Levodopa for the treatment of restless legs syndrome
Información
- DOI:
- https://doi.org/10.1002/14651858.CD005504.pub2Copiar DOI
- Base de datos:
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- Cochrane Database of Systematic Reviews
- Versión publicada:
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- 15 febrero 2011see what's new
- Tipo:
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- Intervention
- Etapa:
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- Review
- Grupo Editorial Cochrane:
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Grupo Cochrane de Trastornos del movimiento
- Copyright:
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- Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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Autores
Contributions of authors
MH: Performing previous work that was the foundation of the current review, conceiving the review, designing the review, co‐ordinating the review, providing general advice on the review, securing funding for the review, screening of obtained publications regarding eligibility, appraising quality of papers, data collection for the review, writing to study authors for additional information, interpretation of data, writing the review, providing a clinical perspective, providing a policy perspective, providing a consumer perspective.
HS: Undertaking searches, screening search results, organizing retrieval of papers, screening retrieved publications regarding eligibility, appraising quality of papers, extracting data from papers, writing to study authors and pharmaceutical companies for additional information, obtaining and screening data on unpublished studies, data management for the review, entering data into RevMan, analysis of data, interpretation of data, writing the review, providing a methodological perspective.
CT: Performing previous work that was the foundation of the current review, co‐ordinating the review, securing funding for the review, providing general advice on the review, interpretation of data, writing the review, providing a clinical perspective, providing a policy perspective, providing a consumer perspective.
RK: Performing previous work that was the foundation of the current review, conceiving the review, designing the review, co‐ordinating the review, securing funding for the review, providing general advice on the review, providing additional data on included trials, interpretation of data, providing a methodological perspective.
LK: Conceiving the review, designing the review, providing general advice on the review, writing the protocol, designing search strategies, analysis of data, interpretation of data.
DR: Co‐ordinating the review, securing funding for the review, providing general advice on the review.
Sources of support
Internal sources
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No sources of support supplied
External sources
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BMBF, Germany.
Grant from the German Federal Ministry for Education and Research (Bundesministerium für Bildung und Forschung ‐ BMBF, grant number DLR 01KG0723)
Declarations of interest
Hanna Scholz has no conflicts of interest to declare.
Claudia Trenkwalder has been an advisor for Boehringer Ingelheim, Cephalon, Mundipharm, Orion Pharma, Novartis, Solvay, Axxonis and UCB. She has received lecture honoraria from Boehringer Ingelheim, UCB, TEVA and Astra Zeneca.
Ralf Kohnen received honoraria for advisory board membership from Pfizer, USA; Axxonis, Germany; Roche, Germany; UCB, Germany; Jazzpharma, USA.
Dieter Riemann received research support from DFG, BMBF, EU (public funding) and from Takeda, Sanofi‐Aventis, Organon, Actelion and Omron. He was on the speakers bureau of Sanofi‐Aventis, Takeda, Servier, Lundbeck, Boehringer‐Ingelheim, GSK, Cephalon and Merz Pharmaceuticals. He was also a member of advisory boards for Sanofi‐Aventis, Lundbeck, GSK, Takeda and Actelion. Dr. Riemann declares that the above mentioned activities have no influence on the content of this article.
Levente Kriston has no conflicts of interest to declare.
Magdolna Hornyak received honoraria and/or lecture fees from Boehringer‐Ingelheim, Germany; GlaxoSmithKline, Germany; Roche, Germany; Pfizer Inc., Germany.
Acknowledgements
This work was supported by a grant from the German Federal Ministry for Education and Research (Bundesministerium für Bildung und Forschung ‐ BMBF, grant number DLR 01KG0723) to MH.
We also thank Carolin Laux for supporting the project during data collection and data management.
Version history
| Published | Title | Stage | Authors | Version |
| 2011 Feb 15 | Levodopa for the treatment of restless legs syndrome | Review | Hanna Scholz, Claudia Trenkwalder, Ralf Kohnen, Levente Kriston, Dieter Riemann, Magdolna Hornyak | |
| 2005 Oct 19 | Levodopa for restless legs syndrome | Protocol | Magdolna Hornyak, Michael M Berner, Levente Kriston, Dieter Riemann | |
Differences between protocol and review
Two outcomes defined in the protocol were specified in detail, two outcomes were added, and two outcome parameters were dropped after discussion in the light of actual research before the search for publications.
PLMS Index and number of patients dropping out due to adverse events were defined as primary and not as secondary outcome parameters. Total sleep time assessed in polysomnography was appended as a primary outcome.
We added clinician rated general improvement (CGI‐I) and number of patients experiencing augmentation in the secondary outcome section. We excluded the planned outcomes “patient satisfaction with treatment” and “daytime functioning” as investigation of these endpoints in levodopa trials was very unlikely.
We investigated not only the first phase of cross‐over trials, but included both phases of cross‐over trials and corrected statistically for the different design when possible (see Reviewer's Handbook, chapter 16.4).
We set search dates from 1985 (instead of 1990) to 2008 in order to obtain all possibly relevant trials. In order to be able to include all possibly relevant studies, trials did not have to implement explicit diagnostic criteria according to the IRLSSG (Walters 1995) but it was permitted to describe similar inclusion criteria of patients.
Search strategies were modified with respect to newly recommended strategies by the Reviewer's Handbook, chapter 6.
We conducted additional searches in online trial registers provided by pharmaceutical companies, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the U.S. National Institutes for Health.
Instead of implementing fixed‐effect models where data were homogeneous, we performed all meta‐analyses using random‐effects models as recommended by the Reviewer's Handbook. As only data for per protocol populations were reported, we performed analyses based on these data.
We could not perform any subgroup analyses on different types of agents, comparator treatment, duration of treatment or dosage of treatment as these parameters did not vary between the included studies. Also study type could not be investigated separately as all studies but one active controlled trial were cross‐over trials. As only few studies contributed data to the primary outcomes, we did not perform subgroup or sensitivity analysis on studies with differing study quality.
