Radicle Science (San Diego, CA) has published the initial findings of its Advancing CBD Education and Science (ACES) study, a longitudinal real-world evidence study with a population sample of nearly 3,000 people. The aim of the study is to determine the effectiveness of botanical products containing CBD.
The open-label randomized controlled trial examined 13 U.S. brands for therapeutic benefits in five health outcomes: well-being, quality of life, long-term pain, feelings of anxiety, and quality of sleep. These findings were assessed across five indices: the World Health Organization (WHO) welfare index -5, the Kemp QOL scale, the Generalized Anxiety Disorder (GAD) scale -7 , the patient-reported outcome measurement information system (PROMIS ™) Sleep Disorder SF 8B scale and PEG-3 scale for pain.
The results showed that participants saw a 71% improvement in well-being, 63% of participants saw a clinically significant improvement in anxiety, 61% experienced a clinically significant improvement in sleep quality and sleep quality. 47% experienced a clinically significant improvement in pain. In addition, the study found that 61% of participants reported feeling an effect between one and four hours after taking their products.
Uniquely, Radicle uses a direct virtual approach to the consumer to conduct its research, which has been ideal during a global pandemic. While this may have its drawbacks, the nature of the ACES study benefited from the direct focus on the consumer.
“Radicle ACES was designed as a real-world randomized, open-label controlled trial. As such, there were no strict dosing protocols as seen in typical hospital clinical trials. Thus, daily doses reported by participants showed greater variability.Fortunately, the large scale of the study still provided the statistical power needed to generate clinically significant findings, “explained Pelin Thorogood, co-founder and CEO of Radicle Science. Nutritional perspectives. “Also considering our D2C virtual approach, we currently do not track changes in blood chemistry; however, because the conditions we study, which are the same ones that most consumers resort to cannabinoids, are related to general pain, sleep, anxiety, there are really no real physical biomarkers, which makes that patient-reported (PRO) outcomes be the gold standard, even in traditional clinical research.
“The main benefits of our D2C virtual approach are the more than 10-fold improvements we offer in the speed and scale of study execution,” Thorogood continued. “Radicle ACES also doubles its premise of diversity by capturing health outcome data from an intentionally heterogeneous population across a variety of pre-existing ethnicities, age groups, geographies, behavioral habits, and health conditions. The combined benefit of large-scale and intentional heterogeneity in our studies is that they have the potential to transform consumer health products into democratized precision solutions. “
The aggregated, anonymous findings will be published in a peer-reviewed journal in early 2022. These results will also include dose-related analyzes and formulations, says Jeff Chen, MD, MBA, co-founder and CEO of Radicle Science.
“In the coming weeks a Radicle ACES benchmarking report will be distributed to participating brands, summarizing participant use and brand results data compared to other brands in the study (anonymously ), ”says Chen. “It will also provide information on how variations in demographics and patterns of use can correlate with reported therapeutic benefits, such as changes in well-being, quality of life, pain, sleep disturbances, and anxiety as well as any side effects “.