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 Side Effects / Interactions
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

Intervention-associated events in n=106 (60%): drowsiness, dizziness, nausea, confusion, vomiting, hypotension, hypercalcemia, increased gamma GT


Most side effects were mild/moderate; no statistical comparisons given; one case of syncope probably related to THC; other events not associated with intervention


Intervention-associated events in n=106 (60%): drowsiness, dizziness, nausea, confusion, vomiting, hypotension, hypercalcemia, increased gamma GT;


Most side effects were mild/moderate; no statistical comparisons given; one case of syncope probably related to THC; other events not associated with intervention


NI
Lichtmann et al. (2018): Results of a Double-Blind, Randomized, Placebo-Controlled Study of Nabiximols Oromucosal Spray as an Adjunctive Therapy in Advanced Cancer Patients with Chronic Uncontrolled PainMost frequently nausea (n=17) and dizziness (n=15); 1 case of disorientation and 1 case of visual hallucinations
Most frequently nausea (n=10) and dizziness (n=5); 1 case of vomiting
Portenoy et al. (2012): Nabiximols for Opioid-Treated Cancer Patients With Poorly-Controlled Chronic Pain: A Randomized, Placebo-Controlled, Graded-Dose TrialCognitive functions: negative effect of nabiximols (no values given); nausea and vomiting; dizziness; drowsiness; disorientation; anorexia, constipation; dry mouth; anemia; diarrhea; dysgeusia headache; asthenia hallucinations; reduced appetite; fatigue; pain; insomnia; stomatitis; weight loss
Cognitive functions: negative effect of nabiximols (no values given); nausea and vomiting; dizziness; drowsiness; disorientation; anorexia, constipation; dry mouth; anemia; diarrhea; dysgeusia headache; asthenia hallucinations; reduced appetite; fatigue; pain; insomnia; stomatitis; weight loss
Cognitive functions: negative effect of nabiximols (no values given); nausea and vomiting; dizziness; drowsiness; disorientation; anorexia, constipation; dry mouth; anemia; diarrhea; dysgeusia headache; asthenia hallucinations; reduced appetite; fatigue; pain; insomnia; stomatitis weight loss
NI
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 (…)

Total adverse events:

  • n=197, of which possibly intervention-associated n=45 and likely intervention-associated n=7
  • Temporary or permanent dose reduction was necessary for 30 patients
  • Adverse events that occurred more than 10 times were: Nausea/vomiting (n=21), fatigue (n=14), pain (n=17), anemia (n=14), dizziness (n=11), dyspnea (n=7), diarrhea (n=7), obstipation (n=7), vertigo (n not reported); no differences in frequencies between arm
  • Of all side effects n=101 were mild, n=71 moderate, n=24 severe (mainly dizziness, nausea/vomiting, dyspnea)
  • 33 very severe side effects such as dyspnoea, tumor progression, vomiting, deterioration of general well-being, death, pain, fever, diarrhoea, exsiccation; 6 of which were life-threatening, 27 required hospitalization

Total adverse events:

  • n=238, of which possibly intervention-associated n=28 and likely intervention-associated n=9
  • Temporary or permanent dose reduction was necessary for 34 patients
  • Adverse events that occurred more than 10 times were: Nausea/vomiting (n=23), fatigue (n=16), pain (n=11), anemia (n=9), dizziness (n=9), dyspnea (n=9), diarrhea (n=6), obstipation (n=6), vertigo (n not reported); no differences in frequencies between arms
  • Of all side effects n=104 were mild, n=113 moderate, n=21 severe (mainly dizziness, nausea/vomiting, dyspnea)
  • 32 very severe side effects such as dyspnoea, tumor progression, vomiting, deterioration of general well-being, death, pain, fever, diarrhoea, exsiccation; 6 of which were life-threatening, 25 required hospitalization

Total adverse events:

  • n=91, of which possibly intervention-associated n=17 and likely intervention-associated n=4
  • Temporary or permanent dose reduction was necessary for 14 patients
  • Adverse events that occurred more than 10 times were: Nausea/vomiting (n=11), fatigue (n=4), pain (n=5), anemia (n=6), dizziness (n=7), dyspnea (n=2), diarrhea (n=2), obstipation (n=2), vertigo (n not reported); no differences in frequencies between arms
  • Of all side effects n=36 were mild, n=43 moderate, n=12 severe (mainly dizziness, nausea/vomiting, dyspnea)
  • 17 very severe side effects such as dyspnoea, tumor progression, vomiting, deterioration of general well-being, death, pain, fever, diarrhoea, exsiccation; 1 of which were life-threatening, 16 required hospitalization