Randomized Clinical Trial
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Feb 6, 2023; 11(4): 830-843
Published online Feb 6, 2023. doi: 10.12998/wjcc.v11.i4.830
Improvement of inflammatory response and gastrointestinal function in perioperative of cholelithiasis by Modified Xiao-Cheng-Qi decoction
Bao-Fang Sun, Fan Zhang, Qiang-Pu Chen, Qiang Wei, Wen-Tao Zhu, Hai-Bin Ji, Xing-Yuan Zhang
Bao-Fang Sun, Fan Zhang, Qiang-Pu Chen, Qiang Wei, Wen-Tao Zhu, Hai-Bin Ji, Xing-Yuan Zhang, Department of Hepatobiliary Surgery, Binzhou Medical University Hospital, Binzhou 256603, Shandong Province, China
Author contributions: Chen QP and Sun BF designed the study and developed the concept; Sun BF, Zhang F, Wei Q, Zhu WT, Ji HB, Zhang XY performed the experiments; Chen QP performed the statistical analysis, revised and finalized the manuscript; Sun BF wrote the manuscript; and all authors read and approved the final version of the manuscript.
Institutional review board statement: The study was reviewed and approved by the Institutional Review Board of Binzhou Medical University Hospital [No. Ethical research (2017-026-01)].
Clinical trial registration statement: This study is registered at ClinicalTrials.gov. The registration identification number is ChiCTR2000033125.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: Technical appendix, statistical code, and dataset are available from the corresponding author at chenqiangpu@bzmc.edu.cn. Participants gave informed consent for data sharing.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Qiang-Pu Chen, Doctor, Full Professor, Department of Hepatobiliary Surgery, Binzhou Medical University Hospital, No. 661 Huanghe Second Road, Binzhou 256603, Shandong Province, China. chenqiangpu@bzmc.edu.cn
Received: October 1, 2022
Peer-review started: October 1, 2022
First decision: November 26, 2022
Revised: December 15, 2022
Accepted: January 9, 2023
Article in press: January 29, 2023
Published online: February 6, 2023
Processing time: 127 Days and 15.5 Hours
Abstract
BACKGROUND

In the perioperative period of biliary surgery, various factors can induce the release of a large number of inflammatory factors, leading to an imbalance in pro-inflammatory and anti-inflammatory responses and resulting in gastrointestinal (GI) dysfunction. Enhanced Recovery After Surgery protocols in biliary surgery have been shown to reduce the stress response and accelerate postoperative recovery. It is crucial to reduce the inflammatory response and promote the recovery of GI function after biliary surgery, both of which are the basis and key for perioperative care and postoperative recovery.

AIM

To better understand the effects of Modified Xiao-Cheng-Qi decoction (MXD) on inflammatory response and GI function in the perioperative management of cholelithiasis and their correlation.

METHODS

This was a prospective randomized placebo-controlled trial, in which 162 patients who received biliary tract surgery were randomly assigned to three groups: MXD group, XD group, and placebo-control group. The observed parameters included frequency of bowel sounds, time of first flatus and defecation, time of diet, and amount of activity after surgery. The serum levels of C-reactive protein (CRP), interleukin (IL)-6, IL-10, serum amyloid A protein (SAA), and substance P were measured by the enzyme-linked immunosorbent assay. Then, the spearman correlation coefficient was used to analyze the relationship between the indicators of GI function and inflammation.

RESULTS

Compared to the placebo-control, improvements in GI function were observed in the MXD groups including reduced incidence of nausea, vomiting, and bloating; and earlier first exhaust time, first defecation time, and feeding time after surgery (P < 0.05). On the 1st and 2nd d after surgery, IL-6, CRP and SAA levels in MXD group were lower than that in placebo control, but substance P level was higher, compared to the control (P < 0.05). Functional diarrhea occurred in both MXD and XD groups without any other adverse effects, toxic reactions, and allergic reactions. Diarrhea was relieved after the discontinuation of the investigational remedies. Bowel sounds at 12 h after surgery, the occurring time of the first flatus, first defecation, postoperative liquid diet and semi-liquid diet were significantly correlated with levels of IL-6, CRP, SAA and substance P on second day after surgery (P < 0.05).

CONCLUSION

Treatment with MXD can relieve inflammatory response and improve GI function after surgery. Moreover, there are significant correlations between them. Furthermore, it does not cause serious adverse reactions.

Keywords: Modified Xiao-cheng-qi Decoction; Cholelithiasis; Inflammatory response; Gastrointestinal function; Enhanced Recovery After Surgery; Perioperative

Core Tip: It is crucial to reduce the inflammatory response and promote the recovery of gastrointestinal (GI) function after biliary surgery, as both are the basis and key for perioperative care and postoperative recovery. Treatment with Modified Xiao-Cheng-Qi decoction can reduce the inflammatory response and improve GI function after surgery. Moreover, a close correlation between them was found in our study. Our findings provide insights into the possible role of inflammatory stress response in the pathogenesis of postoperative GI tract dysfunction (PGID) and support the development of novel therapeutic strategies for the prevention and treatment of postoperative inflammatory stress response and PGID.