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Structured Abstract
Objectives:
Parkinson's Disease (PD) is estimated to affect over 1 percent of the population over age 65. The objective of this systematic review is to assess the quantity and quality of published evidence regarding diagnosis and treatment of patients with PD.
Search Strategy:
English-language literature published from 1990 to 2000 was searched using electronic databases. Searches were supplemented by manually reviewing bibliographies of all accepted studies and selected review articles.
Selection Criteria:
Studies were required to evaluate at least 10 human patients and address pre-defined areas of interest. Only randomized controlled trials (RCTs) were accepted for studies regarding pharmacological treatment.
Data Collection and Analysis:
Pertinent data were evaluated for quality and level of evidence, extracted from accepted studies by one researcher, and reviewed by a second. Data were summarized and synthesized qualitatively. Meta-analyses were performed, comparing standardized mean changes from baseline to outcome in PD severity rating scales.
Main Results:
The database includes 59 studies (3,369 patients) regarding diagnosis, 49 studies (9,968 patients) on pharmacological treatment, 42 studies (1,380 patients) on surgery, 10 studies (392 patients) on psychiatric treatment, and 20 studies (1,049 patients) on ancillary treatment of PD.
PD is diagnosed clinically; evidence does not show that specific tests improve diagnostic accuracy. There is no evidence that different dopamine agonists (DAs) vary in treatment effects. Meta-analysis suggests that in early PD, treatment with DAs plus levodopa (L-dopa) may control PD symptoms better than treatment with L-dopa alone, but this was not a consistent finding. Similarly, no consistent difference in symptom control was found between L-dopa alone and the combination therapy of L-dopa plus selegiline. In patients with advanced disease, treatment with catechol O-methyl transferase (COMT) inhibitors combined with L-dopa provides significantly greater PD symptom control than treatment with L-dopa alone and is associated with lower L-dopa doses; however, long-term (greater than 7 months) results are lacking, and hepatotoxicity is a rare but potentially lethal side effect associated with tolcapone.
For pallidotomy and deep brain stimulation (DBS), endpoint PD scale scores are significantly better than baseline scores. DBS of the subthalamic nucleus (STN) and globus pallidus (GPi) result in significant improvement in PD symptoms, but only STN DBS is associated with decreased L-dopa doses. There are insufficient studies of thalamotomy and tissue transplantation to draw any conclusions regarding their efficacy and safety.
Ancillary treatments, such as physical therapy, improve some symptoms on a short-term basis, but long-term data are lacking. Intensive speech therapy has been shown to improve vocal intensity up to 12 months after treatment; however, long-term results are from only one study of 22 patients.
Conclusions:
PD is diagnosed clinically; there is currently no gold standard premorbid diagnostic test for PD. Meta-analyses of different pharmacological treatments showed that the only medication that consistently controlled PD symptoms better than L-dopa alone was the combination of L-dopa plus COMT inhibitors in patients with advanced PD. Meta-analyses suggest that pallidotomy and DBS result in improvement of PD rating scores. The published literature regarding PD suffers from lack of reporting standardized outcomes.
Contents
- Preface
- Summary
- 1. Introduction
- 2. Methodology
- 3. Results
- 4. Answers to Revised Key Questions
- 5. Strengths and Limitations of the Evidence Base
- 6. Recommendations for Future Research
- Standardize methods of reporting results
- Adequately power studies
- Report L-dopa usage
- Include patients with comorbidities in clinical trials
- Include more elderly patients and members of different racial and ethnic groups in clinical trials
- Perform studies that include patients with younger onset of disease
- Evaluate use of combinations of tests in diagnosing PD
- Improve quality and duration of studies of ancillary treatments for PD
- Report family perceptions relating to patient care
- Continue research on genetic components of PD risk
- Perform long-term studies on efficacy of surgical procedures
- 7. Harnessing the Available Evidence
- References
- Evidence Tables
- Bibliography
- Appendixes
- Appendix A. Major Parkinson's Disease Rating Scales
- Appendix B. Work Plan
- Appendix C. Topic Assessment and Refinement
- Appendix D. Causal Pathways: Diagnosis and Treatment of Parkinson's Disease
- Appendix E. Screening Sheets and Data Extraction Forms
- Appendix F. Statistical Reference
- Appendix G. Technical Experts and Peer Reviewers
- Appendix H. Accepted Studies Log
- Appendix I. Rejected Studies Log
- Appendix J. Studies of Interest Excluded from Database
- Appendix K. Acronyms in This Report
Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services.1 Contract No: 290-97-0016. Prepared by: MetaWorks, Inc., Evidence-based Practice Center, Medford, MA.
Suggested citation:
Levine CB, Fahrbach KR, Siderowf AD, et al. Diagnosis and Treatment of Parkinson's Disease: A Systematic Review of the Literature. Evidence Report/Technology Assessment Number 57. (Prepared by Metaworks, Inc., under Contract No. 290-97-0016.) AHRQ Publication No. 03-E040. Rockville, MD: Agency for Healthcare Research and Quality. June 2003.
This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.
AHRQ is the lead Federal agency charged with supporting research designed to improve the quality of health care, reduce its cost, address patient safety and medical errors, and broaden access to essential services. AHRQ sponsors and conducts research that provides evidence-based information on health care outcomes; quality; and cost, use, and access. The information helps health care decisionmakers—patients and clinicians, health system leaders, and policymakers—make more informed decisions and improve the quality of health care services.
The authors of this report are responsible for its content. Statements in the report should not be construed as endorsement by the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services of a particular drug, device, test, treatment, or other clinical service.
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- Diagnosis and Treatment of Parkinson's DiseaseDiagnosis and Treatment of Parkinson's Disease
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