Scali JJ. Intra-articular sodium hyaluronic acid in the treatment of osteoarthritis of the knee: a long term study. Eur J Rheumatol Inflamm. 1995;15:57-62.

Rheumatology Unit, Hospital Durand - MCBA - Buenos Aires, Argentina

A new therapeutic approach to the treatment of osteoarthritis is presented in this paper. We carried out a long term (30 months), open design study to assess the efficacy and tolerability of repeated courses of treatment with hyaluronic acid (HA) in patients with osteoarthritis of the knee. A total of 75 patients (35 males, 40 females) were included in the study. Treatment was one weekly, intra-articular administration of 20 mg/2 ml HA (Hyalart® - Fidia S.p.A., Abano Terme, Italy) for 5 consecutive weeks and this therapeutic schedule was repeated every 6 months over a period of 25 months. Hence, each patient received a total of 25 intra-articular injections. All 75 patients completed the study. Spontaneous pain decreased after the first treatment course and continued to decrease up to the end of the study when it showed an improvement of 55% compared with baseline values. The other pain parameters assessed also showed substantial decreases throughout the study. Joint flexion and extension showed a statistically significant improvement (p < 0.05) at the end of the study compared with baseline values. A substantial improvement was also observed for morning stiffness and supra-patellar circumference. The overall efficacy was judged as "very good" in 36 cases (48%), "good" in 30 cases (40%) and "poor" in 9 cases (12%). Neither local nor systemic adverse events were observed. Given the interesting results obtained, it would be appropriate to carry out controlled studies to confirm these promising findings.

Important Safety Information for HYALGAN®

HYALGAN® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy, and to simple analgesics, eg, acetaminophen
HYALGAN® is contraindicated in patients with known hypersensitivity to hyaluronate preparations. Intra-articular injections are contraindicated in cases of past and present infections or skin diseases in the area of the injection site
The effectiveness of a single treatment cycle of less than 3 injections has not been established
In the US clinical trial of 495 patients, the only adverse event showing statistical significance vs placebo was injection-site pain
Other adverse events included gastrointestinal complaints, headache, local ecchymosis and rash, local joint pain and swelling, and local pruritus. However, the incidence of these events was similar in the HYALGAN®-treated and placebo groups
In other clinical studies, the frequency and severity of adverse events occurring during repeat treatment cycles did not increase over that reported for a single treatment cycle

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