Research and Training in Complementary and Alternative Medicine

To evaluate alternative, complementary, or unconventional medical treatments.

The following objectives support this goal: (1) coordinate and facilitate the investigation of alternative medical practices through peer-reviewed grant solicitations; (2) interface with the Center's National Advisory

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Council; (3) conduct technology assessment conferences for the purpose of establishing areas of Clinical and Pre-clinical research that need to be further developed within Alternative Medicine; (4) maintain a comprehensive bibliographic data base in conjunction with the National Library of Medicine; (5) develop and continue contacts with international programs in complementary and alternative medicine (CAM); and (6) establish an intra- and extra-mural clinical research fellowship program focusing on broad areas of clinical, scientific, and administrative training in CAM.

The major purpose of all of these programs is to foster collaborations between practitioners of CAM and individuals knowledgeable in biomedical research.

The National Center for Complementary and Alternative Medicine (NCCAM) regularly examines and redefines its research priorities.

Priorities are set to fill gaps in the research portfolio, capitalize on emerging opportunities, and leverage resources.

Using a formal semi-annual planning process, NCCAM considers the existing research portfolio, NCCAM's 5-year strategic plan, plans of other NIH institutes and centers, recommendations of the National Advisory Council for Complementary and Alternative Medicine, as well as input from expert panels and other stakeholders to set its research priorities.

Mechanisms of Action: The research portfolio will have an increased emphasis on studies of the mechanisms underlying complementary and alternative medicine (CAM) approaches.

The reasons for this emphasis are: (1) elucidating the underlying mechanisms of action of CAM therapies will facilitate their integration into conventional medical care; and (2) mechanistic studies of CAM therapies will improve the identification of key study endpoints and thus strengthen the design of CAM clinical trials.

Exploratory Clinical Studies and Phase I and II Clinical Trials: The research portfolio will have an increased emphasis on exploratory, Phase I and Phase II studies of CAM.

The objectives of this focus are to: (1) determine active ingredients, pharmacology, bioavailability, and optimal dosing; (2) obtain preliminary data on safety and efficacy; and (3) conduct exploratory clinical studies (e.g., case control, observational, qualitative and experimental studies) to elucidate mechanisms and test models.

The outcomes of these studies will form the basis for designing larger trials with an enhanced ability to detect a meaningful positive effect, if any, of the CAM modality under study.

Research areas currently of special interest are listed below: (1) anxiety and depression--basic and preclinical research on CAM approaches; (2) cardiovascular diseases--preclinical and early phase clinical studies of CAM approaches to secondary prevention and management of hypertension, atherosclerosis, and congestive heart failure; (3) Eehnomedicine-identification, description, and study of potentially valuable, vanishing traditional or indigenous health care practices in geographic areas where there is little preservation; (4) immune modulation/enhancement-basic and preclinical studies of CAM approaches that may enhance or inhibit immune responses, including inflammation; (5) inflammatory bowel disease and irritable bowel syndrome-CAM approaches to these conditions; (6) insomnia-CAM approaches to primary and secondary insomnia; (7) liver-CAM approaches to liver diseases; (8) obesity/metabolic syndrome-CAM modalities, particularly mind-body treatments, as adjuvant therapies, especially with respect to the metabolic syndrome and type 2 diabetes; 9) respiratory diseases-CAM approaches topreventionandtreatmentofinfectiousrespiratory diseases; and (10) NCCAM continues to be highly interested in research on minority and gender health and on health disparities.

NCCAM continues to accept applications in areas not listed.

All investigators are urged to discuss potential applications with the relevant NCCAM Program Officer.
Examples of Funded Projects

The Centers program is supporting a variety of on-going studies including the use of Mindfulness-Based Stress Reduction, a meditative approach, to help reduce stress and better manage emotions, in people with early stage HIV.

Specifically, the effects of meditation on the immune system will be studied to see if meditation can help slow disease progression and delay the need for antiretroviral treatment.

Center investigators will evaluate whether certain traditional Chinese medicines and an electrical acupuncture technique can be used to prevent addiction relapse and craving for alcohol and drugs of abuse.

They will also seek to determine the physiological mechanisms by which these Chinese medical treatments affect addictive behavior.

Several centers will be exploring the mechanisms of action of acupuncture using both animal models and human studies employing state-of-the-art real-time imaging technology.

Other studies will examine the potential use of antioxidant CAM therapies for asthma.

Researchers will investigate whether these antioxidant treatments can minimize airway inflammation in response to common triggers of asthma, such as ozone or inhaled allergens.

Also explored will be the use of mushroom extracts to enhance the immune system's response to tumors, and the healing power of "placebo" particularly strategies to maximize placebo's benefits, improve clinical trial design, and gain insight into mechanisms underlying mind-body medicine.

Finally, center investigators will study the effects of osteopathic manipulation on the musculoskeletal system, lymphatic fluid flow, and reduction of pain from back and neck strain.

NCCAM is supporting several large, multisite trials designed to provide critical information for patients and providers.

(1) Ginkgo Evaluation on Memory Study.

This is a 10-year primary prevention trial testing whether Ginkgo biloba prevents the onset of Alzheimers Disease or other types of Dementia.

(2) Trial to Assess Chelation Therapy.

This is a 8-year secondary prevention trial testing whether EDTA chelation therapy and/or high-dose vitamins prevent the onset of a subsequent MI in people with coronary artery disease.

(3) Acupuncture for Low Back Pain - a 5-year treatment trial comparing individualized acupuncture treatments and standardized acupuncture treatments to both sham controls and usual conventional care in people who have had low back pain for at least three months.


Agency - Department of Health and Human Services

The Department of Health and Human Services is the Federal government's principal agency for protecting the health of all Americans and providing essential human services, especially to those who are least able to help themselves.


Relevant Nonprofit Program Categories




Program Accomplishments

It is estimated that 326 grants will be funded in fiscal year 2007 and 351 grants in fiscal year 2008. Currently, five developmental centers are supported that incorporate close collaborations between CAM and conventional institutions. One of these developmental centers is at a school of osteopathic medicine, one at a school of chiropratic medicine, and one at a school of traditional chinese medicine (e.g., acupuncture). In addition, developmental centers are funded to study mind/body medicine and botanical products. NCCAM, in collaboration with the NIH Office of Dietary Supplements, supports seven Centers for Dietary Supplements Research. Investigators at these seven centers are investigating the role, if any, of dietary supplements to treat and/or prevent age related diseases, cardiovascular disease including metabolic syndrome, and women's health issues. Several large clinical trials were in progress including: Hypericum for Minor Depression; Ginkgo biloba for Preventing Dementia; Saw Palmento for benign prostatic hyperplasgia; EDTA Chelation therapy for Coronary Artery Disease; Acupuncture to treat chronic back pain; and Soy supplements to treat atherosclerosis. Numerous investigator-initiated research grants were studying the breath of CAM modalities including clinical and basic studies of acupuncture, botanicals, chiropractic, homeopathy, massage therapy, naturopathy, Reiki, and Tai Chi to name a few.

Uses and Use Restrictions

Project grants and cooperative agreements may be made to eligible institutions for the support of various projects in CAM.

The grants may be used for personnel, consultant costs, equipment, supplies, travel, patient costs, animals miscellaneous items, and indirect costs.

For the individual post-doctoral training grant, support is for salary of the trainee, tuition and fees, self-only health insurance, research supplies, equipment, travel to scientific meetings, and related items.

Eligibility Requirements

Applicant Eligibility

The awardee will be either a university, college, hospital, public agency, nonprofit research institution, or for-profit organization that submits an application and receives a grant or cooperative agreement for support of research by a named principal investigator.

Beneficiary Eligibility

Any nonprofit or for-profit organization, company, or institution engaged in biomedical research.

Credentials/Documentation

For-profit organizations costs are determined by in accordance with 48 CFR, Subpart 31.2 of the Federal Acquisition Regulations. Costs will be determined in accordance with HHS Regulations 45 CFR 74, Subpart Q.

Aplication and Award Process

Preapplication Coordination

No preapplication is required.

This program is excluded from coverage under E.O.

12372.

Application Procedures

NIH is in the process of converting to SF424 (Research and Related (R&R)) forms and electronic submission through Grants.gov. Information on this plan and on registering for electronic submission is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-067.html . Updates regarding the transition process are at http://era.nih.gov/ElectronicReceipt/.

Award Procedures

Award Procedure: All accepted applications are evaluated for scientific and technical merit by an appropriate scientific peer review panel and by a national advisory council or board. All applications receiving a priority score ranging from the best (100) to worst (500) compete for available funds based on scientific merit, program relevance, and program balance and are made annually. Initial award provides funds for the first budget period (usually 12 months) and Notice of Grant Award (Form PHS 1533) indicates support recommended for remainder of project period, allocation of Federal funds by budget categories, and special conditions, if any.

Deadlines

New Grants and Cooperative Agreements: February 1, June 1, and October 1. Renewals and Supplements: March 1, July 1, and November 1. Postdoctoral Training, April 5, August 5, and December 5.

Authorization

Public Health Service Act, Sections 222 and 404E; Public Law 103-43, 42 U.S.C. 217a and 283g, as amended; Public Law 92- 463, as amended.

Range of Approval/Disapproval Time

Grants and Cooperation Agreement: Approximately 10 months. Training: For 9 months.

Appeals

A principal investigator (P.I.) may question the substantive or procedural aspects of the review of his/her application by communicating with the staff of the Office. A description of the NIH Peer Review Appeal procedures is available on the NIH homepage www.nih.gov/grants/guide/1997/97.11.21/n2.html .

Renewals

Applications submitted for renewal are reviewed and selected for funding on a competitive basis.

Assistance Considerations

Formula and Matching Requirements

This program has no statutory formula or matching requirements.

Length and Time Phasing of Assistance

Grants and cooperative agreements: Average 3 to 4 years, maximum of 5 years with prior approval before submission. Renewals may be awarded for additional periods of up to 5 years (with prior approval before submission) based on competitive peer review. Funds are provided through Monthly Demand Payment System or an Electronic Transfer System.

Post Assistance Requirements

Reports

Progress reports are required each year.

Annual financial status report is required 90 days after the end of the budget period.

Special reports may be requested by the DHHS.

Terminal reports are required 6 months after the end of the project.

Audits

In accordance with the provisions of OMB Circular No. A- 133 (Revised, June 24, 1997), "Audits of States, Local Governments, and Non-Profit Organizations," nonfederal entities that expend financial assistance of $300,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $300,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in Circular No. A-133. In addition, grants and cooperative agreements are subject to inspection and audits by DHHS and other Federal officials.

Records

Expenditures and other financial records must be retained for 3 years from the day on which the grantee submits the last financial status report for the report period.

Financial Information

Account Identification

75-0896-0-1-552.

Obigations

(Grants) FY 07 $85,484,000; FY 08 est $85,538,000; and FY 09 est not reported.

Range and Average of Financial Assistance

$100,000 to $1,100,000 for grants; $293,000 average. ($26,000-$233,000 for training.)

Regulations, Guidelines, and Literature

Grants will be available under the authority of and administered in accordance with the PHS Grants Policy Statement and Federal regulations at 42 CFR 52 and 42 U.S.C. 241.

Information Contacts

Regional or Local Office

Not applicable.

Headquarters Office

Division of Extramural Research and Training, National Center for Complementary and Alternative Medicine, National Institutes of Health, Department of Health and Human Services, 6707 Democracy Blvd. Suite 401, Bethesda, MD 20892-5475. Telephone: (301) 496-4792 Fax: (301) 402-4741.

Criteria for Selecting Proposals

The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; (6) the relevance and importance to the announced program objectives; and (7) the interfacing of conventional researchers and technology with unconventional/alternative clinicians for the purpose of providing clinical and scientific collaborations when and where appropriate.



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