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The initial step in the polarization of naive T cells is the interaction of APCs, mostly DCs, with a non-self or “danger signaling” antigen. The physical nature of the antigen and the cytokines subsequently released by the APC encountering this antigen determines whether a Th1 or Th2 skewed immune response occurs. For example, when APCs are challenged with intracellular pathogens, like viruses, a common cytokine secreted is IL-12. This cytokine promotes the differentiation of naive T cells into Th1 cells. Maturing Th1 cells then produce the cytokine IFN-γ, which feeds back in an autocrine loop to trigger the development of more APCs as well as further promote the maturation of naïve T cells into Th1 cells. Additional cytokines, like IL-18, also can be secreted to further influence Th1 development by enhancing IL-12 dependent Th1 cell differentiation and effector function. This self-perpetuating cycle of Th1 dominant cytokines persists until the immune challenge is sufficiently reduced.

If APCs are challenged with blood-borne pathogens, cytokines like IL-4 are released to promote Th2 cell differentiation. Additional cytokines like IL-13 also are secreted under certain conditions, and further promote Th2 polarization and development in an IL-4 independent manner. Maturing Th2 cells continue to release IL-4, generating an autocrine feedback loop that further increases the differentiation of naïve T cells to Th2 cells. Th2 cell dominant cytokines are continuously secreted until the blood-borne pathogens are removed or sufficiently reduced. When naïve T cells become Th1 or Th2 polarized they are committed to that specific pathway and cannot be reversed. Cytokines secreted by Th2 cells activate specific B cells for antigen clearance as well as for antibody class switching. Cytokines secreted by the Th1 cells primarily promote inflammation and the activation of cytotoxic T cells. These Th1 and Th2 specific cytokines interact with each other to antagonize their respective maturation and actions. For example, Th1 cells secrete IFN-γ which inhibits proliferation of Th2 cells, whereas Th2 cells secrete the cytokine IL-4 that prevents Th1 cell differentiation. Further regulation of Th1 and Th2 cells occurs with additional subsets of T cells, termed regulatory T cells (Treg) or Th3 cells. Specific regulation of T cells by Th1, Th2 or Treg/Th3 cells will be discussed in the next sections.

Although pain and function were not measured, most participants reported an enhanced relaxation response after treatment.

The cranial therapy was associated with changes in NO levels in exhaled breath. The level of NO increased from 13.3 +/- 2.09 (SD) to 15.0 +/- 2.95 (SD) ppb (P=0.001, based upon the paired t tests of the subjects). The median level of NO before the cranial therapy was 13.0 ppb (ranging from 8 to 17 ppb); after cranial therapy, it was 16.0 ppb (ranging from 6 to 18 ppb).

Although pain and function were not measured, most participants reported an enhanced relaxation response after treatment; the most relaxed participants were those with the highest post-treatment exhaled NO levels.

Practice Implications
This study is the first to explore the physiological effect of cranial therapy on NO production. These finding are significant, especially since we are increasingly learning of the important role that NO plays in various aspects of health. It is also a big step for the cranial community, because despite having a long, rich history and an immense archive of anecdotal evidence, cranial therapy lacks substantial clinical research studies. Currently an explanation of how cranial therapy can produce an increase in exhaled NO levels remains theoretical.

Traditionally, elevated exhaled NO levels have been closely associated with chronic pulmonary conditions such as asthma. This is why it was so vital to choose participants who were qualified as “healthy adults.” Since there were no asthmatic participants, and those with post-treatment elevated levels of NO reported an enhanced relaxation response, I would hypothesize that there is an intimate connection between naturally increasing the body’s ability to produce NO and being able to decrease the devastating effects that stress has on the body. The article also states that this therapy could be a key adjunct in the prevention of coronary artery disease (CAD) and diabetes—both of which damage epithelial lining of blood vessels (indicative of low NO production). When lowered NO levels allow damage to the blood vessels to occur, the endothelium is less able to produce the necessary amount of NO, thus facilitating further endothelial damage. This, over time, can manifest into serious pathological conditions. Given the noninvasive nature of the procedure, this cranial therapy could potentially be an incredible asset to those treating such conditions.

Since the 1990s, NO has been aggressively studied—its relationship to cardiovascular health only discovered in 1998—and it has been found that too little NO, as seen in CAD and diabetic cases, can have a damaging effect, but too much can also be detrimental. In the instance of an excess of NO, further research to examine whether this cranial maneuver may have a modulating effect on NO levels would be interesting, as colleagues in the cranial field have reported positive results with asthmatic patients.

Although this study is small and uncontrolled, which is not typically the type of study highlighted in this column, these findings are relevant to clinical practice. NO is, as we’ve seen, a critical component in maintaining health. In the clinical field, NO and its precursors are being utilized in a variety of ways, ranging from treatment of pulmonary vascular disease in pediatrics, to pain associated with angina, to erectile dysfunction. It’s also becoming a staple for preventative and anti-aging protocols.

We’ve long known that there are noninvasive, effective methods of increasing NO levels, whether through supplementing with arginine or even regular exercise, but until now there has not been a physical modality that has shown a possible systemic increase in NO. These findings also suggest that various healthcare providers and readers of this column may, in addition to their current prevention or treatment protocols, begin to incorporate this type of cranial therapy into their practice.

Study Medication
Subjects received either prunes or psyllium to provide 6 grams per day of fiber for 3 weeks. After a 1-week washout period, therapies were switched.

Outcome Measures
The test subjects maintained a daily symptom and stool diary in which they tracked number of complete spontaneous bowel movements per week, global relief of constipation, stool consistency, straining, tolerability, and taste.

Key Findings
The number of complete spontaneous bowel movements per week (primary outcome measure) and stool consistency scores improved significantly (P<0.05) with dried plums when compared to psyllium.
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Practice Implications
Prunes work. That is, prunes appear to do exactly what everyone has always thought they do; they act as a mild laxative. Although some would think this action is obvious, this study by Attaluri et al may be among the first human clinical trials published in the peer-reviewed literature that demonstrates prunes’ efficacy.

The results of a 2002 clinical trial comparing the effects of prunes versus dried apples on factors that affect bone density “suggest that dried plums may exert positive effects on bone in postmenopausal women.”1 Though the results were favorable, they did not confirm whether prunes act as laxatives.

Two 2010 studies hinted that prunes might act as stool softeners. Both studies compared eating prunes as a snack against cookies. A June 2010 paper that appeared in the journal Appetite informed us that prunes were more effective than sugar cookies at suppressing hunger and creating a sense of satiety.3 A September 2010 article in the Journal of the American Dietary Association reported that snacking on prunes lowered triglyceride levels more than sugar cookies and mentioned a tendency for prunes to soften stools.

Few experienced practitioners or consumers will view these data as new. Instead most will be surprised that this study had to be done in the first place.

There is another paper involving prunes that is worth noting. Appearing in the Journal of the American College of Nutrition in 2007, a review paper compared the effect of eating prunes against eating berries or other fruits on serum antioxidant capacity (AOC). While data from a series of clinical trials “demonstrated that consumption of certain berries and fruits such as blueberries, mixed grape and kiwifruit “increased plasma AOC,” eating prunes or drinking prune juice did not alter measured levels of antioxidant capacity.

With the publication of the current Attaluri et al study, the use of prunes as a laxative has taken the first step away from being the product of “old wives’ tales” (OWT) toward the realm of evidence based medicine (EBM). Adherents of EBM may now prescribe prunes to patients suffering from constipation with less fear of criticism. It should be pointed out that there are weaknesses to this current study: It was single not double-blinded, participants were overwhelmingly female, little is known regarding the etiology of participants’ constipation, and obviously, one study is far from conclusive.

This new advancement in medicine does have an element of the absurd to it. Few experienced practitioners or consumers will view these data as new. Instead most will be surprised that this study had to be done in the first place; the action of prunes on the human digestive tract is self-evident.

The attraction that many us have to EBM, and our resultant desire to find support for therapies in published studies, meta-analyses, or—the Holy Grail of all papers—the Cochrane Reviews, on the surface seems both reasonable and commendable but may become an obstruction to achieving best patient outcomes.

Until now, the evidence suggested we employ psyllium seed fiber as it is more efficacious than sodium docusate.6 Yet practitioners who rely on anecdote, commonsense, and the data obtained via OWT have been using prunes to soften and increase stool frequency all along.

This story about prunes brings to mind how my colleague Steve Austin, ND, when writing years ago about breast cancer, pointed out the distinction between type 1 and type 2 errors in statistics and how different medical professions put greater emphasis on preventing one form of error over the other. For a medical oncologist who prescribes chemotherapy, the demand is to be sure the drugs will have benefit against the cancer. One needs to be certain the drugs will bring benefit as the side effects are so great.7 For naturopathic doctors who employ nontoxic therapies, in this case prunes, the demands should be the opposite. If there is a chance a therapy may help, then we should be interested in trying it: the classic ‘it won’t hurt and it might help’ view of practice.

As for prunes, however, we can now prescribe them with confidence; they have officially graduated from unproven OWT to the trustworthy EBM.

Participants
Ten patients undergoing “fecal bacteriotherapy,” or what in the United States is often termed “fecal transplantation.” In this process the bowel is cleansed with antibiotics and then fecal suspensions from healthy donors are administered daily. In this study the first infusion was administered through a colonoscpe and subsequent doses were given over a 60-minute period through a nasal jejunal tube or via enemas. Bowel flora was analyzed at 4, 8, and 24 weeks post-initial infusion and compared with the initial infused donor fecal suspension to determine whether the donor flora had become a stable microbiota of the feces.
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Key Findings
At each of the post-infusion intervals in which sample were evaluated, “the bacterial populations in the patients’ fecal samples consisted predominantly of bacteria derived from the healthy donor samples. … This is a landmark study and suggests that the manipulation of the colonic microbiota is effective and holds promise for new therapies in the treatment of colonic or metabolic disease.”

Fecal transplantation is not a new. Case reports describing this technique date back at least to the late 1950s. A report by Eiseman el al published in 1958 is credited as the first to describe using fecal enemas, in this case for treatment of pseudomembranous enterocolitis.

This is a landmark study and suggests that the manipulation of the colonic microbiota is effective and holds promise for new therapies in the treatment of colonic or metabolic disease.

Since that time there have been a number of reports using donor stool delivered both rectally or via nasogastric tubes. Most of these reports focus on treating recalcitrant Clostridium difficile infection.

Two other reports on fecal transplantation were published in the same September issue of the Journal of Clinical Gastroenterology as the Grehan et al study. They are of almost equal significance as Grehan’s study and deserve specific mention.

In one, Yoon et al from Montefiore Medical Center in the Bronx reports on 12 cases of C. difficile successfully treated using donor feces transplanted into the colon through colonoscopy. The second paper by Rohlke et al reports on 19 patients again with C. difficile treated with fecal transplantation delivered via colonoscopes. The treatment was successful in all 19 patients treated, and the patients remained disease-free on follow-up of 6 months to 4 years.

This therapy may be beneficial for treating other types disease besides gastroenteritis.

Borody et al reported striking results in a small trial using fecal transplantation therapy to treat ulcerative colitis (UC) in 2003. They treated 6 patients with “severe, recurrent symptoms and UC had been confirmed on colonoscopy and histology.” Utilizing “retention enemas … repeated daily for 5 days, complete reversal of symptoms was achieved in all patients by 4 months … by which time all other UC medications had been ceased. At 1 to 13 years …, there was no clinical, colonoscopic, or histologic evidence of UC in any patient.”

Borody is currently recruiting participants for a trial using fecal transplants to treat patients with Parkinson’s disease.12

At a conference in September 2010, Anne Vrieze and colleagues described the results after transplanting fecal flora from lean donors into patients with metabolic syndrome. Their study was a double-blind, randomized, controlled trial. Starting with 18 male subjects with newly diagnosed metabolic syndrome, half received fecal material from lean male donors and half were implanted with their own feces to serve as controls. At the conclusion of the study, fasting triglyceride levels in those subjects who received donor feces were significantly reduced. No effect was seen in the control group re-instilled with their own feces. Peripheral and hepatic insulin sensitivity significantly improved after 6 weeks in the experimental group but not in the control group.

Current knowledge suggests that the intestinal community of bacterial flora contains at least 1 x 1014 bacteria made up of from 500 to 1,000 different species of anaerobic bacteria.14 Clearly our current methodology of testing these using agar culture media to identify only a handful of species and treating with several limited strains of ‘probiotics’ may be too simple an approach to achieve lasting benefit. Fecal transplantation, although sounding to be primitive, may in fact be a more sophisticated option and have the ability to duplicate a healthy bowel ecosystem in the unwell. As unappealing as it may sound, this may prove to be a useful therapy in coming years.

Study Medication and Dosage
All patients received a standard triple antibiotic therapy for H. pylori infection consisting of a 2-week course of lansoprazole, amoxicillin, and clarithromycin. In addition, twice each day, 46 of the patients drank a cup of kefir and the remaining 36 drank a cup of milk.

Outcome Measures
A urea breath test was performed on all patients 45 days after beginning treatment. A questionnaire was completed 15 days after the start of treatment in order to assess side effects.

Key Findings
Kefir significantly improved triple antibiotic therapy eradication of H. pylori. Infection was eradicated in more than three-quarters of those patients drinking kefir (36 of 46 [78.2%]), compared with only half of those who received antibiotics plus placebo (18 of 36 [50.0%]). Reported side effects occurred significantly less often and were less severe in those who received kefir.

Practice Implications
One cup of kefir twice per day should be added to standard antibiotic protocol used in the treatment of H. pylori. Kefir increased effectiveness of standard treatment by about 30%. The standard pharmaceutical protocols that employ proton pump inhibitors plus 3 separate antibiotics to treat these infections are not 100% successful; cure rates have fallen below 80%.

Yogurt does not appear to have the same benefit. A paper published in January 2011 reported that using a yogurt that contained multiple strains of probiotic bacteria, along with triple antibiotic therapy, to treat H. pylori infection “neither improved H. pylori eradication rates nor reduced the adverse events of treatment.”

Side effects occurred significantly less often and were less severe in those who received kefir.

Kefir differs significantly from yogurt. Yogurt is milk that has been fermented by any of several strains of lactic acid–producing bacteria, typically Lactobacillus acidophilus. Kefir in contrast “is produced by microbial activity of “kefir grains,” which have a relatively stable and specific balance of lactic acid bacteria and yeast.” Yogurt cultures do not contain yeast. Yogurt fermentation requires incubation at warm temperatures, while kefir is fermented at room temperature.

Kefir has become quite popular in recent years because of the many claimed health benefits, including “reduction of lactose intolerance symptoms, stimulation of the immune system, lowering cholesterol, and antimutagenic and anticarcinogenic properties.”

In the literature, kefir is often lumped with other probiotic preparations, and search engines do not distinguish studies on kefir from those on yogurt. For example, a 2009 meta-analysis on fermented milk products and whether they improve H. pylori eradication did not distinguish between them. In this review, the combined data did show a small benefit: “Fermented milk-based probiotic preparations improve H. pylori eradication rates by approximately 5–15%.”

A 2007 meta-analysis that combined data from earlier studies also examined the effect of probiotic preparations on H. pylori eradication by triple antibiotic therapy. This earlier paper also reported slightly improved eradication rates—about 10% over placebo. All of the studies in this earlier review investigated yogurt made from Lactobacilli acidophilus and not kefir.

If kefir increases the efficacy of antibiotics against H. pylori, does it improve antibiotic effect against other types of intestinal infections? Possibly. A 2009 paper reports an open trial in which kefir appeared useful in treating Clostridium difficile infections in combination with antibiotics.

Renowned naturopathic physician, educator, researcher, and natural health pioneer, Joseph E. Pizzorno, Jr., ND, and fellow naturopath, researcher, author, and health expert, Michael T. Murray,ND, have collaborated with Canada’s leading functional food manufacturer to develop the ultimate professional line: Bioclinic Naturals.

Launched in 2009, Bioclinic Naturals consulted extensively with doctors, scientists, nutritionists and patients to create unique formulas that address patient concerns. Bioclinic Naturals is different from other professional lines, according to Murray. “There are gaps in the range of supplements currently available. As NDs, we follow six guiding principles; Bioclinic Naturals products specifically support and align with these,” Murray says. “In developing this product line, we focused on physiology-specific solutions with unique formulas for men and women. At the same time, we kept in mind the importance of optimum nutrition for whole body—whole life health. We have designed them specifically for use under professional guidance to achieve therapeutic results for the patient.”

To ensure pure, potent, safe and effective products, the doctors partnered with the Factors Group of Nutritional Companies. The Factors Group has the facilities, expertise, and technology to manufacture supplements that meet or exceed the most stringent international standards in addition to the demands of clinicians and patients. “Bioclinic Naturals is unique in that it grows many of its own raw materials, produces its own finished products, and has its own quality control laboratory to check every step of the process,” Pizzorno explains. “The company even has its own clinic to conduct clinical trials of innovative products on real patients.”

Professional Support
To support practitioners, Bioclinic Naturals offers a unique service: the Pro2Pro™ Practitioner-Only Support Line. Pro2Pro allows practitioners to ask Pizzorno questions and receive an answer, usually within 24 hours. The service is free to all Bioclinic Naturals customers, and questions can be submitted by email, phone, or fax.

Bioclinic Naturals products are supported with Product Specification, Clinical Highlight, a comprehensive Product Reference Guide, and a soon-to-be-released Clinical Guide. The Clinical Guide presents a functional medicine review focusing on 10 aspects of clinical practice, including common dysfunctions; causes for dysfunctions; methods of assessment using signs, symptoms, and laboratory tests; and natural health approaches and products known to be effective for these health concerns.

Bioclinic Naturals Highlights

Research-driven and clinically proven

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“It is always an honor to host the AANP convention but the 25th Anniversary celebration was even more special because of the depth and breadth of continuing education,” says Karen E. Howard, executive director and CEO of the American Association of Naturopathic Physicians (AANP).

Held August 11–15, 2010, in Portland, Ore., the theme of this year’s convention and exposition was “Celebrating the Foundation of Medicine.” Participants were able to choose from more than 30 concurrent sessions and more than a dozen research sessions to attend. Most of the sessions focused on naturopathic practice and philosophy and were led by respected leaders in the naturopathic profession. The convention was approved for a total of 26 AMA PRA Category 1 credits, and the NCCAOM approved continuing education for acupuncturists. There were 145 exhibitors who supported this event with more than 600 attendees.

According to AANP President Carl Hangee-Bauer, ND, LAc, the sessions featured information that provoked thought and also provided practical pearls that clinicians can use the first day back in the office. He said the convention helped participants “reconnect with friends and celebrate the growth and successes of the naturopathic profession over the past 25 years, as well as look forward to the future.”

The conference objectives, as outlined in the Proceedings, were for attendees to:

• Know more about naturopathic medicine in general and integrating its techniques in their own practice specifically.
• Evaluate the most recent research on practices and modalities in natural medicine and healing.
• Describe specific techniques that are working in clinical settings to help patients heal from a variety of illnesses, with a goal towards improving overall patient care.
• Devise more efficient ways to run their practice, which will help physicians in their endeavor to work more effectively and professionally.

The Convention Content Committee included Sara Thyr, ND (Chair); Wendy Weber, ND (Research Chair); Jami Kupperman, ND; David Field, ND, LAc; Michael Owen, ND; and Michael Slezak, ND. During the annual meeting, Michael Cronin, ND, was voted in as the President-Elect of the organization. This was the first time in the history of the organization that a membership based competitive election was held to choose the next President.

“Our annual convention reinforces the fact that this work is not only changing people’s lives everyday, it is also changing everyday life and the future health of a nation,” concluded Howard.
“Our annual convention reinforces the fact that this work is not only changing people’s lives everyday, it is also changing everyday life and the future health of a nation,” concluded Howard.

Design
One hundred twenty patients with polycystic ovarian syndrome (PCOS) and 14–16 months of infertility were studied in this randomized, controlled clinical trial. Patients were randomly assigned to receive either 1,500 mg/day metformin or 4 grams of myo-inositol plus 400 mcg folic acid daily. In patients where in whom pregnancy occurred, patients underwent ovulation induction with recombinant follicle stimulating hormone (r-FSH) (37.5 units/day) for a maximum of 3 attempts. The primary endpoint was restoration of spontaneous ovulation (measured by monitoring serum progesterone levels weekly and transvaginal ultrasound to confirm). Secondary endpoints included resistance to treatment (percentage of patients who did not restore spontaneous ovulation), pregnancy rate, and abortion rate.

The study demonstrated a statistically significant difference in restoration of spontaneous ovulation in patients taking myo-inositol over metformin.

Key Findings
Fifty percent of the patients who received metformin restored spontaneous ovulation, and 18.3% of these achieved pregnancy. Sixty-five percent of patients treated with myo-inositol restored spontaneous ovulation, and 30% of these achieved pregnancy. In the remaining patients who did not respond to monotherapy, r-FSH was added. In each of the 2 groups (metformin plus r-FSH group or myo-inositol and folic acid plus r-FSH group), 11 pregnancies occurred. The total pregnancy rates were 36.6% for patients receiving metformin and 48.4% for patients receiving myo-inositol. The study demonstrated a statistically significant difference in restoration of spontaneous ovulation in patients taking myo-inositol over metformin. There was an overall higher rate of pregnancy in the myo-inositol group, but the effect was not significant.

Practice Implications
One metabolic feature often observed in patients with PCOS is a defect in inositol metabolism. Inositol plays an important role in insulin and glucose metabolism. Inositol accelerates the dephosphorylation of glycogen synthase and pyruvate dehydrogenase, both rate-limiting enzymes of non-oxidative and oxidative glucose disposal.1 Supplying myo-inositol can accelerate glucose disposal and sensitize insulin action. This may decrease the hyperinsulinemic state that can prohibit proper luteinizing hormone (LH) secretion.

Previous studies have demonstrated that myo-inositol is capable of restoring spontaneous ovarian activity, and consequently fertility, in patients with PCOS. This study is the first to compare the effectiveness of 2 insulin-sensitizing agents, inositol and metformin, in the treatment of chronic anovulation and infertility secondary to PCOS.

In this study, myo-inositol offered a significant advantage over metformin in restoration of spontaneous ovulation in patients with PCOS. This also resulted in a non-significant increase in pregnancy rate. In addition, patients on myo-inositol reported no side effects during the course of treatment. Myo-inositol should be considered as a first-line treatment in patients with PCOS experiencing chronic anovulation or infertility secondary to anovulation.

Notwithstanding the soundness of the regulations, this is challenging terrain. Each area governed by 21 CFR Part 111 requires a sophisticated approach to implementing necessary practices in order to be in compliance. Over the next several months, we will explore several of these areas. Just to set the tone for this exploration, let’s start with exploring the identity of the ingredients a dietary supplement. The majority of ingredients in dietary supplement products originate in the natural world, and, in fact, in the food supply. These ingredients are gathered and processed by suppliers and are then sold to dietary supplement manufacturers. Each ingredient comes to the manufacturer with a certificate of analysis (COA). This COA confirms, among other things, the identity of the ingredient. The manufacturer is required to additionally confirm the identity of every received ingredient by conducting their own testing. So far, so good. However, as usual the devil resides in the details.
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21 CFR Part 111 requires that the method used to test identity be scientifically sound and that the manufacturer ingredient meet manufacturer pre-set specifications in order to be accepted for manufacturing. One of the challenges with this regulation is that there are many scientifically valid ways to verify identity, but not all of these methods are appropriate for all ingredients. Organoleptic testing, although a scientifically valid form of identity testing and an excellent way to identify certain cut and sifted herbal ingredients, is not appropriate for all materials. Certainly a powdered herbal standardized extract would not be a candidate for organoleptic testing. Even more a sophisticated testing method, such as near infrared spectroscopy (NIR) or Fourier transform near-infrared (FT-NIR), would not necessarily be appropriate for identifying this standardized herbal extract powder. Unless the NIR is accompanied by chemometric analysis, this method may leave a tracing for the powder that is not specific enough and may miss an adulterant. Adulterants are substances that mimic the desired ingredient’s tracing on NIR or FT-NIR, allowing a supplier to cut the ingredient with this other, often inert or unrelated, compound. Even more sophisticated identity testing, say chromatography with high-performance liquid chromatography (HPLC), thin layer chromatography (TLC), or gas chromatography (GC), which are typically quite accurate and sensitive to adulterants, can be inaccurate if the equipment has been properly calibrated, maintained, and controlled. Proper equipment operation speaks to the importance of utilizing qualified laboratories that practice good lab practices (GLP) in order to obtain reliable test results. Assuming that the right test and the right lab are in place, another area of concern is the sampling procedures. If the manufacturer accepts several containers of raw material, what method is used to obtain samples for testing? Are the samples truly representative of the entire shipment of raw material? Sampling is a complex process and one that leaves much leeway. This is quite relevant however, given the fact that many suppliers of raw materials are, in fact, brokers. They obtain the material from a variety of sources and mix all of this material into one lot. A sound sampling process will minimize the chances of missing an inferior or adulterated ingredient in the shipment.

While we have just begun to scratch the surface of the challenges of quality in the dietary supplement industry, it should already be abundantly clear how challenging it is to achieve reliable quality practices even for one component: identity. The willingness on the part of the manufacturer to utilize the best methods in order to address these areas of ambiguity and challenge is a hallmark of those suppliers with a commitment to quality manufacturing. Thankfully, these suppliers exist aplenty, and practitioners’ expectations for this level of quality products will reinforce their commitment to quality.

“Exploratory testing can be described as a martial art of the mind. It’s how you deal with a product that jumps out from the bushes and challenges you to a duel of testing. Well, you don’t become a black belt by reading books. You have to work on it.” —James Bach

With passing consideration, one might think that the process of testing a natural product’s quality is straightforward—a simple matter of confirming that the ingredients that are supposed to be in a product are, in fact, the only substances in the product. This path of thinking might continue to embrace the idea that the really only variable in the equation is how often one does the testing. If it were only that simple.

Ensuring the quality of the products that we consume and recommend to patients is anything but a straightforward task. This is particularly true for naturally derived products, which often contain hundreds of phytochemicals arranged in complex matrixes. The starting material is complex and subject to change under even the most innocuous conditions such as exposure to air, moisture, and light. Natural compounds are rather like moving targets which, nonetheless, require the arrows of analysis to consistently find their mark.

Natural compounds are rather like moving targets which, nonetheless, require the arrows of analysis to consistently find their mark.

This issue of the Natural Medicine Journal we debut a column on quality in which various aspects of quality assurance in the dietary supplement industry will be addressed. It will be a practitioner’s journey into the world of dietary supplement manufacturing. As we travel, we will learn the route, appreciate the landscape, and take some keepsakes back into our clinical practices. In order to start our journey, we need a trail guide.

Our guide is called Final Rule 21 Code of Federal Regulations (CFR), Part III. Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. 21 CFR Part 111 contains the regulations of the 1994 Dietary Supplement Health and Education Act. These regulations were established by the FDA to set requirements for validated manufacturing and quality processes in order to ensure product safety. The regulations provide explicit requirements regarding all areas of manufacture, including, but not limited to, physical plant hygiene, quality control requirements, record keeping, manufacturing requirements, ingredient and supplier qualifications, and analytical testing requirements. The guidelines are a hybrid of food safety regulations and pharmaceutical regulations and are more similar overall to pharmaceutical regulations. The regulations are, in fact, a very good trail guide when followed to their letter and spirit, and provide an excellent path toward quality dietary supplements.

Wallace says that his vision involves students and faculty “bridging the gaps with conventional medicine so that they’re working together on a more regular basis.

“We’re looking to train people to be collaborative,” states Wallace. Noting that the origin of the word doctor comes from the Latin verb “docere,” meaning “to teach,” Wallace underscores the importance of education and collaboration at Bastyr. “We’re really focused on educating our patients and other providers about what we do and how we can complement each other, all for the benefit of our patients.”

Expanding Bastyr
Meeting the demand for naturopathic medical schools, Bastyr is planning to open a California campus. Because naturopathic doctors in California are licensed to practice as primary care doctors, the campus expansion will help address the shortage of primary care doctors in the state. The new campus will offer Bastyr University’s Doctor of Naturopathic Medicine degree program, which includes access to an international faculty, diverse curriculum, and a clinical training environment. With the campus expansion comes increased accessibility to Bastyr’s science-based natural medicine program.

In both facilities, Church insists that integrating both science and art in the science-based program will be imperative. “Health is not all about science, and if we presume to say that we look at health holistically, then we have to recognize there’s an awful lot of heart in it,” he says. “We are introducing curricula into the campus, and way beyond curricula we’re introducing conversations at every level with students, faculty, and stakeholders in the community about those things that wouldn’t traditionally be thought of as science, but which in fact contribute to health.

“Arts and sciences, as opposed to just sciences, is a hallmark of the current integration of Bastyr and I believe what will be representative of our future going forward,” states Church.

“Health is not all about science, and if we presume to say that we look at health holistically, then we have to recognize there’s an awful lot of heart in it.”