| Hepatitis B virus has widely spread all over the world due to its strong infectiousness. In 2009, the incidence rate of virus hepatitis in China was 107.30 (1/0.1million), among that, the incidence rate of virus hepatitis B was 88.82 (1/0.1million). The rate of HBsAg carrier was 9.09% in Chinese general population. Up to now the main treatments of chronic hepatitis B are vaccination and antiviral therapy. Antiviral therapy has positive effect, while with high expense. EASL clinical practice guidelines:management of chronic hepatitis B asks for more than 1 year of therapy by applying interferon, and 2 to 3 years with nucleoside/nucleotide analogues (NUCs). Long term usage induces very high proportion of patients with resistance towards these drugs and cost even more.Modern pharmacological studies show that Radix Sophorae flavescentis (botanical name Sophora flavescens, Chinese name Ku Shen) has antiviral, anti-inflammatory and antitumor effect. Many clinical studies report positive results of sophorus species for chronic hepatitis B. This dissertation covers the systematic review of sophorus species for chronic hepatitis B and viremic carriers, which provides clinicians with more treatment evidence.According to the electronic searches,1123 studies concerning sophorus species for chronic hepatitis were found.1 study was found by manual searching. By reading titles and abstracts, among them,663 studies were excluded because they were not randomized clinical trials. Among the 460 studies left,157 studies were excluded because they had different study objectives from this review,95 studies were excluded because they had only liver function data or control group data were not available, and 17 studies were excluded because they were duplicates or published in different journals. A total of 191 studies (n=18799) were included for further assessment.The methodological quality of included studies showed that 2 studies were randomized double-blind placebo controlled multicenter trials,5 studies introduces the allocation sequence generation methods, but no study reported allocation concealment. Most of the included studies had small sample sizes and no report on sample calculation; 37 studies reported follow-up and 17 studies reported dropouts and/or withdrawals; 104 studies reported non-serious adverse events and 1 study reported hepatitis B-related mortality. Funnel plot analyses showed that there were potential biases.According to the included RCTs,1 study reported hepatitis B-related mortality, which showed that matrine group had a significant lower mortality than control group (RR=0.49, CI (0.24,0.99)). There was no report on hepatitis B-related morbidity (such as liver cirrhosis or hepatocellular carcinoma). Also, no quality of life was reported. According to the 69 studies which reported non-serious adverse events showed that the main adverse events in matrine group included anorexia, nausea, bitter taste, epigastric disturb, abdominal distension, diarrhea and local hardening etc. The main adverse events in matrine group included mild fever, lack of strength, influenza-like symptoms, mild sleep disorders, mild leucopenia caused by interferon, dizziness, skin rash caused by tiopronin, panicky etc. Spontaneous remission of all the above symptoms did not interrupt the treatments.30 studies were included on number of participants with undetectable HBsAg after treatment and 7 studies at end of follow-ups.171 studies were included on number of participants with undetectable HBeAg after treatment and 36 studies at end of follow-ups.179 studies were included on number of participants with undetectable HBV-DNA after treatment and 38 studies at end of follow-ups.73 studies were included on number of participants with HBeAg seroconversion after treatment and 19 studies at end of follow-ups.According to these clinical evidences, matrine (oxymatrine) for chronic hepatitis B has firm effect on HBeAg and HBV-DNA decreasing to undetectable level and raising HBeAg seroconversion. About HBeAg decreasing to undetectable level and raising HBeAg seroconversion, matrine (oxymatrine) did not show lower effect than interferon and lamivudine, what's more, the RR value indicated that matrine (oxymatrine) was better than IFN and lamivudine. However, more methodologically rigorous trials are needed to acquire more accurate evidence. About HBV-DNA decreasing to undetectable level, matrine (oxymatrine) showed lower effect than lamivudine, but not with IFN. Compared with other drugs or non-specific interventions, matrine (oxymatrine) showed better effects than these, and matrine (oxymatrine) might has potential effect on decreasing hepatitis B-related morbidity.Up to now, there are a few methodologically rigorous randomized clinical trials on sophorus species for chronic hepatitis B. Placebo usage are limited for ethics concerns and it may cause poor compliance in control group. Therefore, we suggest that making placebo for both matrine (oxymatrine) and control drugs for randomized double-blinding clinical trials is better for acquiring methodologically rigorous studies and more accurate clinical evidences.
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