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.
An 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.)
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.