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Medicine (Baltimore). 2019 Jul;98(29):e16561. doi: 10.1097/MD.0000000000016561.

Efficacy and safety of Hou Gu Mi Xi for peptic ulcer diseases: Study protocol for a randomized controlled trial.

Author information

1
Evidence-based Medicine Research Center, Jiangxi University of Traditional Chinese Medicine, Nanchang, Jiangxi.
2
School of Food Science and Engineering, Inner Mongolia Agricultural University, Hohhot, Inner Mongolia.
3
Department of Gastroenterology, the First Affiliated Hospital of Nanchang University.
4
Department of Gastroenterology, the Third Affiliated Hospital of Nanchang University.
5
Department of Gastroenterology, Jiujiang No.1 People's Hospital.
6
Department of Spleen, Stomach, Liver and Gallbladder Diseases, the Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine.
7
Department of Gastroenterology, Xinyu People's Hospital.
8
Department of Spleen, Stomach, Xinyu Hospital of Traditional Chinese Medicine.
9
Department of Traditional Chinese Medicine, the Second Affiliated Hospital of Nanchang University.
10
Department of Gastroenterology, Nanchang Hospital of Integrated Traditional Chinese and Western Medicine.
11
Internal medicine 1, Nanchang Hongdu Hospital of Traditional Chinese Medicine.
12
Department of Gastroenterology, the Nanchang Third Hospital.
13
Department of Spleen, Stomach, Jiujiang Hospital of Traditional Chinese Medicine.
14
Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, China.

Abstract

BACKGROUND:

Peptic ulcer disease (PUD) is a major burden worldwide. Several challenges remain with standard Western treatment of PUD, such as persistent weakness, fatigue, and relapse. A dietary traditional Chinese medicine (TCM) formula, Hou Gu Mi Xi (HGMX), has been developed as a complementary treatment for PUD.

AIMS:

This multicenter, double-blind, randomized controlled trial will assess efficacy and safety of HGMX in patients with PUD.

METHODS:

Three hundred sixty eligible patients will be assigned to receive HGMX, placebo, HGMX + rabeprazole or placebo + rabeprazole for 4 weeks after 2 weeks of standard Western treatment. This first step, with a 2 × 2 factorial design, will focus on assessing the main and interaction effects of HGMX and rabeprazole on ulcer healing. Then, rabeprazole will be stopped, and HGMX will be continued for up to 1 year. The second step, with a placebo-controlled design, will compare the long-term effects of HGMX and placebo. Extended follow-up with no treatment will continue for up to 2 years. Independent and paired t tests, Pearson χ test and the rank-sum test will be used to compare between-group differences. The P value will be adjusted using the O'Brien & Fleming method for multiple comparisons.

EXPECTED OUTCOMES:

The primary outcomes are total efficacy rate of PUD treatment, quality of ulcer healing, and changes in spleen qi deficiency symptoms. The secondary outcomes include ulcer area, PUD recurrence, Helicobacter pylori eradication rate, gastric function, body weight, and body mass index. Adverse events (AEs), severe AEs, treatment-related AEs, and withdrawal owing to AEs will be recorded to assess treatment safety.

DISCUSSION:

The trial results will provide high-quality evidence for HGMX, as a complementary therapy, for the long-term management of PUD and will be valuable for the development of related guidelines and regulations.

TRIAL REGISTRATION:

The protocol of this trial was approved in all research hospitals and was registered in ClinicalTrials.gov at October 25, 2017(No. NCT03320538).

PMID:
31335741
DOI:
10.1097/MD.0000000000016561
[Indexed for MEDLINE]
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