Objective To systematically evaluate the current evidence from randomized controlled trials (RCTs) on traditional Chinese medicine (TCM) for pulmonary nodules (including early-stage lung cancer), and to provide evidence-based recommendations for future clinical practice and research. Methods Comprehensive searches were conducted across the following databases up to September 2025: Intelligent Clinical Evidence Database of Chinese Patent Medicine, China national knowledge infrastructur (CNKI), VIP Journal Database, Wanfang Data Knowledge Service Platform, Chinese biomedical literature service system (SinoMed), PubMed, Web of Science, Embase, and the Cochrane Library. Extracted data included key characteristics of participants and studies, such as disease subtype, TCM syndrome, year of publication, sample size, TCM therapeutic principles, details of treatment and control interventions, duration of treatment and follow-up, methodological details, and outcome measures. For studies involving Chinese patent medicines, extracted data were categorized using the Aireview Agent and subsequently verified manually. Data from other TCM studies were extracted and verified manually. Results A total of 70 RCTs were included, with the greatest number published in 2024. The studies showed that deficiency of both qi and yin syndrome and phlegm-stasis mutual binding syndrome were the most common TCM syndromes. The main therapeutic principles were resolving phlegm, tonifying qi, and dispersing nodules. In the treatment groups, Chinese herbal decoctions were the predominant intervention. Clinical efficacy was the most commonly reported outcome measure. In the risk-of-bias assessment, the measurement of the outcome domain was most frequently rated at high risk of bias. Conclusion RCTs of TCM interventions for pulmonary nodules (including early-stage lung cancer) exhibited several critical limitations, such as inadequate specification of disease subtypes in participant eligibility criteria, inconsistent TCM syndrome differentiation, failure to report or analyze primary endpoints, and a high risk of bias—particularly in outcome measurement. We recommend developing a core outcome set for TCM interventions in pulmonary nodules. Future clinical trials—whether decentralized or large-scale, multicenter randomized controlled trials should be stratified by disease subtype, use standardized protocols, and strictly adhere to established follow-up guidelines to generate high-quality evidence, particularly for nodules at elevated risk of malignancy.

traditional Chinese medicine  /  pulmonary nodules  /  early-stage lung cancer  /  randomized controlled trials  /  evidence-based medicine