Millions of Americans take herbal supplements. In fact, a survey from 2007 showed that 18 percent of Americans used herbal supplements in the previous year (1). Many take them on a daily basis, hoping they will prevent disease, keep them healthy, or even help treat disease, with or without conventional drugs. Many think that herbal supplements, unlike most medications, are natural substances, and therefore are likely to be safe.

Herbs have been used for thousands of years. Hippocrates, the father of medicine, recognized that there may be potential benefits of taking St. John’s wort for the treatment of mood disturbances. Another substance, saw palmetto, was used by the Egyptians for urinary tract problems in the 15th century B.C. (2).

However, even with a long tradition, are they really safe and effective? Even more, are we getting what the label says is in the bottle? Earlier this year, the NYS Attorney General performed DNA tests on 78 bottles of herbal supplements at Target, GNC, Walmart and Walgreens. Eighty percent did not contain the labeled ingredients, and some contained high levels of mercury, arsenic and lead (3). They also contained some substances that patients may be allergic to when the label on the bottle claimed otherwise.

The problem lies with the fact that herbal supplements are self-regulated. Manufacturers must label them with a disclaimer, saying that the content and health claims have not been reviewed by the FDA and that they are not meant to treat or prevent disease. Would you be comfortable buying drugs that were self-regulated? Probably not!

Many think the worst thing that could happen is they don’t help. Unfortunately, this may not be the worst effect. They may or may not work – the research on most is not very compelling. They also may be harmful on several levels: some cause interactions with drugs, such as Coumadin; some are incorrectly labeled regarding contents or doses; some include unlabeled medications in the bottles; and some cause side-effects. Just because they are said to be natural, doesn’t mean they’re safe.

Let’s look at the evidence.

Content of herbal supplements

We want to be certain that the contents in the bottle match what is on the label. Unfortunately, the recent investigation isn’t the first time the issue has been raised. An earlier study found that not all herbal supplements contain what is claimed, and some contain potentially harmful contaminants or inaccurate concentrations. Canadian researchers tested 44 herbal supplements from a dozen companies in the U.S. and Canada (4). They found that only 48 percent contained the herb that was on the label. In addition, about one-third of these supplements also contained fillers or contaminants. For example, a bottle labeled St. John’s wort actually contained a laxative from a plant called Alexandrian senna, and no St. John’s wort. With two other popular herbs, ginkgo biloba, used for memory, and echinacea, used to treat or prevent colds, there were fillers and potentially harmful contaminants in the bottles. These were identified using a sensitive DNA testing technique called DNA barcoding.

Black Cohosh

Black cohosh is used by women to help treat vasomotor symptoms, specifically, hot flashes associated with menopause. In a local study done at Stony Brook University Medical Center, as many as 25 percent of the bottles tested did not contain black cohosh (5). They tested 36 bottles acquired from brick-and-mortar chain stores and online. David Baker, M.D., an Obstetrics/Gynecology professor, also utilized the DNA barcoding technique mentioned above.

Ginkgo Biloba

Does ginkgo biloba live up to its claim of helping improve memory or prevent dementia? Unfortunately, in the first, large, double-blinded, randomized controlled trials (RCT), the gold standard of trials, results were disappointing (6). Ginkgo biloba was no better in preventing dementia or Alzheimer’s disease than a placebo. There were more than 3,000 participants in the trial; most did not have cognitive issues, but 14 percent had mild cognitive impairment. The treatment group took 120 mg of ginkgo biloba.

This is only one, albeit large, well-designed, study. But at least this supplement is safe, right? Well, in a toxicology study using lab animals, results demonstrated an increased risk of developing cancer, especially thyroid and liver cancers, as well as nasal tumors (7). Researchers point out that, while this is an interesting finding, it does not mean necessarily that the results are transferable to humans. Also, the doses used in this toxicology study were much higher, when compared to those taken by humans.

Red yeast rice and Phytosterols

Lest you think that herbs are not effective, red yeast rice is an herbal supplement that may be valuable for treating patients with elevated levels of cholesterol. In a study in patients with high cholesterol who refused or had painful muscle side effects from statin treatment, results showed that red yeast rice and lifestyle changes were effective in lowering LDL “bad cholesterol” levels (8). Patients making lifestyle changes alone were able to lose weight and maintain lower LDL levels over one year. The patients taking red yeast rice maintained LDL reductions over the year, as well. When phytosterols were added for patients taking red yeast rice, there was no further improvement in cholesterol levels. Again, some herbs may be effective, while others may not.

Resources

By no means are all herbs suspect, but you need to perform some due diligence. What can be done to make sure that doctors and their patients are more confident that the herbal supplements contain what we think? Well the best would be if an agency like the FDA would oversee these products. However, since that has not happened yet, there are resources available. These include Consumer Labs (www.Consumerlabs.com), Center for Science in the Public Interest (www.CSPInet.org), and NIH National Center for Complementary and Alternative Medicine Herb Fact Sheets (www.nccam.nih.gov/health/herbsataglance.htm), and Natural Medicines Comprehensive Database (www.naturaldatabase.com).

Conclusion

When taking herbal supplements, it is very important that patients share this information, including the brand names and doses, with their doctors and pharmacists. Herbal supplements may interact with medications, but they also may not contain labeled ingredients, and could have detrimental effects. If you have symptoms that are not going away, it could be due to these supplements. The best natural approach is always lifestyle modification.

Herbal supplements are sorely lacking proper regulation. So caveat emptor — buyer beware when it comes to taking herbal supplements.

References:

(1) Natl Health Stat Report. 2008. (2) JAMA. 1998;280(18):1604. (3) NYTimes.com. (4) BMC Medicine 2013, 11:222. (5) J AOAC Int. 2012 Jul-Aug;95(4):1023-34. (6) JAMA 2008;300:2253. (7) ntp.niehs.nih.gov. (8) Am Heart J. 2013;166(1):187-196.

Dr. Dunaief is a speaker, author and local lifestyle medicine physician focusing on the integration of medicine, nutrition, fitness and stress management. For further information, go to the website www.medicalcompassmd.com or consult your personal physician.

This article was originally published in the January 23, 2014 issue of Arts and Lifestyles.
Gluten has been gaining in notoriety over the last several years. When we hear someone mention a gluten-free diet, several things tend to come to mind. One may be that this is a healthy diet. Along the same lines, we may think gluten is bad for us. However, gluten-free is not necessarily synonymous with healthy. There are many beneficial products containing gluten.
We might think that gluten-free diets are a fad, like low-fat or low-carb diets. Still, we keep hearing how more people feel better without gluten. Could this be a placebo effect? What is myth and what is reality in terms of gluten? In this article I will try to distill what we know about gluten and gluten-free diets, who may benefit and who may not.
But first, what is gluten? Most people I ask don’t know the answer, which is OK; it is part of the reason I am writing the article. Gluten is a plant protein found mainly in wheat, rye and barley.
Now to answer the question of whether going gluten-free is a fad. The answer is resounding “No,” since we know that patients who suffer from celiac disease, an autoimmune disease, benefit tremendously when gluten is removed.(1) In fact, it is the main treatment.
But what about people who don’t have celiac disease? There seems to be a spectrum of physiological reaction to gluten, from intolerance to gluten (sensitivity) to gluten tolerance (insensitivity). Obviously, celiac disease is the extreme of intolerance, but even these patients may be asymptomatic. Then, there is nonceliac gluten sensitivity, referring to those in the middle portion of the spectrum.(2) The prevalence of NCGS is half that of celiac disease, according to the NHANES data from 2009-2010.(3) However, many disagree with this assessment, indicating that it is much more prevalent and that its incidence is likely to rise.(4) The term was not even coined until 2011.
What is the difference between full-blown celiac disease and gluten sensitivity? They both may have intestinal symptoms, such as bloating, gas, cramping and diarrhea, as well as extraintestinal (outside the gut) symptoms, including gait ataxia (gait disturbance), malaise, fatigue and attention deficit disorder.(5) Surprisingly, they both may have the same results with serological (blood) tests, which may be positive or negative. The first line of testing includes antigliadin antibodies and tissue transglutaminase. These measure a reaction to gluten; however, they don’t have to be positive to have reaction to gluten. HLA–DQ phenotype testing is the second line of testing and tends to be more specific for celiac disease.
What is unique to celiac disease is a histological change in the small intestine, with atrophy of the villi (small fingerlike projections) contributing to gut permeability, what might be called “leaky gut.” Biopsy of the small intestine is the most definitive way to diagnose celiac disease.
Though the research has mainly focused on celiac disease, there is some evidence that shows NCGS has potential validity, especially in irritable bowel syndrome.
Before we look at the studies, what does it mean when a food says it’s “gluten-free”? Well, the FDA has recently weighed in by passing regulation that requires all gluten-free foods to have no more than 20 parts per million of gluten.(6) The agency has given food manufacturers a year to comply with the new standards. Now, let’s look at the evidence.
Irritable bowel syndrome
Irritable bowel syndrome (IBS) is a nebulous disease diagnosed through exclusion, and the treatments are not obvious. That is why the results from a randomized controlled trial, the gold standard of studies, showing that a gluten-free diet significantly improved symptoms in IBS patients, is so important.(7) Patients were given a muffin and bread on a daily basis.
Of course, one group was given gluten-free products and the other given products with gluten, though the texture and taste were identical. In six weeks, many of those who were gluten-free saw the pain associated with bloating and gas mostly resolve; significant improvement in stool composition, such that they were not suffering from diarrhea; and their fatigue diminished. In fact, in one week, those in the gluten group were in substantially more discomfort than those in the gluten-free group. There were 34 patients involved in this study.
As part of a well-written March 4, 2013 editorial in Medscape, by David Johnson, M.D., a professor of gastroenterology at Eastern Virginia Medical School, he questions whether this beneficial effect from the IBS trial was due to gluten withdrawal or to withdrawal of fermentable sugars because of the elimination of some grains, themselves.(8) In other words, gluten may be just one part of the picture. He believes that nonceliac gluten sensitivity is a valid concern.
Autism
Autism is a very difficult disease to quantify, diagnose and treat. Some have suggested gluten may play a role. Unfortunately, in a study with children who had autism spectrum disorder and who were undergoing intensive behavioral therapy, removing both gluten and casein, a protein found in dairy, had no positive impact on activity or sleep patterns.(9) These results were disappointing. However, this was a very small study involving 22 preschool children. Removing gluten may not be a panacea for all ailments.
Antibiotics
The microbiome in the gut may play a pivotal role as to whether a person develops celiac disease. In an observational study using data from the Swedish Prescribed Drug Register, results indicate that those who were given antibiotics within the last year had a 40 percent greater chance of developing celiac disease and a 90 percent greater risk of developing inflammation in the gut.(10) The researchers believe that this has to do with dysbyosis, a misbalance in the microbiota, or flora, of the gastrointestinal tract. It is interesting that celiac disease may be propagated by change in bacteria in the gut from the use of antibiotics.
Not everyone will benefit from a gluten-free diet. In fact, most of us will not. Ultimately, people who may benefit from this type of diet are those patients who have celiac disease and those who have symptomatic gluten sensitivity. Also patients who have positive serological tests, including tissue transglutaminase or antigliadin antibodies are good candidates for gluten-free diets.
There is a downside to a gluten-free diet: potential development of macronutrient and micronutrient deficiencies. Therefore, it would be wise to ask your doctor before starting gluten withdrawal. The research in patients with gluten sensitivity is relatively recent, and most gluten research has to do with celiac disease. Hopefully, we will see intriguing studies in the near future, since gluten-free products have grown to a $4 billion industry that the FDA now has begun to regulate.

References:
(1) Am J Gastroenterol. 2013;108:656-676. (2) Gut 2013;62:43–52. (3) Scand J Gastroenterol. (4) Neurogastroenterol Motil. 2013 Nov;25(11):864-71. (5) medscape.com. (6) fda.gov. (7) Am J Gastroenterol. 2011; 106(3):508-14. (8) medscape.com. (9) 9th annual AIM for Autism Research 2010; abstract 140.007. (10) BMC Gastroenterol. 2013:13(109).

Dr. Dunaief is a speaker, author and local lifestyle medicine physician focusing on the integration of medicine, nutrition, fitness and stress management. For further information, go to the website medicalcompassmd.com or consult your personal physician.

Weight loss should be a rather simple concept. It should be solely dependent on energy balance: the energy (kilocalories) we take in minus the energy (kilocalories) we burn should result in weight loss if we burn more calories than we consume. However, it is much more complicated. Frankly, there are numerous factors that contribute to whether people who want or need to lose weight can.

The factors that contribute to weight loss may depend on stress levels, as I noted in my previous article, “Ways to counter chronic stress.” High stress levels can contribute to metabolic risk factors such as central obesity with the release of cortisol, the stress hormone (1). Therefore, hormones contribute.

Another factor in losing weight may have to do with our motivators. We will investigate this further.

And we need successful weight management, especially when approximately 70 percent of the American population is overweight or obese and more than one-third is obese (2).

Recently, obesity in and of itself was proclaimed a disease by the American Medical Association. Even if you don’t agree with this statement, excess weight has consequences, including chronic diseases such as cardiovascular disease, diabetes, osteoarthritis and a host of others, including autoimmune diseases. Weight has an impact on all-cause mortality and longevity.

It is hotly debated as to which approach is best for weight loss. Is it lifestyle change with diet and exercise, medical management with weight loss drugs, surgical procedures or even supplements? The data show that, while medication and surgery may have their places, they are not replacements for lifestyle modifications; these modifications are needed no matter what route is followed.

But the debate continues as to which diet is best. We would hope patients would not only achieve weight loss, but also overall health.

Let’s look at the evidence.

Low-carbohydrate diets versus low-fat diets

Is a low-carbohydrate, high-fat diet a fad? It may depend on diet composition. In a newly published study of a randomized controlled trial, the gold standard of studies, results showed that a low-carbohydrate diet was significantly better at reducing weight than low-fat diet, by a mean difference of 3.5 kg lost (7.7 pounds), even though calories were similar and exercise did not change (3).

The authors also note that the low-carbohydrate diet reduced cardiovascular disease risk factors in the lipid (cholesterol) profile, such as decreasing triglycerides (mean difference 14.1 mg/dl) and increasing HDL (good cholesterol). Patients lost 1.5 percent more body fat on the low-carbohydrate diet, and there was a significant reduction in inflammation biomarker, C-reactive protein. There was also a reduction in the 10-year Framingham risk score. However, there was no change in LDL (bad cholesterol) levels or in truncal obesity in either group. This study was 12 months in duration with 148 participants, predominantly women, with a mean age of 47, none of whom had cardiovascular disease or diabetes, but all of whom were obese or morbidly obese (BMI 30-45 kg/m2).

Although there were changes in biomarkers, there was a dearth of cardiovascular disease clinical endpoints. This begs the question: Does a low-carbohydrate diet really reduce the risk of developing cardiovascular disease or its subsequent complications? The authors indicated this was a weakness since it was not investigated.

Digging deeper into the diets used, it’s interesting to note that the low-fat diet was remarkably similar to the standard American diet; it allowed 30 percent fat, only 5 percent less than the 35 percent baseline for the same group. In addition, it replaced the fat with mostly refined carbohydrates, including only 15 to 16 g/day of fiber.

The low-carbohydrate diet participants took in an average of 100 fewer calories per day than participants on the low-fat diet, so it’s no surprise that they lost a few more pounds over a year’s time.

Patients in both groups were encouraged to eat mostly unsaturated fats, such as fish, nuts, avocado and olive oil.

As David Katz, M.D., founding director of Yale University’s Prevention Research Center noted, this study was more of a comparison of low-carbohydrate diet to a high-carbohydrate diet than a comparison of a low-carbohydrate diet to a low-fat diet (4).

Another study actually showed that a Mediterranean diet, higher in fats with nuts or olive oil, compared to a low-fat diet showed a significant reduction in cardiovascular events — clinical endpoints not just biomarkers (5). However, both of these studies suffer from the same deficiency: comparing a low-carbohydrate diet to a low-fat diet that’s not really low in fat.

Diet comparisons

Interestingly, in a meta-analysis (a group of 48 RCTs), the results showed that whether a low-carbohydrate diet (including the Atkins diet) or a low-fat diet (including the Ornish plant-based diet), the results showed similar amount of weight loss compared to no intervention at all (6). Both diet types resulted in about 8 kgs (17.6 pounds) of weight loss at six months versus no change in diet. However, this meta-analysis did not make it clear whether results included body composition changes or weight loss alone.

In an accompanying editorial discussing the above meta-analysis, the author points out that it is unclear whether a low-carbohydrate/high animal protein diet might result in adverse effects on the kidneys, loss of calcium from the bones or other potential deleterious health risks. The author goes on to say that for overall health and longevity and not just weight loss, micronutrients may be the most important factor, which are in nutrient-dense foods.

A recent Seventh-day Adventist trial would attest to this emphasis on a micronutrient-rich, plant-based diet with limited animal protein. It resulted in significantly greater longevity compared to a macronutrient-rich animal protein diet (7).

Psyche

Finally, the type of motivator is important in whatever our endeavors. Weight loss goals are no exception. Let me elaborate. A recently published study followed West Point cadets from school to many years after graduation and noted who reached their goals (8). The researchers found that internal motivators and instrumental (external) motivators were very important.

The soldiers who had an internal motivator, such as wanting to be a good soldier, were more successful than those who focused on instrumental motivators, such as wanting to become a general. Those who had both internal and instrumental motivators were not as successful as those with internal motivators alone. In other words, having internal motivators led to an instrumental consequence of advancing their careers.

When it comes to health, an instrumental motivator, such weight loss, may be far less effective than focusing on an internal motivator, such as increasing energy or decreasing pain, which ultimately could lead to an instrumental consequence of weight loss.

There is no question that dietary changes are most important to achieving sustained weight loss. However, we need to get our psyches in line for change. Hopefully, when we choose to improve our health, we don’t just focus on weight as a measure of success. Weight loss goals by themselves tend to lead us astray and to disappoint, for they are external motivators. Focus on improving your health by making lifestyle modifications. This tends to result in a successful instrumental consequence.

References:

(1) Psychoneuroendocrinol Online. 2014 April 12. (2) JAMA 2012;307:491–497. (3) Ann Intern Med. 2014;161:309-318. (4) Huffington Post. 2014 Sept. 2. (5) N Engl J Med. 2014;370:886. (6) JAMA. 2014;312:923-933. (7) JAMA Intern Med. 2013;173:1230-1238. (8) Proc Natl Acad Sci U S A. 2014;111:10990-10995.

Dr. Dunaief is a speaker, author and local lifestyle medicine physician focusing on the integration of medicine, nutrition, fitness and stress management.  For further information, go to the website www.medicalcompassmd.com and/or consult your personal physician.

Gluten has been gaining in notoriety over the last several years. When we hear someone mention a gluten-free diet, several things tend to come to mind. One may be that this is a healthy diet. Along the same lines, we may think gluten is bad for us. However, gluten-free is not necessarily synonymous with healthy. There are many beneficial products containing gluten.

We might think that gluten-free diets are a fad, like low-fat or low-carb diets. Still, we keep hearing how more people feel better without gluten. Could this be a placebo effect? What is myth and what is reality in terms of gluten? In this article I will try to distill what we know about gluten and gluten-free diets, who may benefit and who may not.

But first, what is gluten? Most people I ask don’t know the answer, which is OK; it is part of the reason I am writing the article. Gluten is a plant protein found mainly in wheat, rye and barley.

Now to answer the question of whether going gluten-free is a fad. The answer is resounding “No,” since we know that patients who suffer from celiac disease, an autoimmune disease, benefit tremendously when gluten is removed.(1) In fact, it is the main treatment.

But what about people who don’t have celiac disease? There seems to be a spectrum of physiological reaction to gluten, from intolerance to gluten (sensitivity) to gluten tolerance (insensitivity). Obviously, celiac disease is the extreme of intolerance, but even these patients may be asymptomatic. Then, there is nonceliac gluten sensitivity, referring to those in the middle portion of the spectrum.(2) The prevalence of NCGS is half that of celiac disease, according to the NHANES data from 2009-2010.(3) However, many disagree with this assessment, indicating that it is much more prevalent and that its incidence is likely to rise.(4) The term was not even coined until 2011.

What is the difference between full-blown celiac disease and gluten sensitivity? They both may have intestinal symptoms, such as bloating, gas, cramping and diarrhea, as well as extraintestinal (outside the gut) symptoms, including gait ataxia (gait disturbance), malaise, fatigue and attention deficit disorder.(5) Surprisingly, they both may have the same results with serological (blood) tests, which may be positive or negative. The first line of testing includes antigliadin antibodies and tissue transglutaminase. These measure a reaction to gluten; however, they don’t have to be positive to have reaction to gluten. HLA–DQ phenotype testing is the second line of testing and tends to be more specific for celiac disease.

What is unique to celiac disease is a histological change in the small intestine, with atrophy of the villi (small fingerlike projections) contributing to gut permeability, what might be called “leaky gut.” Biopsy of the small intestine is the most definitive way to diagnose celiac disease.

Though the research has mainly focused on celiac disease, there is some evidence that shows NCGS has potential validity, especially in irritable bowel syndrome.

Before we look at the studies, what does it mean when a food says it’s “gluten-free”? Well, the FDA has recently weighed in by passing regulation that requires all gluten-free foods to have no more than 20 parts per million of gluten.(6) The agency has given food manufacturers a year to comply with the new standards. Now, let’s look at the evidence.

Irritable bowel syndrome

Irritable bowel syndrome (IBS) is a nebulous disease diagnosed through exclusion, and the treatments are not obvious. That is why the results from a randomized controlled trial, the gold standard of studies, showing that a gluten-free diet significantly improved symptoms in IBS patients, is so important.(7) Patients were given a muffin and bread on a daily basis.

Of course, one group was given gluten-free products and the other given products with gluten, though the texture and taste were identical. In six weeks, many of those who were gluten-free saw the pain associated with bloating and gas mostly resolve; significant improvement in stool composition, such that they were not suffering from diarrhea; and their fatigue diminished. In fact, in one week, those in the gluten group were in substantially more discomfort than those in the gluten-free group. There were 34 patients involved in this study.

As part of a well-written March 4, 2013 editorial in Medscape, by David Johnson, M.D., a professor of gastroenterology at Eastern Virginia Medical School, he questions whether this beneficial effect from the IBS trial was due to gluten withdrawal or to withdrawal of fermentable sugars because of the elimination of some grains, themselves.(8) In other words, gluten may be just one part of the picture. He believes that nonceliac gluten sensitivity is a valid concern.

Autism

Autism is a very difficult disease to quantify, diagnose and treat. Some have suggested gluten may play a role. Unfortunately, in a study with children who had autism spectrum disorder and who were undergoing intensive behavioral therapy, removing both gluten and casein, a protein found in dairy, had no positive impact on activity or sleep patterns.(9) These results were disappointing. However, this was a very small study involving 22 preschool children. Removing gluten may not be a panacea for all ailments.

Antibiotics

The microbiome in the gut may play a pivotal role as to whether a person develops celiac disease. In an observational study using data from the Swedish Prescribed Drug Register, results indicate that those who were given antibiotics within the last year had a 40 percent greater chance of developing celiac disease and a 90 percent greater risk of developing inflammation in the gut.(10) The researchers believe that this has to do with dysbyosis, a misbalance in the microbiota, or flora, of the gastrointestinal tract. It is interesting that celiac disease may be propagated by change in bacteria in the gut from the use of antibiotics.

Not everyone will benefit from a gluten-free diet. In fact, most of us will not. Ultimately, people who may benefit from this type of diet are those patients who have celiac disease and those who have symptomatic gluten sensitivity. Also patients who have positive serological tests, including tissue transglutaminase or antigliadin antibodies are good candidates for gluten-free diets.

There is a downside to a gluten-free diet: potential development of macronutrient and micronutrient deficiencies. Therefore, it would be wise to ask your doctor before starting gluten withdrawal. The research in patients with gluten sensitivity is relatively recent, and most gluten research has to do with celiac disease. Hopefully, we will see intriguing studies in the near future, since gluten-free products have grown to a $4 billion industry that the FDA now has begun to regulate.

References:

(1) Am J Gastroenterol. 2013;108:656-676. (2) Gut 2013;62:43–52. (3) Scand J Gastroenterol. (4) Neurogastroenterol Motil. 2013 Nov;25(11):864-71. (5) medscape.com. (6) fda.gov. (7) Am J Gastroenterol. 2011; 106(3):508-14. (8) medscape.com. (9) 9th annual AIM for Autism Research 2010; abstract 140.007. (10) BMC Gastroenterol. 2013:13(109).

Dr. Dunaief is a speaker, author and local lifestyle medicine physician focusing on the integration of medicine, nutrition, fitness and stress management. For further information, go to the website medicalcompassmd.com or consult your personal physician.

Millions of Americans take herbal supplements. In fact, a survey from 2007 showed that approximately 18% of Americans used herbal supplements in the previous year (Natl Health Stat Report. 2008). Many take them on a daily basis, hoping they will prevent disease, keep them healthy or even help treat disease, with or without conventional drugs. Many think that herbal supplements, unlike most medications, are natural substances, and therefore are likely to be safe.

Herbs have been used for thousands of years. Hippocrates, the father of medicine, recognized that there may be potential benefits of St. John’s wort for the treatment of mood disturbances. Another substance, saw palmetto, was used by the Egyptians for urinary tract problems in the 15th century BC (JAMA. 1998;280:1604-1609).

However, even with a long tradition, are they really safe and effective? Even more, are we getting what the label claims is in the bottle? It would be a frightening thought if we were not.

The problem lies with the fact that herbal supplements are self-regulated for the most part. Manufacturers must label them with a disclaimer, saying that the content and health claims have not been reviewed by the Food and Drug Administration and that they are not meant to treat or prevent disease. Would you be comfortable buying drugs that were self-regulated? Probably not!

Many think the worst thing that could happen is they don’t help. Unfortunately, this may not be the worst effect. They may or may not work – the research on most is not very compelling for benefit. They also may be harmful on several levels; some cause interactions with drugs, such as warfarin; some are incorrectly labeled regarding contents or doses; some include unlabeled medications and sometimes exceeding pharmaceutical doses; and some cause side effects. Just because they are said to be natural doesn’t mean they’re safe. Let’s look at the evidence.

Contents of herbal supplements

We want to be certain that the contents in the bottle match what is on the label. Unfortunately, in a recently published study, results showed that not all herbal supplements contain what is claimed, and some contain potentially harmful contaminants or inaccurate concentrations. Canadian researchers tested 44 herbal supplements from a dozen companies in the U.S. and Canada. They found that only 48% contained the herb that was on the label. In addition, about one-third of these supplements also contained fillers or contaminants.

For example, a bottle labeled St. John’s wort actually contained a laxative from a plant called Alexandrian senna, and not St. John’s wort. With two other popular herbs, Ginkgo biloba, used for memory, and Echinacea, used to treat or prevent colds, there were fillers and potentially harmful contaminants found in the bottles. This is not the first time supplements have been tested, but this time researchers utilized a sensitive DNA testing technique called DNA barcoding.

Black cohosh

Black cohosh is used by women to help treat vasomotor symptoms, specifically hot flashes associated with menopause. In a local study done at Stony Brook University Medical Center, results show that as many as 25% of the bottles tested did not contain black cohosh (J AOAC Int. 2012 Jul-Aug;95:1023-1034). They tested 36 bottles acquired from brick-and-mortar chain stores and from online. David Baker, M.D., an OB/GYN professor, also utilized the DNA barcoding technique mentioned above.

Gingko biloba

Does Gingko biloba live up to its claim of helping improve memory or prevent dementia? Unfortunately, in the first large double-blinded randomized controlled trial, the gold standard of trials, results were disappointing (JAMA 2008;300:2253-2262). Gingko biloba was no better in preventing dementia or Alzheimer’s disease than a placebo. There were over 3,000 participants in the trial; most did not have cognitive issues, but 14% had mild cognitive impairment at the start of the trial. The treatment group took 120 mg of Gingko biloba.

This is only one, albeit large, well-designed, study. But at least this supplement is safe, right? Well in a recent toxicology study using lab rats, results demonstrated an increased risk of developing cancer, especially thyroid and liver cancers, as well as nasal tumors (ntp.niehs.nih.gov). Researchers point out that, while this is an interesting finding, it does not mean necessarily that the results are transferable to humans. Also, the doses used in this toxicology study were much higher, when compared to those taken by humans.

Red yeast rice and phytosterols

Lest you think that herbs are not effective, red yeast rice is an herbal supplement that may be valuable for treating patients with elevated levels of cholesterol. In a study in patients with high cholesterol who refused or had painful muscle side effects from statin treatment, results showed that red yeast rice and lifestyle changes were effective in lowering LDL “bad cholesterol” levels (Am Heart J. 2013;166:187-196). Patients making lifestyle changes alone were able to lose weight and maintain lower LDL levels over one year.

The patients taking red yeast rice maintained LDL reductions over the year, as well. When phytosterols were added for patients taking red yeast rice, there was no further improvement in cholesterol levels. Again, some herbs may be effective, while others may not.

Resources

By no means are all herbs suspect, but you need to perform some due diligence. What can be done to make sure that doctors and their patients are more confident that the herbal supplements contain what we think? Well the best would be if an agency like the FDA would oversee these products, however, since that has not happened yet, there are resources available. These include Consumer Lab (consumerlab.com), Center for Science in the Public Interest (cspinet.org), NIH National Center for Complementary and Alternative Medicine Herb Fact Sheets (nccam.nih.gov/health/herbsataglance.htm), and Natural Medicines Comprehensive Database (www.naturaldatabase.com).

Conclusion

When taking herbal supplements, it is very important that patients share this information, including the brand names and doses, with their doctors and pharmacists. Herbal supplements may interact with medications, but they also may not contain labeled ingredients, and could have detrimental effects. If you have symptoms that are not going away, it could be due to these supplements. The best natural approach is always lifestyle modification.

Herbal supplements are sorely lacking proper regulation. So caveat emptor (buyer beware) when it comes to taking herbal supplements.

Dr. Dunaief is a speaker, author and local lifestyle medicine physician focusing on the integration of medicine, nutrition, fitness and stress management. For further information, go to the website www.medicalcompassmd.com and/or consult your personal physician.