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Article: Efficacy and safety of lithium carbonate treatment of chronic spinal cord injuries: A double-blind, randomized, placebo-controlled clinical trial
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TitleEfficacy and safety of lithium carbonate treatment of chronic spinal cord injuries: A double-blind, randomized, placebo-controlled clinical trial
 
AuthorsYang, ML5 3
Li, JJ5 3
So, KF2 4
Chen, JYH4
Cheng, WS4
Wu, J5 3
Wang, ZM5 3
Gao, F5 3
Young, W1 4
 
Keywordschronic spinal cord injury
clinical trial
lithium
neural regeneration
neuropathic pain
 
Issue Date2012
 
PublisherNature Publishing Group. The Journal's web site is located at http://www.nature.com/sc
 
CitationSpinal Cord, 2012, v. 50 n. 2, p. 141-146 [How to Cite?]
DOI: http://dx.doi.org/10.1038/sc.2011.126
 
AbstractStudy 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. © 2012 International Spinal Cord Society All rights reserved.
 
ISSN1362-4393
2012 Impact Factor: 1.899
2012 SCImago Journal Rankings: 1.027
 
DOIhttp://dx.doi.org/10.1038/sc.2011.126
 
ISI Accession Number IDWOS:000300125500011
Funding AgencyGrant Number
China Spinal Cord Injury Network Company Limited
Funding Information:

We thank Dr Limin Liao, Dr Lan Sun, Dr Zhigang Chen, Dr Jimin Xu, Ms Mingqin Dong, Dr Xiandi Zhang and Dr Yukun Yang for significant contributions to this phase II clinical study. The study was supported by China Spinal Cord Injury Network Company Limited.

 
ReferencesReferences in Scopus
 
DC FieldValue
dc.contributor.authorYang, ML
 
dc.contributor.authorLi, JJ
 
dc.contributor.authorSo, KF
 
dc.contributor.authorChen, JYH
 
dc.contributor.authorCheng, WS
 
dc.contributor.authorWu, J
 
dc.contributor.authorWang, ZM
 
dc.contributor.authorGao, F
 
dc.contributor.authorYoung, W
 
dc.date.accessioned2012-05-23T05:42:27Z
 
dc.date.available2012-05-23T05:42:27Z
 
dc.date.issued2012
 
dc.description.abstractStudy 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. © 2012 International Spinal Cord Society All rights reserved.
 
dc.description.natureLink_to_subscribed_fulltext
 
dc.identifier.citationSpinal Cord, 2012, v. 50 n. 2, p. 141-146 [How to Cite?]
DOI: http://dx.doi.org/10.1038/sc.2011.126
 
dc.identifier.citeulike10065230
 
dc.identifier.doihttp://dx.doi.org/10.1038/sc.2011.126
 
dc.identifier.epage146
 
dc.identifier.hkuros199491
 
dc.identifier.isiWOS:000300125500011
Funding AgencyGrant Number
China Spinal Cord Injury Network Company Limited
Funding Information:

We thank Dr Limin Liao, Dr Lan Sun, Dr Zhigang Chen, Dr Jimin Xu, Ms Mingqin Dong, Dr Xiandi Zhang and Dr Yukun Yang for significant contributions to this phase II clinical study. The study was supported by China Spinal Cord Injury Network Company Limited.

 
dc.identifier.issn1362-4393
2012 Impact Factor: 1.899
2012 SCImago Journal Rankings: 1.027
 
dc.identifier.issue2
 
dc.identifier.pmid22105463
 
dc.identifier.scopuseid_2-s2.0-84856683661
 
dc.identifier.spage141
 
dc.identifier.urihttp://hdl.handle.net/10722/146839
 
dc.identifier.volume50
 
dc.languageeng
 
dc.publisherNature Publishing Group. The Journal's web site is located at http://www.nature.com/sc
 
dc.publisher.placeUnited Kingdom
 
dc.relation.ispartofSpinal Cord
 
dc.relation.referencesReferences in Scopus
 
dc.subjectchronic spinal cord injury
 
dc.subjectclinical trial
 
dc.subjectlithium
 
dc.subjectneural regeneration
 
dc.subjectneuropathic pain
 
dc.titleEfficacy and safety of lithium carbonate treatment of chronic spinal cord injuries: A double-blind, randomized, placebo-controlled clinical trial
 
dc.typeArticle
 
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<contributor.author>So, KF</contributor.author>
<contributor.author>Chen, JYH</contributor.author>
<contributor.author>Cheng, WS</contributor.author>
<contributor.author>Wu, J</contributor.author>
<contributor.author>Wang, ZM</contributor.author>
<contributor.author>Gao, F</contributor.author>
<contributor.author>Young, W</contributor.author>
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Author Affiliations
  1. Rutgers, The State University of New Jersey
  2. The University of Hong Kong
  3. China Rehabilitation Research Center
  4. China Spinal Cord Injury Network, Ltd.
  5. Capital Medical University China