Melissa Dengler, ND

What does NCCAM stand for? What does the organization do?

National Center for Complementary and Alternative Medicine

The Federal government’s alternative medicine think tank

Established in 1998 Director: Josephine P. Briggs, M.D. Deputy Director: Jack Killen, M.D. Funding: $128.8 Million (FY 2010) Staff: Approximately 65 FTEs

NCCAM is one of 27 institutes and centers that make up the National Institutes of Health (NIH) within the U.S. Department of Health and Human Services.

www.nih.gov www.hhs.gov

The National Center for Complementary and Alternative Medicine (NCCAM) is the Federal Government's lead agency for scientific research on the diverse medical and health care systems, practices, and products that are not generally considered part of conventional medicine.

Explore complementary and alternative healing practices in the context of rigorous science.

Train complementary and alternative medicine researchers.

Disseminate authoritative information to the public and professionals.

Advancing scientific research Funded more than 2,500 research projects at scientific

institutions across the United States and around the world. Training CAM researchers

Support training for new researchers as well as encourage experienced researchers to study CAM.

Sharing news and information Provide timely and accurate information about CAM

research in many ways, such as through our Web site, Twitter and other social media tools, our information clearinghouse, fact sheets, Lecture Series, continuing medical education programs, and publication databases.

Supporting integration of proven CAM therapies Research helps the public and health professionals

understand which CAM therapies have been proven to be safe and effective.

Scientific research on complementary and alternative medicine (CAM).

Training of CAM researchers. NCCAM only awards funding in response to

grant applications sent to NIH. Scientific review groups at the NIH Center

for Scientific Review (CSR) or NCCAM Special Emphasis Panels provide peer review by assessing the scientific merit of all applications. The funding process is competitive. Applications with the best ratings are considered for funding.

In FY 2008, NCCAM funded 12% of applications received.

5R21AT004509-02 ; MELATONIN AND NIGHTTIME BLOOD PRESSURE IN AFRICAN AMERICANS ; ABRAMSON, JEROME L. et al.; EMORY UNIVERSITY; NCCAM $191,813

1K07AT006063-01; A MODEL INTERPROFESSIONAL CURRICULUM IN INTEGRATIVE MEDICINE; ADLER, SHELLEY R ;UNIVERSITY OF CALIFORNIA SAN FRANCISCO; NCCAM $121,978

1R21AT004966-01A2 ; DELPHINIDIN: A NOVEL AGENT FOR TREATMENT OF PSORIASIS ; AFAQ, FARRUKH UNIVERSITY OF WISCONSIN MADISON; NCCAM $222,750

3U01AT003571-04S1; CLINICAL CENTER FOR PHASE I/II TRIALS OF SILYMARIN IN CHRONIC LIVER DISEASE; AFDHAL, NEZAM HASSAN BETH ISRAEL; DEACONESS MEDICAL CENTER; NCCAM $103,598

Does the government have an interest in promoting alternative medicine?

Do health consumers need to be protected? From who?

It is a conspiracy by drug companies to increase regulation of supplements so that they can corner the market?

Do we need to pay attention to ethnobotanical research?

Epidemiological studies Focus on researching the various factors that

affect the health and disease within population groups in order to determine what interventions can be made to either prevent disease or decrease the risk factors for developing illness.

They are usually very large studies involving whole population groups observed over long periods of time.

The World Health Organizations MONICA project is an example of an epidemiological study.

Prospective/cohort studies Follow a group of individuals who may differ in

regards to certain factors that may be a determining factor in relation to a certain outcome.

For example a group may be followed from a starting point over a period of years with regard to the total number of calories they eat to determine if the amount eaten is a correlating factor in their total body weight. The hypothesis being that the group who eat the most in the future will weigh the most and the group who eat the least will weigh less.

Retrospective cohort studies Similar to prospective except they look back

at data that has been generated and then analyze this information for certain outcomes to determine any likely risk factors.

Tend to be cheaper and less time consuming than prospective cohort research.

Clinical trials Medical research studies designed to answer

specific questions about new therapies, procedures, or treatments, by testing them in people.

This carefully conducted research helps to determine if the therapy is safe and effective.

Clinical trials today are very often drug trials to ascertain whether or not the medication is safe for human use. They are often used to assist in determining if the benefits of the drug outweigh the risks of taking it.

Evidence based outcomes Does not try to single out which factor is the

cause or what the best treatment may be. The approach taken may be a multifaceted. These studies compare the approach used to

other methods of improving health, hence why the emphasis is on the outcome in preference to the treatment.

The challenge is that you cannot determine which of the elements of the corrective approach actually made the difference and which may be unnecessary parts of the protocol.

Case studies Tracks an individual’s symptoms or problems,

the assessments used to determine what may be wrong, the treatments used and how effective they were at dealing with the original health concern.

The “Gold Standard” is the double-blind, placebo controlled randomized trial.

The results of well-designed observational studies (with either a cohort or a case–control design) do not systematically overestimate the magnitude of the effects of treatment as compared with those in randomized, controlled trials on the same topic.

Treatment trials Test treatments for a specific disease or condition.

Prevention trials Study ways to reduce the chance that people who are

healthy, but possibly at risk for a disease, will develop the disease.

Early detection or screening trials Study new ways of finding diseases or conditions before

they produce signs or symptoms. Diagnostic trials

Test new ways to identify, more accurately and earlier, whether people have diseases and conditions.

Supportive care trials, also called quality-of-life trials Study ways of making patients more comfortable and

giving them a better quality of life.

Phase I Researchers test the treatment in a small group of

people, focusing on safety, adverse effects, and sometimes dosage and schedule of administration.

Phase II The treatment is given to a larger number of

people to determine potential usefulness and to further evaluate its safety and adverse effects. This phase can last several years.

Phase III The treatment is usually given to several hundred

or more people to confirm its efficacy and more fully define any adverse effects. Phase III trials often compare the treatment under study with standard treatments.

Randomized trials Each participant is assigned by chance—through a computer or a

table of random numbers—to either an investigational group or a control group. Randomization is used in all Phase III studies and in some Phase II studies. It helps ensure that the study results are attributable to the treatment and not to unrelated factors that might bias the outcome or the interpretation of the results.

Double blind trials Neither the researchers nor the participants know who has been

assigned to which group. Blinding is another way to help minimize the chance of bias influencing the trial results. The information is kept on file at a central office so the research team can find out who was assigned the active treatment if they need to know.

Clinical trials with one or more endpoints An endpoint is a measure that determines whether the treatment

under study has an important effect. An example of an endpoint is whether a person's pain improves

following acupuncture.

A placebo is an inactive treatment designed to resemble the treatment being studied. An example of a placebo is a pill containing sugar instead of the drug being studied.

Another type of placebo, called a "sham," is used when the treatment under study is a procedure (e.g., acupuncture), not a drug or other substance. A sham procedure is designed to simulate the active treatment but

does not have any active treatment qualities. For example, in a clinical trial of acupuncture, the sham procedure might consist of placing acupuncture needles in areas of the body that are not expected to have any therapeutic response.

Placebos are necessary because many factors other than the treatment being studied can influence either the course of an illness or the response of a patient to treatment. For example, many illnesses or symptoms resolve on their own,

and interactions with the provider or a patient's expectations about the treatment may influence the patient's response. These and other factors are part of what is known as the "placebo effect," which researchers try to separate from the effects of the treatment they are studying.

Each clinical trial is unique in its eligibility criteria—i.e., rules for who can participate. The purpose of the criteria is to identify

appropriate participants, based on what is being studied and the questions the researchers hope to answer.

Examples of criteria include type or severity of disease, presence of other illnesses, and history of prior treatment.

As much as possible, clinical trials include people of various ages and ethnic groups and both genders so the results can apply to the general population.

Eligibility criteria are also intended to make the trial as safe as possible for participants.

Institutional Review Board (IRB) An independent group of health care providers, other

experts, and people from the community who make sure that the study is set up and run safely and fairly.

Data Safety Monitoring Board (DSMB) – part of NIH A DSMB is an independent committee made up of

statisticians, physicians, and patient advocates (a majority of whom are not connected with the clinical trial) who regularly monitor data from the trial to ensure that the risks of participation are as small as possible. Their priority is patient safety—they can stop a trial if safety concerns arise or if the trial's objectives have been met.

Informed consent People who are considering taking part in a clinical

trial meet with a member of the research team, who provides key facts about the study, such as:

The research team will check the participants' health at the beginning of the trial, give specific instructions for participating, and monitor their health carefully during the trial.

Participants may be required to perform some tasks between appointments, such as taking medication according to a schedule, completing logs, or answering questionnaires.

Researchers analyze the data from the trial . Researchers share their findings with the

medical community and the public. Results are usually reported in a peer-reviewed

medical journal ("peer-reviewed" means that the report is reviewed before publication by a group of experts in the same field) and/or discussed at scientific meetings.

Media may also cover the results of the study. Participants will be notified about the study

results soon after the study is completed and all its data are analyzed.

A treatment that has been found to be safe and effective in a carefully conducted clinical trial may become a new standard practice.

Even though CAM treatments have been used for a long time, there may be less scientific knowledge available about them than for conventional medical approaches. Without scientific evidence, people already using CAM treatments may be at risk.

Researchers, including many supported by NCCAM, are studying CAM treatments in clinical trials to find answers to questions such as: Does it work? If so, how does it work? For which diseases and conditions does it work? What dose is safe? What dose is effective for a specific disease or condition? What are the adverse effects? How should it be given? Are there situations in which it might be harmful? Can it be used safely with other forms of treatment? Is it better than, or a useful option compared with, other

treatments that are available?

What do you think?

Does anyone have questions about tonight’s seminar on the NCCAM or research?

National Center for Complementary and Alternative Medicine. (2010). Retrieved from https://www.nccam.nih.gov.

NCCAMNational Institutes of Health9000 Rockville PikeBethesda, Maryland 20892 USAE-mail: info@nccam.nih.gov