Narcolepsy and effectiveness of gamma-hydroxybutyrate (GHB): A systematic review and meta-analysis of randomized controlled trials

Summary Objectives Gamma-hydroxybutyrate (GHB) is currently authorized by the European Medicines Agency (EMA) to treat narcolepsy with cataplexy in adults, and by the Food and Drug Administration (FDA) to treat cataplexy in patients with narcolepsy, with an expanded indication for the treatment of e...

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Bibliographic Details
Published in:Sleep medicine reviews 2012-10, Vol.16 (5), p.431-443
Main Authors: Boscolo-Berto, Rafael, Viel, Guido, Montagnese, Sara, Raduazzo, Daniella I, Ferrara, Santo D, Dauvilliers, Yves
Format: Article
Language:English
Subjects:
Adult
Cataplexy
Cataplexy - drug therapy
Cataplexy - physiopathology
GABA-B Receptor Agonists - therapeutic use
Gamma-hydroxybutyrate
GHB
Humans
Meta-analysis
Narcolepsy
Narcolepsy - drug therapy
Narcolepsy - physiopathology
Neurology
Polysomnography
Randomized controlled trials
Randomized Controlled Trials as Topic
RCT
Sleep - drug effects
Sleep - physiology
Sleep Medicine
Sleep Stages - drug effects
Sleep Stages - physiology
Sodium oxybate
Sodium Oxybate - therapeutic use
Systematic review
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Summary:Summary Objectives Gamma-hydroxybutyrate (GHB) is currently authorized by the European Medicines Agency (EMA) to treat narcolepsy with cataplexy in adults, and by the Food and Drug Administration (FDA) to treat cataplexy in patients with narcolepsy, with an expanded indication for the treatment of excessive daytime sleepiness. This study meta-analyses and reviews the effectiveness of GHB on the clinical features of narcolepsy and its neurophysiological correlates. Methods A systematic review of the literature using Medline, Embase, Web of Science, Cochrane reviews, clinical-trials.gov , Scopus, Scirus, and a subsequent meta-analysis were performed. Considered outcomes were: cataplexy attacks, subjective daytime sleepiness, sleep attacks, clinical global impression change (CGI-c), quality of life (QoL), hypnagogic hallucinations, sleep paralysis, mean sleep latencies on the multiple sleep latency test (MSLT) and maintenance of wakefulness test (MWT), nocturnal polysomnographic data. Results Nine randomized controlled trials reporting data on the effectiveness of GHB on narcolepsy were identified, for a total of 1,154 patients (771 patients in the GHB-treated group and 383 in the placebo group). The meta-analysis showed that GHB reduced cataplexy attacks both on a daily (weighted mean difference (WMD) −1.10; 95% confidence interval (CI) −1.29/−0.90, p  
ISSN:1087-0792
1532-2955
DOI:10.1016/j.smrv.2011.09.001