THC:CBD-Spray zeigte eine Verbesserung der Symptome um durchschnittlich 39,0% (ASR-9) nach 12 Wochen, mit besonders ausgeprägtem Effekt bei neuropathischen Schmerzen (54,9% Verbesserung) und guter Verträglichkeit.
Zusammenfassung
Real-World-Register-Analyse aus dem German Pain e-Registry 2017, n=800 Patienten mit schwerem chronischen Schmerz unter THC:CBD-Oromukosalspray als Add-on. ASR-9-Verbesserung (9-Faktor-Symptomrelief) nach 12 Wochen: 39,0±26,5% (95%-CI 36,9–41,1, Median 42%, Range -41 bis +85). Vollständige ASR-9-Response (≥50% Verbesserung in allen 9 Faktoren) bei 15,4% (n=123); ≥50% Verbesserung in ≥5/9 Faktoren bei 56,0% (n=488). Subgruppen-Analyse: neuropathischer Schmerz (n=497, 62,1%) signifikant besser (ASR-9: 54,9±17,2%, Median 56%) vs. gemischter Schmerz (n=249, 31,1%; ASR-9: 18,2±12,0%, Median 19%, p<0,001) und nozizeptiver Schmerz (n=54, 6,8%; ASR-9: -11,9±10,5%, Median -11%, p<0,001). Nebenwirkungen bei 19,9% (n=159), meist mild (81,6%); häufigste TEAEs: gesteigerter Appetit (6,3%, n=50), Dysgeusie (2,9%, n=23). Abbrüche wegen TEAEs: 4,0% (n=32); wegen unzureichender Schmerzlinderung: 14,1% (n=113), überwiegend bei nozizeptivem Schmerz (74,1%, n=40 von 54), selten bei neuropathischem Schmerz (0,2%, n=1, p<0,001).
P
PopulationErwachsene mit schwerem chronischen Schmerz (SCP), n=800, aus dem Deutschen Schmerz-e-Register (GPR), 57% weiblich, Durchschnittsalter 46,3 Jahre
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InterventionTHC:CBD oromukosales Spray (Nabiximols) als Add-on-Therapie über 12 Wochen
O
OutcomeAggregierte 9-Faktor-Symptomlinderung (ASR-9) +39,0±26,5% nach 12 Wochen (95%-KI: 36,9–41,1); signifikant besser bei neuropathischem Schmerz (54,9%) vs. Mischschmerz (18,2%) vs. nozizeptivem Schmerz (-11,9%; p<0,001)
Vertrauen in die Evidenz
Sehr niedrigNiedrigModeratHoch
Sehr niedrig
Niedrigste GRADE-Stufe, die Effektschätzung bleibt unsicher.
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.