Efficacy, tolerability and safety of cannabis-based medicines for cancer pain : A systematic review with meta-analysis of randomised controlled trials.

Efficacy, tolerability and safety of cannabis-based medicines for cancer pain : A systematic review with meta-analysis of randomised controlled trials.

Publication date: May 09, 2019

The importance of medical cannabis and cannabis-based medicines for cancer pain management needs to be determined.

A systematic literature search until December 2018 included CENTRAL, PubMed, SCOPUS and trial registers. Randomised controlled trials (RCTs) investigating medical cannabis and/or pharmaceutical cannabinoids for pain control in cancer patients with a study duration of at least 2 weeks and a sample size of at least 20 participants per study arm were included. Clinical outcomes comprised efficacy (pain intensity, patient impression of improvement, combined responder, sleep problems, psychological distress, opioid maintenance and breakthrough dosage), tolerability (dropout rate due to adverse events) and safety (nervous system, psychiatric and gastrointestinal side effects; serious adverse events). The quality of evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation (GRADE).

Five RCTs with oromucosal nabiximols or tetrahydrocannabinol (THC) including 1534 participants with moderate and severe pain despite opioid therapy were identified. Double blind period of the RCTs ranged between 2 and 5 weeks. Four studies with a parallel design and 1333 patients were available for meta-analysis. The quality of evidence was very low for all comparisons. Oromucosal nabiximols and THC did not differ from placebo in reducing pain, sleep problems, opioid dosages and in the frequency of combined responder, serious adverse events and psychiatric disorders side effects. The number of patients who reported to be much or very much improved was higher with oromucosal nabiximols and THC than with placebo (number needed to treat for an additional benefit 16; 95% confidence interval [CI] 8 to infinite). The dropout rates due to adverse events (number needed to treat for an additional harm [NNTH]: 20; 95% CI 11-100), the frequency of nervous system (NNTH: 10; 95% CI 7-25) and of gastrointestinal side effects (NNTH: 11; 95% CI 7-33) was higher with oromucosal nabiximols and THC than with placebo.

Very low quality evidence suggests that oromucosal nabiximols and THC have no effect on pain, sleep problems and opioid consumption in patients with cancer pain with insufficient pain relief from opioids. The complete manuscript is written in English.

H”auser, W., Welsch, P., Klose, P., Radbruch, L., and Fitzcharles, M.A. Efficacy, tolerability and safety of cannabis-based medicines for cancer pain : A systematic review with meta-analysis of randomised controlled trials. 03497. 2019 Schmerz.

Concepts Keywords
Cannabinoids Medical cannabis
Cannabis Tetrahydrocannabinol
Confidence Interval Nabiximols
Double Blind Medicinal plants
Frequency Euphoriants
Gastrointestinal Entheogens
Manuscript Antiemetics
Meta Analysis Appetite stimulants
Nabiximols Clinical medicine
Nervous System Drugs
Opioid Medicine
Opioids Pain management
Pain Disorders
Pain Management Pain
Pharmaceutical Medicines pain management
Placebo
Psychiatric Disorders
PubMed
Randomised Controlled Trials
SCOPUS
Sleep
Tetrahydrocannabinol
THC
Tolerability

Semantics

Type Source Name
gene UNIPROT WAS
drug DRUGBANK Dronabinol
drug DRUGBANK Nabiximols
disease MESH Development
gene UNIPROT ARMC9
gene UNIPROT AKR1A1
disease DOID cancer
disease MESH cancer
drug DRUGBANK Medical Cannabis

Original Article

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