Liu J P, McIntosh H, Lin H
Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Dept. 7701, H:S Rigshospitalet, Blegdamsvej 9, Copenhagen, Denmark, DK-2100. Jianping
Cochrane Database Syst Rev. 2001;2000(1):CD001940. doi: 10.1002/14651858.CD001940.
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.
To assess the efficacy and safety of traditional Chinese medicinal herbs for chronic hepatitis B infection.
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.
Randomised or quasi-randomised trials with at least three months follow-up. Trials 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 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.
Nine randomised 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 normalisation 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 is too weak to recommend any single herb. Rigorously designed, randomised, double-blind, placebo-controlled trials are required.
乙型肝炎病毒感染是全球范围内严重的健康问题。中药已被广泛用于治疗慢性肝病，并且已经进行了许多对照试验来研究其疗效。
评估中药治疗慢性乙型肝炎感染的疗效和安全性。
检索了以下电子数据库：中国乙肝试验注册库、考克兰补充医学领域试验注册库、考克兰图书馆、医学索引、医学文摘数据库和生物学文摘数据库。手工检索了五种中文期刊和会议论文集。未设语言限制。
随访至少三个月的随机或半随机试验。纳入了中药（单味或复方）与安慰剂、无干预、一般非特异性治疗或干扰素治疗相比较的试验。也纳入了中药加干扰素与单纯干扰素相比较的试验。试验可以是双盲、单盲或非盲法。
由两名评价者独立提取数据。采用Jadad量表加分配隐藏法评估试验的方法学质量。进行意向性分析。
九项随机试验，包括936例患者，符合纳入标准。仅一项试验的方法学质量被认为是充分的。存在显著的漏斗图不对称性（回归系数=3.37，标准误1.40，P=0.047）。在这九项试验中测试了十种不同的草药。与非特异性治疗或安慰剂相比，扶正解毒汤（草药复方）对血清乙肝表面抗原、乙肝e抗原和乙肝病毒DNA的清除有显著的积极作用；猪苓多糖对血清乙肝e抗原和乙肝病毒DNA有作用；苦味叶下珠对血清乙肝e抗原有作用。与干扰素治疗相比，叶下珠复方和kurorinone对血清乙肝e抗原和乙肝病毒DNA的清除以及丙氨酸转氨酶正常化无显著作用。其他所研究的草药无显著作用。
一些中药可能对慢性乙型肝炎有效。然而，证据太薄弱，无法推荐任何一种草药。需要进行严格设计的随机、双盲、安慰剂对照试验。
