Wang Hui, Liu Chunxiang, Zhai Jingbo, Shang Hongcai
Center for Evidence-Based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, China; Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, China.
Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Beijing University of Chinese Medicine, Beijing, China.
Complement Ther Med. 2017 Apr;31:90-99. doi: 10.1016/j.ctim.2017.02.005. Epub 2017 Feb 21.
Niuhuang Jiangya Preparation (NHJYP) is one of the most commonly used traditional Chinese patent medicines for essential hypertension (EH) in China. Our meta-analysis performed a systematic evaluation on the therapeutic efficacy and safety of NHJYP for EH.
Systematic review and meta-analysis.
PubMed, Embase, the Cochrane library, CNKI,VIP, Sinomed, and Wanfang Database were searched up to June 2015. Randomized controlled trials (RCTs) comparing NHJYP or combined with western antihypertensive drugs (WAD) versus WAD were included. Quality of each trial was assessed according to the Cochrane Reviewers' Handbook 5. 1.0. Statistical software (RevMan 5.3) was used for data analysis. The primary outcome was categorical or continuous blood pressure, and the secondary outcome was Traditional Chinese Medicine (TCM) syndrome.
12 RCTs including 1651 cases were identified. The methodological quality of trials was low. Meta-analysis showed that, firstly, NHJYP used alone compared with WAD had no significant effect on BP reduction; however, subgroup analysis was used based on whether apply TCM diagnostic criteria in recruitment. It was suggested that, for population that applied TCM diagnostic criteria, RR=1.35,95% CI:1.17-1.56,P<0.0001; for population that didn't apply TCM diagnostic criteria, RR=0.96,95% CI:0.70-1.33,P=0.81.Reduction in systolic blood pressure (SBP) levels showed similar results. But there was no significant difference in improving diastolic blood pressure (DBP). Secondly, we found that NHJYP plus WAD probably lower BP (RR=1.13,95% CI:1.03-1.24,P=0.01)and improve TCM symptoms than WAD only. And subgroup analysis suggested significant BP reduction effect for population that applied TCM diagnostic. No serious adverse events were reported.
Our review indicated that NHJYP has some beneficial effects in EH patients with liver-yang hyperactivity and abundant phlegm-heat syndrome. However, the evidence is not reliable enough. To produce definite evidence, more rigorously designed trials are needed.
牛黄降压制剂是中国治疗原发性高血压(EH)最常用的中成药之一。我们的荟萃分析对牛黄降压制剂治疗EH的疗效和安全性进行了系统评价。
系统评价和荟萃分析。
检索截至2015年6月的PubMed、Embase、Cochrane图书馆、中国知网、维普资讯、中国生物医学文献数据库和万方数据库。纳入比较牛黄降压制剂或联合西药降压药(WAD)与WAD的随机对照试验(RCT)。根据《Cochrane系统评价员手册》5.1.0评估每个试验的质量。使用统计软件(RevMan 5.3)进行数据分析。主要结局为分类或连续性血压,次要结局为中医证候。
共纳入12项RCT,1651例患者。试验的方法学质量较低。荟萃分析表明,首先,单独使用牛黄降压制剂与WAD相比,在降低血压方面无显著效果;然而,根据纳入研究是否采用中医诊断标准进行亚组分析。结果显示,对于采用中医诊断标准的人群,RR = 1.35,95%CI:1.17 - 1.56,P < 0.0001;对于未采用中医诊断标准的人群,RR = 0.96,95%CI:0.70 - 1.33,P = 0.81。收缩压(SBP)水平降低显示出类似结果。但在改善舒张压(DBP)方面无显著差异。其次,我们发现牛黄降压制剂联合WAD可能比单用WAD更能降低血压(RR = 1.13,95%CI:1.03 - 1.24,P = 0.01)并改善中医症状。亚组分析表明,对于采用中医诊断的人群,血压降低效果显著。未报告严重不良事件。
我们的综述表明,牛黄降压制剂对肝阳上亢兼痰热壅盛证的EH患者有一定益处。然而,证据不够可靠。为了得出确切证据,需要更严格设计的试验。