NEW YORK (Reuters Health) - An investigational, orally absorbed cannabidiol (CBD) product effectively reduced pain after arthroscopic rotator-cuff repair (ARCR) with no safety concerns and high satisfaction from patients in a randomized, placebo-controlled trial.
"There is a huge need for viable alternatives for pain management. In this study, at every time point, CBD continued to outperform placebo in terms of pain control, patient satisfaction, and even opioid consumption," principal investigator Dr. Michael Alaia of NYU Langone Health, in New York City, told Reuters Health by phone.
The study results were presented at the American Academy of Orthopaedic Surgeons (AAOS) annual meeting in Chicago.
The study included 99 adults undergoing ARCR. They were randomly allocated to an oral, buccally absorbed tablet containing 25 mg or 50 mg CBD (Oravexx, Orcosa Inc) three times daily for 14 days following surgery or identical placebo.
"For the first few days after rotator-cuff surgery, patients are in a pretty significant amount of discomfort," Dr. Alaia told Reuters Health.
On the first post-op day, patients receiving CBD experienced 23% less pain on average as measured by the Visual Analog Scale (VAS) pain score compared to patients receiving placebo (4.4 vs. 5.7, P=0.039).
On both the first and second post-op days, patients using the CBD product reported 22% to 25% greater satisfaction with pain control compared with peers taking placebo, also significant differences.
Patients receiving 50 mg of CBD reported lower pain and higher satisfaction with pain control compared to patients receiving placebo or 25 mg CBD.
No major side effects were reported and quantities of opioids consumed were low in both groups with no statistically significant differences in opioid consumption.
This study shows that this proprietary CBD product reduces pain in the immediate perioperative period following ARCR and has an acceptable safety profile, Dr. Alaia said.
He cautioned against patients seeking out CBD products on the market for pain control.
"One of the biggest issues with CBD at this point is that it's completely unregulated. You can buy it over the counter but you don't know what you're getting or what's in it. You don't even know if it's effective. It could be a complete placebo for all you know," he told Reuters Health.
This study examined a "well-designed, carefully scrutinized product under an investigational new drug application sanctioned by" the U.S. Food and Drug Administration (FDA), he noted in a press release.
Further studies with the CBD product are ongoing to confirm dosing and effectiveness in other orthopedic pathologies.
"We have a few studies on deck. Our next study we will evaluate whether CBD can bring down moderate pain from osteoarthritis of the knee," Dr. Alaia told Reuters Health.
Funding for the study was provided by the Jacksonville Jaguars Foundation. Dr. Alaia reported consulting for Arthrex, JRF Ortho, and DePuy Mitek Sports Medicine, and research support from Orcosa, Inc.
SOURCE: https://www.aaos.org/annual/ American Academy of Orthopaedic Surgeons Annual Meeting in Chicago, presented March 25, 2022.
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