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PCSO-524

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PCSO-524 is a patented marine lipid extract [1] containing 30 polyunsaturated fatty acids (PUFAs) including the essential omega-3 fatty acids DHA and EPA.[2] It is extracted from the New Zealand green-lipped mussel (Perna canaliculus). PCSO-524 is the key ingredient in several patented and university studied Omega-3 preparations including Lyprinol® marketed outside the United States[3] and Omega XL® marketed in the United States.[4]

History

Omega-3 fatty acids are commonly found in cold-water fatty fish such as salmon.[5] They are considered "essential" fats because the body needs them but can’t make them; they must come from a dietary source or through supplementation.[6]

While it has been documented that Omega-3 fats are "essential",[7] there is no official US Recommended Daily Allowance (RDA) for Omega-3s in general, or its singular components, DHA and EPA,[8] the FDA recommends that consumers not exceed more than a total of three grams per day of EPA and DHA omega-3 fatty acids, with no more than two grams per day from a dietary supplement.[9]

Clinical studies have shown that both PCSO-524 as well as standardized fish oil (EPA 18% and DHA 12%) have anti-inflammatory activity that can contribute to reduced pain and improved joint mobility for patients who suffer from joint pain and common inflammatory conditions.[10]

PCSO-524 is a natural inhibitor of Lipoxygenase (LOX), an enzyme involved in the process of inflammation,[11] the activity of which has been referenced in clinical trials, with no adverse effects. The studies that are listed in the references have shown an absence of side effects.

Scientific studies

A study conducted at the Clinic of Rheumatology and Internal Medicine, Academic Clinical Hospital, Wroclaw, Poland was designed to compare, from baseline, pain relief and changes in the indicators of quality of life and safety for patients suffering from chronic joint pain taking PCSO-524 compared with patients taking standardized fish oil (EPA 18% and DHA 12%).

The researchers judged the efficacy of PCSO-524 positively with regard to pain relief within the first four weeks and considered it to be beneficial for their quality of life. Subjects treated with PCSO-524 continued to measure further reductions in pain during the 12-week period of the study. The benefits of standardized fish oil (EPA 18% and DHA 12%), administered at the same dosage as PCSO-524, were not evident during the 12-week trial. The researchers concluded that, given the potential side effects, large dosages needed and long duration required for fish oil, practitioners could consider PCSO-524 as an alternative medication for those who suffer from chronic joint pain.[1]

Researchers from the University of Queensland Brisbane, Australia. noted that PCSO-524 exhibits anti-inflammatory activity distinct from that of most NSAIDs, controlling chronic but not acute inflammation. Unlike Cox-1 inhibitors (aspirin, meclofenamic acid) it is not gastro-toxic. Predosing rats with PCSO-524 can modify both (i) the spontaneous and (ii) the oxytocin-induced contractions of the uterus. In humans there is anecdotal evidence that PCSO-524 can relieve dysmenorrhea. This report explores the concept that the uterotrophic actions of PCSO-524 are conditioned by: the intrinsic profile of estrogenic hormones and progestagens and, certain extrinsic stimuli. Evidence from in vitro studies indicates that PCSO-524may mimic that of a leukotriene receptor antagonist in relieving inflammation. [2]

The efficacy and safety of PCSO-524 was assessed as maintenance therapy for children with moderate asthma. A total of 71 children aged 6 to 13 years were enrolled in a 16-week, single centre, double-masked, placebo-controlled, parallel-group trial and randomly assigned to receive either a supplement containing PCSO-524 or a placebo. THe results showed PCSO-524 improved the percentage of children reporting little or no trouble with their asthma at three months of treatment (97% vs. 76% p=0.057). Both groups were able to tolerate a dose reduction of inhaled corticosteroid . There were fewer mild and moderate asthma exacerbations overall in the PCSO-524 group. The supplement containing PCSO-524 was well tolerated. It appears from this study that PCSO-524 is a safe nutritional supplement for children with moderate asthma and that larger prospective controlled studies should explore its potential use as a nutraceutical in asthma as an addition to conventional treatment. [3]

In Hong Kong, researchers used an adjuvant-induced joint pain rat model to investigate the effects of PCSO-524 omega-3-complex on pain. They confirmed the ability of PCSO-524 to control pain at the initial phase of its administration; with similar efficacy to that observed with Naproxen. The pain scores increased again in the group of rats treated with PCSO-524 after day 9–14. The Naproxen treated rats remained pain-free only while treated. However, rats treated with PCSO-524 were apparently cured after 1 year. This study confirmed the anti-inflammatory efficacy of PCSO-524 omega-3-complex, its initial analgesic effect, its tolerance and its long-term healing properties. [4]

Respiratory health is mediated, at least in part, by leukotrienes and other lipid mediators. Research carried out in The Queen Elizabeth Hospital and the University of Adelaide in Australia and the Charite University in Berlin, Germany has demonstrated that PCSO-524 is a modulator of the 5-lipoxygenase pathway, thus its ability to reduce the effects of persistent inflammation that one may find in various allergic reactions and other inflammatory disorders including inflammation of the respiratory airways.

Experimental studies have shown that PCSO-524 is effective in inhibiting 5′-lipoxygenase and cyclo-oxygenase pathways responsible for production of eicosanoids, including leukotrienes and prostaglandins. A study carried out at Saint Petersburg State Medical University, was designed to assess the effect of PCSO-524 on symptoms, peak expiratory flow (PEF) and hydrogen peroxide (H2O2) in expired breath condensate as a marker of airway inflammation in a double-blind randomized, placebo-controlled clinical trial. The authors conclude that PCSO-524 may be effective in promoting respiratory health, noting that there was a decrease in daytime wheeze, the concentration of exhaled H2O2 and an increase in morning PEF in the PCSO-524 group compared to the placebo group, and there were no significant side effects. [5]

References

  1. European Union trademark database (CTM) - PCSO-524.
  2. ERSP Reviews Advertising for Omega XL. ASRC Press Releases.
  3. European Union trademark database (CTM) - Pharmalink.
  4. J. Lello, A. Liang, E. Robinson, D. Leutenegger, A. Wheat (2012). "Treatment Of Children’s Asthma With A Lipid Extract Of The New Zealand Green Lipped Mussel (Perna Canaliculus) (Lyprinol®) - A Double Blind, Randomised Controlled Trial In Children With Moderate To Severe Chronic Obstructive Asthma". The Internet Journal of Asthma, Allergy and Immunology 8 (1). ISSN 1532-0642. http://www.ispub.com/journal/the-internet-journal-of-asthma-allergy-and-immunology/volume-8-number-1/treatment-of-children-s-asthma-with-a-lipid-extract-of-the-new-zealand-green-lipped-mussel-perna-canaliculus-lyprinol-a-double-blind-randomised-controlled-trial-in-children-with-moderate-to-severe-chronic-obstructive-asthma.html. 
  5. Fish and Omega-3 Fatty Acids. American Heart association (7 September 2010).
  6. Omega-3 Fatty Acids. University of Maryland Medical Center.
  7. Erin O'Donnell. Why Omega-3 Is an Essential Part of a Healthy Diet. WebMD the Magazine.
  8. FDA Recommended Daily Allowance of Fish Oil. LiveStrong.com (14 June 2011).
  9. "FDA Announces Qualified Health Claims for Omega-3 Fatty Acids". FDA News Release (US Food and Drug Administration). 8 September 2004. http://www.fda.gov/SiteIndex/ucm108351.htm. 
  10. Jacek Szechinski, Marek Zawadzki (2011). "Measurement of pain relief resulting from administration of Perna Canaliculus Lipid complex PCSO-524™ compared with fish oil for treating patients who suffer from osteoarthritis of the knee and/or the hip joints". Reumatologia 49 (4): 244-252. http://www.lyprinol.de/Szechinski-2011-OA-Lyprinol-Vs-Fishoil-EN.pdf. 
  11. McPhee S, Kalafatis N, Wright PFA, Macrides, TA (December 2001). "The marine oil Lyprinol is a substrate for the 5-lipoxygenase enzyme in porcine neutrophils". Proceedings of the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists Annual Meeting, Dunedin, New Zealand 9: 95. ISSN 1322-4530. 

Other references

  • Shiels IA, Whitehouse MW (September 2000). "Lyprinol: anti-inflammatory and uterine-relaxant activities in rats, with special reference to a model for dysmenorrhoea". Allerg Immunol (Paris) 32 (7): 279-83. PMID 11094641. http://www.ncbi.nlm.nih.gov/pubmed/11094641. 
  • Chi-Ho Lee, John Hon-Kei Lum, Curtise Kin-Cheung Ng, Janice McKay, Yoki Kwok-Chu Butt, Man-Sau Wong, Samuel Chun-Lap Lo (June 2009). "Pain Controlling and Cytokine-regulating Effects of Lyprinol, a Lipid Extract of Perna Canaliculus, in a Rat Adjuvant-induced Arthritis Model '". Complement Alternat Med 6 (2): 239–245. DOI:10.1093/ecam/nem100. PMID PMC2686621. </li>
  • A. Emelyanov1, G. Fedoseev1, O. Krasnoschekova1, A. Abulimity1, T. Trendeleva1and P.J. Barnes (September 2002). "Treatment of asthma with lipid extract of New Zealand green-lipped mussel: a randomised clinical trial". European Respiratory Journal 20 (3): 596-600. PMID 12358334. </li>
  • McPhee S, Hodges L, Wright PFA, Wynne P, Macrides TA (December 2003). "The marine oil, Lyprinol®, is an inhibitor of cyclooxygenase isoforms 1 and 2". Proceedings of the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists Annual Meeting, Sydney 10. ISSN 1322-4530. 
This article uses material from the Wikipedia article PCSO-524, that was deleted or is being discussed for deletion, which is released under the Creative Commons Attribution-ShareAlike 3.0 Unported License.
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