Treatment of restless legs syndrome with gabapentin: a double-blind, cross-over study.
OBJECTIVE
To assess the effects of gabapentin on sensory and motor symptoms in patients with restless legs syndrome (RLS).


METHODS
Patients with RLS (22 idiopathic, 2 secondary to iron deficiency) were randomized and treated for 6 weeks with either gabapentin or placebo. After a 1-week washout they crossed over to the alternative treatment for 6 weeks. Patients were rated at baseline and at scheduled intervals by the RLS Rating Scale, Clinical Global Impression, pain analogue scale, and Pittsburgh Sleep Quality Index. At the end of each treatment period, all-night polysomnography was performed.


RESULTS
Compared to placebo, gabapentin was associated with reduced symptoms on all rating scales. In addition, sleep studies showed a significantly reduced periodic leg movements during sleep (PLMS) index and improved sleep architecture (increased total sleep time, sleep efficiency, and slow wave sleep, and decreased stage 1 sleep). Patients whose symptoms included pain benefited most from gabapentin. The mean effective dosage at the end of the 6-week treatment period was 1,855 mg, although therapeutic effects were already observed at the end of week 4 (1,391 mg).


CONCLUSIONS
Gabapentin improves sensory and motor symptoms in RLS and also improves sleep architecture and PLMS.
Garcia-Borreguero
D
D
Department of Neurology, Fundación Jiménez Díaz, Madrid, Spain. dgarciaborreguero@fjd.es
Larrosa
O
O
de la Llave
Y
Y
Verger
K
K
Masramon
X
X
Hernandez
G
G
D000085:Acetates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000588:Amines; D018592:Cross-Over Studies; D003509:Cyclohexanecarboxylic Acids; D004311:Double-Blind Method; D018691:Excitatory Amino Acid Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D000077206:Gabapentin; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology / Q000517:prevention & control; D010147:Pain Measurement; D017286:Polysomnography; D011897:Random Allocation; D012107:Research Design; D012148:Restless Legs Syndrome / Q000150:complications / Q000188:drug therapy*; D018401:Sample Size; D012890:Sleep / Q000187:drug effects; D016896:Treatment Outcome; D005680:gamma-Aminobutyric Acid
D000085:Acetates; D000588:Amines; D003509:Cyclohexanecarboxylic Acids; D018691:Excitatory Amino Acid Antagonists; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin