Published online Jul 28, 2020. doi: 10.3748/wjg.v26.i28.4170
Peer-review started: April 8, 2020
First decision: June 13, 2020
Revised: June 25, 2020
Accepted: July 16, 2020
Article in press: July 16, 2020
Published online: July 28, 2020
Processing time: 111 Days and 1.7 Hours
Recent research has suggested that although prokinetic agents, acid suppressors, and radical treatment for Helicobacter pylori infection may be effective in patients with functional dyspepsia (FD), a large proportion of patients still failed to respond to these treatments or may suffer from severe adverse reactions. Many traditional Chinese medicinal (TCM) herbs can regulate the status of entire body and have shown special advantages in the treatment of functional diseases.
Although the currently available drugs for FD can, to some extent, improve the symptoms, they are still ineffective or have severe adverse reactions in some patients. The present study was designed to verify the efficacy of Biling Weitong Granules (BLWTG), a TCM herbal compound formula, in alleviating the epigastric pain syndrome (EPS) in FD patients, in an attempt to provide an effective prescription for the clinical treatment of this disease.
The aim of the study was to evaluate the clinical efficacy and safety of BLWTG in treating EPS in patients with FD.
In this multicenter, stratified, randomized, double-blind, placebo-controlled, parallel group clinical trial, eligible patients were randomized into the BLWTG and placebo groups who were treated for 6 wk. Efficacy indicators including the severity and frequency of EPS, the resolution rate of epigastric pain, the total score of FD symptoms and the Functional Digestive Disorders Quality of Life Questionnaire scores and safety indicators including adverse events were observed and compared. Two-sided tests were used for all analyses. P ≤ 0.05 was regarded as significant unless otherwise indicated. A 95% confidence interval was used. Based on the intention-to-treat principle, the last observation carried forward method was applied for imputing missing data (i.e. the missing efficacy data was replaced by the efficacy data of the last follow-up). The efficacy analysis was mainly based on a full analysis set, and the central effect was considered.
The baseline demographic data and clinical characteristics, such as epigastric pain symptoms, pain intensity, and frequency of attacks, were matched between the two groups before randomization. After 6 wk of treatment and after the center effect was eliminated, the epigastric pain was significantly improved in 28.33% and 85.59% of the patients in the placebo and BLWTG groups, respectively (P < 0.05). At 6 wk, the resolution rate of epigastric pain was 15% and 69.49% in the placebo and BLWTG groups, respectively (P < 0.05). The differences of total FD clinical score between these two groups were significant (P < 0.05) at 2, 4 and 6 wk (P < 0.05). The scores of each item and the total score in the Functional Digestive Disorders Quality of Life Questionnaire showed significant differences between the two groups at 6 wk after both the center and interaction effects were eliminated (P < 0.05). There was no significant difference in the incidence of adverse events between the two groups, and no serious adverse event was noted during the observation.
Compared with placebo, BLWTG markedly improved EPS in FD patients without causing serious adverse reactions. BLWTG may be a good analgesic option for EPS in FD patients.
This study only included FD patients with EPS and the results might not be applicable for patients with upper gastrointestinal pain due to other upper abdominal diseases. Our study did not include Helicobacter pylori-positive patients, which also limited the extrapolation of BLWTG to other patient populations. BLWTG is composed of 11 TCM ingredients and its complex action mechanisms warrant further investigation.