1. Ultramicronized palmitoylethanolamide in spinal cord injury neuropathic pain: a randomized, double-blind, placebo-controlled trial.
- Author
-
Andresen, Sven R., Bing, Jette, Hansen, Rikke M., Biering-Sørensen, Fin, Johannesen, Inger L., Hagen, Ellen Merete, Rice, Andrew S. C., Nielsen, Jørgen F., Bach, Flemming W., and Finnerup, Nanna B.
- Subjects
- *
AMIDES , *PAIN management , *SPINAL cord injuries , *SPASTICITY , *CANNABINOIDS , *THERAPEUTICS , *FATTY acids , *ANALGESICS , *ETHANOLAMINES , *ANALYSIS of variance , *COMPARATIVE studies , *LONGITUDINAL method , *RESEARCH methodology , *MEDICAL cooperation , *NEURALGIA , *RESEARCH , *EVALUATION research , *TREATMENT effectiveness , *BLIND experiment , *DISEASE complications - Abstract
Neuropathic pain and spasticity after spinal cord injury (SCI) represent significant problems. Palmitoylethanolamide (PEA), a fatty acid amide that is produced in many cells in the body, is thought to potentiate the action of endocannabinoids and to reduce pain and inflammation. This randomized, double-blind, placebo-controlled, parallel multicenter study was performed to investigate the effect of ultramicronized PEA (PEA-um) as add-on therapy on neuropathic pain in individuals with SCI. A pain diary was completed and questionnaires were completed before and after the 12-week treatment with either placebo or PEA-um. The primary outcome measure was the change in mean neuropathic pain intensity from the 1-week baseline period to the last week of treatment measured on a numeric rating scale ranging from 0 to 10. The primary efficacy analysis was the intention to treat (baseline observation carried forward). Secondary outcomes included a per protocol analysis and effects on spasticity, evoked pain, sleep problems, anxiety, depression, and global impression of change. We randomized 73 individuals with neuropathic pain due to SCI, of which 5 had a major protocol violation, and thus 68 were included in the primary analysis. There was no difference in mean pain intensity between PEA-um and placebo treatment (P = 0.46, mean reductions in pain scores 0.4 (-0.1 to 0.9) vs 0.7 (0.2-1.2); difference of means 0.3 (-0.4 to 0.9)). There was also no effect of PEA-um as add-on therapy on spasticity, insomnia, or psychological functioning. PEA was not associated with more adverse effects than placebo. [ABSTRACT FROM AUTHOR]
- Published
- 2016
- Full Text
- View/download PDF