Sodium Oxybate May Reduce Fibromyalgia Pain: Presented at AAPM

[Andi]

By Crystal Phend

SAN DIEGO, CA -- February 24, 2006 -- The sleep aid sodium oxybate (Zyrem) may also help reduce pain, tenderness, and chronic fatigue from fibromyalgia, according to a preliminary study presented here February 23rd at the 22nd Annual Meeting of the American Academy of Pain Management (AAPM). No drugs are currently approved by the U.S. FDA for the treatment of fibromyalgia.

"Fibromyalgia is notoriously refractory to treatment," said lead investigator Patrick B. Wood, MD, assistant professor of family medicine at the Louisiana State University Health Sciences Center in Shreveport, Louisiana.

The researchers hypothesized that sodium oxybate would regulate neurotransmitter levels required for normal sleep cycles, which are frequently disrupted during stage III and IV sleep in people with fibromyalgia.

"This study demonstrates a pretty novel application of this drug," said Dr. Wood, but he acknowledged that some clinicians have used the drug off label for fibromyalgia.

In the double-blind, multicenter study, 150 fibromyalgia patients were randomized to receive 4.5 g or 6 g of sodium oxybate or placebo. They filled out a daily electronic diary reporting pain and fatigue visual analog scale scores as well as rescue medication use. Other measures of sleepiness, function, and global impression were recorded at office visits throughout the 27-day study.

Both doses of the drug resulted in significant reductions in pain, fibromyalgia impact scores, and patient-reported change in global impression scores compared to placebo.

There was a strong trend toward significant reductions in tender point count and tender point index. The sodium oxybate group reported 1.5 fewer tender points on average and about a 3-point reduction in tender point index score compared with the placebo group. Sleep scores were about 2 points lower on average for the active treatment arm.

There was a dose-dependent increase in nausea, vomiting, headache, and dizziness for patients receiving sodium oxybate compared with those who received placebo.

The authors cautioned that this is preliminary, proof-of-concept data. They are currently designing further studies to determine sodium oxybate's efficacy in treating fibromyalgia.

Orphan Medical, a subsidiary of Jazz Pharmaceuticals, sponsored this study.



http://www.docguide.com/news/content...25711F00660CCF

[beachwalker]

Sodium Oxybate is a brilliant drug for ADHD and sleep disorders I found when it was OTC. It boosted ones dopamine during sleep so that the next morning one needed less dexedrine. However its acute danger with alcohol has authorities nervous as well as its socalled abuse potential, which seems to have only occured when they made it illegal in many countries.

I really admire researchers that buck the system and relook at some of these drugs that have been given a bad reputation that has been over sensationalised. For me Zyrem was a true mood elevator as well as a potent sleep aid with no side-effects (though I never combined it with alcohol) unlike many of the antidepressants and downers they recommend for fybro and CFS.