Fibromyalgia
Conditions
Keywords
Fibromyalgia, Dietary Supplements, Rheumatologic Diseases, Complementary and Alternative Medicine
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTSoy
Drink a shake (vanilla and chocolate taste) once a day for 6 weeks.
OTHERPlacebo
Drink a shake (vanilla and chocolate taste) once a day for 6 weeks.
Sponsors
Physicians Pharmaceuticals, Inc.
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 76 Years
Healthy volunteers
No
Inclusion criteria
* Women and men age 18 - 76 * Able to understand and sign a consent form * Able to participate fully in all aspects of the study * Currently participating in Mayo Clinic's Fibromyalgia Treatment Program
Exclusion criteria
* Pregnant or lactating women * Allergy to soy or other study product ingredients * Diagnosis of bipolar disorder, schizophrenia or dementia * Diagnosis of diabetes mellitus or inflammatory bowel disease * Presently on soy product or use of soy within the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To gather preliminary data on whether dietary soy supplement can improve quality of life in patients with fibromyalgia as measured by the Fibromyalgia Impact Questionnaire (FIQ) and the Center for Epidemiologic Studies Depression Scale (CES-D). | 6 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| To assess the feasibility of recruiting 50 patients with fibromyalgia into a study of using a dietary supplement. | 3 Months |
Countries
United States
Outcome results
None listed