Electro-acupuncture reduced steatosis on MRI-PDFF in patients with non-alcoholic steatohepatitis: a randomized controlled pilot clinical trial

Abstract Background Non-alcoholic steatohepatitis (NASH) had not yet been approved therapy. Electro-acupuncture (EA) has been reported to have potential efficacy. However, high-quality clinical evidence was still lacking. Methods NASH patients were randomized and allocated to either sham acupuncture...

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Main Authors: Jingjie Zhao, Qianyi Wang, Xinyu Zhao, Lina Wu, Juanjuan Li, Wen Zhang, Shuai Xu, Chaoru Han, Yi Du, Xiaofei Tong, Weijia Duan, Di Cao, Hao Ren, Xinyan Zhao, Xiaojuan Ou, Jidong Jia, Hong You
Format: Article
Language:English
Published: BMC 2023-02-01
Series:Chinese Medicine
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Online Access:https://doi.org/10.1186/s13020-023-00724-w
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author Jingjie Zhao
Qianyi Wang
Xinyu Zhao
Lina Wu
Juanjuan Li
Wen Zhang
Shuai Xu
Chaoru Han
Yi Du
Xiaofei Tong
Weijia Duan
Di Cao
Hao Ren
Xinyan Zhao
Xiaojuan Ou
Jidong Jia
Hong You
author_facet Jingjie Zhao
Qianyi Wang
Xinyu Zhao
Lina Wu
Juanjuan Li
Wen Zhang
Shuai Xu
Chaoru Han
Yi Du
Xiaofei Tong
Weijia Duan
Di Cao
Hao Ren
Xinyan Zhao
Xiaojuan Ou
Jidong Jia
Hong You
author_sort Jingjie Zhao
collection DOAJ
description Abstract Background Non-alcoholic steatohepatitis (NASH) had not yet been approved therapy. Electro-acupuncture (EA) has been reported to have potential efficacy. However, high-quality clinical evidence was still lacking. Methods NASH patients were randomized and allocated to either sham acupuncture (SA) or EA group in a 1:1 ratio, with the patient blinded. Each patient received 36 sessions of SA or EA treatment over 12 weeks, followed by additional 4 weeks. The primary outcome was the changes in relative liver fat content measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF). Results A total of 60 patients were enrolled. From baseline to week 12, the reduction of relative liver fat content measured by MRI-PDFF in the EA group (− 33.6%, quantile range: − 52.9%, − 22.7%) was significantly more significant than that in the SA group (− 15.8%, quantile range: − 36.1%, − 2.7%) (p = 0.022). Furthermore, the EA group had more patients who achieved MRI-PDFF to 30% reduction at week 12 (53.3% vs. 25.9%, p = 0.035). EA treatment also significantly reduced body weight (− 3.0 vs. + 0.1 kg, p = 0.034) and BMI (− 1.5 vs. − 0.2 kg/m2, p = 0.013) at week 16. Except for AST (− 27.4 vs. − 16.2 U/L, p = 0.015), other biochemical varieties, including ALT, fasting-glucose, cholesterol, and triglyceride, showed no statistically significant difference. Both groups measured no significant changes in liver stiffness by magnetic resonance elastography (MRE). There were no serious adverse events in either group. Conclusions Twelve weeks of EA effectively and safely reduces relative liver fat content in NASH patients. Further multicenter randomized controlled studies are needed. Trial registration Chinese Clinical Trial Registry, ChiCTR2100046617. Registered 23 May 2021, http://www.chictr.org.cn/edit.aspx?pid=127023&htm=4
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spelling doaj.art-72a6aaa8873a4e46a8aa6034e7a34a6c2023-03-22T12:22:40ZengBMCChinese Medicine1749-85462023-02-0118111210.1186/s13020-023-00724-wElectro-acupuncture reduced steatosis on MRI-PDFF in patients with non-alcoholic steatohepatitis: a randomized controlled pilot clinical trialJingjie Zhao0Qianyi Wang1Xinyu Zhao2Lina Wu3Juanjuan Li4Wen Zhang5Shuai Xu6Chaoru Han7Yi Du8Xiaofei Tong9Weijia Duan10Di Cao11Hao Ren12Xinyan Zhao13Xiaojuan Ou14Jidong Jia15Hong You16Liver Research Center, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center of Digestive DiseasesLiver Research Center, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center of Digestive DiseasesClinical Center for Metabolic Associated Fatty Liver Disease, Capital Medical UniversityLiver Research Center, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center of Digestive DiseasesDepartment of Traditional Chinese Medicine, Beijing Friendship Hospital, Capital Medical UniversityLiver Research Center, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center of Digestive DiseasesDepartment of Traditional Chinese Medicine, Beijing Friendship Hospital, Capital Medical UniversityDepartment of Traditional Chinese Medicine, Beijing Friendship Hospital, Capital Medical UniversityDepartment of Traditional Chinese Medicine, Beijing Friendship Hospital, Capital Medical UniversityLiver Research Center, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center of Digestive DiseasesLiver Research Center, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center of Digestive DiseasesDepartment of Radiology, Beijing Friendship Hospital, Capital Medical UniversityDepartment of Radiology, Beijing Friendship Hospital, Capital Medical UniversityLiver Research Center, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center of Digestive DiseasesLiver Research Center, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center of Digestive DiseasesLiver Research Center, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center of Digestive DiseasesLiver Research Center, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center of Digestive DiseasesAbstract Background Non-alcoholic steatohepatitis (NASH) had not yet been approved therapy. Electro-acupuncture (EA) has been reported to have potential efficacy. However, high-quality clinical evidence was still lacking. Methods NASH patients were randomized and allocated to either sham acupuncture (SA) or EA group in a 1:1 ratio, with the patient blinded. Each patient received 36 sessions of SA or EA treatment over 12 weeks, followed by additional 4 weeks. The primary outcome was the changes in relative liver fat content measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF). Results A total of 60 patients were enrolled. From baseline to week 12, the reduction of relative liver fat content measured by MRI-PDFF in the EA group (− 33.6%, quantile range: − 52.9%, − 22.7%) was significantly more significant than that in the SA group (− 15.8%, quantile range: − 36.1%, − 2.7%) (p = 0.022). Furthermore, the EA group had more patients who achieved MRI-PDFF to 30% reduction at week 12 (53.3% vs. 25.9%, p = 0.035). EA treatment also significantly reduced body weight (− 3.0 vs. + 0.1 kg, p = 0.034) and BMI (− 1.5 vs. − 0.2 kg/m2, p = 0.013) at week 16. Except for AST (− 27.4 vs. − 16.2 U/L, p = 0.015), other biochemical varieties, including ALT, fasting-glucose, cholesterol, and triglyceride, showed no statistically significant difference. Both groups measured no significant changes in liver stiffness by magnetic resonance elastography (MRE). There were no serious adverse events in either group. Conclusions Twelve weeks of EA effectively and safely reduces relative liver fat content in NASH patients. Further multicenter randomized controlled studies are needed. Trial registration Chinese Clinical Trial Registry, ChiCTR2100046617. Registered 23 May 2021, http://www.chictr.org.cn/edit.aspx?pid=127023&htm=4https://doi.org/10.1186/s13020-023-00724-wElectro-acupunctureNon-alcoholic steatohepatitis (NASH)Randomized controlled trial (RCT)MRI-PDFF
spellingShingle Jingjie Zhao
Qianyi Wang
Xinyu Zhao
Lina Wu
Juanjuan Li
Wen Zhang
Shuai Xu
Chaoru Han
Yi Du
Xiaofei Tong
Weijia Duan
Di Cao
Hao Ren
Xinyan Zhao
Xiaojuan Ou
Jidong Jia
Hong You
Electro-acupuncture reduced steatosis on MRI-PDFF in patients with non-alcoholic steatohepatitis: a randomized controlled pilot clinical trial
Chinese Medicine
Electro-acupuncture
Non-alcoholic steatohepatitis (NASH)
Randomized controlled trial (RCT)
MRI-PDFF
title Electro-acupuncture reduced steatosis on MRI-PDFF in patients with non-alcoholic steatohepatitis: a randomized controlled pilot clinical trial
title_full Electro-acupuncture reduced steatosis on MRI-PDFF in patients with non-alcoholic steatohepatitis: a randomized controlled pilot clinical trial
title_fullStr Electro-acupuncture reduced steatosis on MRI-PDFF in patients with non-alcoholic steatohepatitis: a randomized controlled pilot clinical trial
title_full_unstemmed Electro-acupuncture reduced steatosis on MRI-PDFF in patients with non-alcoholic steatohepatitis: a randomized controlled pilot clinical trial
title_short Electro-acupuncture reduced steatosis on MRI-PDFF in patients with non-alcoholic steatohepatitis: a randomized controlled pilot clinical trial
title_sort electro acupuncture reduced steatosis on mri pdff in patients with non alcoholic steatohepatitis a randomized controlled pilot clinical trial
topic Electro-acupuncture
Non-alcoholic steatohepatitis (NASH)
Randomized controlled trial (RCT)
MRI-PDFF
url https://doi.org/10.1186/s13020-023-00724-w
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