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| Analysis of the current status of outcome measures in randomized controlled trials on acupuncture treatment for oculomotor nerve palsy |
| Hits 37 Download times 5 Received:November 22, 2025 |
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| DOI
10.11656/j.issn.1673-9043.2026.04.13 |
| Key Words
oculomotor nerve palsy;acupuncture;randomized controlled trial;outcome indicator;core outcome set |
| Author Name | Affiliation | E-mail | | WANG Bing | Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine, Tianjin 300381, China | | | MENG Yalu | Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine, Tianjin 300381, China | | | WANG Shaokang | Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine, Tianjin 300381, China | | | QU Hui | Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine, Tianjin 300381, China | | | LIU Xin | Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine, Tianjin 300381, China | | | CAO Rui | Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine, Tianjin 300381, China | | | ZHANG Lili | Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine, Tianjin 300381, China | | | DU Yuzheng | Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine, Tianjin 300381, China | drduyuzheng@163.com |
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| Abstract
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| [Objective] Based on literature from the past 20 years，the study analyzes the characteristics of outcome indicators in RCTs evaluating acupuncture for ONP，as well as the existing advantages and limitations，thereby providing a basis for the development of a core outcome set. [Methods] A search was conducted for RCTs related to acupuncture for ONP in databases including PubMed，Cochrane Library，Embase，Web of Science，ClinicalTrials.gov，CNKI，Wanfang Data，VIP，SinoMed，and ChiCTR. The search period was from January 1，2005，to October 1，2025，using a combination of MeSH terms and free-text words. The quality of included studies was assessed using the Cochrane Risk of Bias Tool，and outcome indicators were systematically organized. Two researchers independently screened the literature，extracted study characteristics，and analyzed the outcome indicators of RCTs on acupuncture for ONP. [Results] The initial search yielded 1 379 relevant articles. After multiple rounds of screening，46 articles were finally included，covering a total sample size of 2 785 cases. A total of 32 outcome indicators were used，which were categorized into six types：traditional Chinese medicine syndrome indicators，clinical symptom indicators，clinical efficacy indicators，hemorheological indicators，quality of life indicators，and safety indicators. [Conclusion] The study is the first to comprehensively analyze the outcome indicators of RCTs on acupuncture for ONP. It was found that existing studies have focused on the core symptoms of ONP and explored various acupuncture intervention protocols. Outcome indicators such as palpebral fissure size and diplopia angle have certain clinical rationality. However，several issues remain：insufficient methodological standardization in the literature，unclear prioritization of outcome indicators，non-standardized expression of indicators，lack of clarity regarding their scope of application，advantages and disadvantages，concentrated combined treatment models，insufficient emphasis on the unique characteristics of traditional Chinese medicine and the specific effects of acupuncture，inadequate attention to quality of life，long-term efficacy and economic indicators，and insufficient safety evaluation. Moreover，the differences in therapeutic efficacy for ONP caused by different etiologies have not been fully addressed. It is recommended that researchers，when conducting RCTs，fully draw on existing research，comprehensively understand the outcome indicators for ONP，select scientific and reasonable indicators to evaluate efficacy，establish a standardized and widely recognized core outcome set for acupuncture treatment of ONP，and promote the translation of research findings into high-quality clinical evidence. |
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