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Electro-acupuncture reduced steatosis on MRI-PDFF in patients with non-alcoholic steatohepatitis: a randomized controlled pilot clinical trial
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) o...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9950708/ https://www.ncbi.nlm.nih.gov/pubmed/36829229 http://dx.doi.org/10.1186/s13020-023-00724-w |
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author | Zhao, Jingjie Wang, Qianyi Zhao, Xinyu Wu, Lina Li, Juanjuan Zhang, Wen Xu, Shuai Han, Chaoru Du, Yi Tong, Xiaofei Duan, Weijia Cao, Di Ren, Hao Zhao, Xinyan Ou, Xiaojuan Jia, Jidong You, Hong |
author_facet | Zhao, Jingjie Wang, Qianyi Zhao, Xinyu Wu, Lina Li, Juanjuan Zhang, Wen Xu, Shuai Han, Chaoru Du, Yi Tong, Xiaofei Duan, Weijia Cao, Di Ren, Hao Zhao, Xinyan Ou, Xiaojuan Jia, Jidong You, Hong |
author_sort | Zhao, Jingjie |
collection | PubMed |
description | 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/m(2), 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 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13020-023-00724-w. |
format | Online Article Text |
id | pubmed-9950708 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-99507082023-02-24 Electro-acupuncture reduced steatosis on MRI-PDFF in patients with non-alcoholic steatohepatitis: a randomized controlled pilot clinical trial Zhao, Jingjie Wang, Qianyi Zhao, Xinyu Wu, Lina Li, Juanjuan Zhang, Wen Xu, Shuai Han, Chaoru Du, Yi Tong, Xiaofei Duan, Weijia Cao, Di Ren, Hao Zhao, Xinyan Ou, Xiaojuan Jia, Jidong You, Hong Chin Med Research 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/m(2), 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 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13020-023-00724-w. BioMed Central 2023-02-24 /pmc/articles/PMC9950708/ /pubmed/36829229 http://dx.doi.org/10.1186/s13020-023-00724-w Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Zhao, Jingjie Wang, Qianyi Zhao, Xinyu Wu, Lina Li, Juanjuan Zhang, Wen Xu, Shuai Han, Chaoru Du, Yi Tong, Xiaofei Duan, Weijia Cao, Di Ren, Hao Zhao, Xinyan Ou, Xiaojuan Jia, Jidong You, Hong Electro-acupuncture reduced steatosis on MRI-PDFF in patients with non-alcoholic steatohepatitis: a randomized controlled pilot clinical trial |
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 | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9950708/ https://www.ncbi.nlm.nih.gov/pubmed/36829229 http://dx.doi.org/10.1186/s13020-023-00724-w |
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