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Example Queries - Cannabinoids

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What are the side effects of cannabis?

 InterventionDosage and regimeSide Effects / Interactions
Côté et al. (2016): Improving Quality of Life With Nabilone During Radiotherapy Treatments for Head and Neck Cancers: A Randomized Double-Blind Placebo-Controlled TrialPlacebo


+ all patients: additional administration of antiemetics (metoclopramide) and painkillers (acetaminophen (paracetamol), codeine, hydromorphone or transdermal fentanyl) possible		Placebo tablets
  • once a day before radiotherapy in the first week
  • twice a day in the second week
  • third week until end of radiotherapy: adjusted by radiation oncologist up to maximal 4 tablets
No differences for sleepiness (p=0.32), anxiety (p=0.92) and xerostomia (p=0.83)
Côté et al. (2016): Improving Quality of Life With Nabilone During Radiotherapy Treatments for Head and Neck Cancers: A Randomized Double-Blind Placebo-Controlled TrialNabilon


+ all patients: additional administration of antiemetics (metoclopramide) and painkillers (acetaminophen (paracetamol), codeine, hydromorphone or transdermal fentanyl) possible		0.5 mg nabilone tablets (from Valeant Canada)
  • once a day before radiotherapy in the first week
  • twice a day in the second week
  • third week until end of radiotherapy: adjusted by radiation oncologist up to maximal 4 tablets
No differences for sleepiness (p=0.32), anxiety (p=0.92) and xerostomia (p=0.83)
Fallon et al. (2017) I: Sativex oromucosal spray as adjunctive therapy in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy: two double-blind, randomized, placebo-controlled phase 3 studiesSativexSativex® (Nabiximol, THC 27 mg/mL, CBD 25 mg/mL) via oral spray (self-applied by patient)
  • week 1: dose finding; week 2-5: stable dose, max. 10 sprays
  • first week mean number of sprays: 3.7, stabilized over 4 weeks (6.3 sprays per day)
    		• Overall 68% at least one event; assessed as probably intervention-associated with frequency ≥ 5%:

    Total n=64 (32.2%), of which somnolence n=18 (9%), dizziness n=15 (7.5%), nausea n=10 (5%)


    2 severe side effects associated with intervention: 1x constipation (with 360mg/day morphine equivalents), 1x moderate disorientation and somnolence on day 4 (with 2.5 daily sprays of Sativex)


    None of the deaths related to intervention
    Fallon et al. (2017) I: Sativex oromucosal spray as adjunctive therapy in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy: two double-blind, randomized, placebo-controlled phase 3 studiesPlaceboFirst week mean number of sprays 3.7, stabilized over 4 weeks (7.4 sprays per day)Overall 64% at least one event; assessed as probably intervention-associated with frequency ≥ 5%: Total n=41 (20.7%), of which somnolence n=6 (3%), dizziness n=6 (3%), nausea n=8 (4%)


    2 severe side effects associated with intervention: 1x constipation (with 360mg/day morphine equivalents), 1x moderate disorientation and somnolence on day 4 (with 2.5 daily sprays of Sativex)


    None of the deaths related to intervention
    Fallon et al. (2017) II: Sativex oromucosal spray as adjunctive therapy in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy: two double-blind, randomized, placebo-controlled phase 3 studiesPlaceboWeek 1: dose finding; week 2-5: stable dose, max. 10 sprays
    • Part A: first week average number of sprays: 3.6, second week: 6.4
    • Part B: average daily number: 6.3
    		Part A

    Overall 60% at least one event, assessed as probably intervention-associated with frequency ≥ 5%: Total n=128, 31.7%, somnolence (n=42, 10.4%), nausea (n=21, 5.2%) and dizziness (n=21, 5.2%)


    Part B

    Overall 62% at least one event; assessed as probably intervention-associated with frequency ≥ 5%: Total n=12, 11.7%; somnolence n=0
    ... further results

    What is cannabis recommended for/against?

    No results found.

     Outcome nameOutcome specificationOverall RoB judgment
    Côté et al. (2016): Improving Quality of Life With Nabilone During Radiotherapy Treatments for Head and Neck Cancers: A Randomized Double-Blind Placebo-Controlled TrialUnspecified effectsSleep quality and mood (no information on survey)some concerns
    Côté et al. (2016): Improving Quality of Life With Nabilone During Radiotherapy Treatments for Head and Neck Cancers: A Randomized Double-Blind Placebo-Controlled TrialPainPain with VAS + number of other analgesics usedsome concerns
    Côté et al. (2016): Improving Quality of Life With Nabilone During Radiotherapy Treatments for Head and Neck Cancers: A Randomized Double-Blind Placebo-Controlled TrialQuality of lifeQuality of life (target improvement of 15 points at week 7)some concerns
    Côté et al. (2016): Improving Quality of Life With Nabilone During Radiotherapy Treatments for Head and Neck Cancers: A Randomized Double-Blind Placebo-Controlled TrialNauseaNausea with questionnaire (no further information) + number of antiemetic drugs usedsome concerns
    Côté et al. (2016): Improving Quality of Life With Nabilone During Radiotherapy Treatments for Head and Neck Cancers: A Randomized Double-Blind Placebo-Controlled TrialToxicityToxicity of nabilonesome concerns
    ... further results

    What is the optimal dosage of cannabis for the treatment of nausea?

     Outcome nameOutcome specificationDosage and regime
    Côté et al. (2016): Improving Quality of Life With Nabilone During Radiotherapy Treatments for Head and Neck Cancers: A Randomized Double-Blind Placebo-Controlled TrialNauseaNausea with questionnaire (no further information) + number of antiemetic drugs used
    Grimison et al. (2020): Oral THC:CBD cannabis extract for refractory chemotherapy-induced nausea and vomiting: a randomised, placebo-controlled, phase II crossover trialCINV (Chemotherapy-Induced Nausea and Vomiting)Self-reported "complete response" ("no vomiting", "no clinically significant nausea", defined as nausea <2 on a 10-point scale, and "no use of emergency medication") during the acute (0-24 h), delayed (24-120 h) and general phase (0-120 h) of chemotherapy with diary day -1 to 6 of each cycle)
    Grimison et al. (2020): Oral THC:CBD cannabis extract for refractory chemotherapy-induced nausea and vomiting: a randomised, placebo-controlled, phase II crossover trialCINV (Chemotherapy-Induced Nausea and Vomiting)Complete response, no vomiting or emergency medication 0-120h of chemotherapy
    Johnson et al. (2010): Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of THC:CBD extract and THC extract in patients with intractable cancer-related painNauseaNausea
    Strasser et al. (2006): Comparison of orally administered cannabis extract and delta-9-tetrahydrocannabinol in treating patients with cancer-related anorexia-cachexia syndrome: a multicenter, phase III, randomized, double-blind, placebo-controlled (…)NauseaMeasured daily

    Side effects of Cannabis in placebo-controlled studies -- arm-based

     InterventionSide Effects / Interactions
    Côté et al. (2016): Improving Quality of Life With Nabilone During Radiotherapy Treatments for Head and Neck Cancers: A Randomized Double-Blind Placebo-Controlled TrialPlacebo


    + all patients: additional administration of antiemetics (metoclopramide) and painkillers (acetaminophen (paracetamol), codeine, hydromorphone or transdermal fentanyl) possible    		No differences for sleepiness (p=0.32), anxiety (p=0.92) and xerostomia (p=0.83)
    Fallon et al. (2017) I: Sativex oromucosal spray as adjunctive therapy in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy: two double-blind, randomized, placebo-controlled phase 3 studiesPlaceboOverall 64% at least one event; assessed as probably intervention-associated with frequency ≥ 5%: Total n=41 (20.7%), of which somnolence n=6 (3%), dizziness n=6 (3%), nausea n=8 (4%)


    2 severe side effects associated with intervention: 1x constipation (with 360mg/day morphine equivalents), 1x moderate disorientation and somnolence on day 4 (with 2.5 daily sprays of Sativex)


    None of the deaths related to intervention
    Fallon et al. (2017) II: Sativex oromucosal spray as adjunctive therapy in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy: two double-blind, randomized, placebo-controlled phase 3 studiesPlaceboPart A

    Overall 60% at least one event, assessed as probably intervention-associated with frequency ≥ 5%: Total n=128, 31.7%, somnolence (n=42, 10.4%), nausea (n=21, 5.2%) and dizziness (n=21, 5.2%)


    Part B

    Overall 62% at least one event; assessed as probably intervention-associated with frequency ≥ 5%: Total n=12, 11.7%; somnolence n=0
    Grimison et al. (2020): Oral THC:CBD cannabis extract for refractory chemotherapy-induced nausea and vomiting: a randomised, placebo-controlled, phase II crossover trialPlaceboModerate or severe cannabinoid-related side effects in intervention arm and placebo arm (31% vs. 7%, p=0.002):
    • Significant differences for sedation (19% vs. 4%, p=0.002) and dizziness (10% vs. 1%, p=0.03)
    • No differences for disorientation (p=0.5) and anxiety (p=1.00)
    • No cannabinoid-related serious adverse events reported


    83% of the participants preferred cannabis over placebo and 15% had a preference for placebo (p<0.001)
    Johnson et al. (2010): Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of THC:CBD extract and THC extract in patients with intractable cancer-related painPlaceboNI
    ... further results

    How does cannabis influence nausea and vomiting in cancer patients?

     Results during interventionOverall RoB judgment
    Côté et al. (2016): Improving Quality of Life With Nabilone During Radiotherapy Treatments for Head and Neck Cancers: A Randomized Double-Blind Placebo-Controlled TrialOver the course of the intervention and after: no difference for nausea (p=0.7105) or antiemetic consumption (p=0.6124) between armssome concerns
    Grimison et al. (2020): Oral THC:CBD cannabis extract for refractory chemotherapy-induced nausea and vomiting: a randomised, placebo-controlled, phase II crossover trialResults after 2 cycles, after switching to the other arm:
    • Advantage for intervention arm for percentage for CR (p=0.04), for scales "no vomiting" (p=0.05), "no emergency medication" p=0.04), "no significant nausea" (p=0.03), mean and maximum number of vomiting per day (p=0.003, p=0.001), mean/maximum nausea values (p's<0.001).
    • No difference for complete response and "no significant nausea" (p=0.12)
    		high risk
    Grimison et al. (2020): Oral THC:CBD cannabis extract for refractory chemotherapy-induced nausea and vomiting: a randomised, placebo-controlled, phase II crossover trialResults after 2 cycles, after switching to the other arm:
  • Significant advantage for intervention arm (25%) compared to placebo arm (14%): RR=1.77; 90% CI=1.12,2.79; p=0.041.
    		• high risk
    Johnson et al. (2010): Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of THC:CBD extract and THC extract in patients with intractable cancer-related painNo significant differences between THC:CBD arm/THC arm and placebo armhigh risk
    Strasser et al. (2006): Comparison of orally administered cannabis extract and delta-9-tetrahydrocannabinol in treating patients with cancer-related anorexia-cachexia syndrome: a multicenter, phase III, randomized, double-blind, placebo-controlled (…)Overall Improvement but without significant differences between arm (p=0.367)high risk
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