Objective To evaluate the curative effect and safety of the triplex ext ernal treatment of TCM for knee osteoarthritis.Methods Totally 120 patients wer e randomized into treatment group and control group with sixty in each.The trea tment group accepted triplex external treatment of TCM including lower-limb exercise

manipulation and external use of Chinese medicine

while the control group accepted Kanggu Zengsheng Capsule（Capsule for treating hyperostosis）.Both group s were scored at the 7th

14th and 21st day after the treatment.Then the score results were statistically analyzed.Results The clinic ally-controlled

excellen t

effective and ineffective cases were 0

13

33 and 14 in the treatment group

while 0

1

20 and 39 respectively in the control group.The total effective ra te of the treatment group and control group was 76.7% and 35% respectively

the difference between was statistically significant（P<0.05）.The single symp tom s uch as rest pain at night

early morning stiffness

pain after getting up

walki ng pain

max walking distance and joint function was analyzed before and after t reatment.There was significant difference in symptom scores at 7th

14th and 21 st day after the treatment in both groups（P<0.05）.The scores of treatmen t gro up were superior to those of the control group with statistically significant（P <0.05）.There was no adverse effect case in both groups except for one case of unexplained skin allergy in the treatment group.Conclusion The Triplex external treatment of TCM is safe and could relieve pain and improve joint function in t reating knee osteoarthritis.