Reduction of morning stiffness & improvement in physical function in fibromyalgia (FM) syndrome patients treated sublingually with low doses of human interferon – alpha

One hundred and twelve fibromyalgia syndrome (FMS) patients

were randomized into one of four demographically similar

groups (n = 28/group). Sequential primary FMS patient

volunteers were to receive daily sublingual placebo or

interferon-alpha (IFN-alpha) at 15, 50, or 150 IU. After a

screening evaluation, analgesic or sedative hypnotic

medications were withdrawn. Two weeks later, daily IFN-alpha

or placebo was initiated with follow-up evaluations at 2-week

intervals ending with week 6. One primary, three secondary,

and seven tertiary variables were assessed. Study outcome was

based on improvement in the tender point index (TPI). The TPI

did not improve with any IFN-alpha dose.

However, significant

improvement was seen in morning stiffness and in physical

function with the 50 IU IFN-alpha (p < 0.01). None of the

other outcome means changed significantly and no adverse

events were attributable to IFN-alpha therapy.

Russell IJ, Michalek JE, Kang YK, Richards AB

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