HerbalEGram: Volume 7, Number 2, February 2010


NCCAM’s Future Directions


As the National Center for Complementary and Alternative Medicine (NCCAM) enters its second decade, the center will be taking a new direction in the future. Though the final 2010-2015 Strategic Plan is not expected to be released until late this year, the center’s future years are expected to focus less on the large human clinical trials common in the past and more on fundamental research, as indicated by NCCAM Director Josephine Briggs, MD.1,2 

While NCCAM plans to continue dedicating more than 50% of its research to human studies, according to Dr. Briggs, the focus will shift toward effectiveness-based studies emphasizing interventions in real-world settings.3 Dr. Briggs foresees this research being shaped by a “more holistic, patient-centered approach.”

“All of us recognize that assessing how modalities work in real world settings is critical,” said Dr. Briggs, noting a study that uses existing data, including 5 years of insurance claims, to compare outcomes, quality of care, and costs of patients who use CAM providers for back pain treatment with those who do not (e-mail, February 1, 2010).

In addition to more real-world research, NCCAM is considering research on non-pharmacologic pain management as 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.2

“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.

Specific areas of interest in pain management include the relationships between acupuncture or placebo analgesia and known and well-characterized endogenous opioid pathways; engagement of major pathways of emotion regulation by meditative practices; and 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 herb trials.3 NCCAM usually spends 10% of its funding on large herbal trials, but the center is “not currently planning to start any new large trials.” Dr. Briggs has said that this doesn’t mean NCCAM will abandon 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,” said Dr. Briggs. “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 Future

According to John Weeks, editor and publisher of The Integrator Blog, NCCAM’s hinted-at directions would put the center more in line with the Congressional mandate that established it 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 Congressional mandate that established the center in 1998 (e-mail, January 21, 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 whole-person 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 new direction.2 Dr. Marcus, an immunologist at Baylor College of Medicine, was recently quoted in the December issue of the journal Nature as saying: “I’m encouraged by Dr. Briggs’s 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.”

Though the Nature article, titled “Centre turns away from healing herbs,” states that NCCAM’s list of promising leads is “silent on herbal therapies,” the center’s second 2010 Strategic Plan white paper mentions cranberry (Vaccinium macrocarpon) and curcumin, a compound from turmeric (Curcuma longa), 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,” Dr. Dentali continued. Ending large herbal trials was an appropriate direction for NCCAM to take because that approach to research was overly narrow, he said. “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.”

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, said Dr. Dentali, who agrees on the importance of first looking at botanicals’ chemistry and mechanisms of action in order to find a research approach that can be applied to any herb. Once this is done, it would be appropriate to conduct research on other herbs of interest, such as the use of dandelion (Taraxacum officinale) leaf as a diuretic, he added.

Based on some of the feedback to NCCAM’s 2010 Strategic Plan, several CAM organizations support some of the initiatives suggested by Dr. Briggs, especially outcomes-based research.6 

The Integrated Healthcare Policy Consortium (IHPC) wrote that “NCCAM must 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) also supported outcomes-based researching, stating that NCCAM’s previous “reductionism-based” research is “not amenable to much of what defines integrative or holistic practice.” Organizations that also wrote in support of outcomes-based research were the Association of Accredited Naturopathic Medical Colleges (AANMC), National Center for Homeopathy, the American Association of Naturopathic Physicians (AANP), and more.  

Also common among these groups was the suggestion for an increased focus on cost-effectiveness research,6 and that at least half of NCCAM’s advisory board to be made up of CAM practitioners, as stipulated in the Congressional mandate that created the center.7 

Dr. Briggs also recognized the importance of the advisory council and the knowledge base of its members, but said: “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. However, I believe our council is well composed and meets the specifications of its charter.”

The industry trade group Council for Responsible Nutrition (CRN) submitted input on NCCAM’s Strategic Plan.8 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 for research projects or programs focused on a particular field to 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, as an extramural research program officer.

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


—Lindsay Stafford


References

1. 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.

2. Wadman M. Centre turns away from healing herbs. Nature. 2009;462:711.

3. Weeks J. Roadmaps for our future – interview with NIH NCCAM Director Josephine Briggs, MD. Integrative Practitioner. Available at: http://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. Available at: http://theintegratorblog.com/site/index.php?option=com_content&task=view&id=588&Itemid=93. Accessed January 15, 2010.

5. Paper 2: 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.

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. CRN Submits Comments to NCCAM on 5-Year Strategic Plan. November 2009. Available at: http://www.crnusa.org/pdfs/CRNComments-NCCAM5yrStrategic%20Plan1109.pdf. Accessed January 22, 2010.