Sodium oxybate reduces pain, fatigue, and sleep disturbance and improves functionality in fibromyalgia: Results from a 14-week, randomized, double-blind, placebo-controlled study

Pain 152(5):11 (2011) PMID 21397402

This 14-week, phase 3, double-blind, randomized, controlled trial evaluated sodium oxybate (SXB) 4.5 and 6g per night versus placebo in patients with fibromyalgia (FM). SXB is the sodium salt of @c-hydroxybutyrate (GHB). GHB is an endogenous compound, synthesized from @c-aminobutyric acid (GABA) and found broadly in the central nervous system and body. Among 548 randomized patients, a >=30% reduction in pain was experienced by 54.2% and 58.5% of patients treated with SXB 4.5 and 6g, respectively, versus 35.2% for placebo with a 100-mm Visual Analog Scale (VAS) (P<0.001). Headache, nausea, dizziness, vomiting, diarrhea, anxiety, and sinusitis were the most commonly reported adverse events, with an incidence at least twice that of placebo. These results expand the evidence from previous clinical trials suggesting that SXB is effective and safe in FM. This study expands evidence from previous trials that sodium oxybate provides safe, effective treatment for multiple symptoms experienced by patients with fibromyalgia.