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 suggests 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 fail to respond to these treatments or may suffer from severe adverse reactions. Many traditional Chinese medicinal herbs can regulate the status of the entire body and have special advantages in the treatment of functional diseases. The present study was designed to verify the efficacy of Biling Weitong Granules (BLWTG), a traditional Chinese medicinal herbal compound formula, in alleviating epigastric pain syndrome (EPS) in FD patients, in an attempt to provide an effective prescription for the clinical treatment of this disease.
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 and the time to pain resolution and safety indicators including adverse events were observed and compared.
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.
Core tip: Although the currently available drugs for functional dyspepsia (FD) can, to some extent, improve the symptoms, they are still ineffective or have severe adverse reactions in some patients. The present study evaluated the clinical efficacy and safety of Biling Weitong Granules in treating epigastric pain syndrome in FD patients. Compared with placebo, Biling Weitong Granules markedly relieved the epigastric pain syndrome symptoms and significantly improved the total FD clinical score based on symptoms including postprandial fullness and discomfort, early satiety, epigastric pain, epigastric burning, belching, and pharyngeal obstruction, decreased appetite, fatigue, limb weakness, and irritability, thus, it improved the quality of life without causing serious adverse reactions.