Purified Cannabidiol for Treatment of Refractory Epilepsies in Pediatric Patients with Developmental and Epileptic Encephalopathy

Pietrafusa, Nicola; Ferretti, Alessandro; Trivisano, Marina; Palma, Luca De; Calabrese, Costanza; Pavia, Giusy Carfì; Tondo, Ilaria; Cappelletti, Simona; Vigevano, Federico; Specchio, Nicola

doi:10.1007/s40272-019-00341-x

Cited by 21 publications

(11 citation statements)

References 29 publications

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“…Of the 21 articles obtained, exclusion criteria were applied to obtain eight articles at the end [ Table 1 and Figure 1 ]. [ 16 - 23 ]…”

Section: Resultsmentioning

confidence: 99%

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Use of cannabidiol in the treatment of drug-refractory epilepsy in children and young adults: A systematic review

Chico,

Diaz,

Contreras-Puentes

2024

JNRP

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Objectives: Epilepsy poses a significant challenge in pediatric and adolescent populations, impacting not only seizures but also psychological and cognitive comorbidities, leading to higher mortality rates than the general population. Drug-refractory epilepsy, resistant to conventional treatments, affects a range of 7–20% of pediatric patients. The search for alternative therapies has led to exploring the therapeutic potential of Cannabis sativa L. compounds, particularly cannabidiol (CBD). Examine the use of CBD for treating drug-refractory epilepsy in children and young adults, summarizing existing evidence on its efficacy. Materials and Methods: A systematic review, following Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines, assessed studies from 2018 to 2023, focusing on CBD’s efficacy and safety for treatment-resistant epilepsy in pediatric and juvenile populations. The search spanned seven databases, and the studies underwent rigorous screening and data extraction. Results: Out of 6351 identified articles, eight were selected for review. The included studies reported positive outcomes, with CBD leading to a reduction in seizure frequency ranging from 50% to complete seizure freedom. Adverse effects were mostly mild and reversible, including drowsiness, diarrhea, and loss of appetite. Conclusion: The CBD emerges as a promising tool for refractory epilepsy in pediatric patients, showing efficacy in reducing seizure frequency and improving overall quality of life. Despite mild and reversible adverse effects, CBD’s benefits outweigh the risks. However, more research on long-term effects is needed to fully understand its implications.

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“…Of the 21 articles obtained, exclusion criteria were applied to obtain eight articles at the end [ Table 1 and Figure 1 ]. [ 16 - 23 ]…”

Section: Resultsmentioning

confidence: 99%

“…In the study by Pietrafusa, 37.9% presented an improvement over 50%. [ 16 ] In the studies of Caraballo et al . 80% responded positively, showing a notable decrease in seizure frequency.…”

Section: Resultsmentioning

confidence: 99%

Use of cannabidiol in the treatment of drug-refractory epilepsy in children and young adults: A systematic review

Chico,

Diaz,

Contreras-Puentes

2024

JNRP

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“…After the removal of 1350 duplicate records, the remaining 1930 publications were screened, and 61 studies were selected for full-text review (Figure 1). Following the evaluation of these studies for eligibility, 52 were excluded for the following reasons: 48 studies were not RCTs, 2 did not report AEs, and 2 were reanalyses of previously published articles . Finally, a total of 9 articles met the eligibility criteria and were included in the qualitative and quantitative synthesis …”

Section: Resultsmentioning

confidence: 99%

Adverse Events of Cannabidiol Use in Patients With Epilepsy

et al. 2023

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ImportanceEpilepsy is one of the most common neurologic disorders globally. Cannabidiol (CBD) has been approved for the treatment of epilepsy, but its use has been associated with several different adverse events (AEs).ObjectiveTo investigate the frequency and risk of AEs developing in patients with epilepsy who are using CBD.Data SourcesPubMed, Scopus, Web of Science, and Google Scholar were searched for relevant studies published from database inception up to August 4, 2022. The search strategy included a combination of the following keywords: (cannabidiol OR epidiolex) AND (epilepsy OR seizures).Study SelectionThe review included all randomized clinical trials that investigated at least 1 AE from the use of CBD in patients with epilepsy.Data Extraction and SynthesisBasic information about each study was extracted. I2 statistics were calculated using Q statistics to assess the statistical heterogeneity among the included studies. A random-effects model was used in cases of substantial heterogeneity, and a fixed-effects model was used if the I2 statistic for the AEs was lower than 40%. This study was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guideline.Main Outcomes and MeasuresFrequency of each AE and risk of developing each AE in patients with epilepsy using CBD.ResultsNine studies were included. Overall incidences of 9.7% in the CBD group and 4.0% in the control group were found for any grade AEs. The overall risk ratios (RRs) for any grade and severe grade AEs were 1.12 (95% CI, 1.02-1.23) and 3.39 (95% CI, 1.42-8.09), respectively, for the CBD group compared with the control group. Compared with the control group, the CBD group had a greater risk for incidence of serious AEs (RR, 2.67; 95% CI, 1.83-3.88), AEs resulting in discontinuation (RR, 3.95; 95% CI, 1.86-8.37), and AEs resulting in dose reduction (RR, 9.87; 95% CI, 5.34-14.40). Because most of the included studies had some risk of bias (3 raised some concerns and 3 were at high risk of bias), these findings should be interpreted with some caution.Conclusions and RelevanceIn this systematic review and meta-analysis of clinical trials, the use of CBD to treat patients with epilepsy was associated with an increased risk of several AEs. Additional studies are needed to determine the safe and effective CBD dosage for treating epilepsy.

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“…Moreover, four clinical trials in children with Dravet and Lennox-Gastaut syndromes showed a higher rate of seizure frequency reduction in CBD treated patients ( Lattanzi et al., 2019 ). A study from Pietrafusa et al. (2019) on artisanal medical CBD oil in patients with developmental and epileptic encephalopathy (DEE) suggest that CBD may have beneficial effects in patients with DEE and an acceptable safety profile.…”

Section: Purified Cannabidiol (Epidiolex/epidyolex ® mentioning

confidence: 99%

Cannabidiol Treatment for Refractory Epilepsies in Pediatrics

et al. 2020

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Cannabis extracts in oil are becoming increasingly available, and, during the last years, there has been growing public and scientific interest about therapeutic properties of these compounds for the treatment of several neurologic diseases, not just epilepsy. The discovered role of the endocannabinoid system in epileptogenesis has provided the basis to investigate the pharmacological use of exogenously produced cannabinoids, to treat epilepsy. Although, physicians show reluctance to recommend Cannabis extracts given the lack of high-quality safety available data, from literature data cannabidiol (CBD) results to be a promising and safe anticonvulsant drug with low side-effect. In particular, according to early studies, CBD can reduce the frequency of seizures and lead to improvements in quality of life in children affected by refractory epilepsy. So, for these reasons, the detailed study of the interactions between CBD and anticonvulsant drugs (AEDs) administered simultaneously in polytherapy, is arousing increasing interest, to clarify and to assess the incidence of adverse effects and the relation between dose escalation and quality of life measures. To date, in pediatric age, CBD efficacy and safety is not supported by well-designed trials and strong scientific evidence are not available. These studies are either retrospective or small-scale observational and only during the last years Class I evidence data for a pure form of CBD have been available, as demonstrated in placebo-controlled RCTs for patients affected by Lennox-Gastaut syndrome and Dravet syndrome. It is necessary to investigate CBD safety, pharmacokinetics and interaction with other AEDs alongside performing double-blinded placebo-controlled trials to obtain conclusive data on its efficacy and safety in the most frequent epilepsies in children, not just in the epileptic encephalopathy. This review was aimed to revise the available data to describe the scientific evidence for CBD in Pediatric Epilepsies.

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Purified Cannabidiol for Treatment of Refractory Epilepsies in Pediatric Patients with Developmental and Epileptic Encephalopathy

Cited by 21 publications

References 29 publications

Use of cannabidiol in the treatment of drug-refractory epilepsy in children and young adults: A systematic review

Use of cannabidiol in the treatment of drug-refractory epilepsy in children and young adults: A systematic review

Adverse Events of Cannabidiol Use in Patients With Epilepsy

Cannabidiol Treatment for Refractory Epilepsies in Pediatrics

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