Abstract Objectives: The global use of Chinese herbal medicine formula (CHMF) is increasing, necessitating high-quality clinical trials. However, a lack of specific reporting standards has resulted in inconsistent and incomplete trial protocols, thereby undermining the reliability of the evidence. Although the Standard Protocol Items for Clinical Trials with Traditional Chinese Medicine 2018 (SPIRIT-TCM Extension 2018) provides general guidance, it is not specifically tailored to CHMF. The objective of the study is to develop dedicated guidelines aimed at improving the completeness and quality of clinical trial protocols for CHMF, based on the latest SPIRIT 2025 statement. Methods: A 17 member multidisciplinary working group comprising traditional Chinese medicine (TCM) clinicians, herbalists, and methodologists developed an extension using a modified nominal group technique. The process comprised three structured facilitator-led discussion cycles and two rounds of written consultation, during which the proposed adaptations to all items were iteratively refined and endorsed by all panel members. Results: The SPIRIT Extension for Chinese Herbal Medicine Formula 2025 (SPIRIT-CHMF 2025) was developed. It expands on 15 items from the SPIRIT 2025 checklist, incorporating key CHMF-specific concepts such as TCM syndrome pattern diagnosis, formula composition, and quality control measures. It also provides detailed guidance for sections, including interventions, outcomes, eligibility criteria, and rationale. Conclusions: SPIRIT-CHMF 2025 bridges international trial standards with the unique characteristics of CHMF. Its implementation is expected to standardize protocol development and generate more reliable evidence on the safety and efficacy of TCM.
Gao et al. (Sun,) studied this question.