Efficacy and safety of Tongdutiaoshen acupuncture on insomnia in maintenance hemodialysis patients: A randomized clinical trial protocol
Background: Patients undergoing maintenance hemodialysis (MHD) experience insomnia frequently. Poor sleep quality impairs the quality of life and adversely affects long-term outcomes. Currently, the treatment of insomnia in patients undergoing MHD is mainly based on medication, although it has sever...
| Main Authors: | , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2023-10-01
|
| Series: | Contemporary Clinical Trials Communications |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865423001424 |
| _version_ | 1827819131525660672 |
|---|---|
| author | Pei Wang Zheng Wang Zhong-xin Li Si-hui Ma Yan Li Huan Li Chao Yang Man Yu Jiao Wang Yan-chen An Min Li |
| author_facet | Pei Wang Zheng Wang Zhong-xin Li Si-hui Ma Yan Li Huan Li Chao Yang Man Yu Jiao Wang Yan-chen An Min Li |
| author_sort | Pei Wang |
| collection | DOAJ |
| description | Background: Patients undergoing maintenance hemodialysis (MHD) experience insomnia frequently. Poor sleep quality impairs the quality of life and adversely affects long-term outcomes. Currently, the treatment of insomnia in patients undergoing MHD is mainly based on medication, although it has severe side effects and poor compliance in patients. Therefore, developing complementary and alternative therapies with higher efficacies is important. This study explores the clinical efficacy and safety of Tongdutiaoshen acupuncture in treating insomnia in patients with MHD. Methods: This randomized controlled trial (RCT) will be performed at Beijing Luhe Hospital, affiliated with Capital Medical University in China. We will strictly adhere to the Standards for Reporting Interventions in Clinical Trials of Acupuncture (2010). A total of 110 MHD patients with insomnia will be randomly allocated in a 1:1 ratio to the drug control (DC) or Tongdutiaoshen acupuncture (TA) group. Patients in the control group will be administered estazolam tablets (1 mg/day) for four weeks, followed by a 4-week follow-up period. Based on the background therapy provided for the DC group, the TA group will be administered the interventional cohort three times a week for four weeks in a row, followed by a 4-week follow-up period. The primary endpoints will include the Pittsburgh Sleep Quality Index (PSQI), Hamilton Anxiety Scale (HAM-A), TCM Insomnia Syndrome Score, and clinical response rate, which will be evaluated on days 0, 14, 28, and 56. Secondary endpoints will include sleep data monitoring and related laboratory indices, which will be evaluated on days 0, 28, and 56, respectively. Discussion: This study is designed based on a rigorous methodology to evaluate the efficacy and safety of Tongdutiaoshen acupuncture for insomnia in patients undergoing hemodialysis. The findings of this trial will be published in peer-reviewed journals as reliable evidence. Trial registration: Chinese Clinical Trial Registry ChiCTR2200061967. Registered on July 07, 2022. |
| first_indexed | 2024-03-12T01:09:46Z |
| format | Article |
| id | doaj.art-5ea3324729f14cdbbecfeafcbf16cb86 |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-03-12T01:09:46Z |
| publishDate | 2023-10-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-5ea3324729f14cdbbecfeafcbf16cb862023-09-14T04:54:34ZengElsevierContemporary Clinical Trials Communications2451-86542023-10-0135101196Efficacy and safety of Tongdutiaoshen acupuncture on insomnia in maintenance hemodialysis patients: A randomized clinical trial protocolPei Wang0Zheng Wang1Zhong-xin Li2Si-hui Ma3Yan Li4Huan Li5Chao Yang6Man Yu7Jiao Wang8Yan-chen An9Min Li10Center of Traditional Chinese Medicine, Beijing Luhe Hospital Affiliated to Capital Medical University, No.82, Xinhua South Street, Tongzhou Distract, Beijing, 101149, ChinaCenter of Traditional Chinese Medicine, Beijing Luhe Hospital Affiliated to Capital Medical University, No.82, Xinhua South Street, Tongzhou Distract, Beijing, 101149, ChinaKidney Center, Beijing Luhe Hospital Affiliated to Capital Medical University, No.82, Xinhua South Street, Tongzhou Distract, Beijing, 101149, ChinaKidney Center, Beijing Luhe Hospital Affiliated to Capital Medical University, No.82, Xinhua South Street, Tongzhou Distract, Beijing, 101149, ChinaKidney Center, Beijing Luhe Hospital Affiliated to Capital Medical University, No.82, Xinhua South Street, Tongzhou Distract, Beijing, 101149, ChinaDepartment of Psychiatry, Beijing Luhe Hospital Affiliated to Capital Medical University, No.82, Xinhua South Street, Tongzhou Distract, Beijing, 101149, ChinaDepartment of Psychiatry, Beijing Luhe Hospital Affiliated to Capital Medical University, No.82, Xinhua South Street, Tongzhou Distract, Beijing, 101149, ChinaCenter of Traditional Chinese Medicine, Beijing Luhe Hospital Affiliated to Capital Medical University, No.82, Xinhua South Street, Tongzhou Distract, Beijing, 101149, ChinaCenter of Traditional Chinese Medicine, Beijing Luhe Hospital Affiliated to Capital Medical University, No.82, Xinhua South Street, Tongzhou Distract, Beijing, 101149, ChinaCenter of Traditional Chinese Medicine, Beijing Luhe Hospital Affiliated to Capital Medical University, No.82, Xinhua South Street, Tongzhou Distract, Beijing, 101149, ChinaCenter of Traditional Chinese Medicine, Beijing Luhe Hospital Affiliated to Capital Medical University, No.82, Xinhua South Street, Tongzhou Distract, Beijing, 101149, China; Corresponding author.Background: Patients undergoing maintenance hemodialysis (MHD) experience insomnia frequently. Poor sleep quality impairs the quality of life and adversely affects long-term outcomes. Currently, the treatment of insomnia in patients undergoing MHD is mainly based on medication, although it has severe side effects and poor compliance in patients. Therefore, developing complementary and alternative therapies with higher efficacies is important. This study explores the clinical efficacy and safety of Tongdutiaoshen acupuncture in treating insomnia in patients with MHD. Methods: This randomized controlled trial (RCT) will be performed at Beijing Luhe Hospital, affiliated with Capital Medical University in China. We will strictly adhere to the Standards for Reporting Interventions in Clinical Trials of Acupuncture (2010). A total of 110 MHD patients with insomnia will be randomly allocated in a 1:1 ratio to the drug control (DC) or Tongdutiaoshen acupuncture (TA) group. Patients in the control group will be administered estazolam tablets (1 mg/day) for four weeks, followed by a 4-week follow-up period. Based on the background therapy provided for the DC group, the TA group will be administered the interventional cohort three times a week for four weeks in a row, followed by a 4-week follow-up period. The primary endpoints will include the Pittsburgh Sleep Quality Index (PSQI), Hamilton Anxiety Scale (HAM-A), TCM Insomnia Syndrome Score, and clinical response rate, which will be evaluated on days 0, 14, 28, and 56. Secondary endpoints will include sleep data monitoring and related laboratory indices, which will be evaluated on days 0, 28, and 56, respectively. Discussion: This study is designed based on a rigorous methodology to evaluate the efficacy and safety of Tongdutiaoshen acupuncture for insomnia in patients undergoing hemodialysis. The findings of this trial will be published in peer-reviewed journals as reliable evidence. Trial registration: Chinese Clinical Trial Registry ChiCTR2200061967. Registered on July 07, 2022.http://www.sciencedirect.com/science/article/pii/S2451865423001424InsomniaSleep disorderMaintenance hemodialysisAcupunctureSleep monitoring |
| spellingShingle | Pei Wang Zheng Wang Zhong-xin Li Si-hui Ma Yan Li Huan Li Chao Yang Man Yu Jiao Wang Yan-chen An Min Li Efficacy and safety of Tongdutiaoshen acupuncture on insomnia in maintenance hemodialysis patients: A randomized clinical trial protocol Contemporary Clinical Trials Communications Insomnia Sleep disorder Maintenance hemodialysis Acupuncture Sleep monitoring |
| title | Efficacy and safety of Tongdutiaoshen acupuncture on insomnia in maintenance hemodialysis patients: A randomized clinical trial protocol |
| title_full | Efficacy and safety of Tongdutiaoshen acupuncture on insomnia in maintenance hemodialysis patients: A randomized clinical trial protocol |
| title_fullStr | Efficacy and safety of Tongdutiaoshen acupuncture on insomnia in maintenance hemodialysis patients: A randomized clinical trial protocol |
| title_full_unstemmed | Efficacy and safety of Tongdutiaoshen acupuncture on insomnia in maintenance hemodialysis patients: A randomized clinical trial protocol |
| title_short | Efficacy and safety of Tongdutiaoshen acupuncture on insomnia in maintenance hemodialysis patients: A randomized clinical trial protocol |
| title_sort | efficacy and safety of tongdutiaoshen acupuncture on insomnia in maintenance hemodialysis patients a randomized clinical trial protocol |
| topic | Insomnia Sleep disorder Maintenance hemodialysis Acupuncture Sleep monitoring |
| url | http://www.sciencedirect.com/science/article/pii/S2451865423001424 |
| work_keys_str_mv | AT peiwang efficacyandsafetyoftongdutiaoshenacupunctureoninsomniainmaintenancehemodialysispatientsarandomizedclinicaltrialprotocol AT zhengwang efficacyandsafetyoftongdutiaoshenacupunctureoninsomniainmaintenancehemodialysispatientsarandomizedclinicaltrialprotocol AT zhongxinli efficacyandsafetyoftongdutiaoshenacupunctureoninsomniainmaintenancehemodialysispatientsarandomizedclinicaltrialprotocol AT sihuima efficacyandsafetyoftongdutiaoshenacupunctureoninsomniainmaintenancehemodialysispatientsarandomizedclinicaltrialprotocol AT yanli efficacyandsafetyoftongdutiaoshenacupunctureoninsomniainmaintenancehemodialysispatientsarandomizedclinicaltrialprotocol AT huanli efficacyandsafetyoftongdutiaoshenacupunctureoninsomniainmaintenancehemodialysispatientsarandomizedclinicaltrialprotocol AT chaoyang efficacyandsafetyoftongdutiaoshenacupunctureoninsomniainmaintenancehemodialysispatientsarandomizedclinicaltrialprotocol AT manyu efficacyandsafetyoftongdutiaoshenacupunctureoninsomniainmaintenancehemodialysispatientsarandomizedclinicaltrialprotocol AT jiaowang efficacyandsafetyoftongdutiaoshenacupunctureoninsomniainmaintenancehemodialysispatientsarandomizedclinicaltrialprotocol AT yanchenan efficacyandsafetyoftongdutiaoshenacupunctureoninsomniainmaintenancehemodialysispatientsarandomizedclinicaltrialprotocol AT minli efficacyandsafetyoftongdutiaoshenacupunctureoninsomniainmaintenancehemodialysispatientsarandomizedclinicaltrialprotocol |