Bismuth-containing Quadruple Regimen Research Articles

Bismuth-Containing Quadruple Therapy for Helicobacter pylori Eradication: A Randomized Clinical Trial of 10 and 14 Days.

Bismuth-containing quadruple therapy is the first-line treatment for eradicating Helicobacter pylori (H. pylori). The optimal duration for H. pylori eradication using bismuth-containing quadruple therapy remains controversial. Therefore, we aimed to compare the clinical effects of the 10- and 14-day bismuth-containing quadruple treatment regimen to eradicate H. pylori. Treatment-naïve patients with H. pylori infection (n = 1300) were enrolled in this multicenter randomized controlled study across five hospitals in China. They were randomized into 10- or 14-day treatment groups to receive bismuth-containing quadruple therapy as follows: vonoprazan 20mg twice daily; bismuth 220mg twice daily; amoxicillin 1000mg twice daily; and either clarithromycin 500mg twice daily or tetracycline 500mg four times daily. At least 6weeks after treatment, we performed a 13C-urea breath test to evaluate H. pylori eradication. The per-protocol eradication rates were 93.22% (564/605) and 93.74% (569/607) (p < 0.001) and the intention-to-treat eradication rates were 88.62% (576/650) and 89.38% (581/650) (p = 0.007) for the 10- and 14-day regimens, respectively. Incidence of adverse effects was lower in patients who received 10- vs. 14days of treatment (22.59% vs. 28.50%, p = 0.016). We observed no significant differences in the compliance to treatment or the discontinuation of therapy because of severe adverse effects between the groups. Compared with the 14-day bismuth-containing quadruple regimens, the 10-day regimen demonstrated a non-inferior efficacy and lower incidence of adverse effects. Therefore, the 10-day regimen is safe and tolerated and could be recommended for H. pylori eradication (NCT05049902).

Vonoprazan is Not Inferior to Proton Pump Inhibitors in Bismuth-containing Quadruple Therapy for Helicobacter pylori Eradication: A Meta-analysis of 10 Studies From East Asia.

To investigate the efficacy and safety of vonoprazan based bismuth-containing quadruple therapy (VBCQ) in eradicating Helicobacter pylori (Hp). The VBCQ and the proton pump inhibitor-based bismuth-containing quadruple regimen (PBCQ) were compared by retrieving relevant studies in Pubmed, Embase, Cochrane Library, CNKI, and Wanfang data. Combined analysis was performed with risk ratio (RR) and 95% CI as effect values. A total of 10 studies were enrolled, including 7 randomized controlled trials and 3 cohort studies. In intention-to-treat analysis, the eradication rate of VBCQ (89.24%, 1103/1236) was significantly higher than that of PBCQ (84.03%, 1021/1215), with RR = 1.06 (95% CI: 1.03~1.10). In per-protocol analysis, the eradication rates of VBCQ and PBCQ were 92.94% (895/963) and 87.82% (829/944), respectively, with a significant difference (RR = 1.06, 95% CI: 1.03~1.09). Subgroup analysis of study design types shared similar results. VBCQ and PBCQ showed an incidence of adverse reactions of 37.30% (304/815) and 34.94% (282/807), respectively. Significant differences were not found between the two groups (RR = 1.07, 95% CI: 0.96-1.19), nor in subgroup analysis. The good compliance rates in VBCQ and PBCQ groups were 94.32% (216/229) and 95.13% (215/226), respectively, with no significant difference (RR = 0.99, 95% CI: 0.95~1.04). VBCQ has a higher eradication rate on Hp than PBCQ, while its adverse reactions and compliance are similar to PBCQ. However, we conservatively believe that in Hp eradication, the VBCQ is not inferior to PBCQ because of the small absolute difference.

Efficacy comparison of 7- and 14-day P-CAB based bismuth-containing quadruple regimen with PPI based bismuth-containing quadruple regimen for Helicobacter pylori infection: rationale and design of an open-label, multicenter, randomized controlled trial

BackgroundOwing to its strong acid inhibition, potassium-competitive acid blocker (P-CAB) based regimens for Helicobacter pylori (H. pylori) eradication are expected to offer clinical advantages over proton pump inhibitor (PPI) based regimens. This study aims to compare the efficacy and adverse effects of a 7-day and a 14-day P-CAB-based bismuth-containing quadruple regimen (PC-BMT) with those of a 14-day PPI-based bismuth-containing quadruple regimen (P-BMT) in patients with high clarithromycin resistance.MethodsThis randomized multicenter controlled clinical trial will be performed at five teaching hospitals in Korea. Patients with H. pylori infection who are naive to treatment will be randomized into one of three regimens: 7-day or 14-day PC-BMT (tegoprazan 50 mg BID, bismuth subcitrate 300 mg QID, metronidazole 500 mg TID, and tetracycline 500 mg QID) or 14-day P-BMT. The eradication rate, treatment-related adverse events, and drug compliance will be evaluated and compared among the three groups. Antibiotic resistance testing by culture will be conducted during the trial, and these data will be used to interpret the results. A total of 366 patients will be randomized to receive 7-day PC-BMT (n = 122), 14-day PC-BMT (n = 122), or 14-day P-BMT (n = 122). The H. pylori eradication rates in the PC-BMT and P-BMT groups will be compared using intention-to-treat and per-protocol analyses.DiscussionThis study will demonstrate that the 7-day or 14-day PC-BMT is well tolerated and achieve similar eradication rates to those of 14-day P-BMT. Additionally, the 7-day PC-BMT will show fewer treatment-related adverse effects and higher drug compliance, owing to its reduced treatment duration.Trial registrationKorean Clinical Research Information Service registry, KCT0007444. Registered on 28 June 2022, https://cris.nih.go.kr/cris/index/index.do.

The cure rate of 10-day bismuth-containing quadruple therapy for Helicobacter pylori eradication is equivalent to 14-day: a systematic review and meta-analysis.

Helicobacter pylori (H. pylori) infection is a major cause of duodenal ulcers, gastric ulcers, and gastric cancer. However, the optimal duration for H. pylori eradication therapy remains controversial. Most studies have mainly focused on triple therapy, and there is insufficient research on bismuth-containing quadruple therapy. The aim of this study was to compare the clinical effect of the 10-day bismuth-containing quadruple treatment regimen with the 14-day regime in eradicating H. pylori. We searched PubMed, Embase, Web of Science, and the Cochrane Library for randomized controlled trials published in English until May 2022 according to the eligibility criteria. Summary risk ratios (RRs) and 95% confidence intervals (CIs) for eradication rates, adverse effects, and compliance were calculated for included studies. Four studies, involving 1173 patients, were eligible for inclusion. The eradication rate was similar in the 10-day treatment group and the 14-day treatment group in the intention-to-treat analysis (RR 0.97, 95% CI 0.93 to 1.01). Meanwhile, the incidence of adverse effects was lower in patients who received 10days of treatment than in those who received 14days of treatment and patients' compliance was almost the same between two groups. Compared to the 14-day bismuth-containing quadruple regimens, 10-day regimens had similar efficacy and lower incidence of adverse effects. Therefore, the 10-day regimen is safe and well-tolerated and should be recommended for H. pylori infection.

Diagnosis and treatment of Helicobacter pylori infection by physicians in China: A nationwide cross-sectional study.

To investigate the current state of knowledge and practice of Helicobacter pylori (H.pylori) infection management in China. This nationwide, multicenter, cross-sectional questionnaire survey was conducted between March and April 2021 with respect to the diagnosis and treatment of H.pylori infection in 31 provinces, encompassing over 1000hospitals in mainland China. General physician information, diagnostic and detection status, eradication treatment, reexamination and follow-up after treatment, and basic knowledge of physicians were collected and compared with the Fifth Chinese National Consensus Report on Management of H.pylori infection and the 2016Maastricht V/Florence guidelines. The subgroup analysis was also performed. Of the 6873 questionnaire respondents, 48.8% were males, and 51.2% were females. Approximately, 26.5% of respondents indicated that their hospitals had dedicated clinics for managing H.pylori infection. Moreover, 88.0% of respondents prescribed a bismuth-containing quadruple regimen as the initial eradication treatment, and 92.7% deemed the gastric acid suppression critical. Furthermore, 91.0% of respondents routinely recommended a reexamination 1-2months after eradication therapy, and 95.1% advised patients to stop PPI treatment at least 2weeks before reexamination. The detail of following (the choice of target population/methods; the choice/availability of drugs/regimens, indications for eradication, factors influencing eradication efficacy/improvement methods and factors influencing adherence, management options/factors influencing relapse; the timing and methods, awareness of reinfection rates/prevention measures, and the approach to continuing education, awareness of guidelines, and acceptance of current core concepts of management) was also described. Subgroup analysis further revealed that significant differences were existed in being gastroenterologist or not, different education level, professional title, years of working, and provincial administrative regions. Chinese physicians' skills and knowledge about the diagnosis and treatment of H.pylori infection could be improved. More works on education are needed in future.

The status and progress of first-line treatment against Helicobacter pylori infection: a review.

Helicobacter pylori (HP) is a major causative agent of chronic gastritis and peptic ulcer. HP is also engaged in the development of gastric cancer and gastric mucosa-associated lymphoid tissue lymphoma. It is an important pathogenic factor in various other systemic diseases, such as vitamin B12 deficiency, iron deficiency, and idiopathic thrombocytopenia. The current consensus is that unless there is a special reason, eradication therapy should be implemented whenever HP infection is found, and it is ideally successful the first time. International guidelines recommend that under certain conditions, treatment should be personalized based on drug susceptibility testing. However, drug susceptibility testing is often not available because it is expensive, time-consuming, and difficult to obtain living tissue. Each region has separately formulated guidelines or consensuses on empirical therapy. Owing to an increasing drug resistance rate in various places, the eradication rate of proton pump inhibitor (PPI) triple therapy and sequential therapy has been affected. These regimens are rarely used; the PPI triple especially has been abandoned in most areas. Currently, radical treatment regimens for HP involve bismuth-containing quadruple therapy and concomitant therapy. However, quadruple therapy has its own limitations, such as complex drug administration. To improve the effectiveness, safety, and compliance, many clinical studies have proposed useful modified regimens, which mainly include the modified bismuth-containing quadruple regimen, high-dose dual therapy, and vonoprazan-containing regimens. Studies have shown that these emerging regimens have acceptable eradication rates and safety, and are expected to become first-line treatments in empirical therapy. However, the problem of decline in the eradication rate caused by drug resistance has not been fundamentally solved. This review not only summarizes the effectiveness of mainstream regimens in the first-line treatment of HP infection with the currently increasing antibiotic resistance rates, but also summarizes the effectiveness and safety of various emerging treatment regimens.

Evaluation of different proton pump inhibitors combined with bismuth quadruple regimens in Helicobacter pylori eradication.

To evaluate the efficacy and economics of different proton pump inhibitors (PPIs) combined with bismuth quadruple regimens for Helicobacter pylori (Hp) eradication, a retrospective analysis method was used to collect Hp-positive patients who were treated with a bismuth-containing quadruple regimen (PPIs + amoxicillin + furazolidone + colloid pectin bismuth) from the outpatient department of gastroenterology in our hospital from January to June 2017. A total of 1410 patients were included in the study and divided into four groups according to different PPIs: group A (pantoprazole sodium enteric-coated capsules, 352 cases), group B (esomeprazole magnesium enteric-coated tablets, 462 cases), group C (pantoprazole sodium enteric-coated tablets, 392 cases) and group D (rabeprazole sodium enteric-coated tablets, 204 cases). The eradication rate of Hp and cost-saving in each group were then compared. There were no significant differences of gender (P = 0.526) and age (P = 0.366) between each Hp treatment regimen. The eradication rates of groups A, B, C and D were 91.48%, 89.83%, 86.73% and 90.69%, respectively. No statistical differences of Hp eradication rates were observed between each group yet (P > 0.05). However, the cost of group A was the lowest. In the present study, the Hp eradication rates between different PPIs regimens were similar in treating Hp infection. Nevertheless, the point in favor of pantoprazole capsules is the slightly higher Hp eradication rate and lower drug cost than other PPIs, which provides a significant evidence for the clinical medication decision in treating Hp infection.

THE CLINICAL CHARACTERISTICS, ENDOSCOPIC FINDINGS AND THE EFFICACY OF THE BISMUTH-CONTAINING QUADRUPLE REGIMEN INTREATMENT OF PATIENTS WITH HELICOBACTER PYLORIGASTRODUODENAL INFLAMMATORY AND ULCER AT CAN THO HOSPITAL OF UNIVERSITY OF MEDICINE AND PHARMACY

Background: Helicobacter pylori causes inflammation of the gastric mucosa and is associated with many upper gastrointestinal diseases, including chronic gastritis, peptic ulcer disease and gastric cancer. The treatment of Helicobacter pylori still remains many challenges, because many factors such as the resistance of antibiotics, adverse efects or cost of drugs can affect the treatment’s efficacy. Bismuth-containing quadruple regimen is recommended as a first-line therapy in areas with high clarithromycin and metronidazole resistance as well as an option for patients who have previously failed to respond to Helicobacter pylori eradication therapy. Nowadays there have been very few researches on the effectiveness of this regimen including the replacement of Metronidazole by Tinidazole on Helicobacter pylori infection treatment in our country, especially in Can Tho city. Objective: 1. To describe the clinical characteristics and endoscopic findings of patients with Helicobacter pylori gastroduodenal inflammatory and ulcer. 2. To evaluate the efficacy of Bismuth-based therapy for the treatment of Helicobacter pylori infection. Patients and methods: From November 2019 to May 2020 we carried out our study on 40 patients with Helicobacter pylori infection. All of patients received a quadruple therapy consisted of Rapeprazole 20 mg bid, Colloidal bismuth subcitrate 120mg qid, Tetracycline 500mg qid and Tinidazol 500mg tid for 14 days. The diagnosis of Helicobacter pylori infection was performed by Clotest. Four to eight weeks after completion of therapy, Helicobacter pylori status was rechecked by Clotest or C13 urea-breath test. Results: A total of 40 patients with Helicobacter pylori infection were recruited. The most common clinical characteristics was epigastric pain (75%), the most popularly identified endoscopic findings were erythematous gastritis (57.5%) and ulcer (12.5%). The eradication rates of the Bismuth-containing quadruple regimen on intention to treat (ITT) and per-protocol (PP) analysis were 95% and 97.2%, respectively. Adverse effects occurred in 75% of subjects. The common side effects were fatigue, anorexia and nausea. The compliance rate was 97.5%. Conclusion: Bismuth-containing quadruple regimen achieved very high eradication rates. Side effects were common but not serious. The medication adherence rate was high. Key words: Bismuth-containing quadruple regimen, eradication, Helicobacter pylori infection

Cost-effectiveness of a tailored Helicobacter pylori eradication strategy based on the presence of a 23S ribosomal RNA point mutation that causes clarithromycin resistance in Korean patients.

The Helicobacter pylori eradication rate using conventional triple therapy has decreased due to clarithromycin (CAM) resistance in H.pylori. Recently, dual priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) can be used to detect H.pylori and point mutations in the 23S ribosomal RNA gene causing CAM resistance. This study aimed to evaluate the success rate and cost-effectiveness of tailored H.pylori eradication using DPO-PCR. The H.pylori-positive patients diagnosed by a rapid urease test or DPO-PCR were enrolled from a single academic hospital. The patients with positive rapid urease test results received a CAM-based triple regimen. In the tailored therapy group that underwent DPO-PCR testing, patients with A2142G and/or A2143G point mutations were treated with a bismuth-containing quadruple regimen. The cost-effectiveness of H.pylori eradication success was evaluated according to the average cost per patient and the incremental cost-effectiveness ratio. A total of 243 patients were allocated to the triple therapy group and 124 patients to the tailored therapy group. The first-line eradication rate of H.pylori was significantly higher in the tailored therapy group than in the conventional triple therapy group (92.7% vs 76.5%, P<0.001). The average costs per patient for tailored therapy were $307.37 and $299.59 for first-line and second-line treatments, respectively. Compared with triple therapy, the incremental cost-effectiveness ratios of tailored therapy were $3.96 and -$3.81 per patient for first-line and second-line treatments, respectively. In Korea, tailored H.pylori eradication using DPO-PCR may be more cost-effective than conventional triple therapy.

E‐Poster Presentations – A2) Gastric and Duodenal

E‐Poster Presentations – A2) Gastric and Duodenal

THE EFFICACY OF THE BISMUTH-CONTAINING QUADRUPLE REGIMEN IN HELICOBACTER PYLORI INFETION

Background and Objectives: Bismuth-containing quadruple regimen is recommended as an first-line therapy in areas with high clarithromycin and metronidazole resistance as well as an option for patients who have previously failed to respond to Helicobacter pylori eradication therapy. There have been very few researches on the effectiveness of this regimen on Helicobacter pylori infection treatment in our country. The our study aimed to show the efficacy of Bismuth-based therapy for the treatment of Helicobacter pylori infection. Patients and Methods: The study was carried out on 196 patients with Helicobacter pylori infection. All of patients received a quadruple therapy consisted of Rapeprazole 20 mg bid, Colloidal bismuth subcitrate 120mg qid, Tetracycline 500mg qid and Metronidazole 500mg tid for 14 days. The diagnosis of Helicobacter Pylori infection was performed by Clotest or C13 urea-breath test. Four to eight weeks after completion of therapy, Helicobacter pylori status was rechecked by Clotest or C13 urea-breath test. Results: A total of 196 patients with Helicobacter pylori infection were recruited. The eradication rates of the Bismuth-containing quadruple regimen overall, fornaïve,previously failed to respond to Helicobacter pylori eradication therapy on intention to treat (ITT) and per-protocol (PP) analysis were 97.4-97.3%; 98.3-98.1% and 96.3-96.2%. Side effects occurred in 80.5% of subjects. The common side effects were fatigue, anorexia and nausea. The compliancerate was 98.4%. Conclusions: Bismuth-containing quadruple regimen achieved very highe radication rates. Side effects were common but not serious. The medication adherence rate was high. Key words: Bismuth-containing quadruple regimen, eradication, Helicobacter pylori infection

Therapeutic success with bismuth-containing sequential and quadruple regimens in Helicobacter pylori eradication

Background and study aimsThe success rate of Helicobacter pylori (H. pylori) eradication with the classical triple therapy is gradually declining. In this study, we aimed to compare and assess the efficacies of six different eradication regimens including sequential protocols. Patients and methodsEndoscopically confirmed nonulcer dyspepsia patients were enrolled. H. pylori presence was determined either histologically or by a rapid urease test. Treatment-naive patients were randomly assigned to an either one of three 10-day (OAC, OTMB, and OACB) or one of three sequential protocols (OA+OCM, OA+OCMB, and OA+OMDB) (O=omeprazole, A=amoxicillin, C=clarithromycin, T=tetracycline, M=metronidazole, B=bismuth, D=doxycycline). The eradication was assessed 6–8weeks after the completion of the treatment by a 14C-urea breath test. ResultsIn total, 301 patients were included. Fifty-two percent of the participants (n=157) were female, and the mean age was 44.9years (range=18–70). The intention to treat (ITT) and per protocol (PP) eradication rate for each regimen is as follows: OAC (ITT=61.2%, PP=75%), OTMB (83.3%, 87%), OACB (76.5%, 79.6%), OA+OCM (72.3%, 73.9%), OA+OCMB (82.7%, 89.6%), and OA+OMDB (59.3%, 65.3%). Smoking significantly affected the eradication rate (P=0.04). ConclusionIn this study, OTMB and OA+OCMB were significantly superior to the triple therapy and succeeded to reach the eradication rate proposed by the Maastricht consensus (over 80%). These two bismuth-containing regimens could be considered for first-line therapy in the regions with high clarithromycin resistance.

Efficacy of 1st-line bismuth-containing quadruple therapies with levofloxacin or clarithromycin for the eradication of Helicobacter pylori infection

Background:The aim of the present open-label, randomized control trial was to determine the clinical efficacy and safety of two 1-week bismuth-containing quadruple regimens and 1 levofloxacin-based triple regimen for the eradication of Helicobacter pylori infection in treatment-naive patients. The influence of susceptibility and host CYP2C19 polymorphisms on the efficacy was also evaluated.Methods:Eligible patients were randomly to receive esomeprazole and colloidal bismuth pectin along with clarithromycin and amoxicillin (EBCA), esomeprazole and colloidal bismuth pectin along with levofloxacin and amoxicillin (EBLA), or esomeprazole along levofloxacin and amoxicillin (ELA) for 1 week. The primary outcome was the eradication rate in the intention-to-treat (ITT) and per-protocol (PP) analyses.Results:Overall, 270 patients were randomized. The eradication rates in the above 3 groups were 80.25%, 89.66%, and 81.93% in PP analysis and 72.22%, 86.66%, and 75.56% in ITT analysis, respectively. The eradication rate of EBLA was significantly higher than that of EBCA (P = 0.016) in ITT analysis. No significant differences were found among these groups in terms of adverse effects and compliance. The efficacy was significantly affected by levofloxacin resistance for EBLA (P = 0.01) and ELA (P = 0.04), but not by polymorphisms of CYP2C19 gene for any of the 3 groups.Conclusion:All 1-week bismuth-containing quadruple therapies and levofloxacin-based triple therapy can obtain an acceptable eradication rate, and levofloxacin-based quadruple regimen exhibits the highest eradication rate. The antibiotic resistant rate of levofloxacin was associated with the eradication rate.

CHRONIC HELICOBACTER PYLORI GASTRITIS: THE ERADICATION EFFICACY&amp;NBSP;OF THE&amp;NBSP;BISMUTH-CONTAINING QUADRUPLE REGIMEN (EBMT)

Background: there has not been yet any research on the effectiveness of H. pylori eradication of bismuth-containing quadruple regimen on chronic gastritis patients in our country. Objective: to evaluate H. pylori eradication rate of bismuth-containing quadruple regimen according to intention to treat (ITT), per protocol (PP) analysis, the rate of side effects and medication compliance. Subjects and Methods: from March 2014 to January 2016 we used bismuth-containing quadruple regimen (EBMT) 10 days for H. pylori eradication therapy for 166 chronic gastritis patients diagnosed based on clinical, endoscopic, rapid urease test, histology and culture. Patients were evaluated side effects and medication compliance at the end of treatment (day 11-14). To assess the eradication, repeating endoscopy with both rapid urease test and histological examination were performed at 4 to 8 weeks after stopping treatment course. Results: H. pylori eradication rates on ITT and PP analysis overall, for naïve patients, after one and more two eradication failures were respectively: 80.72-89.33%, 79.51-90.65%, 91.67-91.67% and 75.00-78.95%. Medication adherence rate was 96.99%. The rates of patients experiencing moderate, severe and very severe side effects were: 19.88%, 0.60% and 1.81%. Conclusion: the EBMT 10-day regimen attained high eradication rates in chronic gastritis patients with rare serious side effects and the high compliance rate. We should apply bismuth-containing quadruple regimen in H. pylori eradication therapy for naïve patients or after one eradication failure. Key words: bismuth-containing quadruple regimen, EBMT, eradication, chronic Helicobacter pylori gastritis

Eradication rate and histological changes after Helicobacter pylori eradication treatment in gastric cancer patients following subtotal gastrectomy.

To investigate the eradication rate and histological changes after Helicobacter pylori (H. pylori) eradication treatment following subtotal gastrectomy for gastric cancer. A total of 610 patients with H. pylori infection who had undergone surgery for either early or advanced gastric adenocarcinoma between May 2004 and December 2010 were retrospectively studied. A total of 584 patients with proven H. pylori infection after surgery for gastric cancer were enrolled in this study. Patients received a seven day standard triple regimen as first-line therapy and a 10 d bismuth-containing quadruple regimen as second-line therapy in cases of eradication failure. The patients underwent an esophagogastroduodenoscopy (EGD) between six and 12 mo after surgery, followed by annual EGDs. A further EGD was conducted 12 mo after confirming the result of the eradication and the histological changes. A gastric biopsy specimen for histological examination and Campylobacter-like organism testing was obtained from the lesser and greater curvature of the corpus of the remnant stomach. Histological changes in the gastric mucosa were assessed using the updated Sydney system before eradication therapy and at follow-up after 12 mo. Eradication rates with the first-line and second-line therapies were 78.4% (458/584) and 90% (36/40), respectively, by intention-to-treat analysis and 85.3% (458/530) and 92.3% (36/39), respectively, by per-protocol analysis. The univariate and multivariate analyses revealed that Billroth II surgery was an independent factor predictive of eradication success in the eradication success group (OR = 1.53, 95%CI: 1.41-1.65, P = 0.021). The atrophy and intestinal metaplasia (IM) scores 12 mo after eradication were significantly lower in the eradication success group than in the eradication failure group (0.25 ± 0.04 vs 0.47 ± 0.12, P = 0.023; 0.27 ± 0.04 vs 0.51 ± 0.12, P = 0.015, respectively). The atrophy and IM scores 12 mo after successful eradication were significantly lower in the Billroth II group than in the Billroth I group (0.13 ± 0.09 vs 0.31 ± 0.12, P = 0.029; 0.32 ± 0.24 vs 0.37 ± 0.13, P = 0.034, respectively). Patients with H. pylori following subtotal gastrectomy had a similar eradication rate to patients with an intact stomach. H. pylori eradication is recommended after subtotal gastrectomy.

Third-Line Rescue Therapy with Bismuth-Containing Quadruple Regimen After Failure of Two Treatments (with Clarithromycin and Levofloxacin) for H. pylori Infection

Helicobacter pylori eradication therapy with a proton pump inhibitor (PPI), clarithromycin, and amoxicillin fails in >20% of cases. A rescue therapy with PPI-amoxicillin-levofloxacin still fails in >20% of patients. To evaluate the efficacy and tolerability of a bismuth-containing quadruple regimen in patients with two consecutive eradication failures. Prospective multicenter study of patients in whom 1st treatment with PPI-clarithromycin-amoxicillin and 2nd with PPI-amoxicillin-levofloxacin had failed. A 3rd eradication regimen with a 7- to 14-day PPI (standard dose b.i.d.), bismuth subcitrate (120mg q.i.d. or 240mg b.i.d.), tetracycline (from 250 mg t.i.d. to 500mg q.i.d.) and metronidazole (from 250 mg t.i.d. to 500mg q.i.d.). Eradication was confirmed by (13)C-urea-breath-test 4-8weeks after therapy. Compliance was determined through questioning and recovery of empty medication envelopes. Adverse effects were evaluated by means of a questionnaire. Two hundred patients (mean age 50years, 55% females, 20% peptic ulcer/80% uninvestigated-functional dyspepsia) were initially included, and two were lost to follow-up. In all, 97% of patients complied with the protocol. Per-protocol and intention-to-treat eradication rates were 67% (95% CI60-74%) and 65% (58-72%). Adverse effects were reported in 22% of patients, the most common being nausea (12%), abdominal pain (11%), metallic taste (8.5%), and diarrhea (8%), none of them severe. A bismuth-containing quadruple regimen is an acceptable third-line strategy and a safe alternative after two previous H. pylori eradication failures with standard clarithromycin- and levofloxacin-containing triple therapies.

Sa1917 Third-Line Rescue Therapy With Bismuth-Containing Quadruple Regimen After Failure of Two Treatments (With Clarithromycin and Levofloxacin) to Eradicate Helicobacter pylori Infection

Sa1917 Third-Line Rescue Therapy With Bismuth-Containing Quadruple Regimen After Failure of Two Treatments (With Clarithromycin and Levofloxacin) to Eradicate Helicobacter pylori Infection

Efficacy of Bismuth-Containing Quadruple Therapies for Clarithromycin-, Metronidazole-, and Fluoroquinolone-Resistant Helicobacter pylori Infections in a Prospective Study

We assessed the efficacy and safety of 4 bismuth-containing quadruple regimens as empiric therapies for Helicobacter pylori infections in patients who did not respond to previous treatment. We performed a prospective single-center study of 424 patients with H pylori infection that was not eradicated by previous therapies. Patients were assigned randomly to groups given lansoprazole (30 mg twice daily) and bismuth potassium citrate (220 mg twice daily), along with 500 mg tetracycline and 400 mg metronidazole 4 times daily (LBTM), 500 mg tetracycline and 100 mg furazolidone 3 times daily (LBTF), 1000 mg amoxicillin 3 times and 500 mg tetracycline 4 times daily (LBAT), or 1000 mg amoxicillin and 100 mg furazolidone 3 times daily (LBAF). Eradication was assessed by a (13)C-urea breath test. Antimicrobial susceptibility was assessed in 188 patients by the agar dilution method. Per-protocol rates of H pylori eradication were greater than 90% for all regimens: 93.1% for LBTM (95% confidence interval [CI], 88.1%-98.0%), 96.1% for LBTF (95% CI, 92.4%-99.8%), 94.6% for LBAT (95% CI, 90.0%-99.2%), and 99.0% for LBAF (95% CI, 97.0%-100%). The intention-to-treat response rates were 87.9% for LBTM (95% CI, 81.7%-94.0%), 91.7% for LBTF (95% CI, 87.1%-96.3%), 83.8% for LBAT (95% CI, 76.8%-90.9%), and 95.2% for LBAF (95% CI, 91.1%-99.3%). Significantly more patients had infections eradicated by furazolidone-containing regimens than nonfurazolidone regimens (P = .01). Side effects occurred in 33.6% of subjects and occurred significantly more frequently in the LBTM group than the other 3 groups (vs LBTF, P = .006; vs LBAT, P = .003; vs LBAF, P = .02). Metronidazole resistance was 96.8%; no isolates were resistant to amoxicillin, tetracycline, or furazolidone. Four bismuth-containing quadruple therapies achieved greater than 90% eradication of H pylori in patients who did not respond to previous treatment, including patients with metronidazole resistance. For patients allergic to penicillin, tetracycline and either metronidazole- or furazolidone-containing regimens are recommended. ClincialTrials.gov number, NCT01668927.

Helicobacter pylori Eradication with Ecabet Sodium, Omeprazole, Amoxicillin, and Clarithromycin Versus Bismuth, Omeprazole, Amoxicillin, and Clarithromycin Quadruple Therapy: A Randomized, Open‐Label, Phase IV Trial

Helicobacter pylori infection is a substantial public health problem and plays etiological role in the pathogenesis of many gastroduodenal disorders. The addition of ecabet sodium is proven to improve the efficacy of the standard triple therapy. Our aim was to assess the efficacy and safety of ecabet sodium-containing quadruple therapy versus 10-day bismuth-containing quadruple therapy for H. pylori eradication. We did a randomized, open-label, phase IV trial in four cities (eight sites) in China, comparing the efficacy and safety of 10-days ecabet sodium-containing versus bismuth-containing quadruple therapy in adults with H. pylori infection. Eligible patients were randomly assigned treatment and monitored H. pylori eradication by negative [13C]/[14C] urea breath test 28 days after the treatment as the primary outcome. Symptoms improvement and side effects were the secondary outcome. A total of 311 H. pylori-positive subjects were enrolled: 155 were assigned ecabet sodium quadruple therapy and 156 bismuth quadruple therapy. The eradication rates with ecabet sodium-containing and bismuth-containing quadruple regimens were 68.4% (106/155) and 68.0% (106/156) p = .9339 intention-to-treat (ITT) and 75.4% (104/138) and 77.0% (104/135) p = .7453 per-protocol (PP), respectively. The eradication rates for the ecabet sodium quadruple regimen differed significantly between cities (e.g., 81.2% ITT and 89.6% PP in Shanghai and 50% ITT and 53.5% PP in Xi'an). The symptom improvements and safety profiles were also similar for both treatments. Neither 10-day Ecabet sodium-containing quadruple therapy or 10-day bismuth-containing quadruple therapy can be recommended as empiric therapy in cities with high antibiotic resistance rate of China.

Efficacy of Bismuth-Containing Quadruple Therapy as First-line Treatment for Helicobacter pylori Infection

Background and aim: Helicobacter pylori (H. pylori) infection can cause chronic gastritis, peptic ulcer disease, gastric adenocarcinoma and mucosa-associated lymphoid tissue (MALT) lymphoma. For this reason, eradication of H. pylori has become an important issue. In recent years, failure of eradication therapy with standard eradication regimes had directed toward new therapeutic alternatives. The present study aimed to show the efficacy of bismuth-containing quadruple regimen for the first-line treatment of H. pylori infection. Materials and methods: H. pylori positive patients received a quadruple therapy consisted of esomeprazole 20 mg bid, colloidal bismuth subcitrate 600 mg bid, tetracycline 500 mg qid and metronidazole 500 mg tid for 7 days. The diagnosis of H. pylori infection was performed by the histopathological assessment of gastric biopsies. Six weeks after completion of therapy, H. pylori status was rechecked by C14 urea-breath test. Results: A total of 115 patients have completed the protocols (upper gastrointestinal endoscopy, treatment, urea-breath test). H. pylori eradication rate was found to be 87%. This eradication rate is significantly higher than those of classic triple therapies in the literature. Conclusion: The bismuth-containing quadruple regimen achieved an acceptable and very higher eradication rate than those of classic triple therapies in the literature. It can recommend as a first-line therapy for Helicobacter pylori infection. Abbreviations: HP: Helicobacter pylori; MALT: Mucosaassociated lymphoid tissue lymphoma; PPI: Proton pump inhibitor; CPM: Count per minute; SD: Standard deviation.