The blinding status and characteristics in acupuncture clinical trials: a systematic reviews and meta-analysis
Abstract Background Sham acupuncture is a widely accepted control in acupuncture clinical trials. Given the nature of acupuncture, it is warranted to assess the blinding of sham-controlled trials. Despite the sham acupuncture design having been widely used, the overall blinding of sham acupuncture a...
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BMC
2024-12-01
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| Series: | Systematic Reviews |
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| Online Access: | https://doi.org/10.1186/s13643-024-02692-0 |
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| author | Tinglan Liu Lijiao Jiang Shuangjing Li Shuyang Cheng Rong Zhuang Zhiyi Xiong Chongyang Sun Baoyan Liu Haoran Zhang Shiyan Yan |
| author_facet | Tinglan Liu Lijiao Jiang Shuangjing Li Shuyang Cheng Rong Zhuang Zhiyi Xiong Chongyang Sun Baoyan Liu Haoran Zhang Shiyan Yan |
| author_sort | Tinglan Liu |
| collection | DOAJ |
| description | Abstract Background Sham acupuncture is a widely accepted control in acupuncture clinical trials. Given the nature of acupuncture, it is warranted to assess the blinding of sham-controlled trials. Despite the sham acupuncture design having been widely used, the overall blinding of sham acupuncture and the characteristics of blinding assessment in acupuncture trials are unclear. This research aims to assess the blinding status of acupuncture clinical trials and explore the blinding assessment characteristics in acupuncture trials. Methods This meta-analysis included all the acupuncture clinical trials published in English that performed blinding assessments and reported the results. We searched PubMed, Embase, and Web of Science for randomized controlled trials (RCTs) from inception to April 2024. The primary outcome is Bang’s Blinding Index (Bang’s BI) and 95% credibility interval (CrI) was pooled using a Bayesian hierarchical model. The study adheres to the PRISMA guidelines. Results Sixty-four eligible studies published from 1999 to 2024 were included. The mean of Bang’s BI was − 0.24 (95% CrI − 0.34 to − 0.14, tau2 = 0.13) for the sham acupuncture group and 0.41 (95% CrI 0.32 to 0.49, tau2 = 0.10) for the verum acupuncture group. The characteristics of blinding showed that 62.50% of the trials had a Bang’s BI greater than 0 in the verum group and less than 0 in the sham group; in 28.15% of the trials, the Bang’s BI was greater than 0 in the verum group and greater than 0 in the sham group. Subgroup analysis revealed that area, number of research centers, treatment sessions, acupoints number, and evaluation timepoint can influence blinding results. Conclusion Overall blinding status in current acupuncture clinical trials shows a majority correctly guessing for the verum group and opposite guessing for the sham group. However, in some acupuncture trials, the blinding of sham acupuncture might be compromised. Factors such as the Asian population, penetrating sham needling, and querying participants about their group assignment during the study increase the risk of unblinding and warrant careful consideration in sham acupuncture control design. Furthermore, researchers should closely monitor the blinding status of sham acupuncture and transparently report details of blinding assessments. Systematic review registration PROSPERO CRD42023403595. |
| format | Article |
| id | doaj-art-1b31d3c2c0b841b1a9919f8dbaaf9af4 |
| institution | OA Journals |
| issn | 2046-4053 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | BMC |
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| series | Systematic Reviews |
| spelling | doaj-art-1b31d3c2c0b841b1a9919f8dbaaf9af42025-08-20T02:20:41ZengBMCSystematic Reviews2046-40532024-12-0113111410.1186/s13643-024-02692-0The blinding status and characteristics in acupuncture clinical trials: a systematic reviews and meta-analysisTinglan Liu0Lijiao Jiang1Shuangjing Li2Shuyang Cheng3Rong Zhuang4Zhiyi Xiong5Chongyang Sun6Baoyan Liu7Haoran Zhang8Shiyan Yan9School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineThe Fourth Clinical Medical College, Guangzhou University of Chinese MedicineSchool of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineSchool of Mathematical Sciences, Capital Normal UniversitySchool of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineSchool of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineSchool of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineInstitute of Basic Research in Clinical Medicine, China, Academy of Chinese Medical SciencesCollege of Preschool Education, Beijing Youth Politics CollegeSchool of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineAbstract Background Sham acupuncture is a widely accepted control in acupuncture clinical trials. Given the nature of acupuncture, it is warranted to assess the blinding of sham-controlled trials. Despite the sham acupuncture design having been widely used, the overall blinding of sham acupuncture and the characteristics of blinding assessment in acupuncture trials are unclear. This research aims to assess the blinding status of acupuncture clinical trials and explore the blinding assessment characteristics in acupuncture trials. Methods This meta-analysis included all the acupuncture clinical trials published in English that performed blinding assessments and reported the results. We searched PubMed, Embase, and Web of Science for randomized controlled trials (RCTs) from inception to April 2024. The primary outcome is Bang’s Blinding Index (Bang’s BI) and 95% credibility interval (CrI) was pooled using a Bayesian hierarchical model. The study adheres to the PRISMA guidelines. Results Sixty-four eligible studies published from 1999 to 2024 were included. The mean of Bang’s BI was − 0.24 (95% CrI − 0.34 to − 0.14, tau2 = 0.13) for the sham acupuncture group and 0.41 (95% CrI 0.32 to 0.49, tau2 = 0.10) for the verum acupuncture group. The characteristics of blinding showed that 62.50% of the trials had a Bang’s BI greater than 0 in the verum group and less than 0 in the sham group; in 28.15% of the trials, the Bang’s BI was greater than 0 in the verum group and greater than 0 in the sham group. Subgroup analysis revealed that area, number of research centers, treatment sessions, acupoints number, and evaluation timepoint can influence blinding results. Conclusion Overall blinding status in current acupuncture clinical trials shows a majority correctly guessing for the verum group and opposite guessing for the sham group. However, in some acupuncture trials, the blinding of sham acupuncture might be compromised. Factors such as the Asian population, penetrating sham needling, and querying participants about their group assignment during the study increase the risk of unblinding and warrant careful consideration in sham acupuncture control design. Furthermore, researchers should closely monitor the blinding status of sham acupuncture and transparently report details of blinding assessments. Systematic review registration PROSPERO CRD42023403595.https://doi.org/10.1186/s13643-024-02692-0Acupuncture clinical trialsBlinding assessmentBang’s Blinding IndexBlinding status |
| spellingShingle | Tinglan Liu Lijiao Jiang Shuangjing Li Shuyang Cheng Rong Zhuang Zhiyi Xiong Chongyang Sun Baoyan Liu Haoran Zhang Shiyan Yan The blinding status and characteristics in acupuncture clinical trials: a systematic reviews and meta-analysis Systematic Reviews Acupuncture clinical trials Blinding assessment Bang’s Blinding Index Blinding status |
| title | The blinding status and characteristics in acupuncture clinical trials: a systematic reviews and meta-analysis |
| title_full | The blinding status and characteristics in acupuncture clinical trials: a systematic reviews and meta-analysis |
| title_fullStr | The blinding status and characteristics in acupuncture clinical trials: a systematic reviews and meta-analysis |
| title_full_unstemmed | The blinding status and characteristics in acupuncture clinical trials: a systematic reviews and meta-analysis |
| title_short | The blinding status and characteristics in acupuncture clinical trials: a systematic reviews and meta-analysis |
| title_sort | blinding status and characteristics in acupuncture clinical trials a systematic reviews and meta analysis |
| topic | Acupuncture clinical trials Blinding assessment Bang’s Blinding Index Blinding status |
| url | https://doi.org/10.1186/s13643-024-02692-0 |
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