Efficacy of acupuncture at three nasal acupoints plus acupoint application for perennial allergic rhinitis: A multicenter, randomized controlled trial protocol
Abstract Background Many studies have shown the potential therapeutic effect of acupuncture on allergic rhinitis. Most of these studies were limited by low-quality evidence. Preliminary experiments showed that the use of acupuncture at three nasal acupoints plus acupoint application (AAP) achieves a...
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BMC
2020-01-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-019-4039-3 |
| _version_ | 1818914180004052992 |
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| author | Yin Shou Li Hu Cuihong Zhang Shifen Xu Qi Jin Li Huang Bingrong Li Long Yuan Siwei Xu Kaiyong Zhang Huiru Jiang Bimeng Zhang |
| author_facet | Yin Shou Li Hu Cuihong Zhang Shifen Xu Qi Jin Li Huang Bingrong Li Long Yuan Siwei Xu Kaiyong Zhang Huiru Jiang Bimeng Zhang |
| author_sort | Yin Shou |
| collection | DOAJ |
| description | Abstract Background Many studies have shown the potential therapeutic effect of acupuncture on allergic rhinitis. Most of these studies were limited by low-quality evidence. Preliminary experiments showed that the use of acupuncture at three nasal acupoints plus acupoint application (AAP) achieves a more persistent effect in the treatment of perennial allergic rhinitis than acupuncture alone. In this study, a multicenter, single-blind, randomized controlled trial will be performed, in which acupuncture at nonmeridian acupoints and sham AAP will be used as the control group to evaluate the effect of AAP through long-term observation. Methods The trial is designed on the basis of the Consolidated Standards of Reporting Trials 2010 guidelines and Standards for Reporting Interventions in Controlled Trials of Acupuncture. A total of 120 participants with perennial allergic rhinitis will be randomly assigned to a treatment or control group. A specially appointed investigator will be in charge of randomization. The participants in the treatment group will be treated with acupuncture at EX-HN3, LI20, and EX-HN8 thrice per week for a total of 12 sessions. In addition, they will undergo AAP at DU14, BL13, EX-BI, and RN22. The participants in the control group will be treated with sham AAP. The primary outcome will be the change in the Total Nasal Symptom Score from baseline to the completion of 4-week treatment. Secondary outcomes include changes in visual analog scale and total non-nasal symptom scores from baseline to the second and fourth weeks of treatment, as well as 1, 3, and 6 months after the completion of treatment. Peripheral blood IL-4, IL-5, IL-6, IL-8, and IL-10 levels will be measured, and any side effects related to treatment will be observed and recorded. Discussion It is expected that this randomized clinical trial will provide evidence to determine the effects of AAP compared with acupuncture at nonmeridian acupoints and sham AAP, particularly the long-term effect. These findings will help improve the clinical application of this technique. Trial registration Acupuncture-Moxibustion Clinical Trial Registry AMCTR-ICR-18000179 . Registered on 12 April 2018. |
| first_indexed | 2024-12-19T23:42:17Z |
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| id | doaj.art-753b9230549443ea8bd70d7be48e8aa2 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-19T23:42:17Z |
| publishDate | 2020-01-01 |
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| spelling | doaj.art-753b9230549443ea8bd70d7be48e8aa22022-12-21T20:01:22ZengBMCTrials1745-62152020-01-0121111110.1186/s13063-019-4039-3Efficacy of acupuncture at three nasal acupoints plus acupoint application for perennial allergic rhinitis: A multicenter, randomized controlled trial protocolYin Shou0Li Hu1Cuihong Zhang2Shifen Xu3Qi Jin4Li Huang5Bingrong Li6Long Yuan7Siwei Xu8Kaiyong Zhang9Huiru Jiang10Bimeng Zhang11Department of Acupuncture and Moxibustion, Shanghai General Hospital, Shanghai Jiaotong University School of MedicineAcumox and Tuina Research Section, College of Acumox and Tuina, Shanghai University of Traditional Chinese MedicineShanghai Research Institute of Acupuncture and MeridiansAcupuncture Department, Shanghai Municipal Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of TCMAcupuncture Department, Shanghai Municipal Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of TCMAcupuncture Department, Shanghai Municipal Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of TCMDepartment of Acupuncture and Moxibustion, Shanghai General Hospital, Shanghai Jiaotong University School of MedicineDepartment of Acupuncture and Moxibustion, Shanghai General Hospital, Shanghai Jiaotong University School of MedicineDepartment of Acupuncture and Moxibustion, Shanghai General Hospital, Shanghai Jiaotong University School of MedicineDepartment of Acupuncture and Moxibustion, Shanghai General Hospital, Shanghai Jiaotong University School of MedicineDepartment of Acupuncture and Moxibustion, Shanghai General Hospital, Shanghai Jiaotong University School of MedicineDepartment of Acupuncture and Moxibustion, Shanghai General Hospital, Shanghai Jiaotong University School of MedicineAbstract Background Many studies have shown the potential therapeutic effect of acupuncture on allergic rhinitis. Most of these studies were limited by low-quality evidence. Preliminary experiments showed that the use of acupuncture at three nasal acupoints plus acupoint application (AAP) achieves a more persistent effect in the treatment of perennial allergic rhinitis than acupuncture alone. In this study, a multicenter, single-blind, randomized controlled trial will be performed, in which acupuncture at nonmeridian acupoints and sham AAP will be used as the control group to evaluate the effect of AAP through long-term observation. Methods The trial is designed on the basis of the Consolidated Standards of Reporting Trials 2010 guidelines and Standards for Reporting Interventions in Controlled Trials of Acupuncture. A total of 120 participants with perennial allergic rhinitis will be randomly assigned to a treatment or control group. A specially appointed investigator will be in charge of randomization. The participants in the treatment group will be treated with acupuncture at EX-HN3, LI20, and EX-HN8 thrice per week for a total of 12 sessions. In addition, they will undergo AAP at DU14, BL13, EX-BI, and RN22. The participants in the control group will be treated with sham AAP. The primary outcome will be the change in the Total Nasal Symptom Score from baseline to the completion of 4-week treatment. Secondary outcomes include changes in visual analog scale and total non-nasal symptom scores from baseline to the second and fourth weeks of treatment, as well as 1, 3, and 6 months after the completion of treatment. Peripheral blood IL-4, IL-5, IL-6, IL-8, and IL-10 levels will be measured, and any side effects related to treatment will be observed and recorded. Discussion It is expected that this randomized clinical trial will provide evidence to determine the effects of AAP compared with acupuncture at nonmeridian acupoints and sham AAP, particularly the long-term effect. These findings will help improve the clinical application of this technique. Trial registration Acupuncture-Moxibustion Clinical Trial Registry AMCTR-ICR-18000179 . Registered on 12 April 2018.https://doi.org/10.1186/s13063-019-4039-3Acupuncture at three nasal acupointsAcupoint applicationPerennial allergic rhinitisRandomized controlled trialVisual Analog Scale |
| spellingShingle | Yin Shou Li Hu Cuihong Zhang Shifen Xu Qi Jin Li Huang Bingrong Li Long Yuan Siwei Xu Kaiyong Zhang Huiru Jiang Bimeng Zhang Efficacy of acupuncture at three nasal acupoints plus acupoint application for perennial allergic rhinitis: A multicenter, randomized controlled trial protocol Trials Acupuncture at three nasal acupoints Acupoint application Perennial allergic rhinitis Randomized controlled trial Visual Analog Scale |
| title | Efficacy of acupuncture at three nasal acupoints plus acupoint application for perennial allergic rhinitis: A multicenter, randomized controlled trial protocol |
| title_full | Efficacy of acupuncture at three nasal acupoints plus acupoint application for perennial allergic rhinitis: A multicenter, randomized controlled trial protocol |
| title_fullStr | Efficacy of acupuncture at three nasal acupoints plus acupoint application for perennial allergic rhinitis: A multicenter, randomized controlled trial protocol |
| title_full_unstemmed | Efficacy of acupuncture at three nasal acupoints plus acupoint application for perennial allergic rhinitis: A multicenter, randomized controlled trial protocol |
| title_short | Efficacy of acupuncture at three nasal acupoints plus acupoint application for perennial allergic rhinitis: A multicenter, randomized controlled trial protocol |
| title_sort | efficacy of acupuncture at three nasal acupoints plus acupoint application for perennial allergic rhinitis a multicenter randomized controlled trial protocol |
| topic | Acupuncture at three nasal acupoints Acupoint application Perennial allergic rhinitis Randomized controlled trial Visual Analog Scale |
| url | https://doi.org/10.1186/s13063-019-4039-3 |
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