Ji Yao Wang1,2, Jasmohan S Bajaj3, Jiang Bin Wang4, Jia Shang5, Xin Min Zhou6, Xiao Lin Guo7, Xuan Zhu8, Li Na Meng9, Hai Xing Jiang10, Yu Qiang Mi11, Jian Ming Xu12, Jin Hui Yang13, Bai Song Wang14, Ning Ping Zhang2. 1. Department of Gastroenterology, Zhongshan Hospital Affiliated to Fudan University, Shanghai, China. 2. Center of Evidence-based Medicine, Fudan University, Shanghai, China. 3. Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VA Medical Center, Richmond, Virginia, USA. 4. Department of Gastroenterology, China-Japan Union Hospital of Jilin University, Changchun, Jilin Province, China. 5. Department of Infectious Diseases, Henan Provincial People's Hospital, Zhengzhou, Henan Province, China. 6. Department of Gastroenterology, Xijing Hospital Affiliated to Air Force Medical University, Xi'an, Shaanxi Province, China. 7. Department of Gastroenterology, First Hospital of Jilin University, Changchun, Jilin Province, China. 8. Department of Gastroenterology, First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China. 9. Department of Gastroenterology, Zhejiang Provincial Hospital of Traditional Chinese Medicine, Hangzhou, Zhejiang Province, China. 10. Department of Gastroenterology, First Affiliated Hospital of Guangxi Medical University, Guilin, Guangxi Zhuang Autonomous Region, China. 11. Department of Hepatology, Tianjin Second People's Hospital, Tianjin, China. 12. Department of Gastroenterology, First Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, China. 13. Department of Hepatology, The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan Province, China. 14. Department of Pharmacology and Biostatistics, Institute of Medical Sciences, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Abstract
OBJECTIVE:Lactulose is effective in the treatment and prevention of overt hepatic encephalopathy (OHE), but there are limited data on its use on microbiota in relations to minimal hepatic encephalopathy (MHE) recovery. The present study aimed to assess the efficacy of lactulose in recovery of MHE in aspects of cognitive function, quality of life, and impact on intestinal microbiota. METHODS: This multicenter, open-label randomized controlled trial was conducted in 11 teaching hospitals in China. Participants were randomly allocated on a 2:1 basis to receive lactulose (Gp-L) or no therapy as control (Gp-NL) for 60 days. The primary endpoint was the MHE reversal rate. Gut microbiota were compared between MHE patients and healthy volunteers, as well as lactulose-responders and non-responders. RESULTS: A total of 98 cirrhotic patients were included in the study, with 31 patients in the Gp-NL group and 67 patients in the Gp-L group. At day 60, the MHE reversal rate in Gp-L (64.18%) was significantly higher than that in Gp-NL (22.58%) (P = .0002) with a relative risk of 0.46 (95% confidence interval 0.32-0.67). Number needed to treat was 2.4. Further, there was significantly more improvement in physical functioning in Gp-L (4.62 ± 6.16) than in Gp-NL (1.50 ± 5.34) (P = .0212). Proteobacteria was significantly higher in MHE patients compared with healthy volunteers (12.27% vs 4.65%, P < .05). Significant differences were found between lactulose responders and non-responders in Actinobacteria, Bacteroidetes, Firmicutes, and Proteobacteria. CONCLUSIONS: Treatment with lactulose significantly improves MHE recovery rate, and gut microbiota change in MHE patients can modulate the effectiveness of this therapy. Chinese Clinical Trial Register (ChiCTR) (ID: ChiCTR-TRC-12002342).
RCT Entities:
OBJECTIVE:Lactulose is effective in the treatment and prevention of overt hepatic encephalopathy (OHE), but there are limited data on its use on microbiota in relations to minimal hepatic encephalopathy (MHE) recovery. The present study aimed to assess the efficacy of lactulose in recovery of MHE in aspects of cognitive function, quality of life, and impact on intestinal microbiota. METHODS: This multicenter, open-label randomized controlled trial was conducted in 11 teaching hospitals in China. Participants were randomly allocated on a 2:1 basis to receive lactulose (Gp-L) or no therapy as control (Gp-NL) for 60 days. The primary endpoint was the MHE reversal rate. Gut microbiota were compared between MHE patients and healthy volunteers, as well as lactulose-responders and non-responders. RESULTS: A total of 98 cirrhotic patients were included in the study, with 31 patients in the Gp-NL group and 67 patients in the Gp-L group. At day 60, the MHE reversal rate in Gp-L (64.18%) was significantly higher than that in Gp-NL (22.58%) (P = .0002) with a relative risk of 0.46 (95% confidence interval 0.32-0.67). Number needed to treat was 2.4. Further, there was significantly more improvement in physical functioning in Gp-L (4.62 ± 6.16) than in Gp-NL (1.50 ± 5.34) (P = .0212). Proteobacteria was significantly higher in MHE patients compared with healthy volunteers (12.27% vs 4.65%, P < .05). Significant differences were found between lactulose responders and non-responders in Actinobacteria, Bacteroidetes, Firmicutes, and Proteobacteria. CONCLUSIONS: Treatment with lactulose significantly improves MHE recovery rate, and gut microbiota change in MHE patients can modulate the effectiveness of this therapy. Chinese Clinical Trial Register (ChiCTR) (ID: ChiCTR-TRC-12002342).
Authors: Mohammed El-Mowafy; Abdelaziz Elgaml; Mohamed El-Mesery; Salma Sultan; Tamer A E Ahmed; Ahmed I Gomaa; Mahmoud Aly; Walid Mottawea Journal: Biology (Basel) Date: 2021-01-13
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