OBJECTIVETo observe the clinical efficacy of treating middle-aged and aged patients with knee osteoarthritis (KOA) of yang-deficiency induced cold-damp syndrome (YDICDS) by ozone combined Fugui Gutong Granule (FGG).

METHODSUsing a prospective, randomized controlled clinical trial, 200 KOA patients of YDICDS were randomly assigned to four groups. i.e., the control group (Group A), the Chinese medicine treatment group (Group B), the ozone group (Group C), and the Chinese-r medicine treatment plus ozone group (Group D).Patients in Group A took Voltaren Tablet. Those in Group B took FGG. Those in Group C received ozone injection (10 -18 mL) from knee joint cavity at 25 mg/L, once weekly for 4 weeks in total. Those in Group D received injection from knee joint cavity and took FGG. The therapeutic course for all was one month. The efficacy was assessed using visual analogue scale (VAS) and Western Ontario MacMaster University Osteoarthritis index (WOMAC).

RESULTSThe VAS score was obviously lower in Group D than in Group B and Group A at 24 h and 1 week (P <0. 05). After one month of treatment, the VAS score was obviously lower in Group D than in Group A, B, and C (P < 0.05). After treatment the total integral of WOMAC was 25.34 +/- 2.12 in Group D, obviously lower than that in Group A (44.72 +/- 6.57), Group B (40.58 +/- 5.98), and Group C (38.53 +/- 5. 13), showing statistical difference (P <0.05). The pain score, the joint stiffness score, the score for daily activities were lower in Group D than in Group A (P <0.05). The cured and markedly effective rate was 76.0% in Group D, higher than that of Group A (25. 0%), Group B (25. 0%), and Group C (43.8%), respectively (P < 0.05).

CONCLUSIONOzone combined FGG had advantages in alleviating joint pain, and improving joint stiffness and daily activities of middle-aged and aged patients with KOA of YDICDS.