Scheme optimization of acupoints compatibility and influence factors of the effect. Issue 50 (17th December 2021)

• Record Type: Journal Article
• Authors: Ha, Lijuan; Liu, Xiaona; Liu, Yanze; Zhi, Mujun; Jiang, Hailin; Zhao, Jingying; Wang, Yiming; Xu, Xiaoru; Guo, Le; Cao, Jiazhen; Chen, Liyuan; Yuan, Yue; Li, Tie; Wang, Fuchun
• Is Part Of: Medicine. Volume 100:Issue 50(2021)
• Page Start: e27883
• Publication Date: 2021-12-17
• Subjects: Acupuncture -- Primary insomnia -- RCT; Medicine -- Periodicals; Medicine -- Periodicals; Médecine -- Périodiques; Geneeskunde; Medicine; Periodicals; Periodicals; 610.5
• DOI: 10.1097/MD.0000000000027883
• Languages: English
• ISSNs: 0025-7974

Abstract

Abstract: Background: Acupuncture may be a clinically effective treatment for insomnia. We will perform a multicenter, large-scale, single-blinded, randomized controlled trial to compare the differences in the clinical efficacy between the use of singleacupoints and compatibilityacupoints in the treatment of primary insomnia. Methods/Design: A total of 333 participants will be randomly assigned to 2 acupoint treatment groups or 1 nonacupoint control group in a 1:1:1 ratio by a central stochastic system. The acupuncture groups are: the single acupoint group: Shenmen (HT7); and he compatibility acupoint group: Shenmen (HT7), Baihui (DU20), and Sanyinjiao (SP6). The observation period of this trial will be 10 weeks. All patients will be followed for 1 week before randomization (baseline phase). After randomization, the patients will receive 30 minutes of electro-acupuncture once per day for 5 weeks. In the fourth week after the treatment, follow-up will be performed once. The primary outcome will be the Pittsburgh sleep quality index score at 1 week before randomization and 2 and 8 weeks after randomization. The secondary outcomes will include data from sleep diaries, Athens insomnia scale scores, ShortForm-36 Health Survey scores, electroencephalogram technology results and polysomnogram) results. Patients will be required to complete a sleep diary every day during the treatment period. Patients will also undergo electroencephalogram technology and polysomnogram 1 week before randomization and 5 weeks after randomization. The other secondary outcomes will be measured 1 week before randomization and 5 and 9 weeks after randomization. Discussion: This trial will be helpful in identifying whether acupuncture at compatibility acupoints is more effective than acupuncture at single acupoints. Trial registration: Clinical Trials.govNCT02448602, Registered 5May 2015, https://www.clinicaltrials.gov/ct2/show/NCT02448602?term=NCT02448602&rank=1