胃康片治疗功能性消化不良患者的疗效：一项双盲、随机、安慰剂对照临床试验
Efficacy of Weikang Pian in Patients with Functional Dyspepsia: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial.
作者信息
Yan Lijing, Yu Lijin, Zhao Linlin, Wang Dongsheng, Qin Dilan, Fan Haiwei, Cheng Ling, Qiu Musen, Chen Xiao, Zhou Lu, Qiu Juan, Yao Jiamei, Wang Wenbo, Qiu Xinjian
机构信息
Institute of Integrated Traditional Chinese and Western Medicine, Laboratory of Ethnopharmacology, Xiangya Hospital, Central South University, Changsha, Hunan 410008, China.
Department of Health Management, The Third Xiangya Hospital of Central South University, Changsha, Hunan 410013, China.
出版信息
Evid Based Complement Alternat Med. 2019 Nov 6;2019:4827046. doi: 10.1155/2019/4827046. eCollection 2019.
BACKGROUND
FD (functional dyspepsia) is a common functional gastrointestinal disorder, which lacks effective and safe treatment. Chinese herbal medicine (CHM) has been applied in FD treatment for thousands of years with satisfactory clinical outcomes. Zhishi is a classical traditional Chinese medicine used to treat FD. Weikang pian (WKP) is made of flavonoids extracted from zhishi which could effectively alleviate the symptoms of FD. This research aimed to assess the efficacy and safety of WKP in FD treatment.
METHODS
This was a randomized, double-blinded and placebo-controlled clinical trial. The patients were diagnosed as FD according to RomeIII criteria. Then, FD patients were selected and assigned randomly to either WKP or placebo group. The subjects randomly received WKP or placebo for 4 weeks with 4 tablets each time, 3 times daily. The single dyspepsia symptom (SDS) scale and the gastric emptying function were measured before and after the treatment. Moreover, the safety of the trial and patient compliance were evaluated.
RESULTS
A total of 60 FD patients were eventually enrolled in the trial, among them 45 patients in the WKP group and 15 patients in the placebo group. The primary outcome was the SDS scale, including assessments of postprandial distension, early satiety, epigastric burning, and pain. The secondary outcome was the gastric emptying function. Compared with the placebo group, the symptoms of FD in the WKP group were relieved after 4 weeks of treatment ( < 0.05). Some minor changes appeared in the four groups, but there were no significant differences in gastric emptying parameters of GER (2-hour gastric emptying rate) and GET/2 (gastric semiempty time) ( > 0.05). Severe adverse events were absent. The compliance to treatment was 94%-96%, and there was no significant difference between the groups.
CONCLUSION
WKP can relieve FD symptoms to some extent. This trial is registered with Chinese Clinical Trial Registry (ChiCTR): CTR 20132482.
背景
功能性消化不良（FD）是一种常见的功能性胃肠疾病，缺乏有效且安全的治疗方法。中药已应用于FD治疗数千年，临床疗效令人满意。枳实是用于治疗FD的经典中药。胃康片（WKP）由从枳实中提取的黄酮类化合物制成，可有效缓解FD症状。本研究旨在评估WKP治疗FD的疗效和安全性。
方法
这是一项随机、双盲、安慰剂对照的临床试验。根据罗马III标准将患者诊断为FD。然后，选择FD患者并随机分为WKP组或安慰剂组。受试者随机接受WKP或安慰剂治疗4周，每次4片，每日3次。在治疗前后测量单一消化不良症状（SDS）量表和胃排空功能。此外，评估试验的安全性和患者依从性。
结果
最终共有60例FD患者纳入试验，其中WKP组45例，安慰剂组15例。主要结局是SDS量表，包括对餐后腹胀、早饱、上腹部烧灼感和疼痛的评估。次要结局是胃排空功能。与安慰剂组相比，WKP组治疗4周后FD症状得到缓解（<0.05）。四组出现了一些轻微变化，但GER（2小时胃排空率）和GET/2（胃半排空时间）的胃排空参数无显著差异（>0.05）。未出现严重不良事件。治疗依从性为94%-96%，组间无显著差异。
结论
WKP可在一定程度上缓解FD症状。本试验已在中国临床试验注册中心（ChiCTR）注册：CTR 20132482。
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