A controlled clinical trial with a specifically configured RNA drug, poly(I).poly(C12U), in chronic fatigue syndrome

Clin Infect Dis. 1994 Jan;18 Suppl 1:S88-95. doi: 10.1093/clinids/18.supplement_1.s88.


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).

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Activities of Daily Living
  • Adult
  • Antiviral Agents / adverse effects
  • Antiviral Agents / therapeutic use*
  • Anxiety / complications
  • Anxiety / drug therapy
  • Cognition / drug effects
  • Depression / complications
  • Depression / drug therapy
  • Double-Blind Method
  • Drug Tolerance
  • Exercise Test
  • Fatigue Syndrome, Chronic / drug therapy*
  • Fatigue Syndrome, Chronic / physiopathology
  • Fatigue Syndrome, Chronic / psychology
  • Female
  • Humans
  • Karnofsky Performance Status
  • Male
  • Middle Aged
  • Poly I-C / adverse effects
  • Poly I-C / therapeutic use*
  • Poly U / adverse effects
  • Poly U / therapeutic use*
  • RNA, Double-Stranded / adverse effects
  • RNA, Double-Stranded / therapeutic use*


  • Antiviral Agents
  • RNA, Double-Stranded
  • Poly U
  • poly(I).poly(c12,U)
  • Poly I-C