Friday, October 11, 2019

(Panax ginseng C.A. Mey.) +++ (Siberian Ginseng)



HERBAL 
MEDICINAL








Siberian Ginseng

GINSENG, ORIENTAL GINSENG
(Panax ginseng C.A. Mey.) +++



BY 

RETTODWIKART THENU













Siberian Ginseng
GINSENG, ORIENTAL GINSENG
(Panax ginseng C.A. Mey.) +++



HISTORICAL NOTE (Braun, L and Cohen, M. 2010)
Siberian ginseng has been used for over 2000 years, according to Chinese medical records, where it is referred to as Ci Wu Jia. It was used to prevent colds and flu and to increase vitality and energy. In modern times, it has been used by Russian cosmonauts for improving alertness and energy and to aid in adaptation to the stresses of life in space. It also has been used as an ergogenic aid by Russian athletes before international competitions (Mills & Bone 2000) and used after the Chernobyl accident to counteract the effects of radiation (Chevallier 1996).

SUMMARY AND PHARMACEUTICAL COMMENT (Barnes, J et al., 2007)
The chemistry of Panax ginseng root is well documented. Research has focused mainly on the saponin components (ginsenosides), which are generally considered to be the main active constituents, although pharmacological actions have been documented for certain non-saponin components, principally polysaccharides. Many of the pharmacological actions documented for ginseng, at least in preclinical studies, directly oppose one another and this has been attributed to the actions of the individual ginsenosides. For example, ginsenoside Rb–1 exhibits CNS-depressant, hypotensive and tranquillising actions whilst ginsenoside Rg–1 exhibits CNSstimulant, hypertensive and anti-fatigue actions. These opposing actions are thought to explain the ’adaptogenic’reputation of ginseng, that is the ability to increase the overall resistance of the body to stress and to balance bodily functions. Preclinical studies have indicated that preparations of Panax species and/or their isolated constituents have a range of pharmacological properties; results of these studies provide some supporting evidence for the traditional uses and adaptogenic properties for certain Panax species preparations, although pharmacological explanations for the observed actions are less well understood.
Clinical trials of Panax species preparations have focused on assessing effects related to the reputed adaptogenic properties of this herbal medicinal product, although rigorous clinical investigations are limited. Studies have tested different preparations of different Panax species and different commercial products (which vary qualitatively and quantitatively in their phytochemical composition) administered according to different dosage regimens, and to different study populations making interpretation of the results difficult. At present there is insufficient evidence to support definitely the efficacy of specific Panax species preparations in the various indications for which they are used and/or have been tested.
Similarly, there are only limited clinical data on safety aspects of Panax species preparations. Clinical trials of Panax species root preparations typically have involved small numbers of patients and been of short duration, so have the statistical power only to detect very common, acute adverse effects. The available evidence suggests that preparations of Panax species root are well-tolerated when used for limited periods of time at recommended doses. Rigorous investigation of safety aspects of well-characterised Panax species root preparations administered orally at different dosages, including the effects of long-term treatment, is required. In view of the many pharmacological actions documented, the potential for preparations of Panax species to interfere with other medicines administered concurrently, particularly those with similar or opposing effects, should be considered. In general, and in view of the lack of safety data, it is appropriate to advise against the long-term or otherwise excessive use of Panax species. The use of Panax species during both pregnancy and breastfeeding should be avoided.


SPECIES (FAMILY) (Barnes, J et al., 2007)
Various Panax species (Araliaceae) including:
*Panax ginseng Meyer
†Panax quinquefolius L.
‡Panax notoginseng (Burk.) Chen ex C.Y. Wu
This monograph focuses on P. ginseng, although some information on other Panax species is also included.

SYNONYM(S) (Barnes, J et al., 2007)
*P. quinquefolius var. coreensis Sieb., P. schin-seng T. Nees, P. schin-seng var. coraiensis T. Nees, P. versus Oken, Ren Shen, Asian Ginseng, Chinese Ginseng, Korean Ginseng, Oriental Ginseng
†P. quinquefolius var. americanus Raf., P. quinquefolius var. obovatus Raf., P. cuneataus Raf., P. americanus var. elatus Raf., American Ginseng
‡Aralia quinquifolia var. notoginseng (Burk.), P. Pseudoginseng var. notoginseng (Burk.) Hoo & Tseng, San Qi, Sanchi Ginseng, Tienchi Ginseng

OTHER COMMON NAMES (Linda, S-R. 2010)
American ginseng, Asiatic ginseng, Chinese ginseng, fi ve-fi ngers, Japanese ginseng, jintsam, Korean ginseng, ninjin, Oriental ginseng, schinsent, seng and sang, tartar root, Western ginseng

OTHER NAMES (Braun, L and Cohen, M. 2010)
Ci Wu Jia, devil’s bush, devil’s shrub, eleuthero, eleutherococcus, eleuthero root, gokahi, ogap’I, russisk rod, taigawurzel, touch-me-not, Wu Jia Pi

ORIGIN (Linda, S-R. 2010)
Ginseng is now found throughout the world. Panax quinquefolius is native to North America; Panax ginseng is native to the Far East.

PART(S) USED
Root. White ginseng represents the peeled and sun-dried root whilst red ginseng is unpeeled, steamed and dried.

USES (Linda, S-R. 2010)
Ginseng has been used for a variety of purposes for about 5000 years. It has been used to increase physical endurance and lessen fatigue, to improve the ability to cope with stress, and to improve concentration. It also may improve overall well-being. Many herbalists consider it a tonic.
Investigational Uses
Initial research is exploring the use of ginseng to improve cognitive functioning and to treat diabetes mellitus, hyperlipidemia, seizure disorders, cancer, male infertility, male erectile dysfunction, emphysema, and rheumatoid arthritis and to enhance immunity.


PHARMACOPOEIAL AND OTHER MONOGRAPHS (Linda, S-R. 2010)
BHC 1992(G6)
BHP 1996(G9)
BP 2007(G84)
Complete German Commission E(G3)
Martindale 35th edition(G85)
Ph Eur 2007(G81)
USP29/NF24(G86)

LEGAL CATEGORY (LICENSED PRODUCTS) (Linda, S-R. 2010)
GSL(G37)

CONSTITUENTS

CONSTITUENTS (Linda, S-R . 2010)
The following is compiled from several sources, including General References G2 and G6.
Terpenoids Complex mixture of compounds (ginsenosides or panaxosides) involves three aglycone structural types – two tetracyclic dammarane-type sapogenins (protopanaxadiol and protopanaxatriol) and a pentacyclic triterpene oleanolic acidtype. Different naming conventions have been used for these compounds. In Japan, they are known as ginsenosides and are represented by Rx where 'x' indicates a particular saponin. For example, Ra, Rb-1, Rc, Rd, Rg-1. In Russia, the saponins are referred to as panaxosides and are represented as panaxoside X where 'X' can be A–F. The suffixes in the two systems are not equivalent and thus panaxoside A does not equal Ra but Rg-1.(1) The saponin content varies between different Panax species. For example, in P. ginseng the major ginsenosides are Rb-1, Rc and Rg-1 whereas in P. quinquefolis Rb-1 is the only major ginsenoside.(1)

OTHER CONSTITUENTS (Linda, S-R. 2010)
Volatile oil (trace) mainly consisting of sesquiterpenes including panacene, limonene, terpineol, eucalyptol, a-phellandrene and citral,(2) sesquiterpene alcohols including the panasinsanols A and B, and ginsenol,(3, 4) polyacetylenes,(5, 6) sterols, polysaccharides (mainly pectins and glucans),(7) starch (8– 32%), b-amylase,(8) free sugars, vitamins (B1, B2, B12, panthotenic acid, biotin), choline (0.1–0.2%), fats, minerals. The sesquiterpene alcohols are stated to be characteristic components of Panax ginseng in that they are absent from the volatile oils of other Panax species.(4)

CHEMICAL COMPONENTS (Braun, L and Cohen, M. 2010)
Glycosides (eleutherosides A–M, including saponins, coumarins, lignans, phenylpropanoids, oleanolic acids, triterpenes, betulinic acid and vitamins), steroid glycoside (eleutheroside A), lignans (syringin, sesamin, chlorigenic acid), glycans (eleutherans A–G), triterpenoid saponins (friedelin), saponin (protoprimulagenin A), hydroxycoumarin (isofraxidin), phenolics, polysaccharides, lignans, coumarins and resin. Nutrients include magnesium 723 microgram/g, aluminium 188 microgram/g and manganese 37 microgram/g and vitamins A and E (Eleutherococcus senticosus 2006, Meacham et al 2002, Nissen 2003, Skidmore-Roth 2001, Panossian et al 1999).

QUALITY OF PLANT MATERIAL AND COMMERCIAL PRODUCTS
According to the British and European Pharmacopoeias, Panax ginseng consists of the whole or cut dried root, designated as white ginseng, treated with steam and then dried, designated red ginseng, of Panax ginseng C.A.Meyer.(G81, G84) As with other herbal medicinal products, there is variation in the qualitative and quantitative composition of crude plant material obtained from Panax species and commercial Panax ginseng preparations and those derived from other Panax species. Thirty seven commercial samples of root from P. ginseng (n = 22), P. quinquefolius (n = 10) and P. notoginseng (n = 5) obtained from herbal outlets in Taiwan were analysed to determine their respective chemical profiles.(9) The saponin content of P. notoginseng and P. quinquefolius was higher than that of P. ginseng, although statistical analyses to support this were not performed. Mean total saponin (Rb–1, Rb–2, Rc, Rd, Re, Rf, Rg–1) contents for P. notoginseng, P. quinquefolius wild, P. Quinquefolius cultivated, P. ginseng white, and P. ginseng red were 118.7, 58.0, 43.1, 5.2 and 5.9 mg/g, respectively. Variations in total saponin content within species and types of ginseng were also found: P. notoginseng 23.8–30.7, P. quinquefolius wild 8.7–24.0, P. quinquefolius cultivated 8.4–19.5, P. ginseng white 3.5–9.0, and P. ginseng  red 3.9–7.2 mg/g.(9) In another analytical study, the saponin content of 47 samples of ginseng obtained from 12 Panax taxa was examined using reverse-phase high-performance liquid chromatography. Material from P. ginseng was found to have the lowest total saponin content (5.8–15.6 mg/g).(10) Analysis using gas chromatography (GC) and GC-mass spectrometry of best-selling commercial preparations of Panax species purchased from pharmacies and health-food stores in European countries, Argentina, Canada, China and the USA found variations in their saponin content: P. ginseng, pure root preparations, 1.9–8.1% (n = 14); P. ginseng, extract preparations, 4.9–13.3% (n = 20); P. quinquefolius, 5.2% (n = 1); P. notoginseng, 7.5% (n = 1).(11) Analysis of 25 'ginseng' products available for purchase from a health-food store in the USA included eight products labelled as containing Panax ginseng, four labelled as containing P. quinquefolius, one labelled as containing P. notoginseng, and three labelled as containing mixtures of different species.(12) All of the products labelled as containing Panax species contained ginsenosides, although total ginsenoside content varied: monopreparations of  powdered P. ginseng, 0.29–3.36 mg/100 g product (n = 6); monopreparations of powdered P. quinquefolius, 1.24–2.91 mg/100 g product (n = 2); monopreparation of powdered P. notoginseng, 4.27 mg/100 g product (n = 1); liquid monopreparations of P. ginseng, 0.44–0.69 mg/100 mL product (n = 2); liquid monopreparations of P. quinquefolius, 0.78–1.30 mg/100 mL product (n = 2). Of the 16 products containing Panax species, seven were labelled as containing a specific concentration of ginsenosides, yet the actual content deviated from the labelled amount, containing 18.0–136.8% of the amount stated on the label.(12) All but one of these products contained a lower concentration of ginsenosides than the labelled amount. In 2005, the USA Department of the Interior Fish and Wildlife Service determined that wild P. quinquefolius root must be at least ten years old and have four 'prongs' or leaves before it can be legally exported from the USA.(13) This decision extended the previous five-year minimum age limit determined by the Convention on International Trade in Endangered Species (CITES).(14)

FOOD USE (Barnes, J et al., 2007)
Ginseng (P. ginseng) is listed by the Council of Europe as a natural source of food flavouring (category N2). This category indicates that ginseng can be added to foodstuffs in small quantities, with a possible limitation of an active principle (as yet unspecified) in the final product.(G16)

HERBAL USE (Barnes, J et al., 2007)
Ginseng (P. ginseng) is stated to possess thymoleptic, sedative, demulcent and stomachic properties, and is reputed to be an aphrodisiac. Traditionally, it has been used for neurasthenia, neuralgia, insomnia, hypotonia, and specifically for depressive states associated with sexual inadequacy.(G2, G6, G8, G64) P. ginseng and other Panax species have been used traditionally in Chinese medicine for many thousands of years. Uses include as a stimulant, tonic, diuretic and stomachic,(15) but typically the different species have different clinical uses. Traditionally, use has been divided into two categories: short-term – to improve stamina, concentration, healing process, stress resistance, vigilance and work efficiency in healthy individuals, and long-term –to improve well-being in debilitated and degenerative conditions especially those associated with old age.


Figure 1. Panax ginseng – dried drug substance (root).


DOSAGE

PRODUCT AVAILABILITY (Linda,S-R. 2010)
Capsules, dried root used for decoction, extract, powder, standardized extract, tea, tincture; may be found in creams and lotions used to treat wrinkles
Plant Part Used: Roots

DOSAGES (Linda,S-R. 2010)
Standardized extracts contain 5% ginsenosides (an aglycone chemical component believed to act as a stimulant).
General Use
• Adult PO capsules: 200-500 mg extract daily (Blumenthal, 1998)
• Adult PO infusion: pour boiling water over 3 g herb, let stand 10 min, strain; may be taken tid for 3-4 wk
• Adult PO powdered root: 1-4 g daily
• Adult PO standardized extract: 200-500 mg daily (Blumenthal, 1998)
• Adult PO tincture: 1-2 ml extract daily (1:1 dilution) (Blumenthal, 1998)
Male Infertility
• Adult PO crude herb (root, high quality): 1.5-2 g tid (Murray, Pizzorno, 1998)
• Adult PO extract: 100-200 mg tid standardized to 5% ginsenosides (Murray, Pizzorno, 1998)
Rheumatoid Arthritis
• Adult PO crude herb: 4.5-6 g/day in divided doses
• Adult PO extract: 500 mg daily-tid
Attention Defi cit Hyperactivity Disorder
• Child PO: 200 mg bid in combination with ginkgo biloba _ 4 wk

DOSAGE (Barnes, J et al., 2007)
Traditionally, dosage recommendations differ for short-term use by healthy individuals and long-term use by elderly or debilitated persons. 
·         Short-term (for younger and healthy individuals) 0.5–1.0 g root daily, as two divided doses, for a course generally lasting 15–20 days and with a treatment-free period of approximately two weeks between consecutive courses. Doses are recommended to be taken in the morning, two hours before a meal, and in the evening, not less than two hours after a meal.(15)
·         Long-term (for older individuals and those with poor health) 0.4–0.8 g root daily. Doses may be taken continuously.(1) In China, doses used traditionally and currently are typically 3–9 g root powder daily taken as a decoction.(16) Dosages used in clinical trials vary depending on the Panax species, type of preparation and indication under investigation. Several studies have assessed the effects of a standardised extract of P. ginseng root (G115) at doses of 100–400 mg daily for 4–12 weeks.

DOSAGE AND DURATION OF USE: (Kraft, K and Hobbs C. 2004)
·         Tea: Boil 3 g of the finely cut dried roots for at least 30 or 45 minutes and steep for another 15 minutes. Strain and drink or store in refrigerator for use during the day. If only larger root pieces and whole roots are available, the patient should crush or cut the roots into coarse pieces before use; precrushed roots may also be available.
·         Daily dose: Dry extract: 1–2 g. For a usual 5 : 1 extract, the dose would be about 1 g, equivalent to 2 “0” caps or usually 2 tablets/day. Standardized extract (5–10 % ginsenosides, typically 200 mg per unit); 1–2 capsules or tablets twice daily. Tea: one cup, 3 to 4 times a day. Treatment should be continued for 3 months followed by a break, after which treatment can be re-initiated.

DOSAGES (Duke, J. A et al., 2002)
Tea 3–4 ×/day, 3–4 weeks (PH2); 0.33–0.66 g root 3 ×/day; 0.6–3.0 g root 1–3 ×/day, 3 weeks–3 months (AHP); 0.5–1 g root daily, 15–20 days (CAN); 1–2 g root/day (PH2); 1–9 g root (FAY); 1–10 g root/day (MAB); 0.4–0.8 g root/day, long term (CAN); 1–2 g Asian root/day (APA); 0.5 tsp dried Asian root/cup water 1–2 ×/day (APA); 1 tbsp fresh root (PED);
0.5–2 g dry root (WHO); 2 g dry root:10 ml alcohol/10 mg water (PED); 0.5–3 g dry root/day or 1–6 ml fluid extract (1:2) (KEB); 1–2 g dry root (KOM; PED); 0.5–1 g powdered root (PNC); 3–9 g powdered ginseng/day (AKT); 3 (550 mg) capsules 3 ×/day (Korean); 1–4 (250 mg) StX capsules (5–9% ginsenosides) (APA); 100 mg StX (4–7% ginsenosides) 1–2 ×/day; 1 (535 mg) StX 2 x/day (Korean).

DOSAGE RANGE (Braun, L and Cohen, M. 2010)
• 1–4 g/day dried root or equivalent preparations.
Fluid extract (1:2): 2–8 mL/day (15–55 mL/week).
Tincture (1:5): 10–15 mL/day.
Acute dosing: 4 mL in a single dose before activity.
Extracts with standardised levels of eleutheroside E (syringin) (> 0.5 mg/mL) are recommended. Russian and Korean sources appear to have higher levels of this constituent. So, variations in therapeutic activity may be predicted (Wagner et al 1982). As there can be a significant product variability in the level of eleutherosides between capsules and liquids, standardisation may be necessary for quality assurance (Harkey et al 2001). In practice, Siberian ginseng is often given for 6 weeks with a break of at least 2 weeks before resuming treatment.

ACTIVITIES (Duke, J. A et al., 2002)
Adaptogen (1; KEB; MAB; SHT; WHO); Adrenergic (1; AKT); Alterative (f; CRC; DAA; PED); Analgesic (f; CRC; DAA); Antiaging (f; AKT; MAB); Antiaggregant (1; PH2; PNC); Antialcoholic (1; KEB; MAB; PH2); Antiarrhythmic (1; KEB; PH2); Anticancer (1; PH2); Anticatecholamine (1; PH2); Anticholinergic (1; KEB; PH2); Anticonvulsant (f; FAY); Antidepressant (1; BGB); Antidiuretic (f; KEB); Antifatigue (1; BGB; PNC; WHO); Antihepatomic (1; KEB); Antiinflammatory (1; KEB); Antiischemic (1; KEB); Antimitogenic (1; DAA); Antioxidant (1; BGB; PH2); Antiprolactin (1; WHO); Antiprostatic (1; KEB); Antipsychotic (f; FAY); Antiradiation (1; MAB; WHO); Antiseptic (f; CRC; DAA); Antithromboxane (1; PH2); Antitumor (1; BGB; KEB; WHO); Antiulcer (1; APA; FAY); Antiwrinkle (f; MAB); Antiviral (1; WHO); Anxiolytic (1; BGB; KEB); Aperitif (f; CRC; DAA); Aphrodisiac (1; APA; CRC; DAA); Apoptotic (1; PH2); Bitter (f; PED); Cardiotonic (1; AKT; APA; DAA; KEB; PED); Carminative (f; CRC; DAA); Caspase Stimulator (1; PH2); Chemopreventive (1; MAB); Circulostimulant (1; PED); CNS Sedative (1; FAY; KEB; PNC); CNS Stimulant (1; KEB; PNC); Corticotrophinogenic (1; PH2); Cytotoxic (1; PH2); Demulcent (f; CRC; DAA); Diuretic (f; CRC; DAA); Elevates HDL-Cholesterol (1; MAB); Emetic (f; CRC); Energizer (1; APA); Estrogenic (1; DAA; KEB; PNC); Ethanolytic (1; KEB); Expectorant (f; CRC; DAA); Fatigue (f; APA); Gonadotropic (1; CRC; KEB); Hemopoietic (1; KEB); Hepatoprotective (1; KEB; PH2; WHO); Hepatotonic (1; PED); Hyperglycemic (1; KEB); Hypertensive (1; PNC); Hypocholesterolemic (1; BGB; PH2); Hypoglycemic (1; DAA; KEB; PNC; WHO); Hypotriglyceridemic (1; BGB; PH2); Immunostimulant (1; APA; PED; MAB; PH2; WHO); Interferonigenic (1; KEB; PH2); Memorigenic (1; BGB; KEB); Mineralcorticoid (1; KEB); Mitogenic (1; DAA); Negative Chronotropic (1; PH2); Negative Inotropic (1; PH2); Nervine (f; CRC; PH2); Neurotonic (f; CRC; PH2); Nicotinic (1; PH2); NKC-Genic (1; PH2); NO-genic (1; BGB; PH2); Nootropic (1; KEB); Osteoprotective (1; MAB); Phagocytotic (1; KEB); Positive Inotropic (1; PH2); Radioprotective (1; BGB; FAY; HH2); Respirastimulant (f; FAY); Roborant (f; BGB); Secretagogue (1; APA); Sedative (f; APA; DAA); Serotonilytic (1; KEB); Sialagogue (f; CRC; DAA); Spermatogenic (1; KEB); Stimulant (f; CRC; PNC); Stomachic (f; CRC); Testosteronigenic (1; KEB); Thymoleptic (f; MB); Tonic (1; AKT; CRC; DAA; KOM; MAB; SHT); Tranquilizer (f; CRC; DAA); Ulcerogenic (1; FAY); Vasodilator (1; BGB).

INDICATIONS (Duke, J. A et al., 2002)
Aging (1; CRC; DAA); Alcoholism (1; KEB; MAB; PH2); Amnesia (f; APA; CRC; DAA); Anemia (f; AKT; CRC; FAY); Angina (f; KEB); Anorexia (f; APA; BGB; DAA; PH2); Anxiety (1; BGB; KEB; MAB; PH2); Arrhythmia (1; DAA; KEB; PH2); Asthma (f; CRC; DAA; KEB; MAB); Atherosclerosis (f; CRC; DAA); Bleeding (f; CRC); Bite (f; CRC); Boil (f; CRC); Bruise (f; CRC); Cachexia (2; CRC; KOM; PH2; SHT); Cancer (1; APA; BGB; CRC; DAA; KEB; JLH; PH2; WHO); Cancer, breast (f; JLH); Cancer, lung (1; KEB); Cancer, stomach (f; JLH); Carcinoma (f; JLH); Cardiopathy (f; KEB); Chemotherapy (f; AKT); Cold (f; JAD); Colitis (f; APA); Convalescence (1; KOM; SHT; WHO); Convulsion (f; CRC; DAA; FAY; MAB); Cough (f; CRC; WHO); Debility (2; FAY; KOM; PH2; SHT; WHO); Depression (1; BGB; KEB); Diabetes (1; CRC; KEB; PH2; WHO); Divination (f; CRC); Dysentery (f; CRC; DAA); Dysmenorrhea (f; CRC; DAA); Dyspepsia (f; CRC; DAA; MAB); Dyspnea (f; DAA; KEB; MAB; WHO); Enterosis (f; CRC; DAA); Epilepsy (f; CRC; DAA); Epistaxis (f; CRC; DAA); Fatigue (2; AKT; CRC; DAA; KOM; PH2; SHT; WHO); Fear (f; CRC; DAA); Fever (f; CRC; DAA; WHO); Flu (f; PH2); Gas (f; CRC; DAA); Gastrosis (1; CRC; PH2; WHO); Gonadotrophy (f; DAA); Hangover (f; CRC; DAA); Headache (f; APA; DAA); Heart (f; CRC); Hemoptysis (f; DAA; PH2); Hepatoma (1; KEB; HH2); Hepatosis (2; WHO); High Blood Pressure (f; CRC; DAA); High Cholesterol (1; BGB; KEB; PH2); Hyperglycemia (f; CRC; DAA); Hypoglycemia (1; KEB); Hypothermia (f; WHO); IDDM (1; WHO); Immune Dysfunction (1; JAD); Immunodepression (1; APA; PED; MAB; PH2; WHO); Impotence (1; BGB; DAA; PH2; SHT; WHO); Infection (f; KEB); Infertility (1; BGB; KEB; MAB; PH2); Inflammation (1; KEB); Insomnia (1; APA; CRC; DAA; PH2); Leukopenia (1; KEB); Longevity (1; KEB); Low Blood Pressure (1; CRC; DAA; PNC); Malaria (f; CRC); Menopause (f; KEB); Menorrhagia (f; CRC); Mental Derangement (f; KEB); Morning Sickness (f; WHO); Nausea (f; CRC); Nephrosis (f; CRC); Nervousness (f; APA; CRC; DAA); Neuralgia (f; MAB); Neurasthenia (f; CRC; DAA); Neurosis (f; KEB; PH2; WHO); NIDDM (1; BGB; MAB; WHO); Obesity (1; PH2); Pain (f; CRC; DAA); Palpitation (f; CRC; DAA; KEB); Polyuria (f; CRC; DAA); Post-Menopause (f; BGB); Proctosis (f; CRC); Prolapse (f; KEB; MAB); Radiation Sickness (1; KEB); Respirosis (f; AKT); Rheumatism (f; APA; CRC; DAA; PH2; WHO); Senile Dementia (1; APA; KEB); Sheehan’s Syndrome (1; KEB); Shock (1; DAA; MAB); Slow Thinking (1; SHT); Sore (f; CRC; JLH); Spermatorrhea (f; CRC); Splenosis (f; BGB; CRC; DAA); Sting (f; CRC); Stress (2; KOM; MAB; PHR); Swelling (1; CRC; DAA; JLH); Thirst (f; CRC); Tuberculosis (f; WHO); Tumor (1; BGB; KEB; WHO); Ulcer (1; APA; FAY; WHO); Vertigo (f; CRC; DAA); Virus (1; PH2; WHO); Vomiting (f; PH2); Water Retention (f; CRC; DAA); Wrinkle (f; FAY; MAB).  (Commission E approves as a tonic “for invigoration and fortification in times of fatigue and debility, for declining capacity for work and concentration, also during convalescence” (KOM); reading that reinforces my contention, in my ginseng book, that carrots could do a lot of the same thing at less than 1% of the price. I still feel that much of the literature on ginseng and soy comes from selective publications of sponsored research, making them look undeservedly better than carrot and black beans, for example.)

PHARMACOLOGICAL ACTIONS (Barnes, J et al., 2007)
In the 1950s, early studies on ginseng reported its ability to improve both physical endurance and mental ability in animals and humans.(17) In addition, the 'tonic' properties of ginseng were confirmed by the observation that doses taken for a prolonged period of time increased the overall well-being of an individual, measured by various parameters such as appetite, sleep and absence of moodiness, resulting in an increased work efficiency.(10) Since then, numerous studies have investigated the complex pharmacology of ginseng in both animals and humans. The saponin glycosides (ginsenosides/panaxosides) are generally recognised as the main active constituents in ginseng, although pharmacological activities have also been associated with nonsaponin components. The following sections on preclinical and clinical studies are intended to give an indication of the type of research that has been published for ginseng rather than to provide a comprehensive bibliography of ginseng research papers.
IN VITRO AND ANIMAL STUDIES
Pharmacokinetics There are only limited data on the pharmacokinetics of the constituents of P. ginseng. Ginsenosides Rg–1, Rb–1 and Rb–2 have been detected in the gastrointestinal tract of rats following oral administration of P. ginseng root, although absorption rates are low.(18–21) Corticosteroid-like activity Many of the activities exhibited by Panax ginseng have been compared with corticosteroid-like actions and results of endocrinological studies have suggested that the ginsenosides may primarily augment adrenal steroidogenesis via an indirect action on the pituitary gland.(22) Ginsenosides
have increased adrenal cAMP in intact but not in hypophysectomised rats and dexamethasone, a synthetic glucocorticoid that  provides positive feedback at the level of the pituitary gland, has blocked the effect of ginsenosides on pituitary corticotrophin and adrenal corticosterone secretion.(22) Hormones produced by the pituitary and adrenal glands are known to play a significant role in the adaptation capabilities of the body.(23) Working capacity is one of the indices used to measure adaptation ability and ginseng has been shown to increase the working capacity of rats following single (132%) and seven-day (179%) administration (intraperitoneal).
Furthermore, seven-day administration of ginseng decreased the reduction seen in working capacity when the pituitary– adrenocortical system is blocked by prior administration of hydrocortisone.(23) Hypoglycaemic activity Hypoglycaemic activity has been documented for ginseng and attributed to both saponin and polysaccharide constituents. In vitro studies using isolated rat pancreatic islets have shown that ginsenosides promote an insulin release which is independent of extracellular calcium and which utilises a different mechanism to that of glucose.(24) In addition, in vivo studies in rats have reported that a P. ginseng extract increases the number of insulin receptors in bone marrow and reduces the number of glucocorticoid receptors in rat brain homogenate.(25) Both of these actions are thought to contribute to the antidiabetic action of P. ginseng, in view of the known diabetogenic action of adrenal corticoids and the knowledge that the number of insulin receptors generally decreases with ageing.(25) Hypoglycaemic activity observed in both normal and alloxaninduced hyperglycaemic mice administered P. ginseng or P. quinquefolium (intraperitoneal) has also been attributed to nonsaponin but uncharacterised principles(26–29) or to glycan (polysaccharide) components.(30–34) Glycans isolated from Korean or
Chinese P. ginseng (A–E) were found to possess stronger hypoglycaemic activity than those isolated from Japanese P. ginseng (Q–U).(34) Proposed mechanisms of action have included elevated plasma insulin concentration due to an increase of insulin secretion from pancreatic islets, and enhancement of insulin sensitivity.(32) However, these mechanisms do not explain the total  hypoglycaemic activity that has been exhibited by the polysaccharides and further mechanisms are under investigation.(32) The effect of panaxans A and B from P. ginseng roots on the activities of key enzymes participating in carbohydrate metabolism has been studied.(29) DPG-3-2, a non-saponin component, has been shown to stimulate insulin biosynthesis in pancreatic preparations from various hyperglycaemic (but not normoglycaemic) animals; ginsenosides Rb–1 and Rg–1 were found to decrease islet insulin concentrations to an undetectable level.(27)
Cardiovascular activity Individual saponins from P. notoginseng have been reported to have different actions on cardiac haemodynamics.(35) For instance Rg, Rg-1 and total flower saponins have increased cardiac performance whilst Rb and total leaf saponins have decreased it; calcium antagonist activity has been reported for Rb but not for Rg; Rb but not Rg has produced a protective effect on experimental myocardial infarction in rabbits.(35) Negative chronotropic and inotropic effects in vitro have been observed for ginseng saponins and a mechanism of action similar to that of verapamil has been suggested.(36) In vitro studies on the isolated rabbit heart have reported an increase in coronary blood flow together with a positive inotropic effect.(37)
Anti-arrhythmic action on aconitine and barium chloride (rat) and adrenaline (rabbit)-induced arrhythmias, and prolongation of RR, PR and QTc intervals (rat), have been documented for saponins Rc-1 and Rd-1 from P. notoginseng. The mode of action was thought to be similar to that of amiodarone.(38) Ginsenosides (i.p.) have been reported to protect mice against metabolic disturbances and myocardial damage associated with conditions of severe anoxia.(39) P. notoginseng has produced a marked hypotensive response together with bradycardia following intravenous administration to rats. The dose-related effect was blocked by many antagonists suggesting multi-site activity.(37) Higher doses were found to cause vasoconstriction rather than vasodilation in renal, mesenteric and femoral arteries.(37) The total ginseng saponin fraction (Panax species not specified) has been reported to be devoid of haemolytic activity. However, individual ginsenosides have been found to exhibit either haemolytic or protective activities. Protective ginsenosides include Rc, Rb-2 and Re, whereas haemolytic saponins have included Rg, Rh and Rf.(40) The number and position of sugars attached to the sapogenin moiety was thought to determine activity.(40) Haemostatic activity has also been documented.(41) Oral administration of P. ginseng to rats fed a high cholesterol diet reduced serum cholesterol and triglycerides, increased highdensity lipoprotein (HDL) cholesterol, decreased platelet adhesiveness, and decreased fatty changes to the liver.(42) P. ginseng has also been reported to reduce blood coagulation and enhance fibrinolysis.(43)
Panaxynol and the ginsenosides Ro, Rg-1 and Rg-2 have been documented as the main antiplatelet components in P. ginseng inhibiting aggregation, release reaction and thromboxane formation in vitro.(43) Anti-inflammatory activity and inhibition of thromboxane B2 have previously been described for panaxynol.( 43) Anticomplementary activity in vitro (human serum) has been documented for P. ginseng polysaccharides with highest activity observed in strongly acidic polysaccharide fractions.(7) Effects on neurotransmitters Studies in rats have shown that a standardised P. ginseng extract (G115) inhibits the development of morphine tolerance and physical dependence, of a decrease in hepatic glutathione concentrations, and of dopamine receptor sensitivity without antagonising morphine analgesia, as previously documented for the individual saponins.(44) The inhibition of tolerance was thought to be associated with a reduction in morphinone production, a toxic metabolite which irreversibly blocks the opiate receptor sites, and with the activation of morphinone–glutathione conjugation, a detoxication process. The mechanism of inhibition of physical dependence was unclear but thought to be associated with changed ratios of adrenaline, noradrenaline, dopamine and serotonin in the brain.(44) A total ginsenoside fraction has been reported to inhibit the uptake of various neurotransmitters into rat brain synaptosomes in descending order of gamma-aminobutyrate and noradrenaline, dopamine, glutamate and serotonin.(45–47) The fraction containing ginsenoside Rd was most effective. Uptake of metabolic substrates 2-deoxy-D-glucose and leucine was only slightly affected and therefore it was proposed that the P. ginseng extracts were acting centrally rather than locally as surface active agents. Studies in rats have indicated that the increase in dopaminergic receptors in the brain observed under conditions of stress is prevented by pretreatment with P. ginseng.(48) Hepatoprotective activity Antoxidant and detoxifying activities have been documented.(49) Protection against carbon tetrachloride- and galactosamine-induced hepatotoxicity has been observed in cultured rat hepatocytes for specific ginsenosides (oleanolic acid and dammarane series).(49, 50)
However, at higher doses certain ginsenosides from both series were found to exhibit simultaneous cytotoxic activity.  Cytotoxic and antitumour activity Cytotoxic activity (ED50 0.5 mg/mL) versus L1210 has been documented for polyacetylenes isolated from P. ginseng root.(5, 6, 51) The antitumour effect of ginseng polysaccharides in tumour-bearing mice has been associated with an immunological mechanism of action.(52) Ginseng polysaccharides have been reported to increase the lifespan of tumour-bearing mice and to inhibit the growth of tumour cells in vivo, although cytocidal action was not seen in vitro.(52) Antitumour activity in vitro versus several tumour cell lines has been documented for a polyacetylene, panaxytriol, from P. ginseng.(53) Antiviral activity Antiviral activity (versus Semliki forest virus; 34–40% protection) has been documented for P. ginseng extract (G115, Pharmaton) administered orally to rats.(54) The extract also enhanced the level of protection afforded by 6-MFA, an interferon-inducing agent of fungal origin.(54) P. ginseng has been found to induce in vitro and in vivo production of interferon and to augment the natural killer and antibody dependent cytotoxic activities in human peripheral lymphocytes.(54, 55) In addition, P. ginseng enhances the antibody-forming cell response to sheep red blood cells in mice and stimulates cell mediated immunity both in vitro and in vivo.(54, 55) In view of these observations, it has been proposed that the antiviral activity of P. ginseng may be immunologically mediated.(54, 55)

MAIN ACTIONS (Braun, L and Cohen, M. 2010)
Adaptogenic (modulates stress response) Siberian ginseng appears to alter the levels of different neurotransmitters and hormones involved in the stress response, chiefly at the hypothalamicpituitary- adrenal axis (HPA) axis. Various mechanisms have been proposed including inhibition of catechol-O-methyltransferase, which inactivates catecholamines (Gaffney et al 2001a). As a result, catecholamine levels are not depleted and release of new catecholamines from nerve synapses is decreased (Panossian et al 1999). In theory, this may reduce the risk of the organisms’ adaptive responses becoming depleted and moving into the exhaustionphase of the stress response. In addition, eleutherosides have been shown to improve carbohydrate metabolism and energy provision and increase the synthesis of protein and nucleic acids, although the direct molecular targets responsible for this adaptive response remain unknown (Panossian et al 1999). Eleutherosides have also been reported to bind to receptor sites for progestin, oestrogen, mineralocorticoids and glucocorticoids in vitro and therefore may theoretically exert numerous pharmacological actions important for the body’s stress response (Pearce et al 1982). Owing to such actions, herbalists and naturopaths describe the herb’s overall action as ‘adaptogenic’. The term ‘adaptogen’ describes substances that increase the ability of an organism to adapt to environmental factors and to avoid damage from such factors (Panossian et al 1999). The term ‘allostasis’ (see Clinical note) has been adopted in the medical arena to describe ‘the ability to achieve stability through change’. Although the mechanism of action responsible is still unclear, several theories have been proposed to explain the effect of Siberian ginseng on allostatic systems, largely based on the pharmacological actions observed in test tube and animal studies. Depending on the stage of the stress response, Siberian ginseng can act in different ways to support the ‘stress system’. Research suggests that there is a threshold of stress below which the herb increases the stress response and above which it decreases the stress response (Gaffney et al 2001b). Therefore, for example, if allostatic load is such that responses have become inadequate, then the resulting increase in hormone levels would theoretically induce a more efficient response. Alternatively, situations of chronic overactivity, also due to allostaticload, would respond to Siberian ginseng in a different way, with negative feedback systems being triggered to inactivate the stress response (Gaffney et al 2001a). As a result, Siberian ginseng could theoretically induce quite different effects, largely dependent on whether allostatic responses were underactive or overwhelmed. The dosing regimen may also be significant. While multi-dose administration in chronic stress engages the HPA axis balancing the switch-on and switch-off responses, single doses (~ 4 mL) in acute stress trigger a rapid response from the sympathoadrenal system, resulting in secretion of catecholamines, neuropeptides, adenosine triphosphate (ATP) and nitric oxide (Panossian & Wagner 2005). Studies have demonstrated that maximal effects are achieved around 4 weeks but do not persist at the 8-week time point, which may help to explain the practice of giving Siberian ginseng for 6 weeks with a 2-week break before repeating.

CLINICAL NOTE — ALLOSTASIS (Braun, L and Cohen, M. 2010)
Allostasis is the body’s adaptation to stress. Allostatic (adaptive) systems are critical to survival and enable us to respond to changes in our physical (such as asleep, awake, standing, sitting, eating, exercising and infection) and psychological states (such as anticipation, fear, isolation, worry and lack of control). The consumption of tobacco, alcohol and our dietary choices also induces allostatic responses (McEwan 1998). These systems are complex and have broad boundaries, in contrast to the body’s homeostatic systems (e.g. blood pH and body temperature), which are maintained within a narrow range. Most commonly, allostatic responses involve the sympathetic nervous system and the HPA axis. Upon activation (e.g. when a challenge is perceived), catecholamines are released from nerves and the adrenal medulla, corticotrophin is secreted from the pituitary and cortisol is released from the adrenal cortex. Once the threat has passed (e.g. the environment is more comfortable or infection is controlled), the system is inactivated and levels of cortisol and catecholamine secretion return to baseline. Chronic exposure to stress can lead to allostatic load, a situation resulting from chronic overactivity or underactivity of allostatic systems. The situation is characterised by maladaptive responses whereby systems become inefficient or do not turn off appropriately. Currently, there is much interest in understanding the association between numerous diseases such as cardiovascular disease and overwhelming allostatic load. One measure that is used to gauge an individual’s allostatic response is the cortisol response to a variety of stressors. As such, cortisol
Immunomodulation Siberian ginseng appears to exert an immunomodulatory rather than just an immunosuppressive or stimulating action; however, evidence for the immune enhancing effects of Siberian ginseng is contradictory. Clinical studies in vitro and in vivo have revealed stimulation of general non-specific resistance and an influence on T-lymphocytes, natural killer (NK) cells and cytokines (Bohn et al 1987, Schmolz et al 2001), although other studies suggest that Siberian ginseng does not significantly stimulate the innate macrophage immune functions that influence cellular immune responses (Wang et al 2003). Alternatively, another in-vitro study has demonstrated that activation of macrophages and NK cells does occur and may be responsible for inhibiting tumour metastasis both prophylactically and therapeutically (Yoon et al 2004). The main constituents responsible appear to be lignans (sesamin, syringin) and polysaccharides, such as glycans, which demonstrate immunostimulant effects in vitro (Davydov & Krikorian 2000, Wagner et al 1984). Additionally, effects on the HPA axis will influence immune responses. It has been suggested that eleutheroside E may be responsible for the improved recovery from reduced NK activity and the inhibition of corticosterone elevation induced by forced swimming in mice (Kimura & Sumiyoshi 2004) and may contribute to the antifatigue action.
Antiviral  In vitro studies show a strong antiviral action, inhibiting the replication of ribonucleic acid (RNA) type viruses such as human rhinovirus, respiratory syncytial virus and influenza A virus (Glatthaar- Saalmuller et al 2001).
Anabolic activity  Syringin and other eleutherosides appear to improve carbohydrate metabolism and energy provision by increasing the formation of glucose-6-phosphate and activating glucogen transport (Panossian et al 1999), and Siberian ginseng extracts have been reported to improve the metabolism of lactic and pyruvic acids (Farnsworth et al 1985). Additionally, preliminary evidence of possible anabolic effects makes this herb a popular treatment among athletes in the belief that endurance, performance and power may improve with its use. While initial animal studies showed promise for improving weight gain and increasing organ and muscle weight (Farnsworth et al 1985, Kaemmerer & Fink 1980), clinical studies confirming whether anabolic effects occur also in humans could not be located.

OTHER ACTIONS (Braun, L and Cohen, M. 2010)
Anticoagulant and antiplatelet effects Animal studies have demonstrated prevention against thrombosis induced by immobilisation (Shakhmatov et al 2007), and the 3,4-dihydroxybenzoic acid constituent of Siberian ginseng has demonstrated antiplatelet activity in vivo (Yun- Choi et al 1987). A controlled trial using Siberian ginseng tincture for 20 days in 20 athletes detected a decrease in the blood coagulation potential and activity of the blood coagulation factors that are normally induced by intensive training of the athletes (Azizov 1997). Whether the effects also occur in non-athletes is unknown.
Vascular relaxant In vitro studies have demonstrated vasorelaxant effects for Siberian ginseng. The effect is thought to be endothelium dependent and mediated by NO and/or endothelium-derived hyperpolarising  factor, depending on the size of the blood vessel. Other vasorelaxation pathways may also be involved (Kwan et al 2004).
Anti-allergic In-vitro studies demonstrate that Siberian ginseng has anti-allergic properties in mast cell-mediated allergic reactions (Jeong et al 2001). The mechanism appears to involve inhibition of histamine, tumour necrosis factor-alpha (TNF-alpha) and interleukin-6.
Anti-inflammatory Excess production of nitric oxide (NO) is a characteristic of inflammation, and Siberian ginseng has been shown to significantly suppress NO production and inducible nitric oxide synthase (iNOS) gene expression in a dose-dependent manner (Lin et al 2008). The downregulation of iNOS expression may be the result of inhibition of intracellular peroxide production (Lin et al 2008) or through blocking c-Jun NH2-terminal kinase (JNK) and Akt activation (Jung et al 2007). Contradictory results have been shown for inhibition of cyclooxygenase (COX)-2 expression (Jung et al 2007, Raman et al 2008).
Radioprotective Animal studies have found that administration of Siberian ginseng prior to a lethal dose of radiation produced an 80% survival rate in mice (Miyanomae & Frindel 1988). This result suggests that Siberian ginseng may protect against radiation toxicity.
Cardioprotective Oral administration of Siberian ginseng (1 mL/kg) to rats for 8 days prevented stress-induced heart damage and chronic administration increased beta-endorphin levels and improved cardiac tolerance to D, L-isoproterenol and arrhythmia caused by adrenaline. The cardioprotective and antiarrhythmic effect may be related to an increase in endogenous opioid peptide levels (Maslov & Guzarova 2007). Benefits following a 45-min coronary artery occlusion were not demonstrated in this study (Maslov & Guzarova 2007) but have been in studies using Siberian ginseng in a polypharmacy combination known as ‘Tonizid’® (Lishmanov et al 2008).
Neuroprotective Preliminary animal studies have suggested possibleneuroprotective effects in transient middle cerebral
 artery occlusion in Sprague-Dawley rats. Infarct volume was reduced by 36.6% by inhibiting inflammation and microglial activation in brain ischaemia after intraperitoneal injection of a water extract of Siberian ginseng (Bu et al 2005). Similarly, intraperitoneal injection of Siberian ginseng was found to relieve damage to neurons following hippocampal ischaemia hypoxia and improve the learning and memory of rats with experimentally induced vascular dementia (Ge et al 2004). Siberian ginseng extract appears to protect against neuritic atrophy and cell death under amyloid beta treatment; the effect is thought to be due at least in part to eleutheroside B (Tohda et al 2008). The saponins present in Siberian ginseng have also been shown to protect against cortical neuron injury induced by anoxia/ reoxygenation by inhibiting the release of NO and neuron apoptosis in vitro (Chen et al 2004).
Hepatoprotective Animal studies have demonstrated that an intravenous extract of Siberian ginseng decreased thioacetamide-induced liver toxicity when given before and after thioacetamide administration (Shen et al 1991). More recently, oral administration of aqueous extract and polysaccharide was found to attenuate fulminant hepatic failure induced by D-galactosamine/lipopolysaccharide in mice, reducing serum aspartate aminotransferase (AST), alanineaminotransferase (ALT) and tissue necrosis factor (TNF)-alpha levels (Park et al 2004). The protective effect is thought to be due to the water-soluble polysaccharides. Coadministration of Siberian ginseng may also act to enhance the antihypoxant action of amtizole, improving the protective effect on hepatic antitoxic function and lipid metabolism (Kushnerova & Rakhmanin Iu 2008).
Reduces obesity Animal studies have demonstrated that the inclusion of Siberian ginseng attenuated the ‘weight gain, serum low density lipoprotein (LDL) cholesterol concentration and liver triglyceride accumulation in mice with obesity induced by high-fat diets’ (Cha et al 2004).
Glycaemic control and insulin-sensitising effect Animal studies have indicated a potential for hypoglycaemic effects when used intravenously. Syringin appears to enhance glucose utilisation (Niu et al 2008) and lower plasma glucose levels in animal experiments. The effect may be due to an increase in the release of acetylcholine from nerve terminals, stimulating muscarinic M (3) receptors in pancreatic cells to increase insulin release (Liu et al 2008). Syringin may also enhance the secretion of beta-endorphin from the adrenal medulla to stimulateperipheral micro-opioid receptors, resulting in a decrease of plasma glucose in insulin-depleted diabetic rats (Niu et al 2007). Eleutherans A–G exert marked hypoglycaemic effects in normal and alloxan-induced hyperglycaemic mice (Hikino et al 1986), and eleutherosides show an insulin-like action in diabetic rats (Dardymov et al 1978). However, these effects have not been borne out in human studies (Farnsworth et al 1985) and may not relate to oral dosages of Siberian ginseng. A small, double-blind, randomised, multiple, crossover study using 12 healthy participants actually showed an increase in postprandial plasma glucose at 90 and 120 min when 3 g Siberian ginseng was given orally 40 min before a 75-g oral glucose tolerance test (Sievenpiper et al 2004). More recently, oral administration of an aqueous extract of Siberian ginseng was shown to improve insulin sensitivity and delay the development of insulin resistance in rats (Liu et al 2005). As a result, further trials in people with impaired glucose tolerance and/or insulin resistance are warranted.

CLINICAL USE  (Braun, L and Cohen, M. 2010)
Stress Siberian ginseng is widely used to treat individuals with nervous exhaustion or anxiety due to chronic exposure to stress or what is now termed ‘allostatic load situations’. The biochemical effects on stress responses observed in experimental and human studies provide a theoretical basis for this indication (Abramova et al 1972, Gaffney et al 2001a). One placebo-controlled study conducted over 6 weeks investigated the effects of an ethanolic extract of Siberian ginseng (8 mL/day, equivalent to 4 g/day dried root). In the study, active treatment resulted in increased cortisol levels, which may be consistent with animal research, suggesting a threshold of stress below which Siberian ginseng increases the stress response and above which it decreases the stress response (Gaffney et al 2001b).
Fatigue Siberian ginseng is used to improve physical and mental responses during convalescence or fatigue states. While traditional stimulants can produce a temporary increase in work capacity followed by a period of marked decrease, the initial increase in performance from adaptogens is followed by only a slight dip and performance remains above basal levels (Panossian et al 1999). The ability of Siberian ginseng to increase levels of noradrenaline, serotonin, adrenaline and cortisol provides a theoretical basis for its use in situations of fatigue. However, controlled studies are limited. A randomised, double-blind, placebo-controlled trial of 300 mg/day (E. senticosus dry extract) for 8 weeks assessed health-related quality of life scores in 20 elderly people. Improvements were observed  did not persist to the 8-week time point. It would appear that improvements diminish with continued use (Cicero et al 2004), which may help to explain the practice of giving Siberian ginseng for 6 weeks with a 2-week break before repeating. A recent randomised placebo-controlled trial evaluated the effectiveness of Siberian ginseng in chronic fatigue syndrome (CFS). No significant improvements were demonstrated overall; however, subgroup analysis showed improvements in fatigue severity and duration (P < 0.05), in CFS sufferers with less severe fatigue at 2-month followup (Hartz et al 2004). Further studies are required to determine whether Siberian ginseng may be a useful therapeutic option in cases of mild to moderate fatigue. Commission E approves the use of Siberian ginseng as a tonic in times of fatigue and debility, for declining capacity for work or concentration and during convalescence (Blumenthal et al 2000). In practice, it is often used in low doses in cases of fatigue due to chronic stress (Gaffney et al 2001a).
Ergogenic aid Siberian ginseng extracts have been reported to provide better usage of glycogen and high-energy phosphorus compounds and improve the metabolism of lactic and pyruvic acids (Farnsworth et al 1985). Experimental data suggest that syringin and other eleutherosides may improve carbohydrate metabolism and energy provision by increasing the formation of glucose-6-phosphate and activating glucogen transport (Panossian et al 1999). While initial animal studies showed promise for improving weight gain and increasing organ and muscle weight (Wagner et al 1985), recent randomised, controlled clinical trials have produced inconsistent results in healthy individuals and athletes (Dowling et al 1996, Eschbach et al 2000, Mahady et al 2000), and a recent review concluded that only poorer quality trials have demonstrated benefit while well-designed trials have not shown significant improvement in endurance performance, cardiorespiratory fitness or fat metabolism during exercise ranging in duration from 6 to 120 minutes (Goulet & Dionne 2005). In the mid 1980s, a Japanese controlled study conducted on six male athletes over 8 days showed that Siberian ginseng extract (2 mL twice daily) improved work capacity compared with a placebo (23.3 versus 7.5%) in male athletes, owing to increased oxygen uptake (P < 0.01). Time to exhaustion (stamina) also increased (16.3 versus 5.4%, P < 0.005) (Asano et al 1986). Other research however has failed to confirm these effects (Dowling et al 1996, Eschbach et al 2000). A randomised, double-blind, crossover trial using a lower dose of 1200 mg/day Siberian ginseng for 7 days reported that treatment did not alter steady-state substrate use or 10 km cycling performance time (Eschbach et al 2000). Additionally, an 8-week, double-blind, placebo-controlled study involving 20 experienced distance runners failed to detect significant changes to heart rate, oxygen consumption, expired minute volume, respiratory exchange ratio, perceived exertion or serum lactate levels compared with placebo. Overall, both submaximal and maximal exercise performance were unchanged (Dowling et al 1996). Siberian ginseng may however reduce blood coagulation factors induced by intensive training in athletes (Azizov 1997) and has been shown in combination with micronutrients to improve iron metabolism and immunological responsiveness in 39 high-grade unarmed self-defence sportsmen (Nasolodin et al 2006). Whether these effects also occur in other scenarios is yet to be established. Clinical studies investigating whether ergogenic or anabolic effects observed in experimental studies occur in humans are lacking, and therefore Siberian ginseng cannot currently be recommended to improve athletic performance (Palisin & Stacy 2006). Siberian ginseng does not appear on ‘The 2008 Prohibited List’ of the World Anti-doping Agency (WADA 2008).
Prevention of infection Due to the herb’s ability to directly and indirectly modulate immune responses, it is also used to increase resistance to infection. One doubleblind study of 1000 Siberian factory workers supports this, reporting a 50% reduction in general illness and a 40% reduction in absenteeism over a 12-month period, following 30 days’ administration of Siberian ginseng (Farnsworth et al 1985). More recently, a 6-month controlled trial in males and females with recurrent herpes infection found that Siberian ginseng (2 g/day) successfully reduced the frequency of infection by 50% (Williams 1995). In practice, Siberian ginseng is generally used as a preventative medicine, as administration during acute infections is widely thought to increase the severity of the illness, although this has not been borne out in controlled studies using Siberian ginseng in combination with other herbs. A small randomised controlled trial (RCT) demonstrated a significant reduction in the severity of familial Mediterranean fever in children using a combination of Siberian ginseng with licorice, andrographis and schisandra (Amaryan et al 2003), and a combination of Siberian ginseng with schisandra and rhodiola was found to expedite the recovery of patients with acute non-specific pneumonia (Narimanian et al 2005).
Cancer therapy A polypharmacy preparation known as AdMax®, which contains Eleutherococcus senticosus in combination with Leuzea carthamoides, Rhodiola rosea and Schizandra chinensis, has been shown to boost the suppressed immunity in patients with ovarian cancer who are subject to chemotherapy (Kormosh et al 2006). Which herb or combination of herbs is responsible for the effect is unclear.

OTHER USES (Braun, L and Cohen, M. 2010)
Given the herb’s ability to increase levels of serotonin and noradrenaline in animal studies (Abramova et al 1972), a theoretical basis exists for the use of Siberian ginseng in depression. In traditional Chinese medicine (TCM), Siberian ginseng is used to encourage the smooth flow of Qi and blood when obstructed, particularly in the elderly, and is viewed as a general tonic. It is therefore used for a myriad of indications, usually in combination with other herbal medicines. Numerous studies use Siberian ginseng in combination with other adaptogens, such as Rhodiola rosea and Schisandra chinensis, which may potentially act synergistically for improved effects.

CLINICAL STUDIES (Barnes, J et al., 2007)
Clinical trials of preparations of P. ginseng and other Panax species have focused on assessing effects related to the reputed adaptogenic properties of this herbal medicinal product, although rigorous clinical investigations are limited. Studies have tested different Panax species preparations, including combination herbal preparations containing P. ginseng, which vary qualitatively and quantitatively in their phytochemical composition. Furthermore, different preparations have been administered according to different dosage regimens, and to different study populations making interpretation of the results difficult. A large body of clinical research has been published in the Chinese and other Asian literature, making access difficult, although many of these studies are unlikely to meet contemporary Western standards in terms of their design, analysis and reporting.(16) Therefore, at present there is insufficient evidence to support definitively the efficacy of specific Panax species preparations in the various indications for which they are used and/or have been tested. Details of several clinical trials of ginseng (Panax spp.) preparations published in the English literature are summarised below. Effects on physical performance Several studies have found that preparations of P. ginseng do not improve physical performance in healthy adults. In a randomised, double-blind, placebo-controlled trial, 38 healthy adults received an aqueous extract of P. Ginseng (G115, Pharmaton SA, Lugano, Switzerland) 200 mg twice daily for eight weeks.(56) Participants underwent exhaustive exercise testing before and after the intervention; recovery from exercise was also monitored. At the end of the study, data from 27 participants were available for analysis. No statistically significant differences in physical performance and heart rate recovery were detected between the ginseng and placebo groups.(56) Similar randomised, double-blind, placebo-controlled studies have found that treatment with P. ginseng root extract (G115) 200 mg daily for eight weeks had no statistically significant effects on maximal work performance, oxygen uptake during resting, exercise and recovery, respiratory exchange ratio, minute ventilation, heart rate and blood lactic acid concentrations in 19 healthy adult females (p> 0.05 for each),(57) and no effect on oxygen consumption, respiratory exchange ratio, minute ventilation, heart rate, blood lactic acid concentrations and perceived exertion in 36 healthy adult males who received P. ginseng root extract (G115) 200 or 400 mg daily for eight weeks.(58)
 In a further randomised, doubleblind, placebo-controlled trial involving 28 healthy adults, administration of P. ginseng root extract (not further specified) 200 mg daily for three weeks had no statistically significant effects on maximal exercise capacity, total exercise time, work load, plasma lactate concentrations, haematocrit, heart rate and perceived exertion.(59) As all of these studies involved only small numbers of participants it is possible that they did not have sufficient statistical power to detect a difference between the treatment and placebo groups if one exists. Effects on cognitive performance Several studies have examined the effects of preparations of P. ginseng root, typically the commercial product G115, alone, or in combination with other herbal ingredients, on cognitive performance. Generally, these studies have involved healthy volunteers, and trials evaluating the effects of P. ginseng root preparations on patients with impaired cognitive function are lacking. Further research examining the effects of acute and longer-term administration of preparations of P. ginseng and other Panax species in both healthy individuals and patients with impaired cognitive function are required.(60) In a double-blind, placebo-controlled, crossover study involving 15 healthy individuals, P. ginseng root extract (G115) 200 mg as a single oral dose had significant effects on certain aspects of electroencephalogram recordings, such as reductions in frontal theta and beta activity, when compared with placebo.(61) These findings suggest that P. ginseng root extract can directly modulate cerebroelectrical activity.(61) In a double-blind, placebo-controlled, crossover study, 30 healthy individuals received capsules containing P. ginseng extract (G115) 200 or 400 mg as a single dose before undergoing a battery of tests designed to assess cognitive performance.(62) A statistically significant improvement in one test of cognitive performance (serial sevens) was observed with the lower ginseng dose, compared with placebo, but no statistically significant difference was observed with the higher dose, and there were no statistically significant differences in other tests of cognitive performance for either dose.(62) There was a statistically significant improvement in scores for mental fatigue for both doses when measured after the third battery of tests, but this finding was not consistent when measured at other timepoints. In another double-blind, placebo-controlled, crossover study, 28 healthy individuals received single doses of P. ginseng root extract (G115) 200 mg, an ethanolic extract of guarana (Paullinia cupana) 75 mg, both herbal preparations, or placebo, with a one-week wash-out period between each; participants undertook a battery of cognitive performance tests before and after treatments.(63)
Administration of P. ginseng root extract, compared with placebo, led to statistically significant improvements in some (e.g. speed of attention, speed of memory, secondary memory) but not all (e.g. accuracy of attention, working memory, Bond-Lader mood scales) tests of cognitive performance, although improvements were not observed at every timepoint measured after administration. In  some tests, administration of both ginseng and guarana led to greater improvements than did ginseng alone.(63) In similar experiments, 20 healthy individuals received single doses of P. ginseng root extract (G115) 200, 400, 600 mg, or placebo, and a combination of P. ginseng root extract and Ginkgo biloba leaf  extract at doses of 200 and 120, 400 and 240, 600 and 360 mg, respectively, or placebo.(64) Statistically significant improvements in one cognitive performance test (serial sevens) were observed with administration of P. ginseng root extract 400 mg, compared with placebo, but reduced performance in this test was seen following administration of the 200 mg dose. Following administration of the combination preparation, statistically significant improvements in certain tests at certain timepoints, but these results were not consistent for all doses tested and across all timepoints measured in the study. The effects of the same combination preparation of P. Ginseng and G. biloba on memory were assessed in a randomised, doubleblind, placebo-controlled, multicentre, parallel group trial involving 256 healthy volunteers aged 38–67 years (mean (SD), 56 (7) years).(65) Participants received a preparation containing P. Ginseng root extract and G. biloba leaf extract 100 and 60 mg, respectively, twice daily, 200 and 120 mg, respectively, once daily, or placebo, for 12 weeks. Assessments were undertaken at weeks 4, 8, 12 and 14 of the study. At the end of the study, the primary outcome variable the Quality of Memory Index was significantly improved in the treatment group, compared with the placebo group (p = 0.026). No statistically significant effects were seen with respect to the secondary outcome variables power and continuity of attention, and speed of memory processes.(65)
In a randomised, double-blind, placebo-controlled, parallel group trial, 64 healthy volunteers with neurasthenic complaints received a combination preparation containing P. ginseng root extract and G. biloba leaf extract at doses of 50 and 30 mg, respectively, 100 and 60 mg, respectively, 200 and 120 mg, respectively, or placebo, twice daily, for 12 weeks.(66) At the end of the study, participants in the higher-dose ginseng–ginkgo group, compared with the placebo group, achieved significantly higher scores in tests designed to assess cognitive function (p = 0.008). Hypoglycaemic activity Most studies investigating hypoglycaemic activity of ginseng preparations have assessed effects in healthy (non-diabetic) individuals. In a randomised, single-blind (the study may have been conducted double-blind but this was not specifically stated), placebo-controlled, crossover trial, nine individuals with type-2 diabetes mellitus (mean (standard deviation, SD) glycosylated haemoglobin HbA1c 0.08 (0.005); reference range for well-controlled type-2 diabetes mellitus, 0.065–0.075) received a capsule containing 'American' ginseng (P.quinquefolius, containing protopanaxadiols Rb–1 1.53%, Rb–20.06%, Rc 0.24%, Rd 0.44%, and protopanaxatriols Rg–1 0.1%, Re 0.83%;(67) Chai-Na-Ta Corp, British Columbia, Canada) as a single dose both 40 minutes before a 25 g oral glucose challenge and, on a separate occasion, at the same time as the oral glucose challenge.(68) Incremental glycaemia at 45 minutes was significantly lower following ginseng treatment with either regimen (i.e. given with or before glucose challenge) than it was following placebo administration (p < 0.05 for both). In similar experiments involving non-diabetic individuals, a statistically significant reduction in incremental glycaemia was only observed when ginseng was administered 40 minutes before glucose challenge.(68)
Further experiments in non-diabetic individuals indicated that the effect on postprandial glycaemia was not dose-dependent as glucose tolerance was similar following administration of doses of ginseng ranging from 1–9 g.(69, 70) However, the effect of P. quinquefolius was time-dependent as reductions in postprandial glycaemia were observed only with administration of P. Quinquefolius 40, 80 and 120 minutes,(69, 70) but not 0, 10 and 20 minutes, before glucose challenge.(70) In another similar randomised, blinded, placebo-controlled, crossover trial involving non-diabetic individuals, no effect on post-prandial glycaemia was observed following oral administration 40 minutes before glucose challenge of 6 g of the same commercial P. quinquefolius preparation, but obtained from a different batch.(67) This conflicting result may be due to the lower ginsenoside content of the latter product (containing protopanaxadiols Rb–1 0.65%, Rb–20.02%, Rc 0.11%, Rd 0.12%, and protopanaxatriols Rg-1 0.08%, Re 0.67%).(67)
Other similar studies involving non-diabetic individuals have reported different and less consistent results for preparations of P. ginseng. In two randomised, single-blind, placebo-controlled, crossover studies, 11 individuals received capsules containing 500 mg three-year-old powdered whole root of P. Ginseng (containing protopanaxadiols Rb–1 0.18%, Rb-2 0.09%, Rc0.07%, Rd 0.02%, and protopanaxatriols Rg-1 0.16%, Re 0.17% and Rf 0.12%) at a single dose of 1, 2, 3, 6 and 9 g 40 minutes before glucose challenge.(71) No statistically significant differences were observed for the treatment versus placebo groups. Furthermore, when results for all P. ginseng groups were pooled, the 2- hour plasma glucose concentration was higher in the P. Ginseng group than in the placebo group. These findings are in contrast to effects observed for P. quinquefolius, and could be explained by differences in the ginsenoside content of preparations derived from the two species.(71) In a double-blind, placebo-controlled, crossover study in which 30 non-diabetic individuals received capsules containing P. Ginseng extract (G115) 200 or 400 mg as a single dose before undergoing a battery of tests designed to assess cognitive performance,(62) statistically significant reductions in blood glucose concentrations
occurred for both doses of ginseng at all measured post-treatment timepoints (p < 0.01 for all). Immunomodulatory activity In a randomised, double-blind, placebo-controlled trial, 38 healthy adults received an aqueous extract of P. ginseng (G115, Pharmaton SA, Lugano, Switzerland) 200 mg twice daily for eight weeks.(56) Participants underwent exhaustive exercise testing before and after the intervention in order to effect immunosuppression. At the end of the study, data from 27 participants were available for analysis. No statistically significant differences in secretory immunoglobulin A (IgA; the primary immunoglobulin contained in secretions of the mucosal immune system) parameters were detected between the P. Ginseng and placebo groups, indicating that the P. ginseng preparation had no effect on mucosal immunity.(56)
A randomised, double-blind, placebo-controlled trial involving 60 healthy individuals assessed the effects of two different extracts of P. ginseng on immune parameters.(72) Participants received an aqueous extract of P. ginseng (not further specified) 100 mg, a standardised extract of P. ginseng (G115) 100 mg, or placebo, twice daily for eight weeks. Analysis of participants' blood samples taken before and after four and eight weeks of treatment indicated that both extracts had statistically significant effects on various immune parameters, compared with baseline values,(72) although from a report of the study, it is not clear whether or not these changes were statistically significant when compared with values for the placebo group.
Cancer prevention A small number of epidemiological studies have explored the effects of ginseng use on prevention of cancer. A case–control study involving all cases of newly diagnosed cancer during a one-year time period at a major hospital cancer centre in Korea included 905 cases and 905 age, sex and date of admission matched controls.(73) Of the 905 cases, 62% had a history of 'ginseng' (not further specified) use (determined by face-to-face  interviews using a structured questionnaire), compared with 75% in the control group (p <0.01). The odds ratio (95% confidence interval) (OR; 95% CI) for cancer in relation to ginseng intake was 0.56 (0.45 to 0.69). This study was subsequently extended to include a total of 1987 case–control pairs.(74) Ginseng users had a lower risk of cancer, compared with non-users (OR 0.50; 95% CI 0.44 to 0.58); ORs (95% CI) for being diagnosed with cancer differed for use of different types of ginseng; the lowest being for fresh ginseng extract 0.37 (0.29 to 0.46), white ginseng powder 0.30 (0.22 to 0.41) and red ginseng extract 0.20 (0.08 to 0.50). No decrease in risk was seen with use of fresh ginseng slices, fresh ginseng juice and white ginseng tea: OR (95% CI), 0.79 (0.63– 1.01), 0.71 (0.49–1.03), 0.69 (0.45–1.07), respectively.(74) ORsvwere lowest for ovarian (0.15), larynx (0.18), oesophageal (0.20) and panceatic (0.22) cancers.
The questionnaire used in the case–control studies described above was used to determine ginseng use in a cohort study involving 4634 people aged over 40 years.(75) In this study, 54.7% of cancer cases had a history of ginseng use, compared with 71.2% of individuals without cancer. The relative risk (RR; 95% CI) for cancer was reduced with ginseng intake (0.40, 0.28–0.56; p <0.05). When evaluted by intake of type of ginseng, the RR was significantly reduced with ginseng extract (0.31, 0.13–0.74) and multiple combinations of ginseng preparations (0.34, 0.20–0.53), but not for other types of ginseng.(75) The available evidence for the cancer preventive effect of ginseng preparations in humans is inconclusive, and further methodologically rigorous research is required.(76, 77)
Quality of life The effects of different preparations of P. Ginseng root on quality-of-life measures have been asssessed in several randomised, controlled trials involving different participant groups, including healthy individuals, post-menopausal women and patients with diabetes. A systematic review of trials published by the end of the year 2002 included nine studies, of which eight involved a placebo control group, four involved the administration of monopreparations of P. ginseng root, and five involved combination preparations of P. ginseng and vitamins/minerals.(78)
The review did not provide details of the specific P. Ginseng preparations tested in the trials, only that doses ranged from 80–400 mg daily and that studies lasted from two to nine months. These variations in products tested, together with differences in study design, outcome measures evaluated, and participant groups involved, make overall interpretation of the results difficult and, to some extent, invalid. All but one of the included studies reported improvement in at least one quality-of-life measure, or a subscale, but there were conflicting findings. In essence, at present, evidence of a beneficial effect for P. ginseng on quality-of-life measures is inconclusive. Further research is needed to establish the effects, if any, of preparations of P. ginseng root and other Panax species on quality of life. Furthermore, results of trials should be considered in the context of the chemical profile of individual preparations, since this is likely to differ qualitatively and quantitatively between
products. One of the studies included in the review described above found that P. ginseng root extract (G115) 200 or 400 mg daily for eight weeks had no statistically significant effects on psychological well-being, as assessed using the Positive Affect Negative Affect Scale, in a randomised, double-blind, placebocontrolled trial involving 83 healthy younger adults (mean age 26 years).(79)
Other effects The effects of an aqueous extract of P. ginseng roots on blood alcohol clearance were assessed in an open study involving 14 healthy men aged 25–35 years; each participant served as his own control.(80) Participants consumed a single dose of alcohol (25% ethanol 72 g per 65 kg body weight) over 45 minutes with and without P. ginseng root extract 3 g/kg body weight. Blood samples taken 40 minutes after the end of the period of alcohol ingestion showed blood alcohol concentrations of 0.18% and 0.11% for the control and treatment periods, respectively (p < 0.001). The design of this study does not allow the observed effects to be attributed to ginseng administration, and the hypothesis that P. ginseng increases blood alcohol clearance requires testing in methodologically rigorous randomised, controlled trials.

SIDE-EFFECTS, TOXICITY (Barnes, J et al., 2007)
CLINICAL DATA
There are only limited clinical data on safety aspects of preparations of P. ginseng and other Panax species. There is a lack of formal post-marketing surveillance-type studies, and existing pharmacoepidemiological studies typically have assessed potential benefits and not risks of harm(s). There is a substantial number of placebo-controlled clinical trials of preparations of P. ginseng and other Panax species, although many of these have methodological limitations, including lack of randomisation and/ or double-blinding. Trials have assessed the effects of different preparations, including combination herbal preparations containing different Panax species, which vary qualitatively and quantitatively in their phytochemical composition. Furthermore, different preparations have been administered according to different dosage regimens, and to different study populations (e.g. healthy volunteers, patients with hypertension), making interpretation of the results difficult. The clinical trials of Panax species root preparations available typically have involved small numbers of patients and been of short duration (typically four to 12 weeks), so have the statistical power only to detect very common, acute adverse effects. Rigorous investigation of safety aspects of correctly identified, well-characterised Panax species root preparations administered orally at different dosages, including the effects of long-term treatment, is required. A systematic review of data available up to May 2001 relating to adverse events of monopreparations of P. ginseng preparations identified 48 placebo-controlled trials, 14 trials with an active control group, and 20 uncontrolled studies.(81) Of these, 42 trials involved healthy individuals and athletes, and the remainder involved older individuals, postmenopausal women or patients with hypertension, respiratory diseases, hepatitis, erectile dysfunction. Thirteen placebo-controlled studies provided sufficiently detailed information on reported adverse events. Six of these studies, mostly involving healthy individuals, had assessed the effects of a P. ginseng root extract (G115) typically at a dose of 200 mg daily for three to 16 weeks, although one study lasted for two years. Five other placebo-controlled studies assessed the effects of red P. ginseng root taken for around two to 12 weeks (one study involved administration for one year), and in two other studies, the species and type of ginseng were not clearly specified. Adverse events reported generally were similar in type and frequency to those reported for the placebo groups.(81) Nine placebo-controlled trials, four of which assessed a P. ginseng root extract (G115), stated that no adverse events occurred during the study period.
Placebo-controlled trials of P. ginseng published since the systematic review was conducted, and placebo-controlled trials assessing the effects of preparations of P. quinquefolius, typically  have not provided detailed information on the occurrence of adverse events. One study stated that there was no difference in symptoms, mostly gastrointestinal adverse events, between the P. quinquefolius and placebo groups reported during the study,(67) whereas another study assessing P. quinquefolius stated that no adverse effects occurred during the study.(70) The systematic review also identified publications describing 27 case reports associated with the use of 'ginseng', although for 22 reports no information was provided on the type (i.e. red or white P. ginseng), preparation and dosage of P. ginseng ingested, and it is unlikely that any chemical analysis of the products ingested was undertaken. Four cases of agranulocytosis initially attributed to use of P. ginseng-containing products, were later attributed to undeclared ingredients (aminopyrine and phenylbutazone) detected in the products.(81) For many of the cases, there were other factors, including concurrent medications and cessation of treatment effects, that could explain the observed effects. The cases included six reports of mastalgia, two of post-menopausal vaginal bleeding and one of metrorrhagia (uterine bleeding at irregular intervals, usually for prolonged period of time) in women who had ingested or applied (one case of vaginal bleeding was associated with use of a 'ginseng' face cream(82)) 'ginseng' products. Several of the reports describe positive dechallenge and/ or rechallenge. Most of these reports, however, are from the older literature and involved the use of unlicensed, poorly described products; a causal association with Panax species has not been established, and the relevance of these reports to products marketed currently is not clear. Two cases of mania have also been described. One involved a 35-year-old woman with depressive illness who was stabilised on treatment with lithium and amitriptyline and who stopped lithium treatment and began taking ginseng (not further specified).(83)
 The second report described a 26-year-old-man with no history of psychiatric illness who experienced a manic episode two months after starting treatment with red P. ginseng root 500 to 750 mg daily on five days per week.(84) Analysis of the product found no evidence of notable contaminants. The World Health Organization's Uppsala Monitoring Centre (WHO-UMC; Collaborating Centre for International Drug Monitoring) receives summary reports of suspected adverse drug reactions from national pharmacovigilance centres of over 70 countries worldwide. A systematic review of information available up to May 2001 relating to adverse effects associated with P. ginseng summarised reports from the WHO-UMC database describing a total of 168 adverse reactions associated with monopreparations of ginseng.(81) However, this number of reports relates to unspecified 'ginseng' preparations, not necessarily preparations of P. ginseng. To the end of the year 2005, the WHO-UMC's database contained only nine reports, describing a total of 20 adverse reactions, for monopreparations specified as P. ginseng.(85) In a phase 1 study involving healthy males aged 18–35 years who received an extract of P. ginseng root (21.4 mg/mL; standardised for ginsenosides 10.5%) 20 mL twice daily for ten days, no adverse effects on fertility parameters, including volume of ejaculate, number of spermatozoids per millilitre, and proportions of active, inactive, normokinetic, dyskinetic and akinetic spermatozoids, were observed, compared with baseline values.(86) In 1979, two studies referred to a 'ginseng abuse syndrome' (GAS) which emphasised that most side-effects documented for 'ginseng' were associated with the ingestion of large doses together with other psychomotor stimulants, including tea and coffee. GAS was defined as diarrhoea, hypertension, nervousness, skin eruptions and sleeplessness; other symptoms occasionally observed included amenorrhoea, decreased appetite, depression, euphoria, hypotension and oedema.(87, 88) However, these two studies have been widely criticised over the variety of ginseng and other preparations used, and over the lack of authentication of the ginseng species ingested.(1, G19)
A review of the Russian literature describes symptoms of overdose as those exhibited by individuals allergic to ginseng, namely palpitations, insomnia and pruritus, together with heart pain, decrease in sexual potency, vomiting, haemorrhagic diathesis, headache and epistaxis, and that ingestion of very large doses has been reported to be fatal.(15) The primary publications upon which these statements are based have not been used here, so the quality of the reports, including their descriptions of the ginseng preparations implicated, has not been assessed here.

PRECLINICAL DATA (Barnes, J et al., 2007l)
Results documented for toxicity studies carried out in a number of animal species using standardised extracts (SE) indicate P. Ginseng to be of low toxicity.(89–93) Single doses of up to 2 g SE have been administered to mice and rats with no toxic effects observed.(92) LD50 values (p.o.) in mice and rats have been estimated at 2 g/kg and greater than 5 g/kg.(89) In addition, LD50 values (i.p., mice) have been estimated for individual ginsenosides as 305 mg/kg (Rb-2), 324 mg/kg (Rd), 405 mg/kg (Re), 410 mg/kg (Rc), 1110 mg/kg (Rb-1), 1250 mg/kg (Rg-1), and 1340 mg/kg (Rf); an LD50 (i.v., mice) of 3806 mg/kg has been estimated for the saponins Rc-1 and Rd-1.(89) Doses of approximately 720 mg of a P. ginseng extract (G115) have been administered orally to rats for 20 days with no toxicological effects documented.(93) Daily doses of up to 15 mg G115/kg body weight have been administered orally to dogs for 90 days with no toxic effects documented. An initial increase in excitability which disappeared after two to three weeks was the only observation reported in rats fed 200 mg G115/kg body weight for 25 weeks.(92) P. quinquefolius has been reported to be devoid of mutagenic potential when investigated versus Salmonella typhimurium strain TM677.(94)

CONTRA-INDICATIONS, WARNINGS (Barnes, J et al.,  2007)
The older literature includes statements that the use of P. Ginseng is contra-indicated during acute illness, haemorrhage and during the acute period of coronary thrombosis,(1) and it has been recommended that P. ginseng should be avoided by individuals who are highly energetic, nervous, tense, hysteric, manic or schizophrenic, and that P. ginseng should not be taken with stimulants, including coffee, antipsychotic drugs or during treatment with hormones.(1, G49) The scientific basis and evidence for many of these statements is not clear. However, in view of their documented pharmacological activities, Panax species preparations should be used with caution in patients with diabetes and cardiovascular disorders. In general, and in view of the lack of safety data, it is appropriate to advise against the long-term or otherwise excessive use of Panax species.
Drug interactions In view of the pharmacological actions of Panax species preparations and their isolated constituents described following preclinical and, to a lesser extent, clinical studies, the potential for preparations of Panax species to interfere with other medicines administered concurrently, particularly those  with anticoagulant, hypoglycaemic and/or cardiovascular activity, should be considered.
Two cases of a suspected interaction between 'ginseng' and phenelzine have been documented. One report described insomnia, headache and tremulousness in a 64-year-old woman who began taking a 'ginseng' tea in addition to her existing phenelzine treatment; the woman previously had used 'ginseng' tea alone without experiencing any adverse effects,(95) and three years after the first epidsode of concurrent use of phenelzine and 'ginseng' tea, the woman ingested 'ginseng' capsules and experienced similar  symptoms.(96) A second report described a 42-year-old woman for whom treatment with phenelzine was initiated because of major depressive illness. The woman was also receiving triazolam and lorazepam and began self-treatment with unspecified preparations of ginseng and bee pollen.(97) She experienced headaches, irritability and visual hallucinations. A causal relationship with use of Panax species in these cases cannot be established.
There is an isolated case report of a suspected interaction between P. ginseng and warfarin involving a 47-year-old-man with an aortic heart valve who was receiving warfarin for thromboprophylaxis. Two weeks after the man began treatment with a P. ginseng root extract (Ginsana), his international normalised ratio (INR) fell to 1.5, having previously been stable for nine months.(98) On stopping use of the P. ginseng preparation, his INR returned to within the target range. In a randomised, open-label, crossover study, 12 healthy male individuals received a single dose of warfarin 25 mg alone or after seven days' treatment with capsules containing P. ginseng root (containing extract equivalent to 500 mg root; standardised for ginsenosides 8.93 mg, as ginsenoside Rg–1) two or three times daily.(99) There were no statistically significant differences in area under the plasma-concentration time curve (AUC), elimination half-life (t1/2), total clearance, volume of distribution, maximal plasma concentration (Cmax) and time to maximal concentration for either R-warfarin or S-warfarin when warfarin was taken following P. ginseng treatment, compared with values for ingestion of warfarin alone. There were also no statistically significant differences in protein binding of R- and S-warfarin, or in warfarin pharmacodynamics as assessed using INR values, following P. ginseng administration. By contrast, another drug interaction study involving healthy volunteers found that a preparation of P. quinquefolius root reduced the anticoagulant effect of warfarin. In a randomised, double-blind, placebo-controlled trial, 20 healthy individuals received powdered root of P. quinquefolius (containing Rb–1 1.93%, Rb–2 0.20%, Rc 0.61%, Rd 0.42%, Re 1.68% and Rg–10.35%) 1 g twice daily, or placebo, for three weeks; treatment was taken for a total of three weeks, beginning four days after oral administration of warfarin 5mg daily for three days, concurrently with a second three-day period of warfarin administration, and for four days after the second period of warfarin exposure.(100)
There was a significantly greater reduction in the magnitude of the INR, the primary outcome measure, in the P. quinquefolius group, compared with that in the placebo group (p = 0.0012). The contrasting findings for P. ginseng root and P. Quinquefolius root preparations could be explained by differences in their chemical composition, particularly ginsenoside content. The effects of different Panax species preparations on warfarin pharmacokinetics in patients receiving warfarin treatment or prophylaxis require investigation. In another drug interaction study involving healthy individuals (n = 20), participants received a P. ginseng root extract preparation (Ginsana, Pharmaton, Connecticut, USA; standardised for ginsenosides 4%) 100 mg twice daily for 14 days.(101) Data collected over a one-week period before P. Ginseng administration provided a within-subject control group. At the end of the study, there were no statistically significant changes in the 6-b-hydroxycortisol : cortisol ratio following P. Ginseng administration, compared with baseline values, suggesting that P. ginseng did not induce CYP3A enzyme activity.(101) By contrast, in in vitro experiments, a P. ginseng root extract (G115; standardised for 4% ginsenosides) and a P. quinquefolius root extract (standardised for 10% total ginsenosides) both inhibited CYP1A1, CYP1A2 and CYP1B1 activities in a concentrationdependent manner.(102) P. quinquefolius root extract was 45-fold more potent than P. ginseng root extract in inhibiting CYP1A2. The ginsenosides Rb–1, Rb–2, Rc, Rd, Re, Rf and Rg–1, added to the system either individually or as a mixture, at concentrations reflecting those at which the ginseng extracts caused inhibition, did not affect CYP1A and B enzyme activities. These findings led to the suggestion that other ginsenosides could be responsible for the inhibitory effects on the CYP enzymes investigated, or that the effects could be due to other compounds, such as tannins, as these were not removed from the extracts.(102)
Pregnancy and lactation No fetal abnormalities have been observed in rats and rabbits administered a standardised P. Ginseng extract (40 mg/kg, p.o.) from day 1 to day 15 of pregnancy.(92) P. ginseng has also been fed to two successive generations of rats in doses of up to 15 mg G115/kg body weight/day (equivalent to approximately 2700 mg P. ginseng extract) with no teratogenic effects observed.(89) However, the safety of P. ginseng during pregnancy has not been established in humans and therefore its use should be avoided. Similarly, there are no published data concerning the secretion of pharmacologically active constituents from P. ginseng into the breast milk and use of P. ginseng during lactation is therefore best avoided. However, a more recent study which investigated the effect of ginsenoside Rb–1 on the development of rat embryos during organogenesis in vitro found that median total morphological scores were significantly lower for embryos exposed to ginsenoside Rb–1 at concentrations of 30 mg/mL, compared with those for control embryos (p <0.05).(103) The clinical relevance of these findings is not known. The effects of ginsenoside Rb–1 and other ginsenosides, including the possibility of additive effects, on embryogensis requires further investigation.
The safety of P. ginseng during pregnancy has not been established in humans. Similarly, there are no published data concerning the secretion of pharmacologically active constituents from P. ginseng into the breast milk. In view of the lack of safety data and the findings described above, and until further information is available, the use of P. ginseng preparations during pregnancy and breastfeeding should be avoided.

CONTRAINDICATIONS (Linda, S-R. 2010)
Pregnancy category is 1; breastfeeding category is 2A.
Ginseng should not be given to children. It should not be used by persons with hypertension, cardiac disorders, or hypersensitivity to it. If breast cancer or other estrogen-dependent conditions are present, ginseng should not be used.

SIDE EFFECTS/ADVERSE REACTIONS (Linda, S-R. 2010)
CNS: Anxiety, insomnia, restlessness (high doses), headache
CV: Hypertension, chest pain, palpitations, decreased diastolic blood pressure, increased QTc interval.
GI: Nausea, vomiting, anorexia, diarrhea (high doses)
Ginseng Abuse Syndrome: Edema, insomnia, hypertonia
INTEG: Hypersensitivity reactions, rash

INTERACTIONS (Linda, S-R. 2010)
Drug
Anticoagulants (anisindione, dicumarol, heparin, warfarin),
antiplatelets, salicylates: Ginseng may decrease the action of these products.
Anticonvulsants: Ginseng may provide an additive anticonvulsant action (theoretical).
Antidiabetics (acetohexamide, chlorpropamide, glipizide, metformin, tolazamide, tolbutamide, troglitazone): Because ginseng is known to decrease blood glucose levels, it may increase the hypoglycemic effect of antidiabetics; avoid concurrent use.
Immunosuppressants (azathioprine, basiliximab, cyclosporine, daclizumab, muromonab, mycophenolate, tacrolimus): Ginseng may diminish the effect of immunosuppressants; do not use immediately before, during, or after transplant surgery.
Insulin: Because ginseng is known to decrease blood glucose levels, it may increase the hypoglycemic effect of insulin; avoid concurrent use.
MAOIs (isocarboxazid, phenelzine, tranylcypromine): Concurrent use of MAOIs with ginseng may result in manic-like syndrome.
Stimulants: Use of stimulants (e.g., xanthines) concurrently with ginseng is not recommended; overstimulation may occur.
Herb
Caffeine, guarana, yerba maté, tea: Ginseng with these agents may lead to added stimulation (Jellin et al, 2008).
Ephedra: Concurrent use of ephedra and ginseng may increase hypertension and central nervous system stimulation; avoid concurrent use.
Food
Caffeinated coffee, cola, tea: Overstimulation may occur when ginseng is used with caffeinated coffee, cola, and tea; avoid concurrent use.
Lab Test
Blood glucose: Ginseng may decrease blood glucose (decoctions, infusions).
Plasma partial thromboplastin time, INR: Ginseng may increase plasma partial thromboplastin time and INR.
Serum, urine estrogens: Ginseng may have an additive effect on serum and 24-hour urine estrogens.
Serum digoxin: Ginseng may falsely increase serum digoxin.

CLIENT CONSIDERATIONS (Linda, S-R. 2010)
Assess
·       Assess the reason the client is using ginseng.
·       Assess for hypersensitivity reactions and rash. If these are present, discontinue the use of this herb and administer an antihistamine or other appropriate therapy.
·       Assess for ginseng abuse syndrome: insomnia, edema, and hypertonia.
·       Assess for the use of stimulants, anticoagulants, MAOIs, and antidiabetics (see Interactions).
Administer
·       Instruct the client to store ginseng products in a cool, dry place, away from heat and moisture.
·       Instruct the client to avoid the continuous use of ginseng. The recommendation is to use this herb for no more than 3 continuous months, taking a break between courses (Mills, Bone, 2000).
Teach Client/Family
·       Inform the client that pregnancy category is 1 and breastfeeding category is 2A.
·       Caution the client not to give ginseng to children.
·       Advise the client to use other stimulants and antidiabetics carefully if taking concurrently with ginseng (see Interactions).
·       Warn the client of the life-threatening side effects of ginseng abuse syndrome.
·       Instruct the client that Siberian ginseng and Panax ginseng are not the same.


CLINICAL NOTE — CASE REPORTS OF SIBERIAN GINSENG NEED CAREFUL CONSIDERATION
(Braun, L and Cohen, M. 2010)
Some adverse reactions attributed to Siberian ginseng have subsequently been found to be due to poor product quality, herbal substitution and/ or interference with test results. For example, initial reports linking maternal ginseng use to neonatal androgenisation are now suspected to be due to substitution with another herb, Periploca sepium (called Wu jia or silk vine), as American herb companies importing Siberian ginseng from China have been known to be supplied with two or three species of Periploca (Awang 1991). Additionally, rat studies have failed to detect significant androgenic action (Awang 1991, Waller et al 1992) for Siberian ginseng. Another example is the purported interaction between digoxin and Siberian ginseng, which was based on a single case report of a 74-yearold man found to have elevated digoxin levels for many years (McRae 1996).
It was subsequently purported that the herbal product may have been adulterated with digitalis. Additionally, Siberian ginseng contains glycosides with structural similarities to digoxin that may modestly interfere with digoxin fluorescence polarisation (FPIA), microparticle enzyme (MEIA) results, falsely elevating digoxin values with FPIA and falsely lowering digoxin values with MEIA (Dasgupta & Reyes 2005). It should be noted that measuring free digoxin does not eliminate these modest interferences in serum digoxin measurement by the Digoxin III assay (Dasgupta et al 2008).


ADVERSE REACTIONS (Braun, L and Cohen, M. 2010)
Clinical trials of a 6 months’ duration have shown no side effects from treatment (Bohn et al 1987). High doses may cause slight drowsiness, irritability,anxiety, mastalgia, palpitations or tachycardia, although these side effects may be more relevant to Panax ginseng. It is suggested that a spontaneous subarachnoid haemorrhage in a 53-year-old woman who was using an herbal supplement containing red clover, dong quai and Siberian ginseng was likely to be due to the dong quai (Friedman et al 2007).

SIGNIFICANT INTERACTIONS (Braun, L and Cohen, M. 2010)
As controlled studies are not available, interactions are currently speculative and based on evidence of pharmacological activity and case reports. Studies have reported that normal doses of Siberian ginseng are unlikely to affect drugs metabolised by CYP2D6 or CYP3A4 (Donovan et al 2003).
Anticoagulants  An in-vivo study demonstrated that an isolated constituent in Siberian ginseng has anticoagulant activity (Yun-Choi et al 1987), and a clinical trial found a reduction in blood coagulation induced by intensive training in athletes (Azizov 1997). Whether these effects also occur in nonathletes is unknown. Given that a study looking at the concomitant application of Kan Jang (Siberian ginseng in combination with andrographis) and warfarin did not produce significant effects on the pharmacokinetics or pharmacodynamics of the drug (Hovhannisyan et al 2006), a negative clinical effect is unlikely.
Chemotherapy  An increased tolerance for chemotherapy and improved immune function has been demonstrated in women with breast (Kupin 1984, Kupin & Polevaia 1986) and ovarian (Kormosh et al 2006) cancer undergoing chemotherapy treatment. Caution— as coadministration may theoretically reduce drug effects. However, beneficial interaction may be possible under medical supervision.
Diabetic medications   Claims that Siberian ginseng has hypoglycaemic effects are based on intravenous use in animal studies and not observed in humans for whom oral intake may actually increase postprandial glycaemia (Sievenpiper et al 2004). Observe diabetic patients taking ginseng.
Influenza virus vaccine  Ginseng may reduce the risk of post-vaccine reactions (Zykov & Protasova 1984), a possible beneficial interaction.

CONTRAINDICATIONS AND PRECAUTIONS (Braun, L and Cohen, M. 2010)
Some authors suggest that high-dose Siberian ginseng should be avoided by those with cardiovascular disease or hypertension (blood pressure (BP) > 80/90 mmHg) (Mahady et al 2000). Others merely suggest a caution, as reports are largely unsubstantiated (Holford & Cass 2001). As such, it is recommended that people with hypertension should be monitored  if using high doses. In a study of elderly people with hypertension, 8 weeks of Siberian ginseng use did not affect BP control (Cicero et al 2004). Due to possible effects on glycaemic control (Sievenpiper et al 2004), care should be taken in people with diabetes until safety is established. Suspend use 1 week before major surgery. Traditional contraindications include hormonal changes, excess energy states, fever, acute infection, concurrent use of other stimulants and prolonged use.
PREGNANCY USE
Insufficient reliable information is available, but the herb is not traditionally used in pregnancy.

PATIENTS’ FAQs (Braun, L and Cohen, M. 2010)
What will this herb do for me? Siberian ginseng affects many chemicals involved in switching on and off the body’s stress responses. As such, it is used to improve wellbeing during times of chronic stress; however, scientific research has yet to fully investigate its use in this regard. It may also boost immune function and reduce the frequency of genital herpes outbreaks. Evidence for improved performance in athletes is unconvincing.
When will it start to work? Effects on stress levels should develop within 6 weeks, whereas immune responses develop within 30 days.
Are there any safety issues? It should not be used in pregnancy, and high doses should be used with care by those with hypertension.

PRACTICE POINTS/PATIENT COUNSELLING (Braun, L and Cohen, M. 2010)
·         Siberian ginseng appears to alter the levels of different neurotransmitters and hormones involved in the stress response, chiefly at the HPA axis.
·         It is widely used to treat individuals with nervous exhaustion or anxiety due to chronic exposure to stress or what are now termed ‘allostatic load situations’. It is also recommended during convalescence or fatigue to improve mental and physical responses.
·         Siberian ginseng may increase resistance to infection and has been shown to reduce frequency of genital herpes outbreaks with longterm use.
·         The herb is popular among athletes in the belief that endurance, performance and power may improve with its use, but clinical studies have produced inconsistent results.
·         It is not recommended for use in pregnancy, and people with hypertension should be monitored if using high doses.


PREPARATIONS (Barnes, J et al., 2007)
Proprietary single-ingredient preparations
Argentina: Ginsana; Herbaccion Bioenergizante. Australia: Herbal Stress Relief. Austria: Ginsana. Belgium: Ginsana. Brazil: Ginsana; Ginsex. Canada: Ginsana. Czech Republic: Ginsana. France: Gerimax Tonique. Germany: Ardey-aktiv; Coriosta Vitaltonikum N; Ginsana; Hevert-Aktivon Mono; IL HWA; Orgaplasma. Italy: Ginsana. Malaysia: Ginsana. Mexico: Raigin; Rutying; Sanjin Royal Jelly. Portugal: Ginsana. Russia: Gerimax Ginseng (Геримакс Женьшень); Ginsana (Гинсана). Singapore: Ginsana. Spain: Bio Star. Switzerland:  Ginsana; KintaVital. Thailand: Ginsana; Ginsroy. UK: Korseng; Red Kooga.
Proprietary multi-ingredient preparations
Argentina: Dynamisan; Herbaccion Ginseng Y Magnesio; Optimina Plus; Total Magnesiano con Ginseng; Total Magnesiano con Vitaminas y Minerales; Vifortol. Australia: Bioglan Ginsynergy; Extralife Extra-Brite; Ginkgo Biloba Plus; Ginkgo Complex; Glycyrrhiza Complex; Infant Tonic; Irontona; Nervatona Plus; Panax Complex; Vig; Vig; Vitatona. Austria: Gerimax Plus; ProAktiv. Brazil: Gerin; Poliseng. Canada: Damiana-Sarsaparilla Formula; Energy Plus; Ginkoba. Chile: Gincosan; Mentania. Czech Republic: Gincosan. France: Nostress; Thalgo Tonic; Tonactil. Germany: Ginseng-Complex "Schuh"; Peking Ginseng Royal Jelly N. Hong Kong: Cervusen. Italy: Alvear con Ginseng; Apergan; Bioton; Fon Wan Ginsenergy; Forticrin; Fosfarsile Forte; Fosfarsile Forte; Four-Ton; Ginsana Ton; Neoplus; Ottovis. Malaysia: 30 Plus; Adult Citrex Multivitamin þ Ginseng þ Omega 3; Total Man. Russia: Doppelherz Ginseng Aktiv (Доппельгерц Женьшень Актив); Doppelherz Vitalotonik (Доппельгерц Виталотоник). South Africa: Activex 40 Plus. Singapore: Gin-Vita. Spain: Energysor; Redseng Polivit; Ton Was; Vigortonic. Switzerland: Biovital Ginseng; Burgerstein TopVital; Geri; Gincosan; Imuvit; Supradyn Vital 50þ; Triallin. Thailand: Imugins; Imuvit; Multilim RG; Revitan. UK: Actimind; Red Kooga Co-Q-10 and Ginseng; Regina Royal Concorde; Seven Seas Ginseng; Vitegin Capsules; Wellman. USA: Energy Support; Mental Clarity.


REFERENCE

Barnes, J., Anderson, L. A., and Phillipson, J. D. 2007. Herbal Medicines Third Edition. Pharmaceutical Press. Auckland and London.

Braun, L and Cohen, M. 2010. Hebs and Natural Supplements An Evidence Based Guide 3R D Edition. Elsevier Australia. Australia.

Duke, J. A. with Mary Jo Bogenschutz-Godwin, Judi duCellier, Peggy-Ann K. Duke. 2002. Handbook of Medicinal Herbs 2nd Ed. CRC Press LLC. USA.

Kraft, K and Hobbs, C. 2004 . Pocket Guide to Herbal Medicine. Thieme. Stuttgart New York.

Linda S-Roth. 2010. Mosby’s Handbook Of Herbs & Natural Supplements, Fourth Edition. Mosby Elsevier. USA.

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