Saturday, June 1, 2019

Life with Chronic Conditions: CBD Oil


Does it seem like everywhere you turn there are stores, friends and articles promoting cannabidiol (CBD)? 

In the last few weeks I had a friend ask if it would be good for his arthritis because his pharmacist friend said it helped him. Others have told me it had done wonders for their dogs.

CVS is now carrying CBD products (creams, sprays and lotions) from Curaleaf Holdings in 800 stores in eight states (Alabama, California, Colorado, Illinois, Indiana, Kentucky, Maryland and Tennessee). Walgreens is following CVS’s lead and will sell CBD infused products in 1,500 stores in nine states (Oregon, Colorado, New Mexico, Kentucky, Tennessee, Vermont, South Carolina, Illinois and Indiana).

The FDA held its first public hearing on CBD to help to better regulate CBD products this past week. The take home message from the hearing appears to be the public wants CBD products and too many manufacturers are delivering shoddy goods.  5 Take aways From the FDA’s Hearings on CBD.

So is there science to back up the hype?

What is CBD?
The second most active ingredients of cannabis (marijuana), it is derived from the hemp plant and it does not cause a “high.” CBD can have no more than 0.3% THC (tetrahydrocannabinol the active ingredient in cannabis), while medical marijuana oil may contain up to 5%.

In the late 19th century, cannabis was an important component of British and American physicians’ pharmacopoeia. It’s suspected that the cannabis of this era, and the tinctures made from them, probably contained much more CBD than modern varieties.

Are there proven health benefits?
CBD has been shown to treat some severe childhood epilepsy syndromes. The FDA has approved the first cannabis derived drug for this condition, Epidiolex, which contains CBD.

A double-blind placebo-controlled study published on May 21, 2019 in the American Journal of Psychiatry demonstrated that Epidiolex can reduce cue-induced craving in individuals that had been former heroin users. Furthermore, in these individuals, the drug reduced reports of anxiety, and blood levels of cortisol, a hormone known to increase under conditions of stress and anxiety.

Zynebra Pharmaceuticals recently tested a topical CBD product for osteoarthritis knee pain with mixed results. The Phase 2 clinical study did not meet its primary endpoint of reducing the average pain score, although there were some indications it improved function and reduced pain severity.

A small clinical trial of CBD for Crohn’s disease in Israel in 2017 was also negative, finding “CBD was safe but had no beneficial effects.”

A recent review of studies on CBD oil and other forms of cannabis for the management of neurologic disorders was more positive, finding “there is strongest evidence to indicate benefits in treatment of spasticity and neuropathic pain in multiple sclerosis.”

Animal studies suggest that CBD might be beneficial for some conditions including pain, inflammation, arthritis and anxiety. Note that there is a big difference between animal studies and clinical trials on humans. Some organizations and promoters of CBD refer to “studies” without noting these involved animals. This is the case for Does CBD Oil Really Help Treat Arthritis Pain? April 14, 2019 from the Rheumatoid Arthritis Support Network   

There is a growing body of scientific literature critically assessing the validity of animal experimentation and raises important concerns about its reliability and predictive value for human outcomes and for understanding human physiology. In short, just because it worked in an animal model doesn’t mean it will be equally successful in humans.

However, there are studies underway where CBD is being evaluated for a range of conditions including: addiction, Parkinson’s Disease, schizophrenia, diabetes, MS, autism, cancer, graft-host disease, anxiety and more.

If you are wondering how one product could be such a miracle cure, the author of the recent NY Times Magazine article asked the same question.

How could one family of molecules help so many maladies? The most obvious response is that they might not; all this research is preliminary and might not pan out. But scientists often propose a counter-explanation: Many chronic disorders, even though they seem distinct, are characterized by dysfunction in the same few pathways. Inflammation and oxidative stress, for example, occur in schizophrenia, metabolic disorders, heart disease and other ailments..... There are other examples of a single drug being able to help meliorate a variety of conditions. We know aspirin as a treatment for fever and headache, for example, but in low doses it is also used to reduce the risks of stroke, heart attack and pre-eclampsia in pregnant mothers; it even figures as an adjunct treatment for schizophrenia. Aspirin has its own downsides — an elevated risk of bleeding, for instance — but like CBD, its broad utility may be partly explained by its anti-inflammatory effects. New York Times

Risks?
Though it's often well-tolerated, CBD can cause side effects, such as dry mouth, diarrhea, reduced appetite, drowsiness, difficulty with sleep, weight loss, stomach pain or discomfort, drooling or excessive saliva, problems with walking and fatigue.

CBD can also interact with other medications, primarily those that are changed or broken down by the liver. Medline lists a number of drugs that can interact with CBD including: blood thinners, codeine, Paxil, ibuprofen, Celebrex, Elavil, Prevacid, Valium Priolosec, testosterone, Allegra, morphine and various other drugs, plus possibly caffeine, nicotine, vitamins and nutrional supplements

In addition there are legal issues in some states, but most importantly is the quality control of the product itself. In 2015, the FDA found that many CBD labeled products, actually contained very little CBD. Two years later, a study published in JAMA documented that in 84 products sold online, 26% had less CBD than advertised and 43% had more. As noted above, this was a major issue discussed at yesterday's FDA hearing on CBD.

A significant safety concern with CBD is that it is primarily marketed and sold as a supplement, not a medication, which means it’s not regulated by the FDA. In addition to not knowing therapeutic doses for various conditions, it’s difficult to know exactly how much CBD you are actually getting in a product and if there are additives that could be problematic.

Legality
The 2018 Farm Bill was signed into law in December 2018, effectively legalizing hemp at the federal level by removing it from the federal list of controlled substances and classifying it as an agricultural commodity. As a result, CBD from hemp is legal nationwide at the federal level.

Just this week the Transportation Security Administration has changed its cannabis policy to allow passengers to travel with Epidiolex, the FDA version of CBD that is used to treat epilepsy in children, as well as some CBD oil, "as long as it is produced within the regulations defined by the law" under the 2018 Farm Bill, which legalized hemp and hemp derivatives. The TSA's new rules still ban other forms of marijuana, including CBD oils that have THC, and cannabis-infused products that are still illegal under federal law.

All 50 states have laws legalizing CBD with varying degrees of restriction. You will need to do the research to see how it applies to the state you live in.

Considering CBD?
Be aware that wild claims, such as an effective cancer treatment, are just plain bogus. While more research is needed in humans, there are indications that CBD may be a useful treatment for managing anxiety, insomnia and chronic pain. That said, science needs to be the driving force behind new treatments, not a marketing campaign. People with chronic conditions are often targeted by marketers, so buyer be ware.

Before trying CBD, it’s imperative that you talk to your medical provider in order to understand drug interactions with current treatment regiments. Talk with them about dosing and the most reliable source possible for purchasing CBD. Finally, there are CBD clinical trials that are open and seeking patients. Check https://clinicaltrials.gov to see if you qualify.

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