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<http://www2.cochrane.org/reviews/en/ab008960.html>
Phyllanthus species for chronic hepatitis B virus infection
Xia Y, Luo H, Liu JP, Gluud C
Summary
Phyllanthus species for chronic hepatitis B virus infection
Chronic hepatitis B virus (HBV) infection causes significant mortality,
morbidity, and economic burden worldwide. Although the current approved
therapies are effective, response to treatment is not satisfactory.
Patients are at high risk of developing viral resistance, and serious
adverse events occur. The objective of this review was to evaluate the
benefits and harms of phyllanthus species for patients with chronic HBV
infection. Phyllanthus species appear to be safe and may potentially have
effects on the clearance of viral markers in patients with HBV infection.
However, all of the trials evaluated in this review were of low methodology
quality, ie, have high risk of bias, and there was a risk of random errors
in the majority of comparisons. Furthermore, all analyses showed
substantial heterogeneity. Accordingly, randomised clinical trials with low
risk of bias and large sample size should be conducted to confirm the
effects of phyllanthus species before clinical use is considered.
This is a Cochrane review abstract and plain language summary, prepared
and maintained by The Cochrane Collaboration, currently published in The
Cochrane Database of Systematic Reviews 2011 Issue 4, Copyright © 2011 The
Cochrane Collaboration. Published by John Wiley and Sons, Ltd.. The full
text of the review is available in The Cochrane Library (ISSN 1464-780X).
This record should be cited as: Xia Y, Luo H, Liu JP, Gluud C. Phyllanthus
species for chronic hepatitis B virus infection. Cochrane Database of
Systematic Reviews 2011, Issue 4. Art. No.: CD008960. DOI:
10.1002/14651858.CD008960.pub2 Editorial Group: Hepato-Biliary Group This
version first published online: April 13. 2011 Last assessed as up-to-date:
October 31. 2010
Abstract
Background
Phyllanthus species for patients with chronic hepatitis B virus (HBV)
infection have been assessed in clinical trials, but no consensus regarding
their usefulness exists.
Objectives
To evaluate the benefits and harms of phyllanthus species for patients with
chronic HBV infection.
Search strategy
Searches were performed in The Cochrane Hepato-Biliary Gorup Controlled
Trials Register, The Cochrane Central Register of Controlled Trials
(CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, Science Citation Index
Expanded, and the Chinese Biomedical CD Database, China Network Knowledge
Information, Chinese Science Journal Database, TCM Online, and Wanfang
Database. Conference proceedings in Chinese were handsearched. All searches
were conducted until October 2010.
Selection criteria
Randomized clinical trials comparing phyllanthus species with placebo or no
intervention for patients with chronic HBV infection. Co-interventions were
allowed if all comparison groups had received the same co-interventions. We
included trials irrespective of blinding, publication status, or language.
Data collection and analysis
Two authors selected the trials and extracted the data independently. The
RevMan software was used for statistical analysis of dichotomous data with
risk ratio (RR) with 95% confidence intervals (CI). Risk of bias was
assessed to control for systematic errors. Trial sequential analysis was
used in order to control for random errors.
Main results
A total of 16 randomised trials with 1326 patients were included. One trial
with 42 participants compared phyllanthus with placebo. The trial found no
significant difference in HBeAg seroconversion after the end of treatment
(RR 0.9; 95% CI 0.73 to 1.25) or follow-up (RR 1.00; 95% CI 0.63 to 1.60).
No other outcomes could be assessed. Fifteen trials compared phyllanthus
plus an antiviral drug like interferon alpha, lamivudine, adefovir
dipivoxil, thymosin, vidarabine, or conventional treatment with the same
antiviral drug alone. Phyllanthus did significantly affect serum HBV DNA
(RR 0.69; 95% CI 0.52 to 0.91, P = 0.008; I2 = 71%), serum HBeAg (RR 0.70;
95% CI 0.60 to 0.81, P < 0.00001; I2 = 68%), and HBeAg seroconversion (RR
0.77; 95% CI 0.63 to 0.92, P = 0.005; I2 = 78%), but the heterogeneity was
substantial. The result obtained regarding serum HBV DNA was not supported
by trial sequential analysis. None of the trials reported mortality and
hepatitis B-related morbidity, quality of life, or liver histology. Only
two trials reported adverse events with numbers without significant
differences. No serious adverse events were reported.
Authors' conclusions
There is no convincing evidence that phyllanthus compared with placebo
benefits patients with chronic HBV infection. Phyllanthus plus an antiviral
drug may be better than the same antiviral drug alone. However,
heterogeneity, systematic errors, and random errors question the validity
of the results. Clinical trials with large sample size and low risk of bias
are needed to confirm our findings. Species of phyllanthus should be
reported in future trials, and a dose-finding design is warranted. |
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发表于 2011-4-22 04:27
