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A double‐blind, randomized, placebo‐controlled, parallel group study of THC / CBD spray in peripheral neuropathic pain treatment
Author(s) -
Serpell M.,
Ratcliffe S.,
Hovorka J.,
Schofield M.,
Taylor L.,
Lauder H.,
Ehler E.
Publication year - 2014
Publication title -
european journal of pain
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.305
H-Index - 109
eISSN - 1532-2149
pISSN - 1090-3801
DOI - 10.1002/j.1532-2149.2013.00445.x
Subject(s) - cannabidiol , placebo , medicine , neuropathic pain , anesthesia , randomized controlled trial , clinical trial , confidence interval , allodynia , statistical significance , cannabis , hyperalgesia , nociception , psychiatry , alternative medicine , receptor , pathology
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 S ubject G lobal I mpression of C hange ( 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.