Xiong Xingjiang, Li Xiaoke, Zhang Yuqing, Wang Jie
Department of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Bio-organic and Natural Products Laboratory, McLean Hospital, Harvard Medical School, Belmont, California, USA.
BMJ Open. 2015 Jan 30;5(1):e005355. doi: 10.1136/bmjopen-2014-005355.
This study aimed to summarise the current evidence from randomised control trials (RCTs) concerning treatment of patients with resistant hypertension with Chinese herbal medicine (CHM).
Seven databases, including the Cochrane Library, PubMed, EMBASE, CNKI, VIP, CBM and Wanfang, were systematically searched from their inception to March 2014 for RCTs investigating treatment of resistant hypertension in which CHM was used either as a monotherapy or in combination with conventional medicine versus placebo, no intervention or conventional medicine.
Five trials containing 446 hypertensive patients were identified. The methodological quality of most trials was evaluated as generally low. All included trials compared CHM plus antihypertensive drugs with antihypertensive drugs alone for resistant hypertension. Formulations of CHM included tablet, decoction and injection. It was found that, compared with antihypertensive drugs alone, CHM (tablet) plus antihypertensive drugs resulted in clinically, but not statistically, significant reductions in systolic blood pressure (SBP; weighted mean difference (WMD)=-10.32 mm Hg; 95% CI -21.10 to 0.46; p=0.06) and diastolic blood pressure (DBP; WMD=-3.30 mm Hg; 95% CI -7.66 to 1.06; p=0.14). CHM (decoction) plus antihypertensive drugs also produced a clinically meaningful, but not statistically significant, reduction in SBP (WMD=-12.56 mm Hg; 95% CI -26.83 to 1.71; p=0.08), and did significantly decrease DBP (WMD=-7.89 mm Hg; 95% CI -11.74 to -4.04; p<0.0001). There were no significant differences in SBP (WMD=-3.50 mm Hg; 95% CI -8.95 to 1.95; p=0.21) and DBP (WMD=1.00 mm Hg; 95% CI -1.39 to 3.39; p=0.41) between CHM (injection) plus the antihypertensive drugs group and antihypertensive drugs alone. The safety of CHM remained uncertain.
No definite conclusions about the effectiveness and safety of CHM for resistant hypertension could be drawn. More rigorously designed trials are warranted.
本研究旨在总结当前来自随机对照试验(RCT)的关于使用中药治疗顽固性高血压患者的证据。
系统检索了7个数据库,包括考克兰图书馆、PubMed、EMBASE、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,检索时间从建库至2014年3月,查找调查使用中药单独治疗或与传统药物联合治疗顽固性高血压并与安慰剂、无干预措施或传统药物进行对比的随机对照试验。
共识别出5项包含446例高血压患者的试验。大多数试验的方法学质量评估为普遍较低。所有纳入试验均比较了中药加抗高血压药物与单纯抗高血压药物治疗顽固性高血压的效果。中药制剂包括片剂、汤剂和注射剂。结果发现,与单纯抗高血压药物相比,中药(片剂)加抗高血压药物可使收缩压(SBP;加权均数差(WMD)=-10.32 mmHg;95%可信区间 -21.10至0.46;p=0.06)和舒张压(DBP;WMD=-3.30 mmHg;95%可信区间 -7.66至1.06;p=0.14)出现临床意义上但无统计学意义的降低。中药(汤剂)加抗高血压药物也使收缩压出现了具有临床意义但无统计学意义的降低(WMD=-12.56 mmHg;95%可信区间 -26.83至1.71;p=0.08),并且确实使舒张压显著降低(WMD=-7.89 mmHg;95%可信区间 -11.74至-4.04;p<0.0001)。中药(注射剂)加抗高血压药物组与单纯抗高血压药物组在收缩压(WMD=-3.50 mmHg;95%可信区间 -8.95至1.95;p=0.21)和舒张压(WMD=1.00 mmHg;95%可信区间 -1.39至3.39;p=0.41)方面无显著差异。中药的安全性仍不确定。
关于中药治疗顽固性高血压的有效性和安全性无法得出明确结论。需要更严格设计的试验。