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Sodium oxybate therapy provides multidimensional improvement in Fibromyalgia

Thursday 9 February 2012


From ProHealth:


ProHealthSodium oxybate therapy provides multidimensional improvement in fibromyalgia: Results of an international phase 3 trial – Source: Annals of the Rheumatic Diseases, Jan 31, 2012
by Michael Spaeth, Robert M Bennett, et al.
February 2, 2012

[Note: To read the full text of this article free, click here. The active ingredient in Xyrem®, sodium oxybate is a central nervous system depressant prescribed to reduce daytime sleepiness in narcolepsy patients. The rationale for using sodium oxybate for FM was based on its ability to encourage restorative sleep patterns, and the observation that “disturbed sleep can cause hyperalgesia in chronic pain conditions by dysregulation of the descending pain inhibitory pathways.” Used illegally it is known as the ‘date rape drug’.]

Background: Fibromyalgia is characterized by chronic musculoskeletal pain and multiple symptoms including fatigue, multidimensional function impairment, sleep disturbance and tenderness. Along with pain and fatigue, non-restorative sleep is a core symptom of fibromyalgia.

Sodium oxybate (SXB) is thought to reduce non-restorative sleep abnormalities. This study evaluated effects of SXB on fibromyalgia-related pain and other symptoms.

Methods: 573 patients with fibromyalgia according to 1990 American College of Rheumatology criteria were enrolled at 108 centers in eight countries.

Subjects: were randomly assigned to placebo, sodium oxybate 4.5 g/night or sodium oxybate 6 g/night.

The primary efficacy endpoint was the proportion of subjects with 30% or more reduction in pain visual analogue scale from baseline to treatment end.

Other efficacy assessments included function, sleep quality, effect of sleep on function, fatigue, tenderness, health-related quality of life and subject's impression of change in overall wellbeing.

Results: Significant improvements in pain, sleep and other symptoms associated with fibromyalgia were seen in sodium oxybate-treated subjects compared with placebo.

  • The proportion of subjects with 30% or more pain reduction was:
    - 42.0% for sodium oxybate 4.5 g/night (p=0.002)
    - And 51.4% for sodium oxybate 6 g/night (p<0.001)
    - Versus 26.8% for placebo.
  • Quality of sleep (Jenkins sleep scale) improved by 20% for sodium oxybate 4.5 g/night (p 0.001 or less) and 25% for sodium oxybate 6 g/night (p 0.001 or less) versus 0.5% for placebo.
  • Adverse events with an incidence 5% or more and twice placebo were nausea, dizziness, vomiting, insomnia, anxiety, somnolence, fatigue, muscle spasms and peripheral edema.

Conclusion: These results, combined with findings from previous phase 2 and 3 studies, provide supportive evidence that sodium oxybate therapy affords important benefits across multiple symptoms in subjects with fibromyalgia.

Source: Annals of the Rheumatic Diseases, Jan 31, 2012. PMID:22294641, by Spaeth M, Bennett RM, Benson BA, Wang YG, Lai C, Choy EH. Rheumatologische Schwerpunktpraxis, Munich, Germany. [Email:]


The above originally appeared here.

See also our previous article about sodium oxybate:


26 October 2011: Combination pharmacological management of Fibromyalgia


11 June 2011: Sodium oxybate for Fibromyalgia


22 March 2011: Xyrem not recommended for Fibromyalgia in Europe


22 August 2011: FBI agent, 19 others vote against Jazz Pharma's drug for Fibromyalgia



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