Laslett, LL and Quinn, SJ and Darian-Smith, E and Kwok, M and Fedorova, T and Korner, H and Steels, E and March, L and Jones, G, Treatment with 4Jointz reduces knee pain over 12 weeks of treatment in patients with clinical knee osteoarthritis: a randomised controlled trial, Osteoarthritis and Cartilage: Journal of The Osteoarthritis Research Society International, 20, (11) pp. 1209-1216. ISSN 1063-4584 (2012) [Refereed Article]
Copyright 2012 Osteoarthritis Research Society International.
Objective: 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, 3.5 g/day) on osteoarthritic knee pain, markers of inflammation and cartilage breakdown over 12 weeks.
Patients and methods: 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.
Results: Pain scores significantly reduced in the group who received 4Jointz compared to the group who received placebo after 12 weeks using both the VAS (−9.9 mm, 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 −16.8 mm, P = 0.008) and those with milder radiographic osteoarthritis (OA) (VAS −16.1 mm, 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.
Conclusions: Topical treatment using 4Jointz reduced pain but had no effect on inflammation or cartilage breakdown over 12 weeks of treatment.
|Item Type:||Refereed Article|
|Keywords:||osteoarthritis, knee, musculoskeletal system, clinical trial|
|Research Division:||Medical and Health Sciences|
|Research Group:||Clinical Sciences|
|Research Field:||Rheumatology and Arthritis|
|Objective Group:||Clinical Health (Organs, Diseases and Abnormal Conditions)|
|Objective Field:||Skeletal System and Disorders (incl. Arthritis)|
|Author:||Laslett, LL (Dr Laura Laslett)|
|Author:||Darian-Smith, E (Dr Erica Darian-Smith)|
|Author:||Kwok, M (Mr Michael Kwok)|
|Author:||Korner, H (Professor Heinrich Korner)|
|Author:||Jones, G (Professor Graeme Jones)|
|Web of Science® Times Cited:||4|
|Deposited By:||Menzies Institute for Medical Research|
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