Twelve Integrator Voices on a Theme: NCCIH's Past and Future Plans for Research on Botanicals
Written by John Weeks
Twelve Integrator Voices on a Theme: NCCIH's Past and Future Plans for Research on Botanical Medicines
This Forum is possible through a 2015-2016 investment of Ruth Westreich in the Integrator.
Botanical plan described
Research on botanicals at the National Center for Complementary and Integrative Health (NCCIH) has engendered controversy from NCCIH's earliest days as NCCAM. One after another, year by year, another major herb was summarily dismissed via NCCIH-funded trials. To advocates, it seemed that a system born to serve private sector pharma was picking off public domain botanicals like a hunter shooting ducks on a pond. Methods, doses and preparations were bitterly questioned. Clinicians complained that trials didn't reflect use patterns in practice.
Those Responding to the Call for Perspectives: Thank you each!
Paul Bergner Bevin
Clare, MS, RH(AHG) Bill Egloff Tori
Hudson, ND Sheila Kingsbury, ND, RH(AHG) Michael Levin
Beth Pimentel, ND,
LM William Reddy, LAc, DiplAc
Researcher(Anon) James Snow, RH(AHG) Michael Timms, PhD Eric Yarnell, ND
On September 28, 2015, I sent the Integrator list this invitation: Integrator Forum: What Are Your Views on NCCIH's Past and Future for Botanical Research? I then directly invited participation from a set of professionals close to the botanical field. I asked them to read Hopp's article and share the responses that came first to mind. Some did more than this. Here are 12 community views. I follow with comments. If you have something to add, please send your comments to
for future publication.
___________________________________________
Integrator Forum on NCCIH's Past-and-Future Strategy for Botanical Research
Eric Yarnell, MD
1. Bastyr Faculty Eric Yarnell, ND: "Go back to studying what actually happens in historic practice"
Bastyr University associate professor of botanical medicine Eric Yarnell, ND is also past chair of botanical
medicine at the Southwest College of Naturopathic Medicine, president of Heron
Botanicals, and chief operations officer at Healing Mountain Publishing. He is
the author of Clinical Botanical Medicine, Natural Approach to
Gastroenterology (each in their 2nd editions), and other books and articles. He is one of the go-to professionals in botanicals among naturopathic educators.
"The NCCIH approach so far has been to treat herbs as though
they were drugs. This has failed miserably, as highlighted in Dr. Hopp's piece
in HerbalGram on the negative, large double-blind randomized trials funded by
NCCIH (as NCCAM) in the past. Rather than concluding herbs don't work, one
could conclude that this approach to herbs doesn't work. Never in
"Models for whole-practice or whole-system
studies exist and have already proven
themselves preliminarily, such as
Lynne Shinto, ND, MPH, et al.'s trial on
whole-system naturopathy for people
with multiple sclerosis."
- Eric Yarnell, ND
history were
the extracts (generally highly refined, pseudo-pharmaceutical agents) studied
used. Instead, go back to studying what actually happens in real traditional
medicine. This almost always involves multiple therapies happening
simultaneously, including the healing relationship with a practitioner who
listens and cares, multiple herbs formulated to match the individual, dietary and
lifestyle changes, and other interventions. Models for this type of research
(whole-practice or whole-system studies) exist and have already proven
themselves preliminarily, such as Lynne Shinto, ND, MPH, et al.'s trial on
whole-system naturopathy for people with multiple sclerosis (J Altern
Complement There 2008;14(5):489-96). Stop trying to squeeze drug-like herbal
extracts into the pharmaceutical model and instead focus on studying how
natural medicine is actually practiced."
Note: The whole person Shinto study, which included botanicals, concluded: "Naturopathic medicine combined with usual care for MS showed a trend in
improvement in the General Health subscale of the SF-36, Timed Walk, and
neurologic impairment. Evaluation of naturopathic medicine, as a
multimodality regimen, warrants further investigation."
Bevin Clare, MS, RHG, LDN
2. AHG President Bevin Clare, MS, RH, LDN: "The move to explore herbs in health enhancement is closer to tradition"
Clinical herbalist Bevin Clare, MS, RH, LDN is the president of the American Herbalists Guild, the nation's largest body of
professional herbalists. a clinical herbalist, nutritionist, and is
an associate professor at the Maryland University of Integrative Health. She is also adjunct faculty at MCPHS University (which houses the former NESA and former Massachusetts College of Pharmacy). Her BS is inEthnobotany from Lesley University and MS in Infectious Disease at the London School of Hygiene and Tropical Medicine.
"The
movement of NCCIH to explore herbal medicines and health enhancement could
provide a model for understanding which is closer to their application in
traditional and modern systems of herbalism as utilized by herbalists.
"If
the target of NCCIH can understand the specific
foci of health which can be supported within a disease state model, we will
end up with data which is both useful in a variety of related disease states as
well as a more appropriate niche for botanicals used in integrative models."
- Bevin Clare, MS, RH, LDN
"Herbal
medicines are most effectively used in situations where health enhancement and
support of physiological systems is the goal. The chemical complexity and the
co-evolutionary relationship they share with humans primes them for the subtle
and dynamic support needed to enhance health. Compensatory medicine, on the
other hand, is highly targeted, strong, and by its very nature biologically
over-powering, precisely the kind of medicine herbal medicine in its natural
state is not.
"This
doesn't mean herbal medicines cannot be used for disease states. On the
contrary, they hold immense possibility for people with chronic disease, but in
these cases their effectiveness comes from the individualized approach of
assessing the physiological systems which need support and applying botanicals
in a way which meets the needs of the individual. For example, an individual
suffering from depression may be approached with botanicals which can support
refreshing sleep, a balanced gut / brain axis, support productive energy
levels, and reduce systemic inflammation. The concept of using an herb to
specifically compensate the imbalance which is causing depression is putting
herbal medicine into a disease model which may be best served by the construct
which is pharmaceutical medicine.
"If
the target of NCCIH can be broadly conceptual enough to understand the specific
foci of health which can be supported within a disease state model, such as in
the support of quality of sleep in patients with depression, or the management
of concurrent digestive concerns in patients undergoing chemotherapy, we will
end up with data which is both useful in a variety of related disease states as
well as a more appropriate niche for botanicals used in integrative models."
Michael Timms, PhD
3. Michael Timms, PhD: "Hopp's point is good in measuring wellness outcomes not just pathophysiology"
The academic director for herbal programs at Maryland University of Integrative Health (MUIH), Michael Timms, PhD,
began in this field as a health food store owner. He subsequently
pursued and earned a doctorate after which he was awarded, according to
the MUIH site, "several National
Institute of Standards and Technology/National Institutes of Health
postdoctoral fellowships to design and produce botanical standard
reference materials." He also had a role in developing the online
medicinal plant database, HerbMed, that is now housed at American
Botanical Council.
"In discussing
methodological development, improved biological characterization of herbal
products is needed for conducting trials that speak to potential efficacy.
Dosing protocols need to be improved, by systematically mining both evidence
base and traditional literature. A case in point, the Echinacea rhinovirus
trial (Turner et al., 2005), which was well designed, used a maintenance dose
as opposed to starting with a higher loading dose. The PI on the paper pointed
out that funding limits prevented investigation of multiple dosing regimens.
"Trial design that borrows from systems biology
capable of mapping
complex interactions
(network pharmacology paradigm) is needed,
not only in
herbal research, but in areas of cancer and
HIV treatments that use cocktails
of compounds."
- Michael Timms, PhD
"A more robust
approach to the extraction process rationale, focused on clinical endpoints
rather than pharmaceutical marker compounds, would be a good next step.
Additionally, trial design that borrow from systems biology capable of mapping
complex interactions (network pharmacology paradigm) is needed, not only in
herbal research, but in areas of cancer and HIV treatments that use cocktails
of compounds.
"Dr. Hopp
makes an important point when he noted that the trials also need to measure
wellness outcomes as much as pathophysiological changes. Beyond questionnaire
generated data, addressing the need for effective Wellness 'biomarkers' would
be a useful tact. My hope is that NCCIH would avoid funding animal trials for
evidence for efficacy, since results of pharmaceutical investigations have not
provided strong correlation for effective product development (Pippin, 2013).
"Finally, use
of the FDA Investigational New Drug laws may end up being a barrier to
research.
Turner
RB, Bauer R, Woelkart K, et al. An evaluation of Echinacea angustifolia in
experimental rhinovirus infections. New England Journal of Medicine.
2005;353(4):341-348. Available at: www.ncbi.nlm.nih.gov/pubmed/16049208.
Accessed July 6, 2015.
Neurological,
C., & Hormone, D. M. (2013). Animal Research in Medical Sciences and Animal Law, 51, 469-511.
Bill Reddy, LAc, DiplAc
4. Bill Reddy, LAc,DiplAc: "NCCIH is being myopic by primarily studying Western
herbs"
The Annandale, Virginia-based acupuncture and Oriental medicine (AOM) practitioner William (Bill) Reddy, LAc, DiplAc,
practices in an interprofessional clinic that also includes
chiropractic, massage therapy, and nutrition. Reddy is also a
significant AOM player in national policy work via his role on the executive committee of the 501c4 Integrative Health Policy Consortium. A repeat contributor to Acupuncture Today who will be co-author of 3rd edition of The Scientific Basis of Integrative Medicine, Reddy participated here in a past 2012 Integrator Forum.
"I believe NCCIH is being myopic by primarily studying Western
herbs. The majority of the earth's
population (1.36B Chinese and 1.25B Indians) use Traditional Chinese Medicine (TCM) and Ayurvedic herbs, and their use is
growing outside of those countries, especially in America and the EU. There are currently over 28,000 board
licensed TCM practitioners in the US with over 60 accredited schools teaching
this ancient form of herbal medicine and acupuncture, and those numbers are on
the rise. The National Ayurvedic Medical
Association has 595 current members in the US, representing a small fraction of
the total number of practitioners across the nation.
"PubMed provided 10,505 articles (search dated Oct 2015) in
response to a search query containing the key words 'Traditional Chinese
Medicine.' When I restricted the search
to those papers written in English, the number dropped to 7,420. Perusing the list of authors of the first 60
publications (in English), only one paper (Danish origin) contained non-Asian
names. Even though strategic objective
#2 from the NCCAMs Third Strategic Plan 2011-2015 seeks to advance research on
CAM natural products including 'Traditional Medicine Formulations,' not one
study funded in 2014 (according to the RePORTER under FY2014 new and competing
awards) evaluated any traditional Chinese medicine or Ayurvedic herbs. There were two studies funded on the
mechanisms of acupuncture.
"The only 'fly in
the ointment' is that
one size does not fit all in the Indian
and Chinese
medical systems and
differential diagnosis (in Chinese Medicine)
not only
includes common signs and symptoms,
but also the patient's 'constitution,'
as
well as tongue and pulse information
to 'dial in' the proper herbal combination."
- Bill Reddy, LAc, DiplAc
"There are over 13,000 medicinals in the Chinese Pharmacopoeia,
however, quite a few common varieties are used to treat everyday illnesses:
these herbs include cordyceps, chrysanthemum, hawthorn fruit, ganoderma/reishi
mushroom, rehmannia, rhodiola, atragalus, white peony root, ginseng and
licorice root - with several being adaptogens.
Phytopharmacologist researchers in China, Japan, Korea and other Eastern
countries are far ahead of their Western counterparts in the 21st
century.
"My recommendation to NCCIH leadership is to perform a preliminary
literature review on common Chinese and Ayurvedic herbs and find which ones
have strong scientific support and conduct additional study of those
medicines. Cross-reference that list
with the top health issues in the US to further prioritize the comparative
effectiveness research. The only 'fly in
the ointment' is that one size does not fit all in the Indian and Chinese
medical systems and differential diagnosis (in Chinese Medicine) not only
includes common signs and symptoms, but also the patient's 'constitution,' as
well as tongue and pulse information to 'dial in' the proper herbal combination. Study design must be developed with
well-seasoned Ayurvedic/TCM practitioners closely involved in the process to
develop inclusion/exclusion criteria, etc."
"NCCIH researchers must look to the future, and the majority
of Americans are shifting their focus to options beyond drugs and surgery."
Michael Levin
5. Michael Levin: "If
not NIH, who will invest in clinical research that could drive down drug costs?"
Integrator columnist Michael Levin is a cross-over executive and consultant. His
business
insights are deeply steeped in conventional pharmaceuticals and
medical technology, formed through a first career which included a
stint as a
vice president with Baxter Healthcare, then executive positions with natural products companies including
Tyler Encapsulations and Cardinal Nutrition. He has a passion for
the potential cost
savings from better integration of natural therapeutics.
"While
Dr. Hopp did an outstanding job describing the background behind which
NCCIH has redirected its research priorities away from botanical disease
treatment, I fear the embedded chart may be misunderstood at best, misleading
at worst.
"In
disclosing the St Johns Wort trial, for example, the fact is that this
study (all other study limitations aside for the moment) was a double-blind,
placebo controlled 8-week trial having three treatment arms that
compared effectiveness of SJW or sertraline (Zoloft(tm)) in major depression of
moderate severity against placebo. Neither SJW or Zoloft was found more
effective than placebo, a fact not disclosed in the chart (nor in the title of
the NIH press release!) leaving the casual reader to unfortunately conclude 'SJW doesn't work', thus providing yet another misleading soundbite
for mainstream media and politicians to misuse.
"Yet,
Sertraline remains on the US market as part of a drug class on which America
spent $11-billion last year.
Stunning.
"The
missed opportunity of doing
tightly focused botanical research
in areas where
a) the herb has a
high probability of safely/effectively
providing symptomatic
relief, 2) areas
in which millions of people spend billions
of dollars
on drugs, is a failure in leadership.
"Shouldn't we invest in way to provide
safe and effective relief at a lower cost?" - Michael Levin
"Does
SJW 'work'? The National Library of Medicine ranks SJW as 'likely effective for mild to moderate depression.' Noting the
challenges of variable product quality and after reviewing 29 studies involving
5498 patients, the Cochrane Collaboration concurs with the NLM stating: 'Overall, the St John's wort extract were superior to placebo, similarly
effective as standard antidepressants, and had fewer side effects than standard
antidepressants.'
"While
I appreciate the argument that NCCIH doesn't want to invest in areas covered by
other NIH agencies, a quick review of the National Institute of Mental Health
research priorities shows that more botanical research on St Johns Wort will
not happen. Doing so is outside of their strategic research priorities.
"If
not NIH, who will invest in clinical research that could drive down drug costs?
Certainly not Pharma! (Possibly a few enlightened PBMs might tackle this based
on ROI, but that's a subject for a later date.)
"The
missed opportunity of doing tightly focused botanical research in areas where
a) the herb has a high probability of safely/effectively providing symptomatic
relief in 2) areas in which millions of people spend billions of dollars
on drugs, is a failure in leadership. Shouldn't we invest in way to provide
safe and effective relief at a lower cost?
"As a
taxpayer, I view this as an economic imperative. In addition to depression ($11
billion/year in spending, per IMS), other 'low hanging botanical fruit'
that could help millions of people includes those with sleep disorders ($5
billion in Rx spending, per IMS) and anxiety disorders (billions).
"While
economic impact does not appear to be part of the NIH research priority
charter, it's time we invest tax dollars on smart projects that could reduce
healthcare costs, today! I hope NCCIH reconsiders it mandate. Based upon
the preponderance of global evidence, herbal medicine clearly offers such
opportunities."
Sheila Kingsbury, ND, RH(AHG)
6. Sheila Kingsbury, ND, MS, RH(AHG): "I like the focus on pharmacognosy so we can tease out how the plants work"
The chair of botanical medicine at Bastyr University, Sheila Kingsbury, ND, MS, RH(AHG) has also recently served as a council member of the American Herbalists
Guild. She is a founding director and current president of the Pediatric Association of
Naturopathic Physicians. Kingsbury
worked in the public health field for 5 years prior to her medical training and
has been a labor support doula for 15 years and a Lactation Consultant for 13
years. She is also an advisory board member for the Lloyd Library and Museum.
"I am pleased to see NCCIH
recognizing where modern research falls short in terms of the study of
botanicals and that they acknowledge that what has been plaguing this research
is the variables of dose and preparation, as well as specific parts of the
plant to be used.
""I am pleased to see NCCIH
recognizing
where modern research falls short in terms
of the study of
botanicals and that they
acknowledge that what has been plaguing
this research
is the variables of dose and
preparation, as well as specific parts
of the
plant to be used."
- Sheila Kingsbury, ND, MS, RH(AHG)
"I also like that the new emphasis on doing studies with
a focus more on the pharmacognosy of the plants so that we can really begin to
tease out the information about how the plants work within the body.
Their emphasis on improving the research methodologies with botanicals is much
needed and will likely reflect more useful results with far more impact.
"This article doesn't really affect how I use the plants in my practice. I
have enough clinical experience and education to understand how the plants have
been used traditionally as well as the evidence I've gained in just using them
in practice to make me feel quite confident in their use. I personally
value the traditional information and find it highly useful for knowing how to
work with the botanical medicines. The research, to me, just helps me to
confirm what we already know or to show mechanism. So, this change in
focus will be quite valuable to us who know how the plants work for treating
conditions but lack enough explanation for HOW they work."
Tori Hudson, ND
7. Tori Hudson, ND: "This begs the question of synergy, herb and provider, herb and patient, with a whole approach"
Pioneering integrative clinician, author and internationally-recognized educator Tori Hudson, ND was also an early researcher in the rebirth of the naturopathic profession. She practices at A Woman’s Time , P.C., is program director for the Institute of Women’s Health and Integrative Medicine, and on the faculty at three naturopathic medical schools. Hudson is also director of research and product development at Vitanica.
I had the opportunity to work closely with Hudson on a major 1991 North
American naturopathic medical conference, entitled "Into the Light," that focused on in-office research.
"After a quick read of
the NCCIH piece on the future of botanical research within this NIH entity, I noticed questions in my mind:
"In modern clinical naturopathic/alternative
medical practice, these herbs are not
used
on their own. They are used as a part
of a whole approach including
relationship
with the patient, lifestyle changes, and other
herbs/nutrients.
I think this begs the
question of synergy - synergy between
herb and
provider; synergy between
herb and patient; synergy between herb
and other
ingredients and influences."
- Tori Hudson, ND
"1) Why did so many of
these studies at conventional academic research institutions fail, and why
have others, in other parts of the world, or studies in settings with more
alternative oriented practitioners, succeed? I do not know the answers to
these questions, but obvious issues would arise around dosing, quality of the
product used, and other aspects of study design.
"2) I also am reminded of how these herbs, both historically,
and in modern clinical naturopathic/alternative medical practice, are not used
on their own. They are used as a part of a whole approach including
relationship with the patient, lifestyle changes, and other herbs/nutrients.
I think this begs the question of synergy - synergy between herb and
provider; synergy between herb and patient; synergy between herb and other
ingredients and influences.
"Yes, a double-blind placebo controlled trial
removes variables with a goal of separating out other influences in order to
assess the true validity of the item being studied. But, with due
respect to very smart researchers and very honorable conventional academic
research departments, perhaps instead we should be studying these plants in
such a way that reflects their long treasured traditional history of use, and
reflects how they are actually used in clinical practice, by practitioners who
are familiar with and aligned with the medicine of plants."
James Snow, MA, RH(AHG)
8. MUIH's James Snow, MA, RH(AHG): "The results should still give
pause to anyone looking for simple answers"
Maryland University of Integrative Health (MUIH) assistant provost for academic research James Snow, RH(AHG) also serves the multidisciplinary MUIH as interim academic director for Integrative Health Sciences. He has more than 25 years of experience merging modern scientific perspectives with traditional explanatory models of healing. He is also a passionate advocate of MUIH's commitment to the "healing presence."
"While the herbal formulations and dosages in the NCCIH-funded
clinical studies may be vulnerable to criticism, the results should still give
pause to anyone looking for simple answers on the shelf at the natural food
store. These studies support the position that an herb-drug substitution model,
or a 'one herb for one disease' model, has limited value in disease management.
I applaud NCCIH's decision to shift their focus from funding further research
along these lines. The question is where to go next?
"These studies support the position
that an herb-drug substitution model,
or a 'one herb for one disease' model,
has limited value in disease management.
"I applaud NCCIH's decision to shift their focus
from funding further research
along these lines.
The question is where to go next?" - James Snow, MA, RH(AHG)
"NCCIH has chosen a path that now emphasizes exploration of
mechanisms of action for herbal medicines. This certainly has value but it is
an approach that moves research further away from patient-centered outcomes. Alternative
avenues of inquiry include pragmatic trials designed to investigate whole
systems of herbal medicine. Such trials can help answer the practical question of
whether clinical herbal medicine, in its entirety, is an effective treatment
option in routine care.
"Traditional herbal medicine incorporates individualized and compounded
herbal formulae along with dietary and lifestyle changes. This is entirely distinct from the generic
herbal monotherapy utilized in previous NCCIH clinical studies. Pragmatic pilot
studies, followed by large multicenter pragmatic trials, can investigate herbal
medicine on its own terms and maintain
the focus on patient-centered outcomes. I would like to see NCCIH fund such
studies in parallel with their current research agenda."
Bill Egloff
9. Crane Herbs' Bill Egloff: Two suggestions for research directions in herbs for NCCIH
The Crane Herb Company has recently been in the news as the firm selected by the Cleveland Clinic to fulfill at prescriptions to their patients at their Chinese Herbal Medicine Clinic. (See The Chinese Herb Strategy at
the Cleveland Clinic: Insights from Jamie Starkey, LAc, Program Manager.) Crane's founder and CEO, Bill Egloff is a long-time Integrator reader with whom I have been in dialogue on multiple occasions. He responded to my call for responses with two brief notes on possible research ideas.
A. Clinical Usage of Chinese Herbal medicine in
the USA
Chinese
Herbal medicine is being prescribed by licensed health practitioners in
countries with national health insurance systems, like Switzerland, Germany,
Taiwan and Japan. Research: Do these
countries track the same data fields? What TCM
herbal data should be tracked by state-licensed TCM practitioners? Data
fields might include conditions, herb formula, dosage, side-effects, adverse events,
effectiveness, treatment duration, cost to patient, etc.
B. Clinical Usage of Ma Huang
Ma Huang (Ephedra sinica Stapf) is prescribed safely and
effectively by licensed health practitioners in Switzerland, Canada, Japan and
Taiwan. Ma Huang should be able to be prescribed by state-licensed
practitioners in the USA, if they are trained in the traditional usage of Ma
Huang and pass the NCCAOM Herbal Certification Exam. Research: Clinical usage data from these countries' national health insurance
records would confirm if Ma Huang can be prescribed safely and effectively by
licensed health practitioners. Relevant data would include the patient's
condition, dosage, side-effects and adverse events. Example: Taiwan National Health Insurance shows that in 2013, Ma
Huang was prescribed by doctors in over 300,000 formulas and ICD-9 codes show
conditions for which it was prescribed.
Paul Bergner
10. Herbalist and Educator Paul Bergner: "They could have saved on those trials by reading previous literature"
Commentator Paul Bergner is director of the North American Institute
of Medical Herbalism in Portland, Oregon. He supervised teaching clinics in medical
herbalism and clinical nutrition in Boulder, CO from 1996 until 2013, and has
published and edited the Medical Herbalism journal since 1989. He
has studied and practiced natural medicine, medical herbalism, and nutrition
since 1973. He has authored seven books on medical herbalism, clinical
nutrition, ethnobotany, and naturopathic medicine. I first got to know Bergner in the mid-1980s when we worked in close
collaboration in the re-birth of the naturopathic profession, including
creating the field's first cost-effectiveness document, and reached out to him here.
"Most of these trials were for uses
that no herbalist would ever use them, at odds with the larger body of research, have significant under-dosing, and re-discover what is already well-known."
- Paul Bergner
"Most of those trials were either:
1) For uses
that no herbalist would ever use them. Ginkgo for hypertension? Are you
kidding? How about taking an ACE inhibitor for scabies? That wouldn't work
either.
2) At odds with the larger body of research, for instance Hypericum
on meta-analysis is better than placebo even for major depression.
3) Have
significant under-dosing compared to contemporary herbal practice (the Echinacea
trials).
4) Rediscover what was already well-known; for instance in previous
trials, Serenoa was never much better than placebo for BPH and doesn't
actually work in a clinically-significant way even if there is a statistically-significant result.
Likewise Gingko may benefit a
subclass of the elderly for non-dementia, non-Alzheimers memory loss, but not
memory in general. And Allium has never lowered blood pressure by more
than a small amount, a few points. They could have saved the money on those
trials by just reading what was already established in the literature."
Beth Pimentel, ND, LM
11. Beth Pimentel, ND, LM: "Is herbs as 'complex mixtures' a step toward researching real-world prescribing"
The former dean at the University of Bridgeport College of
Naturopathic Medicine, Beth Pimentel, ND, LM, is presently a consultant
to health professions programs for issues related to accreditation and
curriculum development. Pimentel has served in national leadership roles for the North American Board of Naturopathic Examiners, the Association of Accredited Naturopathic Medical Colleges and the interprofessional Academic Consortium for Complementary and Alternative Health Care. Pimentel offered her comments from a semi-sabbatical that has her on a boat, with her spouse and child, on the way to the Bahamas. She is also a licensed midwife.
"Just
for context - I'm not a researcher and I've been out of the loop for the past
two years as I sail around the Bahamas. Nonetheless, here are my thoughts
on the botanical research at NCCIH.
"The focus on improving research
methodology
and exploring the ways in which 'natural products,
as complex
mixtures or isolated ingredients, interact
with biological systems' seems to be
a good thing."
- Beth Pimentel, ND, LM
"That
NCCIH is changing its research agenda to focus on improving research
methodology and exploring the ways in which 'natural products, as complex
mixtures or isolated ingredients, interact with biological systems' seems to be
a good thing. Building a foundation of evidence for botanical medicines
is important as this is a modality used across complementary and integrative
health and medicine disciplines and professions. Perhaps this is just the
first step in the evolution of NCCIH moving toward the study of real-world
botanical prescribing that is performed on an individual basis in the context
of the whole person. Now that would be something exciting!"
One of the responses I received, from a long-time researcher associated
with an institution that educates professionals into a doctoral level
integrative health field, was the following two-part, short e-dialogue, not for
attribution. The first e-reply:
"The first major research focus is on improved methodology
across all aspects of natural products research. The second major focus is on
exploration of the ways in which natural products, either as complex mixtures
or as isolated ingredients, interact
with biological systems.
I asked the researcher for more. The response:
"So if I'm reading [Hopp's] article
correctly, NCCIH is going to focus botanical research on methodology
and
adverse effects? (It says 'interaction with biological systems' but
from
what that author said, that's likely to translate into drug-botanical
interactions in humans taking both; at least that's my cynical take on
it.) Hopefully I'm wrong. My main response to NCCIH is generally even
briefer: 'Arrrggggghhh.' So I'm not sure any commentary by me would be
helpful."
______________________________________
Comments: Interesting, though not altogether surprising, that the set of respondents consisted mainly of naturopathic physicians and herbalists, with one AOM practitioner. Of the 12, eight hold faculty positions. At least 3 have significant clinical practices and 5 have direct relationships to the industry. One is a PhD who has been funded through the NIH. Missing are MD clinicians or researchers from conventional academic health centers. How might these have reshaped the feel of these perspectives from the whole integrative health and medicine community? What do integrative medical doctors think about this direction? No hint here.
My reading of Hopp's article tracks closely with most of the ground covered:
Appreciating the admission of poor methods in the early herb-for-disease trials.
Liking the interest in the potential of herbs with a health focus.
Intrigued by anticipated basic research that explores the complexity of botanicals. And, in an area strong by many,
Research on real world outcomes in clinical practices that include botanical preparations.
My attention is particularly drawn by #4. In his introductory paragraph, Hopp notes that while NCCIH changed its name from NCCAM, that "the mission has remained the same." Let's look at the first expression of that mission as established by Congress (not by NCCIH/NCCAM), in Section C. of the 1998 public mandate. It reads as follows:
"The Director of the Center shall, as appropriate, study the integration
of alternative treatment, diagnostic and prevention systems,
modalities, and disciplines with the practice of conventional medicine
as a complement to such medicine and into health care delivery systems
in the United States." [Bolding added.]
There appears to be nothing in the NCCIH future priorities, as described by Hopp, that will help "health care delivery systems" learn anything about the value of practitioners who routinely use herbs, whether naturopathic doctors, AOM practitioners, integrative medical doctors, as part of whole system regimes in care delivery. Nor does there seem to be a place for instance, to examine the processes and outcomes at the exciting Chinese herbal therapy initiative at Cleveland Clinic; or of Western botanicals in the multiple systems that employ, or are considering employing, practitioners who use these herbs. Is there room, for instance, for more studies like that by Shinto, et al, cited by Yarnell, that include botanicals in whole system protocols for disease states? Not clear.
"What if what Hopp captured in that chart
of herb-for-disease studies was a function
of garbage in, garbage out?
"One outcome of accepting that chart as truth
is to kill exploration of potential costs savings
and reduced drug-related adverse events
from herb-for-drug substitutions."
I wonder if it is disingenuous to suggest, as Hopp does, that other NIH agencies will take a lead in exploring the possible value of botanicals against diseases. I have more certainty that the chances of another NIH agency showing the imagination to examine the whole system value of these integrative practices approaches zero. Where is home for these questions, if not at NCCIH?
I admit that something rings quite true in James Snow's assessment of the herb-for-disease trials that "the results [even with methods issues] should give
pause to anyone looking for simple answers on the shelf at the natural food
store." At the same time, I wonder if the outcomes would be substantially different were a new version of each of these trials re-run with optimal methods and endpoints. Asking this assumes, of course, that a consensus panel - say of this dozen respondents, plus - could agree on strategies for each herb!
What if what Hopp captured in that chart of herb-for-disease studies was a function of garbage in, garbage out? One outcome of accepting that chart as truth: the decision of NCCIH to dismiss botanicals for disease treatment dis-incentivizes (a.k.a. "kills") exploration of potential costs savings, such as Levin recommends, from herb-for-drug substitutions. Consider the opportunity costs related to financial savings and limitations of adverse events from conventional pharma. Are we ready to dismiss those possible contributions?
The complexity research and focus on health that Hopp describes in NCCIH's future for botanical research are each intriguing and even exciting. Yet at the same time, NCCIH should be a leader at the NIH and for the people of the U.S. in exploring multi-agent, personalized, iterative approaches to chronic disease. Whole system approaches are those the evidence suggest are best for most major conditions. The value to public health is huge, and goes well beyond what is considered integrative health and medicine. This is NCCIH's mantle, whether or not the agency chooses to wear it.
Thus far, NCCIH, increasingly stripped of botanical-prescribing clinicians on its Advisory Council - and even amidst the contributions likely from the future Hopp describes - appears yet to be refusing this calling.