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ME/CFS AUSTRALIA (SA) INC
Registered Charity 698
Email:
sacfs@sacfs.asn.au
Mailing address:
GPO Box 383,
Adelaide,
South Australia 5001
Office:
266 Port Road,
Hindmarsh,
South Australia 5007
Ph: (08) 8346 3237
('834 MECFS')
Office Hours:
Wednesdays, 10am-3pm
Support Line:
(Mondays and Thursdays,
10am-3pm)
Ph: (08) 8346 3237
SA country callers:
Ph: 1300 128 339
(local call)
FIBROMYALGIA HELP: Contact Fibromyalgia SA at the Arthritis Foundation of SA 118 Richmond Road, Marleston 5033 Ph: (08) 8379 5711 |
ME/CFS Australia (SA) Inc supports the needs of sufferers of Myalgic Encephalomyelitis, Chronic Fatigue Syndrome and related illnesses. We do this by providing services and information to members.
Disclaimer
ME/CFS Australia (SA) Inc aims to keep members informed of the various research projects, diets, medications, therapies etc. All communication, both verbal and written, is merely to disseminate information and not to make recommendations or directives.
Unless otherwise stated, the views expressed on this Web site are not necessarily the official views of the Society or its Committee and are not simply an endorsement of products or services.
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Ampligen for Chronic Fatigue Syndrome: Trial Data Released
Thursday 5 April 2012
From About.com's Adrienne Dellwo:
Ampligen for Chronic Fatigue Syndrome: Trial Data Released
Research Brief
A newly released study demonstrated that the drug Ampligen (rintatolimod) improved exercise tolerance and other symptoms of chronic fatigue syndrome (ME/CFS), and also lead to decreased use of other medications.
The study was funded by the drug's manufacturer, Hemispherx Biopharma. High-profile ME/CFS researchers Lucinda Bateman, Charles Lapp and Daniel Peterson were involved.
The 40-week, double-blind, placebo-controlled trial was conducted at 12 clinical sites and included 234 people with severe, long-term ME/CFS. Along with exercise tolerance, researchers looked for improvements in several markers of activity and vitality.
When it came to side effects, 99% of the Ampligen patients reported at least one; however, so did 97% of the patients on a placebo. Researchers say flu-like symptoms, chills, dilation of blood vessels (which lowers blood pressure), and difficulty breathing were the most common side effects of those taking the drug.
Ampligen is given by injection, and researchers say there was no statistical difference in injection-site reactions between the drug and placebo groups.
An odd feature of this study is how long it went on. It was launched in 1998 and concluded in 2004, about 15.5 years later. It also took about 8 more years for it to be published.
In the time that's elapsed, Hemispherx has attempted to secure FDA approval for Ampligen as an ME/CFS treatment, but the FDA in late 2009 rejected the application, recommending that the company provide data from at least one more study involving at least 300 people for 6 months.
This particular study falls short of the recommended number of participants but exceeds the suggested length.
In January, as the Ampligen application was about to expire, Hemispherx announced that the FDA had granted it an extension. It remains to be seen whether Hemispherx will attempt to add this study to the body of evidence before the FDA.
Thus far, no medication has been approved for ME/CFS.
Ampligen is an anti-viral and an immune-system modulator. It's believed to jump-start the body's natural anti-viral mechanism. However, it's a controversial drug that's been tested against a variety of illnesses for more than 3 decades without ever making it onto the market.
Some people with ME/CFS who've taken Ampligen report no improvement, while some report extremely positive results.
Learn more or join the conversation!
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The above, with comments, originally appeared here.
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