuth-based quadruple therapy and non-bismuth quadruple therapies for Helicobacter pylori infection: a network meta-analysis.

Helicobacter pylori (H. pylori) infection is associated with the development of multiple diseases. The eradication rate of H. pylori has gradually decreased, suggesting the need to discover more effective therapies. This study aimed to compare the effectiveness of first-line treatments including high-dose dual therapy (HDDT), bismuth-based quadruple therapy (BQT), sequential therapy (ST), concomitant therapy (CT) and hybrid therapy (HT) by network meta-analysis (NMA). A comprehensive search on PubMed, Embase, Cochrane Library and Web of Science, was performed from their inception to 1 September 2019. A network analysis of randomized controlled trials (RCTs) comparing first-line therapies were carried out using Stata 14.0 and Revman 5.2. Moreover, a sensitivity analysis was conducted by omitting non-Asian studies. Finally, 41 RCTs with 14 119 patients were included. The NMA showed that, in terms of eradication rate, ST for 10 days (ST-10) was significantly lower than CT for 10 or 14 days (CT ≥ 10). Sensitivity analysis among the Asian population showed that ST-10 denoted the lowest effectiveness among the interventions. The ranking results based on probability showed that HDDT ranked first for the eradication rate. As for adverse events, HDDT was significantly less than BQT and CT regardless of duration, while BQT for 14 days represented higher adverse events than ST, HT and CT ≥ 10. HDDT ranked first among the therapies. In conclusion, HDDT for 14 days appeared to be the most optimal first-line therapy for H. pylori among the Asian population with comparable efficacy and compliance but causing fewer adverse events.

Prospective comparative study between two first-line regimens for Helicobacter pylori eradication: Non-bismuth quadruple versus bismuth quadruple therapy

The Maastricht V Consensus recommends quadruple therapies as first-line Helicobacter pylori treatment in high clarithromycin (CLA) resistance areas. To compare efficacy, side effects and compliance between quadruple concomitant non-bismuth vs bismuth quadruple therapy. Prospective study enrolling H. pylori -positive patients. Omeprazol and a three-in-one formulation of bismuth–metronidazol–tetracycline (OBMT-3/1) for 10 days, or combination of omeprazol–clarithromycin–amoxicillin–metronidazol (OCAM) for 14 days, were prescribed. Eradication outcome was assessed by urea breath test or histology. Side effects and compliance were recorded during the treatment period with specific questionnaires. 404 patients were recruited (median age 53 years; 62.87% women). In 382 (183 with OCAM, 199 with OBMT-3/1) the post-treatment test result was available. The eradication rates were 85.94% (CI95%: 80.20–90.52) with OCAM and 88.21% (CI95%: 83.09–92.22) with OBMT-3/1 ( p = 0.595) in intention-to-treat analysis, whilst in per protocol analysis they were 91.12% (CI95%: 85.78–94.95) and 96.17% (CI95%: 92.28–98.45) respectively ( p = 0.083). Compliance over 90% was 91.35% with OCAM and 92.04% with OBMT-3/1 ( p = 0.951). Some side effect was present in 94.02% with OCAM and in 88.89% with OBMT-3/1 ( p = 0.109), being longer (12 vs 7 days, p < 0.0001) and more severe ( p < 0.0001) with OCAM. In a high CLA-resistance area, there are no differences between OBMT-3/1 and OCAM in H. pylori eradication and compliance rates, but OBMT-3/1 achieves a higher safety profile. El Consenso de Maastricht V recomienda tetraterapias como tratamiento de primera línea de Helicobacter pylori en áreas con elevada resistencia a claritromicina (CLA). Comparar la eficacia, los efectos secundarios y el cumplimiento terapéutico entre la tetraterapia sin bismuto y la tetraterapia con bismuto. Estudio prospectivo que incluyó a pacientes con H. pylori . Se prescribió omeprazol y una formulación 3 en uno de bismuto-metronidazol-tetraciclina (OBMT-3/1) durante 10 días, o una combinación de omeprazol-claritromicina-amoxicilina-metronidazol (OCAM) durante 14 días. El resultado de la erradicación se evaluó mediante una prueba de aliento con urea o histología. Los efectos secundarios y el cumplimiento terapéutico se registraron durante el período de tratamiento empleando cuestionarios específicos. Se incluyeron 404 pacientes (mediana de edad de 53 años; un 62,87% de mujeres). El resultado de la prueba posterior al tratamiento estuvo disponible en 382 pacientes (183 con OCAM, 199 con OBMT-3/1). Las tasas de erradicación fueron del 85,94% (IC 95%: 80,20-90,52) con OCAM y del 88,21% (IC 95%: 83,09-92,22) con OBMT-3/1 ( p = 0,595) en el análisis por intención de tratar, mientras que en el análisis por protocolo fueron del 91,12% (IC 95%: 85,78-94,95) y del 96,17% (IC 95%: 92,28-98,45), respectivamente ( p = 0,083). El cumplimiento terapéutico superior al 90% fue del 91,35% con OCAM y del 92,04% con OBMT-3/1 ( p = 0,951). Se observaron efectos secundarios en el 94,02% de los pacientes tratados con OCAM y en el 88,89% de los tratados con OBMT-3/1 ( p = 0,109), y fueron más prolongados (12 frente a 7 días, p < 0,0001) y más graves ( p < 0,0001) con OCAM. En un área con elevada resistencia a la CLA no se observan diferencias entre OBMT-3/1 y OCAM en la erradicación de H. pylori ni en las tasas de cumplimiento, pero OBMT-3/1 presenta un perfil de seguridad superior.

Prospective comparative study between two first-line regimens for Helicobacter pylori eradication: Non-bismuth quadruple versus bismuth quadruple therapy

BackgroundThe Maastricht V Consensus recommends quadruple therapies as first-line Helicobacter pylori treatment in high clarithromycin (CLA) resistance areas. AimsTo compare efficacy, side effects and compliance between quadruple concomitant non-bismuth vs bismuth quadruple therapy. MethodProspective study enrolling H. pylori-positive patients. Omeprazol and a three-in-one formulation of bismuth–metronidazol–tetracycline (OBMT-3/1) for 10 days, or combination of omeprazol–clarithromycin–amoxicillin–metronidazol (OCAM) for 14 days, were prescribed. Eradication outcome was assessed by urea breath test or histology. Side effects and compliance were recorded during the treatment period with specific questionnaires. Results404 patients were recruited (median age 53 years; 62.87% women). In 382 (183 with OCAM, 199 with OBMT-3/1) the post-treatment test result was available. The eradication rates were 85.94% (CI95%: 80.20–90.52) with OCAM and 88.21% (CI95%: 83.09–92.22) with OBMT-3/1 (p=0.595) in intention-to-treat analysis, whilst in per protocol analysis they were 91.12% (CI95%: 85.78–94.95) and 96.17% (CI95%: 92.28–98.45) respectively (p=0.083). Compliance over 90% was 91.35% with OCAM and 92.04% with OBMT-3/1 (p=0.951). Some side effect was present in 94.02% with OCAM and in 88.89% with OBMT-3/1 (p=0.109), being longer (12 vs 7 days, p<0.0001) and more severe (p<0.0001) with OCAM. ConclusionsIn a high CLA-resistance area, there are no differences between OBMT-3/1 and OCAM in H. pylori eradication and compliance rates, but OBMT-3/1 achieves a higher safety profile.