Phyllanthus species for chronic hepatitis B virus infection

April 21, 2011

http://www2.cochrane.org/reviews/en/ab008960.html

Xia Y, Luo H, Liu JP, Gluud C

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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

Collaboration. Published by 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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Phyllanthus species for chronic hepatitis B virus infection

Cochrane Reviews, 04/20/2011

Xia Y et al. – There is no convincing evidence that phyllanthus compared with

placebo benefits patients with chronic hepatitis B virus 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.

Methods• Randomised 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.

• Study included trials irrespective of blinding, publication status, or

language.

• 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

• Total of 16 randomised trials with 1326 patients were included.

• 1 One trial with 42 participants compared phyllanthus with placebo.

Results• 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.

• 15 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.

• 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.

April 21, 2011