Efficacy of S-Adenosylmethionine in Fibromyalgia

Deakin University

Status and phase: Completed; Phase 2

Conditions: Fibromyalgia Syndrome

Treatments: Dietary Supplement: SAM-e (S-Adenosyl-L-Methionine)

Study type: Interventional

Funder types: Other

Identifiers

NCT00528710

DUHREC06

Details and patient eligibility

About

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

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Fibromyalgia by a medical practitioner

Exclusion criteria

• Pregnancy, Manic and hypomanic conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 1 patient group, including a placebo group

P

Placebo Comparator group

Description:

Placebo Control Group

Treatment:

Dietary Supplement: SAM-e (S-Adenosyl-L-Methionine)