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Systematic Review

The Safety of Dronabinol and Nabilone: A Systematic Review and Meta-Analysis of Clinical Trials

1
Department of Pharmacognosy, Faculty of Pharmacy, University of Szeged, 6720 Szeged, Hungary
2
Institute for Translational Medicine, Szentágothai Research Centre, Medical School, University of Pécs, 7624 Pécs, Hungary
3
Centre for Translational Medicine, Semmelweis University, 1085 Budapest, Hungary
4
Division of Pancreatic Diseases, Heart and Vascular Center, Semmelweis University, 1085 Budapest, Hungary
5
Department of Clinical Pharmacy, Faculty of Pharmacy, University of Szeged, 6720 Szeged, Hungary
*
Author to whom correspondence should be addressed.
Academic Editors: Maria Scherma and Adriano Mollica
Pharmaceuticals 2022, 15(1), 100; https://doi.org/10.3390/ph15010100
Received: 13 December 2021 / Revised: 7 January 2022 / Accepted: 11 January 2022 / Published: 14 January 2022
(This article belongs to the Topic Advances in Cannabinoid Research)
Dronabinol, a natural cannabinoid, and its semi-synthetic derivative, nabilone, are marketed as medicines in several countries. The aim of our work was to systematically evaluate the frequency of adverse events related to dronabinol or nabilone treatment compared to placebo. Scientific databases were searched for placebo-controlled clinical studies of patients receiving either dronabinol or nabilone therapy with placebo control groups. This meta-analysis was reported following the PRISMA guidelines using the PICO format, and it was registered with the PROSPERO register. There were 16 trials included in the meta-analysis. In the nabilone studies, drowsiness was more than 7 times as frequent in patients treated with nabilone than in the placebo group (OR: 7.25; 95% CI: 1.64–31.95), and the risk of dizziness (OR: 21.14; 95% CI: 2.92–152.75) and dry mouth was also higher (OR: 17.23; 95% CI: 4.33–68.55). The frequency of headache was not different in the two groups. In case of dronabinol, the frequency of dry mouth (OR: 5.58; 95% CI: 3.19–9.78), dizziness (OR: 4.60 95% CI: 2.39–8.83) and headache (OR: 2.90; 95% CI: 1.07–7.85) was significantly higher in the dronabinol groups, whereas in case of nausea, drowsiness and fatigue there was no difference. The severity of adverse events was typically mild-to-moderate and transient. In a risk-benefit assessment, these adverse effects are acceptable compared to the achievable benefit. However, considering the diversity of the adverse effects, more studies are needed to provide a more accurate assessment on the side effect profiles of these two compounds. View Full-Text
Keywords: nabilone; dronabinol; cannabinoid; adverse effects; safety; Cannabis; meta-analysis nabilone; dronabinol; cannabinoid; adverse effects; safety; Cannabis; meta-analysis
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MDPI and ACS Style

Bajtel, Á.; Kiss, T.; Tóth, B.; Kiss, S.; Hegyi, P.; Vörhendi, N.; Csupor-Löffler, B.; Gede, N.; Hohmann, J.; Csupor, D. The Safety of Dronabinol and Nabilone: A Systematic Review and Meta-Analysis of Clinical Trials. Pharmaceuticals 2022, 15, 100. https://doi.org/10.3390/ph15010100

AMA Style

Bajtel Á, Kiss T, Tóth B, Kiss S, Hegyi P, Vörhendi N, Csupor-Löffler B, Gede N, Hohmann J, Csupor D. The Safety of Dronabinol and Nabilone: A Systematic Review and Meta-Analysis of Clinical Trials. Pharmaceuticals. 2022; 15(1):100. https://doi.org/10.3390/ph15010100

Chicago/Turabian Style

Bajtel, Ákos, Tivadar Kiss, Barbara Tóth, Szabolcs Kiss, Péter Hegyi, Nóra Vörhendi, Boglárka Csupor-Löffler, Noémi Gede, Judit Hohmann, and Dezső Csupor. 2022. "The Safety of Dronabinol and Nabilone: A Systematic Review and Meta-Analysis of Clinical Trials" Pharmaceuticals 15, no. 1: 100. https://doi.org/10.3390/ph15010100

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