Society Logo
ME/CFS Australia Ltd
Please click here to donate ME/CFS South Australia Inc
 
 
Facebook
 
ME/CFS SOUTH AUSTRALIA INC

Registered Charity 3104

Email:
sacfs@sacfs.asn.au

Mailing address:

PO Box 322,
Modbury North,
South Australia 5092

Phone:
1300 128 339

Office Hours:
Monday - Friday,
10am - 4pm
(phone)

ME/CFS South Australia Inc supports the needs of sufferers of Myalgic Encephalomyelitis, Chronic Fatigue Syndrome and related illnesses. We do this by providing services and information to members.

Disclaimer

ME/CFS South Australia Inc aims to keep members informed of various research projects, diets, medications, therapies, news items, etc. All communication, both verbal and written, is merely to disseminate information and not to make recommendations or directives.

Unless otherwise stated, the views expressed on this Web site are not necessarily the official views of the Society or its Committee and are not simply an endorsement of products or services.

Become a Member
DOCX Application Form (Word, 198 KB)
Why become a member?

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

ProHealth.com
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: dr.spaeth@mac.com]

 

The above originally appeared here.

See also our previous article about sodium oxybate:

www

26 October 2011: Combination pharmacological management of Fibromyalgia

www

11 June 2011: Sodium oxybate for Fibromyalgia

www

22 March 2011: Xyrem not recommended for Fibromyalgia in Europe

www

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

 


 

blog comments powered by Disqus

Previous Previous Page