CYNTHIANA, Ky., Nov. 14, 2019 /PRNewswire/PRESS RELEASE -- Ecofibre Limited today announced publication of the results of an 8-week study on Hemp Derived CBD (cannabidiol) in the Journal Postgraduate Medical and Hospital Practice.
Dr. Alex Capano, Chief Science Officer of Ecofibre's Ananda Health business in the United States, said, "Ninety-seven patients completed the study, all of whom had been using opioids for over a year to manage chronic pain. Some patients had been using opioids for decades."
"Ninety-four of those patients added Ananda full spectrum hemp extract (softgels) to their treatment regimen, and in just 8 weeks:
- 53% reduced their use of opioids
- 94% reported improvements in quality of life indices, specifically sleep, pain and/or mood."
"The sleep and pain score improvements were statistically significant using two validated measurement instruments, the Pittsburgh Sleep Quality Index and the Pain Intensity and Interference Scale."
"Ananda Full Spectrum Softgels [each containing 15.7 mg CBD, 0.5 mg THC. 0.3 mg CBDV, 0.9 mg CBDA, and a >1% botanical terpene blend] were well tolerated and demonstrated an excellent safety profile."
Dr. Capano added, "Outside of survey studies, this has been the largest study on the use of CBD to reduce the use of opioids in the treatment of chronic pain."
"It's also the first study on CBD and opioid reduction to identify key data points, such as hemp extract doses, delivery method, and specific cannabinoid content. Most participants used a relatively low dose of 30mg of CBD per day, whereas other studies on CBD have tested very large doses, 10x or 20x that amount. Lower doses of CBD mean reduced risk of side effects and improved outcomes."
Ecofibre Limited Managing Director Eric Wang commented, "This study is part of an ongoing program of work by Ananda to improve our understanding of how CBD can help improve people's lives."
"While the results of the study are very important, and in many ways unique, it's really another stepping stone and resource to continue improving our understanding of the benefits of CBD."
"Our intention not to create another pharmaceutical drug, but rather to continue building the data needed by regulators, doctors, pharmacists and consumers to help educate themselves."
Considerations and Takeaways
Investigators were careful to report on trial recruitment methods and limitations.
Patients recruited from the Murphy Pain Center in Kentucky where the research was carried out were excluded if they had a history of substance use disorder; psychotic disorder; an abnormal drug screen in the past year; history of a non-fatal overdose; any epileptic activity in the past year; cardiac, renal or hepatic co-morbidities; or any known allergy to cannabis-based products.
Study limitations that should be considered include a lack of randomized, placebo-controlled design, a short trial duration, the lack of a control group, and a relatively small sample size – despite being the largest of its kind.
Of the 97 participants, three chose not to complete the trial in its entirety. Two found the minimum 15 mg dosage caused the unwanted side effect of drowsiness. In evidence-based practice, this concern could have been mitigated through lowered dosing for those individuals. Another participant reported that the single 15 mg dose taken twice a day caused her heart to race, whereas a single dose of 30 mg attenuated those effects and enabled trial completion. No significant adverse reactions were reported overall.
The third participant unable to complete the trial did so with the expressed concern that, should the therapy prove effective, he would not be able afford to purchase the product out-of-pocket. He was not the only patient who had this concern. Unless plant-sourced products are covered by insurance or offered at discounted rates through medical programs and institutions, and until all states allow for home grows, access will remain a problem for those without the financial means to purchase products on their own.
Ecofibre provides hemp products to the U.S. and Australian markets. Kentucky-grown full-spectrum hemp extract is used to produce nutraceutical products for human and pet consumption, as well as topical creams and salves in the U.S. In Australia, locally grown hemp is processed into food products including protein powders, de-hulled hemp seed and hemp oil via Ananda Food.
Ecofibre is also developing innovative hemp-based products in textiles and composite materials in partnership with Thomas Jefferson University (TJU) in the United States.
Editor’s note: additional information sourced from the original study was included with the press release content.