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

BACKGROUND: 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. METHODS: 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 20 mg twice daily; bismuth 220 mg twice daily; amoxicillin 1000 mg twice daily; and either clarithromycin 500 mg twice daily or tetracycline 500 mg four times daily. At least 6 weeks after treatment, we performed a 13C-urea breath test to evaluate H. pylori eradication. RESULTS: 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. 14 days 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. CONCLUSION: 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).

High-dose dual therapy versus bismuth-containing quadruple therapy for the eradication of Helicobacter pylori: A systematic review and meta-analysis.

OBJECTIVE: To update evidence-based data comparing the efficacy and safety of high-dose dual therapy (HDDT) and bismuth-containing quadruple therapy (BQT) in eradicating Helicobacter pylori infection through meta-analysis. METHODS: Multiple databases were systematically searched for randomized controlled trials (RCTs) published up to May 18, 2023. Dichotomous data were evaluated using risk ratio (RR) and 95% confidence interval (CI). Subgroup analysis, sensitivity analysis, risk of bias assessment, and quality of evidence evaluation were performed. RESULTS: Twenty RCTs containing 7891 subjects were included in the analysis. There was no statistically significant difference in H. pylori eradication rate between HDDT and BQT in the intention-to-treat (ITT) analysis (86.31% vs 84.88%; RR 1.02, 95% CI 1.00-1.04, P = 0.12). In the per-protocol (PP) analysis, the eradication rates for HDDT and BQT were 90.27% and 89.94%, respectively (RR 1.01, 95% CI 0.99-1.03, P = 0.44). Adverse events were significantly lower with HDDT than with BQT (RR 0.44, 95% CI 0.38-0.51, P < 0.00001). Patient adherence was significantly different between the two groups (RR 1.01, 95% CI 1.00-1.03, P = 0.02). Subgroup analysis based on antibiotic combinations within the BQT group showed a significantly higher eradication rate for HDDT than for BQT only when BQT used amoxicillin combined with clarithromycin (P = 0.0009). CONCLUSIONS: HDDT showed comparable efficacy with BQT for H. pylori eradication, with fewer adverse effects and higher compliance. Due to regional differences, antibiotic resistance rates, and combined BQT antibiotics, more studies are needed for further validation and optimization of HDDT.

Efficacy and safety of cold snare polypectomy versus cold endoscopic mucosal resection for resecting 3-10 mm colorectal polyps: Systematic review and meta-analysis of randomized controlled trials.

Introduction The safety and efficacy of cold snare polypectomy (CSP) compared to those of cold endoscopic mucosal resection (CEMR) have been reported. This meta-analysis compared the efficacy and safety of CEMR and CSP. Methods PubMed, EMBASE, Web of Science, and Cochrane Library databases were systematically searched to identify randomized controlled trials comparing the efficacy and safety of CEMR and CSP in removing 3-10 mm polyps. The outcomes assessed included complete resection rate, intraoperative bleeding rate, delayed bleeding rate, perforation, and polyp removal time. The results are reported as risk ratios (RR) and 95% confidence intervals (CI) derived from a Mantel-Haenszel random effects model. Results Seven studies comprising 1,911 polyps were included in the analysis. The complete resection rate of CEMR was comparable to that of CSP (RR: 1.01, 95% CI: 0.99-1.04, P = 0.32). Comparable results were also demonstrated for intraoperative bleeding rate (polyp-based analysis: RR: 1.22, 95% CI: 0.33-4.43, P = 0.77), delayed bleeding rate (polyp-based analysis: RR: 1.34, 95% CI: 0.44-4.15, P = 0.61), and polyp removal time (mean difference: 28.31 s, 95% CI: -21.40~78.02, P=0.26). No studies reported cases of perforation. Conclusion CEMR has comparable efficacy and safety to CSP in removing 3-10 mm polyps. Further randomized controlled trials with long-term follow-up are warranted to compare and validate efficacy.

Efficacy and safety of a 14-day modified concomitant therapy for refractory Helicobacter pylori infection: a pilot study.

BACKGROUND AND AIM: After three treatment failures, Helicobacter pylori infection is deemed refractory as antibiotic treatment options become significantly limited. This study evaluated the efficacy and safety of a 14-day modified concomitant therapy for managing refractory H. pylori infection. METHODS: Patients who had failed to respond to three or more rounds of H. pylori therapies were recruited for this study. They received a 14-day modified concomitant therapy, including esomeprazole 40 mg, amoxicillin 1000 mg, and furazolidone 100 mg twice daily and tetracycline 500 mg four times daily. Demographic data, adverse events, and patient compliance were recorded. The presence of H. pylori was reevaluated 6 weeks following treatment. Eradication rate was assessed as the primary outcome. RESULTS: Overall, 59 participants received the 14-day modified concomitant therapy. In the intention-to-treat and per-protocol analyses, the eradication rate was 84.7% (50/59) and 89.3% (50/56), respectively. H. pylori was successfully isolated from 75.0% (12/16) of patients. The resistance rate of H. pylori to metronidazole, levofloxacin, and clarithromycin was 91.7% (11/12), 58.3% (7/12), and 50.0% (6/12), respectively. Resistance to amoxicillin, furazolidone, or tetracycline was not observed. The frequency of adverse events was 35.6% (21/59), with no serious adverse events reported. CONCLUSION: The 14-day modified concomitant therapy appears to be appropriate for refractory H. pylori infection and is particularly promising for the Chinese population. A randomized controlled trial is warranted to verify its efficacy, especially in the current environment of increasing antibiotic resistance.

Inadequate gastric preparation and its associated factors for magnetically controlled capsule endoscopy.

Goals: To explore factors associated with inadequate gastric preparation for MCE. Background: Factors associated with inadequate gastric preparation for magnetically controlled capsule endoscopy (MCE) remains unclear. Study: Data of patients who underwent MCE from June 2021 to July 2022 were prospectively collected. The gastric cleanliness score (GCS) of the six stomach regions (gastric cardia, fundus, body, angulus, antrum, and pylorus) was recorded. Patients with GCS score ≥18 were defined as the adequate preparation. Factors related to inadequate gastric preparation were analyzed using a logistic regression model with estimated odds ratios (OR). Results: The mean GCS score of 211 patients was 17.01 ± 2.82. In the multivariable analysis, proton pump inhibitor (PPI) use (OR 3.57; 95% CI 1.69-7.95; p < 0.01) and premedication time after administering simethicone <30 min (OR 2.86; 95% CI 1.10-7.39; p = 0.03) were independent risk factors for inadequate gastric preparation. Comparing the gastric cleanliness of different locations, the median GCS of the lower stomach [10.00, IQR (9.50, 11.00)] was significantly higher than that of the upper stomach [7.00, IQR (6.00, 8.00)] (p <0.001). Conclusion: PPI use and inadequate premedication time (<30 min) may reduce the quality of gastric preparation for MCE. The type, dose, duration of medication, and discontinuation time of PPIs was well worth further exploration. Appropriate control of the type and time of premedication may be the key to improving overall gastric cleanliness.

Vonoprazan is noninferior to proton pump inhibitors in bismuth-containing quadruple therapy for the treatment of Helicobacter pylori infection: A propensity score matching analysis.

OBJECTIVE: This study aimed to evaluate the efficacy and safety of vonoprazan (VPZ) versus proton pump inhibitor (PPI) in clarithromycin-based bismuth-containing quadruple therapy (C-BQT) for the treatment of Helicobacter pylori (H. pylori) eradication. METHODS: Medical records of patients in whom H. pylori was eradicated between 1 July 2018 and 31 December 2021 were retrieved retrospectively from the Outpatient Unit of Qilu Hospital. Efficacy, safety, and compliance were compared between VPZ-based and PPI-based C-BQT, containing vonoprazan 20 mg or proton pump inhibitors (lansoprazole 30 mg or esomeprazole 20 mg), bismuth 220 or 200 mg, amoxicillin 1000 mg, and clarithromycin 500 mg, twice daily for 2 weeks by 1:1 propensity score matching analysis. The trial was registed on ClinicalTrials.gov (registration no. NCT05301725). RESULTS: The H. pylori eradication rates of VPZ-based and PPI-based therapies were 88.8% (151/170) and 87.6% (149/170) in the intention-to-treat analysis, 94.1% (144/153) and 91.1% (144/158) in the per-protocol analysis, respectively. The noninferiority of VPZ to PPI was confirmed in all analyses (P < 0.001). The incidence of adverse events was 30.0% (51/170) and 27.1% (46/170) in the VPZ-based and PPI-based groups, respectively. VPZ-based and PPI-based therapies were well tolerated and showed good patient compliance without significant differences. CONCLUSIONS: VPZ-based therapy resulted in a satisfactory eradication rate and was well tolerated for H. pylori eradication, which are comparable to PPIs in C-BQT as a first-line treatment for H. pylori infection.

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 10 days of treatment than in those who received 14 days 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.

Implementation of WeChat-based patient-doctor interaction in the management of Helicobacter pylori infection: A propensity score matching analysis.

OBJECTIVE: We aimed to investigate if the WeChat-based patient-doctor interaction could affect treatment outcomes of Helicobacter pylori (H. pylori) eradication compared with conventional patient education (CPE) alone. METHODS: Patients treated for H. pylori infection for the first time at our clinic from 1 July 2019 to 31 July 2021 were retrospectively included and divided into the CPE and WeChat groups. Both groups received CPE including verbal education and a specifically designed printout with detailed instructions. Those in the WeChat group were required to join a physician-managed WeChat group chat and they were encouraged to ask questions for clarification. Baseline characteristics were matched using propensity score matching between the two groups. Relevant knowledge and instructions were occasionally shared. Eradication rate, compliance, and adverse events in the two groups were evaluated. RESULTS: A total of 348 patients were included after propensity score matching. Intention-to-treat analysis revealed eradication rate of 85.6% in the WeChat group and 80.5% in the CPE group (P = 0.199), whereas the per-protocol eradication rate was 91.1% and 88.2% (P = 0.399), respectively. Compliance did not differ between the two groups (WeChat group vs CPE group: 92.5% vs 91.4%, P = 0.693). The incidences of adverse events were also comparable between the two groups. CONCLUSIONS: CPE utilization already yields fair H. pylori eradication rate; however, the WeChat-based patient-doctor interaction did not yield better results. More appropriate managements are needed in the future to explore the impact of the WeChat platform on H. pylori eradication.

Clinical practice of Helicobacter pylori infection management by gastroenterologists in secondary and tertiary hospitals: A stratified sampling cross-sectional survey.

OBJECTIVE: To investigate the management of Helicobacter pylori (H. pylori) infection by gastroenterologists from secondary and tertiary hospitals in Shandong Province, China, where there is a high prevalence of H. pylori infection. METHODS: A questionnaire-based, stratified sampling survey was conducted from June 1 to August 30, 2021. The ratio of secondary to tertiary hospitals was set at 2:1. An electronic questionnaire was sent to the gastroenterologists via the WeChat platform. RESULTS: A total of 89.09% (1053/1182) gastroenterologists were included. Overall, 34.19% and 60.59% of gastroenterologists recommended screening for and treating H. pylori infection in patients without any competing factors. The most preferred testing method in secondary and tertiary hospitals was the 13 C-urea breath test (53.92% and 80.48%), but the reexamination rate of results close to the cut-off value was low (55.10% and 59.48%). Gastroenterologists preferred bismuth-containing quadruple therapy (secondary and tertiary hospitals: 96.67% and 98.53%), but the antibiotic combination prescribed for patients with penicillin allergy was suboptimal in secondary hospitals. The overall post-treatment follow-up rate was 64.58%, and gastroenterologists in secondary hospitals were more proactive than those in tertiary hospitals (69.41% vs 60.04%, P = 0.001). Less than 80% of gastroenterologists emphasized the importance of post-treatment reexamination to their patients. Only a minority of gastroenterologists in secondary and tertiary hospitals (30.79% and 34.36%) achieved acceptable eradication rates (exceeding 80%). CONCLUSIONS: Deficiencies exist in gastroenterologists from secondary and tertiary hospitals, and the H. pylori eradication rate is relatively low. Training programs for gastroenterologists are warranted to strengthen their comprehension of guidelines.

[Retrospective study on volume of bone cement injection for concurrent of fracture after thoracolumbar vertebraes kyphoplasty].

OBJECTIVE: To explore relationship between volume of bone cement injection and concurrent of fracture after thoracolumbar osteoporotic vertebral fracture treated by percutaneous kyphoplasty (PKP). METHODS: From January 2006 to December 2008,68 patients with thoracolumbar osteoporotic vertebral fracture treated by PKP were retrospectively analyzed. Among them, 30 patients with less than 3 ml bone cement injection (mean 2.5 ml, low group), including 11 males and 19 females, with an average age of (85.0 +/- 8.5) years (ranging for 60 to 91); 38 cases with over 4 ml bone cement injection (mean 4.5 ml, large group), including 15 males and 23 females,with an average age of (86.0 +/- 9.2) years (ranging for 60 to 93). Factors of concurrent vertebral fractures were observed during follow-up. RESULTS: All patients were followed up from 3.4 to 5.1 years with an average of 3.8 years. Thirteen patients (43.3%) co-occurred fracture in low group,among which strengthened concurrent vertebral fracture occurred in 1 case,upper and lower section adjacent vertebral fracture in 8 cases,distal segment of vertebral fracture in 4 cases; while 18 patients (47.3%) co-occurred fracture in large group,among which strengthened concurrent vertebral fracture occurred in 2 cases, upper and lower section adjacent vertebral fracture in 10 cases,distal segment of vertebral fracture in 6 cases. No significant difference between two groups (P > 0.05). CONCLUSION: Bone cement injection is not main influence factors for treating concurrent of fracture after thoracolumbar osteoporotic vertebral fracture by PKP. Concurrent fracture mainly relates with progress of osteoporosis, the volume of injection volume may appropriately over the volume of balloon.

[Clinical observation of effects and complications of the mid-stage in treating osteoporotic vertebral compression fracture with percutaneous kyphoplasty].

OBJECTIVE: To observe the clinical effects and complications in treating osteoporotic vertebral fractures with percutaneous kyphoplasty (PKP) and in order to found the cause and countermeasures of the complications. METHODS: From March 2006 to March 2007, 31 patients with osteoporotic vertebral fractures were treated with unilateral percutaneous kyphoplasty. There were 11 males and 20 females, ranging in age from 54 to 91 years with the mean of 81 years. All patients were followed up for more than three years. At pre-treatment and postoperatively immediately, 1, 2, 3 years after PKP, the height of anterior vertebral body and thoracic-lumbar and back pain were respectively analyzed by imaging data and VAS scoring. RESULTS: At pre-treatment and postoperatively immediately, 1, 2, 3 years after PKP, the height of anterior vertebral body were (0.9 +/- 0.2), (2.6 +/- 0.3), (2.6 +/- 0.2), (2.5 +/- 0.7), (2.5 +/- 0.4) cm, respectively; the VAS soring were (7.6 +/- 1.4), (2.3 +/- 0.7), (2.4 +/- 0.5), (2.8 +/- 0.3), (3.1 +/- 0.2) scores, respectively. The height of anterior vertebral body recoveried obviously after PKP (P < 0.05); following prolongation of time, the height of anterior vertebral body gradually reduced (P > 0.05). The thoracic-lumbar and back pain relieved obviously after PKP (P < 0.05); following prolongation of time, the pain gradually aggratated, but there was no significant difference (P > 0.05). At final follow up, reinforced vertebral re-fractures was found in 2 cases, adjacent vertebral fractures in 6 cases, distal vertebral fractures in 2 cases, asymptomatic degeneration of adjacent intervertebral in 5 cases. CONCLUSION: PKP have definite and early effects in treating osteoporotic vertebral fractures. But in mid-stage after PKP, the height of anterior vertebral body reduce and the pain aggravate gradually, especially degenerative adjacent vertebral fracture advent. Strict choosing the candidate of the precedure, improvement of materials of perfusion and reducing of volume of bone cement maybe can decrease incidence rate of complications.