Herbal Safety Lesson
Herbal & Supplemental Safety
2 Credit Hours
In the first section of the course, we will go over some background information on herbal and dietary supplements and how the gained popularity in the U.S.
Next, topics and questions regarding herbs and dietary supplement regulations within the United States are discussed, as well as basic safety knowledge on regulatory requirements, cautions, potential adverse effects, and herb-drug interaction.
Herbal & Dietary Supplements Gain Popularity
It was in the late 1960s when a lot of Americans began changing their feelings towards their own health and recovering from illness. Instead of tackling illness once it started, the focus of health started to revolve around disease prevention. People started to discover the therapeutic benefits of herbs and plants, and by the turn of the 21st century, United States medicinal herb sales totaled about $4 billion a year (Castleman, 2009).
Several trends caused a renewed interest in herbal remedies. For one, there was a new excitement for alternative healing arts such as Ayurveda medicine, naturopathy, Chinese medicine such as acupuncture, and Qi gong exercises. These healing arts especially make great use out of healing herbs and supplements.
Popularity of self-care and education regarding health also helped the herbal and dietary supplement industry increase its business. While mainstream Western medicine may lead the pack in scientific research and lead to great break-throughs in medicine, more often than not some feel modern medicine to be impersonal and costly.
Additionally, disdain for pharmaceutical drugs and their side effects have caused consumers to be pro-active in their search for remedies to their ailments that come with more “pros” than they do “cons”.
We also see increase awareness in regards to the environment, climate change, and protection of tropical rainforest. Because of more notoriety of these issues, we see people becoming more concerned of how climate change and destruction of rainforests affect the plants, some of which are herbal medicines and many of which have not been screened for potential medicinal use (Castleman, 2009).
On an interesting side note, the National Cancer Institute and government agencies around the world have launched testing programs, hoping to find therapeutic components of the plants in these areas threatened with destruction (Castleman, 2009).
Furthermore, the educational system increased acceptance of alternative medicine after the 1980s (Castleman, 2009), and currently several prominently known schools such as John Hopkins University, Harvard University, and more now offer programs for degrees in alternative medicine.
To begin, licensing of health practices occurs on the state level. According to the American Herbalists Guide (AHG), there is currently “no licensing or certification for herbalists in any state that precludes the rights of anyone to use, dispense, or recommend herbs. However, naturopathic and acupuncturist licensing laws include clauses and define natural remedies and specifically herbal remedies within the scope of licensed practice. Besides a membership to the AHG, non-licensed credentials can be provided by the NCCAOM through the Diplomate in Chinese Herbology.
The First Amendment of the Constitution protects the right to free speech when providing information to clients related to their health (AHG, 2015). Medical practice is regulated on the state level, and any licensed Chiropractor recommending herbal supplements to their patients should keep abreast of the state statues in which they practice. When dispensing herbs to any patient, it is important to describe the herbal supplement as an aide that may assist in improving their condition or needs.
Herbs should not be described as diagnostic, preventive, treating, or that they cure disease indefinitely because using this language may violate the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) regulations regarding product claims, especially since in that context the herbal remedy can be considered an unapproved drug (AHG, 2015). If dispensing herbs to patients be clear and transparent in the description of use and have them sign an Informed Consent and Disclosure document that puts in writing everything you discussed with them regarding the use of the herb.
The FDA or Food & Drug Administration was established in 1928 but was limited in their authority and somewhat lax about their drug safety standards. After an antibiotic concoction of sulfanilamide killed 107 people because it contained a harmful ingredient, Congress passed the Food, Drug, and Cosmetic Act, which lead to the very first United States Drug regulations.
It was around 1960s when the FDA decided to implement higher drug safety standards after witnessing the effects of approximately 10,000 European babies born with phocomelia, a condition characterized by the shortening or absence of limbs. These birth defects were the side effect of the over-the-counter sleeping aide, Thalidomide.
Thalidomide was marketed as sleeping aide and sedative in the post-war era, entering the German market in 1957, when sleeplessness among the population was quite common.
Additionally, thalidomide was the only non-barbiturate sedative known at the time, which made the drug very popular. After the success of thalidomide in the European market, the drug company hosting the drug petitioned it to the FDA in 1960 to be allowed in the United States market.
In short, the drug was never licensed for production and distribution within the United States; it was however distributed as samples to physicians, to give to their patients to try. The physicians would then document the results of the drug on their patient. Since there were no guidelines to govern clinical trials of new drugs at the time, this was typically how the drugs were tested with little consent or knowledge on behalf of the patient. Thalidomide did impact a small amount of Americans (Botwin Raphael, 2014).
Aside from the drugs apparent sedative effects, an Australian obstetrician noticed that it had positive effects for alleviating the morning sickness associated with pregnancy, and began recommending the drug for this off label purpose. The additional recommendation for Thalidomide unfortunately became a trend worldwide, ultimately leading to devastating birth defects for newborns.
From this point on ward, the FDA began stepping in to the drug manufacturing and regulating process, creating the strict oversight and quality control we see today.
The Dietary Supplement Health & Education (DSHEA) Act of 1994
The Dietary Supplement Health and Education Act of 1994 (DSHEA) is a piece of legislation that regulates the manufacturing of dietary supplements, herbs, and it defines supplements as foods, not drugs.
The reason being for this is to ensure high quality, natural food-supplements, and in addition to side step the drug approval process, which can be very costly. If supplements were categorized as drugs, chances are many of them would fall off the market due to the expense of getting them through new drug approval (Alliance, 2016). The DSHEA only defines permissible labeling claims and places the responsibility on the Food and Drug Administration to show that a product may be inconsumable. It also outlines safety requirements for new dietary ingredients (Alliance, 2016).
The DSHEA describes supplements as “vitamins, minerals, herbs, botanicals, amino acids, substances such as enzymes, organ tissues, glandulars, metabolites, extracts, concentrates, that may be found in forms such as tablets, capsules, soft gels, liquids, or powders.” Herb Labeling requirements include – statement of identity, net quantity of contents, directions for use, other ingredients in descending order of predominance and by common name or proprietary blend (AHG, 2015).
Often times people may relate the word “herb” or “supplement” to “good”, “natural”, and/or “healthy”, but this is not always the case. Herbs are defined as dietary supplements, which enable the manufacturers to produce, sell, and market herbs without first demonstrating safety and efficacy, as is mandatory for pharmaceutical drugs (Bent, 2008).
While the FDA does not provide as strict regulation to the supplement industry as it does the drug industry, it still controls two important aspects of the supplement market. One being good manufacturing practices, and two, product labeling.
There are many herbs that provide us with positive effects but there are others that can be quite harmful to the body if taken in excess, such as ephedra (ephedra may induce hypertension, restlessness, tremors, or tachycardia) as one extreme example.
Ephedra is a derivative of the ma huang herb. In this case, according to Jack Miller, a licensed acupuncturist and President of Pacific College of Oriental Medicine, “If one of the dozens of chemical compounds found in any herb is isolated, concentrated and then used as a drug, there is definitely an increased possibility of toxicity and negative effects. This is compounded when the herb is used for conditions not traditionally indicated” (Miller, 2014).
Due to the contraindications surrounding ephedra and several reports from individuals taking ephedra, in 2004 the Food and Drug Administration (FDA) banned the sale of ephedra dietary supplements because of the adverse reactions people were reporting.
The supplement industry was doing very well by selling the weight loss products containing ephedra and challenged the FDA’s ban. One year after the ban, a federal judge in Utah stated that the FDA had not proven that low doses of ephedra are harmful, and thus “struck down” the FDA’s action (Kilham, 2013). However, the case was taken to the 10th U.S. Circuit Court of Appeals, which reversed the action of the Utah judge and reinstated that ephedra is still illegal in certain quantities.
This ban is still in effect today and carries over into the realm of professional sports. For example, if a professional athlete tests positive for ephedra, this could disqualify them from competing/playing their respective sport professionally (Kilham, 2013). Adverse effects of ephedra are anxiety, irritability, tachycardia and potential nausea to name a few.
Due to the adverse reactions and incidents reported from ephedra usage, some of these including death, the FDA stepped in and issued a ban against ephedra (FDA, 2004). One source reports that the supplement was linked to 155 deaths (MSN, 2004).
Herbal Supplement & Drug Interactions
While certain supplements can enhance and protect components of our health, there are cases where the effects of supplements may be the opposite.
Some herbal supplements can have interactions with prescription drugs, over-the-counter medications, or interfere with cancer interventions such as chemotherapy.
It is important to be aware of the risk factors associated with combining prescription medications with herbal and dietary supplements. Herbal supplements such as echinacea, St. John’s Wort, calcium, ginko biloba, and several others may cause harmful side effects if used in conjunction with certain medications.
A recent study published in the International Journal of Clinical Practice, discovered that herbal and dietary supplements sometimes caused reactions in the body because the supplements may alter the pharmacokinetics of the prescription medications (Ernst, 2012). Pharmacokinetics meaning how the drug is absorbed, it’s distribution, it’s metabolization, and its elimination within the body (Garcia 2012) (Ernst, 2012).
Researchers studied 213 different herbal and botanical supplements, evaluating their interaction with 509 prescription medications. They found nearly 900 adverse reactions resulting from those interactions (Garcia, 2012) (Ernst, 2012).
The study found that herbal supplements like ginkgo and echinacea were more likely to have an adverse interaction with prescription medications than vitamins, amino acids or minerals such as iron or calcium, the study found (Garcia, 2012) (Ernst, 2012).
Many of the complications included heart problems, chest and abdominal pains, and headaches. Patients taking medications for issues involving the cardiovascular system and central nervous system were more likely to experience adverse events (Garcia, 2012) (Ernst, 2012).
In addition, more common side effects presented themselves as gastrointestinal issues from taking prescription drugs and supplements, accounting for 16% of the cases. Neurological complications can also occur, and according to the study accounted for 15% of the cases (Garcia, 2012) (Ernst, 2012).
Prescription drugs to be on the look out for in your patients: aspirin, insulin, warfarin, ticlopidine, and diogoxin (Garcia, 2012). These drugs had the greatest amount of adverse interactions and the herbal supplements flaxseed, echinacea and yohimbe had the greatest amount of side effects (Garcia, 2012).
Scientists say the findings are the “tip of the iceberg,” of much needed research in this area and are also calling for more government control over the use of such herbal and dietary supplements. Researchers also stress the dangers of combining prescription medications with herbal remedies and dietary supplements (Garcia, 2012).
Another source mentions a study from the Journal of Parenteral and Enteral Nutrition, where the researchers found that most herbal supplements exert little to no benefit in the body, with the exception of omega-3s and Vitamin D, which have been proven to be effective (Jackson, 2012).
Vitamin K & Coumadin/Warfarin
Coumadin, the prescription blood thinner (anticoagulant) used to prevent blood clotting, can have a reduced effectiveness from taking Vitamin K. So why and how does Vitamin K reduces the effectiveness of Coumadin?
Well, for starters, vitamin K is used by the body to initiate clotting factors in the blood, to stop the body from loosing too much blood during an injury.
Individuals who have heart disease may use Coumadin to prevent blood from clotting in blood vessels, veins, and arteries, especially if they are already narrowed. As we know, if blood cannot easily pass through these vessels, stroke may occur. Coumadin will help thin the blood, especially in these areas.
Since vitamin K has the opposite effects (initiating coagulation), this could negatively impact the effects of Coumadin has on the patients’ blood.
St. John’s Wort vs. Prescription Birth Control and Anti-depressants.
Today, the herb is touted for its anti-depressant effects. According to a systematic review published in 2005, St. John’s Wort can be helpful in the treatment of mild to moderate depression (Murlow, 2005). For individuals coping with severe depression, two separate studies published in 2001 and 2002 revealed St. John’s Wort to be ineffective.
This herb contains an important compound called hypericin, the primary source of its anti-depressant effects. Additionally, St. John’s Wort contains antiviral compounds and immune-boosting chemicals called flavonoids, making it beneficial against viral, bacterial, and fungal infections (Castleman, 2009).
In regards to treating depression, it appears that St. John’s Wort has some affect on mood by increasing the level of neurotransmitters serotonin, norepinephrine, in addition to levels of dopamine, GABA, and L-glutamate. Compared to other anti-depressants, this herb has a wide spectrum of action. The potent ingredient is the chemical called hypericin, which has a similar mechanism of action to common anti-depressants like Prozac and Zoloft (Schneider, 2006).
St. John’s Wort, a popularly used herb in the treatment of minor depression, can promote the breakdown of prescription birth control and antidepressants, which in turn, reduces their effectiveness. Because herbal supplements are not subject to the same testing or the same post-marketing watch as the FDA approved pharmaceutical drugs are, these interactions are often unknown (ABC, 2011).
St. John’s Wort is an interactive herbal product, and has been shown to interfere with numerous drugs metabolized by the cytochrome P-450 liver enzyme system, including protease inhibitors (commonly used in HIV patients), chemotherapeutic agents, and oral contraceptives (Basch, 2003).
The active compound, hypericin, found within St John’s Wort, is highly active in a broad range of viral infections, including influenza, herpes, polio, hepatitis C, and HIV. It can additionally combat several types of bacteria. In 1988, research at the Weizmann Institute in Israel and New York University discovered that hypericin has dramatic activity against HIV.
This in turn sent many people to stores to purchase St. John’s wort, and some have reported beneficial effects from taking the herb, one of them being improved immune function.
In the late 1990s, protease inhibitors entered the medical scene as powerful AIDS drugs. The hype around St. John’s wort slowly started to wear down. Interestingly enough, individuals who take protease inhibitors should not use St. John’s Wort because the herb interferes with the actions of these drugs (Castleman, 2009).
Consumption of St. John’s Wort has caused AIDS patients to lose control of their HIV because the herb caused an interaction, which eliminated their anti-viral drugs within the body too quickly, states Dr. Raymond Woosley, MD, and PhD. Dr. Woosley also mentions that 40% of patients do not tell their physicians that they are taking herbals, even when asked, and most patients are not asked this important question.
Additionally, St John’s wort has caused individuals to reject transplanted organs because it interferes with cyclosporins, drugs used to control organ transplant rejection.
Some side effects of St. John’s wort can include GI upset, dry mouth, constipation, dizziness, and restlessness. Individuals with bipolar disorder should not consume St. John’s Wort because it may induce mania (Schneider, 2006). If the individual is already on anti-depressant drugs such as SSRI’s, this herb should not be taken in conjunction.
Please be advised that interactions with St. John’s wort and HIV drugs, oral contraceptives, cyclosporine (to control organ transplant rejection) digoxin, theophylline, anticonvulsants, and triptans (drugs to treat migraine symptoms) may occur (Schneider, 2006).
For some individuals, glucosamine oral supplements or injections may be a great choice to help increase joint strength and reduce joint related pain. However for some individuals it may not be the most appropriate choice.
Glucosamine supplementation is typically contraindicated if the individual has shellfish allergies, diabetes, bleeding disorders, or is pregnant or planning to become pregnant, to name a few.
The reason why it is recommended that individuals with shellfish allergies not take glucosamine is because this product comes from shellfish such as shrimp and crab. Shellfish contain glucosamine sulfate, which typically causes the allergic reaction such as throat swelling, diarrhea, contact uticaria, and others.
It is worth mentioning however, that there are conflicting sources in regards to what component of shellfish contain the allergy inducing protein. One source states that glucosamine is produced from the shells of shrimp, lobster and crab, while it is actually the meat of the shellfish that causes the allergic reaction. In contrast, a research article published in 1984 states that it is the shell that causes the swelling and redness (Nagano, 1984).
However there are some manufacturers of glucosamine supplements on the market that offer a product with reduce levels of the shellfish allergen that may cause the allergic reaction. When suggesting dietary supplements to patients, such as glucosamine, it is highly recommended to ask if they have any allergies prior to taking this supplement.
Additionally, those with iodine allergies should avoid glucosamine.
For individuals who have diabetes, supplementing with glucosamine for joint pain may not be the best idea.
Glucosamine is a sugar that utilizes a few glucose processing pathways. The pathway it is processed through is called the “Hexosamine Biosynthetic Pathway”, which takes part in glucose control AND the development of insulin resistance – the hallmark cause of type 2 diabetes (Love, 2005). Additionally, glucosamine is used in laboratory settings to induce insulin resistance to help study the condition of diabetes, and how to treat it with drugs.
Animal studies have also concluded that glucosamine interferes with the liver’s ability to regulate glucose production, the intake of the glucose from surrounding tissue, and the production of insulin in pancreatic beta cells.
In a person with diabetes, the amount of insulin needed to regulate blood sugar levels in the body is insufficient. With this lack of needed insulin, glucose is not absorbed the right way, and we see too high or too low levels of sugar circulating in the blood.
In conclusion, a research study published in 2007 by the American Journal of the Medical Sciences found that individuals taking 1500mg of glucosamine per day for 6 weeks, who already have poor insulin sensitivity, will increase their risk for diabetes if they supplement with glucosamine (Pham, 2007).
Therefore, glucosamine supplementation is not the best option for individuals overweight or at risk for diabetes.
The Benefits of Certain Dietary & Herbal Supplements
Omega-3s & Healthy Joints
While Omega-3 fatty acids or EPA/DHAs are excellent for a wide variety of health components, we will highlight to areas where omega-3 supplementation, or simply consuming it regularly within the diet, can be particularly beneficial.
First are omega-3 EPA/DHA’s uses for joint lubrication and bodily function. Secondly are its applications in improving and stabilizing mood. As we will find out, omega-3 EPA/DHA can be very helpful for individuals coping with depression or mood disorders, and the research says so.
For joints and other inflamed tissues, omega-3s have the ability to reduce wear and tear in these specific areas, and all other areas of the body. Joints, as we know, need lubrication to move and function effectively, and omega-3s are excellent in treating sore joints because they help keep protect the area and keep it smooth for motion.
Inflammation can be a common cause of joint and arthritic pain. Luckily, omega-3s exert their influence directly in the cell membrane. Inside the cell membrane are enzymes called COX.
This next step is important: In an effort to protect the membrane and vital nutrients inside each cell, the Cox enzymes inside the membrane biochemically convert the omega-3 EPA/DHA into potent anti-inflammatories to protect the cell from excess inflammatory chemicals. These chemicals are called cytokines, which bring on the inflammation that lead to wear and tear in the body.
In these cell membranes, we also find omega-6 fatty acids, or arachidonic acid. Omega-6 fatty acids in excessive amounts within the body can be pro-inflammatory.
However as long as omega-3 and omega-6 fatty acids are in balanced amounts, the cell can protect itself with inflammation that actually helps the body, such as fighting off foreign germs that get you sick, but leaving the healthy cells alone.
Now, when we consume a high fat, high sugar, high carbohydrate meal with few omega-3s and ample amounts of omega-6s, the blood and cell membranes are swarmed with omega-6 fatty acids; not a good thing.
Remember those important COX enzymes that are used inside the cell membrane to convert the good omega-3 EPA/DHA into anti-inflammatories? Well now, those COX enzymes are stolen by the harmful omega-6 fatty acids for their own use, converted into PRO-inflammatories, and not enough are left for use by the omega-3s.
Hence, the result you get is an imbalance of the fatty acids, with a surplus of the pro-inflammatory omega-6s; painful or achy joints included.
In 2012, a systematic review was conducted exploring the effects of marine n-3 polyunsaturated fatty acids (or in other words, omega-3s), on immune functions for their effects and clinical outcomes on rheumatoid arthritis.
In conclusion, the study indicated that the types of omega-3s found in seafood and fish oil may be modestly helpful in alleviating some of the symptoms of rheumatoid arthritis (Miles, 2012).
After reviewing results of the study, researchers also noted that many of the participants explained that when taking the fish oil, their morning stiffness was brief, and less joint swelling in pain, which in turn lowered their need for anti-inflammatory drugs to control their symptoms (Miles, 2012).
Omega-3s & Depression
In one recent study, brain researchers found that omega-3 EPA/DHA helps to improve the effectiveness of anti-depressant drugs by helping the serotonin molecules fit better into the receptor sites on brain cell membranes.
In one study, 60 patients with a diagnosed major depressive disorder were dividied into three groups. Group 1 received 1000mg of EPA fish oil daily, group 2 received, 20 mg of Prozac daily, and the 3rd group received a combination of the two (1000mg of EPA fish oil and the Prozac).
The results presented that the combination of Prozac plus EPA was more effective than either of them alone. The results of those who received EPA alone compared with the group who received Prozac alone showed that both are equally effective, but the fish oil takers suffered no side effects.
Other studies show clear benefits of omega-3 fish oil for depression and bipolar disorder were impeccably convincing that the American Psychiatric Association now recommends a dosage greater than 1000mg per day of EPA/DHA fish oil in addition to appropriate psychotropic drugs to treat certain mood disorders.
Another research study conducted on seventy six young adults and adolescents ages 13-25 years old, with early mood disorders, were given doses of 700 mg of EPA and 480 mg of DHA. This group was compared with a placebo group, and the conclusion of the study was that the group given the EPA and DHA supplement showed fewer depressive symptoms and a slower progression of psychoses.
In conclusion research studies have shown that the dosage for beneficial results for mood disorders is 1000-6000 mg (1-6 grams) of EPA per day, with most studies finding positive results at 2000 mg (2 grams) of EPA per day.
Therefore we can conclude that while omega-3s can be great for improving joint swelling and pain, and they are also excellent for stabilizing mood.
Comfrey is a herb that has popular uses as a topical application for easing joint & back pain and also has uses in promoting wound healing. Interestingly enough, this herb has roots in uses dating back to the 1st century A.D., where the Greek physician Dioscorides began prescribing comfrey tea internally for respiratory and gastrointestinal problems. Additional uses for comfrey around this era and after it included fever, gout, hemorrhoids, gangrene, diarrhea, dysentery, and menstrual problems, to name a few.
By the mid 1990s herbalists ceased to recommend comfrey for internal uses because of its potential to cause liver damage. Pyrrolizidine alkaloids, or PAs, are a chemical within the comfrey herb that, in high concentrations, can cause serious liver damage. There have been several human cases of poisoning that were reported after long-term usage of comfrey (Castleman, 2009).
One of comfreys popular uses is topically for the treatment of arthritis or joint & back pain. While comfrey does contain a toxic chemical, only small amounts of this herb used topically can be absorbed through the skin. Transdermal comfrey is not digested, and therefore poses no hazard to the liver.
It is important to note that tests by the FDA researchers have proven that PA content of comfrey varies greatly, and the root of the herb, most often used by those in herbal medicine, contains the highest concentrations. While there has been some claims that PA chemicals are not water soluble, and therefor consumption of comfrey tea is safe and free of PAs, has not been similar to the FDAs research (Castleman, 2009). FDA scientists have identified PAs in comfrey tea as well, indicating comfrey tea unsafe for ingestion due to the potential harmful effects it can have on the liver.
According to one study conducted by German researchers, 220 individuals with painful arthritis of the knee were given either a placebo ointment or a comfrey cream (2 grams, three times per day). After 3 weeks, the comfrey cream provided significantly greater pain relief. At the end of the trial, a reduction of pain by 58.0% was recorded for the comfrey group versus 14.1% for the placebo group.
The results of this study ultimately conclude that Kytta-Salbe comfrey root ointment can be effective for the treatment of osteoarthritis of the knee. The researchers identified that pain was reduced, mobility of the knee was improved, and quality of life was increased (Grube, 2007).
The authors of the study mention that because the comfrey root ointment was significantly superior to the placebo medication with regard to all the parameters, the study identifies the therapeutic efficacy of the comfrey root ointment in the treatment of painful osteoarthritis of the knee (Minigh, 2017).
A separate group of German scientists gave a placebo or comfrey ointment to 142 men with sprained ankles. Yet again, scientists discovered significantly greater pain relief in the group given the comfrey ointment (Castleman, 2009).
Additional therapeutic uses for comfrey lie in it’s ability to help protect skin and promote the growth of new skin cells. The chemical comfrey contains that allows this herb to have such positive wound healing effects is called allantoin. Some studies show that the herb also helps reduce inflammation in compliments to it’s wound healing abilities.
According to the FDA, allantoin is safe in concentrations up to 2%, and is regulated by the FDA when used in skin preparations (CFR, 2016). Allantoin can be found in several over the counter products for dry skin, diaper rash or radiation therapy.
Arnica is another popular herbal supplement that finds its uses in injuries, muscle soreness, and pain, and is typically prescribed by homeopaths. Developed by Germany physician Samuel Hahnemann in the 1830s, homeopathy was very controversial because it used micro-doses of medicines to treat certain ailments. Under the scrutiny of modern pharmacology, they insist that these treatments are so dilute they could not possibly exert any effect.
However, the majority of studies show benefit for this herb, and in homeopathic doses, it can be safe and inexpensive (Castleman, 2009).
For muscle soreness, Norwegian researchers evaluated the effects of runners in Oslo marathons in 1990 and 1995. There was a total of 82 runners in the trial, and half were either given arnica or a placebo. Five pill starting the evening prior to the races and then morning and evening of the race day, including 3 days after. In conclusion, the arnica group reported less muscle soreness than the placebo group (Bruset, 2003).
Furthermore, muscle soreness immediately after the marathon run was lower in the Arnica group than in the placebo group (P = 0.04). Cell damage measured by enzymes was similar in the Arnica and the placebo group (Bruset, 2003).
According to a study published in 2007 by Swedish researchers, topical arnica gel was found to be equally as effective as NSAIDS in reducing osteoarthritic pain of the hand.
In the study, researchers looked at 204 participants from 20 Swiss clinics who had osteoarthritis of the fingers and hands. Half of the participants were given topical arnica gel, the other half was given topical ibuprofen (5%). This was given 3 times per day for three weeks, and study participants left a 4 centimeter gel strip on the arthritic joint for an hour before washing hands.
Upon conclusion of the study, those who used the arnica jell reported 26.6% less pain compared to the 23.9% of the NSAID group. Topical gels, such as an arnica ointment, may be a preferred alternative to individuals wanting to avoid the internal side effects of taking NSAIDs (Castleman, 2009).
Please be advised that it is unsafe to ingest arnica plant material because it is poisonous. High doses of the plant may cause vomiting, nausea, gastrointestinal upset, or potential coma, cardiac arrest, or death. Pregnant or nursing women should also be advised to not consume arnica. Additionally, depending on the individual, arnica may cause allergic reactions or side effects. In the case of homeopathic dosages, where consumption of arnica is too minimal to cause issues, any current medications the patient is on should be evaluated as problematic herb-drug interactions may occur (Castleman, 2009).
Evaluate Patient History & Current Medications
Prior to recommending a herb or supplement to a patient, obtain a list of medications they are currently taking and evaluate if it would still be beneficial for the patient to supplement with the herb or dietary supplement in question.
Does the patient have diabetes? Are they pregnant or planning on becoming pregnant? Is the patient on any blood thinning medications? Do they have severe allergies? If yes, what are they? And so-on and so forth.
If the patient wants to do further research on the herbal supplement that is recommended, provide them with reliable sources to do so.
Stop Herbal Supplements Prior to Surgery
If you aware your patient is taking herbal or dietary supplements and they have an up-coming surgery, it would be best to recommend them to stop taking the herb or supplement at least 2 weeks prior to the surgery date, OR to at the very least, encourage your patient to inform their physician of any herbal or supplemental products they are currently on, prior to surgery.
For safety precautions, the operating physician may recommend that the patient discontinue the herbal/supplemental product further in advance.
While it is important to be aware if the patient is taking herbal/dietary supplements, this should also be communicated transparently to the doctor. This is important and especially pertinent if the patient is taking anticoagulant herbal products. Some anticoagulant herbal products include evening primrose oil, garlic, ginger, turmeric, and white willow (Castleman, 2009).
According to a research study conducted in 2008 by the Journal of General Internal Medicine, lead by Stephen Bent, the results showed that there is limited scientific evidence to establish safety and efficacy of most herbal products. More funding for research, changes in herbal regulation, and increased scientific evidence are needed to prove these products as an efficient alternative to standard medical therapies (Bent, 2008).
It is therefore the duty of providers to be aware of the research in regards to herbal & dietary supplements, to also be aware of the patients’ medical history and background when recommending health supplements.
It is recommended to take into account the following before assigning any patient on a herbal supplement regime: list of current medications, previous reactions to herbs taken, history of depression/anxiety, any heart conditions, and any other medical conditions.
Case Study – Mislabeled Herb Causes Renal Failure
In one case study published in the Journal of Alternative and Complementary Medicine in 1998, a herb called Aristolochia fangchi was mislabeled as Stephania tetrandra.
The mislabeled Stephania tetranda was used in a weight loss program for 100 patients, and the misnamed herb ultimately caused the development of renal disease in these patients. The journal article titled “Misuse of herbal remedies: the case of an outbreak of terminal renal failure in Belgium (Chinese herbs nephropathy”, ultimately expresses the need for tighter control on Chinese herbs (Vanherweghem, 1998).
In 2009, a woman from Missouri filed a cause of malpractice against a medical doctor and Traditional Chinese Medicine (TCM) provider for prescribing herbs that caused her to suffer kidney failure. The herbs contained aristolochic acid, a naturally occurring toxin, and when consumed can cause permanent kidney failure or cancer of the urinary tract. The FDA issues a strong warning for consumers to avoid this herb (medicinenet.com). Since the provider failed to warn her of the herbs alleged side effects, she argued that this fell below the standard of care.
Several incidents of aristolochic acid-related nephropathy have been reported elsewhere in recent years. “Since using a complementary and alternative therapy invariably deviates from the standard of care, physicians cannot undertake a responsible, measured integration of such therapies in clinical practice without risking malpractice exposure,” states Michael H. Cohen, a Newport Beach, California, attorney who specializes in alternative medicine law (Heller, 2009).
Several articles from previous years have also expressed concern in mercury, arsenic, lead and other highly toxic compounds in Chinese herbal formulas. But if inspected, the vast majority of Chinese herbal formulas are safe, effective and free of contaminants. An analysis of the California FDB (Food and Drug Branch) report shows that the problem of contamination in Chinese patent formulas is far less widespread than portrayed in previous reports.
The mission of the California FDB is to “improve the health of all California residents by assuring that foods, drugs, medical devices and certain other consumer products are safe and are not adulterated, misbranded nor falsely advertised; and that drugs and medical devices are effective” (California Department of Public Health).
It is still advised to get all herbal supplements from a reputable source that has standards in checking the formulas for naturally occurring contaminants and potentially deliberates adulteration of herbal formula (Puertas, 2015).
Unfortunately, the true frequency of side effects for most herbs is not known because most have not been tested in large clinical trials and because surveillance systems are much less extensive than those in place for pharmaceutical products. A 2001 review conducted by the Office of the Inspector General concluded that surveillance systems designed to detect adverse reactions to herbs are inadequate and probably detect less than 1% of all events (HHS, 2001).
Expert commentary in published articles from 2002 proposed a variety of helpful and worth while suggestions to change the regulation of herbs that could improve the safety and appropriate uses of these products (Lewis, 2002) (Marcus, 2002).
The expert suggestions include:
(1) Requiring manufacturers to register with the FDA
(2) Mandating safety tests similar to those required for over-the-counter drugs
(3) Requiring all health claims to be supported by data approved by the FDA
(4) Ensuring that product labels provide an accurate list of all ingredients (Bent, 2008).
There is limited rigorous scientific evidence and research studies conducted on the topic to establish the safety and effectiveness of most herbal products (Bent, 2008). According to the article, of the top 10 herbs, only five of them (ginkgo, garlic, St. John’s wort, soy, and kava) have scientific evidence suggesting efficacy (Bent, 2008).
However if the individual investigating consuming the herb has concerns over safety regarding herb-drug interactions, they may elect against it. Additionally the decision to take a herb may hinge on the recommendation of the patients primary care doctor. Weighing in the consideration of other medical therapies that the doctor presents as more effective than herbs, (due to lack of research indicating efficacy) may hinder the decision to use herbal products.
(2015). Legal and Regulatory FAQs. American Herbalists Guild (AHG): An Association of Herbal Practitioners.
Bent, S. (June 2008). Herbal Medicine in the United States
Review of Efficacy, Safety, and Regulation. Journal of General Internal Medicine. Doi: 10.1007/s11606-008-0632-y
Vanherweghem, LJ. (1998). Misuse of herbal remedies: the case of an outbreak of terminal renal failure in Belgium (Chinese herbs nephropathy). Journal of Alternative and Complimentary Medicine. 4(1):9-13.
Puertas, L. (2015). The Truth about Contamination in Chinese Patent Medicines. Acupuncture.com: Gateway to the Chinese Medcine, Health and Wellness.
Miller, J. (2014). Ma Huang Herb Misused and Abused. Pacific College of Oriental Medicine.
Heller, M. (2009). Chinese Medicine Doctor Sued over ‘Dangerous’ Herbs. On Point News.
Alliance for Natural Health USA. (2016). Dietary Supplement Health and Education Act (DSHEA).
Jackson, I. (2012). Dietary Supplements carry Potential Risks and Provide Little Benefit: Report.
Ernst, E. (2012), Interactions between drugs and supplements: the tip of an iceberg?. International Journal of Clinical Practice, 66: 1019–1020. doi: 10.1111/ijcp.12007
Dietary Supplements with Prescription Drugs May Cause Complications. (October 31, 2012). M. Garcia.
Dietary Supplements Carry potential risks and provide little benefit: Report. (October 18, 2012). I. Jackson.
Flemmer, M., Marik, P.E., Do dietary supplements have beneficial health effects in industrialized nations. What is the evidence? Journal of Parenteral and Enteral Nutrition JPEN. March 2012 36 no. 2 159-168. Published online before print January 24, 2012, doi:10.1177/0148607111416485
Alere Staff. (2016). Spinach, Vitamin K and Warfarin. PTINR.com
NIH. (2011). Dietary Supplements: What you need to know.
Woo, C. K., & Bahna, S. L. (2011). Not all shellfish “allergy” is allergy! Clinical and Translational Allergy, 1, 3. http://doi.org/10.1186/2045-7022-1-3
Allergic contact urticaria caused by raw prawns and shrimps: three cases. Nagano T, Kanao K, Sugai T. J Allergy Clin Immunol. 1984 Oct; 74(4 Pt 1):489-93.
Glucosamine Sulfate Safety and Side Effects. (2017). RX List.com.
What is Coumadin? – Important information. (2017). Drugs.
St John’s wort: a systematic review of adverse effects and drug interactions for the consultation psychiatrist. Hammerness P, Basch E, Ulbricht C, Barrette EP, Foppa I, Basch S, Bent S, Boon H, Ernst E, Natural Standard Research Collaboration.
Psychosomatics. 2003 Jul-Aug; 44(4):271-82.
St John’s wort for depression–an overview and meta-analysis of randomised clinical trials.
Linde K, Ramirez G, Mulrow CD, Pauls A, Weidenhammer W, Melchart D
BMJ. 1996 Aug 3; 313(7052):253-8.
Schneider, E.L., Hirschman, L.A. (2006). What your doctor hasn’t told you and the health store clerk doesn’t know – The truth about alternative treatments and what works.
Pham T, Cornea A, Blick KE, Jenkins A and Scofield HR. Oral glucosamine in doses used to treat osteoarthritis worsens insulin resistance. The American Journal of the Medical Sciences 2007; 333(6):333-339.
St. John’s Wort may block the effects of the pill. ABC News.
Castleman, M. (2009). The new healing herbs. The essential guide to more than 125 of natures most potent herbal remedies.
Love DC, Hanover JA. The Hexosamine Signaling Pathway: Deciphering the “O-GlcNAc Code”. Science Strike 2005; 312: 13
France de Bravo, B., Weerasingh G.R. (2015). Glucosamine supplements: Good for joints but possibly risky for diabetes.
Sears, J., Sears, W. (2012). The Omega-3 Effect.
Miles EA, Calder, PC. (2012). Influence of marine n-3 polyunsaturated fatty acids on immune function and a systematic review of their effects on clinical outcomes in rheumatoid arthritis.
NIH. (2015). 7 Things To Know About Omega-3 Fatty Acids.
Castleman, M. (2009). The new healing herbs.
Kilham, C. (2013). Ephedra: A Beneficial and controversial herb.
Botwin Raphael, M., Cronin, E. (2014). Born without arms or legs: The secret legacy of thalidomide.
Carias, E., Samaras, A.T., Fintel, B. (2009). The thalidomide tragedy: lessons for drug safety and regulation.
All the Americans will pull together… The Federal Government’s Evolving Role in Dealing with Disaster: Thalidomide Drug Crisis 1960s. Emory Libraries & Information Technology.
Dietary Supplements with Prescription Drugs May Cause Complications. (October 31, 2012). M. Garcia.
Dietary Supplements Carry potential risks and provide little benefit: Report. (October 18, 2012). I. Jackson.
Ernst, E. (2012), Interactions between drugs and supplements: the tip of an iceberg?. International Journal of Clinical Practice, 66: 1019–1020. doi: 10.1111/ijcp.12007
Minigh, J. (2017). Comfrey Root Ointment Reduces Pain in Patients with Knee Osteoarthritis.
Grube B, Grunwald J, Krug L, Staiger C. Efficacy of a comfrey root (Symphyti offic, radix) extract ointment in the treatment of patients with painful osteoarthritis of the knee: results of a double-blind, randomised, bicenter, place-bocontrolled trial. Phytomed. 2007;14( 1):2-10.
CFR. (2016). Code of Federal Regulations Title 21. Title 21 – Food & Drugs, Chapter I – Food and Drug Administration.
Bruset, S. Tveiten D. (2003). Effect of Arnica D30 in marathon runners. Pooled results from two double-blind placebo controlled studies.
Arnica soothes osteoarthritis pain in hands. Rheumatology International: 2007; Vol. 27, No. 6, 585-91.
FDA. (2004). FDA Issues Regulation Prohibiting Sale of Dietary Supplements Containing Ephedrine Alkaloids and Reiterates Its Advice That Consumers Stop Using These Products.
NBC. (2004). Nationwide ban on ephedra goes into effect.