Placebo Trial Results Lyprinol in Osteoarthritis

Results of a placebo-controlled Hong Kong University study confirm the clinical efficacy of Lyprinol® in patients with Osteoarthritis

Auckland –The results of a new study conducted under rigorous standards confirm the clinical activity and safety of a natural New Zealand marine lipid extract called Lyprinol® in patients with osteoarthritis (OA) and other chronic inflammatory diseases.

Arthritis affects one in three adults and is the greatest single cause of disability in New Zealand. Osteoarthritis is the most common form of arthritis, with half of all New Zealanders over the age of 60 and almost everyone over the age of 80 suffering from the condition.

The latest study validates the findings of over 25 years of pioneering Australian research into this natural extract, and shows Lyprinol® is a safe and effective addition to the therapeutic arsenal. Its composition is a unique combination of polyunsaturated fatty acids that had been investigated by leading Australian research institutes including The Royal Melbourne Institute of Technology (RMIT), The Queen Elizabeth Hospital in Adelaide and The University of Queensland.

Lyprinol® is the unique oil of Perna canaliculus, the green-lipped mussel of New Zealand. A large number of laboratory and clinical studies have confirmed its unique anti-inflammatory activity and safety.

The first double-blind placebo-controlled study with Lyprinol® in patients with osteoarthritis was conducted from 2001-2003 at the Queen Mary Hospital of the University of Hong Kong, an internationally respected institution. The principal investigator was Professor C.S. Lau, MD, Professor of Medicine. The results of the study confirm that Lyprinol® is statistically significantly effective against pain and in the global assessment score.

Treatment of osteoarthritis includes pain control and improvement of patients' function and quality of life. While conventional treatment such as non-steroidal anti-inflammatory drugs and simple analgesics may achieve these goals, their long-term use is associated with serious side effects.

Design of the latest study Eighty patients with knee OA were randomized to receive either Lyprinol® 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 Chinese 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, and patients' global assessment of arthritis in those who took Lyprinol® when compared with controls from week 4 following adjustment for the change in the amount of paracetamol/acetaminophen used between study visits. Patients who took Lyprinol® but not placebo also had improved scores in the CAIMS2-SF physical function and psychological status domains from week 4.

When used over six months, Lyprinol® 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® and placebo-treated patients.
Researchers’ conclusion Prof. C.S. Lau concludes that Lyprinol®, the unique lipid extract of the green-lipped mussel, may be considered a safe option in the treatment of OA. The study is being published in the first 2004 issue of the journal Progress in Nutrition (Mattioli 1885 Publ.).

Lyprinol® is also active in asthmatics, as demonstrated by Professor Aleksander Emelyanov et al in a double-blind placebo-controlled study published in the European Respiratory Journal 2002;20:596-600. Since experimental studies had shown that Lyprinol® 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 asthma in a double-blind randomized, placebo-controlled clinical trial. Forty-six patients with atopic asthma received two capsules of Lyprinol® 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® had beneficial effect in patients with atopic asthma.

Further clinical trials of Lyprinol® are planned for asthma and also psoriasis.

For further information on arthritis in New Zealand, go to the Arthritis New Zealand website at http://www.arthritis.org.nz.

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