European Journal of Neurology 8 (6),
559-565
A. M. O. Bakheita, S. Pittockb,
A. P. Moorec, M. Wurkerd, S. Ottoe, F. Erbguthf and L. Coxong
a Stroke Unit, Mount Gould Hospital,
Plymouth, UK, b Department of Neurology, Beaumont Hospital, Dublin 9, Ireland,
c The Clinical Trials Unit, Fazakerley, Liverpool, UK, d Neurologisches
Reha-Zentrum Godeshohe, Bonn-Bad Godesberg, Germany, e Neurologische Klinik
der Ruhr-Universitat Borhum im St Josef Hospital, Bochum, Germany, f Neurologische
Universitatklinik, Erlangen, Germany, g Ipsen Ltd, Maidenhead, UK
Objective.
To study the efficacy and safety
of botulinum toxin type A (BtxA) in the treatment of upper limb muscle
spasticity, caused by stroke.
Methods.
This was a randomized, controlled
trial. Patients received either placebo injections or a total of 1000 IU
of BtxA (Dysport) into five muscles of the affected arm. Muscle tone was
assessed using the Modified Ashworth Scale (MAS). Other outcome measures
were the change in the joint range of motion (ROM), the Barthel index,
pain score, goal attainment and the subjective evaluation of benefit by
patients and investigators. The patients were assessed blind to randomization
at baseline and 4, 8, 12 and 16 weeks after treatment.
Results.
Fifty nine patients were recruited
and received treatment. One patient was lost to follow-up before the last
scheduled visit of the study. The group of patients who received BtxA had
a significant reduction in the summed MAS score at week 4 compared with
the placebo group (P=0.004). The magnitude of benefit over the 16 week
follow-up period was significantly reduced for the BtxA group in the wrist
(P=0.004) and the finger joints (P=0.001) when compared with the placebo.
There was no statistically significant
difference between the groups in the joint ROM, muscle pain, goal-attainment
or the Barthel index scores at week 4 of the study. At week 16, the BtxA
group showed significantly greater improvement in the passive ROM at the
elbow (P=0.036). The patients’ global assessment of benefit at the end
of the study showed that 16 (50%) patients in the placebo group had ‘much
improved’ or had ‘some improvement’ compared with 24 (92.3%) patients in
the BtxA group (P=0.007). The investigators’ rating for the same item was
16 (50%) and 23 (88.4%) patients, respectively (P=0.002).
Sixteen and twenty patients in the
BtxA and placebo groups, respectively, had an adverse event. The most frequently
reported adverse events were accidental injury, respiratory and urinary
tract infections and muscle pain.
Conclusion. The findings
of the present study suggest that treatment with BtxA in a dose of 1000
units reduces muscle tone in patients with post-stroke upper limb spasticity.
This effect is sustained for at least 16 weeks. BtxA is safe in the dose
used in this study.
Important note.
The authors wish to emphasize that
the botulinum toxin preparation used in this study was Dysport (Ipsen Ltd)
which has a different therapeutic equivalence from other commercially available
product, Botox (Allergan Inc.).
© European Federation of Neurological
Societies