Evidence map›Paper›PMID 31656045›Full record

ArticleBritish journal of clinical pharmacology2020

Adverse events following cannabis for medical use in Tuscany: An analysis of the Italian Phytovigilance database.

Giada Crescioli, Niccolò Lombardi, Alessandra Bettiol, Francesca Menniti-Ippolito, Roberto Da Cas, Maria Parrilli, Martina Del Lungo, Eugenia Gallo, Alessandro Mugelli, Valentina Maggini and 2 more

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In one paragraph

Article in British journal of clinical pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  13. Pharmacological Evaluation of Drugs in Animal Models of Tinnitus.Current topics in behavioral neurosciences · 2021
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Giada CrescioliDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, Florence, Italy.
Niccolò LombardiDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, Florence, Italy.ORCID 0000-0001-5259-2026
Alessandra BettiolDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, Florence, Italy.
Francesca Menniti-IppolitoNational Centre for Drug Research and Evaluation, National Institute of Health, Rome, Italy.
Roberto Da CasNational Centre for Drug Research and Evaluation, National Institute of Health, Rome, Italy.
Maria ParrilliRegional Centre for Pharmacovigilance, Azienda USL Toscana Centro, Florence, Italy.
Martina Del LungoDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, Florence, Italy.
Eugenia GalloDepartment of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
Alessandro MugelliDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, Florence, Italy.
Valentina MagginiDepartment of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
Fabio FirenzuoliResearch and Innovation Center in Phytotherapy and Integrated Medicine - CERFIT, Referring Center for Phytotherapy of Tuscany Region, Careggi, University Hospital, Florence, Italy.
Alfredo VannacciDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, Florence, Italy.ORCID 0000-0003-1911-2021

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsDespite a significant increase in using cannabis for medical purposes, current evidence on its safety in real-world clinical practice is still poorly characterised. By a case-by-case analysis of spontaneous reports of suspected adverse events (AEs) collected in Tuscany within the Italian Phytovigilance database, the aim of the present study was to describe AEs occurred in patients exposed to medical cannabis.

methodsWe evaluated all reports of cannabis-related suspected AEs collected within the Phytovigilance database up to December 2018. Information regarding cannabis therapy, patient's demographic and clinical characteristics, concomitant medications, AE description according to the Medical Dictionary for Regulatory Activities (MedDRA) classification, AE seriousness and AE outcome, were collected. The causality assessment was performed following World Health Organisation-Uppsala Monitoring Centre criteria.

resultsFifty-three cannabis-related AE reports were analysed. The majority of patients were females (77.3%), with a mean age of 61.9 years. Thirty-nine (73.6%) cases were defined as nonserious and the majority of them (86.9%) showed a complete resolution or improvement. Forty-six (86.8%) cases were judged as probably related to cannabis consumption. The most frequently reported system organ class was psychiatric and nervous system disorders, and a potential drug-drug interaction was present in 16 cases.

conclusionCannabis was generally well tolerated and the majority of AEs were mild and transient. Our analysis highlighted important safety issues for clinical practice, in particular the need for an accurate prescription monitoring during the titration phase, particularly in the presence of concomitant medications.

Indexed as

CannabisDrug-Related Side Effects and Adverse ReactionsAdverse Drug Reaction Reporting SystemsDatabases, FactualFemaleHumansItalyMiddle Agedadverse drug reactionsclinical pharmacologydrug safetygeneral practicemedical cannabis

Identifiers

PMID31656045
PMCPMC6983517

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.