Reduction of morning stiffness and improvement in physical function in fibromyalgia 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(IFN-alpha) at 15, 50, or 150 IU, After a screening evalu ation, analgesic or sedative hypnotic medications were withdrawn.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 improvem ent in the tender point index (TPI), The TPI did not improve with any IFN-a lpha dose. However, significant improvement was seen in morning stiffness a nd in physical function with the 50 IU IFN-alpha (p < 0,01), None of the ot her outcome means changed significantly and no adverse events were attribut able to IFN-alpha therapy.