Key result
Wenxin Keli shows antiarrhythmic potential, but definitive clinical efficacy remains unproven across existing trials.
Why the study?
Conventional antiarrhythmic drugs have significant proarrhythmic risks and extracardiac toxicity, motivating evaluation of Wenxin Keli as a potentially safer alternative with unclear pharmacological and clinical evidence.
Does Wenxin Keli, as monotherapy or combination therapy, improve rhythm control and clinical outcomes in patients with cardiac arrhythmias?
Does Wenxin Keli, as monotherapy or combination therapy, improve rhythm control and clinical outcomes in patients with cardiac arrhythmias?
While Wenxin Keli shows potential as a multi-target complementary therapy for arrhythmias, widespread clinical adoption is hindered by significant methodological weaknesses in current evidence and a critical need for rigorous long-term safety and pharmacokinetic trials.
Wenxin Keli should not enter clinical arrhythmia care; leaves open its multi-target potential pending rigorous international RCTs.
Cardiac arrhythmias remain a leading cause of cardiovascular morbidity and mortality worldwide. Although conventional antiarrhythmic drugs are effective, their use is constrained by proarrhythmic risks and extracardiac toxicity. Wenxin Keli (WXKL), a traditional Chinese medicine (TCM) formula, has demonstrated antiarrhythmic properties in preclinical and clinical studies with a reportedly favorable safety profile. This article provides a critical synthesis of WXKL's pharmacological mechanisms, including ion channel modulation (INa, ICaL, Ito), calcium handling, and calcium/calmodulin-dependent protein kinase II signaling, with explicit appraisal of translational limitations. Clinical trial evidence and meta-analyses for atrial fibrillation (AF), premature ventricular contractions, and other indications were systematically evaluated, with detailed discussion of effect sizes, heterogeneity, and methodological quality. Key challenges unique to WXKL as a TCM-derived product-formulation variability, quality control limitations, and regulatory approval pathways-are analyzed in depth. A prioritized research agenda is proposed to address evidence gaps. *These authors contributed equally to this work and share first authorship.
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Fu et al. (2026) conducted a review in Cardiac arrhythmias. Wenxin Keli vs. Conventional antiarrhythmics or placebo was evaluated. Wenxin Keli demonstrates multi-target antiarrhythmic potential, but definitive clinical efficacy remains unproven due to severe methodological flaws and a lack of rigorous international trials.
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