Safety and Effectiveness of Medicinal Cannabis in Patients with Treatment-Refractory Chronic Non-Malignant Pain: A retrospective cohort study
Authors
Kapteina, Simona Andreea Luca ; Desmond, Anna Margareta
Term
5. Term (Master thesis)
Education
Publication year
2023
Abstract
Kroniske non-maligne smerter er udbredte og vanskelige at behandle, og interessen for medicinsk cannabis (MC) som terapeutisk mulighed er stigende. Dette retrospektive kohortestudie undersøgte sikkerhed og effekt af MC hos danske patienter med behandlingsrefraktære kroniske non-maligne smerter i regi af den danske forsøgsordning. Journaldata fra september 2018 til juli 2021 omfattede behandling med tetrahydrocannabinol (THC), cannabidiol (CBD) eller THC:CBD og blev vurderet ved to opfølgninger 4–14 uger efter baseline (F/U1) og igen 4–14 uger senere (F/U2). Primære udfald var smerteintensitet (numerisk rangskala), søvnkvalitet, livskvalitet og bivirkninger. Af 587 egnede patienter indgik 411 ved F/U1 og 184 ved F/U2 (gennemsnitsalder 59 år). En klinisk relevant smertereduktion (≥30 %) blev rapporteret af 22 % ved F/U1 og 33 % ved F/U2 i per-protokol-analysen, og af 15 % og 10 % i intention-to-treat-analysen. Forbedret søvnkvalitet blev rapporteret af 56 % ved begge opfølgninger, mens 42 % og 38 % angav forbedret livskvalitet. Bivirkninger forekom hos 42 % ved F/U1 og 39 % ved F/U2 og var hyppigst ved THC-holdige regimer; de mest rapporterede var neurologiske og generelle gener, herunder hovedpine, svimmelhed og træthed. Ved F/U2 sås en signifikant forskel mellem regimerne: 8 % i THC-gruppen opnåede klinisk relevant smertereduktion mod 33 % i CBD- og 40 % i THC:CBD-gruppen (p = 0,02). Resultaterne indikerer, at THC:CBD i 1:1-koncentration kan være mest effektivt til smertelindring, mens CBD monoterapi generelt var bedst tolereret. Overordnet tyder data på, at MC kan være et relativt sikkert og effektivt alternativ for nogle patienter, men den retrospektive design og frafald mellem opfølgninger begrænser sikkerheden af konklusionerne; fremtidige høj-kvalitetsstudier er påkrævet.
Chronic non-malignant pain is common and difficult to treat, prompting growing interest in medicinal cannabis (MC) as a therapeutic option. This retrospective cohort study evaluated the safety and effectiveness of MC in Danish patients with treatment-refractory chronic non-malignant pain under the national pilot program. Medical records from September 2018 to July 2021 covered treatment with tetrahydrocannabinol (THC), cannabidiol (CBD), or THC:CBD and were assessed at two follow-ups 4–14 weeks after baseline (F/U1) and again 4–14 weeks later (F/U2). Primary outcomes were pain intensity (numeric rating scale), sleep quality, quality of life, and adverse events. Of 587 eligible patients, 411 were included at F/U1 and 184 at F/U2 (mean age 59 years). A clinically relevant pain reduction (≥30%) was reported by 22% at F/U1 and 33% at F/U2 in per-protocol analyses, and by 15% and 10% in intention-to-treat analyses. Improved sleep was reported by 56% at both follow-ups, while 42% and 38% reported better quality of life. Adverse events occurred in 42% at F/U1 and 39% at F/U2, most often with THC-containing regimens; the most common were nervous system and general disorders, including headache, dizziness, and fatigue. At F/U2 there was a significant difference between regimens: 8% in the THC group achieved clinically relevant pain reduction versus 33% in the CBD group and 40% in the THC:CBD group (p = 0.02). Findings suggest that a 1:1 THC:CBD regimen may be most effective for pain reduction, while CBD monotherapy was generally best tolerated. Overall, MC appears to be a relatively safe and effective option for some patients, but the retrospective design and attrition between follow-ups limit certainty; high-quality prospective studies are needed.
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