| Background Hepatitis B (Hep B) is estimated to infect two billion people globally and 60,000 deaths each year. Chronic Hep B virus (HBV) infection can cause chronic hepatitis, cirrhosis and predisposes to hepato-cellular carcinoma. As Chinese herbal medicine become more frequently used recently among Asian and Caucasian population, a report to summarize the best available evidence about the efficacy and safety of CHM would be beneficial for the health care providers to make clinical recommendations, and promote the use of Chinese Medicine in the meantime. Objectives This study aims to analyze the effectiveness of CHM interventions in: 1) disappearance of serum HBeAg, HBV-DNA, and HBsAg; 2) reduction of inflammation activity by normalization of serum aminotransferase activity and improvement of histologic activity; 3) change on the levels of T-lymphocyte subsets, cytokines and NK cell activity; 4) and prevention of liver complications (e.g. chronic hepatitis, cirrhosis, hepato-cellular carcinoma. Also, the study aims to identify, where available, documentations of mechanism of actions; the possible side effects of CHM interventions for hepatitis therapies; and the “syndrome/symptom” according to TCM theory. Methods The pre-specific search strategy was set, and 93 studies (20,106 participants) were identified by electronic and hand searches. The methodological quality of included studies was assessed. Data on syndrome distribution and correlations between syndromes and severity of CHB, were extracted and analyzed. Forty-seven syndromes were identified under 24 different syndrome diagnosis systems for CHB. Results The majority of included studies reported Liver Depression and Spleen Deficiency (LDSD) (52.54% of studies) or Liver-Gallbladder Dampness Heat (LGDH)/Dampness-Heat Obstructing Middle Energizer (DHME) (32.20%) as the major syndromes in CHB patients without cirrhosis. Pooled analysis revealed that LDSD and LGDH/DHME accounted for 61.19% of participants without cirrhosis. In addition, Liver-Kidney Yin Deficiency (LKYinD) (40.99%) and Spleen-Kidney Yang Deficiency (SKYangD) (40.43%) syndromes were common in patients with severe CHB. The percentage of patients with Blood Stasis syndrome increased as the disease progressed to cirrhosis (32.09%). Conclusions To conclude, LDSD and LGDH/DHME syndromes are found in a significant majority of CHB patients, particularly in the early stages. LKYinD, SKYangD and Blood Stasis dominate in patients at more advanced stages. More epidemiological studies of high methodological quality on syndrome distribution in CHB and standardization of syndrome differentiation for CHB are required to confirm the trends indicated by the studies reviewed here; confirming these trends can increase the efficacy of treatment and give guidance to doctors.
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