Carrabba M, Paresce E, Angelini M, Re KA, Torchiana EEM, Perbellini A. The safety and efficacy of different dose schedules of hyaluronic acid in the treatment of painful osteoarthritis of the knee with joint effusion. Eur J Rheumatol Inflamm. 1995;15:25-31.

Intra-articularly administered hyaluronic acid (HA) has been shown to be effective, in the treatment of knee osteoarthritis (OA). We carried out a double-blind randomised placebo- and arthrocentesis-controlled study to evaluate the efficacy of 3 different dose schedules of HA. One hundred patients with knee OA and at least 3cc of joint effusion were enrolled and randomly assigned to the 5 treatment groups.

Pain on movement and at rest, the Lequesne index, joint mobility, volume of joint effusion, intake of analgesic, and overall judgement of efficacy were evaluated at baseline and on Days 7, 14, 21, 28, 35, and 60. Recurrence was also evaluated up to six months. The evaluation of these parameters showed a significantly superior effect of 5 and 3 injections of HA in comparison with placebo, arthrocentesis and one injection of HA.

Long-term monitoring of the patients, over a period of six months, provided evidence of the value of repeated injections of HA in terms of maintenance of the results. Only few local adverse reactions, essentially transitory pain after injection, were reported. These reactions were equally distributed between the groups.

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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