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