A Randomized, Double-Blind, Multicenter, Placebo-Controlled Trial of Qi-Zhi-Wei-Tong Granules on Postprandial Distress Syndrome-Predominant Functional Dyspepsia

Qing Su, Sheng-Liang Chen, Hua-Hong Wang, Lie-Xin Liang, Ning Dai, Bin Lyu, Jun Zhang, Rong-Quan Wang, Ya-Li Zhang, Yue Yu, Jin-Song Liu, Xiao-Hua Hou, Qing Su, Sheng-Liang Chen, Hua-Hong Wang, Lie-Xin Liang, Ning Dai, Bin Lyu, Jun Zhang, Rong-Quan Wang, Ya-Li Zhang, Yue Yu, Jin-Song Liu, Xiao-Hua Hou

Abstract

Background: Functional dyspepsia (FD) is a common upper gastrointestinal disorder worldwide, but the current treatments for FD are still unsatisfactory. The aims of this study were to investigate the efficacy and safety of Qi-Zhi-Wei-Tong granules in patients with postprandial distress syndrome (PDS)-predominant FD.

Methods: The study was conducted as a randomized, double-blinded, multicenter, placebo-controlled design in 197 patients with PDS. All participants received placebo treatment for 1 week. Patients whose total symptom score decreased by <50% after the placebo treatment were recruited into the 4-week treatment period, in which they were randomly assigned to be treated with either Qi-Zhi-Wei-Tong granules or placebo. The patients were then followed for 2 weeks without any treatment. Dyspeptic symptoms were scored at weeks 2 and 4 during the random treatment period and 2 weeks after the treatment. Anxiety and depression symptoms were also scored and compared.

Results: (1) The total effective rates in the Qi-Zhi-Wei-Tong granules group at weeks 2 and 4 during the random treatment period and 2 weeks after treatment were all significantly higher than those in the placebo group (38.82% vs. 8.75%, P < 0.001; 69.14% vs. 16.25%, P < 0.001; 77.65% vs. 21.25%, P < 0.001). (2) The total dyspeptic symptoms scores in the Qi-Zhi-Wei-Tong granules group at weeks 2 and 4 and 2 weeks after treatment were significantly lower than those in the placebo group. (3) The severity and frequency of each dyspeptic symptom at weeks 2 and 4 and the follow-up period were all significantly lower than those in the placebo group. (4) The anxiety scores in the Qi-Zhi-Wei-Tong granules group were significantly lower than those in the placebo group. (5) Qi-Zhi-Wei-Tong granules did not have more adverse effects than the placebo.

Conclusion: Qi-Zhi-Wei-Tong granules offer significant symptomatic improvement in PDS with no more adverse effects than placebo.

Trial registration: https://ichgcp.net/clinical-trials-registry/NCT02460601" title="See in ClinicalTrials.gov">NCT02460601.

Keywords: Clinical Trial; Functional Dyspepsia; Postprandial Distress Syndrome; Qi-Zhi-Wei-Tong Granules.

Conflict of interest statement

There are no conflicts of interest

Figures

Figure 1
Figure 1
Study design.
Figure 2
Figure 2
Flow diagram of patients progress through the RCT phases. RCT: Randomized controlled trial.
Figure 3
Figure 3
Comparison of the severity and frequency of dyspeptic symptoms between the treatment and control groups. (a and b) showing that the severity and frequency of postprandial fullness at weeks 2 and 4 and the follow-up period were all significantly lower than those in the control group and week 0. *P < 0.001. (c and d) showing that the severity and frequency of early satiety at weeks 2 and 4 and the follow-up period were all significantly lower than those in the control group and week 0. *P < 0.05, †P < 0.01, ‡P < 0.001.

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