title: A double-blind, randomized, placebo-controlled, parallel group study of THC/CBD spray in peripheral neuropathic pain treatment.
abstract: BACKGROUND
  Peripheral neuropathic pain (PNP) associated with allodynia poses a significant clinical challenge. The efficacy of Δ(9) -tetrahydrocannabinol/cannabidiol (THC/CBD) oromucosal spray, a novel cannabinoid formulation, was investigated in this 15-week randomized, double-blind, placebo-controlled parallel group study.
  
  
  METHODS
  In total, 303 patients with PNP associated with allodynia were screened; 128 were randomized to THC/CBD spray and 118 to placebo, in addition to their current analgesic therapy. The co-primary efficacy endpoints were the 30% responder rate in PNP 0-10 numerical rating scale (NRS) score and the mean change from baseline to the end of treatment in this score. Various key secondary measures of pain and functioning were also investigated.
  
  
  RESULTS
  At the 30% responder level, there were statistically significant treatment differences in favour of THC/CBD spray in the full analysis (intention-to-treat) dataset [p = 0.034; 95% confidence interval (CI): 1.05-3.70]. There was also a reduction in mean PNP 0-10 NRS scores in both treatment groups that was numerically higher in the THC/CBD spray group, but which failed to reach statistical significance. Secondary measures of sleep quality 0-10 NRS score (p = 0.0072) and Subject Global Impression of Change (SGIC) (p = 0.023) also demonstrated statistically significant treatment differences in favour of THC/CBD spray treatment.
  
  
  CONCLUSIONS
  These findings demonstrate that, in a meaningful proportion of otherwise treatment-resistant patients, clinically important improvements in pain, sleep quality and SGIC of the severity of their condition are obtained with THC/CBD spray. THC/CBD spray was well tolerated and no new safety concerns were identified.
authors.affiliation: Pain Clinic Office, Gartnavel General Hospital, University of Glasgow, UK.
authors.forename: M
authors.initials: M
authors.lastname: Serpell
authors.forename: S
authors.initials: S
authors.lastname: Ratcliffe
authors.forename: J
authors.initials: J
authors.lastname: Hovorka
authors.forename: M
authors.initials: M
authors.lastname: Schofield
authors.forename: L
authors.initials: L
authors.lastname: Taylor
authors.forename: H
authors.initials: H
authors.lastname: Lauder
authors.forename: E
authors.initials: E
authors.lastname: Ehler
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000700:Analgesics / Q000627:therapeutic use*; D002185:Cannabidiol / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D013759:Dronabinol / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009437:Neuralgia / Q000188:drug therapy*; D010147:Pain Measurement; D010523:Peripheral Nervous System Diseases / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000700:Analgesics; D002185:Cannabidiol; D013759:Dronabinol