MANCHESTER, N.H., Nov. 18, 2014 /PRNewswire/ -- Today, a study of 232 patients was presented at the American College of Rheumatology 2014 Annual Meeting demonstrating that co-administered Traumeel® (Tr14) and Zeel® (Ze14) intra-articular (IA) injections are safe and effective treatments for moderate to severe pain associated with knee osteoarthritis (OA) versus IA placebo. The data was discussed today in a podium presentation by Carlos J. Lozada, M.D., Professor of Clinical Medicine, University of Miami Miller School of Medicine.
In the multi-center, double-blind, randomized, controlled trial, patients with moderate-to-severe chronic knee OA were randomized to three weekly IA injections of either Tr14 and Ze14 or saline. The primary efficacy variable was change in knee pain from baseline to end-of-study (week 17) as measured by the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) OA pain subscale. Secondary measures included TOTAL WOMAC and subscores for stiffness and physical function, change in pain following a 50-foot walk, as well as patient and physician global assessments.
By day 15, patients experienced significant reductions in pain, and secondary endpoints were directionally consistent. Of note, the study does not report any related serious adverse events. Adverse events were generally mild and reported as unrelated to treatment.
"In this study of 232 patients, Traumeel and Zeel provided statistically significant and clinically relevant pain relief for patients with osteoarthritis of the knee, a condition for which pain relief can be challenging to achieve," said Dr. Lozada. "I look forward to further research on this treatment to confirm and build on the findings in the study. This potentially represents an additional option in the management of osteoarthritis, especially for those patients who cannot tolerate non-steroidal anti-inflammatory drugs (NSAIDs), are not candidates for corticosteroid treatment or do not respond to other therapies."
Traumeel and Zeel injection solutions have been available globally for more than 60 years to help manage the pain of osteoarthritis. In the last 10 years, more than 1.5 million ampules of Traumeel and Zeel have been sold in the U.S.
"This study supports the clinical feedback we hear from healthcare professionals regarding positive outcomes with Traumeel and Zeel injections in knee osteoarthritis," said Jaclyn Chasse, ND, medical director, Emerson Ecologics. "We are proud to distribute prescription products like Traumeel and Zeel that are safe, effective and backed by clinical evidence."
Emerson Ecologics is the leading provider of injectable Traumeel and Zeel to qualified healthcare practitioners throughout the United States.
About Emerson Ecologics LLC
Founded in 1980, Emerson Ecologics, LLC is the leading distributor of professional-quality nutritional supplements, vitamins and prescription products to healthcare practitioners—representing over 275 brands. Widely recognized for their innovative Emerson Quality ProgramSM (EQP) and headquartered in Manchester, NH, with distribution centers in Virginia and California, Emerson Ecologics is GMP registered by NSF® International. For more information, visit www.emersonecologics.com.
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Note: These statements have not been reviewed by the Food and Drug Administration. They are supported by traditional homeopathic principles.