Berberine containing quadruple therapy for initial Helicobacter pylori eradication: An open-label randomized phase IV trial.

BACKGROUND: Due to increasing antimicrobial resistance, a bismuth-based quadruple regimen has been recommended as an alternative first-line therapy for Helicobacter pylori (H pylori) eradication. However, different results are varied greatly and the availability of bismuth was limited in some countries. We assessed the efficacy and safety of 14-day berberine-containing quadruple therapy as an alternative regimen for H pylori eradication. METHODS: In a randomized, open-label, non-inferiority, phase IV trial between November 25, 2014, and October 15, 2015, 612 treatment-naive patients were randomly assigned to 14-day berberine-containing (n = 308) or 14-day bismuth-containing (n = 304) quadruple therapy. The primary outcomes were eradication rates determined by the C urea breath test (C-UBT) 28 days after the end of treatment. The secondary outcomes were adverse events and compliance. RESULTS: The baseline demographic data including age, gender, body mass index (BMI), general condition and severity score were not statistically different in both groups. The eradication rates in bismuth and berberine groups were 86.4% (266/308) and 90.1% (274/304) in intention-to-treat (ITT) analysis (P = .149), and 89.6% (266/297) and 91.3% (273/299) in per-protocol (PP) analysis (P = .470), respectively. No statistically significant difference was found in the overall incidence of adverse events between both groups (35.7% vs 28.6%, P = .060). CONCLUSIONS: Both regimens achieved the recommended efficacy for H pylori eradication. The berberine-containing quadruple regimen was not inferior to bismuth-containing quadruple regimen and can be recommended as an alternative regimen for H pylori eradication in the local region.

Identification and thermal stability of purple-fleshed sweet potato anthocyanins in aqueous solutions with various pH values and fruit juices.

Thirteen anthocyanins were identified in the purple-fleshed sweet potato cultivar Jihei No. 1. The main anthocyanins were 3-sophoroside-5-glucoside derivatives from cyanidin and peonidin, acylated with p-hydroxybenzoic acid, ferulic acid, or caffeic acid. A unique anthocyanin, delphinidin-3,5-diglucoside was also found. The thermal stability of purple-fleshed sweet potato anthocyanins (PSPAs) followed a first-order kinetics model. Aqueous solutions with various pH (2, 3, 4, 5, and 6) and fruit juices (apple, pear, grapefruit, orange, tangerine, kiwifruit, and lemon) were coloured with PSPAs. The enrichment and degradation kinetics of anthocyanins in these matrices were investigated at 80, 90, and 100°C. A higher stability of anthocyanins was obtained in aqueous solutions with pH 3 and 4 and in apple and pear juices. Moreover, the activation energies for PSPA degradation in aqueous solutions with various pH and fruit juices ranged from 66.56 kJ/mol to 111.57 kJ/mol and 46.76 kJ/mol to 75.68 kJ/mol, respectively.