First Randomized Double Blind Clinical Trial on Swiss Medica’s O24 Fibromyalgia Published in Medical Journal
(Published 2/2/2006 8:00:00 AM EST)
Swiss Medica, Inc. (OTCBB:SWME) is pleased to announce that the randomized double blind clinical trial using O24 Fibromyalgia on patients suffering from Fibromyalgia has been published in the Practical Pain Management Journal, January/February 2006 issue (www.ppmjournal.com). This publication reaches over 37,000 medical professionals in the United States, including physicians, Occupational Health Professionals and Pain Specialists.
The clinical trials were conducted by Dr. Gordon Ko, Medical Director of the Canadian Centre for Integrative Medicine and were run from October 2004 thru January 2005. The results of the clinical study were analyzed by the Institute of Clinical Evaluative Studies, (ICES) in Toronto.
“This publication represents the first time a clinical study for O24 has been published in a medical journal,” said Grant Johnson, President and COO of Swiss Medica. “The findings of the clinical study indicate that the topical O24 product was superior to placebo in the management of Fibromyalgia Syndrome (FMS), with significant improvements documented in both subjective surveys of pain/dysfunction and in objective measures of algometry and hand dynamometry.”
Dr. Gordon Ko (Head, Fibromyalgia clinic) and Dr. David Berbrayer (Head, Dept. Rehabilitation Medicine) at Sunnybrook & Women’s Health Sciences Centre (University of Toronto), directed this 4-6 week pilot study of 153 Fibromyalgia subjects. Of these, 133 participants (87%) completed the study with 68 (51%) using a placebo. The other 65 (49%) used the O24 product. Assessments of these participants were carried out at multiple community clinics in the Greater Toronto Area.
“The group treated with O24 compared to placebo showed statistically significant improvement when measured on the Visual Analog Scale for pain,” noted Dr. Gordon Ko, who is also the Medical Director for the Canadian Centre for Integrative Medicine in Markham, Ontario. Dr. Ko’s clinical study was statistically peer-reviewed by Marko Katic, biostatistician at the Institute of Clinical Evaluative Studies (ICES).
Improvement was also statistically significant for VAS night pain, Jamar hand-grip strength, total number of Fibromyalgia tender points and the average tender point pain threshold as measured by algometry.
– For participants who used O24, 88% of the patients reported mild to markedly better improvement on the 7-point Lanier rating scale. 53% reported moderately better to markedly better improvement using O24.
– Only 7% reported mild improvement from the placebo on the 7-point Lanier rating scale. 79% of the placebo group reported no change in their condition and 14% reported a worsening of their condition.
Dr. Ko concluded about O24, “With the demise of traditional medications, such as the Cox-2 inhibitors, the use of therapies that have such clinical effectiveness, and minimal to insignificant side effects, is exciting news.”
For a full copy of this published article, please visit: http://www.024zone.com/files/Ko_TopicalPainArticle.pdf
O24 Fibromyalgia is the first patented, clinically tested product (OTC or prescription) for Fibromyalgia to be available in national pharmacies in the United States and Canada. O24 Fibromyalgia can be purchased at leading retailers including Rite Aid, Longs Drugs, Sav-On Drugs, Shoppers Drug Mart and Jean Coutu.
Fibromyalgia syndrome is a common and chronic disorder characterized by widespread muscle pain, fatigue, and multiple tender points. The word Fibromyalgia comes from the Latin term for fibrous tissue (fibro) and the Greek ones for muscle (myo) and pain (algia). Tender points are specific places on the body-on the neck, shoulders, back, hips, and upper and lower extremities-where people with Fibromyalgia feel pain in response to slight pressure. Although Fibromyalgia is often considered an arthritis-related condition, it is not truly a form of arthritis (a disease of the joints) because it does not cause inflammation or damage to the joints, muscles, or other tissues. Like arthritis, however, Fibromyalgia can cause significant pain and fatigue, and it can interfere with a person’s ability to carry on daily activities. Also like arthritis, Fibromyalgia is considered a rheumatic condition.
Fibromyalgia affects over 10 million Americans. For unknown reasons, between 80 and 90 percent of those diagnosed with Fibromyalgia are women; however, men and children also can be affected. Most people are diagnosed during middle age, although the symptoms often become present earlier in life. People with certain rheumatic diseases, such as rheumatoid arthritis, systemic lupus erythematosus (commonly called lupus), or ankylosing spondylitis (spinal arthritis) may be more likely to have Fibromyalgia, too.
At present, there are no prescription medications currently approved by the U.S. Food and Drug Administration (FDA) for treating Fibromyalgia.
About Swiss Medica, Inc.
Swiss Medica commercializes proprietary bioscience products that relieve chronic ailments. We increase our market share through focused distribution strategies in multiple sales channels. Swiss Medica’s mission is to be a world leader in the commercialization of life enhancing bioscience products that improve quality of lives. Please visit our websites at www.swissmedica.com ,www.O24zone.com and www.pmsescape.com.
Swiss Medica’s flagship product, the O24 Essential Oil Pain Neutralizer, holds US Patent #6,444,238B1. The O24 pain relief solution has been used and recommended for its fast-acting and long-lasting benefits by healthcare professionals and athletes in the United States, Canada and in Europe. O24 is widely available throughout the United States and Canada in leading pharmacies and other retailers. Customers can also visit www.O24zone.com, for ordering details and store locators for the nearest pharmacy.
Swiss Medica has recently launching the patented O24 Fibromyalgia pain reliever (US Patent #6,444,238B1) over-the-counter in North American retailers. The National Fibromyalgia Association (NFA) recently awarded O24 Fibromyalgia their first NFA Seal of Approval. Over 10 million Americans suffer from the long-term pain associated with Fibromyalgia. In a randomized double blind clinical trial conducted in 2005, 88 per cent of the patients who used O24 Fibromyalgia reported mild to markedly better improvement, versus only 7 per cent who used the placebo. Customers can also visit www.O24zone.com, for ordering details and store locators for the nearest retailer.
Swiss Medica also manufactures PMS Escape(R) which holds US Patent #’s 5760014 and 5612320. PMS Escape(R) is a specially formulated group of carbohydrates, vitamins and minerals, clinically proven to reduce changes in mood and appetite that women experience during the premenstrual period. Customers can also visit: www.pmsescape.com for additional information and ordering details.
Forward-looking statements in this news release are made pursuant to the “Safe Harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements involve risks and uncertainties, including, without limitation, risks relating to acceptance of Swiss Medica’s products in Canada, the United States and other countries, risks related to international sales and purchases and potential foreign currency exchange fluctuations, acceptance of Swiss Medica’s products, increased levels of competition, , dependence on intellectual property rights and other risks detailed from time to time in Swiss Medica’s periodic reports filed with the United States Securities and Exchange Commission and other regulatory authorities.
Swiss Medica, Inc. (OTC Bulletin Board:SWME)
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