Radicle Science has revealed initial findings from the Radicle ACES (Advancing CBD Education and Science) study, a longitudinal real world evidence (RWE) study of nearly 3,000 participants to determine effectiveness of botanical products containing CBD.
This open label RCT examined 13 U.S. brands to determine whether botanical products containing CBD deliver therapeutic benefits across five health outcomes, including well-being, quality of life, longer-term pain, feelings of anxiety, and sleep quality. A full report of the anonymized, aggregate findings will be released in early 2022.
Initial findings indicate a significant number of participants experienced clinically meaningful improvements, meaning they realized distinct and palpable improvements in quality of life through improvements in the respective health outcomes studied. Across all health outcomes, the largest improvements were observed within the first week. Key findings include:
- Participants experienced a 71% improvement in their well-being, on average
- 63% experienced a clinically meaningful improvement in anxiety
- 61% experienced a clinically meaningful improvement in sleep quality
- 47% experienced a clinically meaningful improvement in pain
- 61% reported an effect within one to four hours of taking their product
“With Radicle ACES, we are finally rigorously studying the real-world effectiveness of natural health products people encounter every day,” said Pelin Thorogood, co-founder and executive chair of Radicle Science. “Our audacious mission is to create the new standard of trust and transparency consumers deserve and healthcare providers demand on these widely accessible potential therapies. The large scale and intentional heterogeneity of our studies can transform these consumer health products into democratized precision solutions.”
Radicle ACES, which launched in August and was completed prior to Thanksgiving, employed validated, standardized health indices to gather real-world health outcomes from a diverse population across a variety of ethnicities, age groups, geographies, behavioral habits, and pre-existing health conditions. The four-week study leveraged a unique virtual, direct-to-consumer (D2C) approach to achieve the desired participant population heterogeneity and study execution speed.
“Despite the massive and growing market size, there is still scant data on the effectiveness of over-the-counter cannabinoid products due to the cost, speed and scale limitations of the current approach to scientific research,” said Jeff Chen, MD/MBA, co-founder and CEO of Radicle Science. “Radicle Science re-imagined clinical trials resulting in 10 times cheaper, faster, and larger studies that can finally prove or predict which nonprescription health products to use for a desired effect, benefiting consumers, healthcare providers and brands.”
The Radicle Science platform recruited, screened, and consented nearly 3,000 diverse participants from across the U.S. in less than four days. The Radicle approach eliminates all physical infrastructure and instead collects data directly from participants as they go about their day-to-day life, in their real world environment. Radicle ACES is IRB-approved and registered on ClinicalTrials.gov (ClinicalTrials.gov Identifier: NCT05003882). It maintains the highest levels of scientific rigor by using validated indices to accurately track health outcomes, randomization, and a control group who took no product to reduce confounding and to help determine causality, and appropriate statistical power to ensure the results were unlikely due to random chance.
“The cannabis-based medicine industry has notably advanced the science supporting the efficacy and safety of CBD thanks to the Radicle ACES study,” said Ethan Russo, MD, study collaborator and scientific expert for Radicle Science, and founder and CEO of CReDO Science. “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. 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.”
Radicle Science is a public benefit corporation committed to transparency and public service, and the anonymized aggregate results of the study will be published in a peer-reviewed journal to democratize the findings. Additional studies focused on CBN, THCV and other minor cannabinoids will be kicking off in early 2022.
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