Does CBD Oil Help Dysautonomia

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Many people assume CBD oil its "safe" simply because it's a natural substance. Research suggests that CBD can cause liver damage similar to conventional… Cannabidiol (CBD) can exert neuroprotective effects without being intoxicating, and in combination with Δ<sup>9</sup>-tetrahydrocannabinol (THC) CBD has shown to protect against THC psychosis. Acute concussion and post-concussion syndrome (PCS) can result in autonomic dysfunction in heart rate varia … The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children With Severe Epilepsy (CBD1) The investigators propose to study the effects of cannabidiol (CBD) on

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Many people assume CBD oil its “safe” simply because it’s a natural substance. Research suggests that CBD can cause liver damage similar to conventional medications. We encourage you to talk to your doctors about all treatments you are using. Please don’t assume things are safer simply because they are natural.

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Marijuana Study Finds CBD Can Cause Liver Damage

Although CBD is often revered as a miracle drug, a new study finds that it could be causing liver damage.

For the folks complaining that we shouldn’t post this, here are a few things we’d like you to know. It’s a bit of a long read, so find a comfy seat and kick up your feet.

If CBD has helped you, that’s great! We’re not opposed to the use of CBD or medical marijuana. We’ve asked the notable autonomic researchers to study the use of medical marijuana and CBD in people with autonomic disorders, and have encouraged them to submit grant applications on this topic. No takers yet.

We think it’s important for patients to work with their providers to come up with a treatment plan that is based on the current state of science. That includes understanding identified risks of any treatment, as well as the benefits.

There is a naive assumption by some people that “natural” always means “safe.” That is simply not true. We think it’s important for everyone to understand this. Any biologically active substance can have benefits and risks, and an informed patient would want to know about both.

Research has shown CBD can cause liver damage similar to conventional medications. That doesn’t mean “OMG, don’t take CBD!” We just want you to be aware of potential risks, and to talk to your doctors about all of the treatments you are using, because quite a few common drugs that rely on certain liver enzymes to metabolize may increase the risk of liver damage from CBD use.

Here are some resources for those who would like to read more on liver enzyme/CBD interactions:

1. Hepatotoxicity of a Cannabidiol-Ric h Cannabis Extract in the Mouse Model
https:// www.mdpi.com/ 1420-3049/24/9/ 1694/htm
This was one of the studies discussed in the Forbes article that seemed to irk a lot of people.

Some people noted the higher dose that the mouse received, suggesting this made it irrelevant to humans, who take a smaller dose. However, the journal article notes that the dose was based on allometric scaled mouse equivalent doses. Allometric dosing takes into account that the metabolic rate of an animal is based in large part on its body size. In other words, smaller animals=faster metabolic rate. Allometric dosing is often used in medical research involving animals. The researchers used mouse dosing allometrically equivalent to 5mg/kg human dosing, in their lowest dosing group (on the lower end of CBD dosing used in humans), up to 200mg/kg in their highest dosing group (on the higher end of what humans might take), and several dosing groups between 5-200mg/kg. There were different scientific reasons for each of these doses, which you can read about in the full journal article.

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Other people complained that the study is irrelevant because it was using the FDA approved form of CBD, Epidiolex. Nope, this study was not using Epidiolex. You can read about the process the researchers used to make their own CBD oil directly from cannabis plants in the journal article.

Other people complained that the study was funded by big pharma. You can read the funding sources for almost any research study at the bottom of the article. This article notes federal government funding from the NIH, funding from the American Association for the Study of Liver Diseases Foundation (which appears to be a legit charity for liver diseases), and the Arkansas Biosciences Institute (which appears to be funded by Arkansas tobacco settlement money, and led by university researchers from around the state).

2. Read Section 5.1, Hepatocellular Injury, from the package inset for the first FDA approved CBD product. https:// www.accessdata.f da.gov/ drugsatfda_docs/ label/2018/ 210365lbl.pdf

3. Effect of Cannabidiol on Drop Seizures in the Lennox–Gastaut Syndrome
https:// www.nejm.org/ doi/10.1056/ NEJMoa1714631?ur l_ver=Z39.88-20 03&rfr_id=ori%3 Arid%3Acrossref .org&rfr_dat=cr _pub%3Dwww.ncbi .nlm.nih.gov
Some of the data that lead to the first FDA approval of a CBD product comes from this study. “Elevations in liver aminotransferas e concentrations occurred in 9% of the patients who received cannabidiol.” The study used 10mg and 20mg per day dosing, and some of the patients in each dose level developed elevated liver enzymes. People in the control group did not. Some of the people who had elevated liver enzymes were on other medications, but importantly, some were not. Read the full article for details.

4. A Review of Human Studies Assessing Cannabidiol’s (CBD) Therapeutic Actions and Potential.
https:// www.ncbi.nlm.nih .gov/pubmed/ 30730563
After a detailed discussion of liver enzymes impacted by CBD and known drug interactions with CBD, the pharmacologist author of this July 2019 CBD review article notes, “The potential for so many drug interactions makes patient use of CBD without input from a health care professional risky.”

5. Paradoxical Patterns of Sinusoidal Obstruction Syndrome-Like Liver Injury in Aged Female CD-1 Mice Triggered by Cannabidiol-Ric h Cannabis Extract and Acetaminophen Co-Administrati on
https:// www.mdpi.com/ 1420-3049/24/12/ 2256/htm

6. Pharmacokinetic s, Safety, and Clinical Efficacy of Cannabidiol Treatment in Osteoarthritic Dogs https:// www.frontiersin. org/articles/ 10.3389/ fvets.2018.00165 /full
Discussing an increase in alkaline phosphatase in dogs after four weeks of 2mg/kg dosing of CBO oil.

7. Trial of Cannabidiol for Drug-Resistant Seizures in the Dravet Syndrome
https:// www.nejm.org/ doi/full/ 10.1056/ nejmoa1611618

8. Long‐term cannabidiol treatment in patients with Dravet syndrome: An open‐label extension trial
https:// onlinelibrary.wi ley.com/doi/ full/10.1111/ epi.14628

9. MedlinePlus is a resource from the US National Library of Medicine: “Signs of liver injury have also been reported in some patients, but this is less common [than other side effects].” https:// medlineplus.gov/ druginfo/ natural/ 1439.html

There are numerous other peer-reviewed journal articles discussing potential risks and benefits of CBD. PubMed.gov is a good place to find free journal abstracts, and sometimes full journal articles.

Bottom line. if you’re taking CBD or thinking about taking it, you should know about this potential risk, and you should talk to your doctor about all of the treatments you are using.

Effects of phytocannabinoids on heart rate variability and blood pressure variability in female post-concussion syndrome patients: case series

Cannabidiol (CBD) can exert neuroprotective effects without being intoxicating, and in combination with Δ 9 -tetrahydrocannabinol (THC) CBD has shown to protect against THC psychosis. Acute concussion and post-concussion syndrome (PCS) can result in autonomic dysfunction in heart rate variability (HRV), but less information is available on blood pressure variability (BPV). Furthermore, the effects of phytocannabinoids on HRV and BPV in PCS are unknown. The purpose of this study was to observe the influence of daily administration of CBD or a combination of CBD and THC on HRV and BPV parameters in four female PCS participants. Participants completed a seated 5-min rest followed by six breaths-per-minute paced breathing protocol. Data was collected prior to phytocannabinoid intake and continued over 54 to 70 days. High frequency systolic BPV parameter increased every assessment period, unless altered due to external circumstances and symptoms. HRV parameters showed less consistent and varying responses. These results suggest that CBD can help to improve the altered autonomic dysfunction in those with PCS, and that responses to the drug administration was individualized. Double blinded, randomized controlled trials with greater sample sizes are required to better understand the influences of the varying dosages on human physiology and in PCS.

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Keywords: blood pressure variability; cannabidiol; commotion cérébrale; concussion; post-concussion syndrome; syndrome post-commotion cérébrale; variabilité de la tension artérielle.

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The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children With Severe Epilepsy (CBD1)

The investigators propose to study the effects of cannabidiol (CBD) on cardiac electrical function and the autonomic nervous system in children with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS), when the CBD is administered as an artisanal oil obtained through state dispensaries or other sources. The intent is to begin to assess potential risks and benefits of this therapy in a vulnerable patient population by characterizing the effects of CBD on EKG findings, heart rate variability and the occurrence of seizures.

Condition or disease Intervention/treatment Phase
Lennox-Gastaut Syndrome Dravet Syndrome Procedure: 12-Lead ECG Drug: Cannabidiol Phase 1 Phase 2

Specific Aims/Study Objectives

This is a pilot study to explore the effects of cannabidiol (CBD) on autonomic cardiac function in children with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS) when the CBD is administered as an artisanal oil. This will be achieved by addressing the following specific aims.

Aim #1: To determine the effects of CBD on cardiac function in 30 children with DS and LGS. This is the primary aim of the study: The effects of CBD on the cardiac function of 30 children with DS or LGS will be assessed using a 15-lead electrocardiogram (EKG) and a 24-hour Holter monitor. Investigators hypothesize that there will be no alterations in ventricular repolarization and heart rate variability on the EKG and Holter monitoring, respectively, after taking CBD for 4-8 weeks, compared to when participants were not taking CBD.

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Note: The following aims are secondary to the primary outcome and goal of assessing the effects of CBD on cardiac function.

Aim #2: To assess signs and symptoms of dysautonomia in the presence and absence of CBD. Signs and symptoms of dysautonomia include parental perception of body temperature, skin color in hands and feet, sweating, pupil size, flushing, feeding issues, heart rate, strong emotions, constipation, urination or bowel movement issues, and irritability. These signs and symptoms will be collected using a previously-established dysautonomia survey. Investigators hypothesize there will be no change in qualitative assessments of signs and symptoms of dysautonomia after taking CBD for 4-8 weeks, compared to when participants were not taking CBD.

Aim #3: To determine the effects of CBD on the occurrence of seizures. The number of seizures in children who obtain CBD will be assessed using a 7-day seizure diary (Seizure tracker). Caregivers will record the number of seizures for a 7-day period prior to CBD administration, and repeat the seizure tracking after having received CBD for 4-8 weeks. Change in seizure numbers will be compared pre- and post-CBD administration. Investigators hypothesize that study participants will have lower seizure counts after being on CBD compared to when weren’t taking CBD.

Study Design and Methodology

Study Design: Thirty patients with DS or LGS who are going to register to take medical cannabis (cannabidiol, or CBD) in the state of Minnesota will be offered the opportunity to participate in this study. If consent is obtained, the patient or guardian will be asked to complete a questionnaire developed for this study that documents observable signs and symptoms of dysautonomia, and to complete a seizure diary for 7 days prior to initially receiving the CBD. Each participant will also have a 15-lead electrocardiogram (EKG) and wear a 24-hour Holter monitor, both non-invasive measures of cardiac function, prior to being administered the CBD. The EKG and 24-hour Holter monitor will be interpreted by a cardiac electrophysiologist and will be reviewed for heart rate variability parameters. The dysautonomia questionnaire, seizure diary and cardiac measurements will be repeated 4-8 weeks after the subject has been on a stable regimen of CBD. This time-frame is based on availability of subjects schedules and clinic visits, and it is also greater than 5 half-lives previously reported for CBD (apparent half-life, 21 hours, (15)). Steady-state levels are achieved after 5 half-lives of drug dosing, thus we expect to be at steady-state concentrations.

Subjects who are already on a stable regimen of CBD, yet plan to stop taking CBD at some point for some reason, are also eligible to participate. The parent or guardian will complete the dysautonomia questionnaire and seizure diary (and research staff will be available to help with questions), and the patient will have the 15-lead EKG and 24-hour Holter monitor while still on the CBD. The subjects will then come back 4-8 weeks after their last dose of CBD to have these assessments repeated while off of the CBD. This time frame is based on availability of subjects schedules and clinic visits as well as being substantially greater than 5 half-lives of CBD, the standard wash-out period for pharmacological studies.

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