1 制订中医药临床随机对照试验报告规范（CONSORT for TCM）的必要性中医对疾病及其治疗的认识有别于西医,尤其中医“辨证论治”和“临证察机”的治疗原则比西医分型分类更加复杂，其临床研究因而有不同于西医的特点。但无论多么复杂，...1 制订中医药临床随机对照试验报告规范（CONSORT for TCM）的必要性中医对疾病及其治疗的认识有别于西医,尤其中医“辨证论治”和“临证察机”的治疗原则比西医分型分类更加复杂，其临床研究因而有不同于西医的特点。但无论多么复杂，随机对照试验（RCT）仍是目前公认的中医药防治性研究偏倚可能性最小的设计方案。由于中医药临床试验采用RCT方案仅约30年，试验设计还需要深人探索，试验结果报告还不规范。2005年，中国循证医学中心对中医药临床“随机对照试验”的主要研究者进行电话采访，调查随机方法正确性。展开更多
OBJECTIVE: To evaluate the effectiveness and safety of rhubarb-based Chinese herbal formulae(RCHF), which are widely used to treat hepatic encephalopathy(HE) in China.METHODS: Nine online databases were searched from ...OBJECTIVE: To evaluate the effectiveness and safety of rhubarb-based Chinese herbal formulae(RCHF), which are widely used to treat hepatic encephalopathy(HE) in China.METHODS: Nine online databases were searched from inception to November 22, 2016. Eligible studies were randomized controlled trials of Traditional Chinese Medicine(TCM) treatment for adult patients(≥ 18 years old) with HE. Outcomes such as mortality rate, clinical response rate, blood ammonia level, and alanine aminotransferase were evaluated between TCM group and control group.RESULTS: Thirty studies involving 2661 HE patients were analyzed. Most studies used RCHF treatment.Compared with conventional treatment as usual,lactulose, and vinegar, RCHF were associated with significant improvement in clinical response rate[risk ratio(RR) = 1.33, 95% confidence interval(CI) =1.25, 1.43, I2= 0%; RR = 1.26, 95% CI = 1.14, 1.38, I2=22%; and RR = 1.19, 95% CI = 1.06, 1.33, I2= 0%, respectively] and significant reductions in levels of blood ammonia and alanine aminotransferase. Only minor RCHF-associated adverse events, such as abdominal pain(0.3%), anal tenesmus(0.3%), and diarrhea(2.3%), were reported, and there were no significant differences in these events between the treatment group and the three types of control group.CONCLUSION: The findings suggest that RCHF may be an alternative treatment option for HE patients. More rigorous multicenter studies with larger samples and longer observational periods are needed to confirm these findings.展开更多
文摘1 制订中医药临床随机对照试验报告规范（CONSORT for TCM）的必要性中医对疾病及其治疗的认识有别于西医,尤其中医“辨证论治”和“临证察机”的治疗原则比西医分型分类更加复杂，其临床研究因而有不同于西医的特点。但无论多么复杂，随机对照试验（RCT）仍是目前公认的中医药防治性研究偏倚可能性最小的设计方案。由于中医药临床试验采用RCT方案仅约30年，试验设计还需要深人探索，试验结果报告还不规范。2005年，中国循证医学中心对中医药临床“随机对照试验”的主要研究者进行电话采访，调查随机方法正确性。
基金Supported by Major Projects of National Science and Technology:the Study of Optimal Regimen for Integrative Treatment of Acute-on-chronic Liver Failure(No.2017zx1020-5506-002)Special Scientific Projects from The State Administration of Traditional Chinese Medicine of The People'S Republic of China:the Study on the Mechanism of Chinese Herbs for Chronic Liver Failure Focused on the Signaling Pathway of Lps/tlr4(No.Jdzx2015187)
文摘OBJECTIVE: To evaluate the effectiveness and safety of rhubarb-based Chinese herbal formulae(RCHF), which are widely used to treat hepatic encephalopathy(HE) in China.METHODS: Nine online databases were searched from inception to November 22, 2016. Eligible studies were randomized controlled trials of Traditional Chinese Medicine(TCM) treatment for adult patients(≥ 18 years old) with HE. Outcomes such as mortality rate, clinical response rate, blood ammonia level, and alanine aminotransferase were evaluated between TCM group and control group.RESULTS: Thirty studies involving 2661 HE patients were analyzed. Most studies used RCHF treatment.Compared with conventional treatment as usual,lactulose, and vinegar, RCHF were associated with significant improvement in clinical response rate[risk ratio(RR) = 1.33, 95% confidence interval(CI) =1.25, 1.43, I2= 0%; RR = 1.26, 95% CI = 1.14, 1.38, I2=22%; and RR = 1.19, 95% CI = 1.06, 1.33, I2= 0%, respectively] and significant reductions in levels of blood ammonia and alanine aminotransferase. Only minor RCHF-associated adverse events, such as abdominal pain(0.3%), anal tenesmus(0.3%), and diarrhea(2.3%), were reported, and there were no significant differences in these events between the treatment group and the three types of control group.CONCLUSION: The findings suggest that RCHF may be an alternative treatment option for HE patients. More rigorous multicenter studies with larger samples and longer observational periods are needed to confirm these findings.
