Abstract
Osteoarthritis of the knee is a prevalent and painful condition increasing with age. The aim of this, the first well-controlled randomized controlled trial, was to evaluate the efficacy and safety of co-administered Traumeel11Traumeel and Zeel are registered trade names of Biologische Heilmittel Heel GmbH, Germany. (Tr14) and Zeel1 (Ze14) in patients with knee osteoarthritis (OA) experiencing moderate-to-severe pain.
This was a double-blind, multi-center, randomized, saline-controlled trial. Eligible patients meeting the American College of Rheumatology criteria for knee OA were randomized to 3, weekly intra-articular Tr14/Ze14 (n=119) or saline (n=113) injections. Primary efficacy endpoint was knee pain change from baseline (day 1) to end-of-study visit (day 99), as measured by the WOMAC Pain Subscore. Secondary endpoints included measures of WOMAC OA Index total and subscores, 50-foot walk test, and patient (PGA) and physician (PhGA) global assessments. Safety was assessed by vital signs, treated knee examinations, adverse events (AEs), and concomitant medications use. Effect sizes were calculated post hoc for consistency with published meta-analyses of standard-of-care treatments.
232 patients were randomized with no significant baseline differences. For the primary endpoint Tr14/Ze14 was significantly superior to saline (−32.0 vs. −25.5; p=0.0383, 95% CI for difference: −12.40, −0.35). WOMAC and 50-foot walk pain measures showed statistically significant efficacy for pain relief over study days 15–99 (except Day 29). Safety profile showed no serious adverse events related to the treatment. PhGA indicated significant improvement for Tr14/Ze14 on Days 29, 71 and Day 85.
In this study, intra-articular Tr14/Ze14 provided significant pain relief compared to saline-control throughout the observation period. Treatment effect sizes were clinically relevant, since these were comparable to those reported for standard-of-care treatments. The safety profile was benign.
