Treatment with 4Jointz reduces knee pain over 12 weeks of treatment in patients with clinical knee osteoarthritis: a randomised controlled trial

Abstract

To assess the efficacy of thrice daily topical 4Jointz utilizing Acteev technology (a combination of a standardized comfrey extract and a pharmaceutical grade tannic acid, 3.5g/day) on osteoarthritic knee pain, markers of inflammation and cartilage breakdown over 12 weeks. Adults aged 50-80 years (n=133) with clinical knee OA were randomised to receive 4Jointz or placebo in addition to existing medications. Pain and function were measured using a visual analogue scale (VAS) and the Knee Injury and Osteoarthritis Outcome Score (KOOS) scale at baseline, 4, 8 and 12 weeks. Inflammation was measured analysing IL-6 expression and CTX-2 presence as representative for cartilage breakdown using ELISA, at baseline and 12 weeks. Pain scores significantly reduced in the group who received 4Jointz compared to the group who received placebo after 12 weeks using both the VAS (-9.9mm, P=0.034) and the KOOS pain scale (+5.7,P=0.047). Changes in IL-6 and CTX-2 were not significant (-0.04, P=0.5;-0.01, P=0.68). Post-hoc analyses suggested that treatment may be most effective in women (VAS-16.8mm, P=0.008) and those with milder radiographic osteoarthritis (OA) (VAS-16.1mm, P=0.009). Rates of adverse events were similar in both groups, excepting local rash that was more common amongst participants receiving 4Jointz (21% vs 1.6%, IRR 13.2, P=0.013), but only 26% (n=4) of participants with rashes discontinued treatment. There were no changes in systemic blood results. Topical treatment using 4Jointz reduced pain but had no effect on inflammation or cartilage breakdown over 12 weeks of treatment. Australia and New Zealand Clinical Trials registry ACTRN12610000877088.