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  4. Efficacy and safety of tolperisone versus baclofen among Chinese patients with spasticity associated with spinal cord injury: a non-randomized retrospective study

Efficacy and safety of tolperisone versus baclofen among Chinese patients with spasticity associated with spinal cord injury: a non-randomized retrospective study

Brazilian Journal of Medical and Biological Research, 2021 · DOI: 10.1590/1414-431X2021e11293 · Published: November 1, 2021

PharmacologyNeurologyRehabilitation

Simple Explanation

This study compares two muscle relaxants, tolperisone and baclofen, in treating spasticity (increased muscle tone) caused by spinal cord injury. It looks at how well each drug works, along with any side effects experienced by patients. Patients received either baclofen plus physical therapy, tolperisone plus physical therapy, or physical therapy alone. The researchers measured muscle tone, muscle strength, daily activity performance, and disability levels over six weeks. The results showed that both drug treatments, when combined with physical therapy, improved muscle tone and function compared to physical therapy alone. However, baclofen had more sedative side effects, while tolperisone was associated with digestive issues.

Study Duration
6 weeks
Participants
431 Chinese patients with spasticity associated with spinal cord injury
Evidence Level
Level III; Technical Efficacy Stage: 4

Key Findings

  • 1
    Both baclofen plus physical therapy and tolperisone plus physical therapy significantly improved muscle tone and strength compared to physical therapy alone.
  • 2
    Baclofen plus physical therapy was tentatively effective, while tolperisone plus physical therapy was slightly effective in improving overall outcomes.
  • 3
    Baclofen caused more adverse effects related to sedation, such as asthenia, drowsiness, and sleepiness, while tolperisone was associated with dyspepsia and epigastric pain.

Research Summary

This retrospective study compared the efficacy and safety of tolperisone versus baclofen in Chinese patients with spasticity due to spinal cord injury. Patients received baclofen plus physical therapy (BAF+PT), tolperisone plus physical therapy (TOL+PT), or physical therapy alone (PT). The study found that both BAF+PT and TOL+PT improved muscle tone, muscle strength, functional outcomes, and disability assessment compared to PT alone. However, BAF+PT was associated with more sedative adverse effects. The authors conclude that both baclofen and tolperisone, when combined with physical therapy, can improve daily activities in patients with spasticity. However, tolperisone may be a better choice for patients susceptible to sedative side effects.

Practical Implications

Treatment Choice

Tolperisone may be a preferable option for patients who cannot tolerate the sedative effects of baclofen.

Combined Therapy

Combining either baclofen or tolperisone with physical therapy is more effective than physical therapy alone for managing spasticity.

Further Research

Prospective, randomized controlled trials are needed to confirm these findings and explore optimal dosages and treatment durations.

Study Limitations

  • 1
    Non-randomized retrospective design introduces potential biases.
  • 2
    Lack of information about lesion level, timing, and prior treatments.
  • 3
    Follow-up time of only 6 weeks is a short period.

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