Efficacy and safety of triple therapy containing berberine hydrochloride, amoxicillin, and rabeprazole in the eradication of Helicobacter pylori

Abstract

Objective To estimate the effectiveness and safety of triple therapy containing berberine, amoxicillin, and rabeprazole in the eradication of Helicobacter pylori (H. pylori). Methods This prospective, randomized controlled, open‐label, noninferiority trial included treatment‐naive patients with H. pylori infection who were randomly allocated at a ratio of 1:1 into the berberine triple therapy group (berberine hydrochloride 300 mg thrice daily, amoxicillin 1 g twice daily, and rabeprazole 10 mg twice daily) or standard bismuth‐containing quadruple therapy group (amoxicillin 1 g twice daily, rabeprazole 10 mg twice daily, clarithromycin 500 mg twice daily, and bismuth tartrate 200 mg twice daily) for 14 days. Negative 13C/14C‐urea breath test at 4 weeks after completion of the therapy was regarded as successful eradication. Results Altogether 262 and 262 patients received berberine triple therapy and bismuth‐containing quadruple therapy, respectively. Both intention‐to‐treat (79.8% vs 80.9%, P = 0.742) and per‐protocol analyses (83.6% and 85.1%, P = 0.636) showed comparable eradication rate between the two groups, indicating a noninferior eradication rate (the lower limit of the 95% confidence interval over −10% [−7.9% and −7.87%, respectively]). Adverse events more commonly occurred in the bismuth‐containing quadruple‐therapy group (8.8% vs 16.0%, P = 0.012), while patient compliance and symptom improvement of the two regimens were comparable. Conclusion Triple therapy containing berberine, amoxicillin and rabeprazole is noninferior to bismuth‐containing quadruple therapy in the initial treatment for H. pylori eradication.

Vonoprazan‐based therapies versus PPI‐based therapies in patients with H. pylori infection: Systematic review and meta‐analyses of randomized controlled trials

“…Of these, 759 articles were excluded after the review of titles and abstracts. Finally, 27 studies were included in this meta‐analysis 19–24,27–47 . Seventeen studies were two‐arm RCTs, eight were three‐arm RCTs, and two were four‐arm RCTs.…”

“…However, in these meta‐analyses, only a limited number of studies were included, and the effect of different amoxicillin dosing frequency, and the treatment duration were not considered when synthesizing the results. Moreover, studies with vonoprazan‐based quadruple therapy have been published only recently and thus were not included in the currently published meta‐analyses 19–24 . Hence, a comprehensive comparative analyses of the efficacy and safety of VA dual therapy, VAC triple therapy, and vonoprazan‐based bismuth‐containing quadruple therapy (QBQT), and vonoprazan‐based versus PPI‐based therapies with the consideration of amoxicillin dosing frequency and duration of therapy is needed to guide the treatment of patients with H. pylori infection.…”

Efficacy and Safety of Potassium-Competitive Acid Blockers Versus Proton Pump Inhibitors as Helicobacter pylori Eradication Therapy: A Meta-Analysis of Randomized Clinical Trials

“…However, for salvage therapy (RR=1.20; 95%CI: 0.82-1.75; P= 0.34; I2= 69%), no significant differences were observed between the two groups (Figure 6). References: [39,41,42,44,[46][47][48][49][50][51][52][53][54] P-CAB: potassium-competitive acid blocker; PPI: proton-pump inhibitor; PPA: per-protocol analysis Subgroup analysis based on the country in which the study was conducted: Pooling data from a total of 13 RCTs that assessed eradication rates using a PPA, our analysis revealed significant overall results favoring the P-CAB group over the PPI group (RR=2.02; 95%CI: 1.33-3.08; P= 0.001; I2= 49%). These findings remained consistent when we analyzed the subgroup-specific to Japan (RR=3.33; 95%CI: 1.83-6.06; P< 0.0001; I2= 35%).…”

“…However, for the other countries included in the study, no significant differences were identified between the two groups (RR=1.35; 95%CI: 0.96-1.90; P= 0.09; I2= 0%) (Figure 7). References: [39,41,42,44,[46][47][48][49][50][51][52][53][54] P-CAB: potassium-competitive acid blocker; PPI: proton-pump inhibitor; PPA: per-protocol analysis…”

“…References: [39,41,42,44,[46][47][48][49][50][51][52][53][54] Subgroup analysis based on the country in which the study was conducted: Incorporating a total of 13 RCTs that evaluated eradication rates through an ITT analysis, the findings indicated significant overall results in favor of the P-CAB group compared to the PPI group (RR=1.09; 95%CI: 1.02-1.16; P= 0.01; I2= 65%). These results remained consistent when examining the subgroup specific to Japan (RR=1.21; 95%CI: 1.08-1.34; P< 0.0006; I2= 45%).…”