Efficacy of Weikang Pian in Patients with Functional Dyspepsia: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial

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.

Herbal Medicines in the Treatment of Dyspepsia: An Overview

“…Another study that investigates the efficacy of Chinese herbal medicine to treat FD was performed by Yan et al [80]. Zhishi is a classic, traditional Chinese medicine used to treat FD.…”

“…Those authors employed a random selection in these patients; moreover, a double-blind experiment and a prolonged drug (4 wk) administration was performed. Two important determinations were made by Yan et al [80], the SDS scale assessment and the GE function using radiographic quantification. Interestingly, compared with the placebo group, FD symptoms in the group that received Weikang pian (400 mg, 3 times daily) were relieved after 4 wk of treatment; however, no significant differences in GE parameters were found.…”