Botulinum toxin in the management of childhood muscle spasticity: comparison of clinical practice of 17 treatment centres.

At least two randomized controlled trials (RCTs) have shown botulinum toxin type A (BtxA) to be efficacious and safe when used in the management of muscle spasticity in children. However, the need to use standard treatment protocols in these studies obscures some aspects of routine clinical practice that may have important effect on clinical outcomes. The purpose of this study was to seek additional information on the use of BtxA that is not usually captured by RCTs. This was performed by reviewing the clinical practice of practitioners in 17 treatment centres in Europe. The details of treatment with BtxA, including the dose, site and frequency of injections and the use of anaesthesia or sedation, were abstracted from the patient's records. Information was also obtained on the response to treatment and the occurrence and severity of adverse events. The data on 758 children who received a total of 1,594 treatments in 17 different clinics in Europe were analysed. Ninety-four per cent of patients had cerebral palsy. There was a general agreement on the indications for treatment but the average dose of BtxA used varied between centres. One treatment centre used general anaesthesia (GA) prior to injections in most patients. The reported efficacy and adverse events profile was similar for all centres. The evidence from routine clinical practice for the efficacy and safety of BtxA in the management of muscle spasticity in children, as described in this study, is in agreement with that of most of the open-label and RCTs published to date. The present study also demonstrates the disagreement between clinicians on the optimal dose of BtxA for individual muscles and confirms that the injections can be carried out without GA in almost all cases.