ABSTRACT
OBJECTIVES: COVID-19 sparked a pandemic in December 2019 and is currently posing a huge impact globally. Chinese herbal medicine is incorporated into the Chinese national guideline for COVID-19 management, emphasising the individualisation of herbal treatment guided by pattern differentiation, which is an ICD-11-endorsed approach. However, this was not widely implemented with many provincial governments and hospitals developing their own guideline, suggesting the use of standardised herbal formulae and herbal active ingredients without pattern differentiation. METHODS: Through the case study of COVID-19 guideline implementation, we compared the three approaches of developing Chinese herbal medicine, namely pattern differentiation-guided prescription, standardised herbal formulae, and herbal active ingredients, in terms of their strengths, limitations, and determinants of adoption. RESULTS: Pattern differentiation-guided prescription is the practice style taught in the national syllabus among universities of Traditional Chinese Medicine in China, yet the lack of relevant diagnostic research reduces its reliability and hinders its implementation. Application of standardised herbal formulae is straightforward since the majority of clinical evidence on Chinese herbal medicine is generated using this approach. Nevertheless, it is downplayed by regulatory bodies in certain jurisdictions where the use of pattern differentiation is required in routine practice. Although herbal active ingredients may have clear in vitro therapeutic mechanisms, this may not be translated into real world clinical effectiveness. CONCLUSIONS: Multiple COVID-19 clinical trials evaluating the effectiveness and safety of Chinese herbal medicine prescribed using one of the three approaches described above are progressing. These results will demonstrate the comparative effectiveness among these approaches. Forthcoming clinical evidence from these trials should inform the updating process of the national guideline, such that its recognition and compliance may be strengthened. For longer-term development Chinese herbal medicine, serious investment for establishing high-quality clinical research infrastructure is urgently needed.