A two-stage clinical trial of Phyllanthus amarus on hepatitis B carriers: Failure to eradicate the surface antigen

Dr Balabhai Nanavati Hospital and Research Center, Juhu, Bombay.
Indian Journal of Gastroenterology 02/1994; 13(1):7-8.
Source: PubMed


There have been conflicting data in literature about the value of Phyllanthus amarus in treating hepatitis B virus-related disorders.
To evaluate the role of Phyllanthus amarus in eradication of the virus in hepatitis B carriers.
Phyllanthus amarus was administered to 30 asymptomatic carriers of hepatitis B surface antigen (HBsAg) in a dosage of 250 to 500 mg thrice daily for 4 to 8 weeks.
None of the 30 subjects cleared HBsAg. Phyllanthus amarus was well tolerated, with no clinical side effects or changes in the organ profiles for safety evaluation.
Phyllanthus amarus is not effective in clearing HBsAg in asymptomatic carriers of the antigen.

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    • "The anti-malarial activity of P. niruri in 20 crude extracts from nine African medicinal plants used in Kinshasa, Congo, was confirmed (Tona et al., 1999; Cimanga et al., 2004; Mustofa et al., 2007). P. niruri and amarus are said to offer protection against HBV (Mehrotra et al., 1990), chemical toxins (Lee et al., 2006; Chatterjee et al., 2006; Wang, 2000), liver cancer (Rajeshkumar and Kuttan, 2000) and tumorigenesis (Rajeshkumar et al., 2002; Sripanidkulchai et al., 2002), although the latter is still controversial (Milne et al., 1994; Doshi et al., 1994; Thamlikitkul et al., 1991). "
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    ABSTRACT: Phyllanthus niruri is a plant with medicinal properties. It is often used to treat mild malaria and the elimination of renal stones. However, studies on its toxicity are scarce. The study was carried out to determine if the aqueous leaf extract of P. niruri administered to female Sprague-Dawley rats would illicit evidence of toxicity. Fifteen female rats weighing 150-200 g were divided into 3 groups. Rats in Group 1 were given a single low dose (LD) of 2000 mg/kg b.w. of the extract by oral gavage within 24 hrs. Rats in Group 2 were given a single high dose (HD) of 5000 mg/kg b.w. of the extract by oral gavage within 24 hrs. Rats in Group 3 were not given any extract but drinking water and served as the control group (C). All the rats were observed for signs of toxidromes for 14 days. On the 15(th) day, all the rats were sacrificed. Body organs were harvested for macroscopic examination. Urine and blood samples were drawn and analyzed. Hematological tests performed included full blood count and hemoglobin. Biochemical examinations included bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total protein, albumin, globulin, alkaline phosphatse (ALP), γ-glutamyltranspeptidase (GGT), urea, and creatinine. The results of the three groups were not significantly different. Examination of the various body organs did not show any abnormality. Thus no toxicity was observed at the levels administered. The LD(50) of the aqueous extract is>5000 mg/kg. b.w.
    Full-text · Article · Dec 2011 · Interdisciplinary toxicology
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    • "Some reports have shown the antiviral effect of this plant by reducing the detectable hepatitis B surface antigen (HbsAg) of HBV positive patients (Thyagarajan et al., 1988; Ott et al., 1997). But other studies from China, Thailand, and India showed the failure of P. amarus in eradicating the HbsAg in patients with chronic hepatitis B virus (Leelarasamee et al, 1990; Wang et al, 1991, Doshi et al, 1994). The variation in the clinical effect of these studies has been attributed to many factors such as different species, differences in growing condition and different processing methods (Thyagarajan et al., 2002; Wang, 2000). "
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    ABSTRACT: Phyllanthus amarus (Euphorbiaceae) is used as a folk medicine for jaundice and other diseases in Malaysia and other countries. But, so far, no safety studies have been carried out on this plant with clear documentation, especially with those plants growing in Malaysia. So the aim of this study was to determine the toxic side effects of aqueous extract of leaves of P. amarus (grown in Malaysia) following oral administration in rats. Acute admininstration of P. amarus extract at a dose of 5 g/kg body weight did not produce any signs of toxicity or mortality. In the chronic study, no significant difference (P > 0.05) was observed between the control and P. amarus extract administered (male and female) rats (at the doses of 100, 400 and 800 mg/kg body weight for 6 weeks) in the total body weight gain as well as in the liver marker enzymes analyzed in serum. The non-toxic nature of P. amarus extract administration was confirmed by histological studies [light microscopy, proliferative cell nuclear antigen study and apoptotic study] i.e., no observable changes were found between control and P. amarus extract administered rats. Therefore, acute oral administration of P. amarus extract is non-toxic to the rat liver, even at a dose of 5 g /kg body weight and also the chronic toxicity studies of P. amarus extracts administration showed the absence of cumulative toxicity as reflected by the non-significant change in the parameters studied as well as from the results of the histological studies.
    Full-text · Article · Oct 2006 · African Journal of Traditional, Complementary and Alternative Medicines
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