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A Randomised Placebo Controlled Double Blind Clinical Trial of Cannabis Based Medicinal Product (Sativex) in Painful Diabetic Neuropathy: Depression is a Major Confounding Factor
Diabetes Care, 10/09/09
Selvarajah D et al. – This first ever, trial assessing the efficacy of cannabis has shown it to be no more efficacious than placebo in painful–DPN. Depression was a major confounder and may have important implications for future painful–DPN trials.
Methods- In this randomized controlled trial, 30 subjects with painful–DPN received daily Sativex or placebo.
- Primary outcome measure was change in mean daily pain scores and secondary outcome measures included quality of life assessments.
- There was significant improvement in pain scores in both groups but mean change between groups was not significant.
- There were no significant differences in secondary outcome measures.
- Patients with depression had significantly greater baseline pain scores that improved regardless of intervention.
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