Parental reporting of response to oral cannabis extracts for treatment of epilepsy

In reality CBD oil doesn't work any better than a placebo and there is a large risk it makes the problems even worse.
Highlights from this study from the Department of Pediatrics and Neurology, Children's Hospital Colorado and the University of Colorado, Anschutz Medical Campus:

•Parents in our study reported a 33% response to OCE*.
•The response rate is similar to previously reported placebo response rates.
•Reported response was not correlated with improved background EEG data.

Adverse events (AEs) occurred in 47% of patients with increased seizures (transient or persistent) or new seizures in 21%.


* There was a huge bias, parents that moved to CO to get OCE reported a 47% response but parents originally from CO only a 22% response.

Interesting info.

So many variables

Why are you misrepresenting the findings?

Bubbleblower said:

•Parents in our study reported a 33% response to OCE*.

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Wrong. 57% reported an improvement in seizure control and 33% reported a >50% reduction in seizures

Bubbleblower said:

•The response rate is similar to previously reported placebo response rates.

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Nope. The response rate for the placebo was 15%.

Bubbleblower said:

Adverse events (AEs) occurred in 47% of patients with increased seizures (transient or persistent) or new seizures in 21%.

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You're misrepresenting the stats yet again. There was only a 13% occurrence of increased seizures.

Also in that study it shows that the response rate for those with Lennox-Gastaut Syndrome (LGS) was 88.9%.


btw- the study was for all forms of OCE and not just CBD and the response rate for those using only a THCA OCE was 0% while the response rate for those using CBD and another OCE was 63%. The Entourage Effect FTW!

Also from the study

Many of the families reported improvements in behavior, alertness, language, and motor skills, despite a limited improvement in seizures. The etiology for this improvement is unclear. Many families reported improved sleep, which may have a wide range of effects in a variety of behavioral and cognitive domains [11]. It will be important in further clinical trials to obtain objective assessments of sleep, cognition, and attention. It may be that OCEs have other significant clinical benefits regardless of an effect on seizure frequency

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Our retrospective study of OCE use in pediatric patients with epilepsy demonstrates that some families reported patient improvement with treatment; however, we also found a variety of challenges and possible confounding factors in studying OCE retrospectively in an open-labeled fashion. We strongly support the need for controlled, blinded studies to evaluate the efficacy and safety of OCE for treatment of pediatric epilepsies using accurate seizure counts, formal neurocognitive assessments,
as well as EEG as a biomarker. This study provides Class III evidence that OCE is well tolerated by children and adolescents with
epilepsy.

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You mean the Department of Pediatrics and Neurology, the Children's Hospital Colorado and the University of Colorado, Anschutz Medical Campus as well as the American Epilepsy Society are all misinterpreting their stats???
Have you contacted them yet to point that out?


This is cut and paste from the abstract on the American Epilepsy Society's site;

Results:
Fifty-eight patients were identified. 28 were male (48.3%), 23 had moved to CO to obtain OCE (39.7%). The average age was 7 years (6 months to 23 years) when starting OCE. Of the 58 patients, 28 (48.3%) reported any improvement in seizures and 18 (31.0%) reported a >50% reduction in seizures and were considered treatment responders. If the family had moved to CO for OCE this increased the responder rate to 52% vs. 17% if the family had established care in CO (p<0.01). Treatment responder rate varied, though not achieving statistical significance, based on epilepsy syndrome: Dravet 27%, Doose 0%, LGS 80% and other 30% (Table 1). Of the 16 patients with an electroencephalogram (EEG) prior to and during OCE treatment, only 2 (12.5%) had an improvement in their interictal EEG background. None of the 4 responders with EEG data had any improvement in their interictal EEG. When comparing various reported strains of OCE (i.e. Cannabidiol, Tetrahydrocannabinol) there was no difference in response rate. Many of the families reported benefits outside of seizure frequency including improved behavior/alertness (29%) and improved language (i.e. now using three words) (10%). Adverse events (AEs) occurred in 47% of patients with increased seizures (transient or persistent) or new seizures in 21% with somnolence/fatigue in 14% and rare adverse events of developmental regression (2), new choreiform movements (2), transient hemiparesis (1), status requiring intubation (1), and death (1).

Conclusions:
In this retrospective cohort, less than 1/3 of patients had a >50% reduction in seizure frequency in response to OCE by parental report, and these responses were not associated with a change in interictal EEG. Notably, families who moved to CO for OCE were 3 times as likely to report a >50% seizure reduction than families with established care in CO. Additionally, many of the families reported improvements in behavior, level of alertness, and language. AEs were generally mild; however, rare severe AEs did occur. These findings highlight the need for controlled studies to evaluate the efficacy and safety of OCE for treatment of pediatric epilepsies.


These are the complete highlights from the other group according to the researchers;

• Parents in our study reported a 33% response to OCE.
• Relocating to Colorado had a significant effect on response rates.
• The response rate is similar to previously reported placebo response rates.
• Reported response was not correlated with improved background EEG data.
• Parents reported a variety of additional benefits of OCE and adverse reactions.

In this group none of the responders with EEG data had any improvement in their interictal EEG either.

Here's more recent and larger study published by the American Epilepsy Society
https://www.aesnet.org/meetings_events/annual_meeting_abstracts/view/2414222

RESULTS:
261 patients received at least 3 months of treatment and had available data at last group data collection (136 (52%) were male; average age 11.8 years, range 4 months-41 years; average weight 38 kg; range 6.4-127). The most common diagnoses were DS (44; 17%) and LGS (40; 15%). The average # of concomitant AEDs was 3.0. After 3 months of therapy, the median overall seizure frequency reduction was 45.1% in all patients and 62.7% in DS patients. For LGS patients, the median reduction of atonic seizures from baseline was 71.1%. Among all patients, 47% had a ≥50% reduction in seizures. Seizure-freedom at 3 months occurred in 9% of patients and 13% of DS patients. Clobazam co-therapy was associated with a higher rate of treatment response (≥50% convulsive seizure reduction): 57% v. 39%; this may reflect elevations in the desmethyl clobazam metabolite. Safety data from 313 patients representing 180 patient years was available at 16 sites. Adverse events in ≥10% of patients included somnolence (23%), diarrhea (23%), fatigue (17%), decreased appetite (17%), convulsions (17%) and vomiting (10%). 14 patients (4%) had an adverse event leading to discontinuation of CBD. 36 patients (12%) withdrew primarily due to lack of efficacy. Serious Adverse Events (SAEs) were reported in 106 patients (34%), including 7 deaths, none of which were considered treatment-related. 16 patients (5%) had SAEs that were considered treatment-related, including altered liver enzymes (4 pts; all were also on valproate and clobazam), status epilepticus/convulsion (4), diarrhea (4), decreased weight (3), thrombocytopenia (1), and others.

CONCLUSIONS:
These results from an uncontrolled study support the animal studies and prior reports showing that CBD may be a promising treatment for TRE and it is generally well-tolerated in doses up to 25mg/kg/day. Epidiolex is now being investigated in randomized controlled studies in DS and LGS.

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Yes the efficacy gets higher with more THC, that is exactly my point.

No, compare the results of using CBD only and THCA only in the table found in your OP's PDF.

Your point has been that CBD is medicinally useless but that's not what the newer studies are finding. A mixture of Cannabinoids including CBD is proving to be most effective in a large variety of situations.

ECtraveler said:

Your point has been that CBD is medicinally useless

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Please, I have never said that.
CBD is great if it's well balanced like in the excellent hasj we have here.
High CBD strains however, typically low in terpenoids and dominated by myrcene, are crap.

You are right it's all about the entourage effect, the broader and richer the spectrum the better.
It's not all about one single magic molecule the pharmaceutical maffia can patent.

Speaking of the devil, that study is flawed because in 3 months time many people leave due to lack of efficacy,
adverse events or in more than 2% of the cases even because of death.
Good riddance from their POV, good for their numbers and shareholders value.

i'm pretty sure you are both making the same argument with different details and opinions (of course).

ime; the CBD strains i have grown have not (all) been low in terps, and certainly were very unique from one another in terms of their terpenoid profiles; harlequin, sour tsunami, sour tsu x cannatsu, r4, sour tsu x scotts ogk, otto.

I guess I'm having trouble seeing your point Bubbleblower.

I can speak with some authority on the subject of epilepsy and Cannabis. I'm 70. I have epilepsy and Cannabis can stop my seizures. But it is not a straightforward issue. I'm still experimenting and there are still problems. Issues unresolved are the best mix of Cannabinoids, best method of use (I use an ethanol tincture), and duration of the protective effect.

I don't think this bit of survey research can prove anybody's political point. As far as I can tell it does not address any of the above issues. How a kid's parents use the plant or commercial derivations must vary widely. Dealing with a seizure is hard enough for an adult who doesn't have one of these extreme childhood syndromes. For a parent with a kid having seizure after seizure trying to keep them down it must be near impossible.

As an example, I indirectly scored a little bottle of a product called VPA Cannabidiol, in a sticky glycerine medium. It's useless for me. Supposedly contains 8.5 milligrams of Cannabidiol and 4.25 milligrams of THC per "serving" which is two droppers. I think someone who bought this product for their kid getting multiple seizures a day would also find it useless. Does this prove anything? I don't think so.

I major conclusions they are drawing are all positive from my perspective. They state that Oral Cannabis Extracts are well tolerated in children, they have rare occurence of adverse effects, and that double blind clinical trials are needed. All positive to me.

This is one interesting study. Small number of patients.

I'm always cautious of these Western medicine type studies of single molecule extract, in this case CBD. It's widely agreed-upon that natural whole cannabis works well on many conditions because of the synergistic effects of hundreds of different cannanbinoids and terpenes.

For my problems like asthma and chronic athritis pain I've found that by experimenting with different strains I discovered the best ones for each problem.

That's how herbal medicine works. It's hard to shoe-horn it into the constraints of a typical Western one-chemical, double-blind study. The chemical is pure! No doubt. Pharma/Rockefeller system loves VERY pure extracted molecules. But that's not how traditional herbal medicine works at all.

e.g. a pure shot of CBD extract isn't what Jesus used to cure the people of seizures in bible history. It was an oil of whole cannabis and several other herbs. Chinese herbal medicine doesn't extract single molecules out of plants.

What a fascinatingly useless study.

IMHO, you can bitch and point fingers and interpret any statistic to represent either side of any issue all you want. But the simple fact is that there is proven merit in the medical effectiveness of cannabis in epilepsy treatment, as well as many other human maladies, and that in itself merits further study. I get so sick of reading these Debbie Downer negative bullshit posts. This is NOT political football issue to be kicked around. We are talking quality of life and helping sick get better. Case closed.