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While interesting, this anecdotal observation does not rise to the level of evidence needed to evaluate a potential new therapeutic modality. Gloss and Vickrey conducted a Cochrane systematic review of the use of CBD in the treatment of epilepsy Their methodology included only those trials that were randomized and controlled and excluded case series, case reports, and expert opinion. They were able to identify only 4 randomized controlled studies reported in the literature, and they included a letter to the editor and an abstract.
The total number of subjects enrolled in these studies was 48 11— While only four studies and a letter to the editor were in the actual analysis, the authors included a complete reference listing of all articles reviewed for inclusion. These reports suffered from a number of design flaws, including incomplete baseline quantification of baseline seizure frequency, indeterminate time periods for outcome determination and, in some cases, inadequate or missing statistical analysis—in general, a lack of sufficient detail to adequately evaluate and interpret the findings.
Limitations aside, several studies did report that administration of adjunctive CBD did not result in meaningful changes in seizure frequency 11— The second phase was also double-blinded in 15 patients with epilepsy receiving to mg daily of CBD or placebo for days. Patients continued baseline AED. All subjects tolerated CBD well, with no serious adverse events.
Three other patients receiving CBD had a partial reduction in seizures, and 1 subject had no response. Of the 7 patients receiving placebo, seizure frequency was unchanged in 6, and 1 had clear improvement in seizure control.
Using rigorous review methodology, Gloss and Vickery conclude that based on the low quality of the reports available, there is insufficient data available to draw any conclusions regarding the efficacy and or long-term safety of CBD in treating epilepsy From the data available, it does appear that daily doses of to mg were safe in this small group of patients for a short period of time CBD is well tolerated in humans with doses up to mg not resulting in psychotic symptoms In the few small placebo-controlled studies performed, no significant CNS effects were noted.
Following single doses in humans, the half-life of CBD when taken orally is about 1 to 2 days. Whether these in vitro observations are relevant at plasma concentrations likely to be seen in patients is unclear.
In addition, given its metabolism via CYP3A4, clinical trials of CBD in patients receiving enzyme-inducing AEDs, such as carbamazepine or phenytoin, will require detailed pharmacokinetic studies. A number of difficulties exist in evaluating published data on CBD or marijuana use for epilepsy. The extremely limited published studies were small, poorly described, and not well designed. Contributing to the difficulty of interpreting published studies, CBD products are not produced under the guidance of good manufacturing practices GMP and are not subject to regulations governing labeling, purity, and reliability.
In other words, currently, there is no guarantee of consistency between products, or even differing lots produced by the same manufacturer. Without independent testing e. USP certification of CBD products for content and purity, as well as bioavailability testing of specific products, uncertainty surrounds the use of available CBD products in routine clinical settings. At this time, there does seem to be a growing body of basic pharmacologic data suggesting there may be a role for CBD, especially in the treatment of refractory epilepsy.
However, given the lack of well-controlled trials, we must also ask if we are getting ahead of ourselves. Clearly, this is an emotionally and politically charged issue.
If this were any other uninvestigated pharmaceutical compound, would we feel as compelled to make the agent widely available before statistically valid class 1 evidence was available for review? Until data from well-designed clinical trials are available and reliable, and standardized CBD products that are produced using GMP are available, caution must be exercised in any consideration of using CBD for the treatment of epilepsy.
In the meantime, based upon promising preliminary data, further clinical research should be wholeheartedly pursued. Authors have a Conflict of Interest disclosure which is posted under the Supplemental Materials link. National Center for Biotechnology Information , U. Journal List Epilepsy Curr v. Author information Copyright and License information Disclaimer.
This article has been cited by other articles in PMC. Abstract Over the past few years, increasing public and political pressure has supported legalization of medical marijuana. Basic Pharmacological Mechanisms Cannabidiol pharmacological effects are mediated through G protein coupled receptors, cannabinoid type I CB 1 and cannabinoid type II CB 2 , which are highly expressed in the hippocampus and other parts of the central nervous system 2.
Evidence in Animal Models When administered alone, CBD is an effective anticonvulsant in maximal electrical shock MES , magnesium-free, 4-aminopyridine, and audiogenic models 7 , 8. Clinical Evidence in Epilepsy While animal experimental data clearly suggest a potential benefit, supportive clinical data are quite sparse.
Tolerability and Drug Interactions CBD is well tolerated in humans with doses up to mg not resulting in psychotic symptoms Conclusions At this time, there does seem to be a growing body of basic pharmacologic data suggesting there may be a role for CBD, especially in the treatment of refractory epilepsy.
Supplementary Material Click here for additional data file. Pharmacology and potential therapeutic role in epilepsy and other neuropsychiatric disorders. Cannabidiol displays antiepileptiform and anti-seizure properties in vitro and in vivo. J Pharmacol Exp Ther. Temporal characterization of changes in hippocampal cannabinoid CB 1 receptor expression following pilocarpine-induced status epilepticus.
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