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A double-blind, randomized, placebo-controlled, parallel group study of THC/CBD spray in peripheral neuropathic pain treatment.
Eur J Pain. 2014 Aug; 18(7):999-1012.EJ

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+Show Affiliations

Pain Clinic Office, Gartnavel General Hospital, University of Glasgow, UK.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24420962

Citation

Serpell, M, et al. "A Double-blind, Randomized, Placebo-controlled, Parallel Group Study of THC/CBD Spray in Peripheral Neuropathic Pain Treatment." European Journal of Pain (London, England), vol. 18, no. 7, 2014, pp. 999-1012.
Serpell M, Ratcliffe S, Hovorka J, et al. A double-blind, randomized, placebo-controlled, parallel group study of THC/CBD spray in peripheral neuropathic pain treatment. Eur J Pain. 2014;18(7):999-1012.
Serpell, M., Ratcliffe, S., Hovorka, J., Schofield, M., Taylor, L., Lauder, H., & Ehler, E. (2014). A double-blind, randomized, placebo-controlled, parallel group study of THC/CBD spray in peripheral neuropathic pain treatment. European Journal of Pain (London, England), 18(7), 999-1012. https://doi.org/10.1002/j.1532-2149.2013.00445.x
Serpell M, et al. A Double-blind, Randomized, Placebo-controlled, Parallel Group Study of THC/CBD Spray in Peripheral Neuropathic Pain Treatment. Eur J Pain. 2014;18(7):999-1012. PubMed PMID: 24420962.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A double-blind, randomized, placebo-controlled, parallel group study of THC/CBD spray in peripheral neuropathic pain treatment. AU - Serpell,M, AU - Ratcliffe,S, AU - Hovorka,J, AU - Schofield,M, AU - Taylor,L, AU - Lauder,H, AU - Ehler,E, Y1 - 2014/01/13/ PY - 2013/11/22/accepted PY - 2014/1/15/entrez PY - 2014/1/15/pubmed PY - 2015/5/28/medline SP - 999 EP - 1012 JF - European journal of pain (London, England) JO - Eur J Pain VL - 18 IS - 7 N2 - 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. SN - 1532-2149 UR - https://www.unboundmedicine.com/medline/citation/24420962/A_double_blind_randomized_placebo_controlled_parallel_group_study_of_THC/CBD_spray_in_peripheral_neuropathic_pain_treatment_ L2 - https://doi.org/10.1002/j.1532-2149.2013.00445.x DB - PRIME DP - Unbound Medicine ER -