More and more clinical studies are being conducted to find out and prove the various effects of CBD on our health. One important question is whether CBD can be good for the liver or harm its functions? The new study, which was conducted from August last year to Febuary 2021, looked at the potential effects of CBD on the liver in adults.
The aim of the study provided by ValidCare in the USA was to understand whether any signs of liver dysfunction would show up in people who regularly use CBD and to provide evidence-based data to help determine the appropriate way to regulate hemp products containing CBD.
Also one of the reasons for this study is the fact that hepatocellular injury is a known side effect of the only CBD pharmaceutical product on the market- Epidiolex.
After a successful 7-month study, which started in August 2020 and ended in February 2021, we can finally look at the results, which have pleasantly surprised everyone.
Details of the study on the effects of CBD on the liver
The study involved 839 participants who used hemp-based CBD supplements in oral form (mainly oil with CBD) for at least 60 days. The research used 12 brands of over-the-counter CBD products to fill research gaps for such products.
The results showed that none of the participants had clinical evidence of advanced liver disease, according to the co-investigator of the trial, Dr Jeff Lombardo, a toxicologist. Moreover, he said, less than 10% of the participants experienced small, clinically insignificant increases in liver function tests, regardless of age, product formulation, or amount consumed. Three of the subjects had liver enzyme ALT levels 3 times higher than normal, but since they were taking prescribed medications, it is not known if they were the cause of the elevation or other factors.
In addition, nearly 70% of study participants reported maintaining the same medical health indicators and continuing to take concomitant liver medications, without increasing reported side effects, according to Validcare. Furthermore, other studies of similar groups of subjects showed an increase in liver function indicators by 11%, while this study by about 9%.
“This unexpected, positive finding makes the data even more compelling and provides significant important data to consider secondary safety measures for the entire population,” said co-investigator Dr Keith Aqua, a physician based in Miami.
“We will continue to analyze this real-world data and add a second prospective study to this data to increase the statistical confidence regarding liver safety and secondary measures among different populations and consumers with different medical conditions.”
Study conclusion
Validcare's decentralized clinical research platform and partnerships with national laboratories helped to successfully complete this promising study, delivering the results to brands and FDA officials.
Results from a human safety study on hemp-based CBD consumption found no evidence of toxicity or worsening liver disease in 839 participants.
This evidence-based data has been provided to the FDA for identification and safe regulatory action. Also, these results will help the rest of us regarding the safety of CBD to the liver and may help people in deciding to purchase any oral CBD products for a variety of conditions.
When choosing a product, remember to adhere to the recommended daily dosage and consult with your medical doctor before starting CBD supplementation.
Article author:
Resource:
https://hempindustrydaily.com/scientists-explain-how-liver-study-will-provide-fda-with-real-world-data-on-cbd/
https://hempindustrydaily.com/no-evidence-of-liver-disease-or-elevated-liver-function-cbd-study-shows/
https://validcare.com/press/validcares-clinical-study-reports-preliminary-results-of-cbd-liver-safety/
Article author:
Ondřej Šťovíček
Ondřej is a founder and CEO of Cannadorra. He is mainly taking care of strategic management and development of the international cooperation. His vision is to make hemp available for the medical and practical purposes to everybody.
