Stroke: baclofen decreased muscle tone in spasticity.

Clinical bottom line (level 1b)

  1. Patients with spasticity due to stroke who were given baclofen were more likely to have a greater mean decrease in muscle tone, compared with those given placebo.
  2. Patients given baclofen were more likely to have side effects than those given placebo (NNH = 3 at 6 weeks) .
  3. There was no clear difference in mean Incapacity Status Scale or Oswestry Scale of Grading between the two groups.
Medaer et al: Acta Therapeutica 1991; 17: 323-331
Expires December 2002

The study

Double-blinded ?concealed randomised cross-over trial with intention-to-treat
Setting: general hospital, Belgium

20 patients (aged mean 65 years, 65% female) spasticity due to cerebrovascular lesions (at least 3 months duration)

Excluded if
  • dementia
  • ankylosis or contractures of the joints
  • spinal cord disease
  • Parkinson's disease
  • epilepsy
  • psychosis
  • renal insufficiency
  • peptic ulcer
  • prior treatment with an anti spasticity drug


    • Control Group: (n = 20, 20 analysed): placebo at an initial dose of 2 half tablets per day, increased by half a tablet every 2 days for 2 weeks. The optimum dose was continued for 4 weeks. After a 1 week placebo washout, patients were assigned to baclofen.
    Experimental Group: (n = 20, 20 analysed): baclofen - 2 half tablets per day (5 mg). The dose was increased by half a tablet every 2 days for 2 weeks. After this titration period, the optimal dose was continued for 4 weeks. A placebo washout period followed this for 1 week, and then patients were assigned to placebo.
    A six week observational period without therapy followed this. Patients were given a standardised programme of physical and occupational therapy.
    100% followed for 6 weeks

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNH
    (95% CI)
    side effects 6 weeks 3
    (15.0%)    		 10
    (50.0%)    		 -233%
    (-934% to -8.00%)    		 -35.0%
    (-61.9% to -8.07%)    		 3
    (2 to 12)

    Outcome Control Group
    (SD)    		 Experimental Group
    (SD)    		 Mean Difference
    (95% CI)
    mean Ashworth scale score of increased muscle tone 3.75
    (0.72)     		2.95
    (0.61)     		0.80
    (0.38 to 1.22)
    mean on the Oswestry Scale of Grading 3.20
    (1.32)     		3.80
    (1.11)     		-0.60
    (-1.38 to 0.18)
    mean on the Incapacity Status Scale 12.8
    (5.66)     		12.4
    (5.46)     		0.40
    (-3.16 to 3.96)

  • The neurologist thought that 90% of patients showed moderate to excellent improvement of spasticity on baclofen, compared with 20% with placebo; the occupational therapist thought 40% on baclofen and 5% on placebo improved; the physical therapist thought 80% compared with 20%; the patient thought 65% compared with 40%.

    • Citation

    1. Medaer R, Hellebuyk H, Van Den Brande E, et al: Treatment of spasticity due to stroke: A double-blind, cross-over trial comparing baclofen with placebo. Acta Therapeutica 1991; 17: 323-331
    Contributor: Clare Wotton and Musab Hayatli, December 1999
    Reviewer:

    Clinical Question.
    Patient spasticity after stroke
    Intervention or Exposure baclofen
    Comparison placebo
    Outcome reduction in spasticity