International Journal of Clinical Research

Objective Based on the perspective of ' human experience ', the clinical efficacy and safety of Wumen Qiteng Decoction, an empirical prescription of Professor Gong Zhengfeng, a senior Chinese medicine expert of Wumen Medical School Research Institute of Suzhou Hospital of Traditional Chinese Medicine, in the treatment of Knee Osteoarthritis (KOA) of damp-heat obstruction type were retrospectively analyzed. Methods A total of 200 patients with KOA admitted to Suzhou Hospital of Traditional Chinese Medicine from January 2021 to October 2025 were selected and divided into exposure group (Wumen Qiteng Decoction intervention, 100 cases) and non-exposure group (western medicine symptomatic intervention, 100 cases). The TCM syndrome score, Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) score, Visual Analogue Scale ( VAS ) pain score, inflammatory factors interleukin-1 ( IL-1 ) and interleukin-6 ( IL-6 ), osteoarthritis biomarkers Cartilage Oligomeric Matrix Protein ( COMP ), serum osteocalcin ( BGP ), Bone Alkaline Phosphatase ( BLAP ), Tartrate Resistant Acid Phosphatase-5b ( TRAP-5b ) and joint fluid Matrix Metalloproteinase-3 ( MMP-3 ) and MMP-13 detection levels and clinical efficacy and safety were compared between the two groups before and after treatment. Results After treatment, the improvement of TCM syndrome score, WOMAC score and VAS score in the exposed group was better than that in the non-exposed group (P < 0.05). The total effective rate was 95.00 % in the exposed group and 92.00 % in the non-exposed group (P< 0.05). The exposure group was significantly better than the non-exposure group in reducing serum IL-1, IL-6, COMP levels, regulating bone metabolism markers (increasing BGP and BLAP, reducing TRAP-5b), and inhibiting MMP-3 and MMP-13 levels in synovial fluid (P< 0.05). There was no significant difference in the incidence of adverse reactions between the two groups (4.00 % in the exposed group vs 6.00 % in the non-exposed group, P > 0.05). Conclusion Based on the preliminary summary of ' human experience ' in the real world, Wumen Qiteng Decoction is effective in the treatment of KOA, which can significantly relieve knee pain and improve knee function in KOA patients. Its effect may be related to the inhibition of serum inflammatory factors and arthritis markers in patients. It has good clinical application value and provides an important part of human experience for further high-level clinical real world research.

Knee osteoarthritis; Wumen Qiteng decoction; Retrospective analysis; Clinical research; Human experience; Real-world research