Efficacy and safety of Xinhuang tablet (新癀片) compared with celecoxib and diclofenac sodium in the treatment of knee osteoarthritis with pyretic arthromyodynia: a randomized controlled clinical trial

Objective To evaluate the efficacy and safety of Xinhuang Tablet compared with celecoxib and diclofenac sodium in the treatment of knee osteoarthritis with pyretic arthromyodynia. Methods Ninety patients with knee osteoarthritis of pyretic arthromyodynia were randomly divided into three groups: celecoxib group (group A) , diclofenac sodium group (group B) and Xinhuang tablet group (group C) . The clinical efficacy was evaluated before the treatment, and 3, 7 and 14 days after the treatment, including symptoms, signs and joint index scores which reflected function of joint. Blood and urine samples were taken for testing the liver and renal function before and 14 days after the administration to assess the safety of the drugs. Besides, the adverse reactions were recorded throughout the course of medication. Results The total scores of symptoms in group B and C were lower at 7 and 14 days after the treatment than those before the treatment (P 0.05) . The signs and joint index scores in the three groups were significantly lower at 3, 7 and 14 days after the treatment than those bofore the treatment (P<0.05) ; the scores were lower at 7 days after the treatment in group C than those in group A, and lower at 14 days after the treatment in group B and C than those in group A (P<0.05) . The blood and urine routine, liver and kidney function tests were not shown abnormality after the treatment in the three groups. During the entire course of treatment, only 5 patients revealed adverse gastrointestinal discomfort (16.7%) in group B. Conclusion Xinhuang tablet and diclofenac sodium can all improve clinical symptoms, signs and joint function for patients with knee osteoarthritis of pyretic arthromyodynia as compared with celecoxib, but the possibility of gastrointestinal adverse reactions in diclofenac sodium treatment group may be higher. Key words: Osteoarthritis, knee; Xinhuang tablet; Celecoxib; Diclofenac sodium