Herbal Medicine in the United States: Review of Efficacy, Safety, and Regulation

IntroductionHerbal products have gained increasing popularity in the last decade, and are now used by approximately 20% of the population. Herbal products are complex mixtures of organic chemicals that may come from any raw or processed part of a plant, including leaves, stems, flowers, roots, and seeds. Under the current law, herbs are defined as dietary supplements, and manufacturers can therefore produce, sell, and market herbs without first demonstrating safety and efficacy, as is required for pharmaceutical drugs. Although herbs are often perceived as “natural” and therefore safe, many different side effects have been reported owing to active ingredients, contaminants, or interactions with drugs.ResultsUnfortunately, there is limited scientific evidence to establish the safety and efficacy of most herbal products. Of the top 10 herbs, 5 (ginkgo, garlic, St. John’s wort, soy, and kava) have scientific evidence suggesting efficacy, but concerns over safety and a consideration of other medical therapies may temper the decision to use these products.ConclusionsHerbal products are not likely to become an important alternative to standard medical therapies unless there are changes to the regulation, standardization, and funding for research of these products.

[1]  E. Ernst,et al.  Garlic for treating hypercholesterolemia. A meta-analysis of randomized clinical trials. , 2000, Annals of internal medicine.

[2]  Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk; Final Rule , 2004, Journal of pain & palliative care pharmacotherapy.

[3]  J. Neuhaus,et al.  Safety and efficacy of citrus aurantium for weight loss. , 2004, The American journal of cardiology.

[4]  M. Hazzard Klaus Linde, Gilbert Ramirez, Cynthia D. Mulrow, Andrej Pauls, Wolfgang Weidenhammer, and Dieter Melchart. (1996). St. John's wort for depression—An overview and meta-analysis of randomized clinical trials. British Medical Journal, 313, 3 August 1996, 253-8 , 1997 .

[5]  R. Ko Adulterants in Asian patent medicines. , 1998, The New England journal of medicine.

[6]  A. Avins,et al.  Spontaneous bleeding associated with Ginkgo biloba , 2005, Journal of General Internal Medicine.

[7]  E. Ernst Harmless herbs? A review of the recent literature. , 1998, The American journal of medicine.

[8]  M B Keller,et al.  Effectiveness of St John's wort in major depression: a randomized controlled trial. , 2001, JAMA.

[9]  D. Kroll,et al.  Herbs as medicines. , 1998, Archives of internal medicine.

[10]  E. Ernst,et al.  Efficacy of ginger for nausea and vomiting: a systematic review of randomized clinical trials. , 2000, British journal of anaesthesia.

[11]  D. Rabago,et al.  Assessing the risks and benefits of herbal medicine: an overview of scientific evidence. , 1999, Alternative therapies in health and medicine.

[12]  S. Bent,et al.  Commonly used herbal medicines in the United States: a review. , 2004, The American journal of medicine.

[13]  A. Grollman,et al.  Botanical medicines--the need for new regulations. , 2002, The New England journal of medicine.

[14]  C. DesRoches,et al.  Americans' views on the use and regulation of dietary supplements. , 2001, Archives of internal medicine.

[15]  E. Ernst,et al.  Ginkgo biloba extract for the treatment of intermittent claudication: a meta-analysis of randomized trials. , 2000, The American journal of medicine.

[16]  Jerry Avorn,et al.  Internet marketing of herbal products. , 2003, JAMA.

[17]  P. Vereerstraeten,et al.  Urothelial carcinoma associated with the use of a Chinese herb (Aristolochia fangchi) , 2000, The New England journal of medicine.

[18]  P. Solomon,et al.  Ginkgo for memory enhancement: a randomized controlled trial. , 2002, JAMA.

[19]  J. Birks,et al.  Ginkgo biloba for cognitive impairment and dementia (Review) , 2017 .

[20]  I. Kanfer,et al.  High-performance liquid chromatographic determination of selected flavonols in Ginkgo biloba solid oral dosage forms. , 2004, Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques.

[21]  R. Bauer,et al.  Echinacea for preventing and treating the common cold. , 2000, The Cochrane database of systematic reviews.

[22]  Max H Pittler,et al.  Kava extract versus placebo for treating anxiety , 2003 .

[23]  W. Stigelman,et al.  Goodman and Gilman's the Pharmacological Basis of Therapeutics , 1986 .

[24]  Irwin Ziment,et al.  Evidence-Based Herbal Medicine , 2001 .

[25]  R. Kingston,et al.  The Relative Safety of Ephedra Compared with Other Herbal Products , 2003, Annals of Internal Medicine.

[26]  J. Kaye,et al.  The efficacy of Ginkgo biloba on cognitive function in Alzheimer disease. , 1998, Archives of neurology.

[27]  R. Kessler,et al.  Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. , 1998, JAMA.

[28]  K. Endoh,et al.  Soy isoflavones lower serum total and LDL cholesterol in humans: a meta-analysis of 11 randomized controlled trials. , 2007, The American journal of clinical nutrition.

[29]  P. Barnes,et al.  Complementary and alternative medicine use among adults: United States, 2002. Advance data from vital and health statistics, no. 343 , 2004 .

[30]  T. Perlis,et al.  Effects of Citrus aurantium extract, caffeine, and St. John's Wort on body fat loss, lipid levels, and mood states in overweight healthy adults , 1999 .

[31]  M. Gershwin,et al.  Variability in commercial ginseng products: an analysis of 25 preparations. , 2001, The American journal of clinical nutrition.

[32]  E. Basch,et al.  St John's wort: a systematic review of adverse effects and drug interactions for the consultation psychiatrist. , 2003, Psychosomatics.

[33]  D. Blumenthal,et al.  Privatization and its discontents--the evolving Chinese health care system. , 2005, The New England journal of medicine.

[34]  Adriane Fugh-Bermane The 5-Minute Herb and Dietary Supplement Consult , 2003 .

[35]  D. Schuppan,et al.  Herbal hepatotoxicity. , 2005, Journal of hepatology.

[36]  C. Mulrow,et al.  St John's wort for depression—an overview and meta-analysis of randomised clinical trials , 1996, BMJ.

[37]  M. Pittler,et al.  Kava extract for treating anxiety. , 2001, The Cochrane database of systematic reviews.

[38]  E. Ernst,et al.  The efficacy of ginseng. A systematic review of randomised clinical trials , 1999, European Journal of Clinical Pharmacology.

[39]  B. E. Burnham Garlic as a possible risk for postoperative bleeding. , 1995, Plastic and reconstructive surgery.

[40]  N. Benowitz,et al.  Hemodynamic effects of ephedra-free weight-loss supplements in humans. , 2005, The American journal of medicine.

[41]  Paul G Shekelle,et al.  Efficacy and safety of ephedra and ephedrine for weight loss and athletic performance: a meta-analysis. , 2003, JAMA.

[42]  J. Menke Herbal remedies. , 1997, South Dakota journal of medicine.

[43]  Julie Brown,et al.  Phytoestrogens for vasomotor menopausal symptoms. , 2007, The Cochrane database of systematic reviews.

[44]  J. Swerdlow Nature's Medicine: Plants That Heal , 2000 .

[45]  B. Strom,et al.  Balancing Safety of Dietary Supplements with the Free Market , 2002, Annals of Internal Medicine.

[46]  R. Bauer,et al.  Echinacea for preventing and treating the common cold. , 2008, Planta medica.

[47]  E. Ernst,et al.  Peppermint oil for irritable bowel syndrome: a critical review and metaanalysis , 1998, American Journal of Gastroenterology.

[48]  Norma Pugh,et al.  Effect of Hypericum perforatum (St John's wort) in major depressive disorder: a randomized controlled trial. , 2002, JAMA.

[49]  S. Cummings,et al.  An Internet-Based Randomized, Placebo-Controlled Trial of Kava and Valerian for Anxiety and Insomnia , 2005, Medicine.

[50]  P. Barnes,et al.  Complementary and alternative medicine use among adults: United States, 2002. , 2004, Advance data.

[51]  M. Koren Statin use in a "real-world" clinical setting: aggressive lipid lowering compared with usual care in the Aggressive Lipid-Lowering Initiation Abates New Cardiac Events (ALLIANCE) trial. , 2005, The American journal of medicine.

[52]  Rudolf Bauer,et al.  An evaluation of Echinacea angustifolia in experimental rhinovirus infections. , 2005, The New England journal of medicine.

[53]  Amy Padula,et al.  Spontaneous bleeding associated with ginkgo biloba: a case report and systematic review of the literature: a case report and systematic review of the literature. , 2005, Journal of general internal medicine.

[54]  K. D. Rose,et al.  Spontaneous spinal epidural hematoma with associated platelet dysfunction from excessive garlic ingestion: a case report. , 1990, Neurosurgery.