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WHO Monographs on Selected Medicinal Plants - Volume 1
(1999; 295 pages) View the PDF document
Table of Contents
View the documentAcknowledgements
View the documentIntroduction
View the documentBulbus Allii Cepae
View the documentBulbus Allii Sativi
View the documentAloe
View the documentAloe Vera Gel
View the documentRadix Astragali
View the documentFructus Bruceae
View the documentRadix Bupleuri
View the documentHerba Centellae
View the documentFlos Chamomillae
View the documentCortex Cinnamomi
View the documentRhizoma Coptidis
View the documentRhizoma Curcumae Longae
View the documentRadix Echinaceae
View the documentHerba Echinaceae Purpureae
View the documentHerba Ephedrae
View the documentFolium Ginkgo
View the documentRadix Ginseng
View the documentRadix Glycyrrhizae
View the documentRadix Paeoniae
View the documentSemen Plantaginis
View the documentRadix Platycodi
View the documentRadix Rauwolfiae
View the documentRhizoma Rhei
View the documentFolium Sennae
View the documentFructus Sennae
View the documentHerba Thymi
View the documentRadix Valerianae
View the documentRhizoma Zingiberis
View the documentAnnex. Participants in the WHO Consultation on Selected Medicinal Plants
 

Radix Ginseng

Definition

Radix Ginseng is the dried root of Panax ginseng C.A. Meyer (Araliaceae) (1–5).1

1 Steamed Panax ginseng root is listed in the Japanese pharmacopoeia as "Red Ginseng (Ginseng Radix Rubra)" (2).

Synonyms

Panax schinseng Nees (2).

Other Panax species, including P. quinquefolius L. (American ginseng), P. notoginseng Burk. (San-chi ginseng), P. pseudoginseng Wall. ssp. japonicus Hara = P. japonicus C.A. Meyer (Japanese chikutsu ginseng) and P. notoginseng ssp. himalaicus (Himalayan ginseng) have also been referred to as "ginseng" and used medically (6, 7). However, scientific documentation of these species is insuffi- cient to justify the preparation of a monograph at this time.

Selected vernacular names

Chosen ninjin, ginseng, Ginsengwurzel, hakusan, hakushan, higeninjin, hongshen, hungseng, hungshen, hunseng, jenseng, jenshen, jinpi, kao-li-seng, korean ginseng, minjin, nhan sam, ninjin, ninzin, niuhuan, Oriental ginseng, otane ninjin, renshen, san-pi, shanshen, sheng-sai-seng, shenshaishanshen, shengshaishen, t'ang-seng, tyosenninzin, yakuyo ninjin, yakuyo ninzin, yehshan- seng, yuan-seng, yuanshen (1, 2, 4–10).

Description

A perennial herb with characteristic branched roots extending from the middle of the main root in the form of a human figure. Stem erect, simple, and not branching. Leaves verticillate, compound, digitate, leaflets 5, with the 3 terminal leaflets larger than the lateral ones, elliptical or slightly obovate, 4–15cm long by 2–6.5 cm wide; apex acuminate; base cuneate; margin serrulate or finely bidentate. In general, 1 leaf in the first year with 1 leaflet added annually until the sixth year. Inflorescence a small terminal umbel, hemispherical in early summer. Flowers polygamous, pink. Calyx vaguely 5-toothed. Petals 5, stamens 5. Fruit a small berry, nearly drupaceous, and red when ripe in autumn (8).

Plant material of interest: dried root

General appearance

The main root is fusiform or cylindrical, 2.5–20cm long by 0.5–3.0cm in diameter; externally greyish yellow; upper part or entire root exhibiting sparse, shallow, interrupted, and coarse transverse striations and distinct longitudinal wrinkles; lower part bearing 2–5 branching lateral roots and numerous slender rootlets with inconspicuous minute tubercles. Rhizomes 1–4cm long by 0.3– 1.5 cm in diameter, mostly constricted and curved, bearing adventitious roots and sparse depressed circular stem scars. Texture relatively hard, fracture yellowish white, cambium ring brownish yellow, starchy (1–5).

Organoleptic properties

Colour, greyish white to amber-yellow; odour, characteristic; taste, slightly sweet at first, followed by a slight bitterness (1, 2).

Microscopic characteristics

The transverse section shows cork consisting of several rows of cells; cortex narrow; phloem showing clefts in the outer part, and parenchymatous cells densely arranged and scattered with resin canals containing yellow secretions in the inner part; cambium in a ring; xylem rays broad, vessels singly scattered or grouped in an interrupted radial arrangement, and occasionally accompanied by non-lignified fibres; parenchyma cells containing abundant starch grains and a few clusters of calcium oxalate (1, 3–5).

Powdered plant material

Yellowish white; fragments of resin canals containing yellow secretions; clusters of calcium oxalate (20–68µm in diameter), few, with acute angles; cork cells subsquare or polygonal, with thin and sinuous walls; reticulate and scalariform vessels 10–56µm in diameter; starch granules fairly abundant, simple, subspheroidal, semicircular, or irregular polygonal (4–30µm in diameter), singly or in groups of two to four (1–5).

Geographical distribution

Mountain regions of China (Manchuria), the Democratic People's Republic of Korea, Japan, the Republic of Korea, and the Russian Federation (eastern Siberia) (7, 8). It is commercially produced mainly by cultivation (6).

General identity tests

Macroscopic and microscopic examinations, microchemical tests, and thinlayer chromatographic analysis (1–5).

Purity tests

Microbiology

The test for Salmonella spp. in Radix Ginseng products should be negative. The maximum acceptable limits of other microorganisms are as follows (11–13). For preparation of decoction: aerobic bacteria-not more than 107/g; fungi-not more than 105/g; Escherichia coli-not more than 102/g. Preparations for internal use: aerobic bacteria-not more than 105/g or ml; fungi-not more than 104/g or ml; enterobacteria and certain Gram-negative bacteria-not more than 103/g or ml; Escherichia coli-0/g or ml.

Foreign organic matter

Not more than 2% (2, 3).

Total ash

Not more than 4.2% (2).

Acid-insoluble ash

Not more than 1% (4).

Sulfated ash

Not more than 12% (5).

Alcohol-soluble extractive

Not less than 14.0% (2).

Pesticide residues

To be established in accordance with national requirements. Normally, the maximum residue limit of aldrin and dieldrin for Radix Ginseng is not more than 0.05 mg/kg (13). For other pesticides, see WHO guidelines on quality control methods for medicinal plants (11) and guidelines for predicting dietary intake of pesticide residues (14).

Heavy metals

Recommended lead and cadmium levels are no more than 10 and 0.3mg/kg, respectively, in the final dosage form of the plant material (11).

Radioactive residues

For analysis of strontium-90, iodine-131, caesium-134, caesium-137, and plutonium-239, see WHO guidelines on quality control methods for medicinal plants (11).

Other purity tests

Chemical and water-soluble extractive tests to be established in accordance with national requirements.

Chemical assays

Microchemical, thin-layer chromatographic, and spectrophotometric methods are used for the qualitative and quantitative analysis of ginsenosides (1–5). High-performance liquid chromatography (15–17) and liquid chromatography– mass spectrometry (18) methods are also available.

Characteristic saponins known as ginsenosides, not less than 1.5% calculated as ginsenoside Rg1 (D-glucopyranosyl-6β-glucopyranosyl-20Sprotopanaxatriol, relative molecular mass 800) (3, 5).

Major chemical constituents

The major chemical constituents are triterpene saponins. More than 30 are based on the dammarane structure, and one (ginsenoside Ro) is derived from oleanolic acid (6, 7, 17, 19). The dammarane saponins are derivatives of either protopanaxadiol or protopanaxatriol. Members of the former group include ginsenosides Ra1-3, Rb1-3, Rc, Rc2, Rd, Rd2, and Rh2; (20S)-ginsenoside Rg3; and malonyl ginsenosides Rb1, Rb2, Rc, and Rd. Examples of protopanaxatriol saponins are ginsenosides Re2, Re3, Rf, Rg1, Rg2, and Rh1; 20- gluco-ginsenoside Rf; and (20R)-ginsenosides Rg2 and Rh1. Those considered most important are ginsenosides Rb1, Rb2, Rc, Rd, Rf, Rg1, and Rg2; Rb1, Rb2, and Rg1 are the most abundant. Representative structures are presented below.

 

R1

R2

ginsenoside Rb1

O-glc-(1→2)-glc-

O-glc-(1→6)-glc-

ginsenoside Rb2

O-glc-(1→2)-glc-

O-ara(p)-(1→6)-glc-

ginsenoside Rc

O-glc-(1→2)-glc-

O-ara(f)-(1→6)-glc-

ginsenoside Rd

O-glc-(1→2)-glc-

glc-

 

R2

R3

ginsenoside Re

glc-

O-rha-(1→2)-glc-

ginsenoside Rf

H-

O-glc-(1→2)-glc-

ginsenoside Rg1

glc-

glc-

ginsenoside Rg2

H-

O-rha-(1→2)-glc-

Dosage forms

Crude plant material, capsules and tablets of powdered drugs, extracts, tonic drinks, wines, and lozenges. Store in a cool, dry place in well-sealed containers (20).

Medicinal uses

Uses supported by clinical data

Radix Ginseng is used as a prophylactic and restorative agent for enhancement of mental and physical capacities, in cases of weakness, exhaustion, tiredness, and loss of concentration, and during convalescence (21–29).

Uses described in pharmacopoeias and in traditional systems of medicine

Radix Ginseng has been used clinically in the treatment of diabetes (1), but further clinical studies are needed. The drug is also used in the treatment of impotence, prevention of hepatotoxicity, and gastrointestinal disorders such as gastritis and ulcers (1, 7).

Uses described in folk medicine, not supported by experimental or clinical data

Treatment of liver disease, coughs, fever, tuberculosis, rheumatism, vomiting of pregnancy, hypothermia, dyspnoea, and nervous disorders (7).

Pharmacology

Experimental pharmacology

The suggested mode of action of Radix Ginseng is twofold. First, the drug has an "adaptogenic" effect (30), which produces a non-specific increase in the body's own defences against exogenous stress factors and noxious chemicals (31). Secondly, the drug promotes an overall improvement in physical and mental performance (30–33).

Treatment of cultured mammalian cells, isolated organs, and animal models (primarily mice and rats) with Radix Ginseng before or during exposure to physical, chemical, or psychological stress increased the ability of the respective model systems to resist the damaging effects of various stressors (31). These results were demonstrated in cases of radiation poisoning (34–36), viral infection and tumour load (37, 38), alcohol or carbon tetrachloride poisoning (39–41), oxygen deprivation and hypobaric pressure (42, 43), light or temperature stress, emotional stress, and electrical shock or restricted movement (44, 45, 46). The mechanism by which the drug exerts its activity is most likely through the hypothalamus–pituitary–adrenal axis (47–49) and through its immunostimulant effect (50).

Intraperitoneal administration to rats of ginseng saponin fractions or the ginsenosides Rb1, Rb2, Rc, Rd, and Re elevated serum levels of adrenocorticotropic hormone (ACTH) and corticosterone (51, 52). Pretreatment with dexamethasone, which blocks hypothalamus and pituitary functions, prevented ginseng saponin-mediated release of ACTH and corticosterone, and thereby demonstrated that the increase in serum corticosterone by ginseng occurs indirectly through release of ACTH from the pituitary (51, 52).

The immunomodulatory activity of ginseng appears to be at least partly responsible for its adaptogenic effect (50, 53, 54). Alcohol extracts of Radix Ginseng stimulated phagocytosis in vitro, were mitogenic in cultured human lymphocytes, stimulated the production of interferon, and enhanced the activity of natural killer cells (55, 56). Intraperitoneal administration of an extract of the drug to mice stimulated cell-mediated immunity against Semliki Forest virus, elevated antibody levels against sheep red blood cells and natural killer cells (57), and stimulated the production of interferon (58).

Improvement in physical and mental performance has been observed in mice and rats after oral or intraperitoneal administration of the drug (59–63). Oral administration of ginseng saponin fractions to mice increased endurance and prolonged swimming time in swimming tests (63). However, two studies concluded that ginseng had no positive effects on the physical performance in mice and rats (64, 65). The adaptogenic effects of Radix Ginseng are generally attributed to the ginsenosides (66, 67). The ginsenosides have been shown to alter mechanisms of fuel homeostasis during prolonged exercise, by increasing the capacity of skeletal muscle to oxidize free fatty acids in preference to glucose for cellular energy production (59). Other constituents of Radix Ginseng, such as vanillic and salicylic acid, have also been reported to have "antifatigue" activity in rats (68). Furthermore, the antioxidant activity of ginseng was associated with both the ginsenosides and the flavonoid constituents (31, 69). The ginsenosides protected pulmonary vascular endothelium against freeradical- induced injury (69).

Mice given ginseng extract or ginsenosides Rb1 and Rg2 orally during passive avoidance response tests showed an improvement in learning ability which was negatively influenced by stress (30), and rats showed improved retention of learned behaviour (70). Ginsenosides Rg1 and Rb1 are the active nootropic constituents of the drug (66), and improve memory and learning in normal as well as cognition-impaired animals. The mode of action involves an increase in the synthesis and release of acetylcholine, and a decrease of brain serotonin levels (66). In cerebral and coronary blood vessels, extracts of Radix Ginseng produced vasodilatation, which improved brain and coronary blood flow (71). The vasodilatory activity of the ginsenosides appears to be primarily due to relaxation of vascular smooth muscles. The ginsenosides block the constricting effects of norepinephrine in isolated aorta strips, and inhibit the uptake of 45Ca2+ in the membrane and sarcolemma of rabbit heart tissue. Inhibition of Ca2+ uptake in the muscle membrane contributes to the mechanism of vasodilatation (71).

A number of polypeptides and glycans isolated from Radix Ginseng, named GP and panaxans A–E, respectively, have demonstrated hypoglycaemic activity when given intraperitoneally to mice (72, 73). Two of the glycans, panaxans A and B, have been shown to stimulate hepatic glucose utilization by increasing the activity of glucose-6-phosphate 1-dehydrogenase, phosphorylase a, and phosphofructokinase (72). Panaxan A did not affect plasma insulin levels or insulin sensitivity, but panaxan B elevated the plasma insulin level by stimulating insulin secretion from pancreatic islets, and further enhanced insulin sensitivity by increasing insulin binding to receptors (72). The panaxans are not active after oral administration. Administration of GP (intravenously or subcutaneously) to mice or rats decreased blood glucose and liver glycogen levels (73). Radix Ginseng also contains a number of other constituents with hypoglycaemic activity (72, 74). Adenosine, isolated from a water extract of Radix Ginseng, enhanced lipogenesis and cyclic AMP accumulation of adipocytes, and some of the ginsenosides inhibited ACTH-induced lipolysis, suppressed insulin-stimulated lipogenesis, and stimulated the release of insulin from cultured islets (72).

Subcutaneous administration of a ginseng extract enhanced the mating behaviour of male rats (75). The drug further stimulated spermatogenesis in rat (76), and rabbit testes, and increased the motility and survival of rabbit sperm outside the body (75).

Intragastric or intradermal administration of an ethanol extract of the drug to rats decreased histamine-, pentagastrin-, carbachol- and vagal stimulationinduced gastric secretion, and inhibited gastric ulcers induced by stress or by pyloric ligation (77–79).

Liver-protectant activity of ginseng has been demonstrated in vitro and in vivo (80, 81). Intraperitoneal administration of Radix Ginseng extracts to normal and dexamethasone-treated rats did not influence the blood chemistry of normal rats, but it decreased aspartate aminotransferase and alanine aminotransferase levels in dexamethasone-treated animals, thereby demonstrating a liverprotectant effect (81). However, another study demonstrated that an intraperitoneal injection of a methanol extract of Radix Ginseng had no protective activity against carbon tetrachloride-induced hepatotoxicity in rats (82).

Clinical pharmacology

Antifatigue activity

The results of clinical studies measuring increased performance and antifatigue effects of ginseng extracts are conflicting and, in general, most studies suffer from poor methodology, lack of proper controls, and no standardization of the ginseng extracts used. The influence of chronic Radix Ginseng administration (2 g/day orally for 4 weeks) on substrate utilization, hormone production, endurance, metabolism, and perception of effort during consecutive days of exhaustive exercise in 11 naval cadets was reported. No significant differences were observed between the control group and the group receiving the ginseng supplementation (83). Another clinical trial with eight participants reported no significant difference between placebo and ginseng administration during exhaustive exercise after 7 days of treatment (84). A randomized, double-blind, cross-over study sought the effects of ginseng on circulatory, respiratory, and metabolic functions during maximal exercise in 50 men (21–47 years old) (24). Total tolerated workload and maximal oxygen uptake were significantly higher following ginseng administration than with placebo. At the same workload, oxygen consumption, plasma lactate levels, ventilation, carbon dioxide production, and heart rate during exercise were all lower in the ginseng treatment group. The results indicated that the ginseng preparations effectively increased the work capacity of the participants by improving oxygen utilization (24). A placebo-controlled, cross-over study determined the effects of ginseng on the physical fitness of 43 male triathletes (25). The participants received 200mg of a ginseng preparation twice daily for two consecutive training periods of 10 weeks. No significant changes were observed during the first 10-week period, but ginseng appeared to prevent the loss of physical fitness (as measured by oxygen uptake and oxygen pulse) during the second 10-week period (25). Two further studies with athletes given 100 mg of a standardized ginseng extract twice daily for 9 weeks reported significant improvement in aerobic capacity and reduction in blood lactate and heart rates (26, 27), but placebos or controls were not used in either of the two studies. Further extension of these studies using placebo-controlled, double-blind trials demonstrated significant improvement in the ginseng group as compared with the placebo group (28). Similar results were reported in another study on athletes, and the differences between the ginseng and placebo groups lasted for approximately 3 weeks after the last ginseng dose (29). The effects of 1200mg of Radix Ginseng in a placebocontrolled, double-blind cross-over study in fatigued night nurses were assessed and the results were compared with placebo and with effects on nurses engaged in daytime work (22). Ginseng restored ratings on tests of mood, competence, and general performance, and the study concluded that ginseng had anti-fatigue activity (22).

Aqueous and standardized ginseng extracts were tested in a placebocontrolled, double-blind study for immunomodulatory actions (85). Sixty healthy volunteers were divided into three groups of 20 each and were given either a placebo or 100 mg of aqueous ginseng extract or 100 mg of standardized ginseng extract, every 12 hours for 8 weeks. Blood samples drawn from the volunteers revealed an increase in chemotaxis of polymorphonuclear leukocytes, the phagocytic index, and the total number of T3 and T4 lymphocytes after 4 and 8 weeks of ginseng therapy, as compared with the placebo group. The group receiving the standardized extract also increased their T4: T8 ratio and the activity of natural killer cells. The conclusion of this study was that ginseng extract stimulated the immune system in humans, and that the standardized extract was more effective than the aqueous extract (85).

Psychomotor activity

A double-blind, placebo-controlled clinical study assessed the effect of standardized ginseng extract (100 mg twice daily for 12 weeks) on psychomotor performance in 16 healthy individuals (23). Various tests of pyschomotor performance found a favourable effect on attention, processing, integrated sensory–motor function, and auditory reaction time. The study concluded that the drug was superior to the placebo in improving certain psychomotor functions in healthy subjects (23).

Antidiabetic activity

Radix Ginseng has been shown in clinical studies to have beneficial effects in both insulin-dependent and non-insulin-dependent diabetic patients (86, 87). Oral administration of ginseng tablets (200 mg daily for 8 weeks) to 36 noninsulin- dependent patients elevated mood, improved physical performance, reduced fasting blood glucose and serum aminoterminal propeptide of type III procollagen concentrations, and lowered glycated haemoglobin (87).

Impotence

Ginseng extracts improved sperm production in men and may have some usefulness in treating impotence (32). The ginsenosides, which appear to be the active components, are thought to depress blood prolactin levels, thereby increasing libido (32). In one clinical study, 90 patients with erectile dysfunction were treated with ginseng saponins (600 mg orally per day). Treatment improved rigidity, tumescence, and libido, but not the frequency of coitus (88).

Contraindications

None (21, 50, 89, 90).

Warnings

No information available.

Precautions

General

Diabetic patients should consult a physician prior to taking Radix Ginseng, as ginseng intake may slightly reduce blood glucose levels (86, 87).

Drug interactions

There are two reports of an interaction between Radix Ginseng and phenelzine, a monoamine oxidase inhibitor (91, 92). The clinical significance of this interaction has not been evaluated.

Drug and laboratory test interactions

None reported.

Carcinogenesis, mutagenesis, impairment of fertility

Radix Ginseng is not carcinogenic or mutagenic in vitro, and does not have any effect on fertility (90).

Pregnancy: teratogenic effects

Radix Ginseng is not teratogenic in vivo (90).

Pregnancy: non-teratogenic effects

The safety of Radix Ginseng for use in pregnancy has not been established.

Nursing mothers

Excretion of Radix Ginseng compounds into breast milk and its effects on the newborn have not been established.

Paediatric use

The safety and efficacy of Radix Ginseng use in children have not been established.

Adverse reactions

Various researchers who studied Radix Ginseng extracts using conventional toxicological methods in five different animal models reported no acute or chronic toxicity of the extract (89, 90, 93).

On the basis of Radix Ginseng's long use, and the relative infrequency of significant demonstrable side-effects, it has been concluded that the use of Radix Ginseng is not associated with serious adverse effects if taken at the recommended dose (90, 93). However, in Siegel's open study of 133 patients ingesting large quantities, ginseng was reported to result in hypertension, nervousness, irritability, diarrhoea, skin eruptions, and insomnia, which were collectively called ginseng abuse syndrome (GAS) (94). Critical analysis of this report has shown that there were no controls or analyses to determine the type of ginseng being ingested or the constituents of the preparation taken, and that some of the amounts ingested were clearly excessive (as much as 15 g per day, where the recommended daily dose is 0.5–2g) (50, 90, 95). When the dose was decreased to 1.7 g/day the symptoms of the "syndrome" were rare. Thus the only conclusion that can be validly extracted from the Siegel study is that the excessive and uncontrolled intake of ginseng products should be avoided (90). One case of ginseng-associated cerebral arteritis has been reported in a patient consuming a high dose of an ethanol extract of ginseng root (approximately 6g in one dose) (96). However, again the type and quantity of ginseng extract were not reported. Two cases of mydriasis and disturbance in accommodation, as well as dizziness have been reported after ingestion of large doses (3–9g) of an unspecified type of ginseng preparation (97).

Estrogenic-like side-effects have been reported in both premenopausal and postmenopausal women following the use of ginseng. Seven cases of mastalgia (98–100) and one case of vaginal bleeding in a postmenopausal woman (101) were reported after ingestion of unspecified ginseng products. An increased libido in premenopausal women has also been reported (100). Specific studies on the possible hormonal side-effects of ginseng have been carried out with a standardized ginseng extract (102104). Under physiological conditions, there is no interaction of the ginseng extract with either cytosolic estrogen receptors isolated from mature rat uterus or progesterone receptors from human myometrium (102). Furthermore, clinical studies have demonstrated that a standardized ginseng extract does not cause a change in male and female hormonal status (103, 104).

Posology

Unless otherwise prescribed, daily dose (taken in the morning): dried root 0.5–2g by decoction; doses of other preparations should be calculated accordingly (21, 23, 89).

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