Lymphocyte markers & natural killer cell activity in fibromyalgia (FM) syndrome: effects of low – dose, sublingual use of human interferon – alpha

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A clinical study was designed to utilize flow cytometric

immunophenotyping and chromium release from cultured tumor

target cells to characterize peripheral blood mononuclear

leukocyte (PBML) subpopulations and natural killer activity in

healthy normal controls (n = 18) and in patients with

fibromyalgia syndrome (FMS) at baseline (n = 124) and again

after 6 weeks of treatment with low-doses of orally

administered human interferon-alpha (IFN-alpha). Volunteer

subjects discontinued all analgesic and sedative hypnotic

medications for 2 weeks prior to the baseline phlebotomy.

Laboratory measures included a complete blood count; a

phenotypic analysis of PBML by flow cytometry; and in vitro

natural killer (NK) cell activity. After baseline blood sample

collection, the FMS patients were randomized to one of four

parallel treatment groups (n = 28/group) to receive sublingual

IFN-alpha (15 IU, 50 IU, 150 IU), or placebo every morning for

6 weeks. The tests were repeated at week 6 to evaluate

treatment effects. At baseline, FMS patients exhibited fewer

lymphocytes and more CD25+ T lymphocytes than did normal

controls. By week 6, the main significant and consistent

change was a decrease in the HLA-DR+ CD4+ subpopulation in the

15 IU and 150 IU treatment groups. These data do not support

an immunologically dysfunctional PBML phenotype among patients

with FMS as has been observed in the chronic fatigue syndrome.

Russell IJ, Vipraio GA, Michalek JE, Craig FE, Kang YK, Richards AB