The Long-Term Effectiveness and Safety of Cannabidiol-Enriched Oil in Children With Drug-Resistant Epilepsy

Tzadok, Michal; Hamed, Nasrin; Heimer, Gali; Zohar-Dayan, Efrat; Rabinowitz, Shira; Zeev, Bruria Ben

doi:10.1016/j.pediatrneurol.2022.06.016

Cited by 4 publications

(2 citation statements)

References 28 publications

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“…Finally, 50 studies were included in this systematic review. 18 – 67 A total of 40 prospective studies (including 5 RCTS and 1 non-RCT) and 10 retrospective studies were included. Reasons for excluding full-text articles are presented in the PRISMA flow diagram ( Figure 1 ).…”

Section: Resultsmentioning

confidence: 99%

Long-term efficacy and adverse effects of cannabidiol in adjuvant treatment of drug-resistant epilepsy: a systematic review and meta-analysis

Liu,

He,

2023

Ther Adv Neurol Disord

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Background: Epilepsy is one of the most common chronic brain diseases. Almost one-third of patients have drug-resistant epilepsy (DRE). Cannabidiol is being considered as a potential novel drug for treating DRE. Objectives: To investigate long-term efficacy and safety of cannabidiol in treatment of DRE and the differences in cannabidiol treatment among patients with different characteristics. Design: Systematic review and meta-analysis. Data sources and methods: Medline, Embase, and CENTRAL were searched for literature. RevMan5.4 was used for meta-analysis. The Intention-to-treat set and the random effect were used as the main analysis. Subgroup analyses were performed according to age, dose, concomitant antiseizure medications (ASMs), epilepsy syndromes, and study designs. Results: Fifty studies were included in this systematic review. A total of 4791 participants were collected. The responder rates (seizure frequency reduced at least 50%) at 12-, 24-, 48-, 72-, 96-, and 144-week were 0.40 [0.36, 0.45], 0.39 [0.34, 0.44], 0.37 [0.30, 0.44], 0.27 [0.17, 0.37], 0.22 [0.14, 0.30], and 0.38 [0.23, 0.53]. Seizure-free rates were 0.04 [0.03, 0.06], 0.04 [0.03, 0.05], 0.03 [0.02, 0.05], 0.03 [0.02, 0.03], 0.02 [0.01, 0.03], and 0.04 [0.01, 0.06]. Proportion of adverse events were 0.72 [0.61, 0.83], 0.62 [0.42, 0.81], 0.60 [0.41, 0.79], 0.35 [0.14, 0.56], 0.83 [0.75, 0.90], and 0.96 [0.94, 0.99]. The pooled 12-, 24-, 48-, 96-, and 144-week proportion of serious adverse events were 0.15 [0.09, 0.21], 0.23 [0.14, 0.31], 0.10 [0.06, 0.15], 0.31 [0.24, 0.38], and 0.40 [0.35, 0.45]. Subgroup analyses showed that there was no significant difference on efficacy and safety among age subgroups and epilepsy syndromes subgroups. For most periods, there were no significant difference on efficacy among subgroups of dose and concomitant ASMs. However, higher doses and more concomitant ASMs were associated with higher proportion of adverse events. Conclusion: Cannabidiol treatment of DRE has stable efficacy and fewer adverse events in early period. Long-term use may have decreased efficacy and increased adverse events. Dose escalation may not increase efficacy, but may increase adverse events. Furthermore, cannabidiol use may reduce dosage of other ASMs without reducing efficacy, thereby reducing adverse effects. Cannabidiol may have similar effects in various epilepsy syndromes. Trial registration: PROSPERO (CRD42022351250).

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Section: Resultsmentioning

confidence: 99%

Long-term efficacy and adverse effects of cannabidiol in adjuvant treatment of drug-resistant epilepsy: a systematic review and meta-analysis

Liu,

He,

2023

Ther Adv Neurol Disord

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“…The concentration of CBD in the bloodstream of participants using artisanal oil was lower than that observed in those using imported medicine (Cohen et al 2022). However, according to researchers, artisanal extracts are effective and safe, especially in the treatment of refractory epilepsy, which ensures the importance of access to artisanal extract as a treatment option (Tzadok et al 2022;Sulak et al 2017).…”

Section: Discussionmentioning

confidence: 99%

Chemical Quantification of CBD and THC and Bacteriological Analysis of Artisan Cannabis Sativa Extracts: TheImportance of Regulation

Costa,

Júnior,

Silva

et al. 2023

Preprint

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Objectives Cannabis sativa is a plant species that has been used for millennia, especially in medicinal form, due to its great therapeutic potential. Tetrahydrocannabinol (THC) and cannabidiol (CBD) are the main pharmacologically active substances found in the plant. Efficient methods of extraction, purification and, sometimes, the separation of these cannabinoids are necessary to obtain extracts and compounds that can be used in the search for safe and effective therapeutic responses. Methods In this work, it was possible to analyze the composition of cannabinoids in 41 extracts of Cannabis sp. (32 produced by associations and 9 produced by the patients themselves), determining the amount of THC and CBD in the samples, using the High Performance Liquid Chromatography technique (RP-HPLC), as well as the presence of bacteria, using the Gram method. Results The median concentrations of THC and CBD measured in the samples were 51% and 58%, lower than the expected concentration, respectively. Furthermore, the presence of a Gram positive microorganism was observed in only one sample, suggestive of Staphylococcus Aureus. Conclusion Although associations have a noble social function, quality control in the production of medicines is important, with proper titration of cannabinoids and microbiological analysis of samples, which can be implemented through regulation by the Public Power.

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Adverse events of epidiolex: A real-world drug safety surveillance study based on the FDA adverse event reporting system (FAERS) database

Zhou,

Du,

et al. 2023

Asian Journal of Psychiatry

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The Long-Term Effectiveness and Safety of Cannabidiol-Enriched Oil in Children With Drug-Resistant Epilepsy

Cited by 4 publications

References 28 publications

Long-term efficacy and adverse effects of cannabidiol in adjuvant treatment of drug-resistant epilepsy: a systematic review and meta-analysis

Long-term efficacy and adverse effects of cannabidiol in adjuvant treatment of drug-resistant epilepsy: a systematic review and meta-analysis

Chemical Quantification of CBD and THC and Bacteriological Analysis of Artisan Cannabis Sativa Extracts: TheImportance of Regulation

Adverse events of epidiolex: A real-world drug safety surveillance study based on the FDA adverse event reporting system (FAERS) database

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