Oral capsules of tetra-hydro-cannabinol (THC), cannabidiol (CBD) and their combination in peripheral neuropathic pain treatment.
Zubcevic et al.·European journal of pain (London, England)Impact 2.6
Kein Nutzen nachgewiesenGRADEHoch31 Zitate
Stichproben = 115 Pat.
Dauer8-week treatment period
KontrollePlacebo-Kapseln
EndpunktNRS
Verblindungdoppelblind
DesignRCT
Cannabinoidkombination
THC:CBD1:1
Max. Dosis75.0 mg
Applikationoral
”Kernaussage
CBD, THC und ihre Kombination zeigten keine signifikante Schmerzreduktion gegenüber Placebo bei peripherer neuropathischer Schmerz.
Zusammenfassung
n=115 (ITT) periphere neuropathische Schmerz-Patienten (Polyneuropathie, Post-Zoster-Neuralgie, periphere Nervenverletzung), randomisiert zu CBD (5–50 mg), THC (2.5–25 mg), CBD/THC-Kombination oder Placebo über 8 Wochen. Keines der Cannabinoid-Arme reduzierte Schmerz vs. Placebo (p=0.04–0.60); Effektgrößen Woche 8: CBD +1.14 NRS-Punkte (95% CI 0.11–2.19), THC +0.38 (-0.65 bis 1.4), CBD/THC -0.12 (-1.13 bis 0.89).
P
PopulationErwachsene mit peripherer neuropathischer Schmerzen (schmerzhafte Polyneuropathie, Post-Zoster-Neuralgie, periphere Nervenverletzung), die mindestens eine vorherige evidenzbasierte Pharmakotherapie nicht tolerierten/versagten, n=115 (ITT)
I
InterventionOrale Kapseln CBD (5–50 mg/Tag), THC (2,5–25 mg/Tag) oder CBD/THC-Kombination (5 mg/2,5 mg–50 mg/25 mg/Tag), flexible Dosierung über 8 Wochen
C
KontrollePlacebo-Kapseln (1:1:1:1-Randomisierung)
O
OutcomeKeine signifikante Schmerzreduktion gegenüber Placebo für keinen der Arme; Effektgrößen Woche 8: CBD +1,14 NRS-Punkte (95% CI 0,11–2,19), THC +0,38 (CI −0,65 bis 1,40), CBD/THC −0,12 (CI −1,13 bis 0,89), p=0,04–0,60
Vertrauen in die Evidenz
Sehr niedrigNiedrigModeratHoch
Hoch
Höchste von vier GRADE-Stufen, die Effektschätzung ist sehr verlässlich.
Qualitätsprofil
Größe★★★★★
VerblindungDoppelblind
EffektstärkeKein Nutzen
Zitate / Jahr★★★★★
Autoren
Zubcevic K, Petersen M, Bach FW, Heinesen A, Enggaard TP, Almdal TP, Holbech JV, Vase L, Jensen TS, Hansen CS
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.