PMID- 36394124
OWN - NLM
STAT- MEDLINE
DCOM- 20230117
LR  - 20230419
IS  - 1532-2149 (Electronic)
IS  - 1090-3801 (Print)
IS  - 1090-3801 (Linking)
VI  - 27
IP  - 2
DP  - 2023 Feb
TI  - Safety and effectiveness of cannabinoids to Danish patients with treatment 
      refractory chronic pain-A retrospective observational real-world study.
PG  - 234-247
LID - 10.1002/ejp.2054 [doi]
AB  - BACKGROUND: Cannabinoids are considered a therapeutic option to patients 
      suffering from treatment refractory chronic pain (TRCP) insufficiently relieved 
      by conventional analgesics or experiencing intolerable adverse events (AEs) from 
      those. This study aimed to explore safety and effectiveness of oral cannabinoids 
      among patients with TRCP. METHODS: A retrospective study was conducted among 
      Danish patients with TRCP being prescribed oral cannabinoids. Data on AEs and 
      changes in pain intensity by numeric rating scale (NRS) before and after 
      initiation of oral cannabinoid therapy were analysed. RESULTS: Among 826 eligible 
      patients >/=18 years old, 529 (64%) were included for data analysis at first 
      follow-up (F/U1) (median 56 days from baseline) and 214 (26%) for second 
      follow-up (F/U2) (median 126 days from F/U1). Mean age was 60 +/- 15.9 years and 
      70% were females. AEs were in general reported mild to moderate by 42% of 
      patients at F/U1 and 34% at F/U2. AEs were mainly related to gastrointestinal 
      (F/U1: 17% and F/U2: 13%) and nervous system disorders (F/U1: 14% and F/U2: 11%). 
      Reduction in NRS was significantly different at both follow-up consultations 
      compared with baseline (<0.0001). Clinically relevant pain reduction (NRS >/=30%) 
      was reported by 17% at F/U1 and 10% of patients at F/U2 in intention-to-treat 
      analysis whereas the figures were 32% and 45% respectively, in per-protocol 
      analysis. CONCLUSION: Oral cannabinoid therapy seems to be safe and mildly 
      effective in patients with TRCP. Randomized controlled trials with focus on 
      comparable pain characteristics in diagnostical homogenous patient subgroups are 
      needed for further improvement of evidence level for relief of chronic pain using 
      oral cannabinoids. SIGNIFICANCE: The findings in this retrospective study 
      conducted in a real-world clinical setting suggest a favourable safety profile of 
      cannabinoids. Moreover, one-sixth (intention-to-treat) and one-third 
      (per-protocol) of patients with chronic pain refractory to conventional 
      analgesics, or experiencing intolerable adverse effects, benefited significantly 
      from therapy with oral cannabinoid regimens. Combination of THC and CBD seems 
      overall more effective than cannabinoid monotherapy. Conduction of randomized 
      controlled trials investigating safety and efficacy of cannabinoid therapy to 
      diagnosis specific patient subgroups with comparable clinical and 
      pathophysiological chronic pain characteristics is warranted, hence contributing 
      further to the process of clinical evidence clarification currently in progress.
CI  - (c) 2022 The Authors. European Journal of Pain published by John Wiley & Sons Ltd 
      on behalf of European Pain Federation - EFIC (R).
FAU - Horsted, Tina
AU  - Horsted T
AD  - The Pain Clinic in Copenhagen, Horsted Institute, Copenhagen, Denmark.
FAU - Hesthaven, Karoline Lichon
AU  - Hesthaven KL
AD  - Centre for Clinic Research, North Denmark Regional Hospital, Denmark.
FAU - Leutscher, Peter Derek Christian
AU  - Leutscher PDC
AD  - Centre for Clinic Research, North Denmark Regional Hospital, Denmark.
AD  - Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.
LA  - eng
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20221215
PL  - England
TA  - Eur J Pain
JT  - European journal of pain (London, England)
JID - 9801774
RN  - 0 (Cannabinoids)
RN  - 0 (Analgesics)
SB  - IM
MH  - Female
MH  - Humans
MH  - Adult
MH  - Middle Aged
MH  - Aged
MH  - Adolescent
MH  - Male
MH  - *Cannabinoids/adverse effects
MH  - *Chronic Pain/drug therapy
MH  - Retrospective Studies
MH  - Analgesics/adverse effects
MH  - *Pain, Intractable
MH  - Denmark
PMC - PMC10107230
COIS- KH and PL declare no conflicts of interest. TH has provided medical care to the 
      patients in the study.
EDAT- 2022/11/18 06:00
MHDA- 2023/01/18 06:00
PMCR- 2023/04/17
CRDT- 2022/11/17 13:17
PHST- 2022/10/29 00:00 [revised]
PHST- 2022/03/04 00:00 [received]
PHST- 2022/11/08 00:00 [accepted]
PHST- 2022/11/18 06:00 [pubmed]
PHST- 2023/01/18 06:00 [medline]
PHST- 2022/11/17 13:17 [entrez]
PHST- 2023/04/17 00:00 [pmc-release]
AID - EJP2054 [pii]
AID - 10.1002/ejp.2054 [doi]
PST - ppublish
SO  - Eur J Pain. 2023 Feb;27(2):234-247. doi: 10.1002/ejp.2054. Epub 2022 Dec 15.