Safety and tolerance of a single dose of botulinum toxin type A in patients with local spasticity-associated problems: A prospective open multicenterstudy comprising 204 patients

High dose oral anti-spastic medication is effective in the treatment of spa sticity but has the disadvantage of frequent systemic side effects such as drowsiness and general weakness. Therefore, neurolytic and chemodenervation procedures are further therapeutic options, especially in cases of local s pasticity. Apart from phenol blocks with the risk of persisting painful dys esthesia, botulinum toxin type A (BtxA) appears to be a safe and effective treatment. In 204 patients (mean age, 41.5 years [range 3-91 years]) with a cute (n = 29, mean duration of disease 2.9 months [range, 1-6 months]) and chronic (n = 175, mean duration of disease 111 months [range, 7-500 months] ) spasticity due to stroke, traumatic brain and spinal injury and other les ions of the upper motor neuron, the effects of single-dose BtxA treatment w ere studied. An overall dose of 181.2 units [range, 15-600 units] of BtxA ( Botox(R)) was injected in a mean of 3.3 [1-14] muscles per patient. Results were assessed using a modified Rating of Response to BtxA (RRB, Brin et al . 1995). The RRB includes a pre- and post BtxA assessment of the severity o f spasticity-associated problems (patient's self-assessment), a rating of t he current percentage of normal function in the region of the body selected for BtxA and a global rating of changes induced by BtxA. 191 (93.6%) patie nts demonstrated improvement over a mean of 7.7 weeks [1-36]; no deteriorat ion was observed. Mean overall severity and function improved significantly (p < 0.001). No systemic or severe side effects were registered. Only in 5 .9% of the patients were mild (n = 10) or moderate (n = 2) reversible adver se events reported. We conclude that BtxA injections are safe and effective in the treatment of local spasticity.