PMID- 30688655 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20201001 IS - 1929-0748 (Print) IS - 1929-0748 (Electronic) IS - 1929-0748 (Linking) VI - 8 IP - 1 DP - 2019 Jan 28 TI - Adherence to Consolidated Standards of Reporting Trials (CONSORT) Guidelines for Reporting Safety Outcomes in Trials of Cannabinoids for Chronic Pain: Protocol for a Systematic Review. PG - e11637 LID - 10.2196/11637 [doi] LID - e11637 AB - BACKGROUND: Chronic pain affects a significant proportion of the population and presents a major challenge to clinicians and pain specialists. Despite the availability of pharmacologic treatment options such as opioids, many patients continue to experience persistent pain. Cannabinoids present an alternative option with some data on efficacy; however, to date, a systematic review of adverse events (AEs) assessment and reporting in randomized clinical trials (RCTs) involving cannabinoids has not been performed. As a result, it is unclear whether a clear profile of cannabinoid-associated AEs has been accurately detailed in the literature. As cannabinoids are likely to become readily available for patients in the near future, it is important to study how well AEs have been reported in trials so that the safety profile of cannabinoids can be better understood. OBJECTIVE: With a potentially enormous shift toward cannabinoid use for managing chronic pain and spasticity, this study aims to reveal the adequacy of AE reporting and cannabinoid-specific AEs in this setting. Spasticity is a major contributor to chronic pain in patients with multiple sclerosis (MS), with a comorbidity of 75%. Many cannabinoid studies have been performed in MS-related painful spasticity with relevant pain outcomes, and these studies will be included in this review for comprehensiveness. The primary outcome will be the quality of AE assessment and reporting by adherence to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Secondary outcomes will include the type of AE, method of AE reporting, severity of AE, frequency of AEs, patient withdrawals, and reasons for withdrawals. METHODS: We will perform a systematic review by searching for primary reports of double-blind, randomized controlled trials of cannabinoids compared with placebo and any active comparator treatments for chronic pain, with a primary outcome directly related to pain (eg, pain intensity, pain relief, and pain-related interference). We will search the following databases: MEDLINE, Embase, Cochrane Library, and PsycINFO. RevMan software will be used for meta-analysis. RESULTS: The protocol has been registered on the International Prospective Register of Systematic Reviews (CRD42018100401). The project was funded in 2018 and screening has been completed. Data extraction is under way and the first results are expected to be submitted for publication in January or February 2019. CONCLUSIONS: This review will better elucidate the safety of cannabinoids for the treatment of chronic pain and spasticity through identifying gaps in the literature for AE reporting. Like in any new therapy, it is essential that accurate information surrounding the safety and efficacy of cannabinoids be clearly outlined and identified to balance the benefit and harm described for patients. TRIAL REGISTRATION: PROSPERO CRD42018100401; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=100401. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11637. CI - (c)Mohammed M Mohiuddin, Glenio Mizubuti, Simon Haroutounian, Shannon Smith, Fiona Campbell, Rex Park, Ian Gilron. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 28.01.2019. FAU - Mohiuddin, Mohammed M AU - Mohiuddin MM AUID- ORCID: 0000-0002-1825-4661 AD - Department of Anesthesiology & Perioperative Medicine, Queen's University, Kingston, ON, Canada. FAU - Mizubuti, Glenio AU - Mizubuti G AUID- ORCID: 0000-0002-5515-829X AD - Department of Anesthesiology & Perioperative Medicine, Queen's University, Kingston, ON, Canada. FAU - Haroutounian, Simon AU - Haroutounian S AUID- ORCID: 0000-0003-2231-5452 AD - Washington University Pain Center, Washington University School of Medicine, St. Louis, MO, United States. FAU - Smith, Shannon AU - Smith S AUID- ORCID: 0000-0002-9895-5993 AD - University of Rochester Medical Center, School of Medicine and Dentistry, University of Rochester, Rochester, NY, United States. FAU - Campbell, Fiona AU - Campbell F AUID- ORCID: 0000-0001-6482-0743 AD - Department of Anesthesia and Pain Medicine, University of Toronto, Toronto, ON, Canada. FAU - Park, Rex AU - Park R AUID- ORCID: 0000-0001-5218-8680 AD - Department of Anesthesiology & Perioperative Medicine, Queen's University, Kingston, ON, Canada. FAU - Gilron, Ian AU - Gilron I AUID- ORCID: 0000-0002-5293-8792 AD - Department of Anesthesiology & Perioperative Medicine, Queen's University, Kingston, ON, Canada. AD - Department of Biomedical and Molecular Sciences, Queen's University, Kingston, ON, Canada. AD - Centre for Neuroscience Studies, Queen's University, Kingston, ON, Canada. LA - eng PT - Journal Article DEP - 20190128 PL - Canada TA - JMIR Res Protoc JT - JMIR research protocols JID - 101599504 PMC - PMC6369421 OTO - NOTNLM OT - adverse event reporting OT - adverse events OT - cannabidiol OT - cannabinoids OT - cannabis OT - chronic pain OT - clinical trial OT - marijuana OT - safety OT - systematic review OT - tetrahydrocannabinol COIS- Conflicts of Interest: None declared. EDAT- 2019/01/29 06:00 MHDA- 2019/01/29 06:01 PMCR- 2019/01/28 CRDT- 2019/01/29 06:00 PHST- 2018/07/19 00:00 [received] PHST- 2018/10/28 00:00 [accepted] PHST- 2018/10/23 00:00 [revised] PHST- 2019/01/29 06:00 [entrez] PHST- 2019/01/29 06:00 [pubmed] PHST- 2019/01/29 06:01 [medline] PHST- 2019/01/28 00:00 [pmc-release] AID - v8i1e11637 [pii] AID - 10.2196/11637 [doi] PST - epublish SO - JMIR Res Protoc. 2019 Jan 28;8(1):e11637. doi: 10.2196/11637.