Cannabis-Based Medicine for Neuropathic Pain and Spasticity—A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial
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Cannabis-Based Medicine for Neuropathic Pain and Spasticity—A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial. / Hansen, Julie Schjødtz; Gustavsen, Stefan; Roshanisefat, Homayoun; Kant, Matthias; Biering-Sørensen, Fin; Andersen, Claus; Olsson, Anna; Chow, Helene Højsgaard; Asgari, Nasrin; Hansen, Julie Richter; Nielsen, Helle Hvilsted; Hansen, Rikke Middelhede; Petersen, Thor; Oturai, Annette Bang; Sellebjerg, Finn; Sædder, Eva Aggerholm; Kasch, Helge; Rasmussen, Peter Vestergaard; Finnerup, Nanna Brix; Svendsen, Kristina Bacher.
I: Pharmaceuticals, Bind 16, Nr. 8, 1079, 2023.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Cannabis-Based Medicine for Neuropathic Pain and Spasticity—A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial
AU - Hansen, Julie Schjødtz
AU - Gustavsen, Stefan
AU - Roshanisefat, Homayoun
AU - Kant, Matthias
AU - Biering-Sørensen, Fin
AU - Andersen, Claus
AU - Olsson, Anna
AU - Chow, Helene Højsgaard
AU - Asgari, Nasrin
AU - Hansen, Julie Richter
AU - Nielsen, Helle Hvilsted
AU - Hansen, Rikke Middelhede
AU - Petersen, Thor
AU - Oturai, Annette Bang
AU - Sellebjerg, Finn
AU - Sædder, Eva Aggerholm
AU - Kasch, Helge
AU - Rasmussen, Peter Vestergaard
AU - Finnerup, Nanna Brix
AU - Svendsen, Kristina Bacher
N1 - Publisher Copyright: © 2023 by the authors.
PY - 2023
Y1 - 2023
N2 - Patients with multiple sclerosis (MS) and spinal cord injury (SCI) commonly sustain central neuropathic pain (NP) and spasticity. Despite a lack of consistent evidence, cannabis-based medicine (CBM) has been suggested as a supplement treatment. We aimed to investigate the effect of CBM on NP and spasticity in patients with MS or SCI. We performed a randomized, double-blinded, placebo-controlled trial in Denmark. Patients aged ≥18 years with NP (intensity >3, ≤9 on a numerical rating scale (NRS0-10) and/or spasticity (>3 on NRS0-10) were randomized to treatment consisting of either delta-9-tetrahydrocannabinol (THC), cannabidiol (CBD), a combination of THC&CBD in maximum doses of 22.5 mg, 45 mg and 22.5/45 mg per day, respectively, or placebo. A baseline registration was performed before randomization. Treatment duration was six weeks followed by a one-week phaseout. Primary endpoints were the intensity of patient-reported NP and/or spasticity. Between February 2019 and December 2021, 134 patients were randomized (MS n = 119, SCI n = 15), where 32 were assigned to THC, 31 to CBD, 31 to THC&CBD, and 40 to placebo. No significant difference was found for: mean pain intensity (THC 0.42 (−0.54–1.38), CBD 0.45 (−0.47–1.38) and THC&CBD 0.16 (−0.75–1.08)), mean spasticity intensity (THC 0.24 (−0.67–1.45), CBD 0.46 (−0.74–1.65), and THC&CBD 0.10 (−1.18–1.39), secondary outcomes (patient global impression of change and quality of life), or any tertiary outcomes. We aimed to include 448 patients in the trial; however, due to COVID-19 and recruitment challenges, fewer were included. Nevertheless, in this four-arm parallel trial, no effect was found between placebo and active treatment with THC or CBD alone or in combination on NP or spasticity in patients with either MS or SCI. The trial was registered with the EU Clinical Trials Register EudraCT (2018-002315-98).
AB - Patients with multiple sclerosis (MS) and spinal cord injury (SCI) commonly sustain central neuropathic pain (NP) and spasticity. Despite a lack of consistent evidence, cannabis-based medicine (CBM) has been suggested as a supplement treatment. We aimed to investigate the effect of CBM on NP and spasticity in patients with MS or SCI. We performed a randomized, double-blinded, placebo-controlled trial in Denmark. Patients aged ≥18 years with NP (intensity >3, ≤9 on a numerical rating scale (NRS0-10) and/or spasticity (>3 on NRS0-10) were randomized to treatment consisting of either delta-9-tetrahydrocannabinol (THC), cannabidiol (CBD), a combination of THC&CBD in maximum doses of 22.5 mg, 45 mg and 22.5/45 mg per day, respectively, or placebo. A baseline registration was performed before randomization. Treatment duration was six weeks followed by a one-week phaseout. Primary endpoints were the intensity of patient-reported NP and/or spasticity. Between February 2019 and December 2021, 134 patients were randomized (MS n = 119, SCI n = 15), where 32 were assigned to THC, 31 to CBD, 31 to THC&CBD, and 40 to placebo. No significant difference was found for: mean pain intensity (THC 0.42 (−0.54–1.38), CBD 0.45 (−0.47–1.38) and THC&CBD 0.16 (−0.75–1.08)), mean spasticity intensity (THC 0.24 (−0.67–1.45), CBD 0.46 (−0.74–1.65), and THC&CBD 0.10 (−1.18–1.39), secondary outcomes (patient global impression of change and quality of life), or any tertiary outcomes. We aimed to include 448 patients in the trial; however, due to COVID-19 and recruitment challenges, fewer were included. Nevertheless, in this four-arm parallel trial, no effect was found between placebo and active treatment with THC or CBD alone or in combination on NP or spasticity in patients with either MS or SCI. The trial was registered with the EU Clinical Trials Register EudraCT (2018-002315-98).
KW - cannabidiol (CBD)
KW - cannabis-based medicine (CBM)
KW - delta-9-tetrahydrocannabinol (THC)
KW - neuropathic pain (NP)
KW - spasticity
U2 - 10.3390/ph16081079
DO - 10.3390/ph16081079
M3 - Journal article
C2 - 37630995
AN - SCOPUS:85168915195
VL - 16
JO - Pharmaceuticals
JF - Pharmaceuticals
SN - 1424-8247
IS - 8
M1 - 1079
ER -
ID: 396844453