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Intra-articular hyaluronic acid injection versus oral non-steroidal anti-inflammatory drug for the treatment of knee osteoarthritis: a multi-center, randomized, open-label, non-inferiority trial

21 Jan 2014

IntroductionWhile many of the commonly used conservative treatments for knee osteoarthritis (OA) have been recognized to be effective, there is still insufficient evidence available. Among the pharmacological treatments for knee OA, oral non-steroidal anti-inflammatory drugs (NSAIDs) act rapidly and are recommended for the management of OA. However, frequent and serious adverse effects of NSAIDs have been recognized. Intra-articular injections of hyaluronic acid (IA-HA) for the treatment of knee OA have been shown to reduce pain and improve joint function. However, there has been no qualified direct comparison study of efficacy and safety between IA-HA and NSAIDs for patients with knee OA. The aim of this study was to clarify the efficacy and safety of early-phase IA-HA in comparison to those of NSAID for patients with knee OA.
Methods:
This multi-center, randomized, open-label, parallel-group, non-inferiority comparison study with an oral NSAID involved a total of 200 patients with knee OA. An independent, computer-generated randomization sequence was used to randomly assign patients in a 1:1 ratio to NSAID 3 times per day for five weeks (n = 100) or IA-HA once a week for five weeks (n = 100). The primary endpoint was the percent change in the patient-oriented outcome measure for knee OA, the Japanese Knee Osteoarthritis Measure (JKOM) score. All patients were questioned regarding any adverse events during treatment. The full analysis set (FAS) was used for analysis. The margin of non-inferiority was 10%.
Results:
The analyses of primary endpoint included 98 patients in the IA-HA group and 86 patients in the NSAID group. The difference in the percent changes of JKOM score between the two intervention arms (IA-HA; -34.7% (P <0.001), NSAID; -32.2% (P <0.001)) was -2.5% (95% confidence interval (CI): -14.0 to 9.1), indicating IA-HA was not inferior to NSAID. The frequency of both withdrawal and adverse events in the IA-HA group were significantly lower than those in the NSAID group (P = 0.026 and 0.004, respectively).
Conclusions:
The early efficacy of IA-HA is suggested to be not inferior to that of NSAIDs, and that the safety of early-phase of IA-HA is superior to that of NSAIDs for patients with knee OA.Trial registration: UMIN Clinical Trials Registry (UMIN-CTR), UMIN000001026.

Date: 
21 January 2014

Click here to view the full article which appeared in Arthritis Research & Therapy