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Original Research

Sleep improvement for restless legs syndrome patients. Part III: effect of treatment assignment belief on sleep improvement in restless legs syndrome patients. A mediation analysis

Pages 23-29 | Published online: 02 Apr 2013

References

  • 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.
  • Burbank F, Buchfuhrer MJ, Kopjar B. Sleep improvement for restless legs syndrome (RLS) patients. Part II: Meta-analysis of vibration therapy and FDA-approved RLS drugs in the treatment of RLS. Journal of Parkinsonism and Restless Legs Syndrome. 2013;3:11–22.
  • Baron RM, Kenny DA. The moderator-mediator variable distinction in social psychological research: conceptual, strategic, and statistical considerations. J Pers Soc Psychol. 1986;51(6):1173–1182.
  • Kenny DA, Calsyn RJ, Morse GA, Klinkenberg WD, Winter JP, Trusty ML. Evaluation of treatment programs for persons with severe mental illness: moderator and mediator effects. Eval Rev. 2004;28(4):294–324.
  • Kraemer HC, Wilson GT, Fairburn CG, Agras WS. Mediators and moderators of treatment effects in randomized clinical trials. Arch Gen Psychiatry. 2002;59(10):877–883.
  • Deyo RA, Walsh NE, Schoenfeld LS, Ramamurthy S. Can trials of physical treatments be blinded? The example of transcutaneous electrical nerve stimulation for chronic pain. Am J Phys Med Rehabil. 1990;69(1):6–10.
  • Hays RD, Stewart AL. Sleep measures. In: Stewart AL, Ware JEJ, editors. Measuring Functioning and Well-Being; The Medical Outcomes Study Approach, 4th ed. Durham: Duke University Press; 1998: 235–259.
  • Hays RD, Martin SA, Sesti AM, Spritzer KL. Psychometric properties of the Medical Outcomes Study Sleep measure. Sleep Med. 2005;6(1): 41–44.
  • 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.
  • 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(5):531–539.
  • Imai K, Keele L, Tingley D. A general approach to causal mediation analysis. Psychol Methods. 2010;15(4):309–334.
  • Imai K, Keele L, Tingley D, Yamamoto T. Causal mediation analysis using R. Lecture Notes in Statistics. 2010;196:129–154.
  • Shrout PE, Bolger N. Mediation in experimental and nonexperimental studies: new procedures and recommendations. Psychol Methods. 2002;7(4):422–445.
  • Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med. 2000;342(25):1887–1892.
  • Evans D. Hierarchy of evidence: a framework for ranking evidence evaluating healthcare interventions. J Clin Nurs. 2003;12(1): 77–84.
  • Forsetlund L, Chalmers I, Bjorndal A. When was random allocation first used to generate comparison groups in experiments to assess the effects of social interventions? Economics of Innovation and New Technology. 2007;16(5):371–384.
  • Medical Research Council. Streptomycin treatment of pulmonary tuberculosis. Br Med J. 1948;2(4582):769–782.
  • Ernst E, Resch KL. Concept of true and perceived placebo effects. BMJ. 1995;311(7004):551–553.
  • Kaptchuk T J, Goldman P, Stone DA, Stason WB. Do medic al devices have enhanced placebo effects? J Clin Epidemiol. 2000;53(8):786–792.
  • Ernst E. Placebo: new insights into an old enigma. Drug Discov Today. 2007;12(9–10):413–418.
  • Moerman DE. Cultural variations in the placebo effect: ulcers, anxiety, and blood pressure. MedAnthropol Q. 2000;14(1):51–72.
  • Walsh BT, Seidman SN, Sysko R, Gould M. Placebo response in studies of major depression: variable, substantial, and growing. JAMA. 2002;287(14):1840–1847.
  • Walach H, Sadaghiani C, Dehm C, Bierman D. The therapeutic effect of clinical trials: understanding placebo response rates in clinical trials – a secondary analysis. BMC Med Res Methodol. 2005;5:26.
  • Meissner K, Distel H, Mitzdorf U. Evidence for placebo effects on physical but not on biochemical outcome parameters: a review of clinical trials. BMC Med. 2007;5:3.
  • Hróbjartsson A, Gøtzsche PC. Is the placebo powerless? Update of a systematic review with 52 new randomized trials comparing placebo with no treatment. J Intern Med. 2004;256(2):91–100.
  • Wampold BE, Minami T, Tierney SC, Baskin TW, Bhati KS. The placebo is powerful: estimating placebo effects in medicine and psychotherapy from randomized clinical trials. J Clin Psychol. 2005;61(7):835–854.
  • Fulda S, Wetter TC. Where dopamine meets opioids: a meta-analysis of the placebo effect in restless legs syndrome treatment studies. Brain. 2008;131(Pt 4):902–917.
  • Lilienfeld AM. The Fielding H. Garrison Lecture: Ceteris paribus: the evolution of the clinical trial. Bull Hist Med. 1982;56(1):1–18.
  • Beecher HK, Keats AS, Mosteller F, Lasagna L. The effectiveness of oral analgesics (morphine, codeine, acetylsalicylic acid) and the problem of placebo “reactors” and “non-reactors”. J Pharmacol Exp Ther. 1953;109(4):393–400.
  • Doongaji DR, Vahia VN, Bharucha MP, On placebos, placebo responses and placebo responders. (A review of psychological, psychopharma- cological and psychophysiological factors). I. Psychological factors. J Postgrad Med. 1978;24(2):91–97.
  • Doongaji DR, Vahia VN, Bharucha MP. On placebos, placebo responses and placebo responders. A review of psychological, psychopharmaco- logical and psychophysiological factors. II. Psychopharmacological and psychophysiological factors. J Postgrad Med. 1978;24(3):147–157.
  • Pollo A, Benedetti F. The placebo response: neurobiological and clinical issues of neurological relevance. Prog Brain Res. 2009;175:283–294.
  • Petrovic P, Kalso E, Petersson KM, Ingvar M. Placebo and opioid analgesia - imaging a shared neuronal network. Science. 2002; 295(5560):1737–1740.
  • Kong J, Kaptchuk TJ, Polich G, Kirsch I, Gollub RL. Placebo analgesia: findings from brain imaging studies and emerging hypotheses. Rev Neurosci. 2007;18(3–4):173–190.
  • Oken BS. Placebo effects: clinical aspects and neurobiology. Brain. 2008;131(Pt 11):2812–2823.
  • Scott DJ, Stohler CS, Egnatuk CM, Wang H, Koeppe RA, Zubieta JK. Placebo and nocebo effects are defined by opposite opioid and dopaminergic responses. Arch Gen Psychiatry. 2008;65(2):220–231.
  • Walters AS, Ondo WG, Zhu W, Le W. Does the endogenous opiate system play a role in the Restless Legs Syndrome? A pilot post-mortem study. J Neurol Sci. 2009;279(1–2):62–65.
  • Walters AS. Review of receptor agonist and antagonist studies relevant to the opiate system in restless legs syndrome. Sleep Med. 2002;3(4):301–304.
  • Natarajan R. Review of periodic limb movement and restless leg syndrome. J Postgrad Med. 2010;56(2):157–162.
  • Salas RE, Gamaldo CE, Allen RP. Update in restless legs syndrome. Curr Opin Neurol. 2010;23(4):401–406.
  • Trenkwalder C, Paulus W. Restless legs syndrome: pathophysiology, clinical presentation and management. Nat Rev Neurol. 2010; 6(6):337–346.
  • Zintzaras E, Kitsios GD, Papathanasiou AA, et al. Randomized trials of dopamine agonists in restless legs syndrome: a systematic review, quality assessment, and meta-analysis. Clin Ther. 2010;32(2):221–237.
  • Giummarra MJ, Bradshaw JL. The phantom of the night: restless legs syndrome in amputees. Med Hypotheses. 2010;74(6):968–972.
  • Paice JA, Shott S, Oldenburg FP, Zeller J, Swanson B. Efficacy of a vibratory stimulus for the relief of HIV-associated neuropathic pain. Pain. 2000;84(2–3):291–296.