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Sodium oxybate relieves pain and improves function in fibromyalgia syndrome: A randomized, double-blind, placebo-controlled, multicenter clinical trial
Arthritis & Rheumatism, 01/05/09

Russell IJ et al. – Study shows that sodium oxybate therapy was well tolerated. It significantly improved the symptoms of fibromyalgia syndrome (FMS); further studies are warranted.

Methods

Aim was to evaluate the safety and efficacy of sodium oxybate for management of the symptoms of FMS
FMS pts randomized, to receive 4.5 gm or 6 gm of sodium oxybate or matching placebo x1/night for 8 wks
Primary outcome variable (POV): a composite score for changes from baseline in 3 coprimary self-report measures: PVAS, FIQ score, and PGI-C
A beneficial response rate: 20% improvement in the PVAS and FIQ scores plus a rating of much better or very much better on the PGI-C
Secondary measures: subjective sleep and QoL measures
Analysis were based on an intent-to-treat (ITT) population

Results

ITT population included 188 pts with FMS; 78% of whom completed the trial
Significant benefit was observed with both dosages of sodium oxybate, according to changes in POV and subjective sleep quality
Improvements in the PVAS score were correlated with sleep outcomes
Sodium oxybate was well tolerated overall; dose-related nausea and dizziness tended to resolve with continued therapy