Sodium Oxybate for Fibromyalgia

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

Arthritis Rheum. 2008 Dec 30;60(1):299-309. [Epub ahead of print]

Russell IJ, Perkins AT, Michalek JE; Oxybate SXB-26 Fibromyalgia
Syndrome Study Group.

The University of Texas Health Science Center at San Antonio.

PMID: 19116896


OBJECTIVE: To evaluate the safety and efficacy of sodium oxybate for
management of the symptoms of fibromyalgia syndrome (FMS).

METHODS: Patients with FMS (according to the American College of
Rheumatology 1990 criteria) were randomized, after discontinuing
their prestudy medications for FMS, to receive 4.5 gm or 6 gm of
sodium oxybate or matching placebo once per night for 8 weeks. The
primary outcome variable (POV) was a composite score for changes from
baseline in 3 coprimary self-report measures: patient's pain rating
(in daily electronic diaries) on a visual analog scale (PVAS), the
Fibromyalgia Impact Questionnaire (FIQ) score, and the Patient Global
Impression of Change (PGI-C). A beneficial response rate for the POV
composite score was defined as >/=20% improvement in the PVAS and FIQ
scores plus a rating of "much better" or "very much better" on the
PGI-C. Secondary measures included subjective sleep outcomes (on the
Jenkins Scale for Sleep) and quality-of-life measures. The analyses
were based on an intent-to-treat (ITT) population.

RESULTS: The ITT population included 188 patients with FMS, 78% of
whom completed the trial. Significant benefit was observed with both
dosages of sodium oxybate, according to changes in the POV and
subjective sleep quality. Improvements in the PVAS score were
significantly correlated with sleep outcomes. Sodium oxybate was well
tolerated overall; dose-related nausea (</=28% of patients) and
dizziness (</=18% of patients) tended to resolve with continued therapy.

CONCLUSION: Sodium oxybate therapy was well tolerated and
significantly improved the symptoms of FMS. Further study of sodium
oxybate as a novel therapeutic option for FMS is warranted.

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