Prepared by:
Southern California Evidence-Based Practice Center-RAND
Paul Shekelle, M.D., Ph.D.
Task Order Director
Mary Hardy, M.D.
Task Order Co-Director
Sally C. Morton, Ph.D.
Senior Statistician
Margaret Maglione, M.P.P.
Project Manager/Policy Analyst
Marika Suttorp, M.S.
Statistician
Elizabeth Roth, M.A.
Senior Programmer/Analyst
Lara Jungvig, B.A.
Programmer/Analyst
Walter A. Mojica, M.D., M.P.H.
James Gagné, M.D.
Physician Reviewers
Shannon Rhodes, M.F.A.
Eileen McKinnon, B.A.
Staff Assistants
File Name Description Software Version File Size ________________________________________________________________________________________________ 01front.doc Microsoft Word® Document MS Word® 2002 186KB 19 pages 01front.pdf Adobe Acrobat® Document Adobe Acrobat® 5.0 259KB 19 pages Contents: Cover, Title Page, Preface, Acknowledgment, Structured Abstract, Table of Contents, Summary (Overview, Reporting the Evidence, Methodology, Findings, Future Research) ________________________________________________________________________________________________ 02chap1.doc Microsoft Word® Document MS Word® 2002 207KB 11 pages 02chap1.pdf Adobe Acrobat® Document Adobe Acrobat® 5.0 167KB 11 pages Contents: Chapter 1. Introduction: Purpose, Scope of Work, Background, History and Pharmacology, Table 1. Herbs containing caffeine commonly combined with ephedra in products marketed for weight loss or improved physical performance ________________________________________________________________________________________________ 03chap2.doc Microsoft Word® Document MS Word® 2002 962KB 60 pages 03chap2.pdf Adobe Acrobat® Document Adobe Acrobat® 5.0 1.5MB 60 pages Contents: Chapter 2. Methodology: Original Proposed Key Questions, Technical Expert Panel, Literature Search, Article Review, Meta-Analysis, Safety Assessment, Peer Review, Table 2. Technical expert panel members, Table 3. Technical expert panel suggestions about data collection, Table 4. Measures used in assessing causality, Table 5. Ephedra/ephedrine search methodology, Table 6. Ephedra/ephedrine search methodology - additional databases, Table 7. Categories of adverse events, Table 8. Report reviewers, Figure 1. Screening form for literature, Figure 2. Quality review form for literature, Figure 3a. Adverse events analysis form for death, MI, stroke cases, Figure 3b. Adverse events analysis form for seizure cases, Figure 3c. Adverse events analysis form for psychiatric cases, Figure 4. Brief data collection form for case reports, Figure 5. Examples of MIPER files, Figure 6. Example of duplicate case, Figure 7. Metabolife record screener form ________________________________________________________________________________________________ 04chap3.doc Microsoft Word® Document MS Word® 2002 1.2MB 114 pages 04chap3.pdf Adobe Acrobat® Document Adobe Acrobat® 5.0 5.2MB 114 pages Contents: Chapter 3. Results: Results of Literature Search, Efficacy, Safety Assessment; Table 9. Weight loss trial inclusion results, Table 10. Ephedrine versus placebo, Table 11. Publication bias tests, Table 12. Ephedrine + caffeine versus placebo, Table 13. Ephedrine + caffeine versus ephedrine, Table 14. Ephedrine versus another active weight loss therapy, Table 15. Ephedra versus placebo, Table 16. Ephedra + herbs containing caffeine versus placebo, Table 17. Meta-regression results, Table 18. Exercise trials by Bell and colleagues, Table 19. Summary table of meta-analysis of adverse events reported in controlled trials, Table 20. Summary table of other of adverse events reported in controlled trials, Table 21. Distribution of adverse events in the FDA file according to the Excel Spreadsheet, Table 22. Evidence table of case reports, Table 23. Summary of adverse events with ephedra consumption, Table 24. Summary of adverse events with ephedrine consumption, Table 25. Summary of adverse events not reviewed in detail, Table 26. Summary data of key variables from Metabolife file analysis, Table 27. Comparison of serious cases identified by RAND and by Metabolife, Table 28. Summary of Metabolife medical records ________________________________________________________________________________________________ 05c3figs.doc Microsoft Word® Document MS Word® 2002 347KB 10 pages 05c3figs.pdf Adobe Acrobat® Document Adobe Acrobat® 5.0 194KB 10 pages Contents: Figures for Chapter 3: Figure 8. Literature flow, Figure 9. Ephedrine versus placebo - forest plot, Figure 10. Ephedrine versus placebo - funnel plot, Figure 11. Ephedrine + caffeine versus ephedrine alone - forest plot, Figure 12. Ephedrine + caffeine versus placebo - funnel plot, Figure 13. Ephedrine + caffeine versus ephedrine alone - forest plot, Figure 14. Ephedra + herbs containing caffeine versus placebo - forest plot, Figure 15. Ephedra + herbs containing caffeine versus placebo - funnel plot, Figure 16. Effect sizes by comparison group, Figure 17a. Flow of evidence for adverse events analysis, part 1, Figure 17b. Flow of evidence for adverse events analysis, part 2, Figure 17c. Flow of evidence for adverse events analysis, part 3, Figure 18. Flow of MIPER ID Numbers ________________________________________________________________________________________________ 06chp456.doc Microsoft Word® Document MS Word® 2002 146KB 9 pages 06chp456.pdf Adobe Acrobat® Document Adobe Acrobat® 5.0 136KB 9 pages Contents: Chapter 4. Limitations; Chapter 5. Conclusions: Efficacy, Adverse Consequences; Chapter 6. Future Research ________________________________________________________________________________________________ 07refs.doc Microsoft Word® Document MS Word® 2002 152KB 7 pages 07refs.pdf Adobe Acrobat® Document Adobe Acrobat® 5.0 181KB 7 pages Contents: References ________________________________________________________________________________________________ 08etbls.doc Microsoft Word® Document MS Word® 2002 372KB 14 pages 08etbls.pdf Adobe Acrobat® Document Adobe Acrobat® 5.0 653KB 14 pages Contents: Evidence Tables: Evidence Table 1 - RCTs and CCTs reporting on Athletic Performance Enhancement with Ephedra; Evidence Table 2 - RCTs and CCTs reporting on Weight Loss; Acronyms ________________________________________________________________________________________________ 09app1.doc Microsoft Word® Document MS Word® 2002 235KB 32 pages 09app1.pdf Adobe Acrobat® Document Adobe Acrobat® 5.0 636KB 32 pages Contents: Appendix 1. Bibliography ________________________________________________________________________________________________ To obtain Appendix 2, call the AHRQ Publications Clearinghouse (1-800-358-9295) for a free printed copy. Request "Appendix 2: Metabolife Serious Adverse Events" (Publication No. 03-R206). ________________________________________________________________________________________________ 10app3.doc Microsoft Word® Document MS Word® 2002 784KB 119 pages 10app3.pdf Adobe Acrobat® Document Adobe Acrobat® 5.0 1.4MB 119 pages Contents: Appendix 3. Reviewer Comments ________________________________________________________________________________________________
AHRQ Publication No. 03-E022
Current as of March 2003
Internet Citation:
Ephedra and Ephedrine for Weight Loss and Athletic Performance Enhancement: Clinical Efficacy and Side Effects. File Inventory, Evidence Report/Technology Assessment Number 76. AHRQ Publication No. 03-E022, March 2003. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/clinic/ephedinv.htm
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