How to ESCAPE from Pain? An Observational Study on Improving Pain and Quality of Life with the Cannamedical((R)) Hybrid Cannabis Extract.
Wagner et al.·Advances in therapyImpact 3.7
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Stichproben = 64 Pat.
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EndpunktNRS
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DesignKohortenstudie
Cannabinoidkombination
THC:CBD1:1
Applikationoral
”Kernaussage
Schmerzintensität und Schmerzinterferenz nahmen in beiden Gruppen ab, physische und mentale Gesundheit verbesserten sich, hohe Zufriedenheit berichtet.
Zusammenfassung
Prospektive Beobachtungsstudie (n=64) zu Cannamedical® Hybrid Cannabis Extract THC25:CBD25 bei chronischen Schmerzpatienten über 4 Visiten; NRS-Schmerzintensität sank von 5.46±1.73 (V1) auf 3.37±2.43 (V4) in der ITT-Population; bei Cannabis-naiven Patienten (n=35) Reduktion von 5.92±1.34 auf 2.37±1.69. Pain Interference Subscore verbesserte sich von 5.39±1.92 auf 3.38±2.46 (ITT) bzw. 5.68±1.46 auf 2.54±1.99 (Cannabis-naiv). SF-12 zeigte Verbesserungen in physischer und mentaler Gesundheit; hohe Patienten- und Ärztezufriedenheit.
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PopulationErwachsene (≥18 Jahre) mit chronischem Schmerz in Deutschland, n=64 (ITT; 50% weiblich), davon cannabis-naive Subgruppe n=35
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InterventionCannamedical® Hybrid Cannabis Extract THC25:CBD25, oral/Extrakt, in der klinischen Alltagspraxis
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OutcomeNRS-Schmerzintensität sank im ITT von 5,46 auf 3,37 (V1→V4); in der cannabis-naiven Subgruppe von 5,92 auf 2,37; Pain-Interference-Subscore und Lebensqualität (SF-12 physisch und mental) verbesserten sich in beiden Gruppen
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Autoren
Wagner Y, Samel I, Probst K, Schollenberger L, Ruckes C, Nadstawek J
Introduction: Chronic pain remains a challenge, with standard therapies often providing inadequate pain relief and causing undesirable side effects. Medicinal cannabis has emerged as promising alternative. This study assessed the impact of a cannabis hybrid extract on pain intensity and quality of life in daily clinical use.
Methods: ESCAPE was an observational study and included patients aged >/= 18 years with chronic pain in Germany. The primary objective was to evaluate the effectiveness of the Cannamedical((R)) Hybrid Cannabis Extract THC25:CBD25 on pain during four visits (V1-V4) in clinical practice, and key secondary objectives were pain interference and quality of life. Pain intensity was measured using the Numeric Rating Scale (NRS) of the Brief Pain Inventory (BPI) questionnaire. Pain interference was evaluated with the BPI pain interference subscore, and quality of life-particularly physical and mental health-was assessed with the Short Form-12 (SF-12) questionnaire. Additionally, patient and physician satisfaction with the extract was assessed.
Results: The study included 64 patients (50% female) with chronic pain (intention-to treat population; ITT). Cannabis-naive patients of the ITT were defined as a subgroup and analyzed separately (N = 35). Mean (+/- SD) NRS-assessed pain intensity decreased during the study, in both the ITT (5.46 +/- 1.73 at V1 vs. 3.37 +/- 2.43 at V4) and in the cannabis-naive subgroup (5.92 +/- 1.34 at V1 vs. 2.37 +/- 1.69 at V4). Mean pain interference subscore decreased between V1 and V4 for the ITT (5.39 +/- 1.92 vs. 3.38 +/- 2.46) and the cannabis-naive group (5.68 +/- 1.46 vs. 2.54 +/- 1.99). Physical and mental health improved in both groups and high satisfaction with the hybrid cannabis extract was reported by patients and physicians.
Conclusion: Treatment with the Cannamedical((R)) Hybrid Cannabis Extract THC25:CBD25 in daily clinical practice showed positive effects on patients' pain and quality of life.
Trial Registration: German Clinical Trials Registry identifier DRKS00026906.