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

I. Jon Russell, A. Thomas Perkins, Joel E. Michalek, Robert (Rob) Bennett, Michelle Price, Adam Barron, Tammy Evans, Isam Diab, John Lacombe, Joseph S. Habros, Heather Yatabe, Andrew J. Holman, Robin Meyers, Alan Kivitz, Deb Morrisson, Elliot Kopp, Jane Downs, Philip Mease, Debbie Granner, Abigail NeimanDawn Fanguy, David Nordstrom, Robert Sturgeon, John Pappas, Judy Wilkinson, Ashwin Patkar, Kathryn Tarter, Wanda Haynes, David Seiden, Flora Rosen, Eric A. Sheldon, Mirnaya Alabaci, Stuart L. Silverman, Carol Joseph, N. Lee Smith, Tami Francisco, Daniel Wallace, Inga Arnold, Larry G. Willis, Andrea Craddock, John B. Winfield, Patricia Bradshaw, Patrick Wood, Laura Warren

    Research output: Contribution to journalArticle

    112 Citations (Scopus)

    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 ≥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.

    Original languageEnglish (US)
    Pages (from-to)299-309
    Number of pages11
    JournalArthritis and Rheumatism
    Volume60
    Issue number1
    DOIs
    StatePublished - Jan 2009

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    Sodium Oxybate
    Fibromyalgia
    Controlled Clinical Trials
    Multicenter Studies
    Placebos
    Pain
    Sleep
    Dizziness
    Visual Analog Scale
    Self Report
    Nausea
    Population
    Therapeutics
    Quality of Life
    Safety

    ASJC Scopus subject areas

    • Immunology
    • Immunology and Allergy
    • Rheumatology
    • Pharmacology (medical)

    Cite this

    Sodium oxybate relieves pain and improves function in fibromyalgia syndrome : A randomized, double-blind, placebo-controlled, multicenter clinical trial. / Russell, I. Jon; Perkins, A. Thomas; Michalek, Joel E.; Bennett, Robert (Rob); Price, Michelle; Barron, Adam; Evans, Tammy; Diab, Isam; Lacombe, John; Habros, Joseph S.; Yatabe, Heather; Holman, Andrew J.; Meyers, Robin; Kivitz, Alan; Morrisson, Deb; Kopp, Elliot; Downs, Jane; Mease, Philip; Granner, Debbie; Neiman, Abigail; Fanguy, Dawn; Nordstrom, David; Sturgeon, Robert; Pappas, John; Wilkinson, Judy; Patkar, Ashwin; Tarter, Kathryn; Haynes, Wanda; Seiden, David; Rosen, Flora; Sheldon, Eric A.; Alabaci, Mirnaya; Silverman, Stuart L.; Joseph, Carol; Smith, N. Lee; Francisco, Tami; Wallace, Daniel; Arnold, Inga; Willis, Larry G.; Craddock, Andrea; Winfield, John B.; Bradshaw, Patricia; Wood, Patrick; Warren, Laura.

    In: Arthritis and Rheumatism, Vol. 60, No. 1, 01.2009, p. 299-309.

    Research output: Contribution to journalArticle

    Russell, IJ, Perkins, AT, Michalek, JE, Bennett, RR, Price, M, Barron, A, Evans, T, Diab, I, Lacombe, J, Habros, JS, Yatabe, H, Holman, AJ, Meyers, R, Kivitz, A, Morrisson, D, Kopp, E, Downs, J, Mease, P, Granner, D, Neiman, A, Fanguy, D, Nordstrom, D, Sturgeon, R, Pappas, J, Wilkinson, J, Patkar, A, Tarter, K, Haynes, W, Seiden, D, Rosen, F, Sheldon, EA, Alabaci, M, Silverman, SL, Joseph, C, Smith, NL, Francisco, T, Wallace, D, Arnold, I, Willis, LG, Craddock, A, Winfield, JB, Bradshaw, P, Wood, P & Warren, L 2009, '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, pp. 299-309. https://doi.org/10.1002/art.24142
    Russell, I. Jon ; Perkins, A. Thomas ; Michalek, Joel E. ; Bennett, Robert (Rob) ; Price, Michelle ; Barron, Adam ; Evans, Tammy ; Diab, Isam ; Lacombe, John ; Habros, Joseph S. ; Yatabe, Heather ; Holman, Andrew J. ; Meyers, Robin ; Kivitz, Alan ; Morrisson, Deb ; Kopp, Elliot ; Downs, Jane ; Mease, Philip ; Granner, Debbie ; Neiman, Abigail ; Fanguy, Dawn ; Nordstrom, David ; Sturgeon, Robert ; Pappas, John ; Wilkinson, Judy ; Patkar, Ashwin ; Tarter, Kathryn ; Haynes, Wanda ; Seiden, David ; Rosen, Flora ; Sheldon, Eric A. ; Alabaci, Mirnaya ; Silverman, Stuart L. ; Joseph, Carol ; Smith, N. Lee ; Francisco, Tami ; Wallace, Daniel ; Arnold, Inga ; Willis, Larry G. ; Craddock, Andrea ; Winfield, John B. ; Bradshaw, Patricia ; Wood, Patrick ; Warren, Laura. / Sodium oxybate relieves pain and improves function in fibromyalgia syndrome : A randomized, double-blind, placebo-controlled, multicenter clinical trial. In: Arthritis and Rheumatism. 2009 ; Vol. 60, No. 1. pp. 299-309.
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    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 ≥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.",
    author = "Russell, {I. Jon} and Perkins, {A. Thomas} and Michalek, {Joel E.} and Bennett, {Robert (Rob)} and Michelle Price and Adam Barron and Tammy Evans and Isam Diab and John Lacombe and Habros, {Joseph S.} and Heather Yatabe and Holman, {Andrew J.} and Robin Meyers and Alan Kivitz and Deb Morrisson and Elliot Kopp and Jane Downs and Philip Mease and Debbie Granner and Abigail Neiman and Dawn Fanguy and David Nordstrom and Robert Sturgeon and John Pappas and Judy Wilkinson and Ashwin Patkar and Kathryn Tarter and Wanda Haynes and David Seiden and Flora Rosen and Sheldon, {Eric A.} and Mirnaya Alabaci and Silverman, {Stuart L.} and Carol Joseph and Smith, {N. Lee} and Tami Francisco and Daniel Wallace and Inga Arnold and Willis, {Larry G.} and Andrea Craddock and Winfield, {John B.} and Patricia Bradshaw and Patrick Wood and Laura Warren",
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    T2 - A randomized, double-blind, placebo-controlled, multicenter clinical trial

    AU - Russell, I. Jon

    AU - Perkins, A. Thomas

    AU - Michalek, Joel E.

    AU - Bennett, Robert (Rob)

    AU - Price, Michelle

    AU - Barron, Adam

    AU - Evans, Tammy

    AU - Diab, Isam

    AU - Lacombe, John

    AU - Habros, Joseph S.

    AU - Yatabe, Heather

    AU - Holman, Andrew J.

    AU - Meyers, Robin

    AU - Kivitz, Alan

    AU - Morrisson, Deb

    AU - Kopp, Elliot

    AU - Downs, Jane

    AU - Mease, Philip

    AU - Granner, Debbie

    AU - Neiman, Abigail

    AU - Fanguy, Dawn

    AU - Nordstrom, David

    AU - Sturgeon, Robert

    AU - Pappas, John

    AU - Wilkinson, Judy

    AU - Patkar, Ashwin

    AU - Tarter, Kathryn

    AU - Haynes, Wanda

    AU - Seiden, David

    AU - Rosen, Flora

    AU - Sheldon, Eric A.

    AU - Alabaci, Mirnaya

    AU - Silverman, Stuart L.

    AU - Joseph, Carol

    AU - Smith, N. Lee

    AU - Francisco, Tami

    AU - Wallace, Daniel

    AU - Arnold, Inga

    AU - Willis, Larry G.

    AU - Craddock, Andrea

    AU - Winfield, John B.

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    AU - Wood, Patrick

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    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 ≥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.

    AB - 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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