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Efficacy and safety of lithium carbonate treatment of chronic spinal cord injuries: a double-blind, randomized, placebo-controlled clinical trial.

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  • Additional Information
    • Subject Terms:
    • Subject Terms:
    • Abstract:
      Study design:Lithium has attracted much attention as a neuroregenerative agent for spinal cord injury in animal models. We hypothesized that the lithium can be beneficial to patients with spinal cord injury. The safety and pharmacokinetics of lithium has been studied in our earlier phase I clinical trial, indicating its safety. This is a phase II clinical trial to evaluate its efficacy on chronic spinal cord injury patients.Objectives:The aim of this study was to investigate the efficacy of lithium on chronic spinal cord injury patients.Setting:A major spinal cord injury rehabilitation center in Beijing, China.Methods:Randomized, double-blind, placebo-controlled 6-week parallel treatment arms with lithium carbonate and with placebo. A total of 40 chronic spinal cord injury subjects were recruited. Oral lithium carbonate was titrated or placebo was simulated to maintain the serum lithium level of 0.6-1.2 mmol l−1 for 6 weeks, followed by a 6-month follow-up. The functional outcomes and the neurological classifications, as well as the safety parameters, adverse events and pharmacokinetic data were carefully collected and monitored.Results:No significant changes in the functional outcomes and the neurological classifications were found. The only significant differences were in the pain assessments using visual analog scale comparing the lithium and the placebo group. No severe adverse event was documented in the study.Conclusion:The lithium treatment did not change the neurological outcomes of patients with chronic spinal cord injury. It is worth to investigate whether lithium is effective in the treatment of neuropathic pain in chronic spinal cord injury.Sponsorship:China Spinal Cord Injury Network Company Limited. [ABSTRACT FROM AUTHOR]
    • :
      Copyright of Spinal Cord is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
    • ISSN:
      1362-4393
    • DOI:
      10.1038/sc.2011.126
    • Accession Number:
      71519696
  • Citations
    • ABNT:
      YANG, M. L. et al. Efficacy and safety of lithium carbonate treatment of chronic spinal cord injuries: a double-blind, randomized, placebo-controlled clinical trial. Spinal Cord, [s. l.], v. 50, n. 2, p. 141–146, 2012. DOI 10.1038/sc.2011.126. Disponível em: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=c9h&AN=71519696. Acesso em: 23 nov. 2020.
    • AMA:
      Yang ML, Li JJ, So KF, et al. Efficacy and safety of lithium carbonate treatment of chronic spinal cord injuries: a double-blind, randomized, placebo-controlled clinical trial. Spinal Cord. 2012;50(2):141-146. doi:10.1038/sc.2011.126
    • APA:
      Yang, M. L., Li, J. J., So, K. F., Chen, J. Y. H., Cheng, W. S., Wu, J., Wang, Z. M., Gao, F., & Young, W. (2012). Efficacy and safety of lithium carbonate treatment of chronic spinal cord injuries: a double-blind, randomized, placebo-controlled clinical trial. Spinal Cord, 50(2), 141–146. https://doi.org/10.1038/sc.2011.126
    • Chicago/Turabian: Author-Date:
      Yang, M L, J J Li, K F So, J Y H Chen, W S Cheng, J Wu, Z M Wang, F Gao, and W Young. 2012. “Efficacy and Safety of Lithium Carbonate Treatment of Chronic Spinal Cord Injuries: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial.” Spinal Cord 50 (2): 141–46. doi:10.1038/sc.2011.126.
    • Harvard:
      Yang, M. L. et al. (2012) ‘Efficacy and safety of lithium carbonate treatment of chronic spinal cord injuries: a double-blind, randomized, placebo-controlled clinical trial’, Spinal Cord, 50(2), pp. 141–146. doi: 10.1038/sc.2011.126.
    • Harvard: Australian:
      Yang, ML, Li, JJ, So, KF, Chen, JYH, Cheng, WS, Wu, J, Wang, ZM, Gao, F & Young, W 2012, ‘Efficacy and safety of lithium carbonate treatment of chronic spinal cord injuries: a double-blind, randomized, placebo-controlled clinical trial’, Spinal Cord, vol. 50, no. 2, pp. 141–146, viewed 23 November 2020, .
    • MLA:
      Yang, M. L., et al. “Efficacy and Safety of Lithium Carbonate Treatment of Chronic Spinal Cord Injuries: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial.” Spinal Cord, vol. 50, no. 2, Feb. 2012, pp. 141–146. EBSCOhost, doi:10.1038/sc.2011.126.
    • Chicago/Turabian: Humanities:
      Yang, M L, J J Li, K F So, J Y H Chen, W S Cheng, J Wu, Z M Wang, F Gao, and W Young. “Efficacy and Safety of Lithium Carbonate Treatment of Chronic Spinal Cord Injuries: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial.” Spinal Cord 50, no. 2 (February 2012): 141–46. doi:10.1038/sc.2011.126.
    • Vancouver/ICMJE:
      Yang ML, Li JJ, So KF, Chen JYH, Cheng WS, Wu J, et al. Efficacy and safety of lithium carbonate treatment of chronic spinal cord injuries: a double-blind, randomized, placebo-controlled clinical trial. Spinal Cord [Internet]. 2012 Feb [cited 2020 Nov 23];50(2):141–6. Available from: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=c9h&AN=71519696