Study register · detailRCT (parallel-group) · Cancer · 2010
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
MixedGRADEHigh617 citations
Samplen = 177 Pat.
Durationtwo weeks
ControlPlacebo
EndpointNRS
Blindingdoppelblind
DesignRCT (parallel-group)
Cannabinoidkombination
THC:CBD1:1
Routeoromukosal
”Key finding
THC:CBD showed statistically significant pain relief versus placebo (NRS -1,37 vs. -0,69), but with worsening of nausea and vomiting; THC alone did not differ significantly from placebo.
Summary
Multicentre phase II RCT in n=177 patients with refractory tumor pain despite opioid therapy; THC:CBD extract vs. THC extract vs. placebo over 2 weeks. THC:CBD significantly superior vs. placebo (NRS reduction -1.37 vs. -0.69, p<0.05); 43% vs. 21% achieved >30% pain reduction (OR significant). THC extract alone not significant vs. placebo (-1.01 vs. -0.69). Adverse effects mild/moderate; THC:CBD showed worsening of nausea/vomiting vs. placebo (p=0.02).
P
PopulationAdults with advanced cancer pain and inadequate analgesia despite chronic opioid therapy, n=177
OutcomeNRS pain reduction significant for THC:CBD vs. placebo (−1,37 vs. −0,69); THC vs. placebo not significant (−1,01 vs. −0,69); 43% vs. 21% responders (>30% reduction) for THC:CBD vs. placebo (OR significant)
Confidence in the evidence
Very lowLowModerateHigh
High
The highest of four GRADE levels, the effect estimate is very reliable.
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.