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Objective:To assess the efficacy and safety of Moluodan(摩罗丹) in treating dysplasia in chronic atrophic gastritis(CAG) patients.Methods:This was a multi-centered,double-blind,randomized controlled trial.The total of 196 subjects were assigned to receive either Moluodan or folic acid in a 2:1ratio by blocked randomization.Mucosa marking targeting biopsy(MTB) was used to insure the accuracy and consistency between baseline and after 6-month treatment.Primary outcomes were histological score,response rate of pathological lesions and dysplasia disappearance rate.Secondary endpoints included gastroscopic findings,clinical symptom and patient reported outcome(PRO) instrument.Results:Dysplasia score decreased in Moluodan group(P=0.002),significance was found between groups(P=0.045).Dysplasia disappearance rates were 24.6%and 15.2%in Moluodan and folic acid groups respectively,no significant differences were found(P=0.127).The response rate of atrophy and intestinal metaplasia were 34.6%and23.0%in Moluodan group,24.3%and 13.6%in folic acid group.Moluodan could improve erythema(P=0.044),and bile reflux(P=0.059),no significance between groups.Moluodan was better than folic acid in improving epigastric pain,epigastric suffocation,belching and decreased appetite(P<0.05),with symptom disappearance rates of 37%to 83%.Conclusions:Moluodan improved dysplasia score in histopathology,and erythema and bile reflux score in endoscopy,and superior to folic acid in improving epigastric pain,epigastric suffocation,belching and decreased appetite.
Objective: To assess the efficacy and safety of Moluodan in treating dysplasia in chronic atrophic gastritis (CAG) patients. Methods. This was a multi-centered, double-blind, randomized controlled trial. The total of 196 subjects were assigned to receive either Moluodan or folic acid in a 2: 1 ran by blocked randomization. Mucosa marking targeting biopsy (MTB) was used to insure the accuracy and consistency between baseline and after 6-month treatment. Primary outcomes were histological score, response rate of pathological lesions and dysplasia disappearance rate. Secondary endpoints included gastroscopic findings, clinical symptom and patient reported outcome (PRO) instrument. Results: Dysplasia score decreased in Moluodan group (P = 0.002), significance was found between groups (P = 0.045) Rates were 24.6% and 15.2% in Moluodan and folic acid groups respectively, no significant differences were found (P = 0.127). The response rate of atrophy and intestinal metaplasia were 34.6% a nd23.0% in Moluodan group, 24.3% and 13.6% in folic acid group. Moluodan could improve erythema (P = 0.044), and bile reflux (P = 0.059), no significance between groups. Moluodan was better than folic acid in improving epigastric pain, epigastric suffocation, belching and decreased appetite (P <0.05), with symptom disappearance rates of 37% to 83% .Conclusions: Moluodan improved dysplasia score in histopathology, and erythema and bile reflux score in endoscopy, and superior to folic acid in improving epigastric pain, epigastric suffocation, belching and decreased appetite.