Background: This is an updated version of the original Cochrane review, published in Issue 2, 2009.Kleine-Levin syndrome (KLS) is a rare disorder that mainly affects adolescent men. It is characterised by recurrent episodes of hypersomnia, usually accompanied by hyperphagia, cognitive and mood disturbances, abnormal behavior such as hypersexuality and signs of dysautonomia.In 1990 the diagnostic criteria for Kleine-Levin syndrome were modified in the International Classification of Sleep Disorders, where KLS was defined as a syndrome composed of recurring episodes of undue sleepiness lasting some days, which may or may not be associated with hyperphagia and abnormal behavior.The cause of Kleine-Levin syndrome remains unknown, and several treatment strategies have been used. Some medications have been reported to provide benefit in the treatment of patients with KLS, but because of the rarity of the condition, no long-term follow-up therapies have yet been described.
Objectives: This review aimed to evaluate:1. whether pharmacological treatment for Kleine Levin syndrome is effective and safe.2. which drug or category of drugs is effective and safe.
Search methods: We obtained relevant trials from the following sources: the Cochrane Epilepsy Group Specialized Register (2 May 2013); the Cochrane Central Register of Controlled Trials (CENTRAL Issue 4, The Cochrane Library, April 2013); MEDLINE (1946 to 2 May 2013); SCOPUS (2 May 2013); LILACS (2 May 2013); ClinicalTrials.gov (2 May 2013); WHO International Clinical Trials Registry Platform ICTRP (2 May 2013); reference lists of sleep medicine textbooks; review articles and reference lists of articles identified by the search strategies.
Selection criteria: All randomised controlled trials (RCTs) and quasi-randomised controlled trials looking at pharmacological interventions for Kleine-Levin syndrome were selected. We included both parallel-group and cross-over studies.
Data collection and analysis: Two review authors (MMO and CC) extracted the data reported in the original articles.
Main results: No studies met the inclusion criteria for this systematic review.
Authors' conclusions: Therapeutic trials of pharmacological treatment for Kleine-Levin syndrome with a double-blind, placebo-controlled design are needed.