CAMLAW: Complementary and Alternative Medicine Law Blog

Center to study Echinacea and St. John's wort receives funding renewal

A five-year-old research center dedicated to understanding and improving Echinacea and Hypericum perforatum (St. John's wort) has received $4.4 million in continuation funding from the National Institutes of Health.

The renewal is for three years.

The Iowa Center for Research on Botanical Dietary Supplements at Iowa State University was created in 2002 by the NIH Office of Dietary Supplements. In addition to Iowa State, the center includes researchers at the University of Iowa, Yale University and the U.S. Department of Agriculture's North Central Regional Plant Introduction Station in Ames. A total of 27 researchers are involved (including 13 graduate students).

Echinacea and Hypericum are two of the nation's top selling herbal dietary supplements. Before the center was established, however, there were few scientific studies to understand the plants and their effect on human health.

Researchers in the Iowa Center for Research on Botanical Dietary Supplements work with well- defined plant material, identify the chemical profiles and key compounds that contribute to health benefits and define how they work. The center's primary goal is to improve understanding of the characteristics of the selected extracts that contribute to human health benefits and pave the way for optimizing the supplements.

During the past five years, center researchers have gained insight into the antiviral, anti-inflammatory and immune-boosting mechanisms of specific species of Echinacea, and the antiviral and anti-inflammatory activity of different populations of Hypericum, said Diane Birt, director of the center and distinguished professor of food science and human nutrition at Iowa State.

"In studying the nine different species of Echinacea, we found some species work better than others," Birt said. "This suggests that it will be possible to get an improved preparation that will enhance the supplement's benefit to human health."

Researchers also found that lipid-soluble compounds in Echinacea have appreciable anti-inflammatory activity. In Echinacea and Hypericum, water-soluble compounds, such as polyphenols, seem to contribute to the plant material's antiviral activity.

"This suggests that we're not going to find a single compound or even a subset of compounds that are responsible for health benefits," Birt said. "A complex chemical profile is contributing to the health effects, so it's more likely that we're moving toward improving these supplements rather than identifying chemicals for use as drugs. We are moving toward something like a fingerprint of the biologically active chemicals in the species."

In addition, the researchers have identified some specific compounds in Hypericum that provide much greater activity in combination than individually.

The Iowa Center for Research on Botanical Dietary Supplements brings together plant scientists, biochemists, nutritionists, chemists, immunologists, food scientists, virologists, metabolic scientists and statisticians. Center strengths include genomic analysis, broad-based plant metabolic profiling and an ability to integrate complex datasets by using bioinformatics and other statistical tools, Birt said.

"One particular strength we have is our ability to control the genetics and growth conditions of the plant material used in our cellular and animal model studies," Birt said. "Being able to characterize known-source germplasm is a very important resource for our center."

In the renewal, researchers will continue to conduct the anti-viral, anti inflammatory and pain receptor studies to see how components can block inflammation by stimulating the receptor to down regulate it.

"In the next three years, we'll include emphasis on bioavailability," Birt said. "We don't know if the chemicals we've identified are absorbed. We'll also be looking at the mechanism, focusing on cellular, signaling, pathways and receptors."

And they will add a third plant, Prunella. Also known as self heal, Prunella has been used to treat ailments such as inflammatory bowel disease, fever, headache and diarrhea.

"Prunella grows well in Iowa. We have made some extracts and saw very good activity-both antiviral and anti-inflammatory, so it fits well with what we're doing," Birt said.

The nine Iowa State faculty involved are from four colleges (Liberal Arts and Sciences, Agriculture, Human Sciences and Veterinary Medicine.) In addition, two scientists from the USDA Plant Introduction Center, two faculty from Yale and one from the University of Iowa conduct research for the center.

NIH currently funds six Dietary Supplement Research Centers focused on botanicals. Scientists within these centers emphasize basic and preclinical research of potential benefit to human health.

Echinacea (purple coneflower)

* The second most widely used dietary botanical supplement

* In 2004, sales exceeded $23 million

* There are nine species

* Native to North America

* Historically, indigenous people used the roots medicinally

* Today, three species are used medicinally (E. angustifolia, pallida, and purpurea) to treat or prevent upper respiratory infections or as general immunostimulants

* Clinical studies on the efficacy of Echinacea supplements against infectious disease have had mixed results. Research by The Iowa Center for Research on Botanical Dietary Supplements based on the chemical profiles and bioactivity of the plants could provide a context to reinterpret past studies.

* More information is at http://nccam.nih.gov/health/echinacea/#intro

Hypericum perforatum (St. John's wort)

* It is one of 450 species of Hypericum, which grows wild in Europe and as an escaped weed in North America

* Has a long history of use as a folk remedy for a wide range of ailments, including insomnia, depression, headache, rheumatism and gastritis. It also is applied externally for treatment of wounds.

* In 2004, sales were $9 million

* Studies have shown it to be comparable to standard antidepressants in treating mild to moderate depression and with fewer side effects. Research supports its potential application to a wide range of other health conditions, including premenstrual syndrome and alcohol and smoking cessation.

* More information is at http://nccam.nih.gov/health/stjohnswort/

Prunella vulgaris (self heal)

* Is one of between seven and 15 species of Prunella.

* Along with P laciniata, P. vulgaris has been widely studied as medicinal plants.

* The entire flowering plant has been used for inflammatory bowel disease, fever, headache, diarrhea, liver disease and mouth and throat aliments.

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Contacts:

Wendy Maury, Iowa Center for Research on Botanical Dietary Supplements
Christine A. Swanson, NIH Office of Dietary Supplements
Teddi Barron, ISU News Service

Iowa Center for Research on Botanical Dietary Supplements--key researchers

Iowa State University
Diane Birt, food science and human nutrition
Philip Dixon, statistics
Suzanne Hendrich, food science and human nutrition
Marian Kohut, health and human performance
George Kraus, chemistry
Pat Murphy, food science and human nutrition
Basil Nikolau, professor, biochemistry, biophysics, molecular biology
Michael Wannemuehler, veterinary microbiology and preventive medicine
Eve Syrkin Wurtele, professor, genetics, development and cell biology

North Central Regional Plant Introduction Station
Joe-Ann McCoy, USDA-ARS biologist
Mark Widrlechner, USDA-ARS horticulturalist

University of Iowa
Wendy Maury, associate professor, microbiology

Yale University
Steven Hebert, physiology
Qiang Leng, physiology

Contact: Diane Birt
Iowa State University

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Law Offices of Michael H. Cohen offers general corporate legal services, litigation consultation, and expertise in health law with a unique focus on alternative, complementary, and integrative medical therapies. The firm represents medical doctors, allied health professionals (from psychologists to nurses and dentists) and other clinicians (from chiropractors to acupuncturists), solo entrepreneurs, hospitals, and educational and health care institutions.

Michael H. Cohen is Principal in Law Offices of Michael H. Cohen and also President of the Institute for Integrative and Energy Medicine (also known as the Institute for Health, Ethics, Law, Policy & Society), a forum for exploring legal, regulatory, ethical, and health policy issues involved in the judicious integration of complementary and alternative medical therapies (such as acupuncture and traditional oriental medicine, chiropractic, massage therapy, and herbal medicine) and conventional clinical care. The most recent published book by Michael H. Cohen on health care law, regulation, ethics and policy pertaining to complementary, alternative and integrative medicine and related fields is Healing at the Borderland of Medicine and Religion, which follows Complementary and Alternative Medicine: Legal Boundaries and Regulatory Perspectives (1998), Beyond Complementary Medicine: Legal and Ethical Perspectives on Health Care and Human Evolution (2000), and Future Medicine: Ethical Dilemmas, Regulatory Challenges, and Therapeutic Pathways to Health Care and Healing in Human Transformation (2003).

Health care and corporate lawyer Michael H. Cohen is licensed has been admitted to the Bar of California, Massachusetts, New York, and Washington D.C., and to the Bar of England and Wales as a Solicitor (non-practicing).
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