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Intrathecal and oral baclofen use in adults with spinal cord injury (SCI): a systematic review of efficacy in spasticity reduction and functional improvement, dosing and adverse events

  • Nicholas Dietz
    Affiliations
    Department of Neurological Surgery, University of Louisville, Louisville, KY, USA

    Kentucky Spinal Cord Injury Research Center, Louisville, KY, USA
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  • Sarah Wagers
    Affiliations
    Department of Neurological Surgery, University of Louisville, Louisville, KY, USA

    Kentucky Spinal Cord Injury Research Center, Louisville, KY, USA
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  • Susan J. Harkema
    Affiliations
    Department of Neurological Surgery, University of Louisville, Louisville, KY, USA

    Kentucky Spinal Cord Injury Research Center, Louisville, KY, USA
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  • Jessica M. D'Amico
    Correspondence
    Corresponding Author: Dr. Jessica D'Amico, PhD, Kentucky Spinal Cord Injury Research Center, Frazier Rehabilitation Institute, University of Louisville, 220 Abraham Flexner way, Louisville, KY, U.S.A 40202, +1 502-581-8675
    Affiliations
    Department of Neurological Surgery, University of Louisville, Louisville, KY, USA

    Kentucky Spinal Cord Injury Research Center, Louisville, KY, USA
    Search for articles by this author

      Abstract

      Objective

      To examine the efficacy, dosing, and safety profiles of intrathecal and oral baclofen in treating spasticity after spinal cord injury (SCI).

      Data Sources

      PubMed and Cochrane Databases were searched between 1970-2018 with keywords baclofen, spinal cord injury and efficacy.

      Study Selection

      The database search yielded 588 sources and 10 additional relevant publications. After removal of duplicates, 398 publications were screened.

      Data Extraction

      Data was extracted using the following PICOS criteria: studies including adult SCI patients with spasticity; the intervention could be oral or intrathecal administration of baclofen; selection was inclusive for control groups, surgical management, rehabilitation and alternative pharmaceutical agents; outcomes were efficacy, dosing and adverse events. Randomized controlled trials, observational studies and case reports were included. Meta-analyses and systematic reviews were excluded.

      Data Synthesis

      A total of 98 studies were included with 1,943 patients. Only four randomized, double-blinded and placebo-controlled trials are reported. Thirty-nine studies examined changes in modified Ashworth (MAS; 34 studies) and Penn spasm scores (PSF; 19 studies), with average reductions of 1.7 ± 1.3 and 1.6 ± 1.4 in individuals with SCI, respectively. Of these data, a total of six of the 34 studies (MAS) and two of the 19 studies (PSF) analyzed oral baclofen. Forty-three studies addressed adverse events with muscle weakness and fatigue frequently reported.

      Conclusions

      Baclofen is the most commonly-prescribed antispasmodic following SCI. Surprisingly, there remains a significant lack of large, placebo-controlled, double-blinded clinical trials, with most efficacy data arising from small studies examining treatment across different etiologies. In the studies reviewed, baclofen effectively improved spasticity outcome measures, with increased efficacy through intrathecal administration. Few studies assessed how reduced neural excitability affected residual motor function and activities of daily living (ADL). A host of adverse events were reported which may negatively affect quality of life. Comparative randomized controlled trials of baclofen and alternative treatments are warranted as these have demonstrated promise in relieving spasticity with reduced adverse events and without negatively impacting residual motor function.

      Key words

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