systematic review of dietary supplement efficacy and safety paul m. coates, ph.d. office of dietary...
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Systematic Review Systematic Review of Dietary of Dietary
Supplement Efficacy Supplement Efficacy and Safetyand Safety
Paul M. Coates, Ph.D.Office of Dietary SupplementsOffice of Dietary SupplementsNational Institutes of HealthNational Institutes of HealthDepartment of Health and Human Department of Health and Human ServicesServices
AHRQ Annual MeetingAHRQ Annual MeetingSeptember 2008September 2008
NIH Funding for Dietary NIH Funding for Dietary Supplement Research Has Supplement Research Has
Increased SignificantlyIncreased Significantly
0
50
100
150
200
250
300
1999 2000 2001 2002 2003 2004 2005 2006
$ Million$ Million
ODS Mission is to Strengthen ODS Mission is to Strengthen Knowledge and Understanding of Knowledge and Understanding of
Dietary SupplementsDietary Supplements
Evaluate Scientific Information Stimulate and Support Research Disseminate Research Results Educate the Public to Foster an
Enhanced Quality of Life and Health for U.S. Population
EchinaceaEchinaceaEchinacea purpureaEchinacea purpurea
Evidence-Based Review
Program
Congressional Language for FY Congressional Language for FY 2001 ODS Appropriation2001 ODS Appropriation
“The Office is encouraged, in consultation with NCCAM, AHRQ, and FDA to review the current scientific evidence on the safety and efficacy of dietary supplements now on the market, which could then form a basis for further research, education of practitioners and consumers, and whether further regulatory requirements are necessary.”
Evidence-Based Review Program
Systematic review of the literature, with meta-analysis as appropriate, on DS efficacy and safety
In collaboration with the Agency for Healthcare Research and Quality (AHRQ) Evidence-Based Practice Center Network
Major reason for conducting these reviews is to assist NIH in the development of research agendas
ODS Evidence-Based Review ODS Evidence-Based Review ProgramProgram
Chromium and insulin sensitivity*
Ephedra for weight management and athletic performance enhancement* (with NCCAM)
Omega-3 fatty acids for cardiovascular disease prevention* (with NHLBI) and other health indications
Health effects of soy (with NCCAM)
Antioxidant phytochemicals/B vitamins and neurodegenerative diseases*(with NCCAM)
Multivitamins/multiminerals and chronic disease prevention (with OMAR)
Coagulation, diet, and dietary supplements
Health effects of vitamin D (with multiple partners)*Congressional mandate
Health Effects of Omega-3 Fatty Acids
Asthma Cancer Cardiovascular Disease Cardiovascular Disease Risk Factors Arrhythmogenic Mechanisms Child and Maternal Health Cognitive Function Eye Health Type II Diabetes, Rheumatoid Arthritis, and Other
Diseases Mental Health Organ Transplantation
Health Effects of Omega-3 Fatty Acids
Secondary CVD Prevention Reduces all cause mortality and
other CVD outcomes (sudden death, cardiac death, MI)
Primary CVD Prevention Large, consistent beneficial effect
found for serum triglyceride levels Little or no effect found for other
CV risk factors and markers of CVD
Omega-3 Reports
Heterogeneous data; challenging to evaluate Methods of estimating fish or
omega-3 fatty acid intake Background diets Methods of reporting results
Adverse events from clinical studies appear to be minor However, reporting is spotty
Observations
“Nobody expects the Spanish Inquisition” (Monty Python’s Flying Circus, ca.1970)
Put another way, nobody expected to be meta-analyzed
Product Concerns: Identification Characterization Reproducibility
Issues in Dietary Supplement Issues in Dietary Supplement ResearchResearch
St. John’s WortSt. John’s WortHypericum perforatumHypericum perforatum
Protocol Concerns: Population(s) Endpoints Dose Earlier Phase Studies Publication
Issues (cont’d)Issues (cont’d)
St. John’s WortSt. John’s WortHypericum perforatumHypericum perforatum
