Example Queries - Cannabinoids

What are the side effects of cannabis?

	Intervention	Dosage and regime	Side 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 Trial	Nabilon + 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 studies	Sativex	Sativex® (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) 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 studies	Sativex	Sativex® (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 Part A: first week average number of sprays: 3.6; second week: 6.4 Part B: average daily number: 6.5	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 72% at least one event; assessed as probably intervention-associated with frequency ≥ 5%: Total n=16, 15.5%; somnolence (n=6, 5.8%) More than twice as many patients in Sativex arm discontinued study due to side effects (n=14, 13.6% vs. n=6, 5.8%); no statistical comparison given) None of the deaths related to intervention
Grimison et al. (2020): Oral THC:CBD cannabis extract for refractory chemotherapy-induced nausea and vomiting: a randomised, placebo-controlled, phase II crossover trial	THC:CBD	1-4 capsules (each THC 2.5mg/CBD 2.5mg) 3x daily from one day before chemotherapy to day 5; median (SD) number of capsules: 2 (1-3)	Moderate 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)
Jatoi et al. (2002): Dronabinol Versus Megestrol Acetate Versus Combination Therapy for Cancer-Associated Anorexia: A North Central Cancer Treatment Group Study	Dronabinol	Oral, 2.5mg 2 times a day + liquid placebo	Impotence in 4% of men; vomiting; fluid retention; confused thinking; drowsiness; loss of coordination; inappropriate behavior
... further results

What is cannabis recommended for/against?

	Outcome specification	Results during intervention	Overall 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 Trial	Sleep quality and mood (no information on survey)	Over the course of the intervention and after: no differences for mood (p=0.3214) and sleep quality (p=0.4438) between arms	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 Trial	Pain with VAS + number of other analgesics used	Over the course of the intervention and after: no differences for pain (p=0.6048), analgesic use (p=0.6671), no delay in time to 20% pain increase (p=0.4614) between arms	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 Trial	Quality of life (target improvement of 15 points at week 7)	No difference between arms (p=0.4270), even after controlling for tumor site, treatment method and cancer stage at week 7 or the entire study period	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 Trial	Nausea with questionnaire (no further information) + number of antiemetic drugs used	Over the course of the intervention and after: no difference for nausea (p=0.7105) or antiemetic consumption (p=0.6124) between arms	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 Trial	Toxicity of nabilone	No differences for sleepiness (p=0.3166), anxiety (p=0.9163) and xerostomia (p=0.8341)	some concerns
... further results

How does cannabis influence nausea and vomiting in cancer patients?

	Results during intervention	Overall 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 Trial	Over the course of the intervention and after: no difference for nausea (p=0.7105) or antiemetic consumption (p=0.6124) between arms	some concerns
Grimison et al. (2020): Oral THC:CBD cannabis extract for refractory chemotherapy-induced nausea and vomiting: a randomised, placebo-controlled, phase II crossover trial	Results 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 trial	Results 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 pain	No significant differences between THC:CBD arm/THC arm and placebo arm	high 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