OBJECTIVETo observe the therapeutic efficacy and safety of Gubitong Recipe (, GBT) in treating osteoarthritis (OA) of knee joint.

METHODSNinety patients with knee osteoarthritis were equally assigned, according to a randomizing digital table, to the treatment group and the control group. The treatment group was treated with GBT Decoction one dose every day and the control group with glucosamine sulfate 500 mg thrice a day, respectively, for eight successive weeks. Besides, diclofenac sodium could be given as supplementary dugs with the dosage used recorded if necessary. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, an index reflecting the degree of joint pain, stiffness, and dysfunction) in patients was assessed before and after treatment, and the patients' symptoms were evaluated by visual analogue scale (VAS) as well. Moreover, erythrocyte sedimentation rate (ESR), blood C-reactive protein (CRP), blood and urinary routine tests, liver and kidney function examination, and the adverse reaction that occurred during the treatment period were observed.

RESULTSWOMAC index and integral VAS value were lowered in both groups after treatment, showing significant statistical difference as compared with before treatment (P<0.05), but the decrement of WOMAC index in the treatment group was more significant than that in the control group (P<0.05). ESR and CRP levels remained unchanged in all patients, and the proportion and mean dosage of diclofenac sodium used were similar in the two groups. No evident adverse reaction occurred during the treatment period.

CONCLUSIONGBT is an effective and safe recipe for the treatment of osteoarthritis of knee joint, which could alleviate the joint pain, stiffness, and dysfunction.