Cited by 197Cannabis and Cannabinoid ResearchPain Mechanisms and TreatmentsPain Management and Treatment

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A double‐blind, randomized, placebo‐controlled, parallel group study of THC/CBD spray in peripheral neuropathic pain treatment

Serpell, M., Ratcliffe, S., Hovorka, J., Schofield, M., Taylor, L., Lauder, H., Ehler, E.·2014·European Journal of Pain

DOI 10.1002/j.1532-2149.2013.00445.x

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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 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.

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Authors: Serpell, M., Ratcliffe, S., Hovorka, J., Schofield, M., Taylor, L., Lauder, H., & Ehler, E.
Affiliations: Gartnavel General Hospital (GB)
MAC Clinical Research (United Kingdom) (GB)
General University Hospital in Prague (CZ)
West Suffolk Hospital (GB)
GW Pharmaceuticals (United Kingdom) (GB)
Nemocnice Pardubického Kraje (CZ)
Corresponding author: Serpell, M.
ORCID: Serpell, M.
Ehler, E.
Venue: European Journal of Pain
Publisher: Wiley
Published: 2014-01-13
Volume: 18
Issue: 7
Pages: 999-1012
ISSN: 1090-3801 (ISSN-L)
1532-2149
DOI: 10.1002/j.1532-2149.2013.00445.x
OpenAlex: W2112026566
Cited by: 197
References: 41
Citations by year: 2026: 8 · 2025: 14 · 2024: 15 · 2023: 12 · 2022: 32 · 2021: 24 · 2020: 25 · 2019: 15 · 2018: 20 · 2017: 10 · 2016: 10 · 2015: 9 · 2014: 3
FWCI: 7.78
Type: journal article
Language: en
Open access: closed
Licence: onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations: European Journal of Pain (publishedVersion)
PubMed (publishedVersion)
ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (submittedVersion)
Topics: Health Sciences › Medicine › Pharmacology (medical) › Cannabis and Cannabinoid Research
Health Sciences › Medicine › Physiology (medical) › Pain Mechanisms and Treatments
Health Sciences › Medicine › Anesthesiology and Pain Medicine › Pain Management and Treatment
Keywords: peripheral neuropathic pain, allodynia, oromucosal spray, cannabinoids, tetrahydrocannabinol, cannabidiol, analgesia, sleep quality, treatment-resistant pain, tolerability
MeSH terms: Adult, Aged, Aged, 80 and over, Analgesics, Cannabidiol, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Middle Aged, Neuralgia, Pain Measurement, Peripheral Nervous System Diseases, Dronabinol, Treatment Outcome

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A double‐blind, randomized, placebo‐controlled, parallel group study of THC/CBD spray in peripheral neuropathic pain treatment

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