Randomized double-blind clinical trial of Moluodan (摩罗丹) for the treatment of chronic atrophic gastritis with dysplasia

Xu dong Tang*, Li ya Zhou, Shu tian Zhang, You qing Xu, Quan cai Cui, Li Li, Jing jing Lu, Peng Li, Fang Lu, Feng yun Wang, Ping Wang, Li qun Bian, Zhaoxiang BIAN

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

9 Citations (Scopus)

Abstract

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 2:1 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]

Original languageEnglish
Pages (from-to)9-18
Number of pages10
JournalChinese Journal of Integrative Medicine
Volume22
Issue number1
DOIs
Publication statusPublished - 1 Jan 2016

Scopus Subject Areas

  • Complementary and alternative medicine
  • Pharmacology (medical)

User-Defined Keywords

  • chronic atrophic gastritis
  • folic acid
  • gastric epithelial dysplasia
  • Moluodan
  • randomized clinical trial

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