Assessment and reporting of safety outcomes in clinical trials of cannabinoids for chronic pain: Protocol for a Systematic Review (Preprint) [post]

Mohammed Mohiuddin, Glenio Mizubuti, Simon Haroutounian, Shannon Smith, Fiona Campbell, Ian Gilron
2018 unpublished
BACKGROUND Chronic pain affects a significant proportion of the population and presents a major challenge to clinicians and pain specialists. Despite availability of pharmacologic treatment options such as opioids, chronic pain persists in patients, perhaps because of a lack of analgesic efficacy or poor tolerability due to adverse effects. Cannabinoids present an alternative option; however, it is unclear whether a clear profile of cannabinoid associated adverse events (AE) has been accurately
more » ... detailed in the literature. OBJECTIVE To date, a systematic review of AE assessment and reporting in RCT's involving cannabinoids has not been performed. With a potentially enormous shift towards cannabinoid use for managing chronic pain, this study aims to reveal the adequacy of AE reporting and specific AEs for cannabinoids in chronic pain to gain a better understanding of the safety of cannabinoids for chronic pain. METHODS A systematic review will be performed by searching for primary reports of double-blind randomized controlled trials of cannabinoids, compared to placebo, and any active comparator treatments studied, for chronic pain, with a primary outcome directly related to pain (e.g. pain intensity, pain relief, pain-related interference). RESULTS For this project, we have received funding from the Queen's University Anesthesiology Vandewater Studentship. To date, we are finalizing the search strategy, and will be moving on to review titles, abstracts and full texts. We expect the review to be submitted for publication in the fall of 2018. CONCLUSIONS This review will better elucidate the safety of cannabinoids for treatment of chronic pain through identifying gaps in the literature for adverse event reporting. Like in any new therapy, it is essential that accurate information surrounding the safety and efficacy of cannabinoids are clearly outlined and identified to balance the benefit and harm described for patients.
doi:10.2196/preprints.11637 fatcat:my57kr2o6jhjrfu7yesb4iv7fq