National Center For Complementary And Alternative Medicine Research Articles

Identifying and pursuing research priorities at the National Center for Complementary and Alternative Medicine

As part of its planning process, the National Center for Complementary and Alternative Medicine (NCCAM), a component of the National Institutes of Health, periodically evaluates how well it applies its criteria for setting research priorities. For its most recent evaluation, NCCAM compared funding levels in fiscal years 2000 and 2003 for 18 diseases with a substantial public health burden including Alzheimer's disease, arthritis, back pain, cancer, diabetes, coronary heart disease, HIV/AIDS, migraine, and stroke, with 7 measures of disease burden: 1) prevalence, 2) mortality, 3) years of life lost (YLL), 4) years lost to disability (YLD), 5) disability-adjusted life years (DALY's), 6) direct costs of illness (COI), and 7) total COI. There is an increasing relationship between NCCAM research funding and disease burden over the 4-year study period that reflects funding of specific research initiatives. The strength of the individual correlations varied among measures, with the strongest correlations seen with total COI and the weakest seen with mortality. When applied with its other criteria, measures of disease burden aid identification and matching of NCCAM priorities with levels of support.

Questions and Answers About Using Magnets to Treat Pain

The National Center for Complementary and Alternative Medicine of the National Institutes of Health has published a detailed set of questions and answers about using magnets to treat pain. This resource cites the relevant scientific literature and addresses the following questions. What are magnets? Is the use of magnets considered conventional medicine or complementary and alternative medicine? What is the history of the discovery and use of magnets to treat pain? How common is the use of magnets to treat pain? What are some examples of theories and beliefs about magnets and pain? How are static magnets used in attempts to treat pain? How are electromagnets used in attempts to treat pain? What is known from the scientific evidence about the effectiveness of magnets in treating pain? Are there scientific controversies associated with using magnets for pain? Have any side effects or complications occurred from using magnets for pain? What should consumers know if they are considering using magnets to treat pain? Is the National Center for Complementary and Alternative Medicine (NCCAM) funding research on magnets for pain and other diseases and conditions? The report also includes definitions and three appendices that address the following issues: Research on Theories and Beliefs On How Magnets Might Relieve Pain, General and Systematic Reviews on CAM Magnetic Therapy for Pain Published From August 1999 to August 2003, and Reports on Randomized Clinical Trials of Magnetic Therapy for Pain from January 1997 to March 2004.

Tales from the Trenches: Conducting Yoga Research on Low Back Pain

Clinical studies of Yoga for various medical conditions funded by the National Center for Complementary and Alternative Medicine (NCCAM), a part of the National Institutes of Health (NIH), have been conducted for the past several years. These are important studies for the understanding and acceptance of Yoga therapy by the biomedical community and health care financing institutions. They also raise many fundamental and fascinating questions about how science studies Yoga. The results of major academic studies on Yoga are generally first reported in mainstream medical journals. The International Journal of Yoga Therapy, however, attempts to carry complementary articles describing in much more detail the methodology and other aspects of the studies of special interest to our readers. In the present case, an unusual opportunity arose to explore methodological issues in depth, including the collaboration between the researcher and the Yoga teacher. Karen Sherman, Ph.D., M.P.H., the principal investigator, has extensive experience in studying complementary and alternative medicine (CAM) therapies for back care and is quite conversant with the methodological challenges of Yoga and other CAM research from a variety of perspectives. She also is a longtime Raja-Yoga practitioner. Robin Rothenberg, the Yoga teacher employed for the study, is an experienced Yoga teacher and therapist certified in both the Viniyoga and Iyengar methodologies and a member of IAYT's Advisory Council. Readers may recognize her from her article in the 2004 issue of the journal, "Therapeutic Yoga 101: A Course in Self- Acceptance." The brief description of the low back pain study that appears on the NCCAM website (www.clinicaltrials. gov/ show/NCT00056212) follows: Back problems are among the most prevalent conditions affecting adults and are a leading reason for using complementary or alternative medical (CAM) therapies. Despite the common use of CAM therapies for back pain, little is known about how they compare with conventional treatments. This study will lay the groundwork for a full-scale trial that compares yoga with conventional exercise and usual care for chronic low back pain. This study will randomize 30 people with chronic low back pain to each of the following groups: yoga, a conventional therapeutic exercise program, and usual care. There will be 12 weeks of weekly treatment and follow-up assessments via phone at 6, 12, and 26 weeks to measure each treatment's impact on symptoms, function, quality of life, and utilization and costs of back pain related care. IAYT is most pleased to have this opportunity to explore the story behind the study. We hope this discussion helps our members better understand the science as well as the great amount of work and creativity a study such as this entails. We also hope this discussion helps Yoga therapists and medical researchers better understand each other and encourages further collaboration.

Questions and Answers About Using Magnets to Treat Pain

The National Center for Complementary and Alternative Medicine of me National Institutes of Health has published a detailed set of questions and answers about using magnets to treat pain. This resource cites the relevant scientific literature and addresses the following questions. What are magnets? Is the use of magnets considered conventional medicine or complementary and alternative medicine? What is the history of the discovery and use of magnets to treat pain? How common is the use of magnets to treat pain? What are some examples of theories and beliefs about magnets and pain? How are static magnets used in attempts to treat pain? How are electromagnets used in attempts to treat pain? What is known from the scientific evidence about the effectiveness of magnets in treating pain? Are there scientific controversies associated with using magnets for pain? Have any side effects or complications occurred from using magnets for pain? What should consumers know if they are considering using magnets to treat pain? Is the National Center for Complementary and Alternative Medicine (NCCAM) funding research on magnets for pain and other diseases and conditions? The report also includes definitions and three appendices that address the following issues: Research on Theories and Beliefs on How Magnets Might Relieve Pain, General and Systematic Reviews on CAM Magnetic Therapy for Pain Published from August 1999 to August 2003, and Reports on Randomized Clinical Trials of Magnetic Therapy for Pain from January 1997 to March 2004.

Systems Biology

Systems Biology

Managing social conflict in complementary and alternative medicine research: the case of antineoplastons.

From December 1991 to December 1995, the National Cancer Institute (NCI) initiated phase II clinical trials of A10 and AS2-1 (antineoplastons) infusions in patients with diagnosed primary malignant brain tumors. Four years and more than a million dollars later, these studies were stopped before it was possible to determine the effectiveness of antineoplastons. Both NCI and Dr Burzynski, the developer of antineoplastons, accused one another of attempting to undermine the project. In an effort to determine why this study failed to be completed, the director of the National Institutes of Health Office of Alternative Medicine (OAM), who sponsored the study, commissioned a detailed analysis of the conflicts that led to the study's closure. The intent was to understand the social dynamics surrounding this failed study and to develop a method for managing and possibly preventing such failures in the future. This clinical trial was extremely complex and comprehensive. It involved hundreds of memoranda, letters, and telephone and fax correspondence among a wide number of parties over a 4-year period. All correspondence and other documents from the OAM as well as documentation from NCI were thoroughly examined. In addition, in-depth interviews with key individuals involved in the antineoplaston study were completed and incorporated into the analysis. At least 10 areas of conflict emerged from the analysis including issues around production, quality, and delivery of antineoplastons; commencement of the trial; the role of Dr Burzynski in the trial; types and combinations of cancers; choice of clinical investigators; need for communication; criteria for patient selection and treatment; and evaluation. Each of these issues clearly represented a difference of opinion between the 2 main parties around scientific protocols. Yet contention around these substantive, "scientific" disagreements reflected conflict in attunement (trust, power, and affiliation) between Dr Burzynski and NCI. This article summarizes the findings from this case study.

Complementary and alternative medicine in cardiovascular disease: a review of biologically based approaches

Background The use of complementary and alternative medical (CAM) practices in the United States is growing rapidly. In this manuscript, we review some of the most commonly used biologically based approaches, including herbs, supplements, and other pharmacological therapies, that are encountered in caring for patients with cardiovascular disease, focusing on potential effects, adverse effects, and treatment interactions. Methods Between November 2002 and April 2003, we searched Medline and the National Center for Complementary and Alternative Medicine (NCCAM) web site and its various references and several complementary medicine text books. The key words used were: “cardiovascular diseases,” “coronary disease,” “heart failure, congestive,” “complementary and alternative medicine,” “complementary therapies,” “drug interactions,” and “plants, medicinal.” A keyword search of each individual supplement identified was also performed. Additionally, we relied on expert opinion in the field. Results Potentially serious adverse effects and interactions with conventional cardiovascular therapies exist for many herbs and supplements. There are currently scarce mechanistic data and very limited data on the effect of CAM therapies on clinical outcomes. Conclusions Randomized clinical trials with adequate power to detect effects of CAM therapies on clinical outcomes and safety are needed. Until these data are available, clinicians must be aware of the increasing use of CAM approaches by their patients and the potential for interactions with conventional therapies and should focus on treatment with proven, evidence-based strategies.

Complementary and Alternative Medicine at the NIH

This article summarizes the summer issue of the Complementary and Alternative Medicine at the NIH Newsletter (Volume 8, Number 3), which describes the activities of the National Center for Complementary and Alternative Medicine (NCCAM). This article describes studies examining mind-body therapies, announces plans for research on auto-immune diseases, provides updates on dietary supplements, the Atkins diet, and SARS, and introduces an electronic news bulletin and new fact sheets.

NCCAM support for the Cochrane Collaboration CAM Field

Americans use CAM therapies now more than ever before, yet there is a shortage of accessible high-quality evidence from clinical trials to show which CAM therapies work best and for which conditions. The need for such evidence is great, not only among people with serious, chronic health conditions, but also among healthcare providers, who often require clinical trial evidence before recommending a medical treatment. For the last few years, the University of Maryland Center for Integrative Medicine has been working steadily to meet this need for information by identifying published clinical trials of alternative therapies, summarizing these into rigorous scientific reviews, and disseminating these reviews to the general public and to healthcare providers. In May 2003, the Center was awarded a large 4-year research grant from the National Institutes of Health’s National Center for Complementary and Alternative Medicine (NCCAM) to support and extend this important work.

Complementary and integrative medical therapies, the FDA, and the NIH: definitions and regulation.

The National Center for Complementary and Alternative Medicine (NCCAM) presently defines complementary and alternative medicine (CAM) as covering "a broad range of healing philosophies (schools of thought), approaches, and therapies that mainstream Western (conventional) medicine does not commonly use, accept, study, understand, or make available. The research landscape, including NCCAM-funded research, is continually changing and subject to vigorous methodologic and interpretive debates. Part of the impetus for greater research dollars in this arena has been increasing consumer reliance on CAM to dramatically expand. State (not federal) law controls much of CAM practice. However, a significant federal role exists in the regulation of dietary supplements. The U.S. Food and Drug Administration (FDA) regulates foods, drugs, and cosmetics in interstate commerce. No new "drug" may be introduced into interstate commerce unless proven "safe" and "effective" for its intended use, as determined by FDA regulations. "Foods", however, are subject to different regulatory requirements, and need not go through trials proving safety and efficacy. The growing phenomenon of consumer use of vitamins, minerals, herbs, and other "dietary supplements" challenged the historical divide between drugs and foods. The federal Dietary Supplements Health Education Act (DSHEA) allows manufacturers to distribute dietary supplements without having to prove safety and efficacy, so long as the manufacturers make no claims linking the supplements to a specific disease. State law regulates the use of CAM therapies through a variety of legal rules. Of these, several major areas of concern for clinicians are professional licensure, scope of practice, and malpractice. Regarding licensure, each state has enacted medical licensing that prohibits the unlicensed practice of medicine and thereby criminalizes activity by unlicensed CAM providers who offer health care services to patients. Malpractice is defined as unskillful practice which fails to conform to a standard of care in the profession and results in injury. The definition is no different in CAM than in general medicine; its application to CAM, however, raises novel questions. Courts rely on medical consensus regarding the appropriateness of a given therapy. A framework for assessing potential liability risk involves assessing the medical evidence concerning safety and efficacy, and then aligning clinical decisions with liability concerns. Ultimately research will or will not establish a specific CAM therapy as an important part of the standard of care for the condition in question. Legal rules governing CAM providers and practices are, in many cases, new and evolving. Further, laws vary by state and their application depends on the specific clinical scenario in question. New research is constantly emerging, as are federal and state legislative developments and judicial opinions resulting from litigation.

NIMH to Study Herb’s Efficacy in Minor Depression

Back to table of contents Previous article Next article Clinical & Research NewsFull AccessNIMH to Study Herb’s Efficacy in Minor DepressionJim RosackJim RosackSearch for more papers by this authorPublished Online:18 Apr 2003https://doi.org/10.1176/pn.38.8.0033The National Institute of Mental Health (NIMH), in collaboration with the National Center for Complementary and Alternative Medicine (NCCAM) and the Office of Dietary Supplements, is funding a new clinical trial to look again at the effectiveness of St. John’s wort in treating depression.The multicenter, $4 million study, will look at the effectiveness of the herbal remedy in patients with minor depression, rather than major depression. Many of the more recent, large clinical trials on the herb for major depression have shown it to be largely ineffective; however, results have hinted that for patients with less-severe symptoms, the herb might indeed be effective.NIMH will recruit 300 participants at three centers—Massachusetts General Hospital, Cedars-Sinai Medical Center in Los Angeles, and the University of Pittsburgh Medical Center. Patients with minor depression will randomly be assigned to receive either a standardized extract of St. John’s wort, the SSRI citalopram, or placebo in a 12-week, double-blind trial.Researchers will look for changes in patients’ symptoms, functioning, and quality of life. Those who show no improvement will be switched to the active treatment they had not been assigned to before, while patients who improve will continue to take the originally assigned treatment for an additional 14 weeks, for a total trial duration of 26 weeks.“If the trial demonstrates that citalopram or St. John’s wort benefits patients with minor depression, it will expand our understanding of this underrecognized mood disorder and offer new evidence-based treatment recommendations for either primary care or mental health clinicians,” said Matthew Rudorfer, M.D., associate director of treatment research for NIMH’s Division of Services and Intervention Research.“There is high public interest in herbal remedies for depression,” added NCCAM Director Stephen E. Straus, M.D. “Our intent is to study St. John’s wort for the spectrum of depressive conditions for which the public considers its use. This new study extends our earlier research efforts from the more-serious form of depression to a clinically less-serious one, yet one that is, in fact, of considerable public health significance.”The study will enroll men and women aged 18 to 85 who have experienced depressive symptoms for at least six months, but less than two years, continuously without meeting criteria for either a major depressive episode or dysthymia within the last year. Individuals with comorbid mental disorders, such as schizophrenia, anxiety, and substance abuse disorders, will be excluded from the study, as will persons with active cardiovascular, renal, endocrine, neurological, and certain blood disorders.Participants will receive an initial screening and will be withdrawn from any psychotropic medications at baseline. They will then be followed every two weeks. At baseline, week 12, and week 20, participants will also have blood drawn for laboratory tests.More information on this and other NIH clinical trials is posted on the Web at www.clinicaltrials.gov. ▪ ISSUES NewArchived

National Center for Complementary and Alternative Medicine perspectives for complementary and alternative medicine research in cardiovascular diseases.

The National Center for Complementary and Alternative Medicine (NCCAM) was established in 1998 by the US Congress to conduct and support basic and applied research and research training and disseminate information with respect to identifying, investigating, and validating complementary and alternative therapies. Because of limited appropriations, NCCAM prioritizes its research programs according to the relative use of a modality, the evidence supporting its value and safety, and opportunities to advance the relevant fields of science. While NCCAM's top priority is supporting clinical trials of alternative therapeutics, increasingly it is supporting basic and preclinical research. To accomplish its mission, NCCAM encourages the research community to undertake high-quality and rigorous research in complementary and alternative medicine (CAM). In the area of cardiovascular diseases, NCCAM is supporting clinical trials, specialized centers, research training, and investigator-initiated projects. Virtually all aspects of CAM modalities are open for investigation. Current NCCAM projects are investigating Tai Chi (Taiji) exercise, hawthorn, phytoestrogens, biofeedback, Ayurvedic herbals, acupuncture, qigong, Reiki, meditation, spirituality, Ginkgo biloba, ethylenediaminetetraacetic acid chelation therapy, and special diets.

The New Realities of Money and Politics in Complementary/Alternative Medicine

In the United States (U.S.) today, 90% of all health care consumers use some form of complementary alternative medicine (CAM) as a method of health care and they pay out of pocket. Legitimizing CAM in the U.S. was spearheaded when congress funded the National Center for Complementary and Alternative Medicine (NCAM) as part of the National Institute of Health (NIH). Health care providers and insurance companies are following suit because legal issues about CAM are less obtuse and treatment is less expensive. Additionally, there is less chance of providers being sued for malpractice with fewer invasive treatment and outcome promises.

Complementary and alternative medicine: Opportunities and challenges for cancer management and research

Given the widespread use of diverse complementary and alternative medicine (CAM) approaches by cancer patients, research to establish their safety and efficacy is critical as is improved patient-physician communication about their possible risks and benefits. The mission of the National Center for Complementary and Alternative Medicine (NCCAM) is to support exacting research and disseminate clear and compelling information on CAM. Although many of the challenges facing such research are not unique to CAM, these approaches do present unique challenges, but the opportunities are many for prevention, palliation, and even treatment. Using the current research portfolio of NCCAM to illustrate how the field may mature, this report summarizes the challenges facing CAM investigators, the most fruitful areas for exploration, and existing information resources. Semin Oncol 29:531-545. This is a US government work. There are no restrictions on its use.

Complementary medicine in pediatrics: a review of acupuncture, homeopathy, massage, and chiropractic therapies.

Curr Probl Pediatr Adolesc Health Care 2002;32:353-384.

The National Cancer Institute's perspective and agenda for promoting awareness and research on alternative therapies for cancer.

The widespread use of a variety of nutritional, psychologic, and natural medical approaches, collectively termed complementary and alternative medicine (CAM), has been well documented. Recent surveys demonstrate that between 9% and 91% of U.S. patients with cancer use CAM therapies at some time after their diagnosis. However, there is a paucity of data available to indicate whether these CAM practices are efficacious and safe. Despite, or possibly because of, this controversy there has been considerable growth of interest in CAM by the American public. This interest has also resulted in a growth of research resources. Concurrently there has been an expansion of interest in the conventional medical establishment manifested by the creation of Departments of CAM or Integrative Medicine in respected conventional medical institutions, privately funded research centers and the National Institutes of Health (NIH) Office of Alternative Medicine (OAM)/National Center for Complementary and Alternative Medicine (NCCAM). Communication between conventional and unconventional practitioners is beginning. These changes are leading to a conversion of the dialogue about CAM from a focus on "quackery" to an exploration of the potential for novel therapeutics and the beginnings of focused, rigorous research. The National Cancer Institute is establishing programs to increase the amount and quality of CAM cancer research, support the production of high-quality CAM cancer information, and facilitate the dialogue between CAM practitioners and cancer researchers.

The Function of Meaning and Purpose for Individual Wellness

The authors review the literature on meaning and purpose in life as it relates to models of individual wellness. An overview of wellness models illustrates the importance of a sense of meaning to wellness. Suggestions are provided for how counselors may work with clients' sense of meaning in therapy.

The challenge of educating physicians about complementary and alternative medicine.

The rapid growth of complementary/alternative medicine (CAM) predated both the 1992 establishment of the Office of Alternative Medicine at the National Institutes of Health and the release of Dr. David Eisenberg's 1993 groundbreaking article on the widespread use of CAM. Since these two watershed events, the use of nontraditional medical modalities has seen exponential expansion. Most physicians are not prepared to respond knowledgeably about CAM modalities, and, indeed, sorting out the viable CAM modalities can be a difficult task. Additional factors are poor and inadequate dialogue between physicians and CAM practitioners, doubts about CAM practitioners' competence, a lack of readily identifiable and recognizable qualifications of such practitioners, and the risk of offering unrealistic hope of a cure. All these factors place the patient in a sometimes perilously uncertain position. Incorporating systematic presentation of CAM information into the curricula of medical schools would provide future physicians the necessary tools and knowledge to enable their patients to use CAM modalities appropriately, with limited risks.

Complementary and alternative therapeutics: rigorous research is needed to support claims.

The establishment of the National Center for Complementary and Alternative Medicine (NCCAM) in 1998 as a part of the National Institutes of Health was catalyzed by the increasing interest and use of complementary and alternative medicine (CAM) modalities by the public. This article presents an overview of CAM, summarizes similarities and differences between the regulatory requirements for drugs and CAM/botanical products, identifies several challenges and opportunities for conducting research to demonstrate the safety and efficacy of CAM therapeutics, and highlights the role of NCCAM in supporting and stimulating research in this area.

Research on complementary and alternative medicine using randomized controlled trials.

In 1998, the National Institutes of Health (NIH) formed the National Center for Complementary and Alternative Medicine (NCCAM) from what had formerly been the Office of Alternative Medicine. This presentation opens with a brief discussion on the history of the NIH and the development of CAM at the NIH before moving on to the work of the NCCAM. The NCCAM is moving toward an integration of CAM therapies into conventional medicine, when there is evidence for the value of CAM. One of twenty-five institutes or centers at the NIH, the NCCAM looks at evidence-based medicine and public health. In this context, "public health" means educating the public about its health. The NCCAM supports training to conduct research and plays an important role in disseminating information to the public and to health providers about what works and what is safe. This evolves into the concept of evidence-based medical and public-health practices, that is, making decisions on the basis of evidence from scientifically rigorous studies that are sufficiently large to provide a confident estimate of biologically and medically important benefits and risks. In the hierarchy of generating scientific evidence, randomized controlled trials are considered the "gold standard." The NCCAM entertains proposals for studies that come spontaneously from investigators, or, upon identifying an existing need that is not being met by the investigative community, the NCCAM can initiate a request for proposals. Every proposal is subjected to a rigorous application and review process. Another possible step in the assessment of the evidence from clinical trials is to do a systematic analysis of several studies to bring together all the information that is available. Systematic reviews of smaller studies that individually might have an insufficient sample size can assist in making treatment decisions, but, importantly, they can lead the NCCAM in the development of future, definitive studies. Training to conduct research is especially important to CAM. This presentation outlines several approaches the NCCAM has to training (see http://nccam.nih.gov).