Clinical Evaluation of High Molecular Weight Sodium Hyaluro nate (SPH) on Osteoarthritis of the Knee

Multi-Center Well Controlled Comparative Study

Abstract

The usefulness of high molecular weight sodium hyaluronate (SPH) on osteoarthritis of the knee was examinedby a well controlled comparative study using 5.0ml of 0.5% SPH solution (S) or 5.0ml of 0.01% SPH solution (P) for intra-articular injection. Sixteen institutions participated in this study.
1. Total number of patients examined was 107, in which the number of S group was 52 and that of P group was 55. Among those patients, 98 (S group 48; P group 50) were adopted for the analysis of final global improvement and usefulness, and 103 (S group 50; P group 53) for the analysis of general safety.
2. Five intra-articular injections in total were given in weekly intervals. The final global improvement, general safety and usefulness were evaluated. The S group was significantly superior to the P group in terms of the final global improvement and usefulness. No significant difference was observed between S and P groups in terms of general safety.
3. Effectiveness on SPH for the pains on movement was proved, as shown in the improvement of the objective and subjective symptoms as well as the activities of daily living related to the pains.
4. As adverse side effect, local pain after injection of drugs was observed in one case of S group (1/50) and in one case of P group (1/53), and rash was observed in one case of P group (1/53). However, these symptoms were mild or moderate and disappeared by discontinuing the injection of the drugs. Laboratory examination showed no abnormal findings being caused by the drugs.
5. As SPH is effective for the pains on movement and caused almost no side effect, it is considered that SPH is a useful drug for the treament of osteoarthritis in which pain is the main complaint of the patients.