Herb Remedies For Healing - Herbal Remedies & The FDA

Dec. 9, 2006

Herbal Remedies & The FDA

Medicinal herbs are some of our oldest medicines and their increasing use in recent years is evidence of a public interest in having alternatives to conventional medicine. Herbal medicines continue to be a major market in U.S. pharmacies and constitute a multi-billion dollar industry.

Although approximately 1500 botanicals are sold as dietary supplements or ethnic traditional medicines, herbal formulations are not subject to U.S. Federal Drug Administration (US FDA) premarket toxicity testing to assure their safety or efficacy. Please use with caution!

Aloe vera gel	Widely used herb, both as a dietary supplement and component of cosmetics. The gel has been used for centuries as a treatment for minor burns and is increasingly being used in products for internal consumption.
Black Cohosh	Used to treat symptoms of pre-menstrual syndrome, dysmenorrhea and menopause.
Bladderwrack	A source of iodide used in treatment of thyroid diseases and also used as a component of weight-loss preparations.
Comfrey	Herb consumed in teas and as fresh leaves for salads; however, it contains pyrrolizidine alkaloids (e.g., symphatine), which are known to be toxic. Used externally as an anti-inflammatory agent in the treatment of bruises, sprains, and other external wounds. Based in part on NTP studies on the alkaloid components of comfrey, the FDA has recommended that manufacturer of dietary supplements containing this herb remove them from the market.

Echinacea purpurea extract	The most commonly used medicinal herb in the United States (2002). Used as an mmunostimulant to treat colds, sore throat, and flu.
Ephedra	Also known as Ma Huang: Traditionally used as a treatment for symptoms of asthma and upper respiratory infections. Often found in weight loss and "energy" preparations, which usually also contain caffeine. Use has been associated with side effects such as heart palpitations, psychiatric and upper gastrointestinal effects, and symptoms of autonomic hyperactivity such as tremor and insomnia, especially when take with other stimulants.
Ginkgo biloba extract	Ginkgo fruit and seeds have been used medicinally for thousands of years. The extract of green-picked leaves has shown increasing popularity in the United States. Ginkgo biloba extract promotes vasodilatation and improved blood flow and appears beneficial, particularly for short-term memory loss, headache, and depression.
Ginseng and Ginsenosides	Ginsenosides are thought to be the active ingredients. Ginseng has been used as a treatment for a variety of conditions: hypertension, diabetes, and depression, and been associated with various adverse health effects.
Goldenseal	Traditionally used to treat wounds, digestive problems, and infections. Current uses include as a laxative, tonic, and diuretic. Mistakenly thought to disguise the presence of other drugs in drug tests.
Green Tea Extract	Used for its antioxidative properties,
Kava kava	has psychoactive properties, and is sold as a calmative and antidepressant. A recent report of severe liver toxicity has led to restrictions of its sale in Europe and apparently affected sales in the United States. Some components may alter efficacy/toxicity of therapeutic agents.
Milk Thistle Extract	Used to treat depression and several liver conditions including cirrhosis and hepatitis and to increase breast milk production.
Pulegone	A major terpenoid constituent of the herb, Pennyroyal, is found in lesser concentrations in other mints. Pennyroyal has been used as a carminative insect repellent, emmenagogue, and abortifacient. Pulegone has well-recognized toxicity to the liver, kidney, and central nervous system.
Senna	Laxative with increased use due to the removal of one of the widely used chemical-stimulant type laxatives from the market
Thujone	Terpenoid found in a variety of herbs, including sage and tansy, and in high concentrations in wormwood. Suspected as the causative toxic agent associated with drinking absinthe, a liqueur flavored with wormwood extract.

Are "natural" remedies better?

Are "natural" remedies safe?

Are "natural" remedies worth the money?

Should "natural" remedies be subject to the same regulations as "drugs"?

• "Natural" plant products are not necessarily distinctly different from "drugs". The majority of drugs are derived from or based on plants.

• "Natural" does not mean "meant for the human body". Nature is full of poisons!

• Use of natural remedies still relies on knowledge and careful use.

Herbal/Natural Remedies: Buyer Beware

• Purity, safety, effectiveness or batch-to-batch quality control of herbals are NOT regulated by FDA (see Nov, 1995 Consumer Reports)

• No FDA regulation of claims made on packages except that they cannot say that they treat a specific illness; no research required.

• Huge herbal/supplement lobby has successfully campaigned against regulation.

• Don’t assume they are safe - read about them in reputable source (Herbs of Choice, Honest Herbal).

Example:

Ginseng (used to improve health and energy)

• Rite Aid Imperial ~.001% ginsenosides

• Naturally Korean ~.003%

• Solger Korean, Nature’s Resource, KRG Korean Red ~.025%

• Ginsana ~.030%

• American Ginseng ~.050%

• Herbal Choice .065%

• Walgreen’s Gin-Zing .076%

Herbal/Natural Remedies: Buyer Beware

• Brands may vary 80 fold in concentration of active ingredient – some may be inactive! (see 19)

• Select standardized brands with concentration and dose information. (Nature’s Way, Quanterra, Lichtwer, Bayer)

• Tell your doctor what you are taking – herbs can produce drug interactions and side effects; avoid herb mixtures

• Even beneficial herbs, like beneficial drugs, may not be for every person.

Examples

• Chamomile –used as a digestive and anti-inflammatory, but may irritate those with ragweed/flower allergies

• Echinacea – may boost immunity but shouldn’t be used in pregnancy or autoimmune disorders

Ma Huang, Ephedra, and Ephedrine Containing Products

• Wide range of "herbals" and "supplements" and some OTCs contain these stimulants

• amphetamine-like but not quite as potent or psychoactive, but does stimulate body

• properly used (low doses, occasional) these have been safe and beneficial (e.g. Anti-asthma)

• higher doses or unknown doses much riskier even in young people (stroke, heart attack)

• as with other diet drugs, weight loss tends to be temporary

Ephedra

St. Johns-Wort (Hypericum perforatum)

• ~300 mg of .3% extract is effective in treating mild /moderate depression (not serious cases)

• takes 2-4 weeks for hypericin to work (like drugs)

• Blocks reuptake of 5HT, NE and DA

• side effects: restlessness, stomach upset, dry mouth, dizziness, photosensitivity

• don’t use WITH other antidepressants; don’t use in pregnancy

• Interferes with a CYP enzyme changing sensitivity to drugs such as codeine, caffeine & psychotherapeutic drugs

Other Herbals of Interest

• Ginkgo- may improve blood flow to brain, sold for "mental sharpness" (but increases your tendency to bleed)

Kava

• South Pacific sedative/intoxicant

• antianxiety, sleep-promoting depressant-like action (interacts with other depressants)

Valerian

• also produces mild depressant action

• Kava and Valerian seem to act on GABA receptors like depressant drugs

Sample Drug Interactions

• Gingko & blood thinners

• St. John’s Wort & antidepressants

• Ephedra & caffeine, decongestants, stimulants

• Ginseng and warfarin (Coumadin)

• Kava & sedatives, alcohol, sleeping aids, antipsychotics

• So it is even more important to be a cautious informed consumer of natural/herbal remedies and supplements since regulatory agencies, in this case, cannot protect you.

Toxic Herbs Still Sold

• Chapparal & Comfrey – causes liver damage

• Ephedra (Ma huang) – hi BP and HR, increased risk of stroke, heart attack

• Lobelia – vomiting, seizures, coma

• Yohimbe – GI problems, psychosis, paralysis

Examples of herbal side effects

• Ginkgo – bleeding

• St. John’s Wort – GI upset, fatigue, dizziness, confusion, dry mouth, allergic reactions

• Ephedra – hi BP, arrhythmias, anxiety, insomnia, tremors, kidney stones

• Kava – sedation, slurring, ocular & neck spasms, rash, PD-like symptoms

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