Eradication rates of Helicobacter pylori in treatment-naive patients following 14-day vonoprazan-amoxicillin dual therapy: A multicenter randomized controlled trial in China.

BACKGROUND: Potassium-competitive acid blockers (P-CAB) are recommended for the treatment of Helicobacter pylori infections, but dual therapy of P-CAB with amoxicillin has been poorly studied. The current study compared the efficacy, adverse reactions, compliance, and effects on gut microbiota of 14-day vonoprazan-amoxicillin (VA) dual therapy with esomeprazole, bismuth potassium citrate, amoxicillin, and metronidazole (EBAM) quadruple therapy in treatment-naive patients with H. pylori. MATERIALS AND METHODS: This was a multicenter, open-label, randomized, and controlled, non-inferiority study. Patients (n = 194) enrolled from six centers were randomly divided into either the VA or EBAM group. H. pylori eradication was determined using 13 C urea breath tests (UBT) 4-6 weeks post-treatment. Fecal samples were collected, and gut microbial populations were analyzed by 16S rDNA and metagenomic sequencing technology. RESULTS: Eradication rates of H. pylori in the VA and EBAM groups were 88.7% and 91.8%, respectively, according to intention-to-treat (ITT) analysis; 95.6% and 96.7% with per-protocol (PP) analysis; and 94.5% and 96.7% with modified ITT (mITT) analysis (all p > 0.05). The incidence of adverse reactions in the VA group was significantly lower compared to the EBAM group, and compliance within both groups was good. There was no difference in α-diversity or microbial composition in the VA and EBAM groups at one-month post-treatment compared to baseline, except for a markedly reduced abundance of Bacteroides in the EBAM group. CONCLUSION: VA therapy achieved excellent eradication rates with low adverse reactions, good compliance, and little impact on gut microbiota. VA therapy should be recommended as a first-line treatment against H. pylori.

Prediction of Esophageal Stricture after Endoscopic Submucosal Dissection in Patients with Early Esophageal Cancer.

BACKGROUND: Endoscopic submucosal dissection (ESD) treatment of early esophageal cancer is effective and safe. It is currently the first-line treatment for early esophageal cancer. However, a common side effect is the development of esophageal strictures after ESD. This study was designed to identify the risk factors for esophageal stricture development and to predict its occurrence after ESD. METHODS: In this retrospective study, 150 consecutive patients with early esophageal cancer treated with ESD at Daping Hospital, Chongqing, were enrolled between January 2016 and December 2020. Data on patient demographics, esophageal tumor characteristics, procedure-related factors, and postoperative situations were collected. We identified independent risk factors of esophageal stricture formation using univariate analysis and multivariate logistic regression. The predictive probability was obtained after multivariate logistic analysis. In addition, patients were divided into six groups based on these risk factors and the rate of esophageal stricture in each group was analyzed. RESULTS: The postoperative esophageal stricture rate was 14% (21/150). Tumor location (OR = 5.655, 95% CI: 1.245-25.691, P = 0.025) and circumferential resection range (OR = 16.113, 95% CI: 4.294-60.466, P < 0.001) are independent risk factors for the development of esophageal strictures. According to predictive probability analysis and the rates of stricture in six groups, we developed a possible flow chart to predict stricture formation. CONCLUSIONS: Tumor location and circumferential resection range are reliable risk factors to predict the occurrence of esophageal strictures. Our prediction flow chart suggests that tumors with a circumferential resection range of 1/2-3/4 and located above the upper thoracic segment or a circumferential resection range of > 3/4 have a high risk of postoperative stricture. Thus, timely and effective preventive measures should be taken in these patients following ESD.

High-dose dual therapy versus culture-based susceptibility-guided therapy as a rescue regimen for Helicobacter pylori infection: a randomized controlled trial.

Background: Although the Maastricht VI/Florence consensus report recommended high-dose proton pump inhibitor-amoxicillin dual therapy as possible rescue therapy for Helicobacter pylori infection, clinical evidence of its efficacy was lacking. Objectives: To compare the efficacy, safety, patient compliance, and cost between high-dose dual therapy (HDDT) and culture-based susceptibility-guided therapy (CB-SGT) as a rescue regimen for H. pylori infection. Design: A single-center, open-label, randomized controlled clinical trial. Methods: In all, 146 patients with a history of eradication failure were enrolled and randomly assigned to receive HDDT or CB-SGT. HDDT consisted of esomeprazole 20 mg and amoxicillin 750 mg, both given four times per day (qid). CB-SGT consisted of esomeprazole 20 mg twice daily (bid), amoxicillin 1000 mg bid plus clarithromycin 500 mg bid, metronidazole 400 mg bid, or levofloxacin 500 mg daily (qd) for sensitive patients, in that order. For patients with triple resistance, a bismuth-containing regimen with a high dose of metronidazole was chosen, including esomeprazole 20 mg bid, bismuth 220 mg bid, amoxicillin 1000 mg bid, and metronidazole 400 mg qid. All regimens were given for 14 days. Results: The eradication H. pylori rates achieved with HDDT in the intention-to-treat (ITT), per-protocol, and modified ITT analyses were all 84.9% [62/73, 95% confidence interval (CI): 76.5-93.9%], compared with 83.6% (61/73, 95% CI: 74.9-92.3%), 84.7% (61/72, 95% CI: 76.2-93.2%), and 84.7% (61/72, 95% CI: 76.2-93.2%) with CB-SGT, respectively. For patients with CYP2C19 polymorphisms of intermediate/poor metabolizers, the eradication rates of HDDT and CB-SGT were 90.70% (39/43, 95% CI: 77.86-97.41%) and 84.21% (32/38, 95% CI: 68.75-93.98%), respectively. The difference between groups was 6.49% (95% CI: -8.00% to 20.97%), and the non-inferiority p value was 0.0128. For patients with a treatment interval of more than 3 months, the eradication rates of the two regimens reached 88.71% (95% CI: 78.11-95.34%) and 71.97% (95% CI: 70.02-90.64%). The difference between groups was 6.74% (95% CI: -5.71% to 19.20%), with a non-inferiority p value of 0.0042. Patient adherence was high in both groups. The HDDT had a lower cost and rate of side effects (p < 0.001) compared with CB-SGT. Conclusions: HDDT can reach an eradication rate of 85% in treatment-experienced patients of H. pylori infection and 91% in patients with CYP2C19 polymorphisms of intermediate/poor metabolizers, with good compliance, lower side effects and costs, and less use of antibiotics. In conclusion, HDDT offers an effective rescue regimen for H. pylori infection. Registration: This clinical trial was registered at the Chinese Clinical Trail Registry (trail registration number: ChiCTR1900025044).

10-Day and 14-day high-dose dual therapy for the treatment of Helicobacter pylori: A propensity score matching analysis.

BACKGROUND: Inconsistent eradication rates for Helicobacter pylori have been reported worldwide with dual therapy, perhaps owing to the difference in dose administration and treatment duration. This retrospective study aimed to determine whether high-dose dual therapy (HDDT) with different regimens leads to different eradication rates. The study compares the efficacy and safety of HDDT 10-day vs 14-day and investigates the factors that might affect the eradication rates. MATERIALS AND METHODS: Two comparable treatment groups were based on propensity score matching (PSM). Patients were divided into two groups based on the therapy they underwent: 10-day HDDT and 14-day HDDT (20 mg esomeprazole and 750 mg amoxicillin, administered four times daily). The eradication rates, adverse events (AEs), patient compliance, CYP2C19 gene polymorphisms, and antibiotic resistance rates of the two groups were compared. RESULTS: The intention to treat (ITT) analysis showed that the eradication rates for 10-day and 14-day groups were 78.4% (95% CI 69.6%-87.2%) and 89.7% (95% CI 83.3%-96.2%; p = .039), respectively, while the per-protocol (PP) eradication rates were 80.0% (95% CI 71.3%-88.7%) and 92.9% (95% CI 87.4%-98.5%; p = .014), respectively. The corresponding drug-related AEs were 6.8% (6/88) and 5.7% (5/88; p = .755). No significant differences were observed between the compliance rates of the two groups. The CYP2C19 gene polymorphism had no effect on the eradication rates of the two groups. CONCLUSION: The results showed that the 14-day HDDT affords a higher H. pylori eradication rate than the 10-day HDDT.