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Randomized Controlled Trial
. 2016 Jan;22(1):9-18.
doi: 10.1007/s11655-015-2114-5. Epub 2015 Oct 1.

Randomized Double-Blind Clinical Trial of Moluodan () for the Treatment of Chronic Atrophic Gastritis With Dysplasia

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Randomized Controlled Trial

Randomized Double-Blind Clinical Trial of Moluodan () for the Treatment of Chronic Atrophic Gastritis With Dysplasia

Xu-Dong Tang et al. Chin J Integr Med. .

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].

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

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References

    1. Gut. 2002 Jul;51(1):130-1 - PubMed
    1. Semin Oncol. 1985 Mar;12(1):2-10 - PubMed
    1. Gastric Cancer. 1998 Dec;1(1):31-50 - PubMed
    1. Gut. 2000 Aug;47(2):251-5 - PubMed
    1. Gut. 1999 Nov;45(5):784-90 - PubMed

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