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NCCAM's International Centers for Research on CAM (ICRCs)

To help contribute to its international research goals, the National Center for Complementary and Alternative Medicine (NCCAM) has invested in the creation of several International Centers for Research on CAM (ICRCs). Grants for three such international centers have been awarded, two by NCCAM and a third by the National Cancer Institute (NCI). These awards constitute the second phase of a two-part initiative. In the first phase, eleven awards for "Planning Grants for International Centers for Research on CAM (PICRC)" were made in October 2003 to help support research institutions' efforts to build international partnerships to address significant public health problems.

From these eleven planning grants, three Centers have been selected through a competitive review process for 4 years of grant support through which they will contribute to NCCAM's strategic goals for international research. Specifically, they will:

Establish programs that will carry out rigorous, high-quality research on CAM/traditional medicine (TM) practices at their site of origin, and determine whether these practices are beneficial to health and well being in addressing high priority problems at both local and global levels.
Assist in the development of sustainable research capacity and the scientific and administrative talent needed to carry out such investigation.
Facilitate and encourage international scientific collaborations and exchange between CAM/TM and conventional medical researchers and practitioners.
Contribute to the preservation of systems of traditional and indigenous knowledge.

Each ICRC consists of a partnership between the grantee, a U.S. institution with substantial expertise in biomedical research, and a non-U.S. institution with substantial expertise and experience in an alternative, traditional, or indigenous medical system. Each will include at least three inter-related exploratory or developmental research projects focusing on the science underlying an alternative medical system or practice, and will address health problems important both at the non-U.S. site and in a global health context. Most of the research will be carried out at the non-U.S. site, and investigators will employ a team-oriented multidisciplinary approach. Ultimately, we hope that, in participating in this initiative, the non-U.S. institution should be able to compete successfully and independently for CAM research funding from NCCAM or other NIH institutes and centers, as well as from other private and public sector sources.

Two of the centers are funded by NCCAM in partnership with the Office of AIDS Research (OAR), the Office of Dietary Supplements (ODS), and the Fogarty International Center (FIC). The third center is supported entirely by NCI. These are 4-year U19 cooperative agreements.

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ICRC Centers Managed by NCCAM

Project Name: Functional Bowel Disorders in Chinese Medicine
Principal Investigator: Brian M. Berman, M.D., University of Maryland, Baltimore, MD
Phone: 410-448-6872
E-mail: bberman@compmed.umm.edu

Participating Institutions:

Description: The goal of this International Center is to continue development of a sustainable international research collaboration that will carry out rigorous, multi-disciplinary research on traditional Chinese medicine (TCM) approaches to functional bowel disorders. Irritable bowel syndrome (IBS) is a common condition causing significant symptoms that are difficult to treat. In the U.S., IBS leads to 12 percent of visits to primary care doctors and 28 percent of visits to gastroenterology practices. In Hong Kong, epidemiological studies suggest prevalence of IBS in the general population is as high as 6.6 percent. Currently proven treatment options are generally considered unsatisfactory. Preliminary data suggests that TCM approaches using herbal drugs and/or acupuncture may benefit patients suffering from IBS.

Investigators from the Chinese University of Hong Kong (CUHK); the Center for Integrative Medicine at the University of Maryland, Baltimore; the University of Illinois, Chicago; the University of Western Sydney; and Mayo Medical Center will collaborate on three projects centered at CUHK:

Project #1: To evaluate the effects of electro-acupuncture on IBS. Using a rat model of neonatal stress-induced irritable bowel syndrome, they will examine various parameters of efficacy including behavioral and visceral responses; they will also study levels of neurotransmitter systems believed to play an important role in causing IBS symptoms.
Project #2: To conduct preclinical research on a promising TCM herbal preparation in order to establish the biological potency, safety, adverse effects, and toxicity of a practical, reproducible, quality controlled product.
Project #3: To carry out a pilot clinical trial evaluating the safety and dose-response of the same herbal formulation in patients with IBS.

The Center also includes several important Cores:

The Botanical Core--responsible for authentication, standardization, and quality control of herbal materials.
The Data Management and Statistical Analysis Core--provides expertise on study design, conduct, and statistical analyses.
The Administrative Core--coordinates the overall program and facilitates further research efforts by the collaborators.

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Project Name: The International Center for Indigenous Phytotherapy Studies (TICIPS): HIV/AIDS, Secondary Infections, and Immune Modulation
Principal Investigator: William R. Folk, Ph.D., University of Missouri, Columbia, MO
Phone: 573-882-2841
E-mail: FolkW@missouri.edu

Participating Institutions:

Description: The goals of the International Center for Indigenous Phytotherapy (i.e., herbal medicine) Studies (TICIPS) are to:

Create a collaborative environment of trust, open communication and research;
Support scientifically rigorous and ethical studies of African phytotherapies and health care systems;
Train scientists to conduct the highest caliber research in complementary and alternative medical practices;
Promote conservation of plant biodiversity and protection of indigenous knowledge;
Communicate evidence for the safety and efficacy of indigenous phytotherapies and CAM to health care providers and the public; and
Advance the health and well-being of the African and American peoples.

While the world is increasingly familiar with CAM practices from around the world, little is known about traditional healing practices used in Africa. South Africa is home to some 200,000 traditional healers and 22,000 allopathic doctors responsible for the care of 44 million people who come from many cultures and speak 11 languages. This dual health care system is tremendously challenged by the impact of AIDS and secondary infections, which are decimating the populace, weakening social and political structures, and endangering the prospect of a sustainable, peaceful future. Consequently, TICIPS will target HIV/AIDS, secondary infections and immune modulation and support several innovative and interrelated research projects focusing upon potentially useful indigenous herbal medicines. Research projects to be undertaken include the following:

Project #1: The investigators will conduct a 4-year randomized, double-blind, placebo-controlled study of the safety and efficacy of Lessertia frutescens (also named Sutherlandia frutescens) in South Africans infected with HIV. The goals are to determine the plant's safety and to gather information regarding quality of life and various markers of HIV disease progression. L. frutescens is believed to be useful to alleviate symptoms of HIV/AIDS and is widely used in South Africa for this and other purposes. It is available as a marketed product in South Africa.
Projects #2 and #3: The investigators will carry out in vitro and in vivo preclinical safety and efficacy studies of Artemisia afra--another herbal medicine apparently in wide use by South African traditional healers as a tonic for a wide range of ailments, although little to nothing is known of its safety or efficacy. These experiments will lay the foundation for possible subsequent human clinical trials to test the safety and efficacy of Artemisia afra in patients with cervical cancer and tuberculosis.
Project #4: The investigators will carry out a phase I clinical safety study of A. afra in healthy adults (assuming that evidence of safety is established in Project #3). As noted earlier, the safety and efficacy of A. afra in medical therapy have yet to be established, even though it is in widespread use. This study will also lay the foundation for possible future human clinical trials.

The Center also includes several important Cores:

The Clinical Trials Core--ensures the safety of all human subjects; develops rigorous clinical trial protocols so that accurate, meaningful data come from them.
The Traditional Healers Core--ensures active and meaningful collaboration with senior traditional healers and Council representatives; organizes cross-disciplinary seminars, meetings, training, and other opportunities to facilitate joint exploration of the approaches of both traditional and biomedical healing systems.
The Communication Core--provides external and internal communication services that will help build a sustainable and robust partnership between the research program and the many communities with which it must interface.
The Phytochemistry and Biodiversity Core--supplies research grade botanical products for all TICIPS research ventures; promotes the conservation of South African medicinal plants.
The Administrative Core--coordinates the overall program; provides training, mentoring, career development, and exchange opportunities for staff; ensures full compliance with all applicable laws, regulations, and ethical standards of the Republic of South Africa and the United States of America.

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ICRC Center Managed by the NIH's National Cancer Institute

Project Name: International Center of Traditional Chinese Medicine (TCM) for Cancer
Principal Investigator: Lorenzo Cohen, Ph.D., M.D. Anderson Cancer Center, Houston, TX
Phone: 714-745-4260
E-mail: lcohen@mdanderson.org

Participating Organization:

Fudan University Cancer Hospital, Shanghai, Peoples Republic of China

Description: In the U.S., China, and many other parts of the world, cancer is one of the leading causes of death. CAM use is also significant in both countries, and is especially evident among cancer patients. Careful examination of CAM in cancer, and evaluation of its potential benefit for different treatment modalities is imperative. The goal of this international center is to examine three aspects of TCM in a cancer setting which will correspond to the Center's three projects:

Project #1: Evaluate herbal/natural products that target disease outcomes and treatment and disease-related symptoms. The investigators will continue ongoing research on Huachansu and conduct a randomized, double-blind, placebo-controlled phase II clinical trial. They will also continue review of preclinical in vitro and in vivo studies in order to identify other appropriate herbal/natural products with potential therapeutic use.
Project #2: Investigate the effects of acupuncture on specific clinical symptoms in patients with cancer. A phase I trial will examine the feasibility and initial efficacy of acupuncture to treat radiation-induced mouth dryness and sores (xerostomia).
Project #3: Evaluate the bio-behavioral effects of qigong. A phase II trial of qigong will be conducted in patients with breast cancer who are undergoing radiation treatment at the Fudan University Cancer Hospital to determine the feasibility and initial efficacy of qigong.

Through each of these projects, the Epidemiology Core of this Center will focus primarily on examining the reliability and validity of TCM diagnostic techniques in order to explore the association of specific TCM diagnosis with Western-based medical diagnosis, medical characteristics, and biological markers of susceptibility and prognosis. The Center is also supported by an Administrative Core.

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