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; Zhao-xiang Bian

doi:10.1007/s11655-015-2114-5

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

Updated：2021-08-27

- Randomized double-blind clinical trial of Moluodan (摩罗丹) for the treatment of chronic atrophic gastritis with dysplasia
- Chinese Journal of Integrative Medicine Vol. 22, Issue 1, Pages: 9-18(2016)
- Affiliations：
  
  1. Xiyuan Hospital, China Academy of Chinese Medical Sciences,Beijing,China
  2. Peking University Third Hospital,Beijing,China
  3. Beijing Friendship Hospital Affiliated to Capital Medical University,Beijing,China
  4. Beijing Tiantan Hospital Affiliated to Capital Medical University,Beijing,China
  5. Peking Union Medical College Hospital,Beijing,China
  6. Guang’anmen Hospital, China Academy of Chinese Medical Sciences,Beijing,China
  7. School of Chinese Medicine, Hong Kong Baptist University,Hong Kong SAR,China
- Author bio：
- Funds：
  
  Supported by the 11th Five-Year Plan from Ministry of Sciences and Technology of China (No. 2006BAI04A08)
- DOI：10.1007/s11655-015-2114-5
  CLC：
- Published：2016，
  
  Published Online：1 October 2015，
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Tang, Xd., Zhou, Ly., Zhang, St. et al. Randomized double-blind clinical trial of Moluodan (摩罗丹) for the treatment of chronic atrophic gastritis with dysplasia., Chin. J. Integr. Med. 22, 9–18 (2016). https://doi.org/10.1007/s11655-015-2114-5

Xu-dong Tang, Li-ya Zhou, Shu-tian Zhang, et al. Randomized double-blind clinical trial of Moluodan (摩罗丹) for the treatment of chronic atrophic gastritis with dysplasia. [J]. Chinese Journal of Integrative Medicine 22(1):9-18(2016)
Tang, Xd., Zhou, Ly., Zhang, St. et al. Randomized double-blind clinical trial of Moluodan (摩罗丹) for the treatment of chronic atrophic gastritis with dysplasia., Chin. J. Integr. Med. 22, 9–18 (2016). https://doi.org/10.1007/s11655-015-2114-5 DOI：

Xu-dong Tang, Li-ya Zhou, Shu-tian Zhang, et al. Randomized double-blind clinical trial of Moluodan (摩罗丹) for the treatment of chronic atrophic gastritis with dysplasia. [J]. Chinese Journal of Integrative Medicine 22(1):9-18(2016) DOI： 10.1007/s11655-015-2114-5.

摘要

To assess the efficacy and safety of Moluodan (摩罗丹) in treating dysplasia in chronic atrophic gastritis (CAG) patients. 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. 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%. 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]

Abstract

To assess the efficacy and safety of Moluodan (摩罗丹) in treating dysplasia in chronic atrophic gastritis (CAG) patients. This was a multi-centered

double-blind

response rate of pathological lesions and dysplasia disappearance rate. Secondary endpoints included gastroscopic findings

clinical symptom and patient reported outcome (PRO) instrument. 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%. 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]

关键词

gastric epithelial dysplasiaChronic Atrophic GastritisMoluodanfolic acidrandomized clinical trial

Keywords

gastric epithelial dysplasiaChronic Atrophic GastritisMoluodanfolic acidrandomized clinical trial

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