Objective An evidence assessment was conducted on five commonly used traditional Chinese patent medicines for the treatment of knee osteoarthritis (KOA), using the integrated evidence chain-based efficacy evaluation of traditional Chinese medicine (Eff-iEC) method and the grading of recommendations assessment,development and evaluation (GRADE) system. Methods The internationally recognized GRADE system and Eff-iEC method, which aligns with the characteristics of TCM, were applied in parallel to evaluate the evidence for five high-frequency recommended CPMs from clinical guidelines and expert consensuses. Simultaneously, a Meta-analysis was performed to evaluate their clinical efficacy and safety, using the clinical effective rate as a core indicator for evidence determination. Results GRADE assessment showed that, due to limitations in randomized controlled trials (RCTs) such as blinding and publication bias, among the five Chinese patent medicines, Jintiange Capsules and Biqi Capsules were rated as Grade C (low-quality evidence), while the rest were rated as Grade B (moderate-quality evidence). In contrast, the Eff-iEC method provided different evidence stratification: Jintiange Capsules (AA+B+), Zhuangguguanjie Capsules (BAA), and Biqi Capsules (AA+B+) were identified as high-level evidence. Wangbi Tablets/Capsules (BA+B+), Xianling Gubao Capsules (BA+B+) were identified as moderatelevel evidence. The Meta-analysis showed that CPMs combined with conventional Western medical therapy significantly improved the overall clinical effective rate (RR range 1.15—1.26, all P < 0.05). Notably, Wangbi Tablets/Capsules (RR = 0.41), Xianling Gubao Capsules (RR = 0.57), significantly reduced the risk of adverse reactions, demonstrating efficacy enhancement and toxicity reduction effects. Conclusion The Eff-iEC system and GRADE each have their own advantages in evidence evaluation. The Eff-iEC evaluation system can more comprehensively assess the efficacy evidence of traditional Chinese medicine compared to the GRADE system, avoiding underestimation of value due to flaws in trial design. However, high-quality RCTs are still needed in the future to further strengthen the certainty of the evidence.

Chinese patent medicines  /  knee osteoarthritis  /  GRADE  /  Eff-iEC  /  Jintiange Capsule  /  Biqi Capsule  /  Xianling Gubao Capsule  /  Wangbi Tablets/Capsule  /  Zhuanggu Guanjie Capsule