Fibromyalgia Syndrome
Conditions
Keywords
S-Adenosylmethionine
Brief summary
Fundamentally, the trial aims to conduct a gold-standard test of the clinical impact of SAM-e in the treatment of depressed mood and general symptoms of fibromyalgia (FMS). As such, salient clinical and pathological parameters will be assessed over an 8-week period in 60 patients who will be provided with either SAM-e or a placebo preparation . On the basis of previous literature, it is hypothesised that patients in the active treatment group will experience moderate but significant improvements across the clinical measures, and that these gains will be significantly greater than any reported in the placebo group. All patients will provide informed consent. All procedures will be conducted under medical supervision and the preparation itself is very safe when used in the manner proposed for the trial
Interventions
DIETARY_SUPPLEMENTSAM-e (S-Adenosyl-L-Methionine)
One 400 mg tablet daily in the morning.
Sponsors
Deakin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Fibromyalgia by a medical practitioner
Exclusion criteria
* Pregnancy, Manic and hypomanic conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom reduction in Fibromyalgia. Specifically we expect a reduction in depressive symptoms, sleep disturbances and gastric disturbances. | Measured at three points in time: pre-trial and at 4 and 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Examination of dose-response data and the nature of the placebo effect in these conditions. | Measured at three points in time: pre-trial and at 4 and 8 weeks |
Countries
Australia
Outcome results
None listed