clinical evidence of extract ginseng g-115 in diabetes mellitus patients (dr. j. hudyono, ms, spo

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    Manajer Pelaksana Uji Klinik Obat Farmakologi FKUI -RSCM Staf Panitia Penilai Obat Jadi (PPOJ) Badan POM RI Kelompok Kerja Uji Klinik Badan Pengawas Obat &

    Makanan RI (Badan POM-RI) Staf Pengajar Ilmu Kedokteran Okupasi FK. Ukrida &FKUI Magister & Spesialis Kedokteran Okupasi UniversitasIndonesia Anggota Indonesian Association for the Study ofMedicinals Member Faculty of Pharmaceutical Medicine (MFPM)Royal College, UK Anggota IDI, PERDOKI, PERDAFKI, IKAFI

    Curriculum Vitaedr. J. Hudyono, MS, SpOk, MFPM

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    J. Hudyono

    Clinical Evidence of Extract Ginseng G-115

    in Diabetes Mellitus PatientsJ. Hudyono

    http://www.google.com/url?sa=i&rct=j&q=books&source=images&cd=&cad=rja&docid=jUUqJWyZZISufM&tbnid=nahTdqTm0Aa7PM:&ved=0CAUQjRw&url=http%3A%2F%2Fwww.themillions.com%2F2013%2F01%2Fmy-new-years-resolution-read-fewer-books.html&ei=h6U1UYSGHYS0kQX7w4GwDw&psig=AFQjCNH6Go_tn5uVww6apBKkVLvpzxoq3A&ust=1362556597048876http://www.google.com/url?sa=i&rct=j&q=books&source=images&cd=&cad=rja&docid=jUUqJWyZZISufM&tbnid=nahTdqTm0Aa7PM:&ved=0CAUQjRw&url=http%3A%2F%2Fwww.themillions.com%2F2013%2F01%2Fmy-new-years-resolution-read-fewer-books.html&ei=h6U1UYSGHYS0kQX7w4GwDw&psig=AFQjCNH6Go_tn5uVww6apBKkVLvpzxoq3A&ust=1362556597048876http://www.google.com/url?sa=i&rct=j&q=books&source=images&cd=&cad=rja&docid=jUUqJWyZZISufM&tbnid=nahTdqTm0Aa7PM:&ved=0CAUQjRw&url=http%3A%2F%2Fwww.themillions.com%2F2013%2F01%2Fmy-new-years-resolution-read-fewer-books.html&ei=h6U1UYSGHYS0kQX7w4GwDw&psig=AFQjCNH6Go_tn5uVww6apBKkVLvpzxoq3A&ust=1362556597048876http://www.google.com/url?sa=i&rct=j&q=books&source=images&cd=&cad=rja&docid=jUUqJWyZZISufM&tbnid=nahTdqTm0Aa7PM:&ved=0CAUQjRw&url=http%3A%2F%2Fwww.themillions.com%2F2013%2F01%2Fmy-new-years-resolution-read-fewer-books.html&ei=h6U1UYSGHYS0kQX7w4GwDw&psig=AFQjCNH6Go_tn5uVww6apBKkVLvpzxoq3A&ust=1362556597048876http://www.google.com/url?sa=i&rct=j&q=books&source=images&cd=&cad=rja&docid=jUUqJWyZZISufM&tbnid=nahTdqTm0Aa7PM:&ved=0CAUQjRw&url=http%3A%2F%2Fwww.themillions.com%2F2013%2F01%2Fmy-new-years-resolution-read-fewer-books.html&ei=h6U1UYSGHYS0kQX7w4GwDw&psig=AFQjCNH6Go_tn5uVww6apBKkVLvpzxoq3A&ust=1362556597048876
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    INTRODUCTION

    Diabetes mellitus is a complex disease

    associated with peripheral and central

    complications.

    These complications include retinopathy,

    nephropathy and neuropathy.

    One of the most widely used herbs is Panax

    ginseng; it is valuable in traditional medicine inmany countries (Karaca et al., 2010).

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    Panax Ginseng in Diabetes Mellitus

    Several investigations have

    confirmed the role of

    oxidative stress in

    developmental diabetic

    mediated disorders,possibly via the formation

    offree radicals (Manna et

    al., 2009).

    It is the most efficacious forimmune stimulation and

    the prevention of diabetes

    (Liu et al., 2003)

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    The Chemical Constituents of Ginseng

    Approximately 40 active ingredients have been

    identified, including

    ginsenosides,

    polyacetylenes,

    sesquiterpenes,

    polysaccharides, and peptidoglycans, have been isolated

    Lu, J.M., Yao, Q., Chen, C., 2009. Ginseng compounds: an update on their molecular

    mechanisms and medical applications. Curr. Vasc. Pharmacol. 7, 293302.

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    Three medicinal species of ginseng are

    currentlyrecognized

    1. Panax ginseng C.A. Meyer(Chinese or Koreanginseng, a perennial herb indigenous to themountainous forests of eastern Asia),

    2. Panax japonicus C.A. Meyer(Japanese ginseng,from India, Southern China, and Japan),

    3. Panax quinquefolius(American ginseng, foundgrowing in rich woodland in the eastern and

    central United States and Canada)(Court, 1975; Popov & Goldwag, 1973; Williams,1957).

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    Which One Do We Prefer ??

    1. Panax ginseng C.A. Meyer(Chinese or Koreanginseng, a perennial herb indigenous to themountainous forests of eastern Asia),

    2. Panax japonicus C.A. Meyer(Japanese ginseng,from India, Southern China, and Japan),

    3. Panax quinquefolius(American ginseng, foundgrowing in rich woodland in the eastern and

    central United States and Canada(Court, 1975; Popov & Goldwag, 1973; Williams,1957).

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    Is Panax Ginseng C.A.Meyer has Antioxidant

    Effect????

    Do We Need Antioxidant???

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    Figure 1. Oxidative stress-induced diseases in humans

    www.ijbs.org Int J Biomed Sci vol. 4 no. 2 June 2008

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    Antioxidant

    Agent has ability to block oxidation process at various bio-

    molecular targets such as carbohydrate, lipid, protein, DNA

    by free radicals

    Free radicals Antioxidant Free Radical

    radicals antioxidant

    (non-reaktif)

    Transfer

    e-Reduction oxidation

    electrone

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    What Evidence-Based Says About Panax

    Ginseng C.A. Meyer ?

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    13

    ROS=reactive oxygen species

    MDA=Malondialdehyde

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    14

    (Oxidant)

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    15

    (Oxidant)

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    This Systematic Review Aims

    To evaluate the available evidence from randomized

    clinical trials of the clinical efficacy and safety of

    ginseng.

    Systematic literature searches were performed in 13databases up to March 2009 without language

    restriction.

    All randomized clinical trials evaluating the clinical

    effects or safety of the use of ginseng

    monopreparations (Panax ginseng or P. quinquefolium)

    were considered for inclusion.

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    Methodology

    A total of 411 potentially relevant studies

    were identified and 57 randomized clinical

    trials were included.

    The main indications included glucose metabolism,

    physical performance,

    psychomotor function,

    sexual function,

    cardiac function,

    pulmonary disease, and

    cerebrovascular disease.

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    Conclusion of the Study

    In conclusion, our review compiles the evidence on the

    use of ginseng, finding a strong positive potential for

    glucose metabolism, level 1 of best-

    evidence synthesis.

    psychomotor function, which indicated strong

    evidence (level 1) of efficacy.

    and pulmonary disease, there is strong evidence

    (level 1) that ginseng is effective in pulmonary

    function.

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    Preclinical Study in Diabetes Mellitus

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    FBG and Insulin Level

    Induction of DM: Streptozotocin (STZ) was dissolved in 50 mM sodium citrate solution

    (pH 4.5) containing 150 mM sodium chloride. The solution (6 mg/0.5 ml/100 g body

    weight) was subcutaneously administered in rats (Uchiyama and Yamaguchi, 2003).

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    Lipid Profile and Cytokin

    Proinflammation Profile

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    Liver Oxidant/antioxidant Parameters

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    Conclusion of the Study

    P. ginseng has antihyperglycemic, anti-

    inflammatory, antilipidemic and antioxidant

    effect which may help in the treatment of

    diabetes and diabetic complications

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    Clinical Studies

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    Results

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    The results of two acute placebo-controlled, double-blind cross-over

    studies assessing the effect of Panax ginseng (G115) on blood glucose

    levels are reported.

    In study 1, thirty participants received three treatments: placebo; 200 mg

    G115; 400 mg G115. In study 2, twenty-seven participants received four

    treatments: placebo (0 mg ginseng and 30 mg saccharin); ginseng (200 mg

    ginseng and 30 mg saccharin); placeboglucose (0 mg ginseng and 25 g

    oral glucose); ginsengglucose (200 mg ginseng and 25 g oral glucose).

    Blood glucose levels were measured at baseline (at 09.00 hours after an

    overnight fast) and then 60, 90 (study 1 only) and 120 min post-dose. Both

    studies demonstrated that G115 alone significantly lowers fasting blood

    glucose levels. Conversely, in study 2 there was a significant drink X

    ginseng interaction suggesting opposing glycaemic effects of ginseng

    under fasting and raised blood glucose conditions. These data haveimplications for the use of ginseng in individuals with poor gluco-

    regulation.

    Panax: Ginseng: Acute: Placebo: Blood glucose: Hypoglycaemia: Healthy

    adults

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    The results of two acute placebo-controlled, double-blind cross-over

    studies assessing the effect of Panax ginseng (G115) on blood glucose

    levels are reported.

    In study 1, thirty participants received three treatments: placebo; 200 mg

    G115; 400 mg G115. In study 2, twenty-seven participants received four

    treatments: placebo (0 mg ginseng and 30 mg saccharin); ginseng (200 mg

    ginseng and 30 mg saccharin); placeboglucose (0 mg ginseng and 25 g

    oral glucose); ginsengglucose (200 mg ginseng and 25 g oral glucose).

    Blood glucose levels were measured at baseline (at 09.00 hours after an

    overnight fast) and then 60, 90 (study 1 only) and 120 min post-dose. Both

    studies demonstrated that G115 alone significantly lowers fasting blood

    glucose levels. Conversely, in study 2 there was a significant drink X

    ginseng interaction suggesting opposing glycaemic effects of ginseng

    under fasting and raised blood glucose conditions. These data haveimplications for the use of ginseng in individuals with poor gluco-

    regulation.

    Panax: Ginseng: Acute: Placebo: Blood glucose: Hypoglycaemia: Healthy

    adults

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    http://www.jacn.org/
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    Conclusions

    Together the studies indicate 2 g KRG-rootlets

    is sufficient to achieve reproducible reductions

    in postprandial glycemia.

    But the longterm sustainability of KRG

    selected using this approach remains to be

    tested.

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    Possible mechanisms:

    Modulation of:

    glucose disposal (Yokozawa et al., 1984) ,

    glucose transport (Yamasaki et al., 1993) or

    insulin secretion. Vuksan et al. (2000a), (Waki et

    al., 1982

    The three are not mutually exclusive and the

    latter two may both be mediated by increasedNO production (Roy et al. 1998; Spinas et al.

    1998).

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    Summary

    Ginseng G115 (P. Ginseng C.A. Meyer)

    Has been widely used to treat diabetes

    Has strong positive potential for glucose

    metabolism, level 1 of best-evidence synthesis

    ginseng has antihyperglycemic, anti-

    inflammatory, antilipidemic and antioxidant

    effect which may help in the treatment ofdiabetes and diabetic complications

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    Thank You for Your Attention