title: Randomized double-blind clinical trial of Moluodan () for the treatment of chronic atrophic gastritis with dysplasia.
abstract: 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 ratio 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% and 23.0% 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. [ChiCTR-TRC-00000169].
authors.affiliation: Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China. txdly@sina.com.
authors.forename: Xu-Dong
authors.initials: XD
authors.lastname: Tang
authors.affiliation: Peking University Third Hospital, Beijing, 100191, China.
authors.forename: Li-Ya
authors.initials: LY
authors.lastname: Zhou
authors.affiliation: Beijing Friendship Hospital Affiliated to Capital Medical University, Beijing, 100050, China.
authors.forename: Shu-Tian
authors.initials: ST
authors.lastname: Zhang
authors.affiliation: Beijing Tiantan Hospital Affiliated to Capital Medical University, Beijing, 100050, China.
authors.forename: You-Qing
authors.initials: YQ
authors.lastname: Xu
authors.affiliation: Peking Union Medical College Hospital, Beijing, 100730, China.
authors.forename: Quan-Cai
authors.initials: QC
authors.lastname: Cui
authors.affiliation: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China.
authors.forename: Li
authors.initials: L
authors.lastname: Li
authors.affiliation: Peking University Third Hospital, Beijing, 100191, China.
authors.forename: Jing-Jing
authors.initials: JJ
authors.lastname: Lu
authors.affiliation: Beijing Friendship Hospital Affiliated to Capital Medical University, Beijing, 100050, China.
authors.forename: Peng
authors.initials: P
authors.lastname: Li
authors.affiliation: Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.
authors.forename: Fang
authors.initials: F
authors.lastname: Lu
authors.affiliation: Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.
authors.forename: Feng-Yun
authors.initials: FY
authors.lastname: Wang
authors.affiliation: Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.
authors.forename: Ping
authors.initials: P
authors.lastname: Wang
authors.affiliation: Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.
authors.forename: Li-Qun
authors.initials: LQ
authors.lastname: Bian
authors.affiliation: School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.
authors.forename: Zhao-Xiang
authors.initials: ZX
authors.lastname: Bian
mesh_terms: D002908:Chronic Disease; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D005757:Gastritis, Atrophic / Q000188:drug therapy* / Q000382:microbiology / Q000473:pathology*; D005773:Gastroscopy; D016480:Helicobacter pylori / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D004365:Drugs, Chinese Herbal; C000611388:moluodan
keywords: Moluodan; chronic atrophic gastritis; folic acid; gastric epithelial dysplasia; randomized clinical trial