Sodium oxybate (Xyrem) significantly improves FIQ score

Sodium oxybate Xyrem image
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Quick Look

Does sodium oxybate (Xyrem) decrease the FIQ score?

Science: Yes: At both dosages tested the FIQ score was reduced by at least 18.4 points.

Conclusion: Sodium oxybate appears effective in reducing fibromyalgia impairment, as measured by the FIQ.

Note: Sodium oxybate (Xyrem) has not been approved by the FDA for the treatment of fibromyalgia.

 

Sodium oxybate (Xyrem) appears superior to current FDA approved medications.

Sodium oxybate Xyrem imageAn 8 week trial of sodium oxybate in the treatment of fibromyalgia resulted in a significant decrease in fibromyalgia impairment as measured by the Fibromyalgia Impact Questionnaire (FIQ.)

Among those receiving sodium oxybate, the 4.5 gm dose resulted in a 20.4 point reduction in FIQ and the 6.0 gm dose resulted in an 18.4 point reduction. Those receiving placebo had an 8.6 point reduction in FIQ score.

The therapeutic benefit over placebo therefore ranged from 9.8 points (6.0 gm dose) to 11.8 points (4.5 gram dose.)

 

January 2009

Sodium oxybate relieves pain and improves function in fibromyalgia syndrome: a randomized, double-blind, placebo-controlled, multicenter clinical trial.

Summary of the Abstract

Patients with fibromyalgia were randomized to receive 4.5 gm or 6 gm of sodium oxybate or placebo once per night for 8 weeks. The primary outcome co-measures included pain rating, the Fibromyalgia Impact Questionnaire (FIQ) score, and the Patient Global Impression of Change (PGI-C). A total of 188 patients were studied.

Sodium oxybate was found to be well tolerated and significantly improved the symptoms of fibromyalgia.


One Response to Sodium oxybate (Xyrem) significantly improves FIQ score
  1. Patrick
    May 23, 2011 | 5:03 pm

    I have fibromyalgia, severe, and the lack of sleep and the interupted sleep I experience has made profound changes in my life, with none of it being good. I do not understand why people with narcolepsy have access to Sodium Oxybate, while people with fibromyalgia do not. I read the comments made during the proceedings on whether or not to approve Sodium Oxybate by the FDA, and found many to be absolutely ludicrous. I know there are complications with SO, just like the other 21 medications I take for this horrible disease. However, if it is effective in test after test for people with fibromyalgia, then why not approve it? It seems to be well-controlled – I don’t see any literature or articles regarding SO abuse other than it being the date-rape drug, however, since the fibromyalgia has made a very negative effect on my ability to have sex with my wife, I don’t think that is really going to be a problem (I have to use a testosterine gel daily, and Viagra, and we need to have a lot of planning done before engaging in sex). Let me, in conjunction with my pysician, decide if it may be right for me. I can do that, and I trust my doctor to help me with that process, just like she always has. I would like to have just one good nights sleep again; just one. It has literally been years since I made it through the night without having to wake up numerous times because of pain, severe stiffness, night terrors, etc. and have to get out of bed so that I can go back to sleep again later. Or not. It would make so much difference if I knew that I could go to sleep, have refreshing deep sleep, and waking up feeling refreshed vs. waking up feeling like I just got hit by a truck. Please allow me to decide so I can get some semblance of my former life back. It’s been 11 years and counting, and yes, it does continue to get worse, day by day. Please.