Date of Award
Selective Evidence-Based Medicine Review
Master of Science in Health Sciences - Physician Assistant
Physician Assistant Studies
John Cavenagh, PhD, PA-C
Objective: The objective of this systematic review is to determine whether or not Sodium Oxybate is a safe and effective treatment of pain and sleep-related symptoms of fibromyalgia.
Study design: Review of three English language primary randomized controlled trials published between 2003-2010.
Data Sources: Randomized, controlled clinical trials comparing Sodium Oxybate to a placebo group were found using PubMed and Cochrane database.
Outcome Measured: Disease improvement and adverse effects (nausea). Disease improvement was measure using Disease the Tender point index (TPI) (rated 0-4), subjective daily assessments of pain /fatigue, PVAS score (0= no pain, 100= worst possible pain), FVAS score (0= no fatigue, 100= worst possible fatigue), Fibromyalgia Impact Questionnaire (FIQ) (rated 1-100), The Jenkins Scale for sleep (JSS) (rated 1-20), a quality-of-life questionnaire (SF-36) (rated 1-100), Patient Global Impression of Change (PGI-C), Tender Point Count (TPC) (rated: 0-18), Clinical Global Impression of Change (CGI-S), Epworth Sleepiness Scale (ESS) (rated: 1-24), and Functional Outcome of Sleep Questionnaire (FOSQ) (rated: 5-20). Adverse effects (nausea) were measured using incidence of cases reported.
Results: Three randomized controlled trials were included in this review. The higher dose of Soidum Oxybate (6.0g/day) was shown to be more effective than the lower dose (4.5g/day) at relieving fibromyalgia symptoms. Although the higher dose of Sodium Oxybate was more effective, nausea was more commonly experiences in this group than the group given the lower daily dose.
Conclusion: The results of the randomized controlled trials reviewed demonstrated that Sodium Oxybate 6.0 g/day was more effective than the 4.5g/day dosage at improving fibromyalgia symptoms. However due the adverse effect of nausea 4.5g/day is a safe starting dose for patients. The relatively low incidence of nausea encourages its use in fibromyalgia. Further studies should be done regarding the titration from doses 4.5g/day to 6.0g/day to see if the adverse effect of nausea has a lower incidence.
Grandinette, Britanie A., "Is Sodium Oxybate a Safe and Effective Treatment for Patients with Fibromyalgia" (2012). PCOM Physician Assistant Studies Student Scholarship. 86.