Objective To evaluate the efficacy and safety of diacerein in patients with knee osteoarthritis （OA）. Methods A total of 223 patients satisfying the American College of Rheumatology criteria for knee OA were chosen for this 17-week

randomized

double-dummy

diclofenac sodium-controlled trial

with diacerein dosage of 100 mg/d and diclofenac sodium of 75mg/d. Efficacy and safety of both drugs were evaluated. Results Totally 106 patients in the diacerein group and 107 patients in the diclofenac group were considered qualified for the evaluation. After 12 weeks of treatment

the total effective rates of patients/physicians’ overall assessment in diacerein and diclofenac groups were 65.4%/61.6% and 61.2%/61.2%

respectively （P>0.05）. The primary efficacy parameter [visual analog scale （VAS） assessment of pain on 20 metres walking] and the secondary efficacy parameters [tenderness on palpation

Western Ontario and McMaster Universities Osteoarthritis Index （WOMAC）

and 36-item Short-Form （SF-36） Health Survey] significantly improved compared with baseline in both groups （P<0.05）. In the follow-up period

there were no obvious changes in above parameters in diacerein group. However

in diclofenac group

pain on 20 metres walking

tenderness on palpation

and WOMAC became aggravated after withdrawing the drug for 4 weeks （P<0.05）. Moreover

the consumption of paracetamol was significantly lower in diacerein group than in diclofenac group during follow-up （P<0.001）. The incidences of related adverse events were 35.7% in diacerein and 45.1% in diclofenac group

respectively. Mild-to-moderate gastrointestinal disorders were the most frequent adverse events. Conclusions Diacerein is as effective as diclofenac sodium in treating patients with knee OA. Furthermore

it has better extended effect and a good safety profile. It is generally well tolerated and has no severe adverse effect.