Multivitamin/Mineral Supplements and Prevention of Chronic Disease
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Evidence Report/Technology Assessment Number 139 Multivitamin/Mineral Supplements and Prevention of Chronic Disease Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 540 Gaither Road Rockville, MD 20850 www.ahrq.gov Contract No. 290-02-0018 Prepared by: The Johns Hopkins University Evidence-based Practice Center, Baltimore, MD Investigators Han-Yao Huang, Ph.D., M.P.H. Benjamin Caballero, M.D., Ph.D. Stephanie Chang, M.D., M.P.H. Anthony Alberg, Ph.D., M.P.H. Richard Semba, M.D., M.P.H. Christine Schneyer, M.D. Renee F. Wilson, M.Sc. Ting-Yuan Cheng, M.Sc. Gregory Prokopowicz, M.D., M.P.H. George J. Barnes II, B.A. Jason Vassy Eric B. Bass, M.D., M.P.H. AHRQ Publication No. 06-E012 May 2006 This report is based on research conducted by The Johns Hopkins University Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-02-0018). The findings and conclusions in this document are those of the author(s), who are responsible for its content, and do not necessarily represent the views of AHRQ. No statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services. The information in this report is intended to help clinicians, employers, policymakers, and others make informed decisions about the provision of health care services. This report is intended as a reference and not as a substitute for clinical judgment. This report may be used, in whole or in part, as the basis for the development of clinical practice guidelines and other quality enhancement tools, or as 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. This document is in the public domain and may be used and reprinted without permission except those copyrighted materials noted for which further reproduction is prohibited without the specific permission of copyright holders. Suggested Citation: Huang HY, Caballero B, Chang S, Alberg A, Semba R, Schneyer C, Wilson RF, Cheng TY, Prokopowicz G, Barnes II GJ, Vassy J, Bass EB. Multivitamin/Mineral Supplements and Prevention of Chronic Disease. Evidence Report/Technology Assessment No. 139. (Prepared by The Johns Hopkins University Evidence-based Practice Center under Contract No. 290-02- 0018). AHRQ Publication No. 06-E012. Rockville, MD: Agency for Healthcare Research and Quality. May 2006. The investigators have no relevant financial interests in the report. The investigators have no employment, consultancies, honoraria, or stock ownership or options, or royalties from any organization or entity with a financial interest or financial conflict with the subject matter discussed in the report. ii Preface The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-Based Practice Centers (EPCs), sponsors the development of evidence reports and technology assessments to assist public- and private-sector organizations in their efforts to improve the quality of health care in the United States. This report was funded by the National Institutes of Health Office of Medical Applications of Research (NIH OMAR). The reports and assessments provide organizations with comprehensive, science-based information on common, costly medical conditions and new health care technologies. The EPCs systematically review the relevant scientific literature on topics assigned to them by AHRQ and conduct additional analyses when appropriate prior to developing their reports and assessments. To bring the broadest range of experts into the development of evidence reports and health technology assessments, AHRQ encourages the EPCs to form partnerships and enter into collaborations with other medical and research organizations. The EPCs work with these partner organizations to ensure that the evidence reports and technology assessments they produce will become building blocks for health care quality improvement projects throughout the Nation. The reports undergo peer review prior to their release. AHRQ expects that the EPC evidence reports and technology assessments will inform individual health plans, providers, and purchasers as well as the health care system as a whole by providing important information to help improve health care quality. We welcome comments on this evidence report. They may be sent by mail to the Task Order Officer named below at: Agency for Healthcare Research and Quality, 540 Gaither Road, Rockville, MD 20850, or by e-mail to [email protected]. Carolyn M. Clancy, M.D. Jean Slutsky, P.A., M.S.P.H. Director Director, Center for Outcomes and Evidence Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality Barnett Kramer, M.D., M.P.H. Beth A. Collins Sharp, Ph.D., R.N. Director Acting Director, EPC Program Office of Medical Applications of Research Agency for Healthcare Research and Quality National Institutes of Health Ernestine W. Murray, B.S.N., R.N., M.A.S. EPC Program Task Order Officer Agency for Healthcare Research and Quality iii Acknowledgments The Evidence-based Practice Center thanks Karen Robinson for her assistance in developing the search strategies; Steven Bressler and Archana Ramaswami, for their assistance with literature searching and database management; Gabriel Lai, Karran Phillips, Konstantinos K. Tsilidisand, and Amina Chaudhry for their assistance with article reviewing and data entry; Christine Napolitano for her assistance with budget matters, and Brenda Zacharko for her assistance with final preparations of the report. iv Structured Abstract Objective. To review and synthesize published literature on the efficacy of multivitamin/mineral supplements and certain single nutrient supplements in the primary prevention of chronic disease in the general adult population, and on the safety of multivitamin/mineral supplements and certain single nutrient supplements, likely to be included in multivitamin/mineral supplements, in the general population of adults and children. Data Sources. All articles published through February 28, 2006, on MEDLINE,® EMBASE,® and the Cochrane databases. Review Methods. Each article underwent double reviews on title, abstract, and inclusion eligibility. Two reviewers performed data abstraction and quality assessment. Differences in opinion were resolved through consensus adjudication. Results. Few trials have addressed the efficacy of multivitamin/mineral supplement use in chronic disease prevention in the general population of the United States. One trial on poorly nourished Chinese showed supplementation with combined β-carotene, vitamin E and selenium reduced gastric cancer incidence and mortality, and overall cancer mortality. In a French trial, combined vitamin C, vitamin E, β-carotene, selenium, and zinc reduced cancer risk in men but not in women. No cardiovascular benefit was evident in both trials. Multivitamin/mineral supplement use had no benefit for preventing cataract. Zinc/antioxidants had benefits for preventing advanced age-related macular degeneration in persons at high risk for the disease. With few exceptions, neither β-carotene nor vitamin E had benefits for preventing cancer, cardiovascular disease, cataract, and age-related macular degeneration. β-carotene supplementation increased lung cancer risk in smokers and persons exposed to asbestos. Folic acid alone or combined with vitamin B12 and/or vitamin B6 had no significant effects on cognitive function. Selenium may confer benefit for cancer prevention but not cardiovascular disease prevention. Calcium may prevent bone mineral density loss in postmenopausal women, and may reduce vertebral fractures, but not non-vertebral fractures. The evidence suggests dose- dependent benefits of vitamin D with/without calcium for retaining bone mineral density and preventing hip fracture, non-vertebral fracture and falls. We found no consistent pattern of increased adverse effects of multivitamin/mineral supplements except for skin yellowing by β-carotene. Conclusion. Multivitamin/mineral supplement use may prevent cancer in individuals with poor or suboptimal nutritional status. The heterogeneity in the study populations limits generalization to United States population. Multivitamin/mineral supplements conferred no benefit in preventing cardiovascular disease or cataract, and may prevent advanced age-related macular degeneration only in high-risk individuals. The overall quality and quantity of the literature on the safety of multivitamin/mineral supplements is limited. v Contents Executive Summary.........................................................................................................................1 Evidence Report...........................................................................................................................11 Chapter 1. Introduction .................................................................................................................11 Purpose.....................................................................................................................................11 Specific Aims...........................................................................................................................11 Use of Multivitamins/mineral Supplements in the United States............................................12 Chronic Disease .......................................................................................................................13