Comparative efficacy and safety of traditional Chinese patent medicine for NAFLD in childhood or adolescence: A protocol for a Bayesian network meta analysis.

BACKGROUND: Nonalcoholic fatty liver disease is a common reason for chronic liver disease in children and adults. The increasing incidence of the disease has become one of the most critical public health problems in the 21st century, closely related to genetic and environmental factors. So far, apart from changing lifestyle and diet, modern medicine still lacks effective treatment measures. Chinese patent medicine has the advantages of apparent curative effect, overall regulation and fewer side effects. However, there is a lack of research on the simultaneous comparison of various Chinese patent medicines. Therefore, we used a reticular meta-analysis to indirectly compare the efficacy and safety of different oral Chinese patent medicines through standard reference. METHOD: We will conduct a comprehensive and systematic search of Chinese and English databases from the beginning to December 2020. All randomized controlled trials (RCTs) of oral Chinese patent medicine for NAFLD in children will be searched. The 2 researchers then independently filter the retrieved literature, extract the data according to the data extraction table and assess the risk of bias. We will perform a pair of meta-analyses and a Bayesian network meta-analysis. STATA and Win BUGS software will be used for data analysis. RESULTS: This study will thoroughly compare and analyze the differences in the efficacy of all kinds of TCPM in NAFLD treatment in childhood or adolescence. CONCLUSION: This study will provide reference and evidence support for clinical drug selection optimization. ETHICS AND DISSEMINATION: This study does not require ethical approval. INPLASY REGISTRATION NUMBER: 2020120068.

Complementary and alternative therapies for non-alcoholic fatty liver disease: A Bayesian network meta-analysis protocol.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) has become a global pandemic, and its incidence is increasing year by year. At present, there are no definite curative drugs for the treatment of NAFLD in modern medicine. Surprisingly, complementary and alternative therapies play an important role and have special advantages. In this study, we will adopt Bayesian network meta-analysis (NMA) to evaluate the efficiency and safety of complementary therapy and alternative therapies for NAFLD. METHODS: We will collect randomized controlled trials (RCTs) related to the treatment of NAFLD in PubMed, Cochrane Library, CNKI, and other databases. Two reviewers will screen the literature and extract data in line with the inclusion and exclusion criteria, and then assess the risk of bias according to Cochrane risk of bias assessment tool. The Bayesian NMA will be performed by Stata16.0 and WinBUGS1.4.3. RESULTS: Our study will compare and rank the efficacy and safety of diverse complementary and alternative therapies for NAFLD. CONCLUSION: This study can provide credible evidence for the efficacy and safety of complementary therapies and alternative therapies in the treatment of NAFLD. We expect to assist clinicians and patients to choose the optimal therapeutic regimen. PROTOCOL REGISTRATION NUMBER: INPLASY2020120136.

Chinese herbal medicine combined with entecavir to reduce the off-therapy recurrence risk in HBeAg-positive chronic hepatitis B patients: a multicener, double-blind, randomized controlled trial in China.

BACKGROUND: Nucleos(t)ide analogues (NAs) are the first-line option against chronic hepatitis B (CHB). NAs produce potent suppression of viral replication with a small chance of HBsAg seroclearance and a high risk of virological relapse after discontinuation. The combined therapy of NAs plus traditional Chinese medicine (TCM) is widely accepted and has been recognized as a prospective alternative approach in China. Based on preliminary works, this study was designed to observe the therapeutic effect of TCM plus entecavir (ETV) against HBeAg-positive chronic hepatitis B with respect to reducing the recurrence risk after NA withdrawal. METHODS/DESIGN: The study is a nationwide, multicenter, double-blind, randomized, placebo-controlled trial with a duration of 120 weeks. A total of 18 hospitals and 490 eligible Chinese HBeAg-positive CHB patients will be enrolled and randomly allocated into the experimental group and control group in a 1:1 ratio. Patients in the experimental group will be prescribed TCM formulae (Tiaogan-BuXu-Jiedu granules) plus ETV 0.5 mg per day for consolidation therapy for 96 weeks. Patients in the control group will be prescribed TCM granule placebo plus ETV 0.5 mg per day for the same course. After consolidation therapy, all patients will discontinue their trial drugs and be closely monitored over the next 24 weeks. Once clinical recurrence (CR) occurs, ETV treatment will be restarted. The primary outcome is the cumulative rate of CR at the end of this trial. CONCLUSION: This study is the first of its kind to observe therapeutic effects with respect to reducing recurrence after NA withdrawals after unified integrative consolidation therapy in the CHB population. TRIAL REGISTRATION: Chinese Clinical Trial Registry No. ChiCTR1900021232 . Registered on February 2, 2019.