Study Finds CBD Ineffective for Chronic Pain

By Pat Anson, PNN Editor

There is little evidence that cannabidiol (CBD) products relieve chronic pain and some could be potentially harmful to patients, according to UK and Canadian researchers.

CBD is one of the chemical compounds found in cannabis, but it doesn’t have the same intoxicating effect as tetrahydrocannabinol (THC), the psychoactive ingredient in marijuana. Often marketed as a pain reliever, CBD can be purchased in edibles, beverages, lotions, oils and other products, usually without a prescription.  

“CBD presents consumers with a big problem,” says lead author Chris Eccleston, PhD, Professor of Pain Science at the University of Bath in the UK. “It’s touted as a cure for all pain but there’s a complete lack of quality evidence that it has any positive effects.

“There should be no excuses for misleading the public, and yet it is likely that the public is being misled and possibly placed in harm’s way.”

Eccleston and his colleagues reviewed the results of 16 high-quality clinical trials of CBD products, involving over 900 participants. Their findings, published in in The Journal of Pain, show that CBD provided little or no pain relief in 15 of the 16 studies. The one small trial that did showed improvement in arthritis pain after two weeks of treatment with a topical CBD lotion.

Just as concerning to researchers is that many CBD products sold directly to consumers have significantly more or less CBD than what their labels indicate. Some CBD products also contain THC, when they weren’t supposed to have any.

“There is no good reason for thinking that CBD relieves pain, but there are good reasons for doubting the contents of CBD products in terms of CBD content and purity,” Eccleston wrote. “Regulatory authorities should also take note of the considerable deficiencies existing in the products sold, especially the incorrect labeling of many products, and possible contamination with psychoactive compounds.”

The researchers say regulators in the US, UK and Canada are often slow to respond to the false medical claims of some CBD manufacturers. The FDA occasionally sends warning letters to companies making unsubstantiated claims about CBD, but it rarely results in fines or disciplinary action.

“What this means is that there are no consumer protections,” said co-author Dr Andrew Moore, Director of Pain Research at the University of Oxford. “And without a countervailing body to keep the CBD sellers in check, it’s unlikely that the false promises being made about the analgesic effects of CBD will slow down in the years ahead.”

In a recent review, the FDA said there was “credible scientific support” for cannabis as a pain reliever and recommended that the DEA reschedule it as a Schedule III controlled substance. Such a move would make it legal under federal law for cannabis to be prescribed for medically approved conditions, but would have no impact on CBD products.

In 2022, FDA Commissioner Dr. Robert Califf asked Congress to give his agency the authority to more closely regulate CBD, but no such legislation has been passed. Eccleston says its part of a pattern in which pain sufferers are neglected and left on their own to find relief.

“It’s almost as if chronic pain patients don’t matter, and that we’re happy for people to trade on hope and despair,” he said.

CBD Ineffective for Osteoarthritis Knee Pain

By Pat Anson, PNN Editor

Cannabidiol (CBD) is often touted as an effective pain reliever for arthritis. Studies on animals and anecdotal reports from humans suggest that CBD – the non-psychoactive compound in cannabis -- has anti-inflammatory and pain-relieving effects on joint pain.

But in one of the first randomized, placebo-controlled clinical trials of CBD, researchers at Medical University of Vienna found that CBD is not an effective pain medication for knee osteoarthritis, even at high doses.

The study included 86 men and women who suffered from severe pain due to knee osteoarthritis,  a progressive condition caused by the breakdown of joint cartilage.in the knee. About 10 percent of people over age 60 have knee osteoarthritis (OA).

Half the participants received daily doses of CBD in capsules for eight weeks, titrating up to 600mg per day, which is considered a high dose. The other participants were given placebo capsules with no active ingredient. Neither group knew what they were taking.

The study findings, published in The Lancet Regional Health -- Europe, show that CBD did not have a stronger analgesic effect than the placebo. Adverse events were more common in the CBD group, with over half the participants (56%) reporting diarrhea, abdominal pain, fatigue and other mild side effects.

“Our results do not support the yet clinically unproven hopes for CBD as potential supplement or even replacement of potent analgesics, including opioids,” wrote lead author Sibylle Pramhas, MD, Department of Special Anesthesia and Pain Medicine at MedUni Vienna.

"Our study is the first to provide solid information on the lack of analgesic potential of CBD in a common chronic pain condition, due to the comparatively high oral dosage and the long observation period.”

This isn’t the first time CBD came up short in a clinical study. In 2017, Zynebra Pharmaceuticals tested a CBD gel for knee OA with mixed results. The Phase 2 study did not meet its primary goal of reducing the average pain score, although there were some indications the gel improved function and reduced pain severity. The company has since abandoned plans to use the gel for arthritis pain.

A more recent study of a CBD patch for knee osteoarthritis was withdrawn due to “inadequate funding.” Several other clinical studies of CBD for OA pain are underway or recruiting participants, but no results have been posted.

Currently, osteoarthritis knee pain is treated with analgesics such as acetaminophen (paracetamol), diclofenac, ibuprofen or tramadol. For the time being, they may be the best alternatives for pain relief.   

"CBD is not an alternative for pain therapy for osteoarthritis of the knee, so the search for more effective options must continue," says Pramhas.

Smoking Marijuana More Effective Than CBD Extracts for Back Pain

By Pat Anson, PNN Editor

One of the reasons many medical marijuana users prefer edibles over smoking is that they are perceived as healthier.  Marijuana smoke contains many of the same chemicals and carcinogens as cigarette smoke, and could have harmful effects on people with respiratory or cardiovascular problems.

But a small new study conducted in Israel found that smoking marijuana is better than ingesting it, at least when it comes to treating chronic lower back pain. Researchers enrolled 24 adults with MRI or CT scans that showed evidence of disc herniation or spinal stenosis, and had them try two different types of cannabis treatment.

The first was a cannabis extract rich in cannabidiol (CBD), which was taken sublingually under the tongue daily for 10 months. After a month of no treatment, the same group smoked cannabis flowers rich in tetrahydrocannabinol (THC) up to four times a day for 12 months. Participants were allowed to take pain medication as needed, including oxycodone and acetaminophen.

The study findings, published in the Rambam Maimonides Medical Journal, showed there was little to no improvement in back pain when participants took the extract, but significant improvement when they smoked cannabis. The use of analgesic drugs also dropped significantly while smoking.

Notably, three patients dropped out of the extract phase of the study because it wasn’t helping them, but then returned to participate in the smoking phase.

“The current study is the first, to our knowledge, to indicate that THC-rich smoked therapy is more advantageous in ameliorating LBP (lower back pain), than low THC CBD-rich sublingual extracts. Despite the small number of patients, our data indicate that THC-rich smoked therapy is helpful in mitigating LBP,” researchers reported.

The most commonly reported adverse events during the study were nausea, dizziness, drowsiness and fatigue during the extract phase; sore throat and drowsiness were reported during the smoking phase. All of the adverse symptoms disappeared after a dose tolerance was reached. Most of the adverse effects were in female patients.

A 2019 study of medical marijuana users also found that smoking cannabis provided more pain relief than ingesting it. Over 3,300 people logged their symptoms on a mobile app while using a variety of cannabis products, including dried flower, edibles, tinctures and ointments. Smoking the dried flower provided more pain relief than any other cannabis product, regardless of the amount of THC.

Another problem with CBD edibles is that they are frequently mislabeled. A recent study of 80 CBD oils found that only 43 had concentrations of cannabidiols that were within 10% of their label claims – an accuracy rate of just 54 percent.

Heavy Metals and Plastic Residue Found in Many CBD Products

By Pat Anson, PNN Editor

Yet another study has found evidence that cannabidiol (CBD) products are frequently mislabeled, with over half of the edibles and topicals tested containing significantly more or less CBD than their labels indicated. Researchers at the University of Miami School of Medicine also found that many CBD products are contaminated with low-levels of heavy metals and plastic chemicals.

“Because the cannabis plant is recognized as a bioaccumulator, which is highly effective at absorbing and retaining contaminants (e.g., heavy metals) in soil, it is important to characterize the degree of contamination in CBD products and their label accuracy to better estimate potential health benefits and risks associated with consumption,” researchers explained in the journal The Science of the Total Environment. 

Investigators analyzed 516 CBD products that were purchased online or at retail stores and had them tested at Ellipse Analytics in Denver. About a quarter of the CBD products were edibles.

Less than half of all the products tested had CBD concentrations within 10% of their label claims. Forty percent of the products contained significantly less CBD than claimed by the manufacturer, while 18% contained significantly more CBD.

Of the edible products analyzed, 42% tested positive for the presence of lead, 37% tested positive for mercury, 28% tested positive for arsenic, and 8% tested positive for cadmium. Most contained only trace amounts of heavy metals, but four edibles had lead levels that exceeded California’s recommended limit for daily lead consumption.

THE SCIENCE OF THE TOTAL ENVIRONMENT

Many of the edibles also contained low levels of plastic chemicals – known as phthalates – that are designed to make plastics more flexible. Phthalates leach off plastic and have become pervasive in the air, soil and water. Some phthalates have affected the reproductive systems of animals, although their impact on human health is not clear.

The percentage of CBD edibles with detectable phthalate concentrations ranged from 13% to 80% across four phthalates, with DEHP being the most prevalent. DEHP has been linked to cancer, birth defects and other reproductive harm. Federal law prohibits the manufacture and sale of children’s toys and child care products containing DEHP at levels greater than 0.1%. 

“Low-level contamination of edible CBD products with heavy metals and phthalates is pervasive. There is substantial discrepancy between the product label claims for CBD potency and the amount measured in both edible and topical products, underscoring the need for tight regulations for CBD product label integrity to protect consumers,” researchers concluded.

“Given that the consumer demographic purchasing CBD products includes those afflicted with pain, insomnia, anxiety, and other health conditions, these findings could give consumers and medical practitioners hesitation about the benefits and potential harm of CBD use.”

The study was funded by Jazz Pharmaceuticals and the Clean Label Project, a non-profit that seeks to improve food and consumer product labeling.

Previous studies have also found that many CBD products are mislabeled. A recent study at the University of Kentucky College of Medicine found that only half of the CBD oil products had concentrations of cannabidiols that were within 10% of their label claims. Researchers also found that most CBD oils contained trace amounts of THC (tetrahydrocannabinol), the psychoactive substance in cannabis, including some oils that were labeled "THC Free."

New CBD Drug Developed for Postoperative Pain

By Pat Anson, PNN Editor

An investigational drug containing a fast-acting formula of cannabidiol (CBD) reduced postoperative pain in patients after shoulder surgery, according to small new study.

Patients who took ORAVEXX tablets after minimally invasive rotator cuff surgery had an average of 23 percent less pain after the first day of surgery than those taking a placebo, according to researchers at NYU Langone Health. The tablets are designed to quickly dissolve in the mouth and the CBD absorbed into the bloodstream in less than 3 seconds.

“There is an urgent need for viable alternatives for pain management, and our study presents this form of CBD as a promising tool after arthroscopic rotator cuff repair,” says lead investigator Michael Alaia, MD, associate professor in the Department of Orthopedic Surgery at NYU Langone Health.

“It could be a new, inexpensive approach for delivering pain relief, and without the side effects of anti-inflammatory drugs like NSAIDs and addiction risks linked to opiates. Additionally, CBD has the benefit of pain relief without the psychotropic effects associated with THC or marijuana.”

There are a few caveats about the study. First, only 99 patients were enrolled in this early-stage Phase 1/2 trial. They were divided into two groups: one group took 50 mg of CBD in ORAVEXX tablets three times a day for 14 days, while the other group received a placebo or 25 mg of CBD during the study period.

Importantly, patients in both groups were also prescribed opioids, a low dose of Percocet, and told to wean themselves off the medication as soon as possible.

There were no major side effects reported by either group, but the group receiving 50 mg of CBD reported less pain and greater satisfaction in their pain control.

ORAVEXX is manufactured by Orcosa, which has developed a proprietary drug delivery system called the RITe Platform. The company says it buccal tablets dissolve so quickly in the mouth that fewer active ingredients are needed for a medication to work.

In addition to postoperative pain, the company is also planning studies to evaluate ORAVEXX as a treatment for acute and chronic pain, osteoarthritis pain and inflammation. While the initial results are promising, researchers say it could be years before ORAVEXX is available.

“Our study is examining a well-designed, carefully scrutinized product under an investigational new drug application sanctioned by the FDA. This is currently still experimental medicine and is not yet available for prescription,” said Alaia, who presented the initial findings this week at the annual meeting of the American Academy of Orthopaedic Surgeons.

With Little Regulation, Many CBD Products Are Mislabeled

By Pat Anson, PNN Editor

CBD (cannabidiol) is being touted as a treatment for nearly everything these days, from pain and anxiety to insomnia and high blood pressure. There’s even talk about CBD as a potential treatment for COVID-19.

But how much do we really know about the CBD edibles, beverages, oils and other products being sold over-the-counter without a prescription? Are the labels accurate? Are they really free of THC (tetrahydrocannabinol), marijuana’s psychoactive ingredient, as some manufacturers claim?

A new study by researchers at the University of Wisconsin School of Pharmacy should give pause to consumers who put their faith in labels and a cannabis industry that is largely unregulated. The researchers bought 39 CBD products from retail stores in southwest Wisconsin and analyzed them in a laboratory.

Their findings, recently published in the journal Epilepsy & Behavior, found that the vast majority of CBD product labels are inaccurate, containing either too much CBD, too little or none at all. And some products that claimed to be “THC Free” contained enough to give you a good buzz, whether you wanted it or not.

“Our data demonstrate that despite warning letters issued by FDA over the past few years a substantial number of readily available CBD formulations continue to be mislabeled,” researchers reported. “In some cases, products labeled as having CBD contained virtually no active ingredient. This was particularly true for the aqueous (beverage) products.”

Of the 21 CBD-infused beverages that were tested, only one was accurately labeled. The vast majority (78%) were “over-labeled” – meaning they contained less than 90% of the CBD they were supposed to have. The rest (14%) were “under-labeled” – meaning they had 110% or more CBD than the label indicated.

Other products tested, such as edibles, oils and transdermal patches, weren’t much better. Only about a third of the oils (36%) were appropriately labeled with the right amount of CBD, and one oil made by HempLucid contained enough THC to cause intoxication if someone consumed less than half a bottle.

“We found that over half of the studied oil-based products contained measurable THC. This may be of concern not only for the potential of adverse, or at least unexpected, CNS effects, but THC contamination may also create difficulty for patients who are subject to testing for illicit drugs by their employers, parole officers, and even by their own providers in some states as a prerequisite for continued prescribing of controlled substances,” researchers warned.

The concern about THC showing up in drug tests isn’t an idle one. A recent study at Massachusetts General Hospital found THC in nearly 80% of the urine samples from patients who reported using CBD products, including some who thought they were only consuming CBD.

A recent study by Leafreport had findings that were similar to the University of Wisconsin study. Out of 221 CBD products tested, 60% didn’t match their label claims. On average, the CBD content was off from the label by nearly 25 percent.

Although the 2018 Farm Bill legalized the use of hemp-based products that contain less than 0.3% of THC, the FDA has yet to adopt new rules to regulate the cannabis industry. The FDA says it cannot issue regulations until more is known about the safety of CBD products, so for now the agency is “monitoring the marketplace” and only rarely taking enforcement action.

The FDA is well aware of the discrepancies in CBD labeling. A 2021 study by the agency of 147 cannabis products found that less than half contained CBD within 20% of their label declarations. But as long as a company doesn’t make therapeutic claims about their CBD products or call them food supplements, the FDA will probably leave them alone, even if their labels are inaccurate.

CBD Reduced Burnout and Depression in Healthcare Workers

By Pat Anson, PNN Editor

After a year and a half of social distancing, masks and isolation, are you feeling emotionally burned out from the pandemic?

If so, you’re not alone. A recent survey of over 1,000 workers found that over half reported they were fatigued, depressed and had trouble concentrating.  Another study in the UK found that healthcare providers and other essential workers were particularly at risk of depression due to the stress of COVID-19.

With that in mind, researchers at the University of São Paulo in Brazil recently conducted a study to see if daily doses of cannabidiol (CBD) could relieve emotional exhaustion and burnout symptoms in a cohort of 120 frontline healthcare professionals.

Half of the study’s participants received 300mgs of CBD oil daily for four weeks. The other half did not receive CBD. All participants were evaluated weekly by a psychiatrist and encouraged to exercise.

The research findings, published in JAMA Psychiatry, found that participants who received CBD treatment had a significant reduction in emotional exhaustion and burnout compared to those who did not. CBD consumption was also associated with less anxiety and depression, but had no impact on post-traumatic stress syndrome (PTSD).

Five participants in the CBD group dropped out of the trial after suffering from serious adverse events, mostly elevated liver enzymes. Those cases resolved after CBD of discontinued.

“This randomized clinical trial found that the efficacy and safety of daily treatment with CBD, 300 mg, for 4 weeks combined with standard care was superior to standard care alone for reducing the symptoms of emotional exhaustion, anxiety, and depression among frontline health care professionals working with patients with COVID-19,” researchers reported.

“Burnout among health care workers is an important issue for health care systems, with a direct impact on quality of care. No pharmacological treatment is currently available for the prevention or treatment of burnout symptoms and emotional exhaustion among frontline health care professionals working with patients with COVID-19… Therefore, the results of the present study could have a relevant impact on the mental health of health care staff worldwide.”

The researchers said more placebo-controlled trials were needed to assess whether CBD could be used more broadly as a mental health treatment.

Previous studies have also found that medical cannabis reduced symptoms of depression. A 2020 study conducted in New Zealand found that people consuming up to 300mg daily in CBD oil reported significant improvement in their pain, mobility, anxiety and depression. Some also said they slept better and their appetite improved.

Another 2020 study found that 95% people who smoked or inhaled cannabis through a vaporizer reported a decline in depression within 2 hours. Cannabis with high levels of tetrahydrocannabinol (THC) was particularly effective in reducing depression.

Fibromyalgia Patients Substituting CBD for Pain Medication

By Pat Anson, PNN Editor

With opioid medication increasingly harder to obtain, many people with chronic pain are turning to cannabis-based products for pain relief.  A new survey of fibromyalgia patients suggests that cannabidiol (CBD) works well not only as an alternative to opioids, but for many other pain medications.

Researchers at Michigan Medicine surveyed 878 people with fibromyalgia who were currently using a CBD product and found that 72% of them had substituted CBD for a conventional pain medication.

Over half (59%) reduced or stopped taking non-steroidal anti-inflammatory drugs (NSAIDs), while 53% used CBD as a substitute for opioids, gabapentinoids (35%) or benzodiazepines (23%), an anti-anxiety medication that was once commonly prescribed for pain.

"I was not expecting that level of substitution," said Kevin Boehnke, PhD, a research investigator in the Department of Anesthesiology and the Chronic Pain and Fatigue Research Center at Michigan Medicine.

Fibromyalgia is a poorly understood disorder characterized by widespread body pain, fatigue, poor sleep, anxiety and depression. Standard treatments for fibromyalgia such as gabapentinoids often prove to be ineffective or have unwelcome side effects.

"Fibromyalgia is not easy to treat, often involving several medications with significant side effects and modest benefits," said Boehnke. "Further, many alternative therapies, like acupuncture and massage, are not covered by insurance."

CBD is one of the chemical compounds found in cannabis, but it doesn’t have the same intoxicating effect as tetrahydrocannabinol (THC), the psychoactive ingredient in marijuana.  Some cannabis products contain a combination of THC and CBD, while others just have CBD.

Survey participants who used CBD products containing THC were more likely to report symptom relief and to use them as substitutes for pain medication. This suggests that THC may enhance the therapeutic benefits of CBD.

A recent Israeli study found that people with fibromyalgia who took daily doses of cannabis oil rich in THC had significantly less pain and fatigue.

Another recent study in Israel found that cannabis products – both with and without THC – reduced pain and depression in fibromyalgia patients. Like the findings of the Michigan study, about one out of five patients either stopped taking or reduced their use of opioids and benzodiazepines.

"People are using CBD, substituting it for medication and doing so saying it’s less harmful and more effective,” said Boehnke. “If people can find the same relief without THC's side effects, CBD may represent a useful as a harm reduction strategy."

The Michigan Medicine study was recently published in The Journal of Pain.

Urine Tests Show Medical Cannabis Often Mislabeled

By Pat Anson, PNN Editor

Pick up almost any canned or packaged food in a grocery store and you’ll see a lengthy list of its ingredients, right down to the amount of sodium, fat, vitamins and calories in each serving.

That kind of attention to detail – and truth in advertising -- continues to elude the cannabis industry, according to a new study that found the amount of THC and CBD listed on many medical cannabis products to be wildly inaccurate.

Researchers at Massachusetts General Hospital didn’t test the products themselves, but instead analyzed urine samples from nearly 100 patients who frequently used medical cannabis to treat their pain, anxiety, depression or insomnia. Vaping was the most common form of administration, but patients also smoked or ingested cannabis products purchased at Boston-area dispensaries.   

Laboratory testing showed no CBD metabolites in about a third of the urine samples from patients who said they used cannabis products that were mostly CBD or had equal parts THC and CBD. THC was detected in nearly 80% of those samples, including ones from patients who thought they were only ingesting CBD.

The distinction is important because THC (tetrahydrocannabinol) is the psychoactive ingredient in cannabis that can make users high, while CBD (cannabidiol) is the chemical compound believed to have health benefits.

"People are buying products they think are THC-free but in fact contain a significant amount of THC," says lead author Jodi Gilman, PhD, an investigator in the Center for Addiction Medicine in Massachusetts General’s Department of Psychiatry. "One patient reported that she took a product she thought only contained CBD, and then when driving home that day she felt intoxicated, disoriented and very scared."

About 20% of patients who used a vaporizer had no detectable levels of either THC or CBD in their urine. Researchers think that’s because some vaping devices may not heat cannabis products sufficiently for patients to inhale the active ingredients. THC was more likely to be found in patients who smoked cannabis or ingested it orally.

"A lot of questions about the content of the products and their effects remain," says Gilman. "Patients need more information about what's in these products and what effects they can expect."

The study findings, published in JAMA Network Open, are the latest to show that the actual ingredients in cannabis products vary considerably from their labels. Although 36 states and Washington DC have legalized medical cannabis, there is little consistency in labeling, regulating or testing medical cannabis, as there is for food, supplements and pharmaceutical drugs.

A 2015 study of cannabis edibles sold in California and Washington found that only 17% were labeled accurately. Over half had significantly less CBD than labeled and some had negligible amounts of THC.   

A recent study conducted by the Food and Drug Administration of 147 hemp and cannabis products found that less than half contained CBD within 20% of their label declarations.   

Daily Drop of CBD Oil Reduces Migraine Headaches

By Pat Anson, PNN Editor

A CBD oil formulated for migraine sufferers significantly reduces the number of migraine headaches, according to a survey conducted by Axon Relief, a Utah-based company that makes a line of therapeutic CBD products.

“Our goal was to put out a CBD oil that is specific for people with migraine and to get feedback from them. There is a lot of anecdotal evidence that it works, but we haven’t seen any clinical data really behind it. And so this is kind of a first effort of ours to get some directional data on how effective this is,” says Ben Rollins, founder of Axon Relief.

Axon’s CBD Oil is made from pure hemp seed oil and has about 30mg of CBD per dose, a stronger than average dosage of cannabidiol. It contains no extra flavors, colors or THC (tetrahydrocannabinol), the psychoactive ingredient in cannabis, and is tested by a third-party lab.

The company asked new users of its CBD oil to take the Headache Impact Test (Hit-6™) both before and after a 30-day trial period. The questionnaire asks participants about the frequency and severity of their migraines, and how it impacts their daily lives.

Of the 105 customers who participated in the survey, 86 percent said a daily dose of the CBD oil reduced the impact of their headaches. On average, they also had nearly four fewer headache days per month.

The number of participants with chronic migraine – daily headaches – fell from 15 at the start of the study to 10 after the trial period, a 33% decline.

AXON RELIEF IMAGE

“Since the '90s I've been on constant high doses of carbamazepine and gabapentin. The periodic pain breakthroughs were only controlled by hydrocodone,” one user said. “What a change CBD Oil has made: no more carbamazepine or hydrocodone, and only half the gabapentin -- and far better pain control.”

Another participant said the CBD oil “significantly helped with my chronic migraines. If taken at onset, I can rely on it to take the edge off relatively quickly."

Previous studies have found that inhaled and ingested cannabis help reduce migraine pain.  A recent study of nearly 10,000 people in the U.S. and Canada who used a migraine tracking app found that 82 percent who used cannabis believed it was an effective pain reliever.    

A 2017 study conducted in Israel found that combining THC and CBD in a 200mg oral dose reduced pain by 55 percent in a small group of migraine sufferers.

And a 2016 study at the University of Colorado found that inhaled and ingested cannabis significantly reduced the number of migraine headaches. Inhalation appeared to provide the fastest results, while edible cannabis took longer to provide pain relief.

Axon Relief will soon be introducing an extra strength version of its CBD oil, which will contain about 100mg of CBD per dose. The company is also releasing a new dietary supplement in capsule form that combines CBD with magnesium, CoQ10 and riboflavin – ingredients recommended by the Migraine Trust. 

Pain and Anxiety Reduced in First New Zealand Cannabis Patients

By Pat Anson, PNN Editor

A study of the first patients prescribed medical cannabis after it was legalized in New Zealand in 2017 found that cannabidiol – the non-psychoactive ingredient in marijuana -- significantly improved their chronic pain and anxiety.

Researchers at the University of Auckland analyzed the health records of the first 397 patients prescribed cannabidiol (CBD oil) at a cannabis clinic in Auckland. The patients live with a variety of chronic pain conditions, including fibromyalgia, osteoarthritis, rheumatoid arthritis, neuropathy, multiple sclerosis, migraines and cancer.

Participants were asked to rate their pain, anxiety, mobility and depression before taking CBD oil and four weeks after starting treatment. The CBD doses ranged from 40mg/day to 300mg/day. The recommended daily dose was at least 100 mg.

Patients with non-cancer pain reported significant improvement in their pain, mobility, anxiety and depression. Some also said they slept better and their appetite improved.

Patients with neurological symptoms experienced no improvement with any symptom, and patients with cancer only reported improvement in pain.

Most patients said they were satisfied with CBD oil, with 70% reporting it was good, very good or excellent; while 30% reported no benefit.

Adverse side-effects, which included sedation and vivid dreams, were reported by about 10% of participants, with two patients (0.8 percent) reporting a worsening of a pre-existing condition.

“The study has limitations due to drop-out and other factors, but the findings are consistent with other evidence and underline the need for more research to allow us to fully realise the therapeutic potential of medical cannabis,” said Professor Bruce Arroll, senior author of the study and head of the Department of General Practice and Primary Healthcare at the University of Auckland.

“Our findings show that CBD is well-tolerated in most patients and can markedly ease symptoms in a range of hard-to-treat conditions, and that there are people keen to access this and self-fund the medication.”

Some patients chose not to take CBD oil because of its cost. Patients had to pay $300 (US) for 2500 mg of CBD oil, $150 for an initial consultation, and $75 for a follow-up.

“Our evidence of CBD’s potential benefits in treating pain and anxiety, if corroborated by future clinical trials, suggests we may need to consider subsidising medical cannabis,” said co-author Dr. Graham Gulbransen, who operates the cannabis clinic in Auckland. 

Because the study was observational and relied on patients self-reporting their symptoms, it did not establish a cause-and-effect relationship. It’s also possible the improvement in symptoms was due to a placebo effect.

The findings are published in the British Journal of General Practice Open (BJGP Open).

Hold the CBD and Pass the Gravy

By Pat Anson, PNN Editor

You can now buy cannabis-infused juice, beer, popcorn, gummies, breakfast cereal, and just about every food and drink imaginable with CBD or even THC.  

But you know things are getting out of hand when a company starts selling cannabis-infused turkey gravy – just in time for Thanksgiving.

KIVA Confections – a California company that makes a line of cannabis chocolates and edibles -- has introduced a “groundbreaking” turkey gravy infused with 10mg of THC, the psychoactive compound in marijuana. Thanksgiving dinner will never be quite the same.

“Awkward family dinner conversation? In just under 15 minutes you’ll start feeling the effects, so you can sit back, relax, and let the holiday cheer wash over you,” said Kiva in a tongue-in-cheek blog post

The company plans to introduce a cannabis-infused hot cocoa mix by Christmas.  

KIVA CONFECTIONS

FDA Warns CBD Companies

Federal health officials are finally blowing the whistle on cannabis marketing. The Food and Drug Administration has issued warning letters to 15 companies for illegally selling and marketing cannabis infused products.

Ironically, the FDA’s focus is not on THC, but on cannabidiol (CBD), the seemingly harmless and over-hyped compound in cannabis associated with many health claims. The FDA has revised a Consumer Update to more clearly state that CBD is not recognized as safe for use in human or animal food.

“We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt.’ Aside from one prescription drug approved to treat two pediatric epilepsy disorders, these products have not been approved by the FDA,” Amy Abernethy, MD, FDA Principal Deputy Commissioner, said in a statement.

“We recognize the significant public interest in CBD and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety and quality of many of these products.”

What most concerns the FDA is that CBD is being marketed as a treatment for chronic pain, arthritis, depression, addiction, anxiety and other medical conditions with no clinical evidence that it actually works.

Red Pill Medical of Phoenix, one of the companies that received a warning letter, claims CBD can cure cancer.

“We’ve seen CBD kill prostate cancer cells, kill colon cancer cells…there’s just thousands of anecdotal stories on the internet where people have cured themselves when they were told they had weeks or months to live using CBD,” Red Pill claims in a promotional video.

Another company, Whole Leaf Organics of Los Angeles, was warned about selling CBD products for pets.

“Beneficial and safe for both people and animals, CBD has been known to reduce inflammation, assist with chronic fatigue, alleviate joint and muscle pain, and help in regards to the management of stress and anxiety,” Whole Leaf claims on its website.

One company was warned about marketing CBD products for infants and children, while another was warned about selling CBD for food-producing animals such as chickens and cows.

This isn’t the first time the FDA has warned cannabis companies to be more discerning in their marketing. Similar warning letters were sent in March to three companies for making unsubstantiated health claims about their CBD oils, extracts and edibles.

One of the companies, NutraPure, now has a disclaimer on its website stating that its products “have not been evaluated” by the FDA and “are not intended to diagnose, prevent, treat, or cure any disease.” As PNN reported, however, that didn’t stop a NutraPure representative from recommending the company’s hemp oil to this reporter as a treatment for fibromyalgia.

The FDA says it will “explore potential pathways” for CBD products to be marketed legally and would be providing an update in coming weeks.

In the meantime, pass the gravy.

What Are Health Risks of Vaping CBD?

By Roger Chriss, PNN Columnist

An outbreak of lung illnesses linked to vaping is raising important questions about the safety of vaping cannabis products. The cause is still unclear, but the CDC reports about 76% percent of the patients who became ill vaped products containing THC – the psychoactive ingredient in cannabis. Only about 17% reported vaping a cannabidiol (CBD) product.

At present, very little is known about CBD vaping safety. The World Health Organization’s 2017 report on cannabidiol looked at oral, sublingual and intranasal routes of administration. When the WHO wrote that “CBD is generally well tolerated with a good safety profile,” it was not considering vaping at all.

The Food and Drug Administration still considers CBD in food and drugs sold commercially to be illegal, unless the product falls under the Food, Drug and Cosmetic Act. Vaping CBD does not, and so there has been no testing or regulatory action.

There have been no good human studies on CBD vaping. Research generally looks at CBD in edibles and liquids, or smoked using traditional means.

It is not known what happens to CBD under vaping temperatures, if there are thermal degradants, or important chemical reactions between CBD and other ingredients in vaping liquids or other drugs.

A recent lung tissue study found concerning results about inhaling CBD while using steroids. CBD helps reduce inflammation, but “acts as an antagonist with steroids, overriding the anti-inflammatory potential of steroids when used in combination.”

Last year Vice reported on public health warnings in North Carolina after 90 people became sick with headaches, nausea, hallucinations and other health problems after vaping CBD products. Adulterants appear to have been the problem, and Vice noted that vape oils are poorly regulated and sometimes contain chemicals that “when heated in a vape and inhaled, can cause serious lung irritation.”

A recent study on the quality of CBD liquids used in e-cigarettes is also concerning, finding that “the quality control of manufacturers and the relative safety of these products is uncertain.”

An AP investigation last month found that in lab tests on 30 CBD vape products, ten samples contained synthetic marijuana such as K2 or spice, while others had no CBD at all.

Some states with legalized cannabis do require testing of CBD vapes. But it’s not clear what to test for, and even the lab methods for testing have yet to be validated. It is also not known which cutting agents, adulterants and contaminants should be cause for concern. Lung tissue is fragile, vulnerable in ways the GI tract is not, and not well studied. So testing regimes may ultimately require information we currently lack.

Oversight of cannabis testing is limited. California’s Sequoia Analytical Labs was found to be falsifying lab results last year. Plus, many CBD vapes come from the gray or black markets, or are home-brewed, making attempts at quality control irrelevant. As a result, CBD vaping safety is an open question, assuming it is even possible to make a safe CBD vape.

Fortunately, new research may help. Researchers are testing vaporized cannabis extracts on rats. This will allow for studying the effects of THC and CBD in animal models in a way that closely mimics human behavior.

Such information is urgently needed. Animal studies on vaping are raising concerns about lung cancer risk, but such research may not be representative of how humans vape, limiting their value.

There is ongoing debate on what CBD is good for. And now we also have to consider how CBD should be administered. It may be possible to create a low-risk CBD vape product. But at present we don’t really know how to do it.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society.

Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

The information in this column is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Arthritis Foundation Releases First CBD Guideline

By Pat Anson, PNN Editor

The Arthritis Foundation has become the first major patient advocacy group to release guidelines on the use of cannabidiol (CBD) to treat arthritis pain.  

About 54 million Americans have been diagnosed with arthritis. According to a recent national survey, 79 percent of arthritis patients are currently using CBD, have tried it in the past, or are considering it.

CBD infused products – from edibles to lotions to beverages -- are rapidly going mainstream, even though there is little scientific evidence to support their use. There has also been little guidance for consumers on what products to use or in what doses — until now.

“We are intrigued by the potential of CBD to help people find pain relief and are on record urging the FDA to expedite the study and regulation of these products,” the Arthritis Ffoundation said in a statement.

“While currently there is limited scientific evidence about CBD’s ability to help ease arthritis symptoms, and no universal quality standards or regulations exist, we have listened to our constituents and consulted with leading experts to develop these general recommendations for adults who are interested in trying CBD.”  

CBD is largely extracted from a hemp, a marijuana strain that has only trace amounts of THC, the active ingredient that makes people high.

"Millions of people in the U.S. are likely trying to use cannabinoids to treat pain, and many are doing this in ways that might cause more harm than good, especially when they use high doses of THC," said Daniel Clauw, MD, a professor of anesthesiology at the University of Michigan who was one of the experts the foundation consulted.

"It's important that the Arthritis Foundation has taken a stand on CBD,” Clauw said in a statement. “Right now, it appears to be fairly safe and might help certain types of pain. It's far better to give this guidance, even if preliminary, because otherwise people will have no guidance whatsoever." 

DRUG POLICY ALLIANCE

The new guideline is largely cautionary and does not explicitly recommend CBD as a treatment, stating only that it “may help” with arthritis-related symptoms such as pain, insomnia and anxiety.

When taken in moderate doses, experts say CBD has no major safety issues, although it may interact with some drugs commonly taken for arthritis, such as naproxen (Aleve), celecoxib (Celebrex), tramadol (Ultram), gabapentin (Neurontin), pregabalin (Lyrica) and some antidepressants.

The Arthritis Foundation recommends taking CBD in oral sprays or tinctures so the liquid can be taken under the tongue and be absorbed directly into the bloodstream.

Experts say a “go slow” approach is best, starting with a few drops twice a day and increasing the dose gradually over a period of weeks until an effective dose is reached.

The guideline strongly discourages inhaling or vaping CBD because of the risk of respiratory problems. It also discourages taking CBD in edibles, such as gummies and cookies, because the dosing is unreliable. Experts say the effectiveness of topical lotions and creams with CBD is unclear because they often contain other ingredients.

Other key takeaways from the guideline:

• CBD should never be used to replace disease-modifying drugs that help prevent permanent joint damage in inflammatory types of arthritis.

• CBD use should be discussed with your doctor in advance, with follow-up evaluations every three months or so.

• Buy from a reputable CBD company that has each batch tested for purity, potency and safety by an independent laboratory and provides a certificate of analysis.  

Unlike prescription drugs approved by the Food and Drug Administration, the manufacturing process for CBD products is not subject to FDA review, and there has been no FDA evaluation of their effectiveness, proper dosage, how they could interact with drugs, or whether they have side effects. 

The Federal Trade Commission recently warned companies that make CBD products to stop making unsubstantiated claims that cannabidiol can be used to treat arthritis and other chronic pain conditions.

FDA Warns Curaleaf About Marketing of CBD Products

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration is warning a large cannabis company to stop making unsubstantiated claims that its products can treat chronic pain, cancer, opioid withdrawal and other medical conditions.

An FDA warning letter was sent to Curaleaf, a Massachusetts-based company that sells cannabidiol (CBD) products online and in stores, and operates dispensaries in a dozen states. CVS Health responded to the FDA letter by pulling some Curaleaf products off its store shelves.

“Selling unapproved products with unsubstantiated therapeutic claims — such as claims that CBD products can treat serious diseases and conditions — can put patients and consumers at risk by leading them to put off important medical care. Additionally, there are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD,” acting FDA Commissioner Ned Sharpless, MD, said in a statement. “Consumers should beware of purchasing or using any such products.”

Curaleaf, which claims to be the largest cannabis operator in the United States, makes an extensive line of CBD lotions, creams, oils and skin patches.

It recently began marketing a line of CBD products for pets to treat pain, spasms, anxiety and inflammation in animals.

The FDA’s warning letter to Curaleaf cited a number of unapproved marketing claims made by the company online and in social media, including:

• “CBD was effective in killing human breast cancer cells.”

• “CBD has been linked to the effective treatment of Alzheimer’s disease…”

• “CBD is being adopted more and more as a natural alternative to pharmaceutical-grade treatments for depression and anxiety.”

• “CBD can also be used in conjunction with opioid medications, and a number of studies have demonstrated that CBD can in fact reduce the severity of opioid-related withdrawal and lessen the buildup of tolerance.”

• “CBD oil is becoming a popular, all-natural source of relief used to address the symptoms of many common conditions, such as chronic pain, anxiety … ADHD.”

The FDA gave Curaleaf 15 working days to respond. Failure to correct the violations could result in legal action, including seizure of the company’s products.

“Curaleaf is committed to the highest standards of quality and compliance, and will work collaboratively with the FDA to resolve all issues addressed in the agency's letter,” the company said in a statement.

“Compliance is a top priority for Curaleaf and the Company is fully committed to complying with FDA requirements for all of the products that it markets. We can affirm that nothing in the letter raises any issues concerning the quality and consistency of any Curaleaf product or calls into question the high safety standards of the Company's cultivation and manufacturing processes.”

CBD Products Loosely Regulated

Unlike prescription drugs approved by the FDA, the manufacturing process for CBD products is not subject to FDA review, and there has been no FDA evaluation of their effectiveness, proper dosage, how they could interact with drugs, or whether they have side effects.

Despite the lack of regulatory oversight, there has been explosive growth for CBD companies and their products are starting to appear in mainstream stores. In March, CVS Pharmacy and Walgreens started selling CBD lotions, tinctures, edibles and lozenges — including some made by Curaleaf.

“The only Curaleaf products we are selling are its CBD lotion and CBD transdermal patches,” CVS said in a statement. “Following the FDA’s warning letter to Curaleaf, we will be removing these items from our CBD offering.”  

The FDA sent similar warning letters to three cannabis operators in April. Until now, the enforcement actions have been sporadic and only targeted small companies.

“We will continue to work to protect the health and safety of American consumers from products that are being marketed in violation of the law through actions like those the FDA is taking today. At the same time, we also recognize the potential opportunities and significant interest in drug and other consumer products containing CBD,” said FDA Principal Deputy Commissioner Amy Abernethy, MD.

“We understand this is an important national issue with public health impact and of interest to American hemp farmers and many other stakeholders. The agency has a well-established pathway for drug development and drug approvals, and we remain committed to evaluating the agency’s regulatory policies related to other types of CBD products.”

The FDA held a public hearing on the issue in May, and opened a docket for public comments to obtain scientific data about the safety, manufacturing, quality, marketing, labeling and sale of CBD products. Nearly 4,500 comments were received. The agency plans to report on its progress this fall.

This week Curaleaf announced it will acquire GR Companies, a large cannabis retailer, in a cash and stock deal valued at $875 million. Curaleaf said the purchase solidifies it’s position as “the world's largest cannabis company by revenue and the largest in the U.S. across key operating metrics.”