MediNatura has announced it is now the exclusive importer of the homeopathic injection solutions Neuralgo-Rheum, Traumeel and Zeel, following study data presented at the American College of Rheumatology Annual Meeting.
In the study, researchers found co-administered Traumeel (Tr14, Heel) and Zeel (Ze14, Heel) intra-articular injections were effective treatments for moderate-to-severe pain associated with knee osteoarthritis (OA) vs. intra-articular placebo, demonstrating statistically and clinically relevant pain relief for knee OA, according to a company press release.
The study comprised 232 patients with moderate-to-severe chronic knee OA, with 119 randomly assigned to receive three weekly intra-articular injections of the combination of biological and multi-mineral products not yet approved as treatments for OA by the FDA, and 113 patients randomly assigned to placebo. The study’s primary outcome measured was the change in knee pain from baseline to the conclusion of the study. The researchers assessed clinical relevance through comparison of the proportion of patients with reductions in WOMAC A scores greater than a validated benchmark Minimally Clinically Important Difference (MCID).
According to the researchers, the combination Tr14/Ze14 treatment did not discriminate for WOMAC A Pain as predicted following only one of three injections on day 8; however, treatment outcomes were found to be significantly different on days 15, 43, 57, 71, 85 and 99. Additionally, although the proportion of MCID responders was not considered significant on day 8, the combination treatment was found to be significantly different on all subsequent days except day 29.
The researchers reported no related serious adverse events, and any adverse events reported were considered mild and not related to treatment.
“This study provides clinical evidence to support knee OA treatment with Traumeel and Zeel, providing an additional treatment option especially important for those patients who cannot tolerate NSAIDs, are not candidates for corticosteroid treatment or do not respond to other therapies,” study co-investigator Roland Moskowitz, MD, clinical professor of medicine, University Hospitals, Case Medical Center, said in the release.
Lozada C, et al. Paper #2896. Presented at: American College of Rheumatology Annual Meeting. Nov. 14-19, 2014; Boston.
Disclosure: Lozada reports relationships with Heel and Rio Pharmaceuticals. Please see the abstract for a list of all other authors’ relevant financial disclosures.