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A controlled clinical trial with a specifically configured RNA drug, poly(I).poly(C12U) [Ampligen], in Chronic Fatigue Syndrome (CFS)

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Chronic fatigue syndrome (CFS) is a physically debilitating

illness associated with immunologic abnormalities, viral

reactivation, and impairment of cognition. In a randomized,

multicenter, placebo-controlled, double-blind study of 92

patients meeting the CFS case definition of the Centers for

Disease Control and Prevention, the response of several

laboratory and clinical variables to an antiviral and

immunomodulatory drug, poly(I).poly(C12U), was determined.

Measures of clinical response included Karnofsky performance

score, a cognition scale derived from a self-administered

instrument assessing symptomatology (SCL-90-R), an activities

of daily living scale, and exercise treadmill performance.

After 24 weeks, patients receiving poly(I).poly(C12U) had

higher scores for both global performance and perceived

cognition than did patients receiving placebo. In particular,

patients given poly(I).poly(C12U) had increased Karnofsky

performance scores (P < .03), exhibited a greater ability to

do work during exercise treadmill testing (P = .01), displayed

an enhanced capacity to perform the activities of daily living

(P < .04), had a reduced cognitive deficit (P = .05), and

required less use of other medications (P < .05).

Strayer DR, Carter WA, Brodsky I, Cheney P, Peterson D, Salvato P,

Loveless M, Thompson C, Shapiro DE, Elsasser W, et al

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