THC:CBD spray showed an improvement in symptoms of on average 39,0% (ASR-9) after 12 weeks, with a particularly pronounced effect in neuropathic pain (54,9% improvement) and good tolerability.
Summary
Real-world registry analysis from the German Pain e-Registry 2017, n=800 patients with severe chronic pain under THC:CBD oromucosal spray as add-on. ASR-9 improvement (9-factor symptom relief) after 12 weeks: 39,0±26,5% (95% CI 36,9–41,1, median 42%, range -41 to +85). Complete ASR-9 response (≥50% improvement in all 9 factors) in 15,4% (n=123); ≥50% improvement in ≥5/9 factors in 56,0% (n=488). Subgroup analysis: neuropathic pain (n=497, 62,1%) significantly better (ASR-9: 54,9±17,2%, median 56%) vs. mixed pain (n=249, 31,1%; ASR-9: 18,2±12,0%, median 19%, p<0,001) and nociceptive pain (n=54, 6,8%; ASR-9: -11,9±10,5%, median -11%, p<0,001). Adverse events in 19,9% (n=159), mostly mild (81,6%); most common TEAEs: increased appetite (6,3%, n=50), dysgeusia (2,9%, n=23). Discontinuations due to TEAEs: 4,0% (n=32); due to insufficient pain relief: 14,1% (n=113), predominantly in nociceptive pain (74,1%, n=40 of 54), rarely in neuropathic pain (0,2%, n=1, p<0,001).
P
PopulationAdults with severe chronic pain (SCP), n=800, from the German Pain e-Registry (GPR), 57% female, mean age 46,3 years
I
InterventionTHC:CBD oromucosal spray (nabiximols) as add-on therapy over 12 weeks
O
OutcomeAggregated 9-factor symptom relief (ASR-9) +39,0±26,5% after 12 weeks (95% CI: 36,9–41,1); significantly better for neuropathic pain (54,9%) vs. mixed pain (18,2%) vs. nociceptive pain (-11,9%; p<0,001)
Confidence in the evidence
Very lowLowModerateHigh
Very low
The lowest GRADE level, the effect estimate remains uncertain.
Objective: To evaluate effectiveness, tolerability and safety of an oromucosal spray containing Delta9-tetrahydrocannabinol (THC) and cannabidiol (CBD), as add-on treatment in patients with severe chronic pain (SCP). Methods: Exploratory analysis of anonymized 12-week routine/open-label data provided by the German Pain e-Registry (GPR) on adult SCP patients treated with THC:CBD oromucosal spray in 2017. Results: Among those 30.228 cases documented in the GPR in 2017, 800 (2.6%; 57% female, mean +/- SD age: 46.3+/-9.7 years) received a treatment with THC:CBD. All patients fulfilled the legislative preconditions for a treatment with cannabis as medicine as defined by the German Act Amending Narcotics and Other Regulations. THC:CBD-treatment was followed by an aggregated nine-factor symptom relief (ASR-9) improvement at end of week 12 vs baseline of 39.0+/-26.5% (95%-CI: 36.9-41.1, median: 42, range -41 to 85). A full ASR-9 response (ie, a 50%-improvement in all 9 factors) was found for 123 patients (15.4%), while 488 patients (56.0%) presented with an >/=50% improvement in at least 5 of 9 ASR factors. With a 54.9+/-17.2% (median: 56%, range: -6 to 85) improvement was significantly superior in the neuropathic pain subgroup (n=497, 62.1%) vs those with mixed (n=249, 31.1%; ASR-9: 18.2+/-12.0, median: 19, range: -12 to 42%) or nociceptive pain (n=54, 6.8%; ASR-9: -11.9+/-10.5, median: -11, range: -41% to 12%; p<0.001 for each). 159 patients (19.9%) reported at least one of 206 TEAEs, most of them of mild intensity (n=81.6%). Most frequently reported TEAEs were increased appetite (n=50, 6.3%) and dysgeusia (n=23, 2.9%). TEAE-related discontinuations were reported for 32 patients (4.0%). 113 (14.1%) patients discontinued due to inadequate pain relief, most of them with nociceptive pain (n=40, 74.1%), least with neuropathic pain (n=1, 0.2%; p<0.001). Conclusion: THC:CBD oromucosal spray proved to be an effective and well-tolerated add-on treatment for patients with elsewhere refractory chronic pain - especially of neuropathic origin.