title: Lithium therapy in Kleine-Levin syndrome: An open-label, controlled study in 130 patients.
abstract: OBJECTIVE
  To compare the benefits and risks of lithium therapy vs abstention/other treatments in Kleine-Levin syndrome (KLS).
  
  
  METHODS
  In a KLS cohort followed in a single center, 130 patients regularly took lithium carbonate (median dose 1,000 mg/day; n = 71; 40 children), valproate (n = 5), contraceptive pill (n = 5), or no treatment (n = 49). The disease characteristics (frequency, mean, and longest durations of episodes, time incapacitated per year) were compared before and after follow-up in the lithium vs abstention groups.
  
  
  RESULTS
  The time between KLS onset and therapeutic onset was 69 ± 92 months. The patients were then followed up for a mean of 21.5 ± 17.8 months. Before treatment, the 71 patients treated with lithium tended to have a higher frequency of episodes per year (3.8 ± 2.9 vs 2.9 ± 2.6) and had a longer time spent incapacitated (57 ± 51 vs 37 ± 35 days) than the untreated patients. The mean (-8 ± 20 vs 2 ± 13 days) and longest (-18 ± 35 vs -5 ± 13) episode duration, the time spent incapacitated (-37 ± 65 days vs -10 ± 38), as well as the frequency of episodes per year (-2.6 ± 2.9 vs 1.3 ± 2.78) decreased significantly more in the treated than in the untreated patients. Side effects (reported by 50% of the patients) were mild and classical with lithium (tremor, increased drinking, diarrhea, and subclinical hypothyroidism).
  
  
  CONCLUSIONS
  In this large, prospective, open-label, controlled study, the benefit/risk ratio of lithium therapy is superior to that of abstention, supporting the concept that lithium has anti-inflammatory/neuroprotective effects.
  
  
  METHODS
  This study provides Class IV evidence that for patients with KLS, lithium decreases the frequency and duration of KLS episodes.
authors.affiliation: From the Sleep Disorders Unit and National Reference Center for Narcolepsy, Hypersomnia and Kleine-Levin Syndrome (S.L.-S., T.L.C., E.G., S.L., I.A.), and Department of Biostatistics (J.-L.G.), Pitié-Salpêtrière University Hospital; AP-HP (S.L.-S., I.A.), Brain Research Institute (CRICM-UPMC-Paris 6; Inserm UMR_S 975; CNRS UMR 7225), Sorbonne Universities, UPMC Univ Paris 06; and AP-HP and ER4 (J.-L.G.), Pierre and Marie Curie University, Paris, France.
authors.forename: Smaranda
authors.initials: S
authors.lastname: Leu-Semenescu
authors.affiliation: From the Sleep Disorders Unit and National Reference Center for Narcolepsy, Hypersomnia and Kleine-Levin Syndrome (S.L.-S., T.L.C., E.G., S.L., I.A.), and Department of Biostatistics (J.-L.G.), Pitié-Salpêtrière University Hospital; AP-HP (S.L.-S., I.A.), Brain Research Institute (CRICM-UPMC-Paris 6; Inserm UMR_S 975; CNRS UMR 7225), Sorbonne Universities, UPMC Univ Paris 06; and AP-HP and ER4 (J.-L.G.), Pierre and Marie Curie University, Paris, France.
authors.forename: Thibault
authors.initials: T
authors.lastname: Le Corvec
authors.affiliation: From the Sleep Disorders Unit and National Reference Center for Narcolepsy, Hypersomnia and Kleine-Levin Syndrome (S.L.-S., T.L.C., E.G., S.L., I.A.), and Department of Biostatistics (J.-L.G.), Pitié-Salpêtrière University Hospital; AP-HP (S.L.-S., I.A.), Brain Research Institute (CRICM-UPMC-Paris 6; Inserm UMR_S 975; CNRS UMR 7225), Sorbonne Universities, UPMC Univ Paris 06; and AP-HP and ER4 (J.-L.G.), Pierre and Marie Curie University, Paris, France.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Groos
authors.affiliation: From the Sleep Disorders Unit and National Reference Center for Narcolepsy, Hypersomnia and Kleine-Levin Syndrome (S.L.-S., T.L.C., E.G., S.L., I.A.), and Department of Biostatistics (J.-L.G.), Pitié-Salpêtrière University Hospital; AP-HP (S.L.-S., I.A.), Brain Research Institute (CRICM-UPMC-Paris 6; Inserm UMR_S 975; CNRS UMR 7225), Sorbonne Universities, UPMC Univ Paris 06; and AP-HP and ER4 (J.-L.G.), Pierre and Marie Curie University, Paris, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Lavault
authors.affiliation: From the Sleep Disorders Unit and National Reference Center for Narcolepsy, Hypersomnia and Kleine-Levin Syndrome (S.L.-S., T.L.C., E.G., S.L., I.A.), and Department of Biostatistics (J.-L.G.), Pitié-Salpêtrière University Hospital; AP-HP (S.L.-S., I.A.), Brain Research Institute (CRICM-UPMC-Paris 6; Inserm UMR_S 975; CNRS UMR 7225), Sorbonne Universities, UPMC Univ Paris 06; and AP-HP and ER4 (J.-L.G.), Pierre and Marie Curie University, Paris, France.
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Golmard
authors.affiliation: From the Sleep Disorders Unit and National Reference Center for Narcolepsy, Hypersomnia and Kleine-Levin Syndrome (S.L.-S., T.L.C., E.G., S.L., I.A.), and Department of Biostatistics (J.-L.G.), Pitié-Salpêtrière University Hospital; AP-HP (S.L.-S., I.A.), Brain Research Institute (CRICM-UPMC-Paris 6; Inserm UMR_S 975; CNRS UMR 7225), Sorbonne Universities, UPMC Univ Paris 06; and AP-HP and ER4 (J.-L.G.), Pierre and Marie Curie University, Paris, France. isabelle.arnulf@psl.aphp.fr.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Arnulf
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D017593:Kleine-Levin Syndrome / Q000175:diagnosis* / Q000188:drug therapy* / Q000523:psychology; D016651:Lithium Carbonate / Q000627:therapeutic use*; D008297:Male; D011446:Prospective Studies; D055815:Young Adult
chemical_list: D016651:Lithium Carbonate