To observe clinical efficacy of intra-articular injection of Sodium hyaluronate (SH) accompanied with external application of Sanhua ointment (SHO) for knee osteoarthritis.One hundred and twelve patients with osteoarthritis were randomly divided into two groups, Group I was treated with SH and Group II was treated with SH plus SHO. The entire condition of knee joint in the two groups were compared before and after treatment according to Lysholm's function scoring.The functional score in the two groups at the 2nd week, 5th week, 3rd month and end of 1st year of the treatment course were significantly higher than that before treatment (P < 0.05), and the scores continuously increased within the first 3 months of treatment. Comparison of scores between the two groups showed that scores in Group II was significantly higher than those in Group I at the corresponding period. The total effective rate after 1 year treatment in Group lI was higher than that in Group II (81.5% vs 96.6%, P < 0.05). In Group II , the initial time of symptom improving was earlier and the adverse effect disappeared more quickly than those in Group I markedly.The efficacy of combined therapy of intra-articular injection of SH and SHO for knee osteoarthritis was superior to that of intra-articular injection of SH only.