HONG KONG, Jan. 13 /PRNewswire/ -- The first double-blind placebo-controlled clinical trial of Lyprinol(R) in patients with Osteoarthritis (OA) confirms its effectiveness in the treatment of pain and in increased mobility in patients suffering from OA and other chronic inflammatory diseases. Professor C.S. Lau, co-chief; Division of Rheumatology, the Dept. of Medicine of the University of Hong Kong, facilitated the study. The results could have a significant impact on the American populace as the Arthritis Foundation has found that OA affects nearly 21 million Americans with medical costs estimated from $15.5 billion to $28.6 billion annually. According to the National Center for Health Statistics, 40.5 million American adults suffer from some form of arthritic symptoms.
This latest clinical trial validates the findings of over 25 years of pioneering Australian research regarding Lyprinol(R). Lyprinol(R) is a marine lipid extract derived from the Perna canaliculus or the New Zealand Green-Lipped Mussel. The extract’s composition is a combination of polyunsaturated fatty acids that has been investigated by leading Australian research institutes including The Royal Melbourne Institute of Technology, The Queen Elizabeth Hospital in Adelaide and the University of Queensland and has been found to have unique anti-inflammatory activity.
The clinical trial was conducted from 2001-2003 at the Queen Mary Hospital of the University of Hong Kong. Eighty patients with knee OA were randomized to receive either Lyprinol(R) or placebo for six months. All were allowed paracetamol/acetaminophen rescue treatment during the study and were reviewed at week 0, 2, 4, 8, 12, 18 and 24 for arthritis assessment and safety evaluation. Assessment of the patients’ arthritis included the use of a 100 mm visual analog scale (VAS) for pain, patient’s and physician’s global assessment of arthritis, a validated Chinese version of the Oxford Knee Score (COKS), a validated Chine version of the Arthritis Impact Measurement Scale 2-short form (CAIMS2-SF), erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP).
Clinical Trial Results
There was a greater improvement in the perception of pain as measured by the VAS. Patients’ global assessment of arthritis in those who took Lyprinol(R) when compared with controls from week four following adjustment for the change in the amount of paracetamol/acetaminophen used between study visits. Patients who took Lyprinol(R) but not placebo also had improved scores in the CAIMS2-SF physical function and psychological status domains from week four.
When used over six months, Lyprinol(R) was safe and well tolerated with no serious side effects reported. Further, there were no significant differences in the overall incidence of adverse reactions or withdrawal from study as a result of trial drug toxicity between Lyprinol(R)- and placebo-treated patients.
Researchers’ conclusion
Professor Lau concludes that Lyprinol(R), the unique lipid extract of the green-lipped mussel, may be considered a safe option in the treatment of OA. The clinical trial findings will be published in the first 2004 issue of the journal Progress in Nutrition (Mattioli 1885 Publ.).
This study confirms Australian scientists theory on Lyprinol’s action of being an inhibitor of the main inflammation pathway. A study recently conducted at the Pavlov Medical University, Department of Allergy and Lung Diseases Hospital Therapeutic Clinic, by Professor Aleksander Emelyanov et al in a double-blind placebo-controlled study published in the European Respiratory Journal 2002;20:596-600 clearly showed that Lyprinol significantly reduced the inflammation associated with atopic asthmatics. Previous experimental studies had shown that Lyprinol(R) was effective in inhibiting -5-lipoxygenase and cyclo-oxygenase pathways responsible for production of eicosanoids, including leukotrienes and prostaglandins, the aim of that study was to assess its effect on symptoms, peak expiratory flow (PEF) and hydrogen peroxide (H2O2) in expired breath condensate as a marker of airway inflammation in patients with steroid-naive atopic asthmatics. Forty-six patients with atopic asthma received two capsules of Lyprinol(R) or placebo b.i.d for 8 weeks. There was a significant decrease in daytime wheeze, the concentration of exhaled H2O2 and an increase in morning PEF in the Lyprinol group compared to the placebo group. There were no significant side-effects. The authors concluded that Lyprinol(R) had beneficial effect in patients with atopic asthma by reducing the inflammation.
Further clinical trials of Lyprinol(R) have already been started for moderate to severe asthma and a psoriasis trial will be conducted in the year 2004 in one of Australia’s leading clinics. For further information regarding Lyprinol(R), visit their Web site at http://www.lyprinolusa.com/ or call 1-800-453-1805.
University of Hong Kong
CONTACT: Teri James, +1-602-258-5088, or cell, +1-602-430-0374, for University of Hong Kong
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