Dosing and Safety of Medical Cannabis in Children: Preliminary Findings from a Living Systematic Review

Author(s)

PAUL A, Abulannaz O, Chhabra M, Lê ML, Kelly LE
University of Manitoba, Winnipeg, MB, Canada

OBJECTIVES

Legalization of recreational cannabis in Canada has increased accessibility for families wishing to use cannabis for medical purposes. However, despite wide-spread use, inadequate safety and efficacy data hinders prescribers from considering authorization and evidence informed product selection/dosing. This study aimed to review the existing literature on medical cannabis use in children with regard to dosing and safety.

METHODS

We performed the first search of a living systematic review to identify studies of all designs with a cannabis intervention in children (< 18 years). Databases such as MEDLINE (Ovid), Embase, Scopus, Web of Science, ClinicalTrials.gov were searched (Feb,2019 and update search: Feb,2020) for published and gray literature with no time restriction. Eligible abstracts and full texts were screened in duplicate. Data were extracted on study identifiers and study design (population, intervention, outcome) from included studies.

RESULTS

Out of 3194 studies screened, only 208 met the inclusion criteria among which 99/208 (47.6 %) were clinical trials. Refractory epilepsies such as dravet syndrome, 38/208 (18.3%) and lennox-gastaut syndrome, 33/208(15.9%) were the most commonly reported indications with cannabis treatment. Cannabidiol (CBD) (104/208) was the most commonly studied cannabinoid administered orally,72/104(69.2%). The most frequently reported CBD dosing strategy included 10 or 20 mg/kg/day used in a THC (tetrahydrocannabinol): CBD product ratio of 1:20 in 15/23(65.2%) included studies. Pooled safety data demonstrated the occurrence of decreased appetite, diarrhea and elevated transaminases as frequent adverse events associated with cannabinoid therapy among 397/2,378 (16.7%), 531/2,265 (23.4 %) and 250/2,777 (9%) patients respectively. Adverse events resulted in participant withdrawal in 31/46 studies. Very few deaths (67/4752) were reported in participants receiving a cannabinoid intervention and were unrelated to cannabis.

CONCLUSIONS

The reported dosing and safety data with cannabis are restricted to epileptic conditions and further clinical trials are urgently needed given its widespread use for a variety of pediatric indications.

Conference/Value in Health Info

2021-05, ISPOR 2021, Montreal, Canada

Value in Health, Volume 24, Issue 5, S1 (May 2021)

Code

PIH19

Topic

Clinical Outcomes, Epidemiology & Public Health

Topic Subcategory

Clinical Outcomes Assessment, Comparative Effectiveness or Efficacy, Public Health, Safety & Pharmacoepidemiology

Disease

No Specific Disease

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