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

Chin J Integr Med. 2016 Jan;22(1):9-18. doi: 10.1007/s11655-015-2114-5. Epub 2015 Oct 1.


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].

Keywords: Moluodan; chronic atrophic gastritis; folic acid; gastric epithelial dysplasia; randomized clinical trial.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Chronic Disease
  • Double-Blind Method
  • Drugs, Chinese Herbal / adverse effects
  • Drugs, Chinese Herbal / pharmacology
  • Drugs, Chinese Herbal / therapeutic use*
  • Female
  • Gastritis, Atrophic / drug therapy*
  • Gastritis, Atrophic / microbiology
  • Gastritis, Atrophic / pathology*
  • Gastroscopy
  • Helicobacter pylori / drug effects
  • Humans
  • Male
  • Middle Aged
  • Treatment Outcome


  • Drugs, Chinese Herbal
  • moluodan