ProHealth.com
December 13, 2002
By Kristin Reed
St. Paul, Minnesota, Nov. 25 (Bloomberg) -- Pfizer Inc.'s epilepsy medication may ease restless legs syndrome, a sleep disorder that affects up to 10 percent of all Americans, according to a study appearing tomorrow in the journal Neurology.
People with the disorder suffer from chronic discomfort and "pins and needles" sensations in their limbs, making it hard to lie still or sleep. The study of 24 patients found Neurontin eased symptoms and helped patients sleep better, compared with placebo treatment.
"The more severe the symptoms, the more robust the therapeutic effects of Neurontin, suggesting that (the drug) is a potent agent for treatment of even severe restless legs syndrome," wrote Diego Garcia-Borreguero, a scientist at Madrid's Fundacion Jimenez Diaz and the lead researcher in the study.
Researchers said the drug might offer an alternative to existing treatment, including Valium and other sedatives and opiate-based painkillers such as morphine. Anti-Parkinson's medications, which carry a range of potential health risks, are also used to treat the symptom.
The study is the first to find a benefit when comparing Neurontin against a placebo, researchers said. Past studies have suggested the drug may treat the sleep disorder.
Significantly more of the Neurontin patients, or about 48 percent, experienced side effects, researchers said. Still, none of the patients stopped treatment because of the side effects.
STUDY ABSTRACT:
Neurology 2002 Nov 26;59(10):1573-9
Treatment of restless legs syndrome with gabapentin [neurontin]: A double-blind, cross-over study.
Garcia-Borreguero D, Larrosa O, De La Llave Y, Verger K, Masramon X, Hernandez G.
Department of Neurology (Drs. Garcia-Borreguero, Larrosa, and de la Llave), Fundacion Jimenez Diaz, Madrid.
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 [neurontin] 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.
PMID: 12451200 [PubMed - in process]
|
|
