Lin Lv, Feng-Yun Wang, Xiang-Xue Ma, Zhen-Hua Li, Hai-Jie Ji, Li-Qun Bian, Bei-Hua Zhang, Ting Chen, Xiao-Lan Yin, Xu-Dong Tang, Department of Gastroenterology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China.
World J Gastroenterol. 2017 Aug 14;23(30):5589-5601. doi: 10.3748/wjg.v23.i30.5589.
To assess the efficacy and safety of a Chinese herbal medicine (CHM), Xiangsha Liujunzi granules, in the treatment of patients with functional dyspepsia (FD).
We performed a randomized, double-blind, placebo-controlled trial with patients from three centers. Two hundred and sixteen subjects diagnosed with FD according to ROME III criteria and confirmed by upper gastrointestinal endoscopy and spleen-deficiency and Qi-stagnation syndrome were selected to receive Xiangsha Liujunzi granules or placebo for 4 wk in a 2:1 ratio by blocked randomization. The subjects also received follow-up after the 4-wk intervention. Herbal or placebo granules were dissolved in 300 mL of water. Participants in both groups were administered 130 mL (45 °C) three times a day. Participants were evaluated prior to and following 4 wk of the intervention in terms of changes in the postprandial discomfort severity scale (PDSS) score, clinical global impression (CGI) scale score, hospital anxiety and depression scale (HADS) score, traditional Chinese medicine symptoms score (SS), scores of various domains of the 36-item short form health survey (SF-36), gastric emptying (GE) and any observed adverse effects.
Compared with the placebo group, patients in the CHM group showed significant improvements in the scores of PDSS, HADS, SS, SF-36 and CGI scale ( < 0.05 or < 0.01). They also showed the amelioration in the GE rates of the proximal stomach and distal stomach ( < 0.05 or < 0.01).
Xiangsha Liujunzi granules offered significant symptomatic improvement in patients with FD.
评估中药香砂六君子颗粒治疗功能性消化不良（FD）患者的疗效和安全性。
我们进行了一项随机、双盲、安慰剂对照试验，纳入了来自三个中心的患者。选择了 216 名符合罗马 III 标准且经上消化道内镜和脾虚气滞证证实的 FD 患者，以 2:1 的比例按区组随机分组，接受香砂六君子颗粒或安慰剂治疗 4 周。在 4 周干预后，还对受试者进行了随访。中药或安慰剂颗粒溶于 300 mL 水中。两组患者均每日服用 3 次，每次 130 mL（45°C）。在干预前和干预后 4 周，分别评估餐后不适严重程度量表（PDSS）评分、临床总体印象（CGI）量表评分、医院焦虑抑郁量表（HADS）评分、中医症状评分（SS）、36 项简短健康调查问卷（SF-36）各领域评分、胃排空（GE）以及任何观察到的不良反应的变化。
与安慰剂组相比，中药组患者的 PDSS、HADS、SS、SF-36 和 CGI 量表评分均显著改善（<0.05 或 <0.01）。他们还表现出近端胃和远端胃的 GE 率的改善（<0.05 或 <0.01）。
香砂六君子颗粒可显著改善 FD 患者的症状。
