Title
Efficacy of S-Adenosylmethionine in Fibromyalgia
Double-Blind, Placebo-Controlled Trial of the Impact of S-Adenosyl-L-Methionine (SAM-e) on the Mood and Other Symptoms in Fibromyalgia
Phase
Phase 2Lead Sponsor
Deakin UniversityStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Fibromyalgia SyndromeIntervention/Treatment
s-adenosyl methionine ...Study Participants
70Fundamentally, 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
One 400 mg tablet daily in the morning.
Inclusion Criteria: Diagnosis of Fibromyalgia by a medical practitioner Exclusion Criteria: Pregnancy, Manic and hypomanic conditions