Oral capsules of tetra-hydro-cannabinol (THC), cannabidiol (CBD) and their combination in peripheral neuropathic pain treatment
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Oral capsules of tetra-hydro-cannabinol (THC), cannabidiol (CBD) and their combination in peripheral neuropathic pain treatment. / Zubcevic, Kanita; Petersen, Merete; Bach, Flemming Winther; Heinesen, Aksel; Enggaard, Thomas Peter; Almdal, Thomas Peter; Holbech, Jakob Vormstrup; Vase, Lene; Jensen, Troels Stahelin; Hansen, Christian Stevns; Finnerup, Nanna Brix; Sindrup, Søren H.
I: European Journal of Pain, Bind 27, Nr. 4, 2023, s. 492-506.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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T1 - Oral capsules of tetra-hydro-cannabinol (THC), cannabidiol (CBD) and their combination in peripheral neuropathic pain treatment
AU - Zubcevic, Kanita
AU - Petersen, Merete
AU - Bach, Flemming Winther
AU - Heinesen, Aksel
AU - Enggaard, Thomas Peter
AU - Almdal, Thomas Peter
AU - Holbech, Jakob Vormstrup
AU - Vase, Lene
AU - Jensen, Troels Stahelin
AU - Hansen, Christian Stevns
AU - Finnerup, Nanna Brix
AU - Sindrup, Søren H.
N1 - Publisher Copyright: © 2022 The Authors. European Journal of Pain published by John Wiley & Sons Ltd on behalf of European Pain Federation - EFIC ®.
PY - 2023
Y1 - 2023
N2 - Background: Cannabinoids are often prescribed for neuropathic pain, but the evidence-based recommendation is ‘weak against’. Objectives: The aim was to examine the effect of two cannabinoids and their combination in peripheral neuropathic pain. Methods: This was a randomized, double-blind, trial with treatment arms for cannabidiol (CBD), tetra-hydro-cannabinol (THC), CBD and THC combination (CBD/THC), and placebo in a 1:1:1:1 ratio and flexible drug doses (CBD 5–50 mg, THC 2.5–25 mg, and CBD/THC 5 mg/2.5 mg–50 mg/25 mg). Treatment periods of 8-week duration were proceeded by 1 week for baseline observations. Patients with painful polyneuropathy, post-herpetic neuralgia and peripheral nerve injury (traumatic or surgical) failing at least one previous evidence-based pharmacological treatment were eligible for inclusion. The primary outcome was the change in weekly average of daily pain measured with a numeric rating scale (NRS). Trail Making Test (TMT) was used as one of the tests of mental functioning. Results: In all, 145 patients were included in the study of which 118 were randomized and 115 included in the intention-to-treat analysis. None of the treatments reduced pain compared to placebo (p = 0.04–0.60). Effect sizes as estimated in week 8 (positive values worse and negative better than placebo) were CBD mean 1.14 NRS points (95% CI 0.11–2.19), THC 0.38 (CI −0.65 to 1.4) and CBD/THC −0.12 (−1.13 to 0.89). Conclusions: CBD, THC and their combination did not relieve peripheral neuropathic pain in patients failing at least one previous evidence-based treatment for neuropathic pain.
AB - Background: Cannabinoids are often prescribed for neuropathic pain, but the evidence-based recommendation is ‘weak against’. Objectives: The aim was to examine the effect of two cannabinoids and their combination in peripheral neuropathic pain. Methods: This was a randomized, double-blind, trial with treatment arms for cannabidiol (CBD), tetra-hydro-cannabinol (THC), CBD and THC combination (CBD/THC), and placebo in a 1:1:1:1 ratio and flexible drug doses (CBD 5–50 mg, THC 2.5–25 mg, and CBD/THC 5 mg/2.5 mg–50 mg/25 mg). Treatment periods of 8-week duration were proceeded by 1 week for baseline observations. Patients with painful polyneuropathy, post-herpetic neuralgia and peripheral nerve injury (traumatic or surgical) failing at least one previous evidence-based pharmacological treatment were eligible for inclusion. The primary outcome was the change in weekly average of daily pain measured with a numeric rating scale (NRS). Trail Making Test (TMT) was used as one of the tests of mental functioning. Results: In all, 145 patients were included in the study of which 118 were randomized and 115 included in the intention-to-treat analysis. None of the treatments reduced pain compared to placebo (p = 0.04–0.60). Effect sizes as estimated in week 8 (positive values worse and negative better than placebo) were CBD mean 1.14 NRS points (95% CI 0.11–2.19), THC 0.38 (CI −0.65 to 1.4) and CBD/THC −0.12 (−1.13 to 0.89). Conclusions: CBD, THC and their combination did not relieve peripheral neuropathic pain in patients failing at least one previous evidence-based treatment for neuropathic pain.
U2 - 10.1002/ejp.2072
DO - 10.1002/ejp.2072
M3 - Journal article
C2 - 36571471
AN - SCOPUS:85146346915
VL - 27
SP - 492
EP - 506
JO - European Journal of Pain
JF - European Journal of Pain
SN - 1090-3801
IS - 4
ER -
ID: 335696936