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

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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]

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Authors and Affiliations

  1. Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China

    Xu-dong Tang  (唐旭东), Fang Lu  (陆 芳), Feng-yun Wang  (王凤云), Ping Wang  (王 萍) & Li-qun Bian  (卞立群)

  2. Peking University Third Hospital, Beijing, 100191, China

    Li-ya Zhou  (周丽雅) & Jing-jing Lu  (陆京京)

  3. Beijing Friendship Hospital Affiliated to Capital Medical University, Beijing, 100050, China

    Shu-tian Zhang  (张澍田) & Peng Li  (李 鹏)

  4. Beijing Tiantan Hospital Affiliated to Capital Medical University, Beijing, 100050, China

    You-qing Xu  (徐有青)

  5. Peking Union Medical College Hospital, Beijing, 100730, China

    Quan-cai Cui  (崔全才)

  6. Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China

    Li Li  (李 理)

  7. School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China

    Zhao-xiang Bian  (卞兆祥)

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  1. Xu-dong Tang  (唐旭东)
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  4. You-qing Xu  (徐有青)
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  5. Quan-cai Cui  (崔全才)
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  6. Li Li  (李 理)
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  7. Jing-jing Lu  (陆京京)
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  8. Peng Li  (李 鹏)
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  9. Fang Lu  (陆 芳)
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  10. Feng-yun Wang  (王凤云)
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  11. Ping Wang  (王 萍)
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  12. Li-qun Bian  (卞立群)
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  13. Zhao-xiang Bian  (卞兆祥)
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Corresponding author

Correspondence to Xu-dong Tang  (唐旭东).

Additional information

Supported by the 11th Five-Year Plan from Ministry of Sciences and Technology of China (No. 2006BAI04A08)

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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

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  • DOI: https://doi.org/10.1007/s11655-015-2114-5

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