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People with chronic bad back could soon have reason to jump with joy – of course. A large -scale, randomized, double -blind and controlled clinical study has shown that a specifically formulated cannabis extract can significantly relieve people’s back pain.
In German -based pharmaceutical companies Veritable Developed the extract, the code-named Ver01 and sponsored the phase III attempt. People who reinforced revenue recorded a stronger reduction in pain compared to people on a placebo, as the study researchers stated. The company has already submitted an official approval of its drug in Europe and plans to ensure the approval of the US Food and Drug Administration.
The study carried out in different phases included over 800 adults in which chronic pain in the lower back area was diagnosed. In the first phase, around half of the participants were randomized in order to maintain Ver01 (orally), while the other half received a control substance. The researchers then followed the participants over a period of 12 weeks.
At the end of the 12 weeks, the Ver01 group showed a statistically significant improvement in pain compared to the placebo group.
On an 11-point scale, which was usually used to assess pain, people who have revenue saw an average of 1.9 points, for example compared to an average waste of 1.4 points in the placebo group. People who continue to take the medication after the first phase also had a greater reduction in pain over time. And those of Ver01 also reported a stronger improvement in their sleep quality and their physical functions, while the medication seemed to be safe to be tolerated without signs of dependency or withdrawal.
“In summary, it can be said that this phase-3 study provides robust evidence of the effectiveness and security of Ver01 in the treatment of (chronic pain in the lower back),” the authors wrote in their newspaper. published Monday in natural medicine.
Experts from external experts also seem to be enthusiastic about the potential of the drug.
“This is an excellent study. We have long argued that studies on cannabis or cannabis-based substances have to provide a high degree of evidence: this is,” Jan Vollert, lecturer for neurosciences at the University of Exeter in Great Britain. told The Science Media Center. “It is just a study and we will need further studies to confirm the results, but this is a good signal that the connection could help the patient.”
Many studies have recommended that cannabinoids, the primary connections in cannabis, can help treat pain. Countries in Europe and Asia have it too licensed Specific formulations of cannabis to treat nerve pain. Still Other studies have failed to show a consistent pain of pain from cannabis.
Some of these mixed evidence could be attributed to the fact that cannabis is equipped in many different tribes with a different diversity or another share of these compounds. Versonal and his researchers argue that his extract has the right mix of cannabinoids and other ingredients in order to reliably deliver pain relief. In particular, the extract contains only 5% THC. Although THC is the ingredient that is responsible for the “high” of cannabis 15% or higher).
The pain reduction documented in this latest study is relatively modest. But given the Lack of other effective non-opioid options In the case of back pain, Verben could certainly become widespread alternative treatment, one without the potential for harmful addiction. It is estimated About 40% From adults in the USA, have had back pain in the past three months more than 10% Americans currently have chronic back pain.
After the first publication of his phase -iii data at the beginning of this year Vertanical already did this submitted for the approval of Ver01 in Europe; It is planned to submit approval in Great Britain. The company is also in discussions with the FDA to design a study that the US regulatory authority could convince if it is successful to give approval.