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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

TitleEfficacy and safety of lithium carbonate treatment of chronic spinal cord injuries: A double-blind, randomized, placebo-controlled clinical trial
Authors
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
Citation
Spinal Cord, 2012, v. 50 n. 2, p. 141-146 How to Cite?
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.
Persistent Identifierhttp://hdl.handle.net/10722/146839
ISSN
2014 Impact Factor: 1.804
ISI Accession Number ID
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.

References

 

DC FieldValueLanguage
dc.contributor.authorYang, MLen_HK
dc.contributor.authorLi, JJen_HK
dc.contributor.authorSo, KFen_HK
dc.contributor.authorChen, JYHen_HK
dc.contributor.authorCheng, WSen_HK
dc.contributor.authorWu, Jen_HK
dc.contributor.authorWang, ZMen_HK
dc.contributor.authorGao, Fen_HK
dc.contributor.authorYoung, Wen_HK
dc.date.accessioned2012-05-23T05:42:27Z-
dc.date.available2012-05-23T05:42:27Z-
dc.date.issued2012en_HK
dc.identifier.citationSpinal Cord, 2012, v. 50 n. 2, p. 141-146en_HK
dc.identifier.issn1362-4393en_HK
dc.identifier.urihttp://hdl.handle.net/10722/146839-
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.en_HK
dc.languageengen_US
dc.publisherNature Publishing Group. The Journal's web site is located at http://www.nature.com/scen_HK
dc.relation.ispartofSpinal Corden_HK
dc.subjectchronic spinal cord injuryen_HK
dc.subjectclinical trialen_HK
dc.subjectlithiumen_HK
dc.subjectneural regenerationen_HK
dc.subjectneuropathic painen_HK
dc.titleEfficacy and safety of lithium carbonate treatment of chronic spinal cord injuries: A double-blind, randomized, placebo-controlled clinical trialen_HK
dc.typeArticleen_HK
dc.identifier.emailSo, KF:hrmaskf@hkucc.hku.hken_HK
dc.identifier.authoritySo, KF=rp00329en_HK
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1038/sc.2011.126en_HK
dc.identifier.pmid22105463-
dc.identifier.scopuseid_2-s2.0-84856683661en_HK
dc.identifier.hkuros199491en_US
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-84856683661&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume50en_HK
dc.identifier.issue2en_HK
dc.identifier.spage141en_HK
dc.identifier.epage146en_HK
dc.identifier.isiWOS:000300125500011-
dc.publisher.placeUnited Kingdomen_HK
dc.identifier.scopusauthoridYang, ML=23391357400en_HK
dc.identifier.scopusauthoridLi, JJ=54958128700en_HK
dc.identifier.scopusauthoridSo, KF=34668391300en_HK
dc.identifier.scopusauthoridChen, JYH=54956303400en_HK
dc.identifier.scopusauthoridCheng, WS=54958854100en_HK
dc.identifier.scopusauthoridWu, J=54958570300en_HK
dc.identifier.scopusauthoridWang, ZM=54957062800en_HK
dc.identifier.scopusauthoridGao, F=46261070200en_HK
dc.identifier.scopusauthoridYoung, W=8128819100en_HK
dc.identifier.citeulike10065230-

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