The investigators purposes are to define the prevalence of omeprazole resistance gastroesophageal reflux disease (GERD) in systemic sclerosis (SSc), to compare the efficacy of omeprazole in combination with algycon versus omeprazole in combination with domperidone on the severity of reflux symptoms in omeprazole resistant GERD in SSc, and to compare the efficacy of omeprazole in combination with algycon versus omeprazole in combination with domperidone on the frequency of symptoms in omeprazole- resistant GERD in SSc.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Algycon 1 tab chew tid after meal
placebo (for domperidone) 1 tab oral tid before meal
domperidone (10 mg) 1 tab oral tid before meal
123 Department of Medicine, Faculty of Medicine, Khon Kaen University
Khon Kaen, Changwat Khon Kaen, Thailand
Changing Severity of Heart Burn of SSc Related Omeprazole Resistant GERD Evaluated by Visual Analogue Score (VAS)
VAS scale 0-100 was applied for an outcome measurement of the severity of heart burn. The VAS scale 0 was no symptoms of heart burn and scale 100 was a maximum symptom of heart burn. The changing of the severity of heart burn was the changing of VAS before and after treatment.
Time frame: 8 weeks
Changing of the Severity of Regurgitation
VAS scale 0-100 was applied for an outcome measurement of the severity of regurgitation. The VAS scale 0 was no symptoms of regurgitation and scale 100 was a maximum symptom of regurgitation. The changing of the severity of regurgitation was the changing of VAS before and after treatment.
Time frame: 8 weeks
Changing of Frequency of Symptoms in SSc Related Omeprazole Resistant GERD Evaluated by Frequency Scale for the Symptoms of GERD (FSSG)
Unit scale 0-48 was applied for an outcome measurement of the frequency of symptoms. The unit scale 0 was no symptom and scale 48 was usual symptom of GERD. The changing of the frequency of symptoms was the changing of the unit scale before and after treatment.
Time frame: 8 weeks
the Prevalence of Omeprazole-resistant GERD in SSc After 4 Weeks Treatment With Omeprazole
Time frame: 4 weeks
Changing of the Quality of Life Which is Evaluated by EQ-5DTM
VAS scale 0-100 was applied for an outcome measurement of the quality of life. The VAS scale 0 was the worst quality of life and scale 100 was the best quality of life. The changing of the quality of life was the changing of VAS of quality of life before and after treatment.
Time frame: 8 weeks
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placebo (for alginic acid) 1 tab chew tid after meal