The use of a natural medicine, S-adenolsylmethionine (SAM-e) in the treatment of Fibromyalgia and Chronic Fatigue Syndrome

S-Adenosylmethionine (SAM-e) for the treatment of symptoms of fibromyalgia and chronic fatigue syndrome: A double-blind, randomised, placebo controlled trial.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000377437

Enrollment

120

Registered

2007-07-17

Start date

2007-09-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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) and chronic fatigue syndrome (CFS). We have previously conducted a trial with FMS patients using a low dose of SAM-e over a brief timeframe. The results of this study were encouraging and revealed the possibility that a circadian mechanism relying upon adequate SAM-e levels in the brain may provide a new avenue for treatment. We seek to investigate this finding in a comprehensive trial of SAM-e and to include patients with CFS. As such, salient clinical and pathological parameters will be assessed over a 24-week period in 180 patients who will be provided with the supplement (12 weeks) and placebo preparation (12 weeks). 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

Patients will be randomly allocated into groups to commence the trial (placebo and two treatment conditions). The SAM-e condition receive capsules containing SAM-e 400mg or 800 mg. Subjects will be required to take the capsules (x2) daily in the morning throughout the trial. Each treatment condition is of 8 weeks duration. All individuals will be exposed to all treatment

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Diagnosis of Fibromyalgia by a medical practitioner.Diagnosis of Chronic Fatigue Syndrome by a medical practitioner.

Exclusion criteria

Pregnancy, Concurrent manic illness.

Outcome results