Traditional Chinese medicine-induced cardiac adverse reactions: a critical review of current evidence, knowledge gaps, and pharmacovigilance strategies.

Traditional Chinese Medicine (TCM) holds considerable promise for managing cardiovascular conditions, but its cardiac safety continues to raise legitimate clinical concerns. In this critical review, we synthesize what is currently known about TCM related cardiac adverse reactions, including epidemiological patterns, offending botanical drug metabolites, toxicological pathways, and pharmacovigilance practices. What emerges from our systematic evaluation is a body of evidence that is surprisingly thin in key areas, with knowledge gaps that seriously undermine both risk assessment and clinical decision making. We argue that the field relies too heavily on descriptive case reports and spontaneous notifications, lacks validated causality tools suited to complex botanical drug matrices, and has yet to translate mechanistic discoveries into actionable predictive models. Methodological weaknesses are pervasive: pharmacokinetic and pharmacodynamic interaction data are scarce, real world evidence remains underused in regulatory contexts, and no specific biomarkers exist for early detection of cardiac injury. Preclinical findings, moreover, are difficult to extrapolate to human physiology, and post marketing surveillance systems lag far behind what is needed. In response, we outline a practical agenda that prioritises TCM tailored pharmacovigilance protocols, leverages advanced analytical and computational platforms, and calls for stronger international data sharing frameworks. Our ultimate aim is not merely to catalogue problems, but to offer a critical yet constructive foundation for advancing the cardiac safety science of TCM, so that its integration into global healthcare can proceed on firmer, more evidence based ground.