Objective To assess the efficacy of telbivudine in the treatment of chronic hepatitis B (CHB). Methods Randomized controlled trials (RCTs) of telbivudine therapy vs. lamivudine therapy in both Chinese and English were retrieved from seven electronic databases with a cut-off date in February 2010, including PubMed, EMbase, VIP, CBM, CNKI, and The Cochrane library. The meta-analyses and evaluation on methodology quality were performed for the included studies. Results Two RCTs as Grade-A study were included. The meta-analyses showed that telbivudine was superior to lamivudine in aspects of therapeutic response (RR=1.28, 95%CI 1.10 to 1.48, P=0.001), ALT normalization (RR=1.12, 95%CI 1.01 to 1.23, P=0.02), and PCR-negative HBV DNA or below the lower limit (RR=1.44, 95%CI 1.36 to 1.53, Plt;0.000 01), primary treatment failure (OR=0.28, 95%CI 0.18, to 0.43, Plt;0.000 01), viral breakthrough (OR=0.38, 95%CI 0.32 to 0.47, Plt;0.000 01) and viral resistance (OR=0.44, 95%CI 0.36 to 0.55, Plt;0.000 01). Conclusion Based on the current clinical evidence, telbivudine demonstrates superiority in comparison with lamivudine on all direct measures of antiviral efficacy for CHB. Because of the short follow-up duration and the small sample size of the included studies, it is expected to further discuss the long-term efficacy.
Background Hepatitis B virus infection is a serious health problem worldwide. Traditional Chinese medicinal herbs have been widely used to treat chronic liver diseases, and many controlled trials have been done to investigate their efficacy. Objectives To assess the efficacy and safety of traditional Chinese medicinal herbs for chronic hepatitis B infection. Search strategy Searches were applied to the following electronic databases: the CHBG Trials Register, the Cochrane Complementary Medicine Field Trials-Register, the Cochrane Library, MEDLINE, EMBASE and BIOSIS. Five Chinese journals and conference proceedings were handsearched. No language restriction was used. Selection criteria Randomized or quasi-randomized trials with at least three months follow-up. Thais of Chinese medicinal herbs (single or compound) compared with placebo, no intervention, general non-specific treatment or interferon treatment were included. Trials of Chinese medicinal herbs plus interferon versus interferon alone were also included. Trials could be double-blind, single-blind or not blinded. Data collection and analysis Data were extracted independently by two reviewers. The methodological quality of trials was evaluated using the Jadad-scale plus allocation concealment. Intention-to-treat analyses were performed. Main Resuits Nine randomized trials, including 936 patients, met the inclusion criteria. Methodological quality was considered adequate in only one trial. There was a significant funnel plot asymmetry (regression coefficient= 3.37, standard error 1.40, P=0.047). Ten different medicinal herbs were tested in the nine trials. Compared to non-specific treatment or placebo, Fuzheng Jiedu Tang (compound of herbs) showed significantly positive effects on clearance of serum HBsAg, HBeAg, and HBV DNA; Polyporus umbellatus, polysaccharide on serum HBeAg and HBV DNA; Phyllanthus amarus on serum HBeAg. Phyllanthus compound and kurorinone showed no significant effect on clearance of serum HBeAg and HBV DNA and on alanine aminotransferase normalization compared to interferon treatment. There were no significant effects of the other examined herbs. Reviewer’s conclusions Some Chinese medicinal herbs may work in chronic hepatitis B. However, the evidence too weak to recommend any single herb. Rigorously designed, randomized, double-blind, placebo-controlled trials are required.
Objective To assess the efficacy and safety of Chinese medicinal herbs for asymptomatic hepatitis B virus(HBV) infection. Data Source The trials registers of the Cochrane Hepato-Biliary Group, the Cochrane Library and the Cochrane Complementary Medicine Field were searched in combination with MEDLINE, EMBASE, and handsearches of Chinese journals and conference proceedings. Data Selection Randomized clinical trials with 3 months follow-up comparing Chinese medicinal herbs versus placebo, no intervention, non-specific treatment, or interferon treatment for asymptomatic HBV carriers were included. No language and blinding limitations were applied. Data Extraction Data were extracted independently by two reviewers. The methodological quality of trials was assessed by the Jadad-scale plus allocation concealment. Results Three randomized clinical trials (307 patients) with low methodological quality following patients for three months or more after the end of treatment were included. Herbal compound Jianpi Wenshen recipe showed significant effects on clearance of HBV markers compared to interferon: relative risk 2.40 (95 % CI 1.01 to 5.72) for clearance of serum HBsAg, and 2.54 (1.13 to 5.70) for seroconversion of HBeAg to anti-HBe. Phyllanthus amarus and Astragalus membranaceus showed no significant antiviral effect compared with placebo. Analysis of pooling eight randomized clinical trials with less than three months follow-up did not show a significant benefit of Chinese medicinal herbs on viral markers. No serious adverse event was observed. Conclusions There is insufficient evidence for treatment of asymptomatic HBVcarriers using Chinese medicinal herbs due to the low quality of the trials. Further randomized, double blind, placebo-controlled trials are needed.
Objective To evaluate the efficacy and safety of genus Phyllanthus for chronic HBV infection. Design a systematic review of randomized clinical trials. Methods Randomized trials comparing genus Phyllanthus versus placebo, no intervention, general non-specific treatment, other herbal medicine, or interferon treatment for chronic HBV infection were identified by electronic and manual searches. Trials of Phyllanthus herb plus interferon versus interferon alone were also included. No blinding and language limitations were applied. The methodological quality of trials was assesses, by the Jadadscale plus allocation concealment. Results Twenty-two randomized trials (n=1 947) were identified. The methodological quality was high in five double blind trials and rest was low. The combined results showed that Phyllanthus species had positive effect on clearance of serum HBsAg (relative risk 5.64, 95%C1 1.85 to 17.21) compared with placebo or no intervention. There was no significant difference on clearance of serum HBsAg, HBeAg and HBV DNA between Phyllanthus and interferon. Phyllanthus species were better than non-specific treatment or other herbal medicines on clearance of serum HBeAg, HBeAg, HBV DNA, and liver enzyme normalization. Analyses showed a better effect of the Phyllanthus plus interferon combination on clearance of serum (1.56, 1.06 to 2.32) and HBV DNA (1.52, 1.05 to 2.21) than interferon alone. No serious adverse events were reported. Conclusions Based on the review Phyllanthus species may have positive effect on antiviral activity and liver biochemistry in chronic HBV infection. However, the evidence is not b due to the general low methodological quality and the variations of the herb. Further large trials are needed.
Objective To investigate the current situation of randomized controlled trials or clinical controlled trial (RCT/CCT) on chronic hepatitis B and whether to offer reliable evidence for clinical practice in China. Methods RCT/CCT identified from six Chinese clinical journals were searched manually and assessed according to international standard of evidence-based medicine. Results 308 issues containing 212 therapeutic articles and 88 RCT/CCT on chronic hepatitis B were identified and analyzed. Conclusion the quantity and quality of RCT/CCT of chronic hepatitis B did not meet the need of clinical practice.
Background Hepatitis B is one of the major infectious diseases of mankind, and up to now, there is no effective way to handle it. Recent clinical trials have shown the potential advantages of Kurorinone an extract of Chinese herb, in treament of chronic HBV infection. Objectives Systermically review the safety and efficacy of Kurorinone in treatment of chronic HBV infection. Search strategy With the searching terms including Kurorinone, its products’ name, hepatitis B and chronic carrier status, the trials registers of the Cochrane Hepato- Biliary Group, the Cochrane Complementary Medicine Field, and the central database of the Cochrane Library as well as MEDILINE, EMBASE and Chinese Biomedical CD Database were searched from their date of inception onward. 20 Chinese medical journals and relevant academic conference proceedings have been searched by hand. The reference lists of identified documents were checked as the complementary search. Inclusion Criteria All RCTs that tested Kurorinone for chronic HBV infection were included in this review. Method of the review According the demand of Cochrane systematic review, selection of trial for inclusion, assessment of methodological quality, data extraction and data syntheses would be conducted for each included trial.
Objective To assess the efficacy of lamivudine in patients with HBeAg positive chronic hepatitis B.Methods MEDLINE, SCI, Current Content Connect, The Cochrane Library, and Chinese Biomedical Database were searched from the beginning to September 2005, and the references of eligible studies were manually screened. R.andomized controlled trials comparing lamivudine with non-antiviral interventions （ placebo, no treatment and standard care ） in patients with chronic hepatitis B were eligible for inclusion. Two investigators independently assessed the quality and extracted the data. Heterogeneity was examined by Chi-square test. Fixed and random effect meta-analysis were used to pool the data. Subgroup analyses were used in treatment course. Results Eleven R.CTs were included （ n = 1 237 ）. All reported the effect of lamivudine （100 mg/d） , and one of them included lamivudine （25 mg/d）. The treatment duration of 52 weeks and less than 26 weeks were reported in eight and three RCTs, respectively. Six RCTs adequately applied randomization, while other five RCTs were not reported in detail. Four RCTs adequately enforced allocation concealment, five RCTs enforced blinding bitterly. The others were not reported in detail. It was found by meta-analysis that, compared with the control, lamivudine （100 mg/d, 52 W） could significantly clear HBeAg [42.6% vs. 13% , RR 3.20, 95% CI （2.33, 4. 38）] and clearHBVDNA [71.78% vs. 20, 36%, RR3.42, 95%CI （2.80,4.19）], normalize ALT [65% vs. 34.9%, RR1.91, 95%CI （1.64,2.21）], achieve HBeAgseroconversion [16.1% vs. 7.29% , RR2.12, 95%CI （1.24,3.80） ] and histology response [57. 9% vs. 26.2%, RR 2. 17, 95% CI （ 1.67,2.81 ） ] ; Lanfivudine （100 mg/ d, 12 W） could effectively clear HBV DNA [ 50.7% vs 3.92% , RR 8.68, 95% CI （1.72,43.74 ） ] , but was not effective in loss of HBeAg, HBeAg seroconversion and normalization of ALT, Lamivudine （25 mg/d） could effectively clear HBV DNA [97.7% vs. 22.2% , RR 4.41, 95% CI （2.86,6.79） ] and improve histology response [59.3% vs. 30% , RR1.98, 95% CI （1.31,2.99 ） ], but was not effective in HBeAg seroconversion. Conclusions Lamivudine （100 mg/ d） is effective in clearing HBV DNA and HBeAg, normalizing ALT and achieving HBeAg seroconversion.
Objective To compare the combination of Xiao Chai Hu Tang and interferon versus the simple interferon for the management of chronic hepatitis B (CHB) in terms of clinical therapeutic effect and safety. Methods Such databases as PubMed, CBM disc, CNKI, VIP, Japana Centra Revuo Medicina were searched to include the randomized control trials (RCTs) of treating chronic hepatitis B by using Xiao Chai Hu Tang plus interferon as the treatment group and the interferon as the control group. The quality of the inclusive methodology was evaluated by two reviewers independently. RevMan5.0.24 software was employed for meta-analyses. Results Seven RCTs involving 668 patients were included and all of them were classified as Grade C methodologically. The results of meta-analyses demonstrated: compared with the simple interferon treatment, adding Xiao Chai Hu Tang to interferon was able to significantly increase the HBV-DNA negative conversion ratio (RR=1.44, 95%CI 1.18 to 1.76, P=0.000 4) and the HBeAg negative conversion ratio (RR=1.54, 95%CI 1.21 to 1.94, P=0.000 4); when the intervention duration was more than 12 weeks, the ALT normalization rate was improved significantly (24 weeks: RR=1.39, 95%CI 1.17 to 1.66, P=0.000 2; 12 weeks: RR=1.79, 95%CI 1.23 to 2.61, P=0.002) and the incidence of flu-like symptoms induced by interferon was significantly reduced (liver-protection treatment: RR=0.54, 95%CI 0.40 to 0.73, Plt;0.000 1; Non-liver-protection treatment: RR=0.75, 95%CI 0.59 to 0.95, P=0.02). The funnel plot was asymmetric, indicating publication bias. Conclusion Although Xiao Chai Hu Tang maybe has certain potential supplementary benefits to interferon for the management of CHB. The results of the above meta-analyses should be interpreted prudently because there exit disparities in domestic and international trails with the shortage of double blind or multi-centered clinical trials with high quality. The current evidence provides no way to compare the combination of Xiao Chai Hu Tang plus interferon with the simple interferon for the treatment of CHB and no accurate conclusion in terms of clinical therapeutic effects and safety.
Objective To evaluate the effectiveness and safety of Gansu for chronic hepatitis B. Methods We searched The Cochrane Central Register of Controlled Trials (CCTR), PubMed, EMbase, CBM, CNKI, VIP, and Wanfang databases up to Dce. 2009. The methodological quality assessment and data extraction of the included studies were conducted by two reviewers independently according to the inclusion and exclusion criteria. Meta-analyses were performed for homogeneous studies using RevMan 4.2.10 software. Results A total of 14 studies involving 1 755 patients met the inclusion criteria. Of which, 12 studies did not report randomization method, and the other two studies reported inadequate methods of randomization. None of the studies enforced allocation concealment and performed blinding. We conducted subgroup analyses based on the outcome measures and interventions. The results of meta-analyses showed: (1) In terms of reducing ALT, Gansu + conventional therapy was superior to conventional therapy alone. (2) In terms of the HBsAg seroconversion rate, no significant difference was found between the two groups. (3) In terms of the HBeAg, no significant difference was found between the two groups at 3 months’ follow-up. (4) In terms of the HBV-DNA, Gansu + conventional therapy was superior to conventional therapy alone at 3 and 6 months’ follow-up, but theses differences were not found between Gansu + Lamivudine/ Adefovir and Lamivudine/ Adefovir alone. In terms of reducing the index of hepatic fibrosis, Gansu + conventional therapy was superior to conventional therapy alone. Conclusion Gansu might be effective in normalizing ALT levels, clearing HBV DNA, achieving virus seroconversion and improving hepatic fibrosis, without any serious adverse effects. However, because the overall effects cannot be pooled for analysis, more evidence is needed to support this finding.
Objective To assess the efficacy between Peginterferon α-2a and common Interferon in HBeAg positive chronic hepatitis B. Methods MEDLINE, EBSCO, PubMed, CNKI, WangFang were searched from the beginning to May 2009, and the references of eligible studies were manually screened. Randomized controlled trials comparing Peginterferon-alpha2a with common interferon in HBeAg positive chronic hepatitis B were eligible for inclusion. Jadad score method was adopted to evaluate the methodological quality of included studies. Meta analysis was conducted by RevMan 5.0 software supplied by the Cochrane Collaboration. Subgroup analyses were used in treatment and observation course. Results Six randomized controlled trials were included (n=688). The treatment duration of 48 weeks and 24 weeks were reported in four and two studies, respectively. We carried out subgroup analysis according to treatment. Meta-analysis showed that Peginterferon-alpha2a (180 ug/d, 48 W) could significantly clear HBeAg, clear HBVDNA, normalize ALT and HBeAg seroconversion compared with common Interferon (Plt;0.05). Peginterferon-alpha2a (180 ug/d, 24 W) could effectively clear HBV DNA [P=0.04, RR=1.44, 95%CI (1.01, 2.05)], but was not effective in loss of HBeAg, HBeAg seroconversion and ALT normalization (Pgt;0.05). Conclusion The efficacy of 48 weeks treatment with Peginterferon α-2a is better than common Interferon. The efficacy of 24 weeks treatment with Peginterferon α-2a is only better in HBV-DNA negative rate than common Interferon. However, because the methodological quality of included studies is not high, this conclusion should be carefully considered in clinical use.