Clinical evaluation of the effect of SI-6601A (Intra-articular injective preparation of Sodium Hyaluronate) on temporomandibular joint arthrosis

III: Phase III clinical study

Abstract

A Randomized comparative study by centralized telephone method was conducted on 317 patients with temporomandibular joint arthrosis to determine the efficacy, safety and usefulness of SI-6601A using 1.25ml of 1% sodium hyaluronate (HA group) or of 0.01% sodium hyaluronate (CT group) by intra-articular injection five times continuously at weekly intervals.
(1) The total number of patients enrolled was 317. Among those patients, 297 were adopted for the analysis of final global improvement and usefulness, and 309 for the analysis of overall safety.
(2) With respect to the final global improvement, the effective rate (more than “moderately improved”) for the HA group was 61.0% (94/154), and 33.6% (48/143) for the CT group. The HA group was significantly superior to the CT group.
(3) With respect to overall safety, the incidence of side effects was 3.2% (5/158) for the HA group, 1.3% (2/151) for CT group, and no significant difference was observed between the two groups.
(4) With respect to usefulness, the rate of usefulness (“more than moderately useful”) was 60.4% (93/154) for the HA group, and 35.7% (51/143) for the CT group. The HA group was significantly superior to the CT group.
(5) As for the change of global improvement, the HA group was significantly superior to the CT group. As for improvement in symptoms, the HA group tended to be superior to the CT group in “maximal mouth opening with or without pain”.
(6) The incidence of adverse effects was 3.2% (5/158) for the HA group and 1.3% (2/151) for the CT group, but none of them was severe.
In conclusion, SI-6601A is considered to be useful in the treatment of temporomandibular joint arthrosis.