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Ampligen for Chronic Fatigue Syndrome: Trial Data Released
Thursday 5 April 2012
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.
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The above, with comments, originally appeared here.
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