Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Efficacy, Safety, and Tolerability of THC:CBD Extract and THC Extract in Patients with Intractable Cancer-Related Pain
Johnson et al.·Journal of Pain and Symptom ManagementImpact 0.8
GemischtGRADEHoch617 Zitate
Stichproben = 177 Pat.
Dauerzwei Wochen
KontrollePlacebo
EndpunktNRS
Verblindungdoppelblind
DesignRCT (parallel-group)
Cannabinoidkombination
THC:CBD1:1
Applikationoromukosal
”Kernaussage
THC:CBD zeigte statistisch signifikante Schmerzlinderung gegenüber Placebo (NRS -1,37 vs. -0,69), jedoch mit Verschlechterung von Übelkeit und Erbrechen; THC allein unterschied sich nicht signifikant von Placebo.
Zusammenfassung
Multizentrische Phase-II-RCT bei n=177 Patienten mit refraktärem Tumorschmerz trotz Opioid-Therapie; THC:CBD-Extrakt vs. THC-Extrakt vs. Placebo über 2 Wochen. THC:CBD signifikant überlegen vs. Placebo (NRS-Reduktion -1.37 vs. -0.69, p<0.05); 43% vs. 21% erreichten >30% Schmerzreduktion (OR signifikant). THC-Extrakt allein nicht signifikant vs. Placebo (-1.01 vs. -0.69). Nebenwirkungen mild/moderat; THC:CBD zeigte Verschlechterung bei Übelkeit/Erbrechen vs. Placebo (p=0.02).
P
PopulationErwachsene mit fortgeschrittenem Krebsschmerz und unzureichender Analgesie trotz chronischer Opioidtherapie, n=177
I
InterventionTHC:CBD-Extrakt (oromukosales Spray, n=60) oder THC-Extrakt (n=58), 2 Wochen
C
KontrollePlacebo (n=59)
O
OutcomeNRS-Schmerzreduktion signifikant für THC:CBD vs. Placebo (−1,37 vs. −0,69); THC vs. Placebo nicht signifikant (−1,01 vs. −0,69); 43% vs. 21% Responder (>30% Reduktion) für THC:CBD vs. Placebo (OR signifikant)
Vertrauen in die Evidenz
Sehr niedrigNiedrigModeratHoch
Hoch
Höchste von vier GRADE-Stufen, die Effektschätzung ist sehr verlässlich.
This study compared the efficacy of a tetrahydrocannabinol:cannabidiol (THC:CBD) extract, a nonopioid analgesic endocannabinoid system modulator, and a THC extract, with placebo, in relieving pain in patients with advanced cancer. In total, 177 patients with cancer pain, who experienced inadequate analgesia despite chronic opioid dosing, entered a two-week, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial. Patients were randomized to THC:CBD extract (n = 60), THC extract (n = 58), or placebo (n = 59). The primary analysis of change from baseline in mean pain Numerical Rating Scale (NRS) score was statistically significantly in favor of THC:CBD compared with placebo (improvement of -1.37 vs. -0.69), whereas the THC group showed a nonsignificant change (-1.01 vs. -0.69). Twice as many patients taking THC:CBD showed a reduction of more than 30% from baseline pain NRS score when compared with placebo (23 [43%] vs. 12 [21%]). The associated odds ratio was statistically significant, whereas the number of THC group responders was similar to placebo (12 [23%] vs. 12 [21%]) and did not reach statistical significance. There was no change from baseline in median dose of opioid background medication or mean number of doses of breakthrough medication across treatment groups. No significant group differences were found in the NRS sleep quality or nausea scores or the pain control assessment. However, the results from the European Organisation for Research and Treatment of Cancer Quality of Life Cancer Questionnaire showed a worsening in nausea and vomiting with THC:CBD compared with placebo (P = 0.02), whereas THC had no difference (P = 1.0). Most drug-related adverse events were mild/moderate in severity. This study shows that THC:CBD extract is efficacious for relief of pain in patients with advanced cancer pain not fully relieved by strong opioids.