Oral medicinal cannabinoids to relieve symptom burden in the palliative care of patients with advanced cancer: a double-blind, placebo-controlled, randomised clinical trial of efficacy and safety of 1:1 delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)

Hardy, Janet; Haywood, Alison; Gogna, Gauri; Martin, Jennifer; Yates, Patsy; Greer, Ristan M.; Good, Phillip

doi:10.1186/s13063-020-04541-6

Cited by 29 publications

(27 citation statements)

References 18 publications

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“…( Costiniuk, et al, 2019 ; Hendricks, et al, 2019 ; Urbi, et al, 2019 ; Van der Flier, et al, 2019 ; Efron, et al, 2020 ; Hardy, et al, 2020 ; Jakubovski, et al, 2020 ; Timler, et al, 2020 )…”

Section: Resultsunclassified

Cannabis for Medical Use: Analysis of Recent Clinical Trials in View of Current Legislation

et al. 2022

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Cannabis has long been regarded as a recreational substance in the Western world. The recent marketing authorization of some medicinal products of industrial origin and the introduction onto the market of inflorescences for medical use mean that medical doctors can now prescribe Cannabis-based medicines in those countries which allow it. Nevertheless, there is still considerable controversy on this topic in the scientific community. In particular, this controversy concerns: the plant species to be used; the pathologies that can be treated and consequently the efficacy and safety of use; the routes of administration; the methods of preparation; the type and dosage of cannabinoids to be used; and, the active molecules of interest. As such, although medical Cannabis has been historically used, the results of currently completed and internationally published studies are inconclusive and often discordant. In light of these considerations, the aim of this work is to analyse the current legislation in countries that allow the use of medical Cannabis, in relation to the impact that this legislation has had on clinical trials. First of all, a literature search has been performed (PubMed and SciFinder) on clinical trials which involved the administration of Cannabis for medical use over the last 3 years. Of the numerous studies extrapolated from the literature, only about 43 reported data on clinical trials on medical Cannabis, with these mainly being performed in Australia, Brazil, Canada, Denmark, Germany, Israel, Netherlands, Switzerland, the United Kingdom and the United States of America. Once the reference countries were identified, an evaluation of the legislation in relation to Cannabis for medical use in each was carried out via the consultation of the pertinent scientific literature, but also of official government documentation and that of local regulatory authorities. This analysis provided us with an overview of the different legislation in these countries and, consequently, allowed us to analyse, with greater awareness, the results of the clinical trials published in the last 3 years in order to obtain general interest indications in the prosecution of scientific research in this area.

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Section: Resultsunclassified

Cannabis for Medical Use: Analysis of Recent Clinical Trials in View of Current Legislation

et al. 2022

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“…CBD has been suggested as a potential therapeutic agent for diverse medical conditions, including autoimmune disease, inflammations, cancer or schizophrenia. The reported dose range in humans for different conditions is also very wide, from 16 mg to 3000 mg per day [ 46 , 47 , 48 , 49 ]. CBD has an inverted U-shaped dose–response curve in animal models and human volunteers, with the most effective single oral dose in humans being around 300 mg [ 49 , 50 , 51 ].…”

Section: Discussionmentioning

confidence: 99%

Inclusion of Medium-Chain Triglyceride in Lipid-Based Formulation of Cannabidiol Facilitates Micellar Solubilization In Vitro, but In Vivo Performance Remains Superior with Pure Sesame Oil Vehicle

et al. 2021

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Oral sesame oil-based formulation facilitates the delivery of poorly water-soluble drug cannabidiol (CBD) to the lymphatic system and blood circulation. However, this natural oil-based formulation also leads to considerable variability in absorption of CBD. In this work, the performance of lipid-based formulations with the addition of medium-chain triglyceride (MCT) or surfactants to the sesame oil vehicle has been tested in vitro and in vivo using CBD as a model drug. The in vitro lipolysis has shown that addition of the MCT leads to a higher distribution of CBD into the micellar phase. Further addition of surfactants to MCT-containing formulations did not improve distribution of the drug into the micellar phase. In vivo, formulations containing MCT led to lower or similar concentrations of CBD in serum, lymph and MLNs, but with reduced variability. MCT improves the emulsification and micellar solubilization of CBD, but surfactants did not facilitate further the rate and extent of lipolysis. Even though addition of MCT reduces the variability, the in vivo performance for the extent of both lymphatic transport and systemic bioavailability remains superior with a pure natural oil vehicle.

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“…However, the evidence which supports the efficacy of Cannabis as analgesia is being accumulated. Especially, cases of prescribing Cannabis (CBD, THC, CBD + THC) for diseases caused by cancer [ 36 - 40 ] and other refractory diseases [ 41 - 45 ] are increasing. In addition, research and clinical cases indicating the effectiveness of Cannabis (CBD, THC, CBD + THC) for degenerative brain lesions (e.g., dementia, Alzheimer’s disease, Parkinson’s disease) and neurological diseases are increasing [ 46 - 49 ].…”

Section: Discussionmentioning

confidence: 99%

A Literature Analysis on Medicinal Use and Research of Cannabis in the Meiji Era of Japan

Ahn

Kang²,

Lee³

et al. 2020

J Pharmacopuncture

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Cannabis is a historical plant which has been used as a medicine in East Asia. These days, there are active debates about using cannabis in clinical field. Collecting and comparing cannabis research articles which had been published in the Opening of Japan to spot the interactions between the traditional medicine of Japan, Rangaku which was established in Edo Period and the European medicine which is transferred after Perry Expedition is academically meaningful. This study searched publications, which were listed on Open-Access databases by Dec. 11 th , 2019. We collected research articles which had been published from January 3 rd , 1867 to July 30 th , 1912 also known as Meiji era and uploaded on Open-Access databases. Our searching databases were J-stage, CiNii (Scholarly and Academic Information Navigator), Tokyo Metropolitan Library, The National Diet Library, IRDB (Institutional Repositories DataBase) and KAKEN (Grant-in-Aid for Scientific Research Database). Searching keywords were cannabis, hemp and all their Japanese synonyms and available combinations. We selected final 15 studies which met every selection criteria in the 346,393 collected studies. Cannabis was prescribed in Meiji era of Japan to alleviate pain and cure the digestive, respiratory, urinary, and nervous system diseases such as indigestion, asthma, tuberculosis, gonorrhea and its complications, insomnia, and nervous prostration. Cannabis was medically used in Meiji era of Japan and the reporting and sharing of its clinical effect was published on the medical journals like present days. There were already Cannabis regulations in that era, but its medicinal use was more liberated than nowadays. It may be a chance to reconsider the current legal system, which strictly controls the use of Cannabis.

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Oral medicinal cannabinoids to relieve symptom burden in the palliative care of patients with advanced cancer: a double-blind, placebo-controlled, randomised clinical trial of efficacy and safety of 1:1 delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)

Cited by 29 publications

References 18 publications

Cannabis for Medical Use: Analysis of Recent Clinical Trials in View of Current Legislation

Cannabis for Medical Use: Analysis of Recent Clinical Trials in View of Current Legislation

Inclusion of Medium-Chain Triglyceride in Lipid-Based Formulation of Cannabidiol Facilitates Micellar Solubilization In Vitro, but In Vivo Performance Remains Superior with Pure Sesame Oil Vehicle

A Literature Analysis on Medicinal Use and Research of Cannabis in the Meiji Era of Japan

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