Department of Endocrinology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beixiange 5, Xicheng District, Beijing 100053, China ; Graduate School, Beijing University of TCM, Beijing 100029, China.
Evid Based Complement Alternat Med. 2013;2013:749495. doi: 10.1155/2013/749495. Epub 2013 Jul 11.
Objective. To assess the current clinical evidence of Banxiaxiexin decoction for diabetic gastroparesis (DGP). Methods. Electronic databases were searched until December 2012. No language limitations were applied. We included RCTs using Banxiaxiexin decoction/modified Banxiaxiexin decoction for DGP. No restriction for the control group except acupuncture. Applying clinical effective rate as the main outcome index. Data extraction, analyses and quality assessment were conducted according to the Cochrane review standards. Results. 16 RCTs involving 1302 patients were finally identified, and the methodological quality was evaluated as generally low. The data showed that the effect of Banxiaxiexin decoction (BXXD) for DGP was superior to the control group (n = 1302, RR 1.23, 95% CI 1.17 to 1.29, Z = 8.04, P < 0.00001). Only one trial recorded adverse events, no obvious adverse event occurred. Conclusions. Banxiaxiexin decoction could regain the gastric emptying rate and improve diabetic gastrointestinal symptoms. However, the methodological quality of included studies is low, and long term efficacy and safety are still uncertain, which indicates that the findings above should be read with caution. Thereby, well-designed, large-scale, and high-quality randomized controlled clinical trials with scientific rigor are warranted for stronger evidence in future research.
评估半夏泻心汤治疗糖尿病胃轻瘫(DGP)的临床证据。
检索截至 2012 年 12 月的电子数据库。未应用语言限制。我们纳入了使用半夏泻心汤/改良半夏泻心汤治疗 DGP 的 RCT。对照组除了针灸外无任何限制。以临床有效率作为主要结局指标。根据 Cochrane 评价标准进行数据提取、分析和质量评估。
最终确定了 16 项 RCT,共纳入 1302 例患者,方法学质量总体评价较低。数据表明,半夏泻心汤(BXXD)治疗 DGP 的效果优于对照组(n = 1302,RR 1.23,95%CI 1.17 至 1.29,Z = 8.04,P < 0.00001)。仅有一项试验记录了不良反应,未发生明显不良反应。
半夏泻心汤可以恢复胃排空率并改善糖尿病胃肠道症状。但是,纳入研究的方法学质量较低,长期疗效和安全性仍不确定,这表明上述发现应谨慎解读。因此,未来研究需要更有力的证据,需要开展设计严谨、规模大、高质量、具有科学严谨性的随机对照临床试验。