Objective: Severe adverse effects, including anaphylaxis, have been reported for diclofenac-linked hyaluronate (DF-HA) intra-articular injection for osteoarthritis (OA). Although all the allergic reactions may not occur after the first exposure to the allergen, the most severe of them occur within seconds. In this study, adverse effects and efficacy of the treatment were evaluated in participants who received a DF-HA one-shot injection followed by a hyaluronate (HA) injection.

Methods: Fifty-two patients with knee OA were prospectively randomized into two groups. Participants in the DF-HA group received a DF-HA injection at the initial visit and an HA injection at the four-week visit. Those in the control group received an HA injection every week during the five-week trial. The Lequesne index at the final assessment was compared with that at baseline in both groups. Participants were asked about any adverse effects considered attributable to the treatment they received.

Results: No participant showed severe adverse effects, including anaphylaxis. The remission score was significantly better (P=0.014) in the DF-HA group (6.8±4.5) than in the control group (3.5±4.0).

Conclusion: Adverse effects did not appear when DF-HA was given as a one-shot injection. The remission score was significantly better in the DF-HA group than in the control group. The optimal use of DF-HA would be as a one-shot injection.