Shekelle P, Morton, S., Maglione M, et al. Ephedra and Ephedrine
for Weight Loss and Athletic Performance Enhancement: Clinical Efficacy and
Side Effects. Evidence Report/Technology Assessment No. 76 (Prepared by
Southern California Evidence-based Practice Center, RAND, under Contract No
290-97-0001, Task Order No. 9). AHRQ Publication No. 03-E022. Rockville, MD:
Agency for Healthcare Research and Quality. February 2003.
Evidence Report
Purpose
Scope of
Work
Background
The Problem of Obesity
Enhancing Physical Performance
History
and Pharmacology
Original Proposed Key Questions
Weight Loss
Athletic Performance
Safety Assessment
Technical
Expert Panel
Assessment
of Adverse Events
Literature
Search
Additional
Sources of Evidence
Article
Review
Extraction
of Study-Level Variables and Results
Meta-Analysis
Selection
of Trials for Meta-Analysis
Stratification
of Interventions
Weight Loss Effect Size
Performance of
Meta-Analysis
Analysis
of Dose
Publication
Bias
Meta-Regression
Safety
Assessment
Controlled
Trial Adverse Events
Case Report Adverse Events
Peer
Review
Results of Literature Search
Efficacy Analysis
Adverse
Events Analysis
Efficacy
Weight Loss
Athletic Performance
Safety
Assessment
Controlled
Trials
Case Reports
Efficacy
Weight Loss
Athletic Performance
Adverse Consequences
Table 1. Herbs containing caffeine commonly combined with ephedra in products marketed for weight loss or improved physical performance
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
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 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
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
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