A Conversation on Quality – 3 Things New Patients Need to Know
Posted by Wellevate | Three Minute Difference
When practitioners are asked why they sell dietary supplements to patients, the number one response is that they want patients to have access to high-quality products. For patients however, they rank trust in their clinician and convenience above all else.
This discrepancy between practitioner and patient beliefs about the importance of quality may explain why so many patients end up going elsewhere for refills and ongoing purchases. If patients could understand the importance of product quality on the very first visit, they just might become loyal customers for life.
Patients want to know 3 things about products they purchase:
1. That the products are safe
2. That the products work
3. That the products are worth the cost
FDA regulations do nothing to ensure any of these things.
The responsibility to ensure safety and efficacy falls on individual product manufacturers, which is why the choice of product really does matter. In a quick conversation with every new patient, make sure all of your patients are aware of the following 3 points:
1. The FDA does not test dietary supplements for safety or efficacy before marketing.
There is a law called the Dietary Supplement Health and Education Act (DSHEA) that defines how dietary supplements are regulated. The law states that it is the responsibility of each manufacturer to show that a product is safe and effective before marketing that product. The FDA has no authority to do its own safety review before a product is made available to the public.
A commonly cited study that brings into question the quality of supplements was conducted by authorities in New York in 2014. They analyzed 78 bottles of dietary supplements from major retailers and found that 4 out of 5 products did not contain evidence of the herbs that were stated on the label and many contained contaminants not listed on the label—things like houseplants, powdered radish, and even wheat in products that were labeled “gluten-free.” Some have argued that the type of testing used was not a valid way to identify herbs, but the presence of so many contaminants cannot be dismissed.
Some companies do their own testing of raw materials and final products, but some do not. Product analyses are completely voluntary. High-quality companies will pay for third-party testing to confirm the presence of ingredients, the potency of ingredients, and the absence of contaminants. Common contaminants that are tested for include heavy metals, solvents, pesticides, and microbes.
Voluntary third-party certifications include the USP Verified Mark, Consumer Labs, UL, International Fish Oil Standards (IFOS), and the Emerson Quality Program℠.
2. The FDA does not certify supplement-manufacturing facilities.
The FDA requires companies to follow current Good Manufacturing Practices (cGMPs), but it does not offer any certification for this. cGMPs require that the manufacturing facility be clean, climate-controlled, and run with good quality-control procedures. cGMPs have to do with how products are made—they have nothing to do with what is actually in the final product.
Quality companies go above and beyond the requirements of cGMPs and get third-party certifications related to their manufacturing practices. Voluntary certifications for good manufacturing practices include NSF International and NPA (Natural Products Association). The Emerson Quality Program℠ ensures that all companies distributed through Emerson Ecologics and Wellevate meet or exceed the standards of cGMPs.
3. The FDA does not standardize dosages or forms of ingredients in dietary supplements.
Vitamins and minerals can be sourced from many different places and can be provided in many different forms. Pyridoxine hydrochloride is the cheapest form of vitamin B6, but pyridoxine-5-phosphate (P5P) is the most biologically active form. Niacin can lower serum cholesterol, but only at a dosage of 1000 mg per day. Iron sulfate causes the common side effect of constipation, whereas iron citrate formulated with vitamin C is most readily digested and absorbed.
The form of the ingredient, the dosage of the ingredient, and the formulation of the entire product all influence whether or not a dietary supplement will be effective. High-quality companies rely on a team of medical experts and evidence-based science to formulate products that offer patients the greatest benefits. Part of the Emerson Quality Program℠ is an evaluation of product formulations of all companies distributed through Emerson Ecologics and Wellevate.
Make sure you take the time to have the conversation about quality with every new patient. Always come back to the issues that matter to them. They want to know that the products they purchase are safe, effective, and worth the cost. With the Emerson Quality Program℠ you can assure them of those things with minimal time, energy, or research of your own.
1. Nutrition Business Journal. Practitioner Channel Deep Dive. 2017
Is the FDA Testing My Supplements? was last modified: April 2nd, 2019 by lynn
This study was made with a very low dose BPA exposure. We imagine a worrying levels with regular exposure, possibly including frequent use of disposable water bottles.
In a previous blog, we discussed the mechanisms by which Bisphenol A (BPA), a compound used to make polycarbonate plastics and epoxy resins, induces undesirable weight gain. By disrupting the entire adipocyte metabolism and inducing a pro-inflammatory state, BPA is considered an “obesegen”.
Now, in a first-of-its kind human study by the Journal of the Endocrine Society, BPA has been linked to altering insulin release in non-diabetic subjects, even when people are exposed to what is considered a “safe” daily amount. After witnessing insulin resistance in animal studies, the University of Missouri-Columbia researchers conducted this human study. Non-diabetic men and post-menopausal women were orally administered a safe dose of BPA (50ug/kg body weight, an amount comparable to what they may encounter by handling cash receipts) and were compared to a control group. They assessed the insulin response using an oral glucose tolerance test (OGTT) and hyperglycemic clamp (HG), tests that measure both the initial and later phases of the insulin response to stable levels of glucose.
In the OGTT, a “strong correlation was found between HbA1c and the percent change in the insulinogenic index (Spearman=.92) and the equivalent C-peptide index (Pearson=0.97). In the HG clamp study, several measures of insulin and C-peptide appeared suppressed during the BPA session relative to the control session; the change in insulin Cmax was negatively correlated with HbA1c and the Cmax of bioactive serum BPA”.
Results from both experiments showed that the subjects receiving “safe” amounts of BPA had an altered insulin release compared to the placebo exposure.
Placebos Can Work Even When You Know You’re Taking A Dummy Pill
BY DR. JOSEPH MERCOLA
By definition, a placebo is an inert substance that has no effect on your body. In medical research, placebos (such as sugar pills) are used as controls against which the effects of drugs are measured.
However, the placebo-effect, in which a patient believes he or she is getting an actual drug and subsequently improves despite receiving no active substance at all, has become a well-recognized phenomenon.1 Some studies into the placebo effect have even concluded that many conventional treatments “work” because of the placebo effect and little else.
Indeed, the placebo effect may even be at work in some surgical procedures, as evidenced in studies showing sham knee surgery is as effective as the real thing.2,3 This, despite the fact that the physical problem is in no way addressed.
Placebo Effect Works By Affecting Brain Chemistry And Circuitry
While we know the placebo effect is real, questions abound as to the mechanisms that makes it work. Writing in the journal Neuropsychopharmacology4 in 2011, the researchers highlighted the following observations:
1. First, as the placebo effect is basically a psychosocial context effect, these data indicate that different social stimuli, such as words and rituals of the therapeutic act, may change the chemistry and circuitry of the patient’s brain.
2. Second, the mechanisms that are activated by placebos are the same as those activated by drugs, which suggests a cognitive/affective interference with drug action.
3. Third, if prefrontal functioning is impaired, placebo responses are reduced or totally lacking, as occurs in dementia of the Alzheimer’s type.
As noted by The Washington Post and published studies,5,6 researchers have also discovered a “hierarchy of effectiveness,” with certain types of placebos appearing to have stronger effects than others. For example, injections or creams have stronger placebo effects than pills, and sham injections and sham acupuncture (which also uses needles) being more effective than placebo pills.
Price also matters,7 with expensive pills or treatments garnering better results than inexpensive ones. Lastly, telling the patient that the treatment will relieve their symptoms produces a greater placebo effect than saying it “might” help.
For example, in trials involving placebos for pain relief, the participant’s brains release natural opioids that provide opioid-mediated pain control. So, the placebo effect is tapping into the same pain control centers as opioid drugs. Placebos can also trigger the release of many other natural brain chemicals, such as those involved in making us feel more energized, or those that help us sleep better.
In short, the placebo effect taps into your body’s own virtual pharmacy. Drugs work because your body has chemical receptors for the drugs, but you also have natural brain chemicals that act on those same receptors. This is why placebos so often can mimic the effects of the drugs.
This tells us that the placebo effect is not illusory. Rather, it relies on your body’s own chemicals, which are released in response to or in accordance with your mental or emotional expectations or beliefs. With that in mind, just how far can a placebo take you? Placebo trials on patients with Parkinson’s disease have revealed that even this serious condition can be ameliorated with a dummy pill.
Lack of dopamine is one of the factors producing the symptoms of Parkinson’s, and brain scans show that when Parkinson’s patients are told they’re receiving an active medication, the dopamine levels in their brains increase, even when there’s no active ingredient in the pill. Remarkably, a placebo can release as much dopamine as amphetamines in a person with a healthy dopamine system,8 so the response can be quite dramatic.
Placebos Work Nearly As Well As Antidepressants For Depression
Another excellent example of the placebo effect is that of antidepressants. Research9 published in 2010 suggests antidepressants work no better than a placebo for people with mild to moderate depression.
An earlier meta-analysis10 also concluded the difference between antidepressants and placebo pills is indeed very slight. According to the authors:
“Drug-placebo differences in antidepressant efficacy increase as a function of baseline severity, but are relatively small even for severely depressed patients. The relationship between initial severity and antidepressant efficacy is attributable to decreased responsiveness to placebo among very severely depressed patients, rather than to increased responsiveness to medication.”
Interestingly, investigations reveal the placebo effect is growing in potency among Americans, and it’s having a dramatic real-world impact on the development of new painkillers.
Drug companies are finding it increasingly difficult to get pain-reducing drugs through clinical trials, because as people’s responses to placebos are getting stronger, it makes it more difficult to prove that the drug actually works.11,12
Equally interesting, research shows placebos can work even when the patient is fully aware of the fact that they’re getting a dummy pill.13 This effect appears to be so reliable that entrepreneurs are now selling placebo pills and creams on Amazon.
Placebos Work Even When Patient Knows They’re Not Real
Ted Kaptchuk, professor of medicine at Harvard Medical School, is one of the leading researchers on the placebo effect. Normally, the placebo effect is studied by giving half of the test subjects the real treatment while the other gets a dummy pill, but neither of the groups is aware of what they’re getting.
Kaptchuk was curious what might happen if people knew they were receiving a placebo right from the start. So, in 2009, he launched the first open-label placebo trial,14 enrolling people diagnosed with irritable bowel syndrome (IBS). As reported by Time:15
“The findings were surprising. Nearly twice as many people in the trial who knowingly received placebo pills reported experiencing adequate symptom relief, compared with the people who received no treatment.
Not only that but the men and women taking the placebo also doubled their rates of improvement to a point that was about equal to the effects of two IBS medications that were commonly used at the time. ‘I was entirely confused,’ says Kaptchuk. ‘I had hoped it would happen, but it still defies common wisdom.’”
Overall, nearly 60 percent of the patients given a placebo pill (and, again, told they were receiving a placebo) reported adequate relief from IBS symptoms, compared to just 35 percent of those who received no treatment. Even more astonishing, those taking the placebo reported improvements that were virtually the same as those reported from people taking the strongest IBS medications.
Mind Over Body, Or Is It Body Over Mind? Perhaps Both
Kaptchuk’s team is now working on a replication study with a $2.5 million grant from the National Institutes of Health. So far, 270 people with IBS have participated in this still-ongoing trial.
While it sounds implausible that you would get results when you’re fully aware that you’re taking a dummy pill, Time recounts the story of Linda Buonanno, who participated in Kaptchuk’s 2009 IBS study; three weeks after taking a clearly marked placebo twice a day, she was completely free of symptoms.
This, despite the fact she was sorely disappointed when she realized it was an open placebo trial, and that she wouldn’t receive any real treatment. “I didn’t have a clue what was going on,” Buonanno told Time. “I still don’t.”
After the study ended, her symptoms came back, so Kaptchuk is now treating her in his home clinic — with sugar pills. “All I know is that it works,” Buonanno says. “That’s all I care about.” Kaptchuk admits he doesn’t fully understand it either, but he believes your body may have the ability to respond even when your mind knows the factual truth. Time writes:16
“He struggles to find adequate analogies, but likens it to watching Romeo and Juliet when you know what’s going to happen. If the performance is evocative enough, even though you know it’s fake, ‘your body reacts in ways that go beyond the mind,’ he says. You might get a lump in your throat or tear up.
More important to Kaptchuk than understanding why honest placebos work is figuring out how the gain in scientific knowledge could translate into clinical practice. ‘Placebo has generally been denigrated in medicine, but I always wanted to figure out ways to ethically harness it,’ he says.”
Writing in Readers Digest,17 Robert Anthony Siegel also discusses his own experience with placebo. A longtime friend of John Kelley, psychology professor at Endicott College and deputy director of Harvard’s program in placebo studies and therapeutic encounter, Siegel received a specially-designed placebo to treat chronic writer’s block with accompanying panic attacks and insomnia.
Placebo Effect Accounts For Half Of Therapeutic Value Of Migraine Drug
Kaptchuk’s team has also investigated the placebo effect on migraines, and compared dummy pills against the migraine drug Maxalt (rizatriptan) for recurring migraines.18 Here, as in Kaptchuk’s open-label placebo trial on IBS patients, subjects reported pain relief even when they were informed that they were receiving a placebo, when compared to no treatment at all.
Overall, the placebo effect was found to account for more than 50 percent of the therapeutic value of Maxalt. Kaptchuk explained:19
“This study untangled and reassembled the clinical effects of placebo and medication in a unique manner. Very few, if any, experiments have compared the effectiveness of medication under different degrees of information in a naturally recurring disease.
Our discovery showing that subjects’ reports of pain were nearly identical when they were told that an active drug was a placebo as when they were told that a placebo was an active drug demonstrates that the placebo effect is an unacknowledged partner for powerful medications.”
The Future Of Medicine — Harnessing The Power Of Placebo In Clinical Practice
Alia Crum, Ph.D., a placebo researcher at the Stanford Mind & Body Lab, also stresses that “placebo is not magic.” Rather, the effect is “the product of your body’s ability to heal, which is activated by our mind-sets and expectations … shaped by medical ritual, branding of drugs and the words doctors say.” According to Time:20
“Crum says honest-placebo research is fascinating and important, but she doesn’t see doctors prescribing placebo pills anytime soon. Instead, she’s interested in how doctors can get their patients into the right mindset for medical care.
‘We’ve been pumping billions of dollars into developing new drugs and treatments without making much headway on the chronic-disease crisis,’ she says. ‘What if we spent that same time, money and effort on achieving a greater understanding of the patients’ natural abilities to heal?’…
Crum and a colleague are working with Stanford Primary Care to roll out a curriculum called Medicine Plus, in which medical teams, including everyone from receptionists to physicians, learn how to create an environment that is most conducive for healing.
The strategies focus on leveraging patients’ mind-sets but build on the power of the placebo with the ultimate goal of helping medical practitioners harness the same forces that contribute to placebo effects alongside active medications and treatments, says Crum.
Ideally, she says, one day these types of lessons should be incorporated into care much earlier, when health providers are in medical school.”
While placebo treatments are unlikely to become mainstream anytime soon, discussions and scientific investigations into ways in which the placebo effect may be fruitfully harnessed in clinical practice are underway.
A 2011 special issue of Philosophical Transactions of the Royal Society B (published by the U.K.’s national academy of science) reviewed the available research, concluding that “more rigorously designed studies are needed” to tease out the complexities involved and find ways in which the placebo effect might be adapted for clinical use.21
Perhaps one of the simplest ways for a doctor to harness the placebo effect in clinical practice, without taking any ethical risks, is to tap into empathy and raise the patient’s expectation of relief. Studies have repeatedly found that patients who feel their doctor is warm and empathetic (have so-called good bedside manner) are more apt to get well.
Describing how a medication or treatment can make a patient better has also been shown to have a positive impact, likely because it heightens the patient’s expectations.
This article was brought to you by Dr. Mercola, a New York Times bestselling author. For more helpful articles, please visit Mercola.com today and receive your free Take Control of Your Health E-book!
I have just watched a couple of episodes for the online video series, Awakening from Alzheimer’s.
I highly recommend viewing it to anyone who knows anyone who has suffered Dementia, or for all of us who wish to maintain or brain health into our later years. Trust that I will also be implementing what I learn from this series in my practice.
The series began on 21 September, and currently offers one free episode per day. It appears you may view episode 1 throughout the series. This episode a good taste of some of the interviews with respected clinicians who have seen measurable improvements in their patients’ conditions. You may review all episodes October 6-9, and purchase the series at any time. Episodes appear to be 30-40 minutes in duration, and are posted from 9 AM EST to 9 AM the following day.
During the summer solstice your yang energy reaches its peak. It is important to harness the peak of this yang energy, because as summer shifts into fall yang energy will decline. This great abundance of yang energy will translate throughout your body because during this season you are active and growing.
According to five element theory, during the summer the organ that receives extra energy is the heart. When the seasons change so do the organs we should focus on in the body. You should focus on the heart during summer. Feed the heart heart-nourishing foods and make sure to remain active so the heart receives positive energy. continue reading »
Summer Solstice was last modified: May 30th, 2017 by admin
While the flu is actually not a season, we have become programmed to think of it as the months of November through March. On average, the flu hospitalizes thousands every year, especially the young and elderly. There are also a number of deaths related to the flu, mostly due to people already having compromised immune systems.
The flu, also known as influenza, is a highly contagious respiratory infection that is caused by a number of viruses. To date, there are approximately 26 to 30 different known strains of the flu virus. This is one of the reasons the flu vaccine has only mild efficacy. The flu vaccine itself, typically only covers five to seven strains of the flu. Symptoms of the flu include fever, coughing, a sore throat, fatigue, muscle aches, pains, runny nose and watery eyes. continue reading »
Fighting Flu Season with Acupuncture was last modified: December 27th, 2016 by admin
Oriental medicine (OM) nutrition combines ancient wisdom with modern science. OM nutrition is a holistic approach, which aims to balance all five flavors within most meals with one or two flavors being emphasized for therapeutic purposes. OM nutrition for a hypertension emphasizes bitter flavors, sour flavors and energetically-cooling foods.
OM theory states the bitter flavor benefits the heart in moderation but an excess is harmful as it has a drying effect; for example, coffee is bitter. In moderation coffee acts as vasodilator increasing circulation but in excess it can raise blood pressure and has a diuretic effect. Modern scientific research has discovered while the human genome has 25 bitter taste receptors 12 of these are expressed in the human heart. continue reading »
Nutrition for Heart Health OM Nutrition & Hypertension was last modified: September 12th, 2016 by admin
As the school year kicks back into gear so should the healthy habits that you and your children have before practiced. Notice how I said “practiced,” because we all know during the summer-vacation months we tend to indulge a little. Maybe you have had one too many backyard barbecues, or three too many trips to the favorite ice cream shop down the street. Whatever your summer vice may be don’t worry about it, you can regain those healthy habits from before and introduce them into your children’s lives! continue reading »
7 Ways to Communicate Healthy Habits to Your Kids was last modified: August 30th, 2016 by admin