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    SUMMARY AND PHARMACEUTICAL COMMENT ( HERBAL MEDICINE 3RD 325

    334)

    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 Rb1

    exhibits CNS-depressant, hypotensive and tranquillising actions whilst

    ginsenoside Rg1 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 shortduration, so have the statistical power only to detect very common, acute

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    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.

    KLASIFIKASI TANAMAN

    DESKRIPSI TANAMAN :

    DOSIS :

    HERBAL USE :

    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.

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    UJI KLINIK

    Clinical studies

    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 weredetected 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

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    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 examinedthe effects of preparations

    of P. ginseng root, typically thecommercial 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 healthyindividuals received single doses of P. ginseng root extract

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    (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