Randomized Placebo-Controlled Double-Blind Clinical Trial of Cannabis-Based Medicinal Product (Sativex) in Painful Diabetic Neuropathy

Depression is a major confounding factor

  1. Dinesh Selvarajah, MRCP, MBCHB,
  2. Rajiv Gandhi, MRCP, MBCHB,
  3. Celia J. Emery, PHD and
  4. Solomon Tesfaye, FRCP, MD
  1. From the Diabetes Research Department, Royal Hallamshire Hospital, Sheffield, U.K.
  1. Corresponding author: Dinesh Selvarajah, dinesh.selvarajah{at}gmail.com.

Abstract

OBJECTIVE To assess the efficacy of Sativex, a cannabis-based medicinal extract, as adjuvant treatment in painful diabetic peripheral neuropathy (DPN).

RESEARCH DESIGN AND METHODS In this randomized controlled trial, 30 subjects with painful DPN received daily Sativex or placebo. The primary outcome measure was change in mean daily pain scores, and secondary outcome measures included quality-of-life assessments.

RESULTS 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.

CONCLUSIONS 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 trials on painful DPN.

Footnotes

  • The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this fact.

    • Received June 15, 2009.
    • Accepted September 30, 2009.
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This Article

  1. Diabetes Care vol. 33 no. 1 128-130
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