top herbal products

8/6/2019 Top Herbal Products

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Top Herbal Products: Efficacy and SafetyConcerns

Darrell T. Hulisz, PharmD

Introduction

A recent survey estimated that more than 38 million adults in theUnited States used herbal products and dietary supplements in 2002.[1]

More than half of those users said that these products were importantto their health and well-being, yet only one third told a conventionalhealthcare provider about their use.

Other reports have estimated that 25% of patients who seek medicalattention for a serious medical problem are using "unconventional"therapies, and 70% of those patients do not disclose those practices totheir physician.[2,3] One survey estimated that about 18% of the USpopulation uses herbal therapy on a regular basis.[4]

Herbal products and dietary supplements are widely available insupermarkets and other retail outlets, as well as by mail order. In fact,

only a small percentage of these products (4.5%) are actually sold inpharmacies.[5] Many patients believe they derive health benefits fromthese herbal preparations, yet some remain skeptical and may seekadvice from health professionals prior to use. Thus, it is important forall health professionals to be informed about available products and tobe aware of any potential problems associated with their use.

Concerns About Herbal Products and Dietary Supplements

Unlike prescription and over-the-counter drugs, herbal products are not

regulated by the US Food and Drug Administration (FDA) to determinepurity or potency.[6] In fact, some products may contain contaminants,and their potency is dependent on many factors, such as the climateand soil conditions where they are grown, harvested, and stored. [7]

Some herbal preparations have even been found to containprescription drugs and heavy metals as unlabeled ingredients, and insome cases, these contaminants have resulted in toxicities.[8-17]

The labeling of herbal products is regulated by the Dietary SupplementHealth and Education Act of 1994 (DSHEA).[18] Under this law,

manufacturers may only make general claims about a supplement'seffect on the structure or function of the human body (eg, "supports the


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immune system"). They must include the following statement in theirlabeling: "This product is not intended to diagnose, treat, cure, orprevent any disease."

The labels on herbal products are designed to promote product useand not necessarily to inform the consumer, so health professionalsshould be equipped with a general understanding of popular herbs andsupplements, including knowledge of efficacy, common side effects,risks, and interactions. In addition, they should prospectively seekinformation regarding their patients' use of unconventional medicinesto avoid adverse consequences.

Consumers should be advised that manufacturers of herbalsupplements are not required to demonstrate safety or efficacy prior to

marketing. Before the FDA can remove a product from the market, theagency must prove that the product is unsafe or ineffective. Recentexamples of this include the ban on products containing ephedra dueto adverse cardiovascular effects,[19] and the prohibition of kava amidconcerns about hepatotoxicity.[20]

Patients with medical illness should not use herbs and dietarysupplements without medical supervision. As will be discussed, someherbal products have adverse effects and may interact with prescribedmedications. Furthermore, many conditions that patients try to

diagnose or treat themselves may be serious, requiring a carefulhistory and examination by a healthcare professional. For example,unsupervised use of saw palmetto for urinary symptoms may delay adiagnosis of prostate cancer.[21] Similarly, patients with symptoms suchas chronic insomnia, anxiety, and depressed mood should see theirhealth provider. Patients with cardiovascular disease, hypertension,heart failure, and hyperlipidemia should be under a healthcareprofessional's care and receive appropriate prescription drugs.

The following is an overview of some of the most commonly usedherbal products, including important clinical considerations in the useof these products.

Echinacea for Fighting Cold Symptoms, Boosting Immunity

Echinacea is one of the most popular herbs in the United States,extracted from the purple coneflower that is native to North America.Species include Echinacea purpurea, Echinacea angustifolia, andEchinacea pallida. It has been studied as an adjunct therapy to

enhance the immune system, mostly in upper respiratory tractinfections, and these studies have produced mixed results.[22,23]


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A recent meta-analysis concluded that standardized extracts ofechinacea were effective in the prevention of common cold symptomsafter clinical inoculation, when compared with placebo.[23] The authorsof that study concluded that the likelihood of experiencing a cold was

55% higher with placebo than with echinacea (P< .043).

Some antiviral and bacteriostatic properties have been demonstratedin vitro, and the herb also appears to stimulate the production ofcytokines (interferon, tumor necrosis factor, and interleukins).[24] Animalstudies have revealed probable mechanisms of echinacea-inducedimmune enhancement, such as increasing the number of circulatingwhite blood cells.[25]

Common side effects of echinacea supplements include unpleasant

taste and allergic reactions. Because the flower is related to ragweed,cross allergenicity may occur in individuals allergic to ragweed.[26,27]

Echinacea is not recommended in patients with progressive orautoimmune disorders, including acquired immunodeficiencysyndrome, tuberculosis, multiple sclerosis, collagen disorders, anddiabetes mellitus. Theoretically, since echinacea alters the immunesystem, these disorders may be exacerbated.[28,29] Persistent use ofechinacea has been associated with hepatotoxicity, so it should not betaken by patients who are taking other known hepatotoxins such as

anabolic steroids, amiodarone, methotrexate, or ketoconazole.[30]

While not all randomized controlled trials performed to date haveshown benefit forEchinacea over placebo,[22,31] a Cochrane review in2006 concluded that the aerial parts ofEchinacea purpurea might beeffective for early treatment of colds in adults.[32]

Unfortunately, the optimal dose of echinacea is unknown, and multipleformulations exist, such as capsules, tinctures, teas, and extractedplant juice. Recommended dosages vary widely; for instance, capsulesof Echinacea purpurea extract range from 100 to 500 mg, withmanufacturers' suggested use ranging from 1 to 4 times daily forcommon cold prevention.

Take-home message: Clinicians should inform patients that a widevariety ofEchinacea preparations and doses have been studied andresults are inconsistent, making it difficult to recommend specificproducts. However, E. purpurea seems to be modestly effective forpreventing the common cold in those at risk (eg, sick contacts).

Evidence that the herb may reduce the duration of cold symptoms hasbeen mixed. Patients allergic to ragweed, with progressive


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autoimmune disorders, and on hepatotoxic drugs should avoidechinacea.

Garlic: Warding Off Cardiovascular Disease?

Allium sativum, commonly known as garlic, has been used for

centuries in cooking because of its flavoring properties. Today, it is

used therapeutically by many consumers to prevent heart disease by

controlling high cholesterol and high blood pressure. The suggested

active ingredients are allicin and alliin.Numerous studies, however,

have produced conflicting results regarding garlic's ability to lower

lipids.[33-40] Positive findings in 3 trials exhibited a lowering of cholesterol

in the range of 6.1% to 11.5%, primarily due to the lowering of low-

density lipoproteins.[33-36] Other studies have yielded neutral orconflicting results.[37-39] One 12-week study tested the use of garlic

powder in ambulatory patients, finding a 14% reduction of serum

cholesterol.[40]

Garlic may have modest antihypertensive effects. Studies havedocumented either a small decline in arterial pressure (5% to 7% mmHg) or no change at all.[41] A meta-analysis of 8 trials revealed 3 studiesthat concluded garlic significantly reduced systolic blood pressure, and

4 studies that found reductions in diastolic blood pressure in patientswith mild hypertension.[42]

With regard to potential adverse effects, garlic has been shown toinhibit platelet aggregation in vitro[43-45] and in vivo[46]; thus, it should beused with great caution in individuals with bleeding disorders or inthose who are receiving antiplatelet therapy.[47] There has been 1report of a spontaneous epidural hematoma occurring with garlicsupplementation, but this appears to be an isolated case.[48]

Garlic may also decrease warfarin concentrations.[49-51] Studies to datehave not confirmed this interaction[52,53]; but particularly closemonitoring of the international normalization ratio (INR) for patientstaking both garlic and warfarin is prudent. Patients taking garlicsupplements should discontinue use 7 to 10 days prior to havingsurgical procedures to avoid the potential for prolonged bleeding.[54]

The most prominent side effect of garlic supplementation ismalodorous breath and garlic-like body odor.


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Take-home message: Garlic should be used cautiously in individualsreceiving antihypertensive medications, and blood pressure should bemonitored carefully; orthostatic hypotension is a rare complication forthose on antihypertensives.[55] Also, garlic should be avoided in those

with a history of orthostasis or unexplained dizziness as well as inpatients taking drugs that can increase bleeding, such as aspirin,warfarin and ibuprofen. A lack of standardization of garlic products andformulations makes it difficult to recommend a dose or specific product.For dyslipidemia, patients may benefit from taking 600 to 1200 mg ofgarlic powder daily in divided doses, or up to 4 g of raw garlic daily.

Ginkgo Biloba for Enhancing Memory, Combating Alzheimer'sDisease

Ginkgo biloba is one of the oldest species of living trees, and ginkgosupplements are derived from the tree's leaves. This herbal remedy ismarketed to improve memory, particularly in elderly individuals. Whileits mechanism of action is not fully understood, ginkgo containsflavonoids, terpenoids, and organic acids that are believed to act asfree radical scavengers. These constituents have been shown to:

Inhibit platelet activation factor (reducing thrombosis);

Dilate arteries and capillaries; and

Block the release of chemotactic factors and inflammatorymediators.

Studies in the United States have found that ginkgo stabilized -- and insome cases improved -- cognitive function and socialization in patientswith Alzheimer's disease, although the clinical significance of theimprovement was not known.[56,57] LeBars and colleagues[56] reviewed2020 patients in an intention-to-treat analysis that resulted in a 1.4-point advantage over placebo in the Alzheimer's Disease Assessment

Scale-Cognitive subscale.

In addition, studies have also demonstrated that the standardizedextract of ginkgo biloba (EgB) 761, is effective in reducing symptoms ofclaudication, giving patients a 50% increase in pain-free walkingdistance.[58]

In contrast, a recent clinical trial failed to demonstrate anyimprovement in cognitive function or in the quality of life in cognitivelyintact, older individuals.[59]


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Ginkgo is considered relatively safe, although the leaves have beenassociated with mild gastrointestinal side effects and headache.Ingestion of ginkgo seeds may result in serious neurologic and allergicreactions; therefore, they are not used for medical purposes.[60,61]

Ingestion of leaf-based extracts has been associated with aspontaneous hyphema (blood in the anterior chamber of the eye) in anelderly man,[62] and with spontaneous subdural hematomas.[63]

However, while some isolated adverse events such as these exist, it isconsidered safe when used as directed.

Ginkgolide B, an active component of ginkgo biloba, is a potentinhibitor of platelet-activating factor, which is necessary for normalplatelet aggregation. As with garlic, it should be avoided in patientsusing anticoagulants or antiplatelet therapy, or in those who have

active bleeding such as peptic ulcer disease. Based on case reports,ginkgo is not recommended in patients with seizure disorders.[64-67]

Standardization of product and recommended dosing is lacking, but atypical dose is 40 mg to 80 mg taken 3 times daily, standardized to24% to 27% ginkgo flavone glycosides and 6% to 7% triterpines perdose. A dose of ginkgo extract EGb 761 at 160 mg daily has shownequivalent efficacy compared with donepezil 5 mg daily for thetreatment of Alzheimer's disease.[68]

Take-home message: Ginkgo is a reasonable therapeutic option inpatients with Alzheimer's disease who are also receiving medical care,but providers should remember that the herb has antiplatelet activityand thus may not be appropriate for patients with bleeding disorder oron antiplatelet or anticoagulation agents.

St. John's Wort Used for Depression

This yellow flowering plant (Hypericum perforatum) is named after St.

John the Baptist. Extracts of the flower have been used for centuries to

treat mental illnesses. The herbal product has 10 constituents, of which

hypericin is believed to be the most active ingredient in treating

depression.St. John's wort has a high affinity for gamma-aminobutyric

acid, which, when stimulated, produces an antidepressant effect.[69]

Hypericin also appears to activate dopamine receptors and inhibit

serotonin receptor expression. In vitro, it has been shown to block

reuptake of serotonin and norepinephrine.[70] These mechanisms may

explain the lag time associated with the effectiveness of the herb.


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A number of studies have examined the effectiveness of St. John'swort in depression.[71,72] A meta-analysis of 23 controlled trialsconcluded that it was more effective than placebo in treating mild-to-moderate depression.[72] In a 12-week study of 135 depressed patients,

the herbal extract (900 mg per day) was found to be more effectivethan fluoxetine (20 mg per day).[73] Other investigators have confirmedthe herb's efficacy over placebo in mild-to-moderate depression.[74]

Because of its pharmacology, St. John's wort should not be taken withprescription serotonin uptake inhibitors, as symptoms of serotoninsyndrome have been observed with co-administration (headache,sweating, dizziness, and agitation).[75-77, 85]

In terms of other contraindications, St. John's wort should be avoided

during pregnancy.[78,79]

It has been associated with photosensitivity.[80]

Studies have shown that the herbal product can reduce plasmaconcentrations of digoxin[77,81] and indinavir.[77,82,83] There have beencases of heart transplant rejection associated with the use of St. John'swort that resulted from a reduction in cyclosporine plasmaconcentrations.[84,85] Breakthrough bleeding and unwanted pregnancieshave been reported in women on concomitant therapy of oralcontraceptives and St. John's wort extract.[85,86] This is likely a result ofSt John's wort-induced decreases in ethinyl estradiol or metaboliteconcentrations due to the herb's ability to induce cytochrome P450

(CYP450)-3A4 isoenzyme.

Take-home message: Patients who are depressed should not takethis herb without medical supervision. St. John's wort should bereserved for the mildly depressed patient with an aversion toprescription medication. Clinicians who recommend this botanicalshould be mindful of the numerous potential drug interactions arisingfrom enzyme induction. The most commonly studied dose fordepression is 300 mg taken 3 times a day, standardized to 0.3% to

0.5% hypericin per dose.

Valerian, Chamomile, Ginger: Calming Agents

Valerian

Valerian root (Valeriana officinalis) has been used for centuries for its

calming effects. Medics gave it to soldiers during World War I for thetreatment of shell shock.[87,88] The active ingredients appear to be


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valepotriates (thought to be responsible for the sedative effects) andvaleric acid, both of which mediate the release of gamma-aminobutyricacid. Randomized clinical trials have demonstrated efficacy of valerianroot extract for treating insomnia.[89,90]

Mild side effects have included paradoxical stimulation (restlessnessand palpitations), especially with long-term use. Valerian should not beused in pregnancy. This herb may have an additive effect with othercentral nervous system depressants. Patients should be cautionedregarding the operation of machinery when initiating therapy until theyare accustomed to the effects. Other potential side effects includeheadaches, excitability, and uneasiness. Typical dosages for insomniaare 200-400 mg (standardized to 0.8%-1% valeric acids per dose) atbedtime.

Chamomile

Few human studies have been published on the use of chamomile(Matricaria recutita), yet it is cultivated worldwide for its sedating andcalming properties. The active component apigenin has been shown tobind the same receptors as benzodiazepines, to exert an anxiolytic andmild sedative effect in mice.[91] Chamomile also has moderateantioxidant, antimicrobial, and antiplatelet activity in vitro.[92]

Chamomile is considered safe by the FDA, but it should be used withcaution in individuals who are allergic to ragweed, as cross-allergenicity may occur. Allergic symptoms include tongue thickness,tight sensation in throat, angioedema of lips and eyes, diffuse pruritis,urticaria, and pharyngeal edema.[93,94] Because of its sedative effects,chamomile should be used with caution when taken in conjunction withmedications that have also sedative side effects, or with alcohol. Oraldoses vary from 400 to 1600 mg per day (standardized to 1.2%apigenin per dose). Chamomile is often brewed as a tea; 1 heaping

teaspoon of dried flowers steeped in hot water for 10 minutes may bedrunk up to 3 times a day.

Ginger

Ginger (Zingiber officinale) is cultivated in Asia, Africa, and theCaribbean. It has been used for centuries as a flavoring agent and forits antiemetic properties. The root produces a volatile oil containingshogaol and gingerol.[95] Gingerol and shogaol have demonstratedanalgesic, anti-inflammatory, sedative, antipyretic, and antitussive

properties in vitro and in animals, as well as antioxidant antimicrobial,antifungal, antineoplastic, and antihypertensive benefits; many of these


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effects have yet to be tested in people, however.[96] Human studieshave shown a significant reduction in nausea in patients withhyperemesis gravidarum taking doses of 250 mg 4 times a day, [96-98]

and in patients with perioperative nausea and vomiting taking doses of

1 g prior to surgery.

[99,100]

A study comparing ginger with 100 mgdimenhydrinate and with placebo found that ginger was superior toboth when patients were subjected to a revolving chair designed toproduce motion sickness.[101]

Ginger has exhibited inhibition of thromboxane synthetase thatresulted in prolonged bleeding.[102] Therefore, it is prudent for thosetaking anticoagulants to have their International Normalized Ratio(INR) monitored closely. Ginger can also cause mild gastrointestinal(GI) upset including heartburn, diarrhea, and mouth irritation.[96]

Take-home message: Valerian, chamomile, and ginger can be safelyrecommended in the majority of patients. These agents have shownmodest efficacy for their primary uses. However, patients with chronicanxiety and insomnia should be under the care of a healthcareprofessional and thus should not attempt self-medication withbotanicals.

Ginseng: A Natural Energy Booster

The term ginseng (Panax ginseng, Panax quinquefolius) means "man-root," and the ancient Chinese believed it could benefit all aspects ofthe human body; today, it is mostly used as an energy booster.[103]

"Siberian ginseng" is derived from the Eleutherococcus senticososshrub and has different properties than ginseng from the Panaxfamily[104]; in fact, federal regulation now requires that this product bereferred to as eleuthero to distinguish the 2 herbs.[105]

Derived from the root of the plant, the ginsenosides found in ginsengare a compilation of more than 20 saponin triterpenes and are thoughtto be the active ingredients.[106] Animal studies suggest that thesesteroid-like compounds work by stimulating the secretion ofadrenocorticotropic hormone, resulting in increased production ofcortisol.[107] The herb may also play a role in stimulating the productionof adrenal hormone precursors.

Ginseng is considered by many to enhance physical, sexual, andmental performance, as well as increase resistance to stress. Becausethese potential benefits are somewhat subjective, however, controlled

clinical trials are difficult to interpret. Generally speaking, results fromclinical trials have been equivocal.[103]


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Although it is much too early to tell how this may affect people withdiabetes, animal studies suggest that ginseng may reduce glucoselevels in obese, diabetic mice.[108,109]

Because it can have a mild stimulant effect, it should be avoided bypatients with cardiovascular disease who are taking other stimulants.Ginseng has also been associated with reversible mastalgia andpostmenopausal bleeding, although this appears to be a rare sideeffect.[110] Overuse of ginseng may be associated with diarrhea,hypertension, nervousness, dermatologic eruptions, and insomnia.This herb has also been associated with a reduction in the INR ofwarfarin-treated patients.[111] In addition, ginseng has been associatedwith altered hemostasis and is therefore contraindicated in patientswith active bleeding; patients receiving anticoagulant and/or

antiplatelet medications should be cautioned against using ginseng.[112]

As with many other herbs, ginseng formulations have not beenstandardized, nor have optimal doses been determined, but commonregimens involve 100-600 mg per day in divided doses.

Take-home message: Historically, many claims have been made bysupporters of Panax ginseng formulations; however, robust clinicaltrials are lacking. Patients who use ginseng should be cautioned not toexceed the labeled dosage since adverse effects may occur. Clinicians

should discourage use in patients who are anticoagulated, and thosewith cardiovascular or metabolic disease, such as hypertension anddiabetes.

Saw Palmetto: Effective for Benign Prostatic Hyperplasia?

The extract for saw palmetto (Serenoa repens) comes from the fruit ofthe palm tree and is often used to treat benign prostatic hyperplasia(BPH). Saw Palmetto extract is thought to inhibit 5-alpha reductaseand thus block the conversion of testosterone to dihydrotestosterone,which is responsible for stimulating growth of the prostate gland.[113] Italso blocks the uptake of both hormones by the prostate. Saw palmettomay exhibit some anti-inflammatory effects, presumably by inhibitingcyclooxygenase pathways.[114]

While early clinical studies suggested a modest benefit of sawpalmetto in BPH, more recent studies are less consistent, and theprecise clinical value of saw palmetto for treating urinary symptomsremains undefined.[115,116] In a recent randomized, double-blind,

placebo-controlled trial, 225 men were given either standardized sawpalmetto 160 mg twice daily or placebo for 1 year.[116] There was no


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significant difference between the 2 groups in the change in objectiveurologic symptom scores, maximal urinary flow rate, prostate size,residual volume after voiding, quality of life, or serum prostate-specificantigen levels. The incidence of side effects was similar in the 2

groups.

Side effects are uncommon with saw palmetto, but they may includeheadache and GI upset. There are no known important druginteractions with this herb.[113] The most commonly used dose fortreating BPH is 160 mg twice daily.

Take-home message: Men with obstructive urinary symptoms shouldnot self-medicate with saw palmetto. Such patients should be undermedical supervision, because the symptoms of BPH can mimic other,

more serious disorders, such as prostate cancer and prostatitis. Thisherb should be reserved for men with mild BPH symptoms who havean aversion to prescription drugs and are also under medical care.

Black Cohosh Used to Ease Hot Flashes

Black cohosh (Cimicifuga racemosa) is a plant native to Eastern NorthAmerica. It contains a group of chemicals referred to asphytoestrogens because they mimic the effects of estrogens. For thisreason it was a common remedy used by Native Americans for the

treatment of painful menses (known as squawroot).

Recent clinical trials indicate that black cohosh is somewhat efficaciousin relieving menopause symptoms.[117-121] The majority of the trials usedthe isopropranolic extract of black cohosh at a total dose of 40-80 mgdaily. Most studies were only conducted for a short duration of either 3or 6 months. Thus, further clinical trials are needed to assess efficacyof black cohosh beyond 6 months. Recent investigations do notsupport the earlier estrogen-receptor mediated theory as a plausiblemechanism of action of black cohosh including a randomized, placebo-controlled, 1-year study of 351 women with menopausal symptomsfailed to confirm efficacy of black cohosh.[122]

Black cohosh is generally considered safe without any major life-threatening adverse events.[121] Some patients may experience mildside effects including rash or GI upset. It should not be used inlactating or pregnant women. Since there is still speculation of anestrogen-like effect, black cohosh use should be avoided in womenwith a history of estrogen-dependent tumors or endometrial cancer.

Most authorities suggest limiting its use to 6 months because no long-term trials have been conducted. Black cohosh offers an alternative to


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estrogen for symptoms of menopause, the most widely studied dose is20-40 mg twice daily standardized to 1 mg triterpene glycosides.

Take-home message: Clinical trials using black cohosh to relievemenopausal symptoms have yielded conflicting results. However,some women experience benefits with the herb without apparent sideeffects. It appears to be safe, but use should be limited to no morethan 6 months and should not be used in those with a history ofestrogen-dependent tumors.

Conclusion

Consumers with serious or chronic health complaints will often self-diagnose and self-treat with herbs and supplements. This is not ideal,

because many of these patients need supervised medical care,especially those with depression, prostate disease, dementia, orchronic insomnia.

Health professionals generally should advise against the use of herbsor supplements during pregnancy or lactation, because the effects onfetal development and breast milk excretion are unknown. Similarly,use in infants and younger children should be discouraged.

Patients should be advised to take the same dosages that have been

studied in clinical trials, and not to exceed labeled amounts. Generally,herbs should be consumed only for a limited time. Patients shouldavoid products with labels that fail to specify the exact amount of theherb contained per dosage unit.

Health professionals should elicit a careful history from patientsregarding any plant allergies, especially to ragweed and daisies,recalling that many patients with allergic rhinitis may not know whatallergens trigger their attacks. Patients who are allergic to ragweed andflowers in the daisy family (asters, chrysanthemums) may have allergic

reactions to products containing echinacea and chamomile. Someherbs are photosensitizing (eg, St. John's wort), and patients should becautioned appropriately (especially fair-skinned individuals).

Patients anticipating surgical procedures should discontinue use ofherbs at least 2 weeks prior to surgery, and should notify theanesthesiologist of any routine herb usage.[54] As discussed, someherbals may interfere with normal blood coagulation, predisposingpatients to prolonged bleeding and interactions with warfarin (eg,

garlic, ginkgo, ginseng, and ginger).


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References

[ CLOSE WINDOW ]

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29. Alternative remedies may activate autoimmune disorders.Health News. 2004;10:15.

30.Miller LG. Herbal medicinals: selected clinical considerationsfocusing on known or potential drug-herb interactions. Arch

Intern Med. 1998;158:2200-2211. Abstract31.Barrett BP, Brown RL, Locken K, Maberry R, Bobula JA,D'Alessio D. Treatment of the common cold with unrefinedEchinacea. A randomized, double-blind, placebo-controlled trial.Ann Intern Med. 2002;137:939-946. Abstract

32. Linde K, Barrett B, Wolkart K, Bauer R, Melchart D.Echinacea for preventing and treating the common cold.Cochrane Database Syst Rev. 2006;CD000530.

33. Lawson D. Human medicinal agents from plants.Springville, Utah: American Chemical Society; 1993.

34.Jain A, Vargas R, Gotzkowsky S, McMahon F. Can garlic reducethe levels of serum lipids? A controlled clinical study. Am J Med.1993;94:632-635. Abstract

35.Adler AJ, Holub BJ. Effect of garlic and fish oil supplementationon serum lipid and lipoprotein concentrations inhypercholesterolemic men. Am J Clin Nutr.1997;65:445-450.Abstract

36.Steiner M, Khan AH, Holbert D. Lin R. A double-blind crossoverstudy in moderately hypercholesterolemic men that comparedthe effect of aged garlic extract and placebo administration onblood lipids. Am J Clin Nutr. 1996;64:866-870. Abstract

37.Byrne Dj, Neil HA, Vallance DT, et al. A pilot study of garlicconsumption shows no significant effect on markers of oxidationor sub-fraction composition of low-density lipoprotein includinglipoprotein(a) after allowance for non-compliance and theplacebo effect. Clin Chim Acta. 1999;285:21-33. Abstract

38.Berthold HK, Sudhop T, von Bergmann K. Effect of garlic oilpreparation on serum lipoproteins and cholesterol metabolism: arandomized controlled trial. JAMA. 1998;279:1900-1902.

Abstract39.Isaacsohn JL, Moser M, Stein EA, et al. Garlic powder and

plasma lipids and lipoproteins: a multicenter, randomized,placebo-controlled trial. Arch Intern Med. 1998;158:1189-1194.Abstract

40. Aue W, Eiber W, Hhertkorn E, et al. Hypertension andhyperlipidemia: garlic helps in mild cases. Br J Clin Pract.1990;69:3-6.

41.Silagy C, Neil A. A meta analysis of the effect of garlic on bloodpressure. J Hypertens. 1994;12:463-468. Abstract

42.Silagy CA, Neil AW. A meta-analysis of the effect of garlic onblood pressure. J Hypertens.1994;12:463-468. Abstract
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43.Scharbert G, Kalb l, Duris M, Marschalek C, Kozek-LangeneckerSA. Garlic at dietary doses does not impair platelet function.Anesth Analg. 2007;105:1214-1218. Abstract

44.Allison GL, Lowe GM, Rahman K. Aged garlic extract and its

constituents inhibit platelet aggregation through multiplemechanisms. J Nutr. 2006;136:782S-788S. Abstract45.Rahman K. Effects of garlic on platelet biochemistry and

physiology. Mol Nutr Food Res. 2007;51:1335-1344. Abstract46.Steiner M, Li W. Aged garlic extract, a modulator of

cardiovascular risk factors : a dose-finding study on the effects ofAGE on platelet functions. J Nutr. 2001;131:980S-984S. Abstract

47. Elmer GW, Lafferty WE, Tyree PT, Lind BK. Potentialinteractios between complementary/alternative products andconventional medicines in Medicare population. Ann

Pharmacother. 2007;41:1617-1624. Epub 2007 September 4.48. Rose KD, Croissant PD, Parliament CF, Levin MP.

Spontaneous spinal epidural hematoma with associated plateletdysfunction from excessive garlic ingestion: a case report.Neurosurgery 1990;26:880-882.

49.Izzo AA, Ernst E. Interactions between herbal medicines andprescribed drugs: a systematic review. Drugs. 2001;61:2163-2175. Abstract

50.Evans V. Herbs and the brain: friend or foe? The effects ofginkgo and garlic on warfarin use. J Neurosci Nurs. 2000;32:229-232. Abstract

51.Fugh-Berman A. Herb-drug interactions. Lancet. 2000;355:134-138. Abstract

52.Vaes LP, Chyka PA. Interactions of warfarin with garlic, ginger,ginkgo, or ginseng: nature of the evidence. Ann Pharmacother.2000;34:1478-1482. Abstract

53.Macan H, Uykimpang R, Alconcel M, et al. Aged garlic extractmay be safe for patients on warfarin therapy. J Nutr.2006;136:793S-795S. Abstract

54.Ang-Lee MK, Moss J, Yuan CS. Herbal medicines andperioperative care. JAMA. 2001;286:208-216. Abstract

55.Staba EJ, Lash L, Staba JE. A commentary on the effects ofgarlic extraction and formulation on product composition. J Nutr.2001;131:1118S-1119S. Abstract

56.Le Bars P, Katz M, Berman N, Turan M, Freedman A,Schatzberg A. A placebo-controlled , double-blind, randomizedtrial of an extract of ginkgo biloba for dementia. JAMA.1997;278:1327-1332. Abstract

57.Hindemarch I, Subhan Z. The pharmacological effects of ginkgobiloba extract in normal healthy volunteers. Int J Clin PharmacolRes. 1984;4:89-93. Abstract
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58. Ernest E. Ginkgo biloba extract in peripheral arterydiseases: a systemic research based on controlled studies in theliterature. Fortsch Med. 1996;114:85-87.

59.Carlson JJ, Farquhar JW, DiNucci E, et al. Safety and efficacy of

a ginkgo biloba-containing dietary supplement on cognitivefunction, quality of life, and platelet function in healthy,cognitively intact older adults. J Am Diet Assoc. 2007;107:422-432. Abstract

60.Rowim J, Lewis SL. Spontaneous bilateral hematomasassociated with chronic ginkgo biloba ingestion have alsooccurred. Neurology. 1996;46:1775-1776. Abstract

61. Woerdengag HJ, Van Beck TA. Ginkgo biloba. AdverseEffects of Herbal Drugs. Vol 3. Berlin, Germany: Springer-Verlag;1997.

62. Rosenblatt M, Mindel J. Spontaneous hyphema associatedwith ingestion of ginkgo biloba extract (letter). N Engl J Med.1997;336:1108.

63.Chung KF, McCusker M, Page CP, Dent G, Guinoit P, BarnesPJ. Effect of ginkolide mixture in antagonizing skin and plateletresponses to platelet activating factor in man. Lancet.1987;1:248-251. Abstract

64.Granger AS. Ginkgo biloba precipitating epileptic seizures. AgeAgeing. 2001;30:523-525. Abstract

65. Spinella M. Herbal medicines and epilepsy: the potentialfor benefit and adverse effects Epilepsy Behav. 2001;2:524-532.

66.Harms SL, Garrard J, Schwinghammer P, Eberly LE, Chang Y,Leppik IE. Ginkgo biloba use in nursing home elderly withepilepsy or seizure disorder. Epilepsia. 2006;47:323-329.Abstract

67.Kupiec T, Raj V. Fatal seizures due to potential herb-druginteractions with Ginkgo biloba. J Anal Toxicol. 2005;29:755-758.Abstract

68.Mazza M, Capuano A, Bria P, Mazza S. Ginkgo biloba and

donepezil: a comparison in the treatment of Alzheimer'sdementia in a randomized placebo-controlled double-blind study.Eur J Neurol. 2006;13:981-985. Abstract

69. Muller W. Effects of Hypericum extract on the suppressionof serotonin receptors. J Geriat Psychiatry Neurol. 1994;7:s63-64.

70.Muller WE, Rolli M, Schafer C, Hafner U. Effects of hypericumextract (LI 160) in biochemical models of antidepressant activity.Pharmacopsychiatry. 1997;30:102-107. Abstract

71.Gastpar M, Singer A, Zeller K. Comparative efficacy and safetyof a once-daily dosage of hypericum extract STW3-VI andcitalopram in patients with moderate depression: a double-blind,
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randomised, multicentre, placebo-controlled study.Pharmacopsychiatry. 2006;39:66-75. Abstract

72.Linda K, Gilber R, Murlow C, Paulis A, Weidenhammer W,Meichart D. St. John's wort for depression: an overview and

meta-analysis of randomized trials. BMJ. 1996;313:253-257.Abstract73.Fava M, Alpert J, Nierenberg AA, et al. A double-blind,

randomized trial of St John's wort, fluoxetine, and placebo inmajor depressive disorder. J Clin Psychopharmacol.2005;25:441-447. Abstract

74.Lecrubier Y, Clerc G, Didi R, Kieser M. Efficacy of St. John's wortextract WS 5570 in major depression: a double-blind, placebo-controlled trial. Am J Psychiatry. 2002;159:1361-1366. Abstract

75.Barnes J, Anderson LA, Phillipson JD. St John's wort (Hypercum

perforatum L.): a review of its chemistry pharmacology andclinical properties. J Pharm Pharmacol. 2001;53:583-600.Abstract

76.Zhou S, Chan E, Pan SQ, Huang M, Lee EJ. Pharmacokineticinteractions of drugs with St John's wort. J Psychopharmacol.2004;18:262-276. Abstract

77.Izzo AA. Drug interactions with St. John's wort (Hypericumperforatum): a review of the clinical evidence. Int J ClinPharmacol Ther. 2004;42:139-148. Abstract

78. Grush LR, Nierenberg A, Keefe B, et al. St. John's wortduring pregnancy. JAMA. 1998;280:1566.

79.Duqoua JJ, Mills E, Perri D, Korean G. Safety and efficacy of St.John's wort (hypericum) during pregnancy and lactation. Can JClin Pharmacol. 2006;13:e268-e276. Abstract

80. Lane-Brown MM. Photosensitivity associated with herbalpreparations of St John's wort (Hypericum perforatum). Med JAust. 2000;172:302.

81.Johne A, Brockmoller J, Bauer S, Maurer A, Langheinrich M,Roots I. Pharmacokinetic interaction of digoxin with an herbal

extract from St. John's wort (Hypericum perforatum). ClinPharmacol Ther. 1999;66:338-345. Abstract

82.Piscitelli SC, Burstein AH, Chaitt D, Alfaro RM, Falloon J.Indinavir concentrations and St. John's wort. Lancet.2000;355:547-548. Abstract

83.Piscetelli SC, Burstein AH, Chaitt D, Alfaro RM, Falloon J.Indinavir concentrations and St John's wort. Lancet.2000;355:547-548. Abstract

84.Ruschitzka F, Meier PJ, Turina M, Luscher TF, Noil G. Acuteheart transplant rejection due to St. John's wort. Lancet.2000;355:548-549. Abstract
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85.Mannel M. Drug interactions with St John's wort: mechanismsand clinical implications. Drug Saf. 2004;27:773-797. Abstract

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486. Abstract90. Donath F, Quispe S, Diefenbach K, Maurer A, Fietze I,

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91.Viola H, Wasowski C, Levi de Stein M, et al. Apigenin, acomponent of Matricaria recutita flowers, is a centralbenzodiazopine receptor-ligand with anxiolytic effects. PlantaMed. 1995;61:213-216. Abstract

92.McKay DL, Blumberg JB. A review of the bioactivity and potentialhealth benefits of chamomile tea (Matricaria recutita L.).Phytother Res. 2006;20:519-530. Abstract

93. Casterline CL. Allergy to chamomile tea. JAMA.1980;4:330-331.

94.Benner MH, Lee HJ,. Anaphylactic reaction to chamomile tea. JAllergy Clin Immunol. 1973;52:307-308. Abstract

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96.White B. Ginger: an overview. Am Fam Physician.

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and vomiting with ginger. Ann Pharmacother. 2005;39:1710-1713. Epub 2005 August 30.

98.Borrelli F, Capasso R, Aviello G, Pittler MH, Izzo AA.Effectiveness and safety of ginger in the treatment of pregnancy-induced nausea and vomiting. Obstet Gynecol. 2005;105:849-856. Abstract

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101. Mowrey DB, Clayson DE. Motion sickness, ginger and

psychophysics. Lancet. 1982;1:655-657. Abstract102. Backon J. Ginger: inhibition of thromboxane synthetaseand stimulation of prostacycline: relevance for medicine andpsychiatry. Med Hypothesis. 1986;20:271-278.

103. Coleman CI, Hebert JH, Reddy P. The effects of Panaxginseng on quality of life. J Clin Pharm Ther. 2003;28:5-15.Abstract

104. Harkey MR, Henderson GL, Gershwin ME, Stern JS,Hackman RM. Variability in commercial ginseng products: ananalysis of 25 preparations. Am J Clin Nutr. 2001;73:1101-1106.

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106. Radad K, Gille G, Liu L, Rausch WD. Use of ginseng inmedicine with emphasis on neurodegenerative disorders. JPharmacol Sci. 2006;100:175-186. Epub 2006 March 4.

107. Kim DH, Moon YS, Jung JS, Min S. Effects of ginsengsaponin administered intraperitoneally on the hypothalamo-pituitary-adrenal axis in mice. Neurosci Lett. 2003;343:62-66.Abstract

108. Xie JT, Wang CZ, Ni M, et al. American ginseng berry juiceintake reduces blood glucose and body weight in ob/ob mice. JFood Sci. 2007;72:S590-S594. Abstract

109. Yoon SH, Han EJ, Sung JH, Chung SH. Anti-diabeticeffects of compound K versus metformin versus compound K-metformin combination therapy in diabetic db/db mice. BiolPharm Bull. 2007;30:2196-2200. Abstract

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114. Buck AC. Is there a scientific basis for the therapeuticeffects of serenoa repens in benign prostatic hyperplasia?Mechanisms of action. J Urol. 2004;172:1792-1799. Abstract

115. Avins AL, Bent S. Saw palmetto and lower urinary tract

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benign prostatic hyperplasia. N Engl J Med. 2006;354:557-566.Abstract

117. Jacobson JS, Troxel AB, Evans J, et al. Randomized trialof black cohosh for the treatment of hot flashes among womenwith a history of breast cancer. J Clin Oncol. 2001;19:2739-2745.Abstract

118. Wuttke W, Seidlova-wuttke D, Gorkow C. The Cimicifuga

preparation BNO 1055 vs. conjugated estrogens in a double-blind placebo-controlled study: effects on menopause symptomsand bone markers. Maturitas. 2003;44:S67-S77. Abstract

119. Frei-Kleiner S, Schaffner W, Rahlfs VW, Bodmer CH,Birkhauser M. Cimicifuga racemosa dried ethanolic extract inmenopausal disorder: a double-blind placebo-controlled clinicaltrial. Maturitas. 2005;51:397-404. Abstract

120. Nappi RE, Malavasi B, Brundu B, Facchinetti F. Efficacy ofCimicifuga racemosa on climacteric complaints: a randomizedstudy versus low-dose transdermal estradiol. GynecolEndocrinol. 2005;20:30-35. Abstract

121. Osmers R, Friede M, Liske E, Schnitker J, FreudensteinJ,Henneicke-von Zepelin HH. Efficacy and safety of ispropranolicblack cohosh extract for climacteric symptoms. Obstet Gynecol.2005;105:1074-1083. Abstract

122. Newton KM, Reed SD, LaCroix AZ, Grothaus LC, EhrlichK, Guiltinan J. Treatment of vasomotor symptoms of menopausewith black cohosh, multibotanicals, soy, hormone therapy, orplacebo: a randomized trial. Ann Intern Med. 2006;145:869-879.

Abstract
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