March 25 (UPI) — A tablet formulated with cannabidiol, or CBD, reduces pain after shoulder surgery, with no safety concerns, a study presented Friday during the American Academy of Orthopaedic Surgeons meeting found.
The tablet, called Oravexx, developed by New Jersey-based life sciences firm Orcosa, contains 50 milligrams of CBD and safely managed pain after minimally invasive rotator-cuff surgery, the data showed.
In addition, treatment with it did not produce any of the side effects associated with CBD use, such as nausea, anxiety and liver problems, the researchers said, during the meeting in Chicago.
“There is an urgent need for viable alternatives for pain management, and our study presents this form of CBD as a promising tool after arthroscopic rotator cuff repair,” study co-author Dr. Michael J. Alaia said in a press release.
“It could be a new, inexpensive approach for delivering pain relief,” said Alaia, an associate professor of orthopedic surgery at NYU Langone Health in New York City.
CBD is an ingredient in marijuana that does not cause the drug’s intoxicating effects, according to Harvard Health. It does not contain tetrahydrocannabinol, or THC, the ingredient that makes marijuana users “high.”
As a result, researchers have explored using the marijuana extract for medical purposes, including for relief of pain and anxiety symptoms, but results to date have been mixed.
For this phase 1/2 clinical trial, the first stage in testing, Alaia and his colleagues recruited 99 adults who underwent minimally invasive rotator cuff surgery at either NYU Langone Health and or the Baptist Health/Jacksonville Orthopaedic Institute in Florida.
The participants, all of whom were between 18 and 75 years old, were prescribed a low dose of the pain-killer Percocet during recovery and instructed to wean off the narcotic as soon as possible, the researchers said.
They were then instructed to take the CBD tablet or a placebo, or sham treatment that offers no clinical benefit for comparison purposes, three times a day for 14 days after their surgery, according to the researchers.
On the first day after surgery, the patients who took the CBD tablet experienced 23% less pain, on average, based on a commonly used assessment, compared with those on the placebo, the data showed.
On both the first and second days after surgery, patients who took the CBD tablet reported up to 25% greater satisfaction with pain control compared to those receiving placebo, the researchers said.
No major side effects were reported, they said.
Despite the promising results, the researchers cautioned against using commercialized CBD products to manage pain without consulting with a physician.
Multiple phase 2 studies, the second step in the development process, are in the planning stages and will evaluate the drug’s potential benefits for other acute and chronic pain management issues, the researchers said.
“This is currently still experimental medicine and is not yet available for prescription,” Alaia said.