Abstract
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 (P < 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) (P > 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.
Highlights
Functional dyspepsia (FD) is a common functional gastrointestinal disorder, which lacks effective and safe treatment
It was conducted in accordance with Clinical Guideline of New Drug for Traditional Chinese Medicine, the Helsinki Declaration and Guidelines for Good Clinical Practice, with approval from China SFDA (No: 2008L04094). is trial was approved by the Ethics Committee of Xiangya Hospital of Central South University (Ethical Code: 20110530(2)). e study was registered with Chinese Clinical Trial Registry (ChiCTR): CTR 20132482
A total of 82 patients were recruited in this study, among which 22 were excluded because of various reasons. 60 patients were eventually enrolled in the trial and randomly assigned to four groups, placebo group (n 15, 7 males and 8 females), group 1 (n 15, 8 males and 7 females), group 2 (n 15, 6 males and 9 females), and group 3 (n 15, 5 males and 10 females)
Summary
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. Weikang pian (WKP) is made of flavonoids extracted from zhishi which could effectively alleviate the symptoms of FD. E single dyspepsia symptom (SDS) scale and the gastric emptying function were measured before and after the treatment. Compared with the placebo group, the symptoms of FD in the WKP group were relieved after 4 weeks of treatment (P < 0.05). CHM has been applied in FD treatment for thousands of years in China with satisfactory clinical outcomes. WKP is made of flavonoids extracted from zhishi which could effectively and safely alleviate the symptoms of FD. Previous studies have shown that Aurantii fructus immaturus flavonoid (AFIF), the major effective constituent of AFI, could promote gastric emptying process in FD rats [14]
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