World’s Largest Real-Life Study on CBD Products Finds Improvements in Pain, Anxiety, Sleep, and Well-Being
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Read Time:5 Minute, 42 Second
History’s largest real-world evidence study, consisting of nearly 3,000 participants, has just produced some stunning results on the use of commercially available — as in off-the-shelf-anyone-can-buy-them-right-now, cannabidiol (CBD) products.
Known as the ACES trial, (Advancing CBD Education and Science), participants experienced a 71% improvement in their well-being on average, while 63% experienced an improvement in anxiety and sleep quality, and 47% experienced improvements in pain levels. 61% of participants reported an effect within one to four hours of taking their product.
The group behind the trial is Radicle Science, a health-tech startup looking to revolutionize the way in which natural consumer products are studied and evaluated for efficacy.
“Radicle Science has delivered much-needed clarity to a confusing marketplace where consumers are baffled as to which products and dosages might best serve their needs,” says Ethan Russo, MD, one of the study’s collaborators working with Radicle. “Radicle is charting a compelling and innovative course towards offering personalized predictive data on the health effects of cannabidiol products consumed by millions of Americans every day”.
And indeed it is millions. A 2019 Gallup poll found that an estimated 14%, or at least 1 in 7 Americans that answer Gallup polls, report to use CBD; mostly for pain, even though a Consumer Brand Association study in July of 2021 found that consumer knowledge of CBD is around 3.3 out of 10.
“Despite the massive and growing market size, there is still scant data on the effectiveness of over-the-counter cannabinoid products,” says Jeff Chen, MD and CEO of Radicle Science.
WaL reported in June on a Radicle Science study on the use of a CBD product for women under the brand Rae Wellness, which also found very significant improvements in the reporting of anxiety, which was sustained over a 60-day period.
PICTURED: Jeff Chen MD, co-founder of Radicle Science.
Radicle methods
Radicle uses crowd-sourced data and machine learning while eliminating all physical infrastructure to conduct its trials, yet they establish the same regulations as randomized-controlled trials (RCTs), the gold standard of medical research.
For example, 208 participants took one of a selection of 13 off-the-shelf or over-the-counter CBD products, while a group of 298, which received nothing but placebo, acted as the control group. Respected scientific indices standardized by the WHO and NIH were used to measure participants’ self-reported data, and the trial organizers didn’t know who got placebo and who got CBD.
ACES was launched in August, and for comparison, it was finished before Thanksgiving, whereas one meta-analysis found the average time it takes an RCT to finish is 20 months, rising to 3 and a half years if the time from recruitment to completion is 2 years in itself.
The restrictions of RCTs are well known, both in money and time, but there are others, such as the fact that the overwhelming recruitment of those who participate in the gold standard comes from those who live within 5-10 miles of the location where the trial is taking place, either in a hospital or a university setting.
“If you’re a pharma company, and you’re doing your pivotal trials, that’s an expensive process—tens sometimes hundreds of millions of dollars and 3-5 years; that’s one shot-able,” Dr. Chen told WaL. “You need to make damn sure that the people in your study are going to have the best odds of having effectiveness with your drug, and the least amount of odds of having a bad side effect”.
If, Chen explains, the trial is one of the one-shot opportunities, and the drug in question is one for insomnia, the exclusion criteria might be as high as 1,000 to 1. People with low income, who drink coffee, who have depression or chronic pain, or maybe who haven’t had success with Ambien, a common insomnia drug, all would be excluded to better the odds of the trial’s success.
“Study groups are really artificial,” says Chen. “They’re selecting an artificial population that doesn’t look like anybody in America. You conduct the study in a very artificial setting; hospitals, doctors, you very strictly dose people, you dose them to a very regimented schedule”.
“At the end maybe you see a benefit, but this data doesn’t actually represent how the drug will work in the real world. In the real world, people look very different than those in the clinical trial, doctors’ behavior in prescribing the drug can look very different, and consumers using the drug have a very different relationship to it—they might skip doses, they might double up on doses,” he said.
Making waves with leaves
The study was funded collectively by the 13 brands which were trialed. The products were tested by Radicle and a third party to see if they contained the ingredients reported, at the levels at which they were reported, and then the companies supplied enough doses to cover 3,000 people over the 4-week period.
It’s generally considered that a reported rate of clinically-significant effects greater than 60% represents some of humanity’s most successful medications. For example, acetaminophen, the base ingredient in many off-the-shelf painkillers, confers around a 52% reported effect for headaches, around 20% higher than placebo one trial found.
For three of the four measured effects to have been reported as improved by greater than 60% is a major success, all the more impressive when one considers the nature of Radicle’s method—that they’re not excluding nearly anyone, nor are they policing the dosing habits.
By including the “noise” the results are purer in a way.
“Looking at the results, clearly it differs depending on which condition, but yes it looks pretty darn robust,” says Chen “One caveat here, this is just the top line result. The next layer of analyses we want to run is starting to dive into those who didn’t experience a clinically-significant improvement”.
Radicle plans to release the updated findings, including conditions and results based on demographic, underlying conditions or dose-dependencies, to see if there are habits or conditions that disrupt the benefit conferred by the CBD. They also plan to continue their research into CBD using their breakneck speed, opening the field into THCV for focus and appetite suppression, CBN, and other minor cannabinoids. WaL
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