Dopamine Agonists for the Treatment of Restless Legs Syndrome (Review)
Total Page:16
File Type:pdf, Size:1020Kb
Dopamine agonists for the treatment of restless legs syndrome (Review) Scholz H, Trenkwalder C, Kohnen R, Kriston L, Riemann D, Hornyak M This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2011, Issue 5 http://www.thecochranelibrary.com Dopamine agonists for the treatment of restless legs syndrome (Review) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. TABLE OF CONTENTS HEADER....................................... 1 ABSTRACT ...................................... 1 PLAINLANGUAGESUMMARY . 2 SUMMARY OF FINDINGS FOR THE MAIN COMPARISON . ..... 2 BACKGROUND .................................... 6 OBJECTIVES ..................................... 8 METHODS ...................................... 8 Figure1. ..................................... 10 Figure2. ..................................... 11 RESULTS....................................... 13 Figure3. ..................................... 16 Figure4. ..................................... 18 Figure5. ..................................... 20 Figure6. ..................................... 22 Figure7. ..................................... 24 Figure8. ..................................... 26 Figure9. ..................................... 28 Figure10. ..................................... 30 ADDITIONALSUMMARYOFFINDINGS . 31 DISCUSSION ..................................... 36 AUTHORS’CONCLUSIONS . 38 ACKNOWLEDGEMENTS . 38 REFERENCES ..................................... 39 CHARACTERISTICSOFSTUDIES . 47 DATAANDANALYSES. 92 Analysis 1.1. Comparison 1 Dopamine agonists versus placebo, Outcome 1 Change on IRLS. 95 Analysis 1.2. Comparison 1 Dopamine agonists versus placebo, Outcome 2 Medication subgroups: change on IRLS. 97 Analysis 1.3. Comparison 1 Dopamine agonists versus placebo, Outcome 3 Change in periodic limb movements in sleep index. .................................... 99 Analysis 1.4. Comparison 1 Dopamine agonists versus placebo, Outcome 4 Medication subgroups: change in periodic limb movementsinsleepindex. 100 Analysis 1.5. Comparison 1 Dopamine agonists versus placebo, Outcome 5 Change in sleep efficiency. 101 Analysis 1.6. Comparison 1 Dopamine agonists versus placebo, Outcome 6 Medication subgroups: change in sleep efficiency. ................................... 103 Analysis 1.7. Comparison 1 Dopamine agonists versus placebo, Outcome 7 Number of dropouts due to adverse events. 104 Analysis 1.8. Comparison 1 Dopamine agonists versus placebo, Outcome 8 Medication subgroups: number of dropouts duetoadverseevents. 106 Analysis 1.9. Comparison 1 Dopamine agonists versus placebo, Outcome 9 Responder rates on CGI-I. 108 Analysis 1.10. Comparison 1 Dopamine agonists versus placebo, Outcome 10 Medication subgroups: responder rates on CGI-I. .................................... 110 Analysis 1.11. Comparison 1 Dopamine agonists versus placebo, Outcome 11 Change in self rated quality of sleep. 112 Analysis 1.12. Comparison 1 Dopamine agonists versus placebo, Outcome 12 Medication subgroups: change in self rated qualityofsleep. ... ... ... ... ... ... ... ... ... ... .. 113 Analysis 1.13. Comparison 1 Dopamine agonists versus placebo, Outcome 13 Change in disease specific quality of life. 115 Analysis 1.14. Comparison 1 Dopamine agonists versus placebo, Outcome 14 Medication subgroups: change in disease specificqualityoflife. 116 Analysis 1.15. Comparison 1 Dopamine agonists versus placebo, Outcome 15 Responder rates on PGI. 117 Analysis 1.16. Comparison 1 Dopamine agonists versus placebo, Outcome 16 Medication subgroups: responder rates on PGI...................................... 118 Analysis 1.17. Comparison 1 Dopamine agonists versus placebo, Outcome 17 Number of patients experiencing adverse events. .................................... 120 Dopamine agonists for the treatment of restless legs syndrome (Review) i Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 1.18. Comparison 1 Dopamine agonists versus placebo, Outcome 18 Medication subgroups: number of patients experiencingadverseevents. 122 Analysis 1.19. Comparison 1 Dopamine agonists versus placebo, Outcome 19 Change in daytime tiredness. 124 Analysis 1.20. Comparison 1 Dopamine agonists versus placebo, Outcome 20 Medication subgroups: change in daytime tiredness. ................................... 126 Analysis 1.21. Comparison 1 Dopamine agonists versus placebo, Outcome 21 Subgroup analysis: Effect of randomisation onchangeonIRLS.. 128 Analysis 1.22. Comparison 1 Dopamine agonists versus placebo, Outcome 22 Subgroup analysis: Effect of study origin on changeonIRLS.................................. 130 Analysis 2.1. Comparison 2 Active trials: dopamine agonists versus levodopa, Outcome 1 Change on IRLS. 131 Analysis 2.2. Comparison 2 Active trials: dopamine agonists versus levodopa, Outcome 2 Change in periodic limb movementsinsleep. 132 Analysis 2.3. Comparison 2 Active trials: dopamine agonists versus levodopa, Outcome 3 Number of dropouts due to adverseevents. ... ... ... ... ... ... ... ... ... ... .. 132 Analysis 2.4. Comparison 2 Active trials: dopamine agonists versus levodopa, Outcome 4 Responder rates on CGI-I. 133 Analysis 2.5. Comparison 2 Active trials: dopamine agonists versus levodopa, Outcome 5 Change in self rated quality of sleep...................................... 133 Analysis 2.6. Comparison 2 Active trials: dopamine agonists versus levodopa, Outcome 6 Change in quality of life. 134 Analysis 2.7. Comparison 2 Active trials: dopamine agonists versus levodopa, Outcome 7 Number of patients experiencing adverseevents. ... ... ... ... ... ... ... ... ... ... .. 134 Analysis 2.8. Comparison 2 Active trials: dopamine agonists versus levodopa, Outcome 8 Change in daytime tiredness. 135 Analysis 3.1. Comparison 3 Active trials: lisuride vs. ropinirole, Outcome 1 Change on IRLS. 135 Analysis 3.2. Comparison 3 Active trials: lisuride vs. ropinirole, Outcome 2 Number of dropouts due to adverse events. 136 Analysis 3.3. Comparison 3 Active trials: lisuride vs. ropinirole, Outcome 3 Responders on CGI-I. 136 Analysis 3.4. Comparison 3 Active trials: lisuride vs. ropinirole, Outcome 4 Change in self-rated quality of sleep. 137 Analysis 3.5. Comparison 3 Active trials: lisuride vs. ropinirole, Outcome 5 Change in quality of life. 137 Analysis 3.6. Comparison 3 Active trials: lisuride vs. ropinirole, Outcome 6 Number of patients experiencing adverse events. .................................... 138 Analysis 3.7. Comparison 3 Active trials: lisuride vs. ropinirole, Outcome 7 Change in daytime tiredness. 138 ADDITIONALTABLES. 138 APPENDICES ..................................... 140 WHAT’SNEW..................................... 144 HISTORY....................................... 144 CONTRIBUTIONSOFAUTHORS . 144 DECLARATIONSOFINTEREST . 145 SOURCESOFSUPPORT . 145 DIFFERENCES BETWEEN PROTOCOL AND REVIEW . .... 145 INDEXTERMS .................................... 146 Dopamine agonists for the treatment of restless legs syndrome (Review) ii Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. [Intervention Review] Dopamine agonists for the treatment of restless legs syndrome Hanna Scholz1, Claudia Trenkwalder2, Ralf Kohnen3, Levente Kriston4, Dieter Riemann5, Magdolna Hornyak1 1Interdisciplinary Pain Canter, University Medical Center, Freiburg, Freiburg, Germany. 2Paracelsus - Elena Hospital, Centre of Parkin- son and Movement Disorders, Kassel, Germany. 3RPS Research Germany GmbH, Nuremberg and University Erlangen-Nuremberg, Nürnberg, Germany. 4Department of Medical Psychology, University Medical Center, Hamburg - Eppendorf, Hamburg, Germany. 5Department of Psychiatry and Psychotherapy, University Medical Center, Freiburg, Freiburg, Germany Contact address: Magdolna Hornyak, Interdisciplinary Pain Canter, University Medical Center, Freiburg, Breisacher Strasse, 64, Freiburg, 79106, Germany. [email protected]. Editorial group: Cochrane Movement Disorders Group. Publication status and date: Edited (no change to conclusions), published in Issue 5, 2011. Review content assessed as up-to-date: 18 January 2011. Citation: Scholz H, Trenkwalder C, Kohnen R, Kriston L, Riemann D, Hornyak M. Dopamine agonists for the treatment of restless legs syndrome. Cochrane Database of Systematic Reviews 2011, Issue 3. Art. No.: CD006009. DOI: 10.1002/14651858.CD006009.pub2. Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. ABSTRACT Background According to clinical guidelines, dopamine agonists are the first-line treatment of restless legs syndrome (RLS). Objectives To evaluate efficacy and safety of dopamine agonists for RLS. Search methods We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library 2008, Issue 4), MEDLINE, EMBASE, PsycINFO and CINAHL, from January 1985 to December 2008, plus reference lists of articles. We contacted pharmaceutical companies. Selection criteria We included double-blind randomised controlled trials (RCTs) of dopamine agonist treatment versus placebo or other treatment for a period of at least seven days in patients with RLS (≥ 18 years). Outcomes included the International RLS Severity Rating Scale (IRLS), Clinical Global Impressions (CGI-I), polysomnography and self rated sleep quality, quality of life, daytime functioning, and safety parameters. Data collection and analysis Two reviewers extracted data separately; assessed risk of bias; and contacted pharmaceutical