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Review

Improving sleep for patients with restless legs syndrome. Part II: meta-analysis of vibration therapy and drugs approved by the FDA for treatment of restless legs syndrome

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Pages 11-22 | Published online: 02 Apr 2013

References

  • Willis T. Instructions for Curing the Watching Evil in The London Practice of Physick. London, UK: Bassett and Crooke; 1685.
  • Clark MM. Restless legs syndrome. J Am Board Fam Pract. 2001;14: 368–374.
  • Konofal E, Karroum E, Montplaisir J, Derenne JP, Arnulf I. Two early descriptions of restless legs syndrome and periodic leg movements by Boissier de Sauvages (1763) and Gilles de la Tourette (1898). Sleep Med. 2009;10:586–591.
  • American Academy of Sleep Medicine. International Classification of Sleep Disorders: Diagnostic and Coding Manual, 2nd ed. Westchester, NY: American Academy of Sleep Medicine; 2005.
  • Walters AS. Towards a better definition of the restless legs syndrome. Mov Disord. 1995;10:634–642.
  • Yoakum RH. Restless Legs Syndrome Relief and Hope for Sleepless Victims of a Hidden Epidemic. New York, NY: Fireside; 2006.
  • Mata IF, Bodkin CL, Adler CH, et al. Genetics of restless legs syndrome. Parkinsonism Relat Disord. 2006;12:1–7.
  • Bonati MT, Ferini-Strambi L, Aridon P, Oldani A, Zucconi M, Casari G. Autosomal dominant restless legs syndrome maps on chromosome 14q. Brain. 2003;126:1485–1492.
  • Allen RP, Barker PB, Wehrl F, Song HK, Earley CJ. MRI measurement of brain iron in patients with restless legs syndrome. Neurology. 2001;56:263–265.
  • Barriere G, Cazalets JR, Bioulac B, Tison F, Ghorayeb I. The restless legs syndrome. Prog Neurobiol. 2005;77:139–165.
  • Cervenka S, Palhagen SE, Comley RA, et al. Support for dopaminergic hypoactivity in restless legs syndrome: a PET study on D2-receptor binding. Brain. 2006;129:2017–2028.
  • Buchfuhrer MJ, Wayne HA, Kushida CA. Restless Legs Syndrome: Coping With Your Sleepless Nights. New York, NY: Demos; 2007.
  • Spiegelhalder K, Feige B, Paul D, et al. Cerebral correlates of muscle tone fluctuations in restless legs syndrome: a pilot study with combined functional magnetic resonance imaging and anterior tibial muscle electromyography. Sleep Med. 2008;9:177–183.
  • Paulus W, Dowling P, Rijsman R, Stiasny-Kolster K, Trenkwalder C, de Weerd A. Pathophysiological concepts of restless legs syndrome. Mov Disord. 2007;22:1451–1456.
  • Lettieri CJ, Eliasson AH. Pneumatic compression devices are an effective therapy for restless legs syndrome: a prospective, randomized, double-blinded, sham-controlled trial. Chest. 2009;135:74–80.
  • Mitchell UH, Myrer JW, Johnson AW, Hilton SC. Restless legs syndrome and near-infrared light: an alternative treatment option. Physiother Theory Pract. 2011;27:345–351.
  • Trenkwalder C, Paulus W. Restless legs syndrome: pathophysiology, clinical presentation and management. Nat Rev Neurol. 2010;6:337–346.
  • Earley CJ, Connor JR, Beard JL, Clardy SL, Allen RP. Ferritin levels in the cerebrospinal fluid and restless legs syndrome: effects of different clinical phenotypes. Sleep. 2005;28:1069–1075.
  • Mizuno S, Mihara T, Miyaoka T, Inagaki T, Horiguchi J. CSF iron, ferritin and transferrin levels in restless legs syndrome. J Sleep Res. 2005;14:43–47.
  • Earley CJ, Horska A, Mohamed MA, Barker PB, Beard JL, Allen RP. A randomized, double-blind, placebo-controlled trial of intravenous iron sucrose in restless legs syndrome. Sleep Med. 2009;10: 206–211.
  • Kanter AH. The effect of sclerotherapy on restless legs syndrome. Dermatol Surg. 1995;21:328–332.
  • Aukerman MM, Aukerman D, Bayard M, Tudiver F, Thorp L, Bailey B. Exercise and restless legs syndrome: a randomized controlled trial. J Am Board Fam Med. 2006;19:487–493.
  • Eliasson AH, Lettieri CJ. Sequential compression devices for treatment of restless legs syndrome. Medicine (Baltimore). 2007;86: 317–323.
  • Mitchell UH, Johnson AW, Myrer B. Comparison of two infrared devices in their effectiveness in reducing symptoms associated with RLS. Physiother Theory Pract. 2011;27:352–359.
  • Cui Y, Wang Y, Liu Z. Acupuncture for restless legs syndrome. Cochrane Database Syst Rev. 2008;4:CD006457.
  • Longe SE, Wise R, Bantick S, et al. Counter-stimulatory effects on pain perception and processing are significantly altered by attention: an fMRI study. Neuroreport. 2001;12:2021–2025.
  • Burbank F, Buchfuhrer MJ, Kopjar B. Sleep improvement for restless legs syndrome (RLS) patients. Part I. Pooled analysis of two prospective, double-blind, sham-controlled, multi-center, randomized clinical studies of the effects of vibrating pads on RSL symptoms. Journal of Parkinsonism and Restless Legs Syndrome. 2013;3:1–10.
  • Blitz B, Dinnerstein AJ, Lowenthal M. Attenuation of experimental pain by tactile stimulation effect of vibration at different levels of noxious stimulus intensity. Percept Mot Skills. 1964;19:311–316.
  • Talati R, Phung OJ, Mather J, Coleman CI. Effect of non-ergot dopamine agonists on health-related quality of life of patients with restless legs syndrome. Ann Pharmacother. 2009;43:813–821.
  • Trotti LM, Rye DB. Restless legs syndrome. Handb Clin Neurol. 2011;100:661–673.
  • Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. J Clin Epidemiol. 2009;62:e1–e34.
  • Tao KM, Li XQ, Zhou QH, Moher D, Ling CQ, Yu WF. From QUOROM to PRISMA: a survey of high-impact medical journals’ instructions to authors and a review of systematic reviews in anesthesia literature. PLoS One. 2011;6:e27611.
  • Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ. 2009; 339:b2700.
  • Hays RD, Stewart AL. Sleep measures. In: Stewart AL, Ware JEJ, editors. Measuring Functioning and Well-Being; The Medical Outcomes Study Approach, 4th ed. London, UK: Duke University Press; 1998.
  • Borenstein M, Hedges LV, Higgins J, Rothstein H. Introduction to Meta-Analysis. West Sussex, UK: John Wiley and Sons Ltd; 2009.
  • Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ. 2003;327:557–560.
  • Higgins JPT, Green S, editors. Cochrane Handbook for Systemic Reviews of Interventions: Cochrane Book Series. Chichester, UK: John Wiley & Sons; 2008.
  • Allen RP, Kosinski M, Hill-Zabala CE, Calloway MO. Psychometric evaluation and tests of validity of the Medical Outcomes Study 12-item Sleep Scale (MOS sleep). Sleep Med. 2009;10:531–539.
  • Abetz L, Arbuckle R, Allen RP, Mavraki E, Kirsch J. The reliability, validity and responsiveness of the Restless Legs Syndrome Quality of Life questionnaire (RLSQoL) in a trial population. Health Qual Life Outcomes. 2005;3:79.
  • Hays RD, Martin SA, Sesti AM, Spritzer KL. Psychometric properties of the Medical Outcomes Study Sleep measure. Sleep Med. 2005;6: 41–44.
  • Mantel N, Haenszel W. Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst. 1959;22:719–748.
  • Song F, Loke YK, Walsh T, Glenny AM, Eastwood AJ, Altman DG. Methodological problems in the use of indirect comparisons for evaluating healthcare interventions: survey of published systematic reviews. BMJ. 2009;338:bll47.
  • Walters AS, Ondo WG, Dreykluft T, Grunstein R, Lee D, Sethi K. Ropinirole is effective in the treatment of restless legs syndrome. TREAT RLS 2: A 12-week, double-blind, randomized, parallel-group, placebo-controlled study. Mov Disord. 2004;19:1414–1423.
  • Trenkwalder C, Garcia-Borreguero D, Montagna P, et al. Ropinirole in the treatment of restless legs syndrome: results from the TREAT RLS 1 study, a 12 week, randomised, placebo controlled study in 10 European countries. J Neurol Neurosurg Psychiatry. 2004;75: 92–97.
  • Kushida CA, Becker PM, Ellenbogen AL, Canafax DM, Barrett RW Randomized, double-blind, placebo-controlled study of XP13512/ GSK1838262 in patients with RLS. Neurology. 2009;72:439–446.
  • Ferini-Strambi L, Aarskog D, Partinen M, et al. Effect of pramipexole on RLS symptoms and sleep: a randomized, double-blind, placebo-controlled trial. Sleep Med. 2008;9:874–881.
  • Benes H, Mattern W, Peglau I, et al. Ropinirole improves depressive symptoms and restless legs syndrome severity in RLS patients: a multicentre, randomized, placebo-controlled study. J Neurol. 2011;258: 1046–1054.
  • Allen R, Becker PM, Bogan R, et al. Ropinirole decreases periodic leg movements and improves sleep parameters in patients with restless legs syndrome. Sleep. 2004;27:907–914.
  • Lee DO, Ziman RB, Perkins AT, Poceta JS, Walters AS, Barrett RW A randomized, double-blind, placebo-controlled study to assess the efficacy and tolerability of gabapentin enacarbil in subjects with restless legs syndrome. J Clin Sleep Med. 2011;7:282–292.
  • Bogan RK, Fry JM, Schmidt MH, Carson SW, Ritchie SY. Ropinirole in the treatment of patients with restless legs syndrome: a US-based randomized, double-blind, placebo-controlled clinical trial. Mayo Clin Proc. 2006;81:17–27.
  • Kushida CA, Geyer J, Tolson JM, Asgharian A. Patient- and physician-rated measures demonstrate the effectiveness of ropinirole in the treatment of restless legs syndrome. Clin Neuropharmacol. 2008;31: 281–286.
  • Oertel WH, Benes H, Garcia-Borreguero D, et al. Rotigotine transdermal patch in moderate to severe idiopathic restless legs syndrome: a randomized, placebo-controlled polysomnographic study. Sleep Med. 2010;11:848–856.
  • Hening WA, Allen RP, Ondo WG, et al. Rotigotine improves restless legs syndrome: a 6-month randomized, double-blind, placebo-controlled trial in the United States. Mov Disord. 2010;25:1675–1683.
  • Trenkwalder C, Benes H, Poewe W, et al. Efficacy of rotigotine for treatment of moderate-to-severe restless legs syndrome: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2008;7:595–604.
  • GlaxoSmithKline. Results summary for ROR104836. Available from: http://www.gsk-clinicalstudyregister.com/result_detail. jsp;jsessionid=4E9BEA7633869AF24A2836793FCAB8ED?prot ocolId=ROR104836&studyId=B6AA2828–2901–48C5-A084–823 ABA244376&compound=ropinirole. Accessed February 21, 2012.
  • Allen RP, Kushida CA, Atkinson MJ. Factor analysis of the International Restless Legs Syndrome Study Group’s scale for restless legs severity. Sleep Med. 2003;4:133–135.
  • Sensory Medical. NCT00877916 and NCT01145651 trial summaries, 2012. Available from: http://www.sensorymedical.com. Accessed March 29, 2012.
  • Abetz L, Arbuckle R, Allen RP, et al. The reliability, validity and responsiveness of the International Restless Legs Syndrome Study Group rating scale and subscales in a clinical-trial setting. Sleep Med. 2006;7:340–349.
  • Mirapex product insert. Ingelheim, Germany: Boehringer Ingelheim; 2011. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/ label/2011/020667s025lbl.pdf. Accessed December 30, 2011.
  • GlaxoSmithKline staff. Requip product insert. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020658s018s020s021lbl.pdf. Accessed December 30, 2011.
  • GlaxoSmithKline staff. Horizant product insert. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022399s000lbl.pdf. Accessed January 31, 2013.
  • Cohen J. Statistical Power Analysis for the Behavioral Sciences, 2nd ed. Hillsdale, NJ: Lawrence Erlbaum Associates; 1988.
  • Hansen RA, Song L, Moore CG, et al. Effect of ropinirole on sleep outcomes in patients with restless legs syndrome: meta-analysis of pooled individual patient data from randomized controlled trials. Pharmacotherapy. 2009;29:255–262.
  • Scholz H, Trenkwalder C, Kohnen R, Riemann D, Kriston L, Hornyak M. Dopamine agonists for restless legs syndrome. Cochrane Database Syst Rev. 2011;3:CD006009.
  • Hogl B, Garcia-Borreguero D, Trenkwalder C, et al. Efficacy and augmentation during 6 months of double-blind pramipexole for restless legs syndrome. Sleep Med. 2011;12:351–360.
  • Burbank F Sleep improvement for restless legs syndrome (RLS) patients. Part III: Effects of treatment assignment belief on sleep improvement in RLS patients. A mediation analysis. Journal of Parkinsonism and Restless Legs Syndrome. 2013;3:23–29.
  • Gardner WJ, Licklider JCR, Weisz AZ. Suppression of pain by sound. Science. 1960;132:32–33.
  • Riley JF, Levine FM. Counterstimulation and pain perception: effects of electrocutaneous vs auditory stimulation upon cold pressor pain. Pain. 1988;35:259–264.
  • Melzack R, Weisz AZ, Sprague LT. Stratagems for controlling pain: contributions of auditory stimulation and suggestion. Exp Neurol. 1963;8:239–247.
  • Morosko TE, Simmons FF. The effect of audio-analgesia on pain threshold and pain tolerance. J Dent Res. 1966;45:1608–1617.
  • Reavis KM, Chang JE, Zeng FG. Patterned sound therapy for the treatment of tinnitus. Hear J. 2010;63:21–24.
  • Margo A, Hemsley DR, Slade PD. The effects of varying auditory input on schizophrenic hallucinations. Br J Psychiatry. 1981;139:122–127.
  • 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.
  • Fulda S, Wetter TC. Where dopamine meets opioids: A meta-analysis of the placebo effect in restless legs syndrome treatment studies. Brain. 2008;131:902–917.