INTRODUCTION: Whether 10-day short-course vonoprazan-amoxicillin dual therapy (VA-dual) is noninferior to the standard 14-day bismuth-based quadruple therapy (B-quadruple) against Helicobacter pylori eradication has not been determined. This trial aimed to compare the eradication rate, adverse events, and compliance of 10-day VA-dual regimen with standard 14-day B-quadruple regimen as first-line H. pylori treatment. METHODS: This prospective randomized clinical trial was performed at 3 institutions in eastern China. A total of 314 treatment-naive, H. pylori–infected patients were randomly assigned in a 1:1 ratio to either 10-day VA-dual group or 14-day B-quadruple group. Eradication success was determined by ¹³C-urea breath test at least 4 weeks after treatment. Eradication rates, adverse events, and compliance were compared between groups. RESULTS: Eradication rates of VA-dual and B-quadruple groups were 86.0% and 89.2% (P = 0.389), respectively, by intention-to-treat (ITT) analysis; 88.2% and 91.5% (P = 0.338), respectively, by modified ITT analysis; and 90.8% and 91.3% (P = 0.884), respectively, by per-protocol (PP) analysis. The efficacy of the VA-dual remained noninferior to B-quadruple therapy in all ITT, modified ITT, and PP analyses. The incidence of adverse events in the VA-dual group was significantly lower compared with that in the B-quadruple group (P < 0.001). Poor compliance contributed to eradication failure in the VA-dual group (P < 0.001), while not in the B-quadruple group (P = 0.110). DISCUSSION: The 10-day VA-dual therapy provided satisfactory eradication rates of >90% (PP analysis) and lower rates of adverse events compared with standard 14-day B-quadruple therapy as first-line H. pylori therapy. TRAIL REGISTRATION NUMBER: ChiCTR2300070100.

OBJECTIVE: To conduct a meta-analysis of published, full-length, randomized controlled trials evaluating the efficacy of endoscopic band ligation (EBL) versus pharmacological therapy for the primary and secondary prophylaxis of variceal hemorrhage in patients with cirrhosis.METHODS: Literature searches were conducted using the PubMed, EMBASE and Cochrane Library databases. Eighteen randomized clinical trials that fulfilled the inclusion criteria were further pooled into a meta-analysis.RESULTS: Among 1023 patients in 12 trials comparing EBL with beta-blockers for primary prevention, there was no significant difference in gastrointestinal bleeding (RR 0.79 [95% CI 0.61 to 1.02]), all-cause deaths (RR 1.06 [95% CI 0.86 to 1.30]) or bleeding-related deaths (RR 0.66 [95% CI 0.38 to 1.16]). There was a reduced trend toward significance in variceal bleeding with EBL compared with beta-blockers (RR 0.72 [95% CI 0.54 to 0.96]). However, variceal bleeding was not significantly different between the two groups in high-quality trials (RR 0.84 [95% CI 0.60 to 1.17]). Among 687 patients from six trials comparing EBL with beta-blockers plus isosorbide mononitrate for secondary prevention, there was no effect on either gastrointestinal bleeding (RR 0.95 [95% CI 0.65 to 1.40]) or variceal bleeding (RR 0.89 [95% CI 0.53 to 1.49]). The risk for all-cause deaths in the EBL group was significantly higher than in the medical group (RR 1.25 [95% CI 1.01 to 1.55]); however, the rate of bleeding-related deaths was unaffected (RR 1.16 [95% CI 0.68 to 1.97]).CONCLUSIONS: Both EBL and beta-blockers may be considered first-line treatments to prevent first variceal bleeding, whereas beta-blockers plus isosorbide mononitrate may be the best choice for the prevention of rebleeding.

Current endoscopic methods in the control of acute nonvariceal bleeding have a small but clinically significant failure rate. The role of over-the-scope clips (OTSCs) as the first treatment has not been defined. To compare OTSCs with standard endoscopic hemostatic treatments in the control of bleeding from nonvariceal upper gastrointestinal causes. A multicenter, randomized controlled trial. (ClinicalTrials.gov: NCT03216395). University teaching hospitals in Hong Kong, China, and Australia. 190 adult patients with active bleeding or a nonbleeding visible vessel from a nonvariceal cause on upper gastrointestinal endoscopy. Standard hemostatic treatment (n = 97) or OTSC (n = 93). The primary outcome was 30-day probability of further bleeds. Other outcomes included failure to control bleeding after assigned endoscopic treatment, recurrent bleeding after initial hemostasis, further intervention, blood transfusion, and hospitalization. The 30-day probability of further bleeding in the standard treatment and OTSC groups was 14.6% (14 of 97) and 3.2% (3 of 93), respectively (risk difference, 11.4 percentage points [95% CI, 3.3 to 20.0 percentage points]; P = 0.006). Failure to control bleeding after assigned endoscopic treatment in the standard treatment and OTSC groups was 6 versus 1 (risk difference, 5.1 percentage points [CI, 0.7 to 11.8 percentage points]), respectively, and 30-day recurrent bleeding was 8 versus 2 (risk difference, 6.6 percentage points [CI, -0.3 to 14.4 percentage points]), respectively. The need for further interventions was 8 versus 2, respectively. Thirty-day mortality was 4 versus 2, respectively. In a post hoc analysis with a composite end point of failure to successfully apply assigned treatment and further bleeds, the event rate was 15 of 97 (15.6%) and 6 of 93 (6.5%) in the standard and OTSC groups, respectively (risk difference, 9.1 percentage points [CI, 0.004 to 18.3 percentage points]). Clinicians were not blinded to treatment and the option of crossover treatment. Over-the-scope clips, as an initial treatment, may be better than standard treatment in reducing the risk for further bleeding from nonvariceal upper gastrointestinal causes that are amenable to OTSC placement. General Research Fund to the University Grant Committee, Hong Kong SAR Government.

Objectives To determine the incidence and intensity of household impoverishment induced by cancer treatment in China. Design Average income and daily consumption per capita of the households and out-of-pocket payments for cancer care were estimated. Household impoverishment was determined by comparing per capita daily consumption against the Chinese poverty line (CPL, US$1.2) and the World Bank poverty line (WBPL, US$1.9) for 2015. Both pre-treatment and post-treatment consumptions were calculated assuming that the households would divert daily consumption money to pay for cancer treatment. Participants Cancer patients diagnosed initially from 1 January 2015 to 31 December 2016 who had received cancer treatment subsequently. Those with multiple cancer diagnoses were excluded. Data sources A household questionnaire survey was conducted on 2534 cancer patients selected from nine hospitals in seven provinces through two-stage cluster/convenience sampling. Findings 5.89% (CPL) to 12.94% (WBPL) households were impoverished after paying for cancer treatment. The adjusted OR (AOR) of post-treatment impoverishment was higher for older patients (AOR=2.666–4.187 for ≥50 years vs <50 years, p<0.001), those resided in central region (AOR=2.619 vs eastern, p<0.01) and those with lower income (AOR=0.024–0.187 in higher income households vs the lowest 20%, p<0.001). The patients without coverage from social health insurance had higher OR (AOR=1.880, p=0.040) of experiencing post-treatment household impoverishment than those enrolled with the insurance for urban employees. Cancer treatment is associated with an increase of 5.79% (CPL) and 12.45% (WBPL) in incidence of household impoverishment. The median annual consumption gap per capita underneath the poverty line accumulated by the impoverished households reached US$128 (CPL) or US$212 (WBPL). US$31 170 395 (CPL) or US$115 238 459 (WBPL) were needed to avoid household impoverishment induced by cancer treatment in China. Conclusions The financial burden of cancer treatment imposes a significant risk of household impoverishment despite wide coverage of social health insurance in China.