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International Journal of Medicinal Mushrooms

 

ISSN for PRINT: 1521-9437

Institutional price:

$538.00

Issues per year:

4

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Best Paper Award Selection - Editorial Board Site

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2002, Volume4

Issue 4

  112 pages  

   

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Issue price - $128.00  

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  • A Phase I/II Study of a Ganoderma lucidum (Curt.: Fr.) P. Karst. (Ling Zhi, Reishi Mushroom) Extract in Patients with Chronic Hepatitis В
  • Yihuai Gao
    Institute of Food, Nutrition and Human Health, Massey University; Landcare Research, Private Bag 92170, Auckland, New Zealand

    Shufeng Zhou
    Division of Pharmacy, School of Life Sciences, Faculty of Science, Queensland University of Technology, Queensland 4001, Australia; and Department of Pharmacy, Faculty of Science, National University of Singapore, Singapore

    Guoliang Chen
    Division of Traditional Chinese Medicine, New Zealand Institute of Natural Medicines, Auckland, New Zealand

    Xihu Dai
    Department of Internal Medicine, Fuzhou General Hospital of Nanjing Military Region of the Peoples' Liberation Army, Fuzhou, R.P. China

    Jingxian Ye
    Department of Integrated Medicine. Hospital of Fujian University of Traditional Chinese Medicine, Fuzhou, R.P. China

    He Gao
    Division of Traditional Chinese Medicine, New Zealand Institute of Natural Medicines, Auckland, New Zealand


    ABSTRACT

    The polysaccharide fractions and triterpenes isolated from Ganoderma lucidum have shown protection effects on the liver in animal studies. This double-blind, randomised, and multicentered study aimed to evaluate the safety and effect of a G. lucidum extraction, Ganopoly, in chronic hepatitis B. Ninety patients with chronic hepatitis B, hepatitis В viral (HBV) DNA positivity, and aminotransferase elevation were included in this multicenter prospective randomized Phase I/II study. Patients were randomized to be given Ganopoly (n = 60) or placebo (n = 30) for 12 weeks, then followed up for 13 weeks. Effect of therapy on levels of HBV DNA and aminotransferase activities in serum and hepatitis В е antigen (HBeAg) status were investigated. There were 78 assessable patients who entered the trial for efficacy and safety; 13 of 52 (25%) patients receiving Ganopoly responded by reducing HBeAg and HBV DNA, compared to 1 of 26 (4%) in the control group (P < 0.05). Among those with serum aspartate aminotransferase (AST) values < 100 U/L (n = 29), 41% (12/29) responded, and among those with AST values > 100 U/L (n = 23), 65% (15/23) responded. Within the 6-month study period, 33% (17/ 52) of treated patients had normal aminotransferase (ALT) values, and 13% (7/52) had cleared hepatitis B surface antigen (HBsAg) from serum, whereas none of the controls had normal ALT values or had lost HBsAg. Eight of 60 patients in Ganopoly group and 4 of 30 in the controls were unable to be followed up due to loss or withdrawal. Our study indicates that Ganopoly is well tolerated and appears to be active against HBV in patients with chronic hepatitis B.

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