Effectiveness and safety of Moluodan in the treatment of precancerous lesions of gastric cancer: A randomized clinical trial

Tian Hui Zou¹, Qin Yan Gao¹, Si De Liu², Yan Qing Li³, Xiang Jun Meng⁴, Guo Xin Zhang⁵, Zi Bin Tian⁶, Xiao Ping Zou⁷, Song He⁸, Xiao Hua Hou⁹, Rong Lin⁹, Jing Nan Li¹⁰, Zhong Yin Zhou¹¹, Yan Li¹², Meng Chun Wang¹², Bang Mao Wang¹³, De An Tian¹⁴, Shu Jie Chen¹⁵, Qian Cao¹⁵, Liang Ping Li¹⁶, Zhi Rong Wang¹⁷, Xi Zhong Shen¹⁸, Bing Rong Liu¹⁹, Xiao Yan Yan²⁰, Ying Xuan Chen¹, Jing-Yuan Fang¹

Affiliations

¹ Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, State Key Laboratory of Systems Medicine for Cancer, NHC Key Laboratory of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
² Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong Province, China.
³ Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, China.
⁴ Department of Gastroenterology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine; Shanghai Key Laboratory of Gut Microecology and Associated Major Diseases Research; Center for Digestive Diseases Research and Clinical Translation of Shanghai Jiaotong University, Shanghai, China.
⁵ Department of Gastroenterology and Hepatology, Jiangsu Province Hospital, Nanjing, Jiangsu Province, China.
⁶ Department of Gastroenterology, The Affiliated Hospital of Qingdao University, Qingdao, Shandong Province, China.
⁷ Division of Gastroenterology and Hepatology, The Affiliated Drum Tower of Nanjing University Medical School, Nanjing, Jiangsu Province, China.
⁸ Department of Gastroenterology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.
⁹ Department of Gastroenterology and Hepatology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei Province, China.
¹⁰ Department of Gastroenterology and Hepatology, Peking Union Medical College Hospital, Beijing, China.
¹¹ Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, Hubei Province, China.
¹² Department of Gastroenterology and Hepatology, Shengjing Hospital of China Medical University, Shenyang, Liaoning Province, China.
¹³ Department of Gastroenterology and Hepatology, Tianjin Medical University General Hospital, Tianjin, China.
¹⁴ Department of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei Province, China.
¹⁵ Department of Gastroenterology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China.
¹⁶ Department of Digestive Diseases, Sichuan Provincial People's Hospital, Chengdu, Sichuan Province, China.
¹⁷ Department of Gastroenterology, Tongji Hospital of Tongji University, Shanghai, China.
¹⁸ Department of Gastroenterology, Zhongshan Hospital, Fudan University, Shanghai, China.
¹⁹ Department of Gastroenterology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.
²⁰ Department of Biostatistics, Peking University Clinical Research Institute, Beijing, China.

PMID: 38342693
DOI: 10.1111/1751-2980.13251

Randomized Controlled Trial

Effectiveness and safety of Moluodan in the treatment of precancerous lesions of gastric cancer: A randomized clinical trial

Tian Hui Zou et al. J Dig Dis. 2024 Jan.

. 2024 Jan;25(1):27-35.

doi: 10.1111/1751-2980.13251. Epub 2024 Feb 11.

Authors

Affiliations

¹ Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, State Key Laboratory of Systems Medicine for Cancer, NHC Key Laboratory of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
² Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong Province, China.
³ Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, China.
⁴ Department of Gastroenterology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine; Shanghai Key Laboratory of Gut Microecology and Associated Major Diseases Research; Center for Digestive Diseases Research and Clinical Translation of Shanghai Jiaotong University, Shanghai, China.
⁵ Department of Gastroenterology and Hepatology, Jiangsu Province Hospital, Nanjing, Jiangsu Province, China.
⁶ Department of Gastroenterology, The Affiliated Hospital of Qingdao University, Qingdao, Shandong Province, China.
⁷ Division of Gastroenterology and Hepatology, The Affiliated Drum Tower of Nanjing University Medical School, Nanjing, Jiangsu Province, China.
⁸ Department of Gastroenterology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.
⁹ Department of Gastroenterology and Hepatology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei Province, China.
¹⁰ Department of Gastroenterology and Hepatology, Peking Union Medical College Hospital, Beijing, China.
¹¹ Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, Hubei Province, China.
¹² Department of Gastroenterology and Hepatology, Shengjing Hospital of China Medical University, Shenyang, Liaoning Province, China.
¹³ Department of Gastroenterology and Hepatology, Tianjin Medical University General Hospital, Tianjin, China.
¹⁴ Department of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei Province, China.
¹⁵ Department of Gastroenterology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China.
¹⁶ Department of Digestive Diseases, Sichuan Provincial People's Hospital, Chengdu, Sichuan Province, China.
¹⁷ Department of Gastroenterology, Tongji Hospital of Tongji University, Shanghai, China.
¹⁸ Department of Gastroenterology, Zhongshan Hospital, Fudan University, Shanghai, China.
¹⁹ Department of Gastroenterology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.
²⁰ Department of Biostatistics, Peking University Clinical Research Institute, Beijing, China.

PMID: 38342693
DOI: 10.1111/1751-2980.13251

Abstract

Objective: To investigate the clinical potential and safety of Moluodan to reverse gastric precancerous lesions.

Methods: Patients aged 18-70 years diagnosed with moderate-to-severe atrophy and/or moderate-to-severe intestinal metaplasia, with or without low-grade dysplasia, and negative for Helicobacter pylori were recruited in this randomized, double-blind, parallel-controlled trial. The primary outcome was the improvement of global histological diagnosis at 1-year follow-up endoscopy using the operative link for gastritis assessment, the operative link for gastric intestinal metaplasia assessment, and the disappearance rate of dysplasia.

Results: Between November 3, 2017 and January 27, 2021, 166 subjects were randomly assigned to the Moluodan group, 168 to the folic acid group, 84 to the combination group, and 84 to the high-dose Moluodan group. The improvement in global histological diagnosis was achieved in 60 (39.5%) subjects receiving Moluodan, 59 (37.8%) receiving folic acid, 26 (32.1%) receiving the combined drugs, and 36 (47.4%) receiving high-dose Moluodan. Moluodan was non-inferior to folic acid (95% confidence interval: -9.2 to 12.5; P = 0.02). High-dose Moluodan had a trend for better protective efficacy, though there was no statistical significance. The disappearance rate of dysplasia was 82.8% in the Moluodan group, which was superior to folic acid (53.9%; P = 0.006). No drug-related serious adverse events were observed.

Conclusions: One pack of Moluodan three times daily for 1 year was safe and effective in reversing gastric precancerous lesions, especially dysplasia. Doubling its dose showed a better efficacy trend.

Keywords: atrophy; chemoprevention; dysplasia; gastric neoplasms; intestinal metaplasia.

© 2024 Chinese Medical Association Shanghai Branch, Chinese Society of Gastroenterology, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine and John Wiley & Sons Australia, Ltd.

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References

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Effectiveness and safety of Moluodan in the treatment of precancerous lesions of gastric cancer: A randomized clinical trial

Affiliations

Effectiveness and safety of Moluodan in the treatment of precancerous lesions of gastric cancer: A randomized clinical trial

Authors

Affiliations

Abstract

References

REFERENCES

Publication types

MeSH terms

Substances

LinkOut - more resources

Full Text Sources

Medical