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Sodium oxybate relieves pain and improves function in fibromyalgia syndrome: a randomized, double-blind, placebo-controlled, multicenter clinical trial.
Arthritis Rheum. 2009 Jan; 60(1):299-309.AR

Abstract

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 >or=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 (<or=28% of patients) and dizziness (<or=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.

Authors+Show Affiliations

The University of Texas Health Science Center at San Antonio, San Antonio, TX 78229-3900, USA. russell@uthscsa.eduNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19116896

Citation

Russell, I Jon, et al. "Sodium Oxybate Relieves Pain and Improves Function in Fibromyalgia Syndrome: a Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial." Arthritis and Rheumatism, vol. 60, no. 1, 2009, pp. 299-309.
Russell IJ, Perkins AT, Michalek JE, et al. Sodium oxybate relieves pain and improves function in fibromyalgia syndrome: a randomized, double-blind, placebo-controlled, multicenter clinical trial. Arthritis Rheum. 2009;60(1):299-309.
Russell, I. J., Perkins, A. T., & Michalek, J. E. (2009). Sodium oxybate relieves pain and improves function in fibromyalgia syndrome: a randomized, double-blind, placebo-controlled, multicenter clinical trial. Arthritis and Rheumatism, 60(1), 299-309. https://doi.org/10.1002/art.24142
Russell IJ, et al. Sodium Oxybate Relieves Pain and Improves Function in Fibromyalgia Syndrome: a Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial. Arthritis Rheum. 2009;60(1):299-309. PubMed PMID: 19116896.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Sodium oxybate relieves pain and improves function in fibromyalgia syndrome: a randomized, double-blind, placebo-controlled, multicenter clinical trial. AU - Russell,I Jon, AU - Perkins,A Thomas, AU - Michalek,Joel E, AU - ,, PY - 2009/1/1/entrez PY - 2009/1/1/pubmed PY - 2009/3/6/medline SP - 299 EP - 309 JF - Arthritis and rheumatism JO - Arthritis Rheum VL - 60 IS - 1 N2 - 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 >or=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 (<or=28% of patients) and dizziness (<or=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. SN - 0004-3591 UR - https://www.unboundmedicine.com/medline/citation/19116896/Sodium_oxybate_relieves_pain_and_improves_function_in_fibromyalgia_syndrome:_a_randomized_double_blind_placebo_controlled_multicenter_clinical_trial_ L2 - https://doi.org/10.1002/art.24142 DB - PRIME DP - Unbound Medicine ER -