The research aims to investigate whether trimebutine maleate combined with rabeprazole can improve the clinical efficacy in patients With refractory Los Angeles grade A or B reflux esophagitis . A total of 500 patients with Grade A or B reflux esophagitis refractory to rabeprazole will be randomly divided into two groups.One will continue to receive rabeprazole treatment,and the other group will receive extra oral trimebutine maleate 200 mg three times daily for 4 weeks. The end of the study for every patient is the improvement of main symptoms. The primary and secondary analyses are the main symptoms score, endoscopy results, Gastroesophageal reflux disease questionnaire(GerdQ) score,Hospital Anxiety and Depression Scale(HADS) score, Athens insomnia scale and World Health Organization Quality of Life-Bref(WHOQOL-BREF)scale scores at the baseline and final assessments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Rabeprazole 20mg once daily was administered during the 8 weeks' screening stage ,then oral trimebutine maleate 200mg three times daily combined with rabeprazole 20mg once daily were administered to the experimental arm for 4 weeks.
Rabeprazole 20mg once daily was administered during the 8 weeks' screening stage,and rabeprazole 20mg once daily was administered to other arm for additional 4 weeks.
Xijing Hosipital of Digestive Disease
Xi'an, Shaanxi, China
The change of main symptom (heartburn,acid regurgitation,non-cardiac chestpain,hoarseness,et,al)score from baseline to the end of 8 weeks
After the screening,the investigators defined the patients with main symptom score improvement less than 50% as the refractory reflux esophagitis patients. The results before and after treatment will be compared.
Time frame: baseline ,the end of 8 weeks
The change of main symptom (heartburn,acid regurgitation,non-cardiac chestpain,hoarseness,et,al)score from the end of 8 weeks to the end of 12 weeks
Time frame: the end of 8 weeks , the end of 12 weeks
change of GerdQ score from baseline to the end of 8 weeks
The results before and after treatment will be compared
Time frame: baseline,the end of 8 weeks
change of GerdQ score from the end of 8 weeks to the end of 12 weeks
The results before and after treatment will be compared
Time frame: the end of 8 weeks,the end of 12 weeks
change of Athens insomnia scale score from baseline to the end of 8 weeks
Athens insomnia scale score was used to evaluate the quality of sleep. The results before and after treatment will be compared
Time frame: baseline,the end of 8 weeks
change of Athens insomnia scale score from the end of 8 weeks to the end of 12 weeks
Athens insomnia scale score was used to evaluate the quality of sleep. The results before and after treatment will be compared
Time frame: the end of 8 weeks,the end of 12 weeks
change of WHOQOL-BREF score from baseline to the end of 8 weeks
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The quality of life for the refractory reflux esophagitis patients was assessed with the WHOQOL-BREF.The results before and after treatment will be compared
Time frame: baseline , the end of 8 weeks
change of WHOQOL-BREF score from the end of 8 weeks to the end of 12 weeks
The quality of life for the refractory reflux esophagitis patients was assessed with the WHOQOL-BREF.The results before and after treatment will be compared
Time frame: the end of 8 weeks, the end of 12 weeks
change of HADS score from baseline to the end of 8 weeks
Depression and anxiety was assessed with HADS.The results before and after treatment will be compared
Time frame: baseline,the end of 8 weeks
change of HADS score from the end of 8 weeks to the end of 12 weeks
Depression and anxiety was assessed with HADS.The results before and after treatment will be compared
Time frame: the end of 8 weeks , the end of 12 weeks
change of the results of upper gastrointestinal endoscopy from baseline to the end of 12 weeks
If the patients complete the upper gastrointestinal endoscopy before and after the treatment,the results of the mucosal healing will be analyzed.
Time frame: baseline,the end of 12 weeks
The dietary habits of the patients with refractory Los Angeles class A or B reflux esophagitis
Time frame: baseline
The comorbidities(e.g.,hypertension,chronic kidney disease,diabetes,IBS,Functional dyspepsia,et,al) of the patients with refractory Los Angeles class A or B reflux esophagitis
Time frame: baseline
the smoking and alcohol drinking habits of the patients with refractory Los Angeles class A or B reflux esophagitis
Time frame: baseline