Botulinum toxin treatment of adult spasticity : a benefit-risk assessment

Drug Saf. 2006;29(1):31-48. doi: 10.2165/00002018-200629010-00003.


Injections of botulinum toxin have revolutionised the treatment of focal spasticity. Before their advent, the medical treatment for focal spasticity involved oral anti-spasticity drugs, which had decidedly non-focal adverse effects, and phenol injections. Phenol injections could be difficult to perform, could cause sensory complications and had effects that were of uncertain duration and magnitude. Furthermore, few neurologists knew how to perform them as they were mostly the province of rehabilitation specialists. Botulinum toxin can produce focal, controllable muscle weakness of predictable duration, without sensory adverse effects. Randomised clinical trials (RCTs) involving patients with spasticity resulting from a variety of diseases (mainly stroke and multiple sclerosis) have clearly shown that botulinum toxin type A (Dysport and Botox) can temporarily (for approximately 3 months) reduce spastic hypertonia in the elbow, wrist and finger flexors of the upper limbs, and the hip adductors and ankle plantar flexors in the lower limbs. The clinical benefits from this reduction of neurological impairment are best shown in the upper limb, with less disability of passive function and reduced caregiver burden. In the lower limbs, there is improved perineal hygiene from hip adductor injections. The benefits of reducing ankle plantar flexor tone are less well established. Pain is also reduced, possibly by mechanisms other than muscle weakness. Improved active function has not yet been clearly demonstrated in RCTs, only in open-label trials. The safety of botulinum toxin-A is impressive, with minimal (mainly local) adverse effects. There are little data on the use of botulinum toxin type B (Myobloc or Neurobloc) in spasticity and the only RCT that has examined this did not show tone reduction; dry mouth appeared to be a very common adverse effect. There are also very little data to allow a benefit-risk comparison of phenol and botulinum toxin injections; each have their clinical and technical advantages and disadvantages, and phenol is much less costly than botulinum toxin.

Publication types

  • Review

MeSH terms

  • Adult
  • Botulinum Toxins / therapeutic use
  • Botulinum Toxins, Type A / adverse effects
  • Botulinum Toxins, Type A / therapeutic use*
  • Humans
  • Motor Neuron Disease / drug therapy*
  • Muscle Spasticity / drug therapy*
  • Muscle Spasticity / etiology
  • Neuromuscular Agents / adverse effects
  • Neuromuscular Agents / therapeutic use*
  • Randomized Controlled Trials as Topic
  • Risk Assessment


  • Neuromuscular Agents
  • rimabotulinumtoxinB
  • Botulinum Toxins
  • Botulinum Toxins, Type A