Efficacy of S-Adenosylmethionine in Fibromyalgia
- Conditions
- Fibromyalgia Syndrome
- Interventions
- Dietary Supplement: SAM-e (S-Adenosyl-L-Methionine)
- Registration Number
- NCT00528710
- Lead Sponsor
- Deakin University
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- Diagnosis of Fibromyalgia by a medical practitioner
- Pregnancy, Manic and hypomanic conditions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description P SAM-e (S-Adenosyl-L-Methionine) Placebo Control Group
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Deakin University
🇦🇺Burwood, Victoria, Australia