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[Systematic review of safeness and therapeutic efficacy of cannabis in patients with multiple sclerosis, neuropathic pain, and in oncological patients treated with chemotherapy].

Abstract

BACKGROUND

medical cannabis refers to the use of cannabis or cannabinoids as medical therapy to treat disease or alleviate symptoms. In the United States, 23 states and Washington DC (May 2015) have introduced laws to permit the medical use of cannabis. Within the European Union, medicinal cannabis laws and praxis vary wildly between Countries.

OBJECTIVES

to provide evidence for benefits and harms of cannabis (including extracts and tinctures) treatment for adults in the following indications: control of spasticity and pain in patients with multiple sclerosis; control of pain in patients with chronic neuropathic pain; control of nausea and vomiting in adults with cancer receiving chemotherapy.

METHODS

we searched the Cochrane Central Register of Controlled Trials, PubMed, and EMBASE from inception to September 2016. We also searched for on-going studies via ClinicalTrials.gov and the World Health Organization and International Clinical Trials Registry Platform (ICTRP) search portal. All searches included also non-English language literature. All relevant randomized controlled trials (RCTs) evaluating the safety and efficacy of cannabis (including extracts and tinctures) compared with placebo or other pharmacological agents were included. Three authors independently evaluated the titles and abstracts of studies identified in the literature searches for their eligibility. For studies considered eligible, we retrieved full texts. Three investigators independently extracted data. For the assessment of the quality of evidence, we used the standard methodological procedures recommended by Cochrane and GRADE working Group.

RESULTS

41 trials (4,550 participants) were included; 15 studies considered efficacy and safety of cannabis for patients with multiple sclerosis, 12 for patients with chronic pain, and 14 for patients with cancer receiving chemotherapy. The included studies were published between 1975 and 2015, and the majority of them were conducted in Europe. We judged almost 50% of these studies to be at low risk of bias. The large majority (80%) of the comparisons were with placebo; only 8 studies included patients with cancer receiving chemotherapy comparing cannabis with other antiemetic drugs. Concerning the efficacy of cannabis (compared with placebo) in patients with multiple sclerosis, confidence in the estimate was high in favour of cannabis for spasticity (numerical rating scale and visual analogue scale, but not the Ashworth scale) and pain. For chronic and neuropathic pain (compared with placebo), there was evidence of a small effect; however, confidence in the estimate is low and these results could not be considered conclusive. There is uncertainty whether cannabis, including extracts and tinctures, compared with placebo or other antiemetic drugs reduces nausea and vomiting in patients with cancer requiring chemotherapy, although the confidence in the estimate of the effect was low or very low. In the included studies, many adverse events were reported and none of the studies assessed the development of abuse or dependence.

CONCLUSIONS

there is incomplete evidence of the efficacy and safety of medical use of cannabis in the clinical contexts considered in this review. Furthermore, for many of the outcomes considered, the confidence in the estimate of the effect was again low or very low. To give conclusive answers to the efficacy and safety of cannabis used for medical purposes in the clinical contexts considered, further studies are needed, with higher quality, larger sample sizes, and possibly using the same diagnostic tools for evaluating outcomes of interest.

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  • Authors+Show Affiliations

    ,

    Dipartimento di epidemiologia del Servizio sanitario regionale della Regione Lazio, ASL Roma 1.

    ,

    Dipartimento di epidemiologia del Servizio sanitario regionale della Regione Lazio, ASL Roma 1.

    ,

    Dipartimento di epidemiologia del Servizio sanitario regionale della Regione Lazio, ASL Roma 1.

    ,

    Dipartimento di epidemiologia del Servizio sanitario regionale della Regione Lazio, ASL Roma 1.

    ,

    Dipartimento di epidemiologia del Servizio sanitario regionale della Regione Lazio, ASL Roma 1. r.saulle@deplazio.it.

    ,

    Dipartimento di epidemiologia del Servizio sanitario regionale della Regione Lazio, ASL Roma 1.

    ,

    Dipartimento di epidemiologia del Servizio sanitario regionale della Regione Lazio, ASL Roma 1.

    Dipartimento di epidemiologia del Servizio sanitario regionale della Regione Lazio, ASL Roma 1.

    Source

    Epidemiologia e prevenzione 41:5-6 pg 279-293

    MeSH

    Adult
    Analgesics
    Antiemetics
    Antineoplastic Agents
    Cannabinoids
    Clinical Trials as Topic
    Cross-Over Studies
    Evidence-Based Medicine
    Humans
    Hypnotics and Sedatives
    Italy
    Medical Marijuana
    Multiple Sclerosis
    Muscle Spasticity
    Nausea
    Neoplasms
    Neuralgia
    Parasympatholytics
    Phytotherapy
    Plant Extracts
    Sleep Initiation and Maintenance Disorders
    Treatment Outcome
    Vomiting

    Pub Type(s)

    Journal Article
    Review
    Systematic Review

    Language

    ita

    PubMed ID

    29119763

    Citation

    Amato, Laura, et al. "[Systematic Review of Safeness and Therapeutic Efficacy of Cannabis in Patients With Multiple Sclerosis, Neuropathic Pain, and in Oncological Patients Treated With Chemotherapy]." Epidemiologia E Prevenzione, vol. 41, no. 5-6, 2017, pp. 279-293.
    Amato L, Minozzi S, Mitrova Z, et al. [Systematic review of safeness and therapeutic efficacy of cannabis in patients with multiple sclerosis, neuropathic pain, and in oncological patients treated with chemotherapy]. Epidemiol Prev. 2017;41(5-6):279-293.
    Amato, L., Minozzi, S., Mitrova, Z., Parmelli, E., Saulle, R., Cruciani, F., ... Davoli, M. (2017). [Systematic review of safeness and therapeutic efficacy of cannabis in patients with multiple sclerosis, neuropathic pain, and in oncological patients treated with chemotherapy]. Epidemiologia E Prevenzione, 41(5-6), pp. 279-293. doi:10.19191/EP17.5-6.AD01.069.
    Amato L, et al. [Systematic Review of Safeness and Therapeutic Efficacy of Cannabis in Patients With Multiple Sclerosis, Neuropathic Pain, and in Oncological Patients Treated With Chemotherapy]. Epidemiol Prev. 2017;41(5-6):279-293. PubMed PMID: 29119763.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - [Systematic review of safeness and therapeutic efficacy of cannabis in patients with multiple sclerosis, neuropathic pain, and in oncological patients treated with chemotherapy]. AU - Amato,Laura, AU - Minozzi,Silvia, AU - Mitrova,Zuzana, AU - Parmelli,Elena, AU - Saulle,Rosella, AU - Cruciani,Fabio, AU - Vecchi,Simona, AU - Davoli,Marina, PY - 2017/11/10/entrez PY - 2017/11/10/pubmed PY - 2018/7/20/medline SP - 279 EP - 293 JF - Epidemiologia e prevenzione JO - Epidemiol Prev VL - 41 IS - 5-6 N2 - BACKGROUND: medical cannabis refers to the use of cannabis or cannabinoids as medical therapy to treat disease or alleviate symptoms. In the United States, 23 states and Washington DC (May 2015) have introduced laws to permit the medical use of cannabis. Within the European Union, medicinal cannabis laws and praxis vary wildly between Countries. OBJECTIVES: to provide evidence for benefits and harms of cannabis (including extracts and tinctures) treatment for adults in the following indications: control of spasticity and pain in patients with multiple sclerosis; control of pain in patients with chronic neuropathic pain; control of nausea and vomiting in adults with cancer receiving chemotherapy. METHODS: we searched the Cochrane Central Register of Controlled Trials, PubMed, and EMBASE from inception to September 2016. We also searched for on-going studies via ClinicalTrials.gov and the World Health Organization and International Clinical Trials Registry Platform (ICTRP) search portal. All searches included also non-English language literature. All relevant randomized controlled trials (RCTs) evaluating the safety and efficacy of cannabis (including extracts and tinctures) compared with placebo or other pharmacological agents were included. Three authors independently evaluated the titles and abstracts of studies identified in the literature searches for their eligibility. For studies considered eligible, we retrieved full texts. Three investigators independently extracted data. For the assessment of the quality of evidence, we used the standard methodological procedures recommended by Cochrane and GRADE working Group. RESULTS: 41 trials (4,550 participants) were included; 15 studies considered efficacy and safety of cannabis for patients with multiple sclerosis, 12 for patients with chronic pain, and 14 for patients with cancer receiving chemotherapy. The included studies were published between 1975 and 2015, and the majority of them were conducted in Europe. We judged almost 50% of these studies to be at low risk of bias. The large majority (80%) of the comparisons were with placebo; only 8 studies included patients with cancer receiving chemotherapy comparing cannabis with other antiemetic drugs. Concerning the efficacy of cannabis (compared with placebo) in patients with multiple sclerosis, confidence in the estimate was high in favour of cannabis for spasticity (numerical rating scale and visual analogue scale, but not the Ashworth scale) and pain. For chronic and neuropathic pain (compared with placebo), there was evidence of a small effect; however, confidence in the estimate is low and these results could not be considered conclusive. There is uncertainty whether cannabis, including extracts and tinctures, compared with placebo or other antiemetic drugs reduces nausea and vomiting in patients with cancer requiring chemotherapy, although the confidence in the estimate of the effect was low or very low. In the included studies, many adverse events were reported and none of the studies assessed the development of abuse or dependence. CONCLUSIONS: there is incomplete evidence of the efficacy and safety of medical use of cannabis in the clinical contexts considered in this review. Furthermore, for many of the outcomes considered, the confidence in the estimate of the effect was again low or very low. To give conclusive answers to the efficacy and safety of cannabis used for medical purposes in the clinical contexts considered, further studies are needed, with higher quality, larger sample sizes, and possibly using the same diagnostic tools for evaluating outcomes of interest. SN - 1120-9763 UR - https://www.unboundmedicine.com/medline/citation/29119763/[Systematic_review_of_safeness_and_therapeutic_efficacy_of_cannabis_in_patients_with_multiple_sclerosis_neuropathic_pain_and_in_oncological_patients_treated_with_chemotherapy]_ L2 - http://www.epiprev.it/node/3810 DB - PRIME DP - Unbound Medicine ER -