Published online Jul 28, 2021. doi: 10.3748/wjg.v27.i28.4710
Peer-review started: March 31, 2021
First decision: May 28, 2021
Revised: May 28, 2021
Accepted: July 6, 2021
Article in press: July 6, 2021
Published online: July 28, 2021
Gastroesophageal reflux disease (GERD) has a high prevalence worldwide, and its incidence is increasing annually. According to the preliminary experiment of the research group, Modified Xiaochaihu Decoction (MXD) could relieve the symptoms of GERD.
The effects of MXD on GERD manifestations and relapse prevention need to be further explained. Therefore, we performed a prospective, double-blind, and double-simulation study.
To verify the efficacy of MXD for GERD and its effect on esophageal motility.
Using randomization, double-blinding, and a simulation design to compare the GERD-Q scale score and esophageal manometry between patients under the treatment of MXD (treatment group) and omeprazole (control group).
In total, 288 patients were divided into the treatment group and control group. The GERD-Q scale score in both groups decreased significantly compared to those before treatment (P < 0.01). However, no significant difference was observed between the two groups (P > 0.05). Esophageal manometry showed that participants with sphincter pressure reduction and the proportion of ineffective swallowing (more than 50%) improved in both groups from baseline (P < 0.01), especially in the treatment group (P < 0.05). The percentage of small intermittent contractions, large intermittent contractions, and increased pre-phase contractions in the treatment group significantly improved compared with baseline (P < 0.05) but did not improve in the control group (P > 0.05). The percentage of weak esophageal contractility (distal contractile integral < 450 mmHg·s·cm) improved in both groups (P < 0.01). The relapse rate in the treatment group was lower than that in the control group at the 1 mo (P < 0.01) and 3 mo follow-up (P < 0.05).
MXD has a similar therapeutic effect to omeprazole in mild-to-moderate GERD. The therapeutic effect may be related to increased pressure in the lower esophageal sphincter and reduced ineffective swallowing.
Our results supported that MXD has a similar therapeutic effect to omeprazole in mild-to-moderate GERD and could improve esophageal motility.