A randomized trial of medical cannabis in patients with stage IV cancers to assess feasibility, dose requirements, impact on pain and opioid use, safety, and overall patient satisfaction

Zylla, Dylan; Eklund, Justin; Gilmore, Grace; Gavenda, Alissa; Guggisberg, Jordan; Vazquez‐Benitez, Gabriela; Pawloski, Pamala A.; Arneson, Thomas J.; Richter, Sara; Dahmer, Stephen; Tracy, Matthew; Dudek, Arkadiusz Z.

doi:10.1007/s00520-021-06301-x

Cited by 39 publications

(27 citation statements)

References 21 publications

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“…Seven controlled trials (1795 participants) investigated the opioid-sparing effect of cannabinoids in patients with different forms of cancer pain. One small, non-randomized study found a non-significant effect of cannabis on pain control [ 67 ], and a second pilot found no effect of medical cannabis on pain, but an increase in opioid dose in a group that received delayed cannabis [ 68 ] (Table 2c ). The remaining studies were all larger single or double-blind randomized trials.…”

Section: Resultsmentioning

confidence: 99%

Opioid-sparing effect of cannabinoids for analgesia: an updated systematic review and meta-analysis of preclinical and clinical studies

Nielsen

Murnion

Winters

et al. 2022

Neuropsychopharmacol.

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Cannabinoid co-administration may enable reduced opioid doses for analgesia. This updated systematic review on the opioid-sparing effects of cannabinoids considered preclinical and clinical studies where the outcome was analgesia or opioid dose requirements. We searched Scopus, Cochrane Central Registry of Controlled Trials, Medline, and Embase (2016 onwards). Ninety-two studies met the search criteria including 15 ongoing trials. Meta-analysis of seven preclinical studies found the median effective dose (ED50) of morphine administered with delta-9-tetrahydrocannabinol was 3.5 times lower (95% CI 2.04, 6.03) than the ED50 of morphine alone. Six preclinical studies found no evidence of increased opioid abuse liability with cannabinoid administration. Of five healthy-volunteer experimental pain studies, two found increased pain, two found decreased pain and one found reduced pain bothersomeness with cannabinoid administration; three demonstrated that cannabinoid co-administration may increase opioid abuse liability. Three randomized controlled trials (RCTs) found no evidence of opioid-sparing effects of cannabinoids in acute pain. Meta-analysis of four RCTs in patients with cancer pain found no effect of cannabinoid administration on opioid dose (mean difference −3.8 mg, 95% CI −10.97, 3.37) or percentage change in pain scores (mean difference 1.84, 95% CI −2.05, 5.72); five studies found more adverse events with cannabinoids compared with placebo (risk ratio 1.13, 95% CI 1.03, 1.24). Of five controlled chronic non-cancer pain trials; one low-quality study with no control arm, and one single-dose study reported reduced pain scores with cannabinoids. Three RCTs found no treatment effect of dronabinol. Meta-analyses of observational studies found 39% reported opioid cessation (95% CI 0.15, 0.64, I2 95.5%, eight studies), and 85% reported reduction (95% CI 0.64, 0.99, I2 92.8%, seven studies). In summary, preclinical and observational studies demonstrate the potential opioid-sparing effects of cannabinoids in the context of analgesia, in contrast to higher-quality RCTs that did not provide evidence of opioid-sparing effects.

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Section: Resultsmentioning

confidence: 99%

Opioid-sparing effect of cannabinoids for analgesia: an updated systematic review and meta-analysis of preclinical and clinical studies

Nielsen

Murnion

Winters

et al. 2022

Neuropsychopharmacol.

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“…Yan Lairong, Wei Hongyan, and Zhang Gong clearly pointed out in the “investigation of mental health status of family members of cancer patients and analysis of related factors” that the family members of cancer patients have psychological disorders to a certain extent. Among them, the score of anxiety level was higher compared to the domestic norm, there was obvious anxiety, and the anxiety degree of some relatives reached the clinical level [ 27 ]. However, due to the personal limitations of cancer escorts, some are unable to identify and relieve their anxiety in a timely manner.…”

Section: Discussionmentioning

confidence: 99%

Study on the Conduction Analysis and Blocking Intervention Scheme of Emotional Disorders between Cancer Patients and Their Families

Zhang

Song

et al. 2022

Computational and Mathematical Methods in Medicine

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Objective. To analyze the transmission and blocking intervention scheme of emotional disorders between cancer patients and their families. Methods. About 150 patients with cancer and 150 family members with mood disorders treated in a tertiary hospital in North China from March 2021 to Octobor2021 were enrolled. The patients were randomly assigned into control group and study group. The control group received routine intervention, and the study group received the diagnosis, intervention, and treatment strategies of doctor-patient-affective disorder. The factors related to the transmission of emotional disorders between cancer patients and their families were analyzed, and the alterations of anxiety, depression, social support, and satisfaction of the two groups were compared under different blocking intervention schemes. Results. (1) Univariate analysis indicated that there were significant differences in family age, family income, sex, location of tumor, course of disease, TNM stage, somatic symptoms, and the incidence of anxiety and depression. There exhibited no significant difference between the gender of the family, the years of education of the family, the occupational status of the family, the relationship between the family and the patient, the mode of payment of the patient’s medical expenses, the age of the patient, the mode of treatment of the patient, the degree of knowledge of the disease, and the incidence of anxiety and depression ( P > 0.05 ). The anxiety and depression status of relatives were taken as dependent variables, and the age of family members, family income status, sex of patients, location of tumor, course of disease, TNM stage, and physical symptoms of patients were taken as independent variables, and the data were analyzed by Logistic regression analysis. Logistic regression analysis indicated that family income, tumor location, disease course, TNM stage, and somatic symptoms were the risk factors of anxiety and depression in relatives. (2) Comparison of social support status and intergroup, the objective support, subjective support, support utilization, and total score of social support in the study group were higher compared to the control group. In terms of the depression score before intervention, there exhibited no significant difference ( P > 0.05 ), but after intervention, the depression score of the two groups decreased, and the depression score of the study group was lower compared to the control group before intervention, 1 week, 2 weeks, 3 weeks, and 4 weeks after intervention ( P < 0.05 ). In terms of the anxiety score before intervention, there exhibited no significant difference ( P > 0.05 ), but after intervention, the anxiety score of the two groups decreased, and the anxiety score of the study group was lower compared to the control group before intervention, 1 week, 2 weeks, 3 weeks, and 4 weeks after intervention ( P < 0.05 ). Comparison of the satisfaction between the two groups and the study group was very satisfied in 56 cases, satisfactory in 14 cases, and general in 5 cases, and the satisfaction rate was 100.00%. The control group was very satisfied in 35 cases, satisfactory in 23 cases, general in 12 cases, and dissatisfied in 5 cases, and the satisfaction rate was 93.33%. The satisfaction of the study group was higher compared to the control group ( P < 0.05 ). Conclusion. Family income, tumor location, course of disease, TNM stage, and somatic symptoms are the risk factors of anxiety and depression in relatives. After establishing the diagnosis, intervention and treatment strategies of doctor-patient-affective disorder, the emotional disorder of family members of cancer patients, is significantly promoted, and the intervention satisfaction is high, so the scheme is worth promoting.

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“…( Almog, et al, 2020 ; Birnbaum, et al, 2019 ; Efron, et al, 2021 ; Freeman, et al, 2020 ; Grimison, et al, 2020 ; Hotz, et al, 2021 ; Hurd, et al, 2019 ; Izgelov, et al, 2020 ; Lintzeris, et al, 2020 ; Mitelpunkt, et al, 2019 ; O'Neill, et al, 2021 ; Perkins, et al, 2020 ; Pretzsch, et al, 2019a ; Pretzsch, et al, 2019c ; Wall, et al, 2019 ; Xu, et al, 2020 ; Yassin, et al, 2019 ; Zylla, et al, 2021 )…”

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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A randomized trial of medical cannabis in patients with stage IV cancers to assess feasibility, dose requirements, impact on pain and opioid use, safety, and overall patient satisfaction

Cited by 39 publications

References 21 publications

Opioid-sparing effect of cannabinoids for analgesia: an updated systematic review and meta-analysis of preclinical and clinical studies

Opioid-sparing effect of cannabinoids for analgesia: an updated systematic review and meta-analysis of preclinical and clinical studies

Study on the Conduction Analysis and Blocking Intervention Scheme of Emotional Disorders between Cancer Patients and Their Families

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

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