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.
閱讀完整摘要
Phyllanthus species for patients with chronic hepatitis B virus (HBV) infection have been assessed in clinical trials, but no consensus regarding their usefulness exists.
目的
To evaluate the benefits and harms of phyllanthus species for patients with chronic HBV infection.
搜尋策略
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.
選擇標準
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. We included trials irrespective of blinding, publication status, or language.
資料收集與分析
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.
主要結果
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.
作者結論
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.
