Although the National Center for Complementary and Alternative Medicine (NCCAM) will not release its 2010 Strategic Plan until late this year, the center has revealed that its research goals will take a new direction.

As indicated by NCCAM Director Josephine Briggs, MD, NCCAM’s future years will focus less on the large human clinical trials typical of its past and instead move more toward fundamental research.^1,2 And while the center plans to continue dedicating more than 50% of its research to human studies, the focus will shift toward effectiveness-based studies emphasizing interventions in real-world settings.³ Dr. Briggs foresees this research adopting a “more holistic, patient-centered approach.”

“All of us recognize that assessing how modalities work in real world settings is critical,” said Dr. Briggs. As an example, she pointed to a new study that “is using existing data (including 5 years of insurance claims) to compare patients who use CAM providers to treat their back pain with those who do not. The study will evaluate back pain-related outcomes, quality of care, costs, and use of other services” (e-mail, February 1, 2010).

In addition to more real-world research, NCCAM is considering research on non-pharmacologic pain management to be particularly important.⁴ Because NCCAM sees symptom management as an area of high promise, it will distance itself from, but not completely abandon, the study of possible cures and treatments for chronic diseases.¹

“Pain conditions are the most common reason for CAM use, and they are some of the hardest to treat with conventional medical approaches,” said Dr. Briggs.

In particular, NCCAM expects to support pain management-related research addressing the relationships between acupuncture or placebo analgesia and endogenous opioid pathways; engagement of major pathways of emotion regulation by meditative practices; and the importance of the practitioner-patient interaction, context effects, and the placebo response.⁵

In order to fund this new area of research, NCCAM will redirect funds from other investigator-initiated areas, including that of large herbal trials.³ NCCAM usually spends 10% of its funding on these studies, but the center is “not currently planning to start any new large trials.” According to Dr. Briggs, this doesn’t mean NCCAM will desert its natural products portfolio.

“In the area of herbal products and other natural products, we need to build good basic science understanding of how these compounds work,” she said. “Building the mechanistic understanding of herbals is really important. We’re also quite interested in probiotics, which is an exciting area of research promise for NCCAM. We think these areas need further work before we do further large clinical trials of herbal supplements.”

Input on Strategic Plan and NCCAM’s Future

According to John Weeks, editor and publisher of The Integrator Blog, NCCAM’s new direction would put the center more in line with the Congressional mandate that established it in 1998 and would help more CAM modalities become integrated into the general healthcare system.

“Focusing on large herbal RCTs [randomized-controlled trials] was never what Congress intended,” Weeks said of the mandate (e-mail, January 21-February 7, 2010). “I believe Congress was wise in its direction. The focus was on looking at the value of the actual practices consumers are and were choosing—all of which are holistic and multi-agent, not single agent.

“I think looking at practices in which botanicals are a part of a whole person protocol is a much better direction than stand-alone efficacy trials,” Weeks continued. “We would potentially gain information on what happens when herbs are part of the kinds of wholeperson practices, which are typical of all integrative practitioners and often even in the self-care practice of consumers, rather than simply being used as drug substitutes.”

Donald Marcus, MD, a longtime critic of NCCAM, is also pleased with the center’s purported direction.¹ Dr. Marcus, an immunologist at Baylor College of Medicine, was quoted in the December 2009 issue of the journal Nature as saying: “I’m encouraged by Dr. Briggs’ receptiveness to comments and criticisms and her commitment to altering the research priorities of NCCAM. The best thing they could do with the NCCAM is to dissolve it. But that’s not going to happen.”

“I think it is important that [NCCAM critics] are supportive of Dr. Briggs, because she is taking a scientific approach, and she should,” said Steven Dentali, PhD, chief science officer of the American Herbal Products Association (AHPA; oral communication, January 25, 2010). “Nobody should have a problem if the right science is applied in the right way.”

The Nature article published in December, titled “Centre turns away from healing herbs,” stated that NCCAM’s list of promising leads was “silent on herbal therapies;” however, a white paper released by NCCAM in 2009 regarding the center’s 2010 Strategic Plan listed cranberry (Vaccinium macrocarpon, Ericaceae) and curcumin, a compound from turmeric (Curcuma longa, Zingiberaceae), as promising research areas.⁵ The remaining natural products include polyphenols and flavonoids, omega fatty acids, and probiotics.

“In my view, [NCCAM is] not walking away from botanicals; I think they’re taking a sensible approach,” said Dr. Dentali. Ending large herbal trials was an appropriate direction for NCCAM to take because that approach to research was overly narrow, he explained. “The clinical trials that NCCAM did were not properly informed by a basic knowledge of what these botanicals do. Just because [NCCAM] did a clinical trial that didn’t find a benefit doesn’t mean there isn’t another benefit to be found.”

According to Dr. Dentali, cranberry is a good herb to focus on because it has significant supporting research, and the curcumin product NCCAM is looking into is well-defined. Once botanicals’ chemistry and mechanisms of action are examined in order to find a research approach that can be applied to any herb, it would be appropriate to conduct research on additional, specific herbs of interest, such as the use of dandelion (Taraxacum officinale, Asteraceae) leaf as a diuretic, he added.

The input of some CAM organizations on NCCAM’s anticipated 2010 Strategic Plan signal that there is already support for some of the initiatives suggested by Dr. Briggs, especially the idea of conducting more outcomes-based research.

The Integrated Healthcare Policy Consortium (IHPC), for instance, wrote that NCCAM should start funding outcomes-based research that gathers data on costs and other factors, which will facilitate the integration of CAM into mainstream healthcare delivery. The Academic Consortium for Complementary and Alternative Health Care (ACCAHC) stated that research should seek to understand the actual effectiveness experiences of consumers. And the American Holistic Medical Association (AHMA) expressed a preference for outcomes-based research over NCCAM’s previous “reductionism-based” research.

Many of these groups also suggested that NCCAM adopt an increased focus on cost-effectiveness research and that at least half of NCCAM’s advisory council consist of CAM practitioners, as stipulated in the Congressional mandate that created the center.^6,7

“With our diverse portfolio of CAM modalities and diseases, it is challenging to have a council with the necessary mix of expertise, which is why we often include additional ad hoc members,” said Dr. Briggs. “However, I believe our council is well composed and meets the specifications of its charter.”

In February 2010, NCCAM announced the addition of 5 new advisory council members.⁸ Three of those new members have CAMrelated backgrounds: Adam Burke, PhD, a licensed acupuncturist and director of San Francisco State University’s Institute for Holistic Health Studies; Susan Folkman, PhD, founding director of the Osher Center for Integrative Medicine at the University of California-San Francisco; and Janet Kahn, PhD, a long-time massage therapist and the executive director of IHPC, as well as faculty preceptor in the Fellowship in Complementary and Alternative and General Medicine at Harvard Medical School.

“Overall, [Dr.] Briggs appears to be striking a good balance in these appointments—2 with strong credibility in the conventional community, 2 with strong relationships and respect inside the licensed complementary healthcare fields, and one, Folkman, who has a good deal of respect in both,” said Weeks.

The industry trade group Council for Responsible Nutrition (CRN) submitted comments regarding NCCAM’s 2010 Strategic Plan in late 2009.⁹ CRN suggested that NCCAM conduct shorter and more cost effective intervention strategies by using biomarkers as modifiable endpoints for both disease and “wellness.” CRN also supports NCCAM research using multi-component CAM treatment approaches, subjects who are considered “at risk” and not diagnosed with a disease or condition, and comparisons of the safety, efficacy, and costs of CAM treatments with conventional medical approaches. It also called for NCCAM to create an appropriate research paradigm for studying nutrient and CAM-related questions and recommended that research projects or programs focused on a particular field be reviewed by experts in that field.

Dr. Dentali of AHPA echoed this suggestion, proposing that CAM practitioners work with natural products-oriented pharmacognosists in the design and guidance of NCCAM studies. And because botanicals are complex mixtures that don’t always act like pure compounds, it is essential to include botanical experts in herbal trials, he said, adding that NCCAM has shown progress by hiring pharmacognosist Craig Hopp, PhD, and naturopathic physician Wendy Weber, ND, PhD, as extramural research program officers.

“You really do need expertise to do [the research] properly,” said Dr. Dentali.

—Lindsay Stafford

References

1. Wadman M. Centre turns away from healing herbs. Nature. 2009:462; 711.
2. Henson S. Critics Call for Review of NCCAM; NCCAM Responds. HerbClip. June 15, 2007 (No. 100362-330). Austin, TX: American Botanical Council. Review of NCCAM is overdue by Marcus D, Grollman. Science. 2006;313:301-302; and in defense of NCCAM by Straus SE, Chesney MA. Science. 2006;313:303-304.
3. Weeks J. Roadmaps for our future—interview with NIH NCCAM Director Josephine Briggs, MD. Integrative Practitioner. Available at: www.integrativepractitioner.com/article_ektid13196.aspx. Accessed January 15, 2010.
4. Weeks J. Why isn’t NCCAM’s 10th anniversary focusing on real world outcomes? Answers from Director Briggs. The Integrator Blog. August 28, 2009. Available at: http://theintegratorblog.com/site/index.php?option=com_content&task=view&id=588&Itemid=93. Accessed January 15, 2010.
5. NCCAM Priority Setting—Framework and Other Considerations. National Center for Complementary and Alternative Medicine website. Available at: http://plan.nccam.nih.gov/index.cfm?module=paper2. Accessed January 19, 2010.
6. Weeks J. Organizations on NCCAM’s Strategic Plan: IHPC, ACCAHC, AHMA, AANP, IAYT, NCH, AANMC and MTF. The Integrator Blog. December 1, 2009. Available at: http://theintegratorblog.com/site/index.php?option=com_content&task=view&id=614&Itemid=93. Accessed February 11, 2010.
7. Weeks J. How NCCAM’s “real world” congressional mandate is optimal for NCCAM’s 2010-2015 Strategic Plan. The Integrator Blog. November 6, 2009. Available at: http://theintegratorblog.com/site/index.php?option=com_content&task=view&id=606&Itemid=189. Accessed January 19, 2009.
8. NCCAM’s advisory council welcomes 5 new members [press release]. Bethesda, MD: National Center for Complementary and Alternative Medicine; February 5, 2010.
9. CRN Submits Comments to NCCAM on 5-Year Strategic Plan. November 2009. Council for Responsible Nutrition website. Available at: www.crnusa.org/pdfs/CRNComments-NCCAM5yrStrategic%20Plan1109.pdf. Accessed January 22, 2010.