Radicle Science (San Diego, CA) has released the initial findings of its Advancing CBD Education and Science (ACES) study, a longitudinal real world evidence study with a sample population of nearly 3,000 people.
Radicle Science (San Diego, CA) has released the initial findings of its Advancing CBD Education and Science (ACES) study, a longitudinal real world evidence study with a sample population of nearly 3,000 people. The study’s aim is to determine the effectiveness of botanical products containing CBD.
The open label randomized controlled trial examined 13 U.S. brands for therapeutic benefits across five health outcomes: well-being, quality of life, longer-term pain, feelings of anxiety, and sleep quality. These findings were assessed through five indices: the World Health Organization (WHO)-5 Well Being Index, the Kemp QOL scale, the Generalized Anxiety Disorder (GAD)-7 scale, the Patient-Reported Outcomes Measurement Information System (PROMIS™) Sleep Disturbance SF 8B scale, and the PEG-3 Scale for pain.
Results showed that participants saw a 71% improvement in well-being, with 63% of participants seeing a clinically meaningful improvement in anxiety, 61% experiencing a clinically meaningful improvement in sleep quality, and 47% experiencing a clinically meaningful improvement in pain. Additionally, the study found that 61% of participants reported feeling an effect within one to four hours of taking their products.
Uniquely, Radicle employs a virtual, direct-to-consumer approach in conducting its research, which has been ideal during a global pandemic. While this can have its disadvantages, the nature of the ACES study benefited from the direct-to-consumer approach.
“Radicle ACES was designed as a real-world, open label randomized controlled trial. As such, there were no stringent dosing protocols as seen in typical hospital based clinical trials. Thus, the daily doses reported by participants showed greater variability. Thankfully, the large scale of the study still provided the needed statistical power to generate clinically meaningful findings,” explained Pelin Thorogood, co-founder and executive chair of Radicle Science to Nutritional Outlook. “Also given our virtual, D2C approach, we currently don’t track changes in blood chemistry; however, since the conditions we study – which are the very same conditions most consumers turn to cannabinoids for – are related to general pain, sleep, anxiety, there are really no real physical biomarkers, making patient reported outcomes (PROs) the golds standard, even in traditional clinical research.
“The primary advantages of our virtual, D2C approach are the greater than 10x improvements we offer in study execution speed and scale,” continued Thorogood. “Radicle ACES also doubles down on its diversity premise by capturing health outcome data from an intentionally heterogeneous population across a variety of ethnicities, age groups, geographies, behavioral habits, and pre-existing health conditions. The combined benefit of the large scale and intentional heterogeneity of our studies is that they have the potential to transform consumer health products into democratized precision solutions.”
The anonymized, aggregate findings will be published in a peer-reviewed journal in early 2022. These results will also include analyses related to dose and formulations, says Jeff Chen, MD, MBA, co-founder and CEO of Radicle Science.
“A Radicle ACES Benchmarking Report will be distributed to participating brands in the coming weeks, summarizing participant usage and outcome data from their brand compared to other brands in the study (in an anonymized manner),” says Chen. “It will also provide insights on how variations in demographics and usage patterns may correlate to reported therapeutic benefits, such as changes in well-being, quality of life, pain, sleep disturbance, and anxiety, as well as any side effects.”