PMID- 31977375
OWN - NLM
STAT- MEDLINE
DCOM- 20210726
LR  - 20210726
IS  - 1536-5409 (Electronic)
IS  - 0749-8047 (Linking)
VI  - 36
IP  - 4
DP  - 2020 Apr
TI  - Adherence to Consolidated Standards of Reporting Trials (CONSORT) Guidelines for 
      Reporting Safety Outcomes in Trials of Medical Cannabis and Cannabis-based 
      Medicines for Chronic Noncancer Pain: A Systematic Review.
PG  - 302-319
LID - 10.1097/AJP.0000000000000807 [doi]
AB  - OBJECTIVE: Current treatments for chronic pain have limited effectiveness and 
      tolerability. With growing interest in the potential of cannabinoids, there is a 
      need to inform risk-benefit considerations. Thus, this focused systematic review 
      assesses the quality of safety assessment and reporting in chronic noncancer pain 
      cannabinoid trials. METHODS: The protocol for this review has been published, 
      and, registered in PROSPERO. We searched MEDLINE, Embase, The Cochrane Library, 
      Scopus, and PsychINFO for double-blind, placebo-controlled, randomized controlled 
      trials of cannabinoids for chronic pain, with a primary outcome related to pain. 
      The primary review outcome is adherence to the 2004 Consolidated Standards of 
      Reporting Trials (CONSORT) Harms extension. Secondary outcomes included type, 
      reporting method, frequency and severity of adverse events (AEs), trial 
      participant withdrawals, and reasons for withdrawals. RESULTS: In total, 43 
      studies (4436 participants) were included. Type of cannabinoid (number of 
      studies) included nabiximols (12), dronabinol (8), nabilone (7), oral cannabis 
      extract preparations (5), smoked tetrahydrocannabinol (5), vaporized 
      tetrahydrocannabinol (3), novel synthetic cannabinoids (2), sublingual cannabis 
      extract preparations (1). The median CONSORT score was 7. On average, 3 to 4 
      recommendations of the CONSORT guidelines were not being met in trials. Seventeen 
      trials did not provide their method of AE assessment, 14 trials did not report on 
      serious AEs and, 7 trials provided no quantitative data about AEs. DISCUSSION: 
      Better harms assessment and reporting are needed in chronic pain cannabinoid 
      trials. Improvements may be achieved through: expanded education/knowledge 
      translation increased research regulation by ethics boards, funding agencies and 
      journals, and greater emphasis on safety assessment and reporting throughout 
      research training.
FAU - Mohiuddin, Mohammed M
AU  - Mohiuddin MM
AD  - Departments of Anesthesiology & Perioperative Medicine.
FAU - Mizubuti, Glenio B
AU  - Mizubuti GB
AD  - Departments of Anesthesiology & Perioperative Medicine.
FAU - Haroutounian, Simon
AU  - Haroutounian S
AD  - Washington University Pain Center, Washington University School of Medicine, St. 
      Louis, MO.
FAU - Smith, Shannon M
AU  - Smith SM
AD  - School of Medicine and Dentistry, University of Rochester Medical Center, 
      University of Rochester, Rochester, NY.
FAU - Rice, Andrew S C
AU  - Rice ASC
AD  - Pain Research Group, Department of Surgery and Cancer, Faculty of Medicine, 
      Imperial College London, London, UK.
FAU - Campbell, Fiona
AU  - Campbell F
AD  - Department of Anesthesia and Pain Medicine, The Hospital for Sick Children, 
      University of Toronto, Toronto, ON, Canada.
FAU - Park, Rex
AU  - Park R
AD  - Departments of Anesthesiology & Perioperative Medicine.
FAU - Gilron, Ian
AU  - Gilron I
AD  - Departments of Anesthesiology & Perioperative Medicine.
AD  - Biomedical and Molecular Sciences.
AD  - Centre for Neuroscience Studies, Queen's University, Kingston.
LA  - eng
GR  - CIHR/Canada
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Systematic Review
PL  - United States
TA  - Clin J Pain
JT  - The Clinical journal of pain
JID - 8507389
RN  - 0 (Analgesics)
RN  - 0 (Medical Marijuana)
SB  - IM
MH  - Analgesics
MH  - *Cannabis
MH  - *Chronic Pain/drug therapy
MH  - *Guideline Adherence
MH  - Humans
MH  - *Medical Marijuana/therapeutic use
MH  - Randomized Controlled Trials as Topic/*standards
EDAT- 2020/01/25 06:00
MHDA- 2021/07/27 06:00
CRDT- 2020/01/25 06:00
PHST- 2020/01/25 06:00 [pubmed]
PHST- 2021/07/27 06:00 [medline]
PHST- 2020/01/25 06:00 [entrez]
AID - 00002508-202004000-00010 [pii]
AID - 10.1097/AJP.0000000000000807 [doi]
PST - ppublish
SO  - Clin J Pain. 2020 Apr;36(4):302-319. doi: 10.1097/AJP.0000000000000807.