For those adults treating with nonpsychoactive CBD, what dosage did you start with? Specifically for 22%/05% CBD/THC ratio with 22 mg dosage for 140 pound adult. How many doses per day to start and incremental increase over how much time? Thanks
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I would also appreciate some assistance. [email protected] Thank u
I would love some assistance as well. [email protected] Thank you
The person you need to be discussing this with is your neurologist. Mant people think that MJ can help a person with issues they have. Other people think it will get them high. Doctors will know dosages and can help a person get those set. Too much can be as harmful as too little when it comes to medications. MJ can be different so I won’t go into that. Contact your neurologist. Understand that he will need to know if you are doing this so if you have a seizure he can look at th ammount along with your regular AED in order to set dosage levels.
By the time the CBD dose was increased to 10–12 mg/kg/day, all participants -except for participant A-07, who had a normal background activity on the initial EEG– had an improvement in their EEG encephalopathy rating scale with most improving by one point on the rating scale. Participant A-03 had an improvement by two points. During the course of the study, three participants had an improvement in their EEG Spike Index scores. Participants A-03 and A-04 had resolution of their continuous spike activity in sleep. Full details of EEG results are provided in Supplementary Figures 2A,B.
The age-related developmental changes that influence drug PK and pharmacodynamics (PD) complicate the development of appropriate dosing regimens for pediatric age groups (6). Without an understanding of dose concentration-effect relationship, a dosing regimen is largely empirical and/or anecdotal, and fraught with potential safety concerns.
Although the reported improvement in seizure control and quality of life are promising, these findings must be interpreted with caution as there are several limitations in this preliminary report, in particular the small sample size and potential reporting bias inherent with open label studies. The lack of a placebo group and self-reporting of outcomes may limit the ability to discern any placebo effect which is seen in many drug trials. Reporting fatigue experienced by caregivers also may be a confounder, in particular for seizure frequency data.
Safety and Tolerability Outcome Measures
Escalating doses of CBD-enriched CHE from 2–3 mg/kg/day to 10–12 mg/kg/day resulted in no serious adverse events related to the CHE. Parents reported sleepiness/lethargy and irritability in most participants, but these side effects were assessed after starting the study drug and were likely pre-existing. Transient increases in sleepiness and irritability in three participants taking clobazam resolved after clobazam dose was decreased, suggesting these side-effects could be secondary to an interaction between the CHE and clobazam (14). Laboratory monitoring noted significant elevations in GGT, AST, and lipase levels in two participants, both of whom were also taking valproic acid. Participant A-03’s marked elevation of GGT was likely secondary to sepsis, which occurred during the study. Participant A-04’s transient and non-significant elevation of AST and significant elevation of lipase levels were likely secondary to a predisposition to hepatic and pancreatic dysfunction from high-dose valproic acid and corroborates observations reported elsewhere (3, 16). The fact that this participant had a preexisting elevated GGT suggests that liver enzymes should be screened prior to starting CHE, especially if the child is already prescribed valproic acid.
An “entourage” effect in which the clinical efficacy of cannabinoids when used in combination are greater than when used individually has been demonstrated in several animal models of epilepsy but has yet to be reported for human trials (25–27). While we saw clinical efficacy with regards to reduction in seizure frequency and improvements in QoL scores with CBD doses lower than those reported in studies using pharmaceutical grade CBD, the small number of participants reported require caution when interpreting the results and preclude drawing definite conclusions in particular with regards to possible entourage effect. Additionally, CARE-E was not designed to compare efficacy of CHE to pharmaceutical grade CBD. This can only be addressed in a head to head comparative study.
Seizures occurring in a cluster were counted as a single seizure due to challenges arising from caregivers individually recording each seizure within a cluster. The data from the seizure logs was entered into REDCap (9) at each visit and underwent an independent audit performed by the University of Saskatchewan Clinical Trial Support Unit. To allow for variations in the length between study visits, the average daily number of seizures between visits was calculated by dividing the number of seizures recorded between each visit by the number of days between visits.
At time of enrolment, all participants failed at least 2 appropriate anticonvulsants, and none were using the ketogenic diet or had a vagal nerve stimulator. All participants were fully compliant with all study protocols. Table 1 summarizes study participant characteristics. As per the publishing guidelines of this journal the participants’ gender is not included and age at recruitment is provided in ranges (1–3, 4–6, 7–10 years).