Herbs

Sock's Toxicity And Drugs In RA:

Products marketed as "dietary supplements" include a diverse range of products, from traditional nutrients, such as vitamins or minerals, to such substances as high-potency free amino acids, botanicals, enzymes, animal extracts, and bioflavanoids that often have no scientifically recognized role in nutrition.

There is currently no systematic evaluation of the safety of products marketed as dietary supplements. Dietary supplements routinely enter the marketplace without undergoing a safety review by FDA. Published studies on the safety of these products are extremely sparse. There is no systematic collection and review of adverse reaction reports for dietary supplements, as there is for drugs, and physicians rarely seek information about their patients' use of dietary supplements.

Despite the lack of any system for gaining information about the risks of dietary supplements, an increased number of reports of adverse reactions to dietary supplement products has recently been recognized. Because of concern about these products, FDA has, in the last year, initiated an effort to collect and evaluate existing studies and case reports on safety problems associated with dietary supplements.

As a result of that effort, FDA has begun to identify dietary supplements for which serious adverse reactions have been documented. A list of selected dietary supplements associated with serious safety problems follows. This list is not intended to include all hazardous ingredients in dietary supplements.

Herbal and other botanical ingredients of dietary supplements include processed or unprocessed plant parts (bark, leaves, flowers, fruits, and stems), as well as extracts and essential oils. They are available in a variety of forms, including water infusions (teas), powders, tablets, capsules, and elixirs, and may be marketed as single substances or in combination with other materials, such as vitamins, minerals, amino acids, and non-nutrient ingredients. Although data on the availability, consumer use, and health effects of herbals are very limited, some herbal ingredients have been associated with serious adverse health effects.

A. Chaparral (Larrea tridentata)

Chaparral, commonly called the creosote bush, is a desert shrub with a long history of use as a traditional medicine by Native Americans. Chaparral is marketed as a tea, as well as in tablet, capsule, and concentrated extract form, and has been promoted as a natural antioxidant "blood purifier," cancer cure, and acne treatment. At least six cases (five in the United States and one in Canada) of acute non-viral hepatitis (rapidly developing liver damage) have been associated with the consumption of chaparral as a dietary supplement. Additional cases have been reported and are under investigation.

In the majority of the cases reported thus far, the injury to the liver resolves over time, after discontinuation of the product. In at least two patients, however, there is evidence that chaparral consumption caused irreversible liver damage. One patient suffered terminal liver failure requiring liver transplant.

Most of these cases are associated with the consumption of single ingredient chaparral capsules or tablets; however, a few of the more recent cases appear to be associated with consumption of multi-ingredient products (capsules, tablets or teas) that contain chaparral as one ingredient. Chemical analyses have identified no contaminants in the products associated with the cases of hepatitis. Products from at least four different distributors and from at least two different sources have been implicated thus far.

After FDA's health warning, many distributors of chaparral products voluntarily removed the products from the market in December of 1992. Some chaparral products remain on the market, however, and other distributors who removed their products from the market are seeking to clarify the status of these products.

B. Comfrey (Symphytum officinale (common comfrey), S. asperum (prickly comfrey), S. X uplandicum (Russian comfrey))

Preparations of comfrey, a fast-growing leafy plant, are widely sold in the United States as teas, tablets, capsules, tinctures, medicinal poultices, and lotions. Since 1985, at least seven cases of hepatic veno-occlusive disease--obstruction of blood flow from the liver with potential scarring (cirrhosis)--including one death, have been associated with the use of commercially available oral comfrey products.

Comfrey, like a number of other plants (e.g., Senecio species), contains pyrrolizidine alkaloids. The toxicity of pyrrolizidine alkaloids to humans is well-documented. Hepatic veno-occlusive disease following ingestion of pyrrolizidine alkaloid-containing products, has been documented repeatedly throughout the world. Hepatic veno-occlusive disease is usually acute and may result in fatal liver failure.

In less severe cases, liver disease may progress to a subacute form. Even after apparent recovery, chronic liver disease, including cirrhosis, has been noted. Individuals who ingest small amounts of pyrrolizidine alkaloids for a prolonged period may also be at risk for development of hepatic cirrhosis. The diagnosis of pyrrolizidine alkaloid-induced hepatic veno-occlusive disease is complex, and the condition is probably underdiagnosed.

The degree of injury caused by pyrrolizidine alkaloid-containing plants, like comfrey, is probably influenced by such factors as the age of the user, body mass, gender, and hepatic function, as well the total cumulative dose ingested and the type of exposure (i.e., whether exposure was to leaves or roots, infusions or capsules).

Infants in general appear to be particularly susceptible to adverse effects of exposure to pyrrolizidine alkaloids; there are reports of infants developing hepatic veno-occlusive disease following acute exposure of less than one week. Transplacental pyrrolizidine poisoning has been suggested by the occurrence of hepatic disease in the newborn infant of a woman who consumed herbal tea during pregnancy.

Although liver damage is the major documented form of injury to humans from pyrrolizidine alkaloid-containing herbals, animal studies suggest that their toxicity is much broader. Animals exposed to pyrrolizidine alkaloids have developed a wide range of pulmonary, kidney and gastro-intestinal pathologies. Pyrrolizidine alkaloid-containing plants, including comfrey, have also been shown to cause cancer in laboratory animals.

Four countries (the United Kingdom, Australia, Canada, and Germany) have recently restricted the availability of products containing comfrey, and other countries permit use of comfrey only under a physician's prescription.

C. Yohimbe (Pausinystalia yohimbe)

Yohimbe is a tree bark containing a variety of pharmacologically active chemicals. It is marketed in a number of products for body building and "enchanced male performance." Serious adverse effects, including renal failure, seizures and death, have been reported to FDA with products containing yohimbe and are currently under investigation.

The major identified alkaloid in yohimbe is yohimbine, a chemical that causes vasodilation, thereby lowering blood pressure. Yohimbine is also a prescription drug in the United States. Side effects are well recognized and may include central nervous system stimulation that causes anxiety attacks.

At high doses, yohimbine is a monoamine oxidase (MAO) inhibitor. MAO inhibitors can cause serious adverse effects when taken concomitantly with tyramine-containing foods (e.g., liver, cheeses, red wine) or with over-the-counter (OTC) products containing phenylpropanolamine, such as nasal decongestants and diet aids. Individuals taking yohimbe should be warned to rigorously avoid these foods and OTC products because of the increased likelihood of adverse effects.

Yohimbe should also be avoided by individuals with hypotension (low blood pressure), diabetes, and heart, liver or kidney disease. Symptoms of overdosage include weakness and nervous stimulation followed by paralysis, fatigue, stomach disorders, and ultimately death.

D. Lobelia (Lobelia inflata)

Lobelia, also known as Indian tobacco, contains pyridine-derived alkaloids, primarily lobeline. These alkaloids have pharmacological actions similar to, although less potent than, nicotine. There have been several reported cases of adverse reactions associated with consumption of dietary supplements containing lobelia.

Depending on the dose, lobeline can cause either autonomic nervous system stimulation or depression. At low doses, it produces bronchial dilation and increased respiratory rate. Higher doses result in respiratory depression, as well as sweating, rapid heart rate, hypotension, and even coma and death. As little as 50 milligrams of dried herb or a single milliliter of lobelia tincture has caused these reactions.

Because of its similarity to nicotine, lobelia may be dangerous to susceptible populations, including children, pregnant women, and individuals with cardiac disease. Lobelia is nevertheless found in dietary supplement products that are marketed for use by children and infants, pregnant women, and smokers.

E. Germander (Teucrium genus)

Germander is the common name for a group of plants that are contained in medicinal teas, elixirs and capsules or tablets, either singly or in combination with other herbs, and marketed for the treatment of obesity and to facilitate weight loss.

Since 1986, at least 27 cases of acute nonviral hepatitis (liver disease), including one death, have been associated with the use of commercially available germander products in France. These cases show a clear temporal relationship between ingestion of germander and onset of hepatitis, as well as the resolution of symptoms when the use of germander was stopped.

In 12 cases, re-administration of germander was followed by prompt recurrence of hepatitis. Recovery occurred gradually in most cases, approximately two of six months after withdrawal of germander. Analyses of these cases does not indicate a strong relationship between the dosage or duration of ingestion and the occurrence of hepatitis.

Although the constituent in germander responsible for its hepatic toxicity has not been identified, germander contains several chemicals, including polyphenols, tannins, diterpenoids, and flavonoids.

On the basis of the 27 French hepatitis cases, the French Ministry of Health has forbidden the use of germander in drugs. Its use has been restricted in other countries.

F. Willow Bark (Salix species)

Willow bark has long been used for its analgesic (pain killing), antirheumatic, and antipyretic (fever-reducing) properties. Willow bark is widely promoted as an "aspirin-free" analgesic, including in dietary supplement products for children. Because it shares the same chemical properties and the same adverse effects as aspirin, this claim is highly misleading. The "aspirin-free" claim is particularly dangerous on products marketed, without warning labels, for use by children and other aspirin-sensitive individuals.

The pharmacologically active component in willow bark is "salicin," a compound that is converted to salicylic acid by the body after ingestion. Both willow bark and aspirin are salicylates, a class of compounds that work by virtue of their salicylic acid content. Aspirin (acetylsalicylic acid) is also converted to salicylic acid after ingestion.

All salicylates share substantially the same side effects. The major adverse effects include irritation of the gastric mucosa (a particular hazard to individuals with ulcer disease), adverse effects when used during pregnancy (including stillbirth, bleeding, prolonged gestation and labor, and low-birth-weight infants), stroke, and adverse effects in children with fever and dehydration.

Children with influenza or chickenpox should avoid salicylates because their use, even in small doses, is associated with development of Reye syndrome, which is characterized by severe, sometimes fatal, liver injury.

Salicylate intoxication (headache, dizziness, ringing in ears, difficulty hearing, dimness of vision, confusion, lassitude, drowsiness, sweating, hyperventilation, nausea, vomiting, and central nervous system disturbances in severe cases) may occur as the result of over-medication, or kidney or liver insufficiency. Hypersensitivity, manifested by itching, broncho-spasm and localized swelling (which may be life-threatening), can occur with very small doses of salicylates, and may occur even in those without a prior history of sensitivity to salicylates. Approximately 5 percent of the population is hypersensitive to salicylates.

G. Jin Bu Huan

Jin Bu Huan is a Chinese herbal product whose label claims that it is good for "insomnia due to pain," ulcer, "stomachic ¬sic| neuralgia, pain in shrunken womb after childbirth, nervous insomnia, spasmodic cough, and etc." Jin Bu Huan has been recently reported to be responsible for the poisoning of at least three young children (ages 13 months to 2 2 years), who accidentally ingested this product. The children were hospitalized with rapid-onset, life-threatening bradycardia (very low heart rate), and central nervous system and respiratory depression. One child required intubation (assisted breathing). All three utlimately recovered following intensive medical care.

Although the product label identified the plant source for Jin Bu Huan as Polygala chinensis, this appears to be incorrect since preliminary analyses indicate the presence of tetrahydropalmatine (THP), a chemical not found in Polygala. THP is found, however, in high concentrations in plants of certain Stephania species. In animals, exposure to THP results in sedation, analgesia, and neuromuscular blockade (paralysis). The symptoms of the three children are consistent with these effects.

An additional case of THP toxicity, reported in the Netherlands, appears to be associated with the same product, and is being investigated.

H. Herbal products containing Stephania and Magnolia species

A Chinese herbal preparation containing Stephania and Magnolia species that was sold as a weight-loss treatment in Belgium has been implicated recently as a cause of severe kidney injury in at least 48 women. These cases were only discovered by diligent investigations by physicians treating two young women who presented with similar cases of rapidly progressing kidney disease that required renal dialysis.

Once it was determined that both these women had used the herbal diet treatment, further investigation of kidney dialysis centers in Belgium found a total of 48 individuals with kidney injury who had used the herbal product.

At the time that a report of these adverse effects was published in February 1993, 18 of the 48 women had terminal kidney failure that will require either kidney transplantation or life-long renal dialysis.

I. Ma huang

Ma huang is one of several names for herbal products containing members of the genus Ephedra. There are many common names for these evergreen plants, including squaw tea and Mormon tea. Serious adverse effects, including hypertension (elevated blood pressure), palpitation (rapid heart rate), neurophathy (nerve damage), myopathy (muscle injury), psychosis, stroke, and memory loss, have been reported to FDA with products containing Ma huang as ingredients and are currently under investigation.

The Ephedras have been shown to contain various chemical stimulants, including the alkaloids ephedrine, pseudoephedrine and norpseudoephedrine, as well as various tannins and related chemicals. The concentrations of these alkaloids depends upon the particular species of Ephedra used. Ephedrine and pseudoephedrine are amphetamine-like chemicals used in OTC and prescription drugs. Many of these stimulants have known serious side effects.

Ma huang is sold in products for weight control, as well as in products that boost energy levels. These products often contain other stimulants, such as caffeine, which may have synergistic effects and increase the potential for adverse effects.

Amino acids are the individual constituent parts of proteins. Consumption of foods containing intact proteins ordinarily provides sufficient amounts of the nine amino acids needed for growth and development in children and for maintenance of health of adults.

The safety of amino acids in this form is generally not a concern. When marketed as dietary supplements, amino acids are sold as single compounds, in combinations of two or more amino acids, as components of protein powders, as chelated single compounds, or in chelated mixtures. Amino acids are promoted for a variety of uses, including body-building. Some are promoted for claimed pharmacologic effects.

The Federation of American Societies for Experimental Biology (FASEB) recently conducted an exhaustive search of available data on amino acids and concluded that there was insufficient information to establish a safe intake level for any amino acids in dietary supplements, and that their safety should not be assumed.

FASEB warned that consuming amino acids in dietary supplement form posed potential risks for several subgroups of the general population, including women of childbearing age (especially if pregnant or nursing), infants, children, adolescents, the elderly, individuals with inherited disorders of amino acid metabolism, and individuals with certain diseases.

At least two of the amino acids consumed in dietary supplements have also been associated with serious injuries in healthy adults.

A. L-tryptophan

L-tryptophan is associated with the most serious recent outbreak of illness and death known to be due to consumption of dietary supplements. In 1989, public health officials realized that an epidemic of eosinophilia-myalgia syndrome (EMS) was associated with the ingestion of L-tryptophan in a dietary supplement. EMS is a systemic connective tissue disease characterized by severe muscle pain, an increase in white blood cells, and certain skin and neuromuscular manifestations.

More than 1,500 cases of L-tryptophan-related EMS have been reported to the national Centers for Disease Control and Prevention. At least 38 patients are known to have died. The true incidence of L-tryptophan-related EMS is thought to be much higher. Some of the individuals suffering from L-tryptophan-related EMS have recovered, while other individuals' illnesses have persisted or worsened over time.

Although initial epidemiologic studies suggested that the illnesses might be due to impurities in an L-tryptophan product from a single Japanese manufacturer, this hypothesis has not been verified, and additional evidence suggests that L-tryptophan itself may cause or contribute to development of EMS. Cases of EMS and related disorders have been found to be associated with ingestion of L-tryptophan from other batches or sources of L-tryptophan.

These illnesses have also been associated with the use of L-5-hydroxytryptophan, a compound that is closely related to L-tryptophan, but is not produced using the manufacturing process that created the impurities in the particular Japanese product.

B. Phenylalanine

A number of illnesses, including those similar to the eosinophilia myalgia syndrome (EMS) associated with L-tryptophan consumption, have been reported to FDA in individuals using dietary supplements containing phenylalanine. There are also published reports of scleroderma/scleroderma-like illnesses, which have symptoms similar to EMS, occurring in children with poorly controlled blood phenylalanine levels, as well as in those with phenylketonuria (PKU), a genetic disorder characterized by the inability to metabolize phenylalanine.

Vitamin and mineral dietary supplements have a long history of use at levels consistent with the Recommended Dietary Allowances (RDA's) or at low multiples of the RDA's, and are generally considered safe at these levels for the general population. Intakes above the RDA, however, vary widely in their potential for adverse effects.

Certain vitamins and minerals that are safe when consumed at low levels are toxic at higher doses. The difference between a safe low dose and a toxic higher dose is quite large for some vitamins and minerals and quite small for others.

A. Vitamin A

Vitamin A is found in several forms in dietary supplements. Preformed vitamin A (vitamin A acetate and vitamin A palmitate) has well-recognized toxicity when consumed at levels of 25,000 International Units (IU) per day, or higher. (Beta-carotene does not have the potential for adverse effects that the other forms of vitamin A do, because high intakes of beta-carotene are converted to vitamin A in the body at much lower levels).

The RDA for vitamin A is 1,000 retinol equivalents (RE) for men, which is equivalent to 3,300 IU of preformed vitamin A, and 80 percent of these amounts for women.

The adverse effects associated with consumption of vitamin A at 25,000+ IU include severe liver injury (including cirrhosis), bone and cartilage pathologies, elevated intracranial pressure, and birth defects in infants whose mothers consumed vitamin A during pregnancy.

Groups especially vulnerable to vitamin A toxicity are children, pregnant women, and those with liver disease caused by a variety of factors, including alcohol, viral hepatitis, and severe protein-energy malnutrition.

There are some studies that suggest vitamin A toxicity has occurred at levels of ingestion below 25,000 IU. In addition, the severity of the injuries that occur at 25,000 IU suggests that substantial, but less severe and less readily recognized, injuries probably occur at somewhat lower intakes. Most experts recommend that vitamin A intake not exceed 10,000 IU for most adults or 8,000 IU for pregnant and nursing women.

B. Vitamin B₆

Neurologic toxicity, including ataxia (alteration in balance) and sensory neuropathy (changes in sensations due to nerve injury), is associated with intake of vitamin B₆ (pyridoxine) supplements at levels above 100 milligrams per day. As little as 50 milligrams per day has caused resumption of symptoms in an individual previously injured by higher intakes. The RDA for vitamin B₆ is 2 milligrams. Vitamin B₆ is marketed in capsules containing dosages in the 100-, 200-, and 500-milligrams range.

C. Niacin (nicotinic acid and nicotinamide)

Niacin taken in high doses is known to cause a wide range of adverse effects. The RDA for niacin is 20 milligrams. Niacin is marketed in dietary supplements at potencies of 250 mg, 400 mg, and 500 mg, in both immediate and slow-release formulations. Daily doses of 500 mg from slow-release formulations, and 750 mg of immediate-release niacin, have been associated with severe adverse reactions, including gastrointestinal distress (burning pain, nausea, vomiting, bloating, cramping, and diarrhea) and mild to severe liver damage.

Less common, but more serious (in some cases life-threatening), reactions include liver injury, myopathy (muscle disease), maculopathy of the eyes (injury to the eyes resulting in decreased vision), coagulopathy (increased bleeding problems), cytopenia (decreases in cell types in the blood), hypotensive myocardial ischemia (heart injury caused by too low blood pressure), and metabolic acidosis (increases in the acidity of the blood and urine).

Niacin (nicotinic acid) is approved as a prescription drug to lower cholesterol. Many of the observed adverse reactions have occurred when patients have switched to OTC formulations of niacin, and particularly when they have switched from immediate-release formulations to dietary supplements containing slow-release niacin formulations without the knowledge of their physicians.

D. Selenium

Selenium is a mineral found in dietary supplement products. At high doses (approximately 800 to 1,000 micrograms per day), selenium can cause tissue damage, especially in tissues or organs that concentrate the element. The toxicity of selenium depends upon the chemical form of selenium in the ingested supplement and upon the selenium levels in the foods consumed. Human injuries have occurred following ingestion of high doses over a few weeks.

A. Germanium

Germanium is a nonessential element. Recently, germanium has been marketed in the form of inorganic germanium salts and novel organogermanium compounds, as a "dietary supplement." These products are promoted for their claimed immunomodulatory effects or as "health-promoting" elixirs.

Germanium supplements, when used chronically, have caused nephrotoxicity (kidney injury) and death. Since 1982, there have been 20 reported cases of acute renal failure, including two deaths, attributed to oral intakes of germanium elixirs. In surviving patients, kidney function has improved after discontinuation of germanium, but none of the patients have recovered normal kidney function.

One particular organogermanium compound, an azaspiran organogermanium, has been studied for its potential use as an anticancer drug. Forty percent of the patients in this study experienced transient neurotoxicity (nerve damage), and two patients developed pulmonary toxicity. Because of these side effects, medically supervised administration of this drug with monitoring for toxicity has been recommended for those using germanium chronically.

When considering complementary therapy,the question is the cost of the therapy worth the benefit one is to recieve ? Many therapies give symptomatic relief of pain,but the relief may be comparable or less then a standard NSAID. For example,a well publisized supplement cost $200 + per month,and in reality the pain relief is equal to a standard NSAID.

The evidence that glucosamine builds up cartilage is meagre. And even in the studies that show that it might, the amount of cartilage built up is miniscule. The studies have been done in osteoarthritis, not in rheumatoid arthritis where the damage to cartilage is much more aggressive.

Any potential benefit of cartilage repair would be outweighed by the destructive inflammatory process of rheumatoid arthritis. Glucosamine might reduce some of the pain in the knee but it needs to be taken for 2-3 months to determine such a benefit.

The degree of cartilage loss in your knee and the prescence of rheumatoid arthritis make it very unlikely that glucosamine sulfate would restore any meaningful amount of cartilage, if any at all.

However, glucosamine is useful for osteoarthritis, not rheumatoid arthritis. Devil's claw has not been shown to help rheumatoid arthritis and it may have some hormonal side effects such as abortion.

Some persons believe that liquid cod liver oil helps their arthritis by lubricating their joints. However there is no real evidence to support such claims. In fact, joints are lubricated by mucus like hyaluronic acid not by oils such as the fatty oils in cod liver oil.

Cod liver oil contains vitamins A and D and omega-3 polyunsaturated fatty acids. Vitamins A and D are not known to help arthritis but vitamin D is important for normal bone growth and maintenance.

There is a danger in taking too much cod liver oil and developing vitamin A and D toxicity. The omega-3 fatty acids include EPA (eicosapentenoic acid) and DHA (docosahexanoic acid) which have been shown to have a mild anti-inflammatory effect on arthritic joints. However, these fatty acids can be purchased in a pure form with an exact dosage and without the danger of developing vitamin A and D toxicity.

Some Guidelines For Using Herbal Products:

1. Approach any herbal medicine as you would a prescription drug or over-the-counter (OTC) drug. Herbals can have adverse effects, drug interactions, contraindications (conditions when they should not be used), and all the other problems that go along with the kinds of medications you are used to. Some are widely recognized to be dangerous, but are still allowed to remain on the market.

In fact, you should even be more cautious when using an herbal than a prescription or over-the-counter (OTC) drug for many reasons.

Herbals are virtually unregulated. You are not protected by the same government controls exercised over prescription and OTC drugs. This means there is no assurance that what it says on the label is in the bottle. Also, because of lack of regulatory controls, herbals are marketed in a way that may make them look like what they aren't and they are held out with claims they can't fulfill. Their labels may not disclose their adverse effects and everything else you would expect on drug labels.

Lack of knowledge about herbals. Only now are medical, pharmacy and other professional schools gearing up to give their students the kind of intense instructions they should have on the subject.

Some herbal medicines are unsafe, ineffective, and potential killers.

When initiating a course of herbal medicine treatment, start with one herb only so you can clearly identify its adverse effects and benefits. Otherwise, if you start with a bunch at one time, it may not be clear which one is causing problems or which one is working. The same process makes sense in initiating drug therapy.

2. People with special conditions should proceed with special caution, and get the advice of a doctor, pharmacist or other qualified professional before taking an herbal medicine.

People with special conditions include but are not limited to

Pregnant and nursing mothers

Anyone with impaired immune system

Anyone with impaired liver or kidney function

Anyone with chronic disease such as diabetes or heart disease,

Young children (especially infants)

Senior citizens

Anyone taking prescription medicines

The Mayo Clinic Family Health Book (2nd edition) says flat-out, "Don't give herbal supplements to children."

If in doubt, anyone, in perfect health or not, should get the advice of their doctor.

In some cases, it may be more convenient to ask your pharmacist, who may be able to advise you on the herbal medicine and whether you should consult your doctor before taking it. You should use your pharmacist as an automatic check on what your doctor recommends in terms of drugs, herbal medicines, food supplements and the like.

3. When getting advice from your doctor, pharmacist or other qualified professional on herbal medicines or on other matters, you should tell them about all the herbal medicines you're taking, along with other nutritional supplements, vitamins, minerals, prescription and over-the-counter drugs. In other words, what herbal medicines you're taking should be part of your medical history. A competent doctor should ask you about all of the drugs, nutritional supplements, herbal medicines and anything else you're taking as a part of your medical history and before prescribing any treatment.

When seeking advice from a pharmacist or any other professional, you should also be sure your medical history is fully communicated.

4. When getting advice from your doctor, pharmacist, or other health care professional, make an allowance for the fact that the major focus on herbal medicines is so new, your advisor may simply not be informed on the subject. Recently, the American Pharmaceutical Association found only one-third of pharmacists felt comfortable in advising patients about herbal medicines. The percentage of doctors, in my view, is likely to be just as low or probably lower. Dr. Dan Hussar, a leading authority on pharmacy practice, says that pharmacists are in a unique position to assume a major role in counseling on herbal medicines and will become the authorities on the subject. Other professional groups can also be expected to develop expertise in this area.

5. Check it out yourself by going to the growing number of useful books and web sites on the subject. There are now many sources available for checking out herbal medicines on your own. We've already mentioned The PDR for Herbal Medicines. Other good sources are the Review of Natural Products (formerly called The Lawrence Review of Natural Products), published by the same company that puts out the widely used and highly regarded Facts and Comparisons on drugs; Dr. Varro Tyler's books including The Honest Herbal, available in paperback and hardback, and Herbs of Choice: The Therapeutic Use of Phytomedicinals; The Professional's Handbook of Complementary and Alternative Medicines published by the Springhouse Corporation; The American Pharmaceutical Association Practical Guide to Natural Medicines; Dr. James A. Duke's The Green Pharmacy; and Jean Carper's books, including Miracle Cures and Food Your Miracle Medicine.

There is also a web site maintained by the National Institutes of Health that includes a data base of studies on herbal medicines at http://odp.od.nih.gov/ods/. Other valuable sites, among many others, are those of the American Botanical Council, www.herbalgram.org., and the site of the American Herbal Products Association, www.ahpa.org. A good continuing source of information on herbal medicines is Consumer Reports on Health, the newsletter published by Consumer Reports.

6. Don't fall for the idea that herbal medicines are perfectly safe because they are natural. There are huge catalogs of natural substances that can be deadly ranging from arsenic and hemlock to opium (from the poppy). And what could be more natural than the rays of the sun, which can cause melanoma and other skin cancers? Of course, as the PDR for Herbal Medicines notes, "Some -- such as ginkgo, valerian, and saw palmetto -- seem genuinely useful, while others -- such as ephedra, tansy, and nightshade -- can actually be dangerous." The Mayo Clinic Family Health Book (2nd edition) reports that Ma huang may cause a dangerous increase in blood pressure, and germanium's long-term use may cause kidney damage and death. Yohimbe may cause tremors, anxiety, high blood pressure and rapid heart beat; and chaparral may cause liver disease. Mayo also notes that toxic chemicals in comfrey, borage and coltsfoot may cause liver disease.

7. Avoid the widespread fallacy that if some is good, more is better. This is dangerous. Whenever you start taking extraordinarily large doses of an herbal you increase the chances of adverse effects and other problem. The same is true for medicines, vitamins, minerals and all other dietary supplements.

8. If you do decide to use a herbal medicine, ask your doctor and pharmacist for recommendations on the brand to buy, and check out the brand and source. Many suggest that you increase your chances of getting a standard and reliable product if you buy an herbal from one of the major drug companies that are now moving into the market. Other suggestions of quality include products that carry the seal of the National Formulary (NF), which indicates the product meets the specified guidelines of the U.S. Pharmacopoeia (USP), a respected standard-setting organization. Such products whose manufacturer asserts they meet NF standards will be coming onto the market by the end of 1999. However, the USP is still in the process of setting standards for herbals and is many years from completing the job.

Still another indication of quality is the fact that the product is also sold in Germany, where higher regulatory standards are set for herbs. In Germany, an agency of the government — called the Commission E — regulates herbals in a fashion similar to the FDA's regulation of drugs in the U.S. Commission E has published 300 monographs on herbal medicines and has allowed about 700 herbals on the market. Some 80 percent of German doctors use herbals. Dr. Ara DerMarderosian, a nationally known expert on herbals, says if you want more information, you can write or call manufacturers and they should provide details about their product and the testing and quality control standards. Many manufacturers have toll-free 800 numbers making it easy to contact them. In the case of bulk herbs, one expert, June E. Riedlinger, offers this advice: "If the patient is buying bulk herbs, it is important to select a product that is labeled with the identity of the plant and that still has its color, is free of evidence of bacteria or fungus, and carries data indicating when the plant was collected."

9. Buy any herbal from a reliable store so you increase your chances of getting a fresh product and a quality product. Check any expiration dates or other freshness information on the label. Varro E. Tyler says, "The labeling of herbal products should show the scientific name of the botanical, the name and address of the actual manufacturer, a batch or lot number, the date of manufacture, and the expiration date." You should also check for dosage information (it may indicate dosage information under a section entitled "recommendation" or "suggested use"). Also check for storage information (which may say store in a cool, dry and dark place which is inaccessible to children; some containers say store in a dry place at controlled room temperature. Avoid heat above 80 degrees Fahrenheit). Some containers come with child resistant caps and safety seals.

10. While using an herbal medicine be alert for any possible adverse effects and report them to your doctor immediately. You should be aware that any new symptoms may relate to the herbal medicine. Some recommend you keep a journal and record each day the effect you experience in using the product. Dr. Varro E. Tyler has advised pharmacists to "advise patients to cease taking a natural product (herbal medicine) immediately if adverse effects (e.g., allergy, stomach upset, skin rash, headache) occur."

11. You should also report your experience with adverse effects to the Food and Drug Administration at 800-332-1088 (more easily remembered as 800-FDA-1088) or the U.S. Pharmacopeia at 800-4USP-PRN (the PRN stands for Practice Reporting Network). That number is more easily dialed at 800-487-7776. Those two organizations share information.

12. Don't put off needed medical treatment with the hope that some self-prescribed herbal medicine will solve your problem. You can endanger your health and life by delaying treatment of many conditions that may progress to become much more dangerous or even fatal if not promptly treated. Don't try to use herbal medicines in place of needed medical advice.

13. Approach any recommended herbal medicine or any other medical recommendation for that matter, with a skeptical and inquiring mind. Ask questions. Get answers. Check out recommendations. And needless to say, don't rely on medical advice from a clerk or owner of a health food store. Remember that herbals are neither panaceas nor therapeutic pariahs. They range from dangerous to valuable, and some are used by the most highly qualified physicians. As in much of life, two key Latin words, which make sense in all languages and in all contexts, are worth observing — caveat emptor. Buyer and user beware.

Complementary and alternative medicine, as defined by NCCAM, is a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine. While some scientific evidence exists regarding some CAM therapies, for most there are key questions that are yet to be answered through well-designed scientific studies--questions such as whether they are safe and whether they work for the diseases or medical conditions for which they are used.

The list of what is considered to be CAM changes continually, as those therapies that are proven to be safe and effective become adopted into conventional health care and as new approaches to health care emerge.

Are complementary medicine and alternative medicine different from each other?

Yes, they are different.

Complementary medicine is used together with conventional medicine. An example of a complementary therapy is using aromatherapy to help lessen a patient's discomfort following surgery.
Alternative medicine is used in place of conventional medicine. An example of an alternative therapy is using a special diet to treat cancer instead of undergoing surgery, radiation, or chemotherapy that has been recommended by a conventional doctor.

What is integrative medicine?

Integrative medicine, as defined by NCCAM, combines mainstream medical therapies and CAM therapies for which there is some high-quality scientific evidence of safety and effectiveness.

What are the major types of complementary and alternative medicine?

NCCAM classifies CAM therapies into five categories, or domains:

1. Alternative Medical Systems

Alternative medical systems are built upon complete systems of theory and practice. Often, these systems have evolved apart from and earlier than the conventional medical approach used in the United States. Examples of alternative medical systems that have developed in Western cultures include homeopathic medicine and naturopathic medicine. Examples of systems that have developed in non-Western cultures include traditional Chinese medicine and Ayurveda.

2. Mind-Body Interventions

Mind-body medicine uses a variety of techniques designed to enhance the mind's capacity to affect bodily function and symptoms. Some techniques that were considered CAM in the past have become mainstream (for example, patient support groups and cognitive-behavioral therapy). Other mind-body techniques are still considered CAM, including meditation, prayer, mental healing, and therapies that use creative outlets such as art, music, or dance.

3. Biologically Based Therapies

Biologically based therapies in CAM use substances found in nature, such as herbs, foods, and vitamins. Some examples include dietary supplements herbal products, and the use of other so-called "natural" but as yet scientifically unproven therapies (for example, using shark cartilage to treat cancer).

4. Manipulative and Body-Based Methods

Manipulative and body-based methods in CAM are based on manipulation and/or movement of one or more parts of the body. Some examples include chiropractic or osteopathic manipulation, and massage.

5. Energy Therapies

Energy therapies involve the use of energy fields. They are of two types:

Biofield therapies are intended to affect energy fields that purportedly surround and penetrate the human body. The existence of such fields has not yet been scientifically proven. Some forms of energy therapy manipulate biofields by applying pressure and/or manipulating the body by placing the hands in, or through, these fields. Examples include qi gong, Reiki, and Therapeutic Touch.
Bioelectromagnetic-based therapies involve the unconventional use of electromagnetic fields, such as pulsed fields, magnetic fields, or alternating current or direct current fields.

What is NCCAM's role in the field of complementary and alternative medicine?

NCCAM is the Federal Government's lead agency for scientific research on complementary and alternative medicine. NCCAM's mission is to explore complementary and alternative healing practices in the context of rigorous science, to train CAM researchers, and to inform the public and health professionals about the results of CAM research studies.

Notes

Conventional medicine is medicine as practiced by holders of M.D. (medical doctor) or D.O. (doctor of osteopathy) degrees and by their allied health professionals, such as physical therapists, psychologists, and registered nurses. Other terms for conventional medicine include allopathy; Western, mainstream, orthodox, and regular medicine; and biomedicine. Some conventional medical practitioners are also practitioners of CAM.

Other terms for complementary and alternative medicine include unconventional, non-conventional, unproven, and irregular medicine or health care.

Some uses of dietary supplements have been incorporated into conventional medicine. For example, scientists have found that folic acid prevents certain birth defects, and a regimen of vitamins and zinc can slow the progression of an eye disease called age-related macular degeneration (AMD).

Dictionary of Terms

Aromatherapy :Aromatherapy involves the use of essential oils (extracts or essences) from flowers, herbs, and trees to promote health and well-being.

Ayurveda: is a CAM alternative medical system that has been practiced primarily in the Indian subcontinent for 5,000 years. Ayurveda includes diet and herbal remedies and emphasizes the use of body, mind, and spirit in disease prevention and treatment.

Chiropractic: is a CAM alternative medical system. It focuses on the relationship between bodily structure (primarily that of the spine) and function, and how that relationship affects the preservation and restoration of health. Chiropractors use manipulative therapy as an integral treatment tool.

Dietary supplements: Congress defined the term "dietary supplement" in the Dietary Supplement Health and Education Act (DSHEA) of 1994. A dietary supplement is a product (other than tobacco) taken by mouth that contains a "dietary ingredient" intended to supplement the diet. Dietary ingredients may include vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, and metabolites. Dietary supplements come in many forms, including extracts, concentrates, tablets, capsules, gelcaps, liquids, and powders. They have special requirements for labeling. Under DSHEA, dietary supplements are considered foods, not drugs.

Electromagnetic fields: Electromagnetic fields (EMFs, also called electric and magnetic fields) are invisible lines of force that surround all electrical devices. The Earth also produces EMFs; electric fields are produced when there is thunderstorm activity, and magnetic fields are believed to be produced by electric currents flowing at the Earth's core.

Homeopathic medicine is a CAM alternative medical system. In homeopathic medicine, there is a belief that "like cures like" meaning that small, highly diluted quantities of medicinal substances are given to cure symptoms, when the same substances given at higher or more concentrated doses would actually cause those symptoms.

Massage therapists manipulate muscle and connective tissue to enhance function of those tissues and promote relaxation and well-being.

Naturopathic medicine is a CAM alternative medical system in which practitioners work with natural healing forces within the body, with a goal of helping the body heal from disease and attain better health. Practices may include dietary modifications, massage, exercise, acupuncture, minor surgery, and various other interventions.

Osteopathic medicine is a form of conventional medicine that, in part, emphasizes diseases arising in the musculoskeletal system. There is an underlying belief that all of the body's systems work together, and disturbances in one system may affect function elsewhere in the body. Some osteopathic physicians practice osteopathic manipulation, a full-body system of hands-on techniques to alleviate pain, restore function, and promote health and well-being.

Qi gong is a component of traditional Chinese medicine that combines movement, meditation, and regulation of breathing to enhance the flow of qi (an ancient term given to what is believed to be vital energy) in the body, improve blood circulation, and enhance immune function.

Reiki is a Japanese word representing Universal Life Energy. Reiki is based on the belief that when spiritual energy is channeled through a Reiki practitioner, the patient's spirit is healed, which in turn heals the physical body.

Therapeutic Touch is derived from an ancient technique called laying-on of hands. It is based on the premise that it is the healing force of the therapist that affects the patient's recovery; healing is promoted when the body's energies are in balance; and, by passing their hands over the patient, healers can identify energy imbalances.

Many alternative therapies aren't the complete treatment for the acute illness. Those therapies shouldn't replace proven treatments for medical therapy or what your physician recommends, and the therapies really aren't the cure for arthritis. And I think those kinds of pieces of information are important.

The term "complementary" is more appropiate. These are remedies and therapies that can be used in conjunction with conventional medicine to go a long way towards easing pain and some of the inflammation symptoms of rheumatoid arthritis too, but they are not a cure. There is no cure for arthritis.

It's a chronic disease, unfortunately, right now, though there are many advances coming along. People need to know they shouldn't give up their good conventional medicine to try some unproven therapies.

The thunder god vine is that vine that was researched in Texas. It's been used in China for some time now for both rheumatoid arthritis and for lupus, another autoimmune arthritis disease that's inflammatory. And an interesting study, shows that though they acknowledge that it has helped with some of the pain and inflammation of rheumatoid arthritis, that some women who were using it for lupus were having some bone density loss. So, again, you have to be as careful with supplements and with herbs as you would be with your conventional drugs.

Many people have heard about glucosamine and chondroitin. These are very popular supplements. They've been used in Europe for decades, and many rheumatologists now are recommending that their patients with osteoarthritis, which is the cartilage-destroying kind of joint disease.

Many studies, mostly European studies, have shown that glucosamine actually makes patients with osteoarthritis better. We don't have any studies in the inflammatory rheumatoid that we can point to,although many patients with RA have secondary osteoarthritis. Glucosamine is not recommended for RA therapy.

The other question that has been raised and has been published in The Lancet is whether or not chondroitin sulfate in our patients where their cartilage is being worn down either by rheumatoid arthritis or by osteoarthritis is really going to slow that process down. The one paper that's been presented at arthritis meetings and published used an x-ray technique that was prior to the one we use since 1994. The NIH recently did a large study on glucosomine for osteoarthritis.

The glucosamine study, actually, that was presented at the big arthritis meeting that showed that maybe if you take glucosamine, you might not have the joint narrowing that's associated with cartilage loss. But how do you know when you're buying a bottle of glucosamine that it actually has glucosamine in it?

The herbs and supplements are not regulated as medicines. They are regulated as food, really, as dietary supplements. Anyone can decide to put a product on the market and make some claims for it, not medical claims…and until that product hurts someone, it won't be taken off the market.

That means that anyone can decide to put a product on the market and make some claims for it, not medical claims, some very carefully worded claims like "supports joint health," and until that product hurts someone, it won't be taken off the market. This is a situation that I'm very concerned about and a number of physicians and people, in fact, who work in the alternative medicine field are concerned about. So, it's really a buyer beware situation.

Whenever you hear about something like glucosamine that's been used successfully in a study, maybe ask your reference librarian to help you find out which product was used in that study and try to use it.

When we talk about herbs, the guidance that my experts give me is to perhaps avoid the herbs from Asia, which may be contaminated because of pollution there and may even be deliberately adulterated in some cases to make them appear stronger, but to perhaps stick with the German herbs because in Germany, herbs are regulated more like medicine, so you're probably more likely to get a good product that way.

When an herb is used as a drug, it becomes a drug. Anything strong enough to help you is strong enough to hurt you, and when you talk about natural, you have to realize that snake venom is natural, poison ivy is natural, and those things can kill you. And more is not better.

One of the really interesting things to come out most recently was the National Institutes of Medicine. They looked at vitamins, again, and they really lowered the daily recommended limit for some of them. Vitamin C is one of those vitamins that people had recommended in megadoses, and people are saying that's not a good idea now.

More is not better. You really need to stick with the dosage that's been recommended by your physician, and more and more doctors are learning about herbs and supplements, too, or one that a reliable herbalist recommends. And more is not better.

There was a recent article -- It was in JAMA, Journal of the American Medical Association -- that said that megadoses of certain vitamins increase your risk of hip fracture.

Some patients take things like Chinese black pearls (it has an assortment like predisone derivates in it-deadly when used incorrectly )and all of those other unknown herbs that especially patients know little about except by hearsay,and the internet can be a dangerous source of information in some cases,and they've had a significant toxicity and side effects. Sometimes some of these things that are brought in, especially from Asia, need to probably go through some testing before they're used widely.

Many people get substantial pain relief from acupuncture, but not all. They have been able to actually measure physiological responses to acupuncture. We know that it increases the production of something called endorphins, which are our feel-good hormones, and that helps relieve pain.

We don't know exactly how acupuncture works in other ways. Some people have no response at all. It simply doesn't work for them. But for many people acupuncture or acupressure, which is acupressure without the needles -- putting pressure on these points -- can give substantial pain relief.

We're asking for a medical, Western definition of what that might be. The theory behind acupuncture is thousands of years old. It's based on the Chinese philosophy that a vital life energy inhabits all of us, that we're born with it, and that it flows through our bodies on invisible channels called meridians.

And when that vital life energy is blocked in some way, it either results in illness or it causes illness. And by applying pressure or little pinpricks at specific points along these invisible meridians, which were devised thousands of years ago, they can unblock the vital life energy and restore and maintain health.

In Western medicine, doctors are not taught any of this, and perhaps physicians and healthcare givers need to keep an open mind about it.

The other thing is people need to consider, what the downside risk is because not all natural things have no side effects, and many of them do have side effects as we know. One can take too much digitalis. One can take too much autumn crocus leaf or colchicine and get significant stomach troubles from that.

And then hopefully this is going to be a complementary, whether it be acupressure or acupuncture or a herb therapy, but a complementary therapy to the currently available and proven Western therapies that not only make our rheumatoid patients feel better but also slow their progressive, erosive, destructive disease.

What rheumatologists in North America and most of Europe do is, try change one variable at a time. For example, if they're going to do a study to see if a DMARD or DMARDs is working for rheumatoid arthritis, they would keep the patient's non-steroidal drug stable. They would keep their analgesic or pain medicine such as Ultram stable, and keep the patient's prednisone dose if they were on cortisone or prednisone stable, and they would add one thing to change the picture. And for the example a DMARD or DMARDs or it may be add a placebo and do a comparative study.

The problem is, patients will often try multiple things. They will go to the health food store, and they will buy extra vitamins. They might buy some herbs. They may try a new exercise program. They may try acupuncture, and also at the same time, as their Western physician may be adjusting their medical management. Therefore, that's a long answer to say it's really impossible to tell without a really well-designed clinical trial where this would be a single change in their therapy.

There actually have been a number of Western studies done that showed that acupuncture did relieve osteoarthritis pain, particularly knee pain. There's a Scandinavian study, and their's a group at the University of Maryland that did a recent study that showed it relieved pain also. So, there is growing evidence that acupuncture does something, that it does relieve pain in some people.

It's one of the crossover alternatives, one of the ones that's become not only complementary but integrative, which is one of the new words that people use, meaning that it's become integrated into some conventional care centres.

That's an enormous change. And you also find that many organizations like Kaiser Permanente will pay for or give you greatly reduced rates on things such as stress reduction, meditation, even yoga and tai chi. So, the so-called alternative therapies are -- some of them -- being integrated right into some conventional practices.

Meditation can be described as a concentration technique, a kind of one-point focus where you focus on perhaps a word that's repeated or a physical sensation or a thought, and when you focus on that, you let everything else go by, and don't pay as much attention to it. And people who practice this find that they become very relaxed and that they are more centered and more able to cope with the stresses of life, which brings up another point.

Rheumatoid arthritis, like many of the autoimmune inflammatory diseases, is very responsive to stress. That means that situations of physical and mental and emotional stress can actually provoke a flare, a period of accelerated inflammation and great pain. So, meditation when practiced regularly can help people relax and relieve stress. It's been shown to relieve pain that way.

Biofeedback people may be familiar with. Some people call it meditation with machines. In biofeedback you're hooked up painlessly to a monitoring machine of some kind, either a little television monitor that shows waves going up and down or something that makes sounds, and you practice relaxation techniques and learn to control your bodily responses. You learn what to do to, say, make the temperature in your hands rise or slow your heart beat, and this technique has been used to help people relax, which also helps them deal with chronic pain.

Hypnosis is another concentration technique,with controversy. They say that all hypnosis really is self-hypnosis, that people can't do it to you. Someone can lead you into a hypnotic state by helping you, again, focus your concentration, take yourself to a place where you are very relaxed and you're in a state of relaxed alertness, if that doesn't sound too contradictory, where you're relaxed and yet very able to focus on things. Your concentration is much improved. Some small studies have been done,and its mixed,a few say it helps others say it does not. Others say the differences may be whether its self-hypnosis or hypnosis by a therapist.

The relaxation techniques and stress-reduction techniques that are really being accepted pretty much wholesale in hospitals across the country, many of these are based on programs that were pioneered by Jon Kabat-Zinn at the University of Massachusetts. And his Mindfulness Meditation Stress Reduction Program is used in more than 250 hospitals around the country.

And it's a program that will last between six and ten weeks where people with chronic pain will come and learn a little yoga, learn a little meditation, and learn how to do a kind of deep relaxation, many times with audio tapes where you play a tape that shows you how to begin relaxing your body from your toes up to your head.

And patients found, actually, when they were having a great deal of pain would reach that point where they wanted to try to not go for the Vicodin because then they wouldn't be able to really work, that if they would lie down and do a 45-minute deep relaxation, it could really restore them and really push the pain back.

Visualization and guided imagery are techniques. Just playing music, like white sound kind of music or relaxing music. There are many CDs out that are sounds of the sea, sounds of the forest. People can put those on and lie back and relax with music. Things that help you to relax and help you to think of other things work.