Systematic developments of evidence-based Chinese herb-drug interaction monographs for a clinical decision-support database

Introduction The global use of Chinese herbal medicines (CHMs) alongside pharmaceutical drugs has increased the need for systematic assessment of herb–drug interactions (HDIs) to support safe integrative practice. However, existing databases show limited CHM coverage, inconsistent evidence grading, and poor clinical interpretability. This review describes the systematic development of evidence-based Chinese HDI monographs for IMgateway (https://www.imgateway.net), using dual-language English and Chinese evidence, predefined evidence-level classification, causality assessment, and interaction likelihood grading to support clinically interpretable decision-making. Methods A structured three-phase methodology was applied to evaluate 200 commonly used Chinese herbs. Comprehensive searches were conducted across English- and Chinese-language databases. Standardized criteria were developed to assess interaction likelihood, strength of evidence, mechanistic plausibility, causality, and potential clinical relevance across different levels of available evidence. Results A total of 497 peer-reviewed articles were included, from which 595 HDI monographs were developed. The included evidence comprised clinical studies, including randomized controlled trials (RCTs) and human case reports, and preclinical studies, including in vitro and in vivo investigations. Based on monograph classification, 241 monographs were derived from RCTs, 27 from human case reports, and 327 from preclinical studies. Interactions were categorized according to evidence level and assigned likelihood classifications. Seven HDIs were categorized as “avoid combination,” and 114 as “caution,” highlighting clinically significant safety concerns. In addition, 295 HDIs were classified as potentially beneficial, 73 as unlikely, and 106 as unresolved. Evidence strength was further classified as well-established (n = 28), good (n = 76), limited (n = 395), and unknown (n = 96). Conclusion By integrating dual-language evidence and standardized grading criteria, the database enhances prescribing safety, supports patient counselling, and strengthens pharmacovigilance in integrative healthcare settings. Continuous updates and prospective validation will further improve its clinical applicability.