Are Dietary Supplements Safe?

Supplement Safety

How much do you know about supplement safety?  If you don’t know a lot, you are not alone.  A 2002 study of primary care physicians found that 42% were not aware of any drug-herb interactions that had appeared in the medical literature, nor had they treated a patient that had one.  A more recent study (2007) of internal medicine residents revealed that one-third did not know that supplements do not need to be approved by the FDA, or that safety and efficacy data are not required before supplements are put on the market.

This ignorance is not limited to physicians in training.  A survey of consumers has shown that 68% of consumers believed that supplements were regulated by the government, 59% believed dietary supplements were FDA-approved like medications, and 55% believed that manufacturers could not make claims of product efficacy without scientific evidence.

Regulation of Supplements

Here are the facts:  dietary supplements are currently regulated according to the Dietary Supplement Health and Education Act of 1994.  This permits the initial marketing of an herbal or other dietary supplement product without proof of safety, efficacy, bioavailability, or standardization.  The manufacturer is held responsible for ensuring a product’s safety.  The FDA is responsible for taking action against any product that is found to be unsafe after it is on the market, and for monitoring information on labeling and package inserts.  The Federal Trade Commission is responsible for any false advertising claims.  You can find more detailed information about supplements and how they are regulated from the government.

Use of Herbal Supplements is Common

Studies of surgical patients have shown that nearly one third take at least one herbal product on a regular basis.  The problem is that many patients don’t discuss this to the surgeon or to the anesthesiologist prior to surgery.  Without the bottle in hand, one in five patients were unable to identify what they were taking when asked.  A study of pregnant women in Australia revealed that 36% took an herbal product while pregnant.  A 2007 survey showed that 38% of American adults and 12% of children used dietary supplements.

What is the Best Way to Be Safe with Dietary Supplements?

You can be a responsible consumer of dietary and herbal supplements by reading labels carefully.

Look for certifications such as “USP Dietary Supplement Verified”, or certification by ConsumerLab, NSF International, or Good Housekeeping.  The certifications vary, but it’s a start, and they at least indicate evidence of laboratory testing.  USP stands for U.S. Pharmacopeia, and the standard include testing for uniformity, cleanliness, and freedom from environmental contaminants such as lead, mercury, or drugs.  It is safer to buy single-herb products that clearly show how much of the herb each dose contains than to buy a mixture of several herbals with unknown amounts of each herb.  And be very wary of buying any herbs that have not been manufactured in the U.S., EU, or Canada, as supplements from other countries have been found to contain contaminants.

Resource for learning more:

http://www.nlm.nih.gov/medlineplus/druginformation.html

http://www.naturalstandard.com/

References:

1. Ashar BH, Rice TN, Sisson SD. Physicians’ understanding of the regulation of dietary supplements. Arch. Intern. Med. 2007;167(9):966-969.
2. Ashar BH, Rice TN, Sisson SD. Medical residents’ knowledge of dietary supplements. South. Med. J. 2008;101(10):996-1000.
3. Kennedy J. Herb and supplement use in the US adult population. Clin Ther. 2005;27(11):1847-1858.
4. Timbo B, Ross M, Mccarthy P, Lin C. Dietary Supplements in a National Survey: Prevalence of Use and Reports of Adverse Events. Journal of the American Dietetic Association. 2006;106(12):1966-1974.
5. Barnes PM, Bloom B, Nahin R. CDC National Health Statistics Report #12. Complementary and Alternative Medicine Use Among Adults and Children: United States, 2007. December 10, 2008.

by Christina Peterson, M.D.

updated July 10 , 2021

Herbal Supplements and Medications: an Overview of Herb-herb and Drug-herb interactions

The Risk for Drug-Herb Interactions is Not Trivial

Herbal supplements, vitamins, and dietary supplements are widely used.  Depending on the study you look at, 25-85% of people who see doctors at a given time are using herbal supplements.  About 15 million adult Americans are at risk for possible adverse interactions between prescription drugs and herbs or high dose vitamins, according to the Journal of the American Medical Association.  A British study (2003) found that of the 62% who took herbal preparations.  1 in 20 were taking a potentially dangerous combination.  How can you make sure you’re not at risk?

The 20,000 or so herbal supplements that are on the market in the US alone only come under the direct scrutiny of the FDA if there is a problem, or when a product is selected for spot-checking.  While information about interactions is increasing rapidly, it is still quite limited.  The best sources of information are your pharmacist or your physician, although be aware that for many of these products, the information is simply not yet known.

Twenty Herbs and Five Classes of Medications that can Interact

This is not an exhaustive analysis of herbal supplements, but an overview of some of the more common herb and drug combinations that can affect the headache sufferer.

Barbiturates

“Well, I don’t take barbiturates!” you might to yourself indignantly.  Except that you do if you take Fioricet* or anything else with butalbital in it.  Combining this with kava kava can cause undue sedation.  It should also be noted that there have been reports of liver failure from kava kava alone, and taking it in conjunction with acetaminophen (or paracetamol) is not wise, as this enhances risk to the liver.

Calcium channel blockers

Calcium channel blockers taken in combination with dong quai can drop blood pressure significantly.  So can taking hawthorn leaf.  The combination of verpamail and guarana can cause hyperstimulation of the nervous system.  Gingko can inhibit the metabolism of diltiazem.

SSRI anti-depressants

SSRI antidepressants such as Prozac, Paxil, and Lexapro should not be taken in conjunction with St. John’s wort as this can result in serious side effects.  St. John’s wort acts on the same brain receptors as these medications.

Tricyclic antidepressants

St, John’s wort should also not be taken with tricyclic antidepressants (amitriptyline, doxepin, imipramine, desipramine, protriptyline) as it can reduce the effective level of drug in your system.  With high enough doses, serious side effects can occur.

ACE-Inhibitors

Lisinopril, enalapril, ramipril, and other ACE-inhibitors are sometimes used off-label as migraine preventive medications.  Combining them with cayenne, used internally, can increase the risk of cough sometimes seen as an adverse effect of the ACE-inhibitors.

Aspirin and anti-inflammatories

There is a wide range of herbs that interact with the coagulation process.  Most of these cause bleeding by interfering with the platelets (clotting cells).  In small doses, this effect can be desirable.  It’s why a baby aspirin is recommended in older individuals for cardiovascular protection.  However, if you use these herbals in combination with one another or with pharmaceuticals that have a similar effect, you may discoverthe hard waythat you have gone far beyond any desirable goal.

The four most commonly used herbs that interact with blood clotting are known as the four G’s:  Ginger (also called sheng jiang, shen jing, shokyo, or shoga), Garlic, Gingko biloba (also called maidenhair or kew tree), and Ginseng (sometimes called Panax; Siberian ginseng is also known as Eleutherococcus).  Many headache sufferers take aspirin-containing analgesics or other nonsteroidal anti-inflammatory medications (especially indomethacin) and should know of the potential for interactions that can result in bleeding.  In the case of migraine, it should be the Four G’s and an F, because feverfew falls into this category as well.

Other herbs with anti-coagulant properties are chamomile, dong quai (or tang kuei), and horse chestnut.  Other anti-platelet herbs are:  bilberry, bromelain, cayenne, flaxseed oil, green tea, meadowsweet, motherwort, turmeric, and willow.

Make Sure You are not at Risk for Interactions

Be safe, not sorry.  If you are taking more than one medication, the possibility for interactions increases greatly.  Drug-drug interactions are already an issue for many people, especially for those who have more than one prescribing provider.  If you are also taking herbal supplements, it increases the potential for further drug-herb interactions.  Talk to your pharmacist if you have any concerns about this; they are far more qualified to answer your questions than the clerk at the health food store.

What Should I Do If I’m Worried About Drug-Herb Interactions?

If you are concerned that you might be experiencing an adverse reaction to a vitamin, mineral, or herbal supplement, talk to your health care provider.  Some of these reactions are predictable symptoms related to taking too much.  Others may be due to contaminants in a product, or due to a drug-herb interaction.  If your doctor or health care provider is not certain, a call to your pharmacist may be helpful.  Databases listing this information are being updated frequently.  It’s important to let someone know if you think your are having a reaction.  Adverse reactions to supplements are supposed to be reported to MedWatch which is a reporting program of the FDA.  That way, accurate information can be collected.  This can be helpful to someone else in the future.

by Christina Peterson, M.D.

Should you be taking magnesium?

What is the Role of Magnesium in Migraine?

Two double-blind studies have shown that magnesium supplementation may reduce the frequency of migraine.1,2  Research studies reveal that magnesium levels affect serotonin receptors, and also have an effect on nitric oxide synthesis and release, as well as on NMDA receptors—all brain structures and chemicals suspected to be important in migraine. In small studies, both migraine and cluster headache patients have responded during headache attacks to intravenous magnesium. In a larger double-blind controlled study looking at prevention, the treatment group receiving 600 mg of magnesium for a 12 week period experienced a 41.6% reduction in headaches as compared to only 15.8% reduction in migraine headaches in the placebo group.2  Another controlled trial at a dose of 485 mg did not show benefit.3

What magnesium does in your body

It is responsible for over 300 essential metabolic reactions in the body. It is required for synthesizing proteins in the mitochondria, the metabolic powerhouses of your cells, and for generating energy in most of the body’s basic cellular reactions. It is necessary for several steps in the synthesis of DNA and RNA. Magnesium is also present in a number of other important enzymes. As important as it is intracellularly, 60% of the body’s magnesium is present in bone, and 27% in muscle.

Magnesium supplements

If you decide to take supplemental magnesium, the recommended starting dose is 400-500 mg/day in divided doses. The limiting factor for most people is diarrhea. If you are on a migraine preventative medication that is constipating, like amitriptyline or verapamil, this might be a plus.  It’s always wise to check with your doctor before starting on magnesium, especially if you are on medication. Warning:  If you have heart disease or kidney disease, or are prone to kidney stones, be sure to talk to your doctor before starting on magnesium or a calcium magnesium supplement.

To be metabolized effectively, magnesium must be taken with calcium, or with adequate calcium in the diet. The amount of calcium should be no more than double the amount of magnesium— this is the ratio commonly recommended for women. Men may require less calcium, and sometimes take a ratio of calcium/magnesium that is equivalent mg/mg. Many people take in only 60-70% of the recommended daily allowance in the first place, and then things like stress and caffeine can deplete that further throughout the day. There is emerging evidence to suggest that dietary intake of calcium may be preferable to calcium supplements in women and men who are middle-aged or elderly.

Migraine sufferers have been found to have a relative magnesium deficiency in their bloodstream between migraine attacks, and intracellular magnesium levels drop even further during a migraine attack. Magnesium oxide, magnesium citrate,  and magnesium sulfate, are bioavailable—look for mixed salts of these forms, or magnesium gluconate or magnesium glycinate, which are ionized, and  biologically active; if you develop diarrhea from those forms of magnesium, look for chelated magnesium. Magnesium carbonate dissolved in CO2- rich water is 30% more bioavailable than magnesium found in foods or in pill-format.

Magnesium–drug interactions

Some medications may not be completely absorbed if taken at the same time as magnesium.  Digoxin absorption, for example, may be decreased due to magnesium.  Nitrofurantoin and anti-malarials may also be decreased in absorption due to magnesium.  Magnesium may interfere with quinolone or tetracycline antibiotics, and can interfere with anticoagulants. Diuretics such as furosemide (Lasix®) or hydrochlorothiazide can result in magnesium depletion.  Iron supplements may interfere with magnesium supplement absorption. It is best not to take magnesium at the same time as medications.  If you have concerns about whether or not you should be taking magnesium, or about the timing of magnesium and your medications, your pharmacist may be of help in advising you.

Foods rich in magnesium:

  Potential headache triggers:            Not usually headache triggers:

peanuts brown rice
almonds blackstrap molasses
hazel nuts kiwi fruit
bananas broccoli
tofu spinach
soy beans swiss chard
avocado tomato paste
peanut butter sweet potato
chocolate pumpkin seeds
cocoa powder succotash
black-eyed peas cooked artichoke
whole grain cereals cooked okra
chick peas beet greens
split peas acorn squash
lentils baked potato
beans fresh apricots
dried apricots raisins
yogurt milk

Note:  not all suspect trigger foods are triggers in all headache sufferers.

References:

1. Mauskop A, Altura BM. Role of magnesium in the pathogenesis and treatment of migraines. Clin Neurosci. 1998;5(1):24-27

2. Peikert A, Wilimzig C, Kohne-Volland R. Prophylaxis of migraine with oral magnesium: results from a prospective, multi-center, placebo-controlled and double-blind randomized study. Cephalalgia. 1996;16(4):257-263

3. Pfaffenrath V, Wessely P, Meyer C, et al. Magnesium in the prophylaxis of migraine–a double-blind placebo-controlled study. Cephalalgia. 1996;16(6):436-440

by Christina Peterson, M.D.

Complementary And Alternative Medicine

What is the definition of alternative medicine?

What is complementary and alternative medicine (CAM), and how does it differ from “conventional” medicine? At the present time, conventional medicine is considered to be that delivered by MDs, DOs, and the allied health professionals they have customarily worked with in the past, such as psychologists, RNs, MSWs, registered dietitians, and physical and occupational therapists. CAM practitioners, however, work with conventional medical practitioners on an increasingly common basis. Therefore, the term “integrative medicine” is becoming favored over the term “complementary and alternative” medicine.

Complementary medicine has meant those forms of non-conventional medicine used in conjunction with conventional treatment; alternative medicine has meant those used instead of conventional medicine.

CAM includes chiropractic doctors, naturopathic doctors, acupuncture, homeopathic medicine, Ayurvedic medicine, mind-body techniques, bioelectromagnetic therapies, aromatherapy, Reiki, Qi gong, T’ai Chi, therapeutic touch, and herbal remedies. As some treatment modalities previously considered to be “CAM” have become more mainstream, and have received more scrutiny and research evidence, they have achieved “conventional” status, such as massage, biofeedback, and cognitive behavioral therapy.

Integrative Medicine and CAM for Migraine

Biofeedback, cognitive behavioral therapy, and other types of counseling or psychotherapy have been studied for headache sufferers, and can be effective. There have also been positive studies of acupuncture for migraine.

Formal studies of aromatherapy suggest benefit from lavender and peppermint oil for the treatment of headaches.

Headaches: Better Coping Through Biofeedback

Biofeedback for Relaxation Techniques in Headache Management

In the previous article, we reviewed the relationship between headaches and anxiety. Given this well-established connection, promotion of the relaxation response is a key goal for many seeking to reduce the frequency and intensity of headaches.

It would be nice if stress reduction were as simple as popping your favorite CD into the stereo or kicking your heels up on the couch for a few minutes. Unfortunately, it’s often not that easy, especially in the face of recurrent pain. Without the proper skills—that’s right, skills—in place, you may not get far in your quest for the elusive relaxation response. Even after weeks of doing various exercises in deep breathing, mental imagery, and muscular relaxation, the migraineur may be left to wonder: is this stuff really going to work, or is relaxation just another gimmick to be filed away with snake oil?

Real Step-by-step Progress in Relaxation Training Skills

With biofeedback, you can verify whether your new relaxation skills really are working. The proof is in the electronic sensor that monitors different physical functions that occur during the relaxation response. Depending on the type of biofeedback, you might see the rise and fall of your finger surface temperature on a computer monitor. Or, you might hear a tone that fluctuates with the levels of muscle tension in your forehead, neck, or shoulders. This feedback provides a window into your body’s functions, and it does so in a way that is comfortable and non-invasive.

With time and practice, better body awareness translates to better body control. Once the ability to evoke a relaxation response is established through the biofeedback equipment, it becomes easier for clients to apply the relaxation skills during their daily activities. Typically, after a few weeks of practice in biofeedback, many individuals naturally begin to apply their new skills to real-life situations. Of course, a good biofeedback practitioner will go a step beyond this natural learning process, by helping the client to develop individually tailored strategies for generalizing the skills.

Advantages of Biofeedback

The enhanced learning curve that comes through biofeedback is just one of the positive aspects of this type of treatment. Many clients like the fact that biofeedback involves neither needles nor drugs. A related advantage is the fact that, unlike with various headache and pain medications, there are few if any negative side effects associated with biofeedback. Also, the fact that biofeedback is a teaching tool for relaxation means that once the skills are learned, you can continue to benefit as long as you choose to maintain practice; there is no continuing cost after treatment is completed.

Finding a Biofeedback Practitioner

As in all areas of medicine and allied health, there are highly effective biofeedback practitioners as well as less skilled ones. If you are interested in finding a good clinician, you should plan to do a little research. Your primary care physician, neurologist, or migraine headache specialist may have information about where to find biofeedback providers in your area. Additionally, two good internet resources are the websites of the Association for Applied Psychophysiology and Biofeedback (aapb.org) and the Biofeedback Certification Institute of America (bcia.org). When you contact a potential provider, it’s a good idea to ask how long they’ve worked in biofeedback, what health conditions they have treated, and whether they are certified in biofeedback. Although there are effective clinicians who are not formally certified, finding a practitioner who has met certification requirements helps you to be more assured of your choice in a practitioner.

Biofeedback clinicians who work with migraine headache are often masters or doctoral level psychologists, but you may also find practitioners in counseling, physical therapy, and other allied health professions. What’s most important from a consumer standpoint is that you find a professional who has specific experience in treating headache conditions.

What About Insurance?

The willingness of health insurance companies to reimburse for biofeedback therapy varies among insurance carriers as well as among different health conditions. Fortunately, because the effectiveness of biofeedback for migraine is particularly well-documented, the chance of receiving insurance reimbursement is often greater than for other health conditions. Contact your insurance provider for further information, and solicit assistance from health care professionals familiar with your history and diagnosis. As an alternative to direct insurance, some individuals may be able to use flexible healthcare spending accounts or make affordable out-of-pocket payments. Such options are well-justified by the pain relief and improved functioning that the therapy can provide.

From Headache Understanding to Ability to Cope

The challenge of using relaxation skills to control migraines is not so much in understanding the connection between mind and body (you’ve already figured that out); the challenge is in building new skills to override the automatic and often subtle effects of anxiety on migraine pattern and intensity. If you’re willing to explore, biofeedback can help to light the way.

written by Luke Patrick, PhD

Luke Patrick, Ph.D. is a licensed psychologist practicing in Portland, Oregon. He specializes in the psychological management of chronic illness, as well as biofeedback and sport psychology.