Fibromyalgia Clinical Trial
Official title:
Effect of Revival Soy on Fibromyalgia Pain
Fibromyalgia is characterized by widespread pain that can lead to significant patient dysfunction and economic burden to society. The management of patients with fibromyalgia is difficult and no single treatment modality has been successful. We propose to study the effect of dietary soy supplement on quality of life associated with fibromyalgia.
Fibromyalgia syndrome is a chronic, generalized pain syndrome that affects the
musculoskeletal system (1). This syndrome is typically diagnosed in patients who experience
generalized musculoskeletal pain and have excessive tenderness in at least 11 of 18 specific
points (2). Although the primary cause of fibromyalgia syndrome is unclear, a growing body
of evidence indicates that the widespread pain associated with this syndrome is due to
abnormalities in the central nervous system. Therefore, drug therapy for fibromyalgia
syndrome is most often aimed at the central nervous system and includes tricyclic
antidepressants, selective serotonin reuptake inhibitors, dual serotonin and norepinephrine
reuptake inhibitors, analgesics, and anticonvulsants (1).
In addition to medical therapies, complementary and alternative medicine therapies have been
used to treat fibromyalgia syndrome symptoms (3). Soy is a widely used dietary supplement
that has not been previously tested for treating fibromyalgia syndrome.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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