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A randomised double-blind 16-week study of ritanserin in fibromyalgia (FM) syndrome: clinical outcome & analysis of autoantibodies to serotonin, gangliosides & phospholipids

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By Olin R, Klein R, Berg PA • www.ProHealth.com • February 16, 1998


The aim of the study was to evaluate in a double-blind manner
the effect of the long-acting 5-hydroxytryptamine 2
(5-HT2)-receptor blocker Ritanserin on clinical symptoms in
patients with fibromyalgia syndrome (FM) and on production of
antibodies to serotonin, gangliosides and phospholipids,
recently shown to have a high incidence in this disease.

Fifty-one female patients with typical FM were included in the
16-week study: 24 received Ritanserin and 27 received a
placebo. Antibodies to 5-HT, gangliosides (Gm1) and
phospholipids (thromboplastin) were determined by
enzyme-linked immunosorbent assay at day 0 and at the end of
week 16. The psychological and physical status, including
tender points, of the patients was evaluated at day 0 and at
the end of weeks 4 and 16. At the end of the study, there was
an improvement (p < 0.05) in feeling refreshed in the morning
in the Ritanserin-treated group and headache was also
significantly improved compared with the placebo group. There
was no difference in pain, fatigue, sleep, morning stiffness,
anxiety and tender point counts in the Ritanserin and placebo
groups. Fifty-one per cent of the 51 patients had at least one
of the three antibodies to 5-HT, Gm1 and phospholipids. The
incidence and activity of these antibodies were not influenced
by Ritanserin or placebo. The observation that Ritanserin has
only a small effect on clinical symptoms indicates that
disturbances in serotonin metabolism or uptake may be only one
factor in the pathogenesis of the disease. The high incidence
of a defined autoantibody pattern in FM could again be
confirmed in this study. However, it remains speculative
whether immunological reactions are, indeed, involved.




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