A new trial looking at the effects of a line of commercially-available CBD health products from a company called Rae Wellness has found significant improvements in anxiety in women, a demographic that totally unrepresented in CBD research.
The trial was conducted by a new startup called Radicle Science that looks to bypass the billion-dollar safety and efficacy requirements of FDA approval, by harnessing crowdsourced information and machine learning technologies for the direct-to-consumer medicine market.
The trial is the first human trial on the effects of commercial CBD, and to the company’s knowledge the first to be done exclusively on women. Women tend to have double the risk for developing anxiety than men, and many of the trialists approached CBD use in response to developing anxiety.
Between 15-30 milligrams of CBD use in women significantly reduced levels of reported anxiety over a period of 30 days. The low levels of anxiety were sustained over the following sixty days in cases where one dose was taken daily. While it wasn’t controlled for placebo, other strengths of the trial have Radicle Science hopeful their results can be built on to produce a good body of evidence for further research into the topic of CBD use among women.
“While there are thousands of CBD brands being used by tens of millions of Americans, there is virtually no data on which formulations, used in what manner, for which types of individuals, may offer the most benefit,” explains Jeff Chen, CEO and Co-Founder of Radicle Science, who launched the startup following his work at the UCLA Cannabis Research Initiative.
“It incredible to see my team executing diligently and it was such an amazing experience working with Rae on this study,” Chen tells WaL. “But we have so much work ahead of us and so much room to improve our studies and technology. Pharma has had decades and untold billions of dollars spent research and developing their products. Our task at hand is generating research and data for the entire natural products world for a tiny fraction of the time and cost”.
Speaking for themselves
Cannabis sativa has been cultivated for use in commercially available medicine now for several years, and CBD oils, tinctures, vapes, capsules, and more have flooded the market. Cannabidiol, one of several hundred different compounds found in the plant, has been shown in pre-clinical and clinical research to possess immense therapeutic benefits, particularly for inflammation, as CBD is received by the onboard endo-cannabinoid system which signals to areas that regulate or trigger immune responses.
The results of the Radicle Science trial had a particular narrative. 1,350 women aged 22-44 participated, and were sorted into 9 groups, some of which were asked to take a single Rae Wellness CBD product every day for 30 days.
The participants were in a bad way. Prior to the trial’s commencement, a company white paper said 95% of them reported sleep disorders, 99% reported they had high levels of stress, while 96% reported anxiety. Pain, digestive health, and libido were all self-reported at levels above 72% and below 90%.
While their scores on a clinically relevant and utilized self-reported anxiety scale all went down significantly over the 30 days, the other findings speak for themselves.
There were no statistically significant differences found in broad-spectrum versus full-spectrum doses (containing 0.3% THC), the size of the doses (15-20 compared with 25-30 milligrams), the delivery method, or the age of the participant.
“I think it means more research is needed!” Chen tells WaL. “Our study is just the first blip on the radar”.
It seems to suggest that the only important detail is whether or not the participant was taking CBD, or placebo; a hugely positive and significant finding.
A phase II trial that will look for levels of sleep quality, digestive health, pain, quality of life, and sexual satisfaction, as well as possible variations in the effects that could be found in demographic information, and time of day the medicine was consumed, is slated to launch this November. WaL