On November 14, Ecofibre Limited announced that they had published the outcomes of the 8-week study on CBD (cannabidiol), which is extracted from hemp in the Journal, Postgraduate Medical and Hospital Practice.
The Chief Science Officer of Ecofibre Ananda Health business in America, Dr. Alex Capana, said that 97 patients participated in the study, all the patients had been using opioids for more than a year to treat chronic pain. Besides, some had been consuming opioids for several decades.
Among all the patients, 94 of them added full-spectrum hemp CBD products (softgels) to their treatment program, and after the eight weeks 53% of the patients showed a reduction in opioid usage while 94% revealed an improvement in the quality of life measures such as better sleep, uplifted mood, and minimal or no pain.
The researchers used the Pittsburgh Sleep Quality Index and Pain Intensity and Interference Scale to statistically measure sleep quality and pain intensity, which showed a significant improvement.
The Ecofibre LTD Full-Spectrum softgels contains 15.7 mg of CBD, 0.5 mg of THC, 0.3 mg of CBDV, 0.9 of CBDA, and>1% of botanical terpene blend. The components of the softgels are safe and tolerable.
Not considering the survey, the study on the use of Hemp-Derived CBD in the reduction of opioid consumption and management of chronic pain has been the most significant in the marijuana industry, added Dr. Capano.
He further said that it is the first study to identify key data points on CBD and opioid reduction, such as doses of hemp extract, methods of consumption or use, and specific marijuana compounds. The majority of the patients involved in the study used lower doses of CBD, i.e., 30mg per day, while other studies focusing on CBD used ten or twenty times more. Patients who used lower doses reported minimal side effects and enhanced results.
Eric Wang, the managing director of Ecofibre Limited, noted that the study is still ongoing, and its primary purpose is to help people understand how CBD improves the quality of life. He added that the clinical trial is a stepping stone, and its results help advance people’s knowledge of CBD benefits.
Wang further said that the company’s goal is to add on the existing data to help educate regulators, doctors, pharmacists, and consumers.
The researchers were careful in patient recruitment and limitations for the clinical trials. The clinical was conducted in Kentucky at the Murphy Pain Center, where patients with a history of substance use disorder; a history of a non-fatal; psychotic disorder; an abnormal drug screen in the past year; epileptic episodes with the past year; cardiac arrest; renal; or if they are allergic to marijuana-based products.
Despite the study being the largest, it should consider the limitations such as a short trial period, placebo-controlled design, absence of participant’s control, a rather small sample size.
Three of the 97 participants opted out of the study midway. Another two experienced drowsiness as a side effect after consuming 15mg of CBD, and this was mitigated by lowering the dosage. Another patient said that her heartbeat increased significantly after using 15mg twice a day; the side effects were offset with a single dose of 30mg of CBD, which saw them to the end of the clinical trials. During the clinical trials, the participants did not report any severe reactions.
Out of the three who dropped out of the trials, one of them cited the high cost of the products should the therapy prove to be successful. Some of the other participants expressed the same concern. The patients further said that unless the products are issued under the insurance or sold at discounted prices through medical programs or institutions, accessing the CBD products will remain a challenge for those who are not financially stable.
Ecofibre Limited supplies hemp to the United States and Australian markets. The full-spectrum hemp extracts grown in Kentucky are used in the production of nutraceutical products for people and pet consumption. It is also used to make topical creams and salves in America. In Australia is used in the production of wellness products such as protein powders, or de-hulled hemp seed and oil through Ananda Food.
Ecofibre has partnered with Thomas Jefferson University to develop hemp-based fabrics and composite materials in the U.S.