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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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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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