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Chinese herbs for hepatitis B
Clinical bottom line:
Some benefit was shown for particular Chinese
herbal medicines, or compounds, in trials of poor methodological quality
which reported antiviral and biochemical response rather than clinically
relevant outcomes like prolonged survival, mortality, and development of
liver cirrhosis or hepatocellular carcinoma. Few trials confirmed the
diagnosis of chronic hepatitis B by liver biopsy. At present there is no
evidence from high quality studies and the use of Chinese herbal
medicines cannot be recommended in this context.
Hepatitis B is an infectious disease of the liver. It is
a serious health problem with more than two billion sufferers worldwide,
around 350 million of which are chronic carriers of the disease.
Associated risks include cirrhosis of the liver and liver cancer from
which more than one million people die annually. The virus is spread by
contact with infected body fluids or from mother to child. The standard
treatment for hepatitis B is alpha-2b-interferon which is expensive, has
serious adverse effects and does not always prevent recurrence of the
disease. Historically, Chinese herbal medicines have been used to treat
liver disease, including chronic hepatitis B.
Liu JP, McIntosh H, lin H. Chinese medicinal
herbs for chronic hepatitis B (Cochrane review). In: The Cochrane
Library, Issue 1, 2001. Oxford: Update Software.
Date review completed
: Last update June 2000
Number of trials included
Number of patients
: 936 in total
Control group :
placebo, alpha-2b-interferon, non-specific treatment (e.g. vitamins,
Main outcomes :
Viral response, biochemical response, adverse effects.
Inclusion criteria were randomised or quasi-randomised
controlled trial which assessed Chinese herbal medicine in the treatment
of chronic hepatitis B with a minimum follow-up period of three months.
Chronic hepatitis B was defined as serum HBsAg positive persisting for
at least six months, with elevated aminotransferase (ALT) and/or
aspartate aminotransferase (AST) or with recurrent fluctuation, with or
without liver biopsy findings compatible with chronic hepatitis. Chinese
herbal medicines could consist of a single herb or a combination of
herbs, or be used in combination with alpha-2b-interferon.
Medline, EMBASE, BIOSIS, the Cochrane Hepato-Biliary
group register and the Cochrane Collaboration trials register were
searched. In addition several, mainly Chinese, journals were hand
searched. No language restrictions were made. Methodological quality was
assessed using a validated scale. Relative risk and weighted mean
difference, with 95% confidence intervals, were calculated using pooled
Nine studies had adequate follow-up and were included in
the analyses; these assessed 10 different Chinese herbal medicines. All,
except one, of the studies were of poor methodological quality, with a
mean sample size of 106 patients (range 25 to 252). The mean age of
patients was 32 years. The constituents and dose of the herbs varied.
Median duration of treatment was three months (range one to six).
Non-specific treatments used as control included vitamins, alcamin,
hypoxanthosine, potassium magnesium aspartate, coenzyme A pantothenic
acid, and adenosine triphosphate. There was no significant effect of
Potenlini, Kangdu Wan, Anisodamine plus salviae miltorrhizae or
kuorinone compared with control for any of the assessed outcomes.
Fuzheng Jiedu Tang (a compound of herbs) produced
significant antiviral activity compared with vitamin plus hypoxanthosine.
The relative risks were 5.19 (95% confidence interval 1.24 to 21.79) for
clearance of serum HBsAg, 10.85 (3.56 to 33.06) for clearance of serum
HBeAg, and 8.50 (1.23 to 58.85) for clearance of serum HBV DNA.
Phyllanthus amarus (a single herb) produced
significantly better clearance of serum HBeAg than vitamin plus
hypoxanthosine plus alcamin over three months, relative risk 3.35 (1.49
to 7.56). There was no significant difference between Phyllanthus amarus
and interferon (5 mega units every two days for three months) on
clearance of serum HBeAg and HBV DNA.
Polyporus umbellatus polysaccharide was significantly
better than vitamin C plus hypoxanthosine at improving serum HBeAg in
two trials; relative risks 3.06 (95% confidence interval 1.13 to 8.29).
There was no significant effect of Polyporus umbellatus polysaccharide
on clearance of serum HBeAg and HBV DNA.
Eight trials (628 patients) compared Chinese herbs plus
interferon with interferon alone. The average dose of interferon was
1.84 mega units per day, and the median duration of treatment was four
months. Follow-up was shorter than three months in all studies. Chinese
herbal medicine plus interferon was significantly better than interferon
alone for clearance of serum HBeAg (relative risk 2.02 (1.63 to 2.51)),
HBsAg (relative risk 2.61 (1.10 to 6.21)), and HBV DNA (relative risk
(1.90 (1.50 to 2.41)).
In four trials (189 patients), Chinese herbal medicines
were significantly more effective than placebo or non-specific treatment
at normalisation of serum ALT, relative risk 1.41 (1.14 to 1.75).
Combinations of Chinese herbal medicine with interferon
were significantly more effective than interferon alone at normalisation
of serum ALT (204 patients), relative risk 1.66 (1.30 to 2.13).
Significant superiority of the combination was also shown in two trials
(122 patients) for AST normalisation, relative risk 1.83 (1.31 to 2.55).
Eight trials mentioned adverse effects. Ascites and
lower limb oedema were reported in one patient with early-stage
cirrhosis of the liver who took Potenlini. Enlarged lymph nodes which
persisted for more than one week were reported with Polyporus umbellatus
polysaccharide (8/60 patients). Dry throat was associated with Kang Du
Wan. Anisodamine and Salviae miltiorrhizae were associated with thirst
and rapid heart rate. None of the reported adverse effects were serious.
The reviewers mentioned that Chinese herbal medicines have been reported
to cause serious adverse effects, including liver toxicity.
The included studies were of poor methodological
quality. Only two were double blind; the others made no attempt at
blinding. In addition, only three trials confirmed the presence of
chronic hepatitis B by liver biopsy. Clinically relevant end-points
which were not assessed in the trials were mortality, development of
liver cirrhosis and hepatocellular carcinoma, and survival. Instead,
antiviral and biochemical response were assessed. These showed that
Fuzheng Jiedu, Polyporus umbellatus polysaccharide and Phyllanthus
amarus were more effective than non-specific treatment or placebo. The
evidence for Fuzheng Jiedu was stronger since significant improvement
was shown for several antiviral markers. It is not known, though, how
effective these non-specific treatments are in chronic hepatitis B. The
superiority of combinations of Chinese herbal medicines with interferon
over interferon alone relied on an analysis of several different herbal
medicines; there was insufficient information to determine the benefit
of particular Chinese herbal medicines. At present high quality studies
are not available and the results of these trials should be interpreted
Identifier CHINESE HERBAL MEDICINE FOR CHRONIC HEPATITIS