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ARTICLES: D. Garcia-Borreguero, O. Larrosa, Y. de la Llave, K. Verger, X. Masramon, and G. Hernandez Treatment of restless legs syndrome with gabapentin: A double-blind, cross-over study Neurology 2002; 59: 1573-1579 [Abstract] [Full text] [PDF]

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Diego Garcia-Borreguero, Xavier Masramon, BsC, Barcelona, Spain   (16 January 2003)

Treatment of restless legs syndrome with gabapentin: A double-blind, cross-over study

Brendan J Burchell   (15 January 2003)

Reply to Burchell 16 January 2003
Diego Garcia-Borreguero Sleep Disorders Unit, Madrid, Xavier Masramon, BsC, Barcelona, Spain Send Correspondence to journal: Re: Reply to Burchell DGarciaBorreguero{at}fjd.es Diego Garcia-Borreguero, et al.	We thank Dr. Burchell for his interest in our article. [1] In this study, gabapentin caused a nonsignificant increase in malaise. However, we do not consider malaise a serious side effect. While malaise is an unspecific term that was used to summarize any combination of dizziness and other CNS symptoms (eg, headache), dizziness is a well known side effect of gabapentin, and is usually mild and transient.[2] In our article,[1] we included under Table 2 any adverse effects reported during the study, not taking into consideration duration or severity. None of the 6 cases that were coded as malaise reached a level of severity that would have requested (either by the patient or by the treating physician) discontinuation of the study. The calculation of the sample size was based on the data provided by a previous study. [3] Most controlled studies in the RLS literature have used smaller samples than we did. [4] We consider that, compared to other controlled studies, neither the number of patients nor the duration of observation (6 weeks) was “small.” Furthermore, the use of a cross-over design allowed to double the number of observations. We agree that retrospective comparisons between different drugs are needed and that a description of the effect-size statistics for every new study would be helpful. A Table containing this data is provided. References 1. Garcia-Borreguero D, Larrosa O, De la Llave Y, Verger K, Masramon X, Hernandez G. Treatment of restless legs syndrome with gabapentin: A double-blind, cross-over study. Neurology. 2002;59:1573-1579. 2. Pfizer Inc. Neurontin International Product Information. 2003. 3. Adler CH. Treatment of restless legs syndrome with gabapentin. Clin Neuropharmacol. 1997;20:148-151. 4. Hening W, Allen R, Earley C, Kushida C, Picchietti D, Silber M. The treatment of restless legs syndrome and periodic limb movement disorder. An American Academy of Sleep Medicine Review. Sleep. 1999;22:970-999.
Treatment of restless legs syndrome with gabapentin: A double-blind, cross-over study 15 January 2003
Brendan J Burchell, University Senior Lecturer University of Cambridge Send Correspondence to journal: Re: Treatment of restless legs syndrome with gabapentin: A double-blind, cross-over study bb101{at}cam.ac.uk Brendan J Burchell	In this case, one of the reasons given for testing gabapentin is because of "the side-effect profile ... and the likelihood of long-term complications associated with dopaminergic drugs" . While there is no mention of side-effects for gabapentin the abstract, and no single adverse event produced a statistically significant difference between the drug and placebo, a careful scrutiny of Table 2 suggests cause for concern. Six of the 23 cases (26%) reported malaise while taking gabapentin, compared to only two (8%) in the placebo condition. The tripling of the rate of a serious condition is a concern even though such a small sample size does not achieve statistical significance. Also, as other drugs have also been shown to be effective against RLS in randomized trials, perhaps new results could be published with size-of-effect statistics so that the relative effectiveness of different drugs can be gauged.