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 assess the efficacy and safety of Chinese herbal medicine for the treatment of functional dyspepsia (FD) and compare the difference of efficacy between Chinese herbal medicine and western medicine. Methods Based on the principles and methods of Cochrane systematic reviews, we searched the Cochrane Central Register of Controlled Trials, MEDLINE, CBMdisc and CNKI from inception to Dec. 2008. And we also handsearched relevant journals and conference proceedings. We evaluated the risk of bias in the included randomized controlled trials(RCTs) according to the Cochrane Handbook for Systematic Reviews. The Cochrane Collaboration’s software RevMan 4.2.8 was used for meta-analysis. Results Seven studies involving 981 patients were identified. The results of meta-analysis showed that: (1) There was no significant difference between Dalitong granule and cisaprid in effective rates (RR=1.03, 95%CI 0.97 to 1.09, P=0.36), piman syndrome (RR=1.06, 95%CI 0.96 to 1.18, P=0.23), gastric emptying function (RR=1.05, 95%CI 0.76 to 1.45, P=0.78), syndromes of TCM (WMD=0.41, 95%CI –1.05 to 1.87, P=0.58), pulse and tongue picture (RR=1.00, 95%CI 0.69 to 1.45, P=0.98), and adverse reaction (RR=1.00, 95%CI 0.69 to 1.45, P=0.46). (2) There was no significant difference between Weishuan pellet and cisaprid on effective rates (RR=1.02, 95%CI 0.96 to 1.07, P=0.53), piman syndrome (RR=1.06, 95%CI 0.97 to 1.15, P=0.19), gastric emptying function (RR=1.05, 95%CI 0.86 to 1.28, P=0.63), syndromes of TCM (WMD=0.70, 95%CI 0.11 to 1.29, P=0.02) and adverse reaction (RR=0.33, 95%CI 0.02 to 5.28, P=0.44). (3) There was no significant difference among Jianpiyiqi prescription (RR=1.16, 95%CI 1.00 to 1.34, P=0.05), Liqifuwei oral liquid (RR=1.00, 95%CI 0.91 to 1.11, P=0.94) and Jianpixiaozhang granules (RR=0.88, 95%CI 0.76 to 1.00, P=0.06) compared with cisaprid in effective rates (Pgt;0.05). (4) There was no significant difference between Hewei Xiaopi Capsule and domperidone on effective rates (RR=1.11, 95%CI 0.87 to 1.41, P=0.42) and piman syndrome (RR=1.07, 95%CI 0.93 to 1.24, P=0.35). Conclusion Chinese herbal medicine has a better clinical cure rate and marks of TCM syndrome on FD than western medicine. But we have no adequate evidence to confirm whether western medicine can be substituted by Chinese herbal medicine for the treatment of FD. Therefore, we need more high quality RCTs to confirm this conclusion.
Objective To assess the effectiveness and safety of traditional Chinese medicinal herbs for subfertility. Method Databases used including MEDLINE, EMBASE, CBM and the Cochrane Controlled Trial Register (CCTR). Potentially related trials in reference lists of studies were hand searched. Published RCTs in any languages and length whether they were blind or unblind, were included. Treatments were Chinese medicinal herbs (single or compound), and controls were placebo, standard medical intervention, or no intervention. Data were extracted independently by two reviewers and analyzed with Revman 4.2 softeware. Results 7 randomized trials, including 1 042 patients met inclusion criteria. Methodological quality of all trials was poor. Chinese medicinal herbs were effective compared with routine antibiotics [RR 1.49, 95％CI (1.37 to1.62), Plt;0.000 01] and resulted in higher pregnancy rate [RR 1.46, 95%CI (1.09 to,1.96), P=0.01]. There were no adverse events reported in treatment group. Conclusions Some Chinese medicinal herbs may be effective for subfertility. However, the evidence is too weak to draw a conclusion. More strictly designed, randomized, double-blind, placebo-controlled trials are required.
Objective To assess the effectiveness and safety of Chinese medicinal herbs for female immune-caused subfertility. Methods Databases included: MEDLINE (1966-2002.2), EMBASE (1984-2002.2), CBM (1978-2002.2) and Cochrane Controlled Trial Register, CCTR (Issue 1, 2002). Reference lists of trials were handsearched. Published randomized controlled trials (RCTs) whether blind or unblind, any languages and length of follow up were included. Treatments included Chinese medicinal herbs (single or compound). Controls were placebo and western medicine, or no intervention. Data were extracted independently by two reviewers and analyzed with Revman 4.2. Results Six RCTs were included, all of which were poor in methodological quality. Because of different therapies in the treatment and control groups, we did not perform meta-analysis. The No.1 anti-immune tablet was more effective than corticosteroid plus condom during intercourse both in the pregnancy rate (RR 3.75, 95%CI 1.61 to 8.75, P=0.002) and AsAb negative rate (RR 1.66, 95%CI 1.23 to 2.22, P=0.000 8). Bushen Xiezhuo Soup was more effective than antibiotic in the pregnancy rate (RR 2.97, 95%CI 1.60 to 5.50, P=0.000 6) and antisperm antibody (AsAb) negative rate (RR 2.33, 95%CI 1.54 to 3.54, Plt;0.000 1)。Zhenqi Zhuanyin Soup was as effective as IUI in pregnancy rate (RR 1.80, 95%CI 0.58 to 5.60, P＝0.31) but more effective than IUI in AsAb negative conversion rate (RR 9.61, 95%CI 3.22 to 28.67, Plt;0.000 1), Zhenqi Zhuanyin Soup combined with IUI was more effective than IUI in pregnancy rate (RR 3.60, 95%CI 1.32 to 9.85,P=0.01) and AsAb negative rate (RR 8.92, 95%CI 2.98 to 26.75, Plt;0.000 1). Conclusions Some Chinese medicinal herbs may work well in subfertility treatment. However, the evidence is too weak to draw a conclusion for there are deficiencies in strict randomization, blinding and follow-up.More strictly designed, randomized, double-blind, placebo-controlled trials are required.
Objective To assess the efficacy and safety of Chinese medicinal herbs for treating endometriosis. Methods We searched Cochrane Library, MEDLINE, EMBASE, CBM (from establishment to 2003). Randomized controlled trials (RCTs) and quasi-randomized controlled trials of patients with endometriosis were included. The quality of included studies such as randomization, blinding, allocation concealment and loss of follow up were evaluated and meta-analysis was performed by RevMan 4.3 software. Results Ten RCTs or quasi-RCTs involving 1 120 patients were included. Because of different therapies in the treatment and control groups, the results of outcome were described separately. Most of included studies suggested that the effects of traditional Chinese medicine (TCM) on general effect, pregnancy rate improvement and alleviating dysmenorrhoea were similar to Danazol or Tamoxifen, only a few studies showed better effects. There was no evidence to support that TCM was more effective than western medicine in reducing the size of endometriotic cysts. Only one study mentioned the recurrence rate and showed that TCM enema had lower recurrence rate than oral Tamoxifen with OR 0.17, 95%CI 0.04 to 0.67. Five studies mentioned adverse reactions and showed TCM had fewer adverse effects than western medicine. Conclusions Chinese medicinal herbs are effective in treating endometriosis with fewer adverse effects. The evidence is not b enough because of low quality of the included studies. Therefore, more high quality randomized controlled trials are required.
ObjectiveTo evaluate the safety and efficacy of Chaihu drop-pill in the treatment of common cold (wind-heat syndrome). MethodsA multi-center, double blind, double dummy, randomized controlled trial was conducted. A total of 479 patients with common cold (wind-heat syndrome) diagnosed between February and August, 2011, were randomly divided into two groups:the trial group (n=359) and the control group (n=120). The trial group received Chaihu drop-pill and Yinchai granule analogue three times a day, while the control group received Yinchai granule and Chaihu drop-pill analogue. The therapeutic courses of both groups were 3 days. Clinical symptoms, syndromes, and adverse effects were observed before and after the treatment. Furthermore, blood, urine and stool test, hepatorenal function test and electrocardiogram were also carried out before and after treatment. ResultsAfter treatment, the healing rates of the trial group and the control group were 32.4%, 20.2% (for full analysis set) and 32.6%, 20.5% (for per protocol set), and the overall response rates were 96.3%, 87.4% (for full analysis set) and 96.5%, 87.2% (for per protocol set). There were significant differences between the two groups (P<0.01). No adverse effects were found in the trial. ConclusionChaihu drop-pill is effective and safe in the treatment of common cold (wind-heat syndrome).
The 12th Asian Conference on Pharmacoepidemiology (ACPE) has been successfully held from October 11st to 13rd, 2019 in Kyoto, Japan. More than 600 representatives from 33 countries and regions participated in the meeting. The arrangement of this conference mainly included: education session program, contributed papers report, symposium and poster presentation, which provided good opportunity for participants to communicate. Moreover, it promoted the dissemination and utilization of advanced methods and technologies of global pharmacoepidemiology, especially in Asia region, and provided technical support in order to ensure the safety and efficacy of public. Moreover, it was the first time that the symposium on herbal and Traditional Medicines has been set up in the ACPE. This paper introduced the main details of the contents
在临床干预试验中，运用随机分配是对照试验中控制偏倚和混杂的最佳工具。研究人员必须确保在试验报告中包含读者所需要的信息，以判断结果的有效性及其意义。事实上，完整的试验报告可让临床医生改进他们的临床实践，以反映当前最佳证据，并改善患者临床终点。制定 CONSORT 声明可协助研究人员、作者、审稿人及编辑了解临床试验报告中所需的必要信息。CONSORT 声明适用于任何干预措施，包括草药产品。当前草药干预措施的对照试验未充分报告 CONSORT 建议的信息条目。我们希望最近制定的 CONSORT 建议条目扩展版能更准确地报告草药干预措施随机对照试验，使其更加完整。我们编写的这份解释性文件除概述了每项建议的理由外，还提供了 CONSORT 条目和相关详细说明，并为每项建议提供了良好报告和经验证据的范例，以帮助作者能更好地运用它们。随着越来越多的证据积累和反馈意见的收集，这些有关草药产品临床试验报告的建议可随时进行修订。