Electroacupuncture for mild-to-moderate dry eye: study protocol for a multicentre, randomised, single-blind, sham-controlled trial
Introduction Dry eye (DE) is a multifactorial ocular surface disease causing considerable medical, social and financial implications. Currently, there is no recognised long-term, effective treatment to alleviate DE. Clinical evidence shows that electroacupuncture (EA) can improve DE symptoms, tear s...
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BMJ Publishing Group
2023-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/12/e069369.full |
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| author | Yue Zhao Guang Yang Yun-Qiong Lu Mei-Yan Li Jue Hong Yan-Ting Yang Xue-Jun Wang Xie-He Kong Zhao Ma Xin-Yun Huang Yue-Lan Zou Xing-Tao Zhou Xiao-Peng Ma |
| author_facet | Yue Zhao Guang Yang Yun-Qiong Lu Mei-Yan Li Jue Hong Yan-Ting Yang Xue-Jun Wang Xie-He Kong Zhao Ma Xin-Yun Huang Yue-Lan Zou Xing-Tao Zhou Xiao-Peng Ma |
| author_sort | Yue Zhao |
| collection | DOAJ |
| description | Introduction Dry eye (DE) is a multifactorial ocular surface disease causing considerable medical, social and financial implications. Currently, there is no recognised long-term, effective treatment to alleviate DE. Clinical evidence shows that electroacupuncture (EA) can improve DE symptoms, tear secretion and tear film stability, but it remains controversial whether it is just a placebo effect. We aim to provide solid clinical evidence for the EA treatment of DE.Methods and analysis This is a multicentre, randomised, sham-controlled trial. A total of 168 patients with DE will be enrolled and randomly assigned to EA or sham EA groups to receive 4-week consecutive treatments and follow-up for 24 weeks. The primary outcome is the change in the non-invasive tear break-up time (NIBUT) from baseline to week 4. The secondary outcomes include tear meniscus height, the Schirmer I test, corneal and conjunctival sensation, the ocular surface disease index, corneal fluorescein staining, the numerical rating scale and the Chinese DE-related quality of life scale.Ethics and dissemination The trial protocol and informed consent were approved by the Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine (identifier: 2021–119), Shanghai Eye Disease Prevention and Treatment Center (identifier: 2022SQ003) and Eye and ENT Hospital of Fudan University (identifier: 2022014).Trial registration number NCT05552820. |
| format | Article |
| id | doaj-art-afb9874637274ef2a1edb4e4ace6b256 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2023-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-afb9874637274ef2a1edb4e4ace6b2562025-02-11T12:45:16ZengBMJ Publishing GroupBMJ Open2044-60552023-12-01131210.1136/bmjopen-2022-069369Electroacupuncture for mild-to-moderate dry eye: study protocol for a multicentre, randomised, single-blind, sham-controlled trialYue Zhao0Guang Yang1Yun-Qiong Lu2Mei-Yan Li3Jue Hong4Yan-Ting Yang5Xue-Jun Wang6Xie-He Kong7Zhao Ma8Xin-Yun Huang9Yue-Lan Zou10Xing-Tao Zhou11Xiao-Peng Ma121Bristol Myers Squibb, Princeton, NJ, USADepartment of Clinical Laboratory, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, ChinaYueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, ChinaEye and ENT Hospital of Fudan University, Shanghai, ChinaShanghai Research Institute of Acupuncture and Meridian, Shanghai, ChinaShanghai Research Institute of Acupuncture and Meridian, Shanghai, ChinaEye and ENT Hospital of Fudan University, Shanghai, ChinaShanghai Research Institute of Acupuncture and Meridian, Shanghai, ChinaDepartment of Cardiology, Beijing Anzhen Hospital, Capital Medical University, 2 Anzhen Road, Chaoyang District, Beijing, ChinaYueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, ChinaShanghai Eye Disease Prevention and Treatment Center, Shanghai, ChinaEye and ENT Hospital of Fudan University, Shanghai, ChinaYueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, ChinaIntroduction Dry eye (DE) is a multifactorial ocular surface disease causing considerable medical, social and financial implications. Currently, there is no recognised long-term, effective treatment to alleviate DE. Clinical evidence shows that electroacupuncture (EA) can improve DE symptoms, tear secretion and tear film stability, but it remains controversial whether it is just a placebo effect. We aim to provide solid clinical evidence for the EA treatment of DE.Methods and analysis This is a multicentre, randomised, sham-controlled trial. A total of 168 patients with DE will be enrolled and randomly assigned to EA or sham EA groups to receive 4-week consecutive treatments and follow-up for 24 weeks. The primary outcome is the change in the non-invasive tear break-up time (NIBUT) from baseline to week 4. The secondary outcomes include tear meniscus height, the Schirmer I test, corneal and conjunctival sensation, the ocular surface disease index, corneal fluorescein staining, the numerical rating scale and the Chinese DE-related quality of life scale.Ethics and dissemination The trial protocol and informed consent were approved by the Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine (identifier: 2021–119), Shanghai Eye Disease Prevention and Treatment Center (identifier: 2022SQ003) and Eye and ENT Hospital of Fudan University (identifier: 2022014).Trial registration number NCT05552820.https://bmjopen.bmj.com/content/13/12/e069369.full |
| spellingShingle | Yue Zhao Guang Yang Yun-Qiong Lu Mei-Yan Li Jue Hong Yan-Ting Yang Xue-Jun Wang Xie-He Kong Zhao Ma Xin-Yun Huang Yue-Lan Zou Xing-Tao Zhou Xiao-Peng Ma Electroacupuncture for mild-to-moderate dry eye: study protocol for a multicentre, randomised, single-blind, sham-controlled trial BMJ Open |
| title | Electroacupuncture for mild-to-moderate dry eye: study protocol for a multicentre, randomised, single-blind, sham-controlled trial |
| title_full | Electroacupuncture for mild-to-moderate dry eye: study protocol for a multicentre, randomised, single-blind, sham-controlled trial |
| title_fullStr | Electroacupuncture for mild-to-moderate dry eye: study protocol for a multicentre, randomised, single-blind, sham-controlled trial |
| title_full_unstemmed | Electroacupuncture for mild-to-moderate dry eye: study protocol for a multicentre, randomised, single-blind, sham-controlled trial |
| title_short | Electroacupuncture for mild-to-moderate dry eye: study protocol for a multicentre, randomised, single-blind, sham-controlled trial |
| title_sort | electroacupuncture for mild to moderate dry eye study protocol for a multicentre randomised single blind sham controlled trial |
| url | https://bmjopen.bmj.com/content/13/12/e069369.full |
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