Randomized Placebo-ControlledudDouble-Blind Clinical Trial ofudCannabis-Based Medicinal Productud(Sativex) in Painful Diabetic Neuropathy

摘要

Objective: To assess the efficacy of Sativex, a cannabis-based medicinal extract, as adjuvantudtreatment in painful diabetic peripheral neuropathy (DPN).udResearch design and methods: In this randomized controlled trial, 30 subjectsudwith painful DPN received daily Sativex or placebo. The primary outcome measure wasudchange in mean daily pain scores, and secondary outcome measures included quality-of-lifeudassessments.udResults: There was significant improvement in pain scores in both groups, but meanudchange between groups was not significant. There were no significant differences in secondaryudoutcome measures. Patients with depression had significantly greater baseline pain scores thatudimproved regardless of intervention.udConclusions: This first-ever trial assessing the efficacy of cannabis has shown it to beudno more efficacious than placebo in painful DPN. Depression was a major confounder and mayudhave important implications for future trials on painful DPN.ud