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.
ObjectiveTo evaluate the clinical efficacy and safety of telbivudine (TEV) combined with adefovir dipivoxil (ADV) for chronic hepatitis B (CHB), so as to provide references for clinical practice and research.
MethodsWe electronically searched databases including The Cochrane Library (Issue 7, 2013), PubMed, EMbase, Web of Science, CBM, CNKI, VIP, and WanFang Data from inception to August 21st, 2013, for the relevant randomized controlled trials (RCTs). Other sources were also retrieved. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and assessed the quality of included studies. Then, meta-analysis was performed using RevMan 5.1 software.
ResultsA Total of 11 RCTs involving 1 010 patients were included. The trial group were given TEV combined with ADV, while the control group were given TEV alone or ADV alone. The results of metaanalysis showed that, the combined use was superior to TEV alone or ADV alone in improving HBV-DNA negative rates at 12-, 24-, 48-weeks, HBeAg negative rates at 12-, 24-, 48-weeks, and ALT recovery rates at 12-, 24-weeks (P < 0.05). The results of qualitative analysis showed that, the trial group had a lower drug resistance rate, and both were alike in the incidence of adverse reaction.
ConclusionCompared with TEV alone or ADV alone, TEV combined with ADV could improve the clinical efficacy of treating CHB which is also fairly safe. Due to the limited quantity and quality of the included studies, the aforementioned conclusion still needs to be further verified by conducting more large-scale and high quality RCTs.
Objective To assess the effectiveness and safety of Jiuweirougan granule in the treatment of chronic hepatitis with hepatic fibrosis. Methods A double-blind, double dummy and randomized controlled method was adopted. Forty-six patients were selected by using the inclusion and exclusion criteria and were randomizedly allocated to the treatment group (n=23, Jiuweirougan 10 g, twice a day) and the control group (n=23, treated with Biejiaruangan 4 pills, three times a day). The duration of treatment for both groups lasted for 6 months. Results Two patients in the treatment group dropped out halfway through the study, while one patient in the control group was withdrawal for irregular treatment. Analysis according to intention-to-treat (ITT) and per-protocol (PP) was conducted. In the treatment group, the effective rates of TCM (Traditional Chinese Medicine) on the syndrome were 82.61% (19/23) (ITT) and 90.48% (19/21) (PP), while in the control group, there were 86.96% (20/23) (ITT) and 86.36% (19/20) (PP). There was no significant difference between the two groups (P＞0.05). The improvement rate of serum parameters in the treatment group such as hyaluronic acid (HA), type Ⅲ procollagen (PCⅢ), type Ⅳ collagewn (CⅣ) and laminin (LN) were 28.57% (6/21), 23.81% (5/21), 28.57% (6/21) and 4.76% (1/21), respectively, while in control group, the rates were 36.37% (8/22),13.64% (3/22), 36.37% (8/22) and 9.09% (2/22), respectively. No significant difference was seen between the two groups (P＞0.05). ITT and PP analysis revealed similar results. No obvious adverse effects were noted. Conclusion Jiuweirougan granule may improve chronic hepatitis with fibrosis, and its effect is equal to that of Biejiaruangan. No obvious toxic-adverse effects were seen.
Objective To evaluate the effectiveness and safety of kushenin for chronic hepatitis B. Methods We searched The Cochrane Hepato-Bil iary Group Controlled Trials Register (March, 2006), The Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 1, 2006), MEDLINE (1966 to present), EMBASE (1966 to present), OVID (1965 to present), the Chinese Biomedical Database (CBM) (1978 to 2006) and CNKI. Qual ity assessment and data extraction were conducted by two reviewers independently, and disagreement, if any, was resolved by discussion. Meta-analyses were performed for homogeneous studies. Results A total of 56 studies involving 5156 patients met the inclusion criteria. These included 3 randomized controlled trials (RCTs), 7 quasi-RCTs, and 46 other studies that did not report randomization methods. None of the trials enforced allocation concealment and only one trial performed blinding.We conducted subgroup analyses based on the outcome measures and interventions. Compared with interferon,the HBeAg seroconversion rate at 12 months after treatment was lower in patients treated with kushenin (RR=0.72, 95%CI 0.58 to 0.90); compared with lamivudine, a lower HBV DNA seroconversion rate after 12 and 24 weeks of treatment was associated with kushenin (RR=0.48, 95%CI 0.33 to 0.70; RR=0.40, 95%CI 0.26 to 0.63). No significant differences were noted between the kushenin group and the control group for all the other outcome measures. Conclusion Kushenin might be effective in normal izing 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 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.
ObjectiveTo systematically review the efficacy and safety of Heluo Shugan capsule in the treatment of hepatitis B fibrosis.
MethodWe searched PubMed, The Cochrane Library (Issue 8, 2015), CBM, CNKI, VIP and WanFang Data from their inception to August 2015, to collect randomized controlled trials (RCTs) on Heluo Shugan capsule for hepatitis B fibrosis. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then meta-analysis was performed using RevMan 5.3 software.
ResultsA total of 15 RCTs involving 1 840 patients were included. The results of meta-analysis showed that: (1) As for reduced level of serum hyaluronic acid (HA), Heluo Shugan capsule was superior to placebo (MD=82.31, 95%CI 37.44 to 127.19, P=0.000 3), but worse than Fuzheng Huayu capsule (MD=-137.45, 95% CI-196.29 to-78.62, P < 0.000 01), Fufang Biejia Ruangan tablet (MD=-51.19, 95% CI-67.58 to-34.81, P < 0.000 01) and Anti-fibrosis decoction (MD=-82.13, 95% CI-102.37 to-61.88, P < 0.000 01). (2) As for reduced level of serum laminin (LN), Heluo Shugan capsule was superior to placebo (MD=36.83, 95% CI 11.84 to 61.82, P=0.004), but worse than Fufang Biejia Ruangan tablet (MD=-36.00, 95% CI-64.29 to-7.71, P=0.01), Ganfujian capsule (MD=-22.14, 95% CI-37.28 to-7.00, P=0.004) and Anti-fibrosis decoction (MD=-38.64, 95% CI-75.00 to-2.29, P=0.04). (3) As for reduced level of serum procollagen type III peptide (PCIII), Heluo Shugan capsule was superior to placebo (MD=47.17, 95% CI 32.68 to 61.66, P < 0.000 01), but worse than Fuzheng Huayu capsule (MD=-4.80, 95% CI-9.08 to-0.51, P=0.03), Dahuang Zhechong pills (MD=-53.77, 95% CI-105.01 to-2.53, P=0.04), Ganfujian capsule (MD=-46.82, 95% CI-66.30 to-27.34, P < 0.000 01) and Anti-fibrosis decoction (MD=-28.68, 95% CI-55.59 to-1.77, P=0.04). (4) As for reduced level of serum type-IV-collagen (IV-C), Heluo Shugan capsule was superior to placebo (MD=72.77, 95% CI 47.65 to 97.89, P < 0.000 01), but worse than Fuzheng Huayu capsule (MD=-34.69, 95% CI-56.65 to-12.73, P=0.002), Dahuang Zhechong pills (MD=-21.26, 95%CI-38.79 to-3.73, P=0.02), Fufang Biejia Ruangan tablet (MD=-69.04, 95%CI-124.38 to-13.69, P=0.01), Ganfujian capsule (MD=-19.84, 95% CI-37.41 to-2.27, P=0.03) and Anti-fibrosis decoction (MD=-37.98, 95% CI-72.99 to-2.96, P=0.03).
ConclusionCurrent evidence shows that, Heluo Shugan capsule was superior to placebo, but worse than Fufang Biejia Ruangan tablet, Fuzheng Huayu capsule, Dahuang Zhechong pills, Ganfujian capsule and Anti-fibrosis decoction in reducing the level of serum hepatic fibrosis. Due to the limited quantity and quality of included studies, more high-quality, large-scale RCTs are need to verify the above conclusion.
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 different doses of interferon alfa (INF-α) in the treatment of chronic hepatitis C (CHC). Methods Such databases as MEDLINE, EMbase, CENTRAL, CBM, CNKI, VIP and WanFang Data were searched to collect the randomized controlled trials (RCTs) on different doses of INF-α in the treatment of CHC published before August, 2012. According to the inclusion and exclusion criteria, two reviewers independently screened literature, extracted data and evaluated the quality of the included studies, and then meta-analysis was performed using RevMan 5.0 software. Results A total of 13 RCTs involving 1 442 patients were included. The results of meta-analysis on different doses of INF-α showed that, a) There was no significant difference in the complete response rate between the 3 MU dose group and the 1 MU dose group (RR=0.83, 95%CI 0.52 to 1.32, P=0.43), but there was significant difference in the sustained response rate between those 2 groups (RR=1.89, 95%CI 1.00 to 3.59, P=0.05); and b) No significant differences were found in the complete response rate among the 3 MU dose group, the 6 MU dose group, and the 1 MU dose group. Conclusion INF-α in dose of 3 MU, 3 times daily, is effective in treating CHC, but it would not rule out that higher dose takes more effective action. When INF-α is used to treat CHC, an individualized medication should be applied according to patients’ tolerance and economic status.
ObjectiveTo investigate the psychological status of patients with chronic hepatitis B during the anti-virus treatment.
MethodThe questionnaires of 150 outpatients with chronic hepatitis B treated between May 2013 and May 2014 were collected. And the date was properly processed.
ResultsAll the patients were suffering from different degrees of worries, and the top 3 rates of worries were:the recurrence after stop using drugs (88.00%), the side effects of long-term medication (78.00%) and discrimination from people seeing the package of drugs (69.33%).
ConclusionsPatients with chronic hepatitis B are in different degrees of psychological hazard during the treatment of anti-virus; further nursing work in psychological counseling and health education are needed to eliminate the hidden trouble, as to enhance the curative effect.
Objective To evaluate the effectiveness and safety of treatment with Fuzheng Huayu capsule for liver fibrosis of chronic hepatitis B (CHB). Methods We searched MEDLINE, EMBASE, Cochrane Database of Controlled Trials (CCTR), CBMweb and CNKI up to March 2008. The references of retrieved literature were also hand searched. Randomized controlled trials (RCTs) which compared Fuzheng Huayu capsule with placebo or other drugs were collected. Data extraction and quality assessment were performed by two reviewers independently. The Cochrane Collaboration’ s software RevMan 4.2.10 was used for data analyses. Results Seven RCTs involving 590 cases of liver fibrosis of CHB were included. As for their methodological quality, one was graded A, one was graded B and the others were graded C. We carried out subgroup analyses based on treatment course and intervention measures. In terms of reducing haluronic acid, Fuzheng Huayu capsule was more effective than Huoluo Shugan capsule when the treatment course was 3 months (WMD=–61.75, 95%CI –105.20 to –18.30); significant differences were also noted between Fuzheng Huayu capsule and placebo (WMD=–187.72, 95%CI –244.23 to –31.21) or Huoluo Shugan capsule (WMD=–120.03, 95%CI –158.41 to –81.65) when the treatment course was 6 months. In terms of reducing IV-C, Fuzheng Huayu capsule was more effective than Gantaile when the treatment course was 6 months (WMD=–72.32, 95%CI –84.30 to –60.34). As for improving liver fibrosis at stage S, significant differences were observed between Fuzheng Huayu capsule and Gantaile (RR=2.33, 95%CI 1.37 to 3.96) or Huoluo Shugan capsule (RR=1.30, 95%CI 1.03 to 1.65). Except a very small number of gastrointestinal reactions, no significant adverse reactions were reported. Conclusion Fuzheng Huayu capsule is effective in reducing haluronic acid and improving liver fibrosis at stage S, especially when the treatment course is prolonged from 3 months to 6 months. No significant adverse reactions are reported. Because most of the included trials are of poor quality and small sample size, more high-quality RCTs are needed.
