Abstract
BACKGROUND: Several studies have proved that diacerein effectively treats knee osteoarthritis (OA). All studies used branded diacerein. Recently, generic diacerein has been available in several countries, with limited studies comparing the efficacy of generic and branded diacerein for knee OA treatment. METHODS: Among 200 eligible patients, 94 were randomized to take a daily 50 mg of generic diacerein (Diaceric®); group A or branded diacerein (Artrodar®); group B for treating mild to moderate knee OA. All patients were assigned 5-visit assessments and followed until 24 weeks. The primary outcome was a visual analog scale (VAS) on the motion. The secondary outcomes were 2 patient-report outcome measures (PROMs): the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index and the Short Form-12 (SF-12), as well as 3 performance-based measures (PBMs): 5-time sit to stand test (5 × SST), the time up and go test (TUGT), and the 3-minute walk test (3MWT). RESULTS: There were 47 patients in group A and 47 in group B, with no patients lost for FU. Among all patients, 79.8% were female with a mean age of 63.2 years in group A and 64.8 years in group B. The Kellgren and Lawrence (KL) grade II was the most common in both groups. There were no differences in all demographic data. At 24-week follow-up (FU), both groups had significantly improved VAS, with a 12-week earlier improvement in the branded diacerein. In addition, the PBMs, including 5 × SST and 3MWT, significantly improved from 12-week FU in both groups, with insignificantly improved WOMAC and SF-12 and no serious adverse events in either group. CONCLUSION: After a 24-week FU, the generic diacerein had similar efficacy as the branded diacerein in significantly improving VAS and PBMs: 5 × SST and 3MWT. However, the latter had a faster statistically improved VAS than the former.