Testing For Diagnosis & Functional Solutions
Innovative testing providers aid practitioners in their search for effective and efficient personalized treatments for their patients.
Rameek Singh Bhogal, BS, DC, DABCI, has been in private chiropractic practice for 11 years. For the first five years, he cared for patients as most chiropractors do, correcting spinal subluxations utilizing a number of technique approaches with a great deal of discipline. It was in his fifth year of practice that his chiropractic education came full circle.
“I realized that unless I started to focus on the cause of these subluxations, I was going to keep seeing the same thing over and over again,” said Dr. Bhogal, who is also an assistant professor at Palmer College of Chiropractic. “It was from this point in time that I sought out functional testing and diagnostics to help qualify and quantify my patients’ true cause of their physiologic dysfunctions.”
The functional testing model and paradigm has become the center point of Dr. Bhogal’s practice, Peak Potential Chiropractic & Holistic Health in Davenport, IA, in the last six years with an emphasis in adrenal spectrum imbalance and gut/brain/immune health.
Functional vs. Diagnostic
For Dr. Bhogal, functional testing is rooted in the fact that every major homeostatic system is interrelated. “Various routine lab values can be evaluated in conjunction with a specific organ or organ system, and this has traditionally worked fairly well for diagnostic testing,” he said. “But what else can we glean from these values?
“A functional practitioner will go beyond just that organ or specific system and use functional physiology to associate an abnormally high or low lab value with other systems,” he explained. “This interconnectedness then takes us down the functional path and the second major difference: more specialized tests.”
Jacob Teitelbaum, MD, author of the free iPhone and Android application “Cures AZ,” and the best-selling book From Fatigued to Fantastic!, has been focused on treating chronic fatigue, pain, chronic fatigue syndrome (CFS) and fibromyalgia since 1977. He sees standard diagnostic testing suffering from a critical misunderstanding on the part of most physicians about how to use them.
“Most normal ranges are based on two standard deviations, which means you have to be in the lowest 2.5 percent of the population to be abnormal. To highlight how faulty this approach is, it would define three quarters of Americans who are in poverty as being ‘normal,’” he said, noting that recent studies suggest that this approach misses the large majority of people who need thyroid hormone, and results in approximately one million excess heart attack deaths each year in women. “Functional testing, instead of being based on two standard deviations, looks at the impact occurring and the person’s biochemistry.”
Dr. Teitelbaum uses a wide array of standard diagnostic testing including hormone, ferritin (iron) and vitamin B12 levels as well as numerous other standard diagnostic tests. “These are helpful if one knows to interpret them in the context of the individual person’s signs or symptoms—rather than based on whether they are in the ‘normal range,’” he said.
“Where much of standard diagnostic testing misses those people who need treatment, my concern with some functional tests is that they may over diagnose. This can result in making people fairly neurotic—which in the past has been largely a problem of standard medicine,” Dr. Teitelbaum explained. He added that he finds it more reliable to treat people based on their overall symptoms and examination, using standard testing, which is covered by the health insurance rather than functional testing. “On the other hand, many of the functional tests in the past helped me to get a better understanding of how to interpret standard testing.”
Meanwhile, Dr. Bhogal said he believes that while some traditional practitioners have criticized functional practitioners for utilizing “esoteric” tests, “in the end, we are simply gathering physiologic data to make the best informed decision for our patient,” he said.
Whatever a practitioner’s school of thought, providers have been innovating testing programs to help them reach those decisions.
Diagnostic Options
Cellular Research’s Meta-Oxy Kit
Testing the complex biochemical process for true oxidative stress has traditionally taken excessive time and money. But Shayne Morris, PhD, CEO and founder of Utahbased Cellular Research Labs, has discovered non-invasive and inexpensive ways to understand what the body is telling us. “Cellular Research Laboratories was born of a passion for innovation and the desire to take natural health to the next level,” said Dr.Morris, who has used his PhD in biochemistry to work as a formulator in the natural medicine field.
The company offers in-office diagnostics, including its Meta-Oxy kits, which tests oxidative stress damage via malendialdahyde, an indicator to oxidative stress levels of the body.
“Meta-Oxy is a quick and easy test that measures malondialdehyde in the urine. Toxic adlehydes are released into the bloodstream when fats, including cell membranes, are oxidized. The kidneys excrete them in the urine. Thus, Meta-Oxy is a general measure of cell membrane damage due to free radical peroxidation of lipids,” Dr. Morris explained. “Practitioners simply pipette some urine into the vial and look for it to turn a shade of magenta. The darker the magenta color, the more cellular damage occurring.”
Dr. Jack Tips, ND, PhD, Chom, CCN, with Apple-a-Day Health Services in Austin, TX, offers a three-part program consisting of homeopathic remedy, nutritional and herbal supplements, and dietary guidelines, and has been utilizing Cellular Research Labs’ tests. “Cellular Research provides cutting-edge lab analyses that raise the standards of clinical practice, dispelling theory in the light of effective clinical outcomes,” he said, noting that the virtues of lab tests in clinical practice are well established. “They provide a scientific basis and justification for remedial action, as well as before and after proof of efficacy. Judicious use of lab tests help the patient know more about themselves and serves to engage patients in the process of helping their bodies heal.”
Cellular Research consistently has both peer reviewing by university professors and practitioners providing feedback on the accuracy of its testing. “For instance, we have hard data provided by mass spec and other diagnostic equipment that we are having accurate feedback from the Meta-Oxy test, however there is on rare occasion trouble reading the results,” said Dr.Morris. “When we get feedback like this from practitioners, we take it back to the labs to improve the test functionality.”
The company is currently working on a less expensive way to electronically test and read biochemical markers, which will put a numerical value to a previously qualitatively deduced value.
QuinTron’s Hydrogen Breath Testing
Small intestine bacterial overgrowth (SIBO) is a chronic bacterial infection of the small intestine. The infection is of bacteria that normally live in the gastrointestinal tract, but have abnormally overgrown in a location not meant for so many bacteria, according to Allison Siebecker, ND, MSOM, Lac, who specializes in the treatment of SIBO at The National College of Natural Medicine in Portland, OR. The bacteria interfere with normal digestion and food absorption, and are associated with damage to the lining or membrane of the small intestine, or leaky gut syndrome.
“The small intestine is a hard place to get to,” said Dr. Siebecker. “If we want to see or sample the small intestine, endoscopy only reaches into the top portion, and colonoscopy only reaches into the end portion. The middle, which is substantial (about 17 feet), is not accessible except by surgery. And stool testing predominantly reflects the large intestine.
“Luckily, there is a non-invasive test commonly used in SIBO research: the hydrogen breath test,” she said.
According to Eric Hamilton, vice president of Wisconsin-based QuinTron Instrument Company, manufacturer of the hydrogen breath test (HBT), breath tracegases were first used as an indicator that complex sugars (disaccharides) were not broken down (hydrolyzed) and absorbed in the small intestine during the digestion of foods. Hydrogen was measured in the breath after administering a dose of the sugar to be studied. The widest application of the test was for lactose malabsorption or lactose intolerance. “The HBT replaced a blood test, which was based on the absence of a blood glucose response following lactose ingestion. The blood test is not as reliable as the HBT since it produces a greater proportion of false-negative and false-positive tests,” said Hamilton. “When the reliability and simplicity of the HBT was demonstrated with lactose, it was soon applied to other complex sugars like fructose (from fruits), maltose (from some starches) and sucrose (common table sugar, which is rarely absorbed). It has also been used to indicate that some people are unusually sensitive to sorbitol.”
As studies indicated that methane was also an important intestinal gas to be considered, QuinTron developed analyzers that measure breath samples for both hydrogen and methane. “The addition of methane measurement provides practitioners with the most comprehensive information to help treat their patients with carbohydrate malabsorption and SIBO,” said Hamilton.
According to Dr. Siebecker, a HBT can be used to diagnose several conditions: H pylori infection, carbohydrate malabsorption and SIBO. “Breath testing measures the hydrogen and methane gas produced by bacteria in the small intestine that has diffused into the blood, then lungs, for expiration. Hydrogen and methane are gases produced by bacteria, not by humans. The gas is graphed over the small intestine transit time of two or three hours and compared to baseline,” Dr. Siebecker explained. “Patients drink a sugar solution of glucose or lactulose after a oneor two-day preparatory diet. The diet removes much of the food that would feed the bacteria, allowing for a clear reaction to the sugar drink.”
Practitioners have a choice in how to provide HBT to their patients. Some prefer to have a QuinTron BreathTracker on-site, which allows them to have immediate information, while others participate in a kit program, which allows them to dispense QuinTron breath test kits to their patients so they can easily collect their own samples. The samples are then submitted to a facility where analysis is performed on a BreathTracker SC instrument, which is considered the ‘gold standard’ for breath analysis, according to Hamilton.
Dr. Siebecker uses this testing with just about all of her patients, and offered three reasons why it’s her go-to diagnostic tool. “It shows whether the patient in fact has SIBO, how severe the case might be and how high their gas levels are—all of which affect the prognosis and treatment required to bring bacteria down,” she said.
The one warning she offered, should practitioners utilize a testing facility with a breath-testing device, is that they be sure the unit measures methane as well as hydrogen, as there is a unit that doesn’t test for both.
In addition to measuring hydrogen and methane, the BreathTracker SC utilizes an added feature for sample contamination detection and correction based on carbon dioxide measured in every sample, ensuring a quality study.
Diagnos-Techs’ Saliva Testing Panels
Washington-based DiagnosTechs, Inc. is a clinical diagnostic and research saliva testing laboratory. According to John J.White, MDCM, the company’s chief medical advisor, unlike serum testing, saliva testing is non-invasive, accurate (especially for hormones), done in a patient’s home and, importantly, provides the opportunity for chronobiology, which is the capability for testing over time for those functions that vary during a day or a month.
“More than 2,200 proteomes have been identified in saliva, and 1,200 in salivary ductal secretions themselves. The latter have comparable proteomes with serum,” said Dr. White, who noted that DiagnosTechs’ saliva testing costs approximately a third of comparable serum testing.
Founded in 1987, Diagnos-Techs was the first clinical diagnostic salivary laboratory in North America and has been offering an ever-expanding group of tests:
The first panel offered by DiagnosTechs is the Adrenal Stress Index, which assesses the effect of acute and chronic stress on a patient’s daily circadian rhythm, measuring free cortsiol four times throughout the day. “We add measurements of DHEA and DHEA-S (to assay anabolic reserves), fasting and post-prandiol insulin, 17-OH progesterone (the direct antecedent of cortisol), gluten (a common stressor) and total secretory IgA (another assay of stress),” said Dr. White. “All of this information in composite can provide a deep understanding of the status and underlying causes of a patient’s state of stress.”
Diagnos-Techs’ Gastrointestional (GI) Health Panel was offered as an answer to the diagnosis many patients receive when they have non-specific but definite abdominal complaints, and often have negative endoscopies, abdominal screens and stool tests. White explained that it is a broad 22-item survey comprising direct exam of two separate stool specimens, chemical and immunologic testing of the desiccated stool, and immunologic assessment of salivary IgA antibodies to food allergens and parasitic infestations. The company recently improved its stool analysis with the acquisition of a MALDI-TOF Mass Spectrometer (only available in five percent of all laboratories), which can identify more than 4,000 microorganisms. “Our panel has proven to be effective both in diagnosing and for ruling out many common problems. As an example, a gastroenterologist in a one-person practice has reported that the use of our panel unearthed an average of 70 ‘functional GI disorder’ patients per year who had three infections/parasitic infections each,” he said.
The company continuously verifies the accuracy of its panels by in-house quality assurance, national testing and intermittent outside mass spectrometry verification. And in view of the testing sophistication, DiagnosTechs provides complementary medical consultation to practitioners to review test results.
A Functional Approach
Pharmasan Labs’ Functional Assays
Wisconsin-based Pharmasan Labs initially processed urinary neurotransmitters and salivary hormones. Today, Pharmasan Labs is a state-of-the-art, Clinical Laboratory Improvement Amendments (CLIA) certified, 22,000-square-foot specialty reference laboratory with 12 PhDs and two Mds on staff. The company offers more than 100 laboratory testing services including urinary transmitters, salivary and serum hormones, MELISA metal sensitivity, NK cell activity and stimulated cytokine analysis.
“Pharmasan’s unique assays provide an integrated snapshot of patient biomarkers and are designed to assist practitioners in assessing complex and chronic conditions,” said Bradley Bush, ND, director of clinician affairs with NeuroScience, Inc., a partner company launched by one of Pharmasan’s founders, Dr. Gottfried Kellermann, offering uniquely formulated products that address the complexity revealed in Pharmasan’s lab tests. “These include conditions related to the nervous system (including autism, depression and anxiety), HPA Axis dysfunction (including fatigue, weight issues and chronic illnesses), endocrine imbalance (including PMS, hot flashes and libido) and sleep disturbances.”
Donielle Wilson, ND, has been in practice for 13 years, primarily treating patients suffering from fatigue, anxiety, PMS, fertility, digestive complaints and allergies. She became aware of Pharmasan Labs about 10 years ago, seeking a better way of addressing adrenal-related health concerns and to balance neurotransmitters effectively using nutrients and herbs.
While she will often utilize diagnostic testing, such as blood work for anemia, low thyroid function, etc., certain functional tests offered by the company—salivary cortisol and urinary adrenaline and neurotransmitters— have made a marked difference in her practice.
“The research I completed last year in my practice showed that the only symptom that correlates with cortisol and epinephrine levels is fatigue, and even then fatigue can exist with varying cortisol and epinephrine levels. So the only way to really know what a patient needs is to measure the levels,” said Dr.Wilson. “The most significant thing from my research is that it is not possible to guess cortisol levels (or neurotransmitter levels) based on symptoms. Testing (salivary cortisol and urinary epinephrine) makes it possible to create an individualized approach to helping patients with symptoms, and to withstanding the effects of stress.”
In addition, Dr.Wilson will utilize NeuroScience’s products as part of the companies’ “Assess & Address” program, noting that “for many patients, they are efficient and effective,” she said.
Dunwoody Labs’ “Gut Triad”
Dunwoody Labs (formerly NutraTest Labs) in Wisconsin has been providing diagnostic tests for just three years, but the analytes and profiles it brings to market come with thousands of published papers, as it has contracted with those who had developed the methodology so it could quickly bring published markers to physicians.
“The model was to find and measure one pathway that relates to one condition. In order to bolster a system, you need testing that reflects the context or landscape of the person,” said Cheryl Burdette, ND, president and director of education at Dunwoody, who works in an integrative clinic, Progressive Medical, that embraces functional medicine. “Profiles directed at measuring the health of a person, rather than the disease process in the system, was necessary. These are profiles that were designed to assess the function of the body, but also the context of toxicity from chemicals, infections, imbalanced immune response or oxidative stress.”
Dunwoody offers a style of food sensitivity testing that measures IgG subtype responses to food, but also measures c3d, an immune component that triggers reactivity in alternative complement cascade. This can trigger some of the most inflammatory of reactions, which are most clinically relevant, according to Dr. Burdette.
The company’s latest profile is the “Gut Triad,” which combines the three major reasons for dysbiosis into one profile, providing focus on some of the major reasons for disease, according to Dr. Burdette. “The gut is either irritated from bugs, foods or an inability to clear histamine. This profile combines stool culture, food sensitivity c3d/IgG testing as well as diamine oxidases, the enzyme that degrades histamine and zonulin, a marker specific to gut permeability,” she said, noting that zonulin is the gatekeeper of tight junctions between gut mucosal cells. “When zonulin levels are high, tight junctions are eroded, and the phenomenon of leaky gut is initiated and perpetuated.We can measure zonulin, and as it comes down we know that we have restored gut health, which is pivotal in helping all conditions driven by inflammation.”
This is a clinically complete tool in gut assessment that guides clinical decision making in a meaningful way, said Dr. Burdette, who noted that this test was designed out of years of practice of integrative practitioners who recognize “we can improve health by improving the gut through diet and other interventions.
“It has been exciting to take what I have seen in the world of patient care and find well-referenced biomarkers that we can apply improve our medicine,” she added. “If we can improve our ability to identify a root cause in prevention and disease management, we can speed the path to recovery and augment prevention.”
Testing Advice
One of the reasons Dr. Teitelbaum doesn’t use functional testing frequently is because they tend not to be covered by insurance, he said. Another is that they tend to over diagnose problems, as in the case of some genetic testing. “The results, reports, I have seen would leave many people afraid to walk out the door or eat anything, despite the people being just fine,” he said. “Although they can be helpful, my advice would be careful not to make the person neurotic based on the results.
“For most tests of nutritional status,” he added, “I find it far more reliable, and much less expensive, to simply give overall nutritional support with a good vitamin powder and omega-3 source. I do check a ferritin and keep it over 60 and a B12 level, which I keep over at least 540.”
Dr. Bhogal utilizes diagnostic testing with 80 percent of his patient base, but about 50 percent of his total patient base comes for functional testing. Ultimately, his advice is to “hit the books” and “change your paradigm.”
“So much of our basic physiology learned in our respective professional schools is the basis of being able to conduct a good functional analysis,” he said. “The second component goes back to understanding the innate intelligence the body has to heal and care for itself and to work with it. The most successful functional practitioners end up making minimal succinct and targeted changes in a patient’s
FOR MORE INFORMATION:
Cellular Research Laboratories/Systemic Formulas, (800) 455-4647, www.systemicformulasmedia.com
Diagnos-Techs, Inc., (800) 878-3787, www.diagnostechs.com
Dunwoody Labs, (678) 736-6374, www.dunwoodylabs.com
NeuroScience, Inc., (715) 294-2144, www.neuroscience.com
Pharmasan Labs, (715) 294-4315, www.pharmasan.com
QuinTron Instrument Company, (800) 542-4448, www.quintron-usa.com
An Eye for Lyme Disease
According to NeuroScience, Inc.’s Director of Clinician Affairs Bradley Bush, ND, the traditional two-tiered Lyme test (ELISA and Western Blot) detects antibodies to Borrelia burgdoferi, but the sensitivity of this test can be as low as 30 percent, depending on the stage of infection. In addition, a large proportion of Lyme disease patients may be misdiagnosed using antibody-based tests because they appear to be antibody-negative.
After 18 months of development and validation, NeuroScience’s partner company, Pharmasan Labs, launched iSpot Lyme, a novel diagnostic tool for detecting the bacterial infection caused by B. burgdoferi, the causative agent of Lyme disease.
“In contrast, a cell-based immune assay called enzyme-linked immunospot (ELISpot) offers sensitivity that is 20- to 200-fold higher than ELISA,” said Dr. Bush. “Pharmasan Labs developed the proprietary iSpot Lyme assay, which detects B. burgdoferi-specific T cell responses with 84 percent sensitivity and can even detect responses in seronegative individuals.”
Researchers at Pharmasan Labs conducted a thorough literature research and experiment design, setting up and optimizing the Lyme enzyme-linked ELISpot assay, fully validating it following the guidelines of the CLIA program, conducting a study with approximately 500 samples from diagnosed Lyme patients as well as healthy controls, and completing data analysis using the standard method receiver operating characteristic (ROC) curve for assessing diagnostic tests.
Additionally, Pharmasan Labs and NeuroScience, Inc. presented its findings to a group of Lyme specialists at the International Lyme and Associated Diseases Society (ILADS) last fall. Several experts agreed to trial the test, review the report format and give feedback before the product was launched.
