Category Archives: Nausea/Vomiting

Association Between Medical Marijuana Cardholder Status and Antiemetic Overuse

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“Introduction: The conscientious prescribing of antiemetics by chemotherapy-induced nausea and vomiting (CINV) risk was highlighted in the American Society of Clinical Oncology (ASCO) “Choosing Wisely” recommendations. The pharmacologic properties of medical marijuana (MMJ) may allow for decreased incidence of CINV; however, little is known about the effects of MMJ on the use of antiemetics. This study aimed to determine if MMJ cardholder status, which enables access to MMJ, is associated with antiemetic overuse among patients with cancer. 

Materials and Methods: This population-based secondary data analysis examined a retrospective cohort derived from the linked Arkansas All Payers Claims Database (2013-2020) and MMJ cardholder registry (2013-2019). The cohort consisted of 20,558 patients with cancer aged 18 and older with a chemotherapy claim in an outpatient setting within 12 months of a cancer diagnosis. Exposure was a registration to receive an MMJ card that permitted access to MMJ. The primary outcome of interest was antiemetic overuse, as characterized by the ASCO recommendation. Antiemetic use associated with chemotherapy was identified through filled prescriptions and medical claims. Multivariable logistic regression, adjusted for baseline demographic and prescription characteristics, was used to calculate the adjusted odds ratios (aOR) of antiemetic overuse among MMJ cardholders compared with non-MMJ cardholders. 

Results: Among 20,558 eligible patients, 436 (2.1%) had an MMJ card at some point in the study period. Antiemetic overuse was identified in 7.5% of chemotherapy cycles. Compared with non-MMJ cardholders, MMJ cardholders were less likely to experience antiemetics overuse (aOR: 0.76, p < 0.001). Patients with fewer chemotherapy cycles and younger in age had higher odds of antiemetic overuse compared with those with more chemotherapy cycles. The risk of antiemetic overuse did not differ based on gender and rurality of residency. Route of chemotherapy administration, CINV risk category, and type of cancer also impacted the odds of antiemetic overuse. 

Discussion: The findings indicate that MMJ cardholders are significantly less likely to experience antiemetic overuse than non-MMJ cardholders. Further investigation into the use, effectiveness, and safety of cannabis for CINV mitigation is needed to inform patient and provider decision-making.”

https://pubmed.ncbi.nlm.nih.gov/39419579/

https://www.liebertpub.com/doi/10.1089/can.2024.0083

Cannabis for Refractory Chemotherapy-Induced Nausea and Vomiting

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“Chemotherapy-induced nausea and vomiting (CINV) is a dreaded side effect of chemotherapy that remains common despite substantial advances in antiemetic treatments. Cannabis products have long had a role in the treatment of refractory CINV, but evidence supporting their use is outdated. In the article that accompanies this editorial, Grimison et al4 present results from a trial of a novel cannabis product that may be of benefit for CINV refractory to treatment with currently recommended antiemetics.

In conclusion, the trial by Grimison et al4 represents the first large trial of THC:CBD for CINV and demonstrates encouraging results for secondary prevention of refractory CINV. For patients receiving moderate- or high-emetic-risk chemotherapy, THC:CBD may be considered as an option for secondary prophylaxis of CINV for patients who had refractory nausea in a previous cycle despite guideline-concordant treatment. However, the applicability and generalizability of the evidence is limited by heterogeneity in the patient population, changes in antiemetic guidelines since the conception of the trial, and availability of THC:CBD. Additional trials should compare THC:CBD to other antiemetics, particularly to olanzapine, both in chemotherapy-naïve patients and in those with CINV refractory to standard antiemetic regimens. Further research is also warranted regarding optimal THC:CBD ratios to alleviate nausea while preventing adverse effects associated with THC.”

https://ascopubs.org/doi/10.1200/JCO.24.00438

Oral Cannabis Extract for Secondary Prevention of Chemotherapy-Induced Nausea and Vomiting: Final Results of a Randomized, Placebo-Controlled, Phase II/III Trial

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“Purpose: The aim of this randomized, placebo-controlled, two-stage, phase II/III trial was to determine the efficacy of an oral cannabis extract in adults with refractory nausea and/or vomiting during moderately or highly emetogenic, intravenous chemotherapy despite guideline-consistent antiemetic prophylaxis. Here, we report results of the prespecified combined analysis including the initial phase II and subsequent phase III components.

Patients and methods: Study treatment consisted of oral capsules containing either tetrahydrocannabinol 2.5 mg plus cannabidiol 2.5 mg capsules (THC:CBD) or matching placebo, taken three times a day from days -1 to 5, in addition to guideline-consistent antiemetics. The primary measure of effect was the difference in the proportions of participants with no vomiting or retching and no use of rescue medications (a complete response) during hours 0-120 after the first cycle of chemotherapy on study (cycle A).

Results: We recruited 147 evaluable of a planned 250 participants from 2016 to 2022. Background antiemetic prophylaxis included a corticosteroid and 5-hydroxytryptamine antagonist in 97%, a neurokinin-1 antagonist in 80%, and olanzapine in 10%. THC:CBD compared with placebo improved the complete response rate from 8% to 24% (absolute difference 16%, 95% CI, 4 to 28, P = .01), with similar effects for absence of significant nausea, use of rescue medications, daily vomits, and the nausea scale on the Functional Living Index-Emesis quality-of-life questionnaire. More frequent bothersome adverse events of special interest included sedation (18% v 7%), dizziness (10% v 0%), and transient anxiety (4% v 1%). There were no serious adverse events attributed to THC:CBD.

Conclusion: THC:CBD is an effective adjunct for chemotherapy-induced nausea and vomiting despite standard antiemetic prophylaxis, but was associated with additional adverse events. Drug availability, cultural attitudes, legal status, and preferences may affect implementation. Future analyses will evaluate the cost-effectiveness of THC:CBD.”

https://pubmed.ncbi.nlm.nih.gov/39151115/

“In conclusion, an oral formulation of THC:CBD was an effective adjunct to standard antiemetics for prevention and treatment of refractory CINV, with adverse effects including sedation and dizziness, but no increase in serious adverse events. Our data support the claim that oral THC:CBD is an effective and safe option for the prevention of refractory CINV. Availability, access, affordability, cultural attitudes, societal barriers, and legal barriers may limit implementation.”

https://ascopubs.org/doi/10.1200/JCO.23.01836

Clinical Benefits and Safety of Medical Cannabis Products: A Narrative Review on Natural Extracts

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“Interest in medical cannabis and cannabis-based medicinal products (CBMPs) has increased greatly in recent years. Two cannabinoids are of principal importance; delta-9-tetrahydrocannabinol (∆9-THC), the primary psychoactive component, and also cannabidiol (CBD), considered non-intoxicating. Each has distinct mechanisms of action and different therapeutic potentials. CBMPs differ in their ∆9-THC and CBD components; predominantly ∆9-THC, balanced formulations with equivalent ∆9-THC and CBD elements, and CBD-predominant products.

In this narrative review, we evaluate the published evidence for the clinical benefits of CBMPs and overall benefits in well-being. We also review the overall safety profile and discuss the potential for dependence with CBMPs. Evidence can be drawn from a wide range of randomized and other controlled studies and from observational real-world studies.

Most data from observational registry studies are supportive of ∆9-THC-based products (∆9-THC-predominant or balanced CBMPs) in the management of chronic neuropathic pain. Balanced products are also effective in reducing spasticity in multiple sclerosis. Most CBMPs show benefit in providing symptomatic benefits in reducing anxiety, nausea, and in improving sleep, but the place of specific products is more subtle, and choice guided by specific circumstances. Symptomatic improvements are accompanied by improved quality of life and well-being. Safety data indicate that CBMPs are generally well tolerated in most patients without specific contraindications. The majority of adverse effects are non-serious, and transient; most are principally associated with ∆9-THC and are dose-dependent. In contrast to recreational cannabis use, there is little evidence from clinical studies that CBMPs have any potential for dependence.”

https://pubmed.ncbi.nlm.nih.gov/39096481/

https://link.springer.com/article/10.1007/s40122-024-00643-0

Medical cannabis use in oncology and associated outcomes: A scoping review

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“Background: Natural and synthetic cannabinoids are being used worldwide to treat various symptoms in cancer patients. This study aims to map the therapeutic benefits and adverse effects associated with the use of cannabis-based drugs in these outcomes.

Methods: Following Joanna Briggs Institute guidelines a scoping review was conducted. The study protocol was available in the Open Science Framework public repository. An extensive search strategy involving databases like Cochrane Library, Embase, CINAHL, Medline/PubMed, Lilacs, Google Scholar, and Open Gray for gray literature analysis was executed by a skilled librarian. The inclusion criteria were primary studies (observational and randomized) that evaluated the efficacy and safety of cannabinoids in cancer patients. The review encompassed studies of diverse designs, publication years, and types, as long as they addressed cannabinoids’ impact in oncology.

Results: Twenty-nine (82.86%) out of total of 35 were randomized and 6 (14.14%) were non-randomized. About 57.1% of studies utilized registered products as interventions, with THC being the most natural cannabinoid cited in variable doses and administration routes. Moreover, 62.85% of studies specified the cancer types (breast, lung, sarcomas, hematological and reproductive system), while only one study detailed cancer staging. The evaluated outcomes encompassed nausea and vomiting (77.14%), appetite (11.43%), pain (8.57%), and tumor regression (2.86%) across different proportions of studies.

Conclusion: Cannabinoids show promise in managing pain, emesis, and anorexia/cachexia linked to cancer progression. New randomized clinical trials with a larger number of participants and observational studies on long-term safety are crucial to affirm their medicinal utility for cancer patients unresponsive to conventional drugs.”

https://pubmed.ncbi.nlm.nih.gov/38477532/

https://journals.sagepub.com/doi/10.1177/10781552241239006

Oral Tetrahydrocannabinol (THC):Cannabinoid (CBD) Cannabis Extract Adjuvant for Reducing Chemotherapy-Induced Nausea and Vomiting (CINV): A Randomized, Double-Blinded, Placebo-Controlled, Crossover Trial

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“Objective: To evaluate the effects of tetrahydrocannabinol (THC):cannabinoid (CBD) (1:1) oil in reducing chemotherapy-induced nausea and vomiting (CINV) in gynecologic cancer patients who received moderate-to-high emetogenic chemotherapy.

Material and method: This was a randomized, double-blinded, crossover and placebo-controlled trial. The study was conducted at the Gynecologic Oncology Units, Bhumibol Adulyadej Hospital (BAH), Royal Thai Air Force, Bangkok, Thailand, between August and November 2022. Participants had gynecologic cancer and received moderate-to-high emetogenic chemotherapy. Subjects were randomized and divided into two groups (A and B) based on the block of four randomization method. In the first cycle, groups A and B received THC:CBD extract oil 1:1 (TCEO) and placebo before chemotherapy administration. In the second cycle, groups A and B received placebo and TCEO before chemotherapy administration. Both groups received per protocol antiemetic medication during chemotherapy. Nausea score and side effects were recorded.

Results: A total of 60 cases were recruited. After exclusion, 54 cases were included in the study. The mean age of participants was 54.4 years. The mean body mass index (BMI) was 26.5 kg/m2. Fifty-nine (21/54) percent cases were the advanced stages of cancer. The nausea score of TCEO and placebo groups were 2.11 and 2.99, respectively (P < 0.05). More than half of the participants (36/54) reported dizziness and sedation side effects. Dry mouth, confusion, anxiety, and palpitation of both groups were comparable.

Conclusion: The cannabinoid extract (THC:CBD) was an appropriate adjuvant agent to reduce CINV in patients with gynecologic cancer who received high-emetogenic chemotherapy. Dizziness and sedation were the major side effects.”

https://pubmed.ncbi.nlm.nih.gov/37608911/

https://www.dovepress.com/oral-tetrahydrocannabinol-thccannabinoid-cbd-cannabis-extract-adjuvant-peer-reviewed-fulltext-article-IJWH

Evaluation of Sex Differences in the Potential of Δ 9-Tetrahydrocannabinol, Cannabidiol, Cannabidiolic Acid, and Oleoyl Alanine to Reduce Nausea-Induced Conditioned Gaping Reactions in Sprague-Dawley Rats

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“Introduction: Cancer patients report nausea as a side effect of their chemotherapy treatment. Using the pre-clinical rodent model of acute nausea-lithium chloride (LiCl)-induced conditioned gaping-our group has demonstrated that exogenous cannabinoids may have antinausea potential. 

Materials and Methods: With the goal of evaluating the role of sex as a factor in pre-clinical research, we first compared the conditioned gaping reactions produced by varying doses of LiCl in male and female rats using the taste reactivity test (Experiment 1). 

Results: LiCl produced dose-dependent conditioned gaping similarly in male and female rats with the highest dose (127.2 mg/kg) producing robust conditioned gaping, with this dose used in subsequent experiments. Next, we examined the antinausea potential of THC (Experiment 2), CBD (Experiment 3), cannabidiolic acid (CBDA; Experiment 4) and oleoyl alanine (OlAla; Experiment 5) in both male and female rats. THC, CBD, CBDA, and OlAla dose dependently reduced conditioned gaping in both male and female rats in a similar manner. 

Conclusions: These results suggest that cannabinoids may be equally effective in treating nausea in both males and females.”

https://pubmed.ncbi.nlm.nih.gov/35984924/

https://www.liebertpub.com/doi/10.1089/can.2022.0158

Protective Effects of Cannabis sativa on chemotherapy-induced nausea in a rat: Involvement of CB1 receptors

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“Cyclophosphamide is an anticancer and immunosuppressive agent used in the treatment of various malignancies but causing gastrointestinal distress.

Cannabis sativa (C. sativa) and its derivatives have been used for the treatment of human gastrointestinal disorders. A purpose of this study was to investigate the effect of C. sativa on nausea induced by cyclophosphamide in rats.

Results showed that C. sativa ameliorates cyclophosphamide-induced emesis by increasing in body weight and normal diet intake with a decrease in kaolin diet intake after 7 days. Moreover, C. sativa significantly decreases (serotonin) 5HT, dopamine and noradrenaline, as well as, decreasing oxidative stress and inflammation. Administration of C. sativa significantly increased the expression of CB1R in intestinal homogenate. Treatment with C. sativa, also, improved the histological feature of an intestinal tissue.

These results suggested that C. sativa possess antiemetic, antioxidant and anti-inflammatory effects in chemotherapy-induced nausea in rats by activating CB1R.”

https://pubmed.ncbi.nlm.nih.gov/35861135/

https://onlinelibrary.wiley.com/doi/10.1111/fcp.12821

The Effectiveness of Common Cannabis Products for Treatment of Nausea

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“Background: Even though the Cannabis plant has been used to treat nausea for millennia, few studies have measured real-time effects of common and commercially available cannabis-based products.

Study: Using the Releaf App, 886 people completed 2220 cannabis self-administration sessions intended to treat nausea between June 6, 2016 and July 8, 2019. They recorded the characteristics of self-administered cannabis products and baseline symptom intensity levels before tracking real-time changes in the intensity of their nausea.

Results: By 1 hour postconsumption, 96.4% of people had experienced symptom relief with an average symptom intensity reduction of -3.85 points on a 0 to 10 visual analog scale (SD=2.45, d=1.85, P<0.001). Symptom relief was statistically significant at 5 minutes and increased with time. Among product characteristics, flower and concentrates yielded the strongest, yet similar results; products labeled as Cannabis indica underperformed those labeled as Cannabis sativa or hybrid; and joints were associated with greater symptom relief than pipes or vaporizers. In sessions using flower, higher tetrahydrocannbinol and lower cannabidiol were generally associated with greater symptom relief (eg, within 5 min).

Conclusions: The findings suggest that the vast majority of patients self-selecting into cannabis use for treatment of nausea likely experience relief within a relative short duration of time, but the level of antiemetic effect varies with the characteristics of the cannabis products consumed in vivo. Future research should focus on longer term symptom relief, including nausea-free intervals and dosing frequency; the risks of consumption of medical cannabis, especially among high-risk populations, such as pregnant women and children; and potential interactions between cannabis, conventional antiemetics, other medications, food, tobacco, alcohol, and street drugs among specific patient populations.”

https://pubmed.ncbi.nlm.nih.gov/35258504/

https://journals.lww.com/jcge/Abstract/2022/04000/The_Effectiveness_of_Common_Cannabis_Products_for.8.aspx


Cannabis sativa L. as a Natural Drug Meeting the Criteria of a Multitarget Approach to Treatment

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ijms-logo“Cannabis sativa L. turned out to be a valuable source of chemical compounds of various structures, showing pharmacological activity. The most important groups of compounds include phytocannabinoids and terpenes.

The pharmacological activity of Cannabis (in epilepsy, sclerosis multiplex (SM), vomiting and nausea, pain, appetite loss, inflammatory bowel diseases (IBDs), Parkinson’s disease, Tourette’s syndrome, schizophrenia, glaucoma, and coronavirus disease 2019 (COVID-19)), which has been proven so far, results from the affinity of these compounds predominantly for the receptors of the endocannabinoid system (the cannabinoid receptor type 1 (CB1), type two (CB2), and the G protein-coupled receptor 55 (GPR55)) but, also, for peroxisome proliferator-activated receptor (PPAR), glycine receptors, serotonin receptors (5-HT), transient receptor potential channels (TRP), and GPR, opioid receptors.

The synergism of action of phytochemicals present in Cannabis sp. raw material is also expressed in their increased bioavailability and penetration through the blood-brain barrier. This review provides an overview of phytochemistry and pharmacology of compounds present in Cannabis extracts in the context of the current knowledge about their synergistic actions and the implications of clinical use in the treatment of selected diseases.”

https://pubmed.ncbi.nlm.nih.gov/33466734/

https://www.mdpi.com/1422-0067/22/2/778