Abstract
BackgroundAcupuncture, as an important component of traditional Chinese medicine (TCM), has been widely applied in the treatment of chronic insomnia in China, while there is no clinical study related to its therapeutic mechanism.Methods/designA single-center, single-blind, randomized, placebo-controlled trial will be conducted at Jiangsu Hospital of Traditional Chinese Medicine. A total of 60 patients will be registered. Eligible participants will be randomly divided into acupuncture group and sham acupuncture group (n = 30 cases in each group). Patients in both groups will be treated once every other day, three times per week for 4 weeks. The primary outcome measures are Pittsburgh Sleep Quality Index (PSQI) and concentrations of adrenocorticotropic hormone (ATCH), corticotrophin-releasing hormone (CRH), and cortisol (CORT). Secondary outcome measures are Insomnia Severity Index (ISI) and Fatigue Severity Scale (FSS).DiscussionThis study aims to evaluate the therapeutic effects of acupuncture on chronic insomnia by using PSQI, ISI, and FSS. The mechanism of acupuncture on CIPs will be preliminarily discussed by analyzing the changes in concentrations of CRH, ACTH, and CORT before and after treatment.Trial registrationChinese Clinical Trials Register, ChiCTR1800020298.
Highlights
Acupuncture, as an important component of traditional Chinese medicine (TCM), has been widely applied in the treatment of chronic insomnia in China, while there is no clinical study related to its therapeutic mechanism
This study aims to evaluate the therapeutic effects of acupuncture on chronic insomnia by using Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), and Fatigue Severity Scale (FSS)
The mechanism of acupuncture on chronic insomnia patients (CIPs) will be preliminarily discussed by analyzing the changes in concentrations of corticotrophin-releasing hormone (CRH), Adrenocorticotropic hormone (ACTH), and CORT before and after treatment
Summary
Acupuncture, as an important component of traditional Chinese medicine (TCM), has been widely applied in the treatment of chronic insomnia in China, while there is no clinical study related to its therapeutic mechanism. Insomnia is a condition of unsatisfactory sleep quality and is associated with daytime functional impairment [1, 2]. 6–10% of patients meet the diagnostic criteria for insomnia [3]. Chronic insomnia is a severe sleep disorder. Due to concerns related to dependence and side effects, chronic insomnia patients (CIPs) are often eager to choose non-pharmacological treatments [20, 21]. Cognitive behavioral therapy (CBT) as a psychotherapeutic treatment for insomnia has been proven to be effective [2]. Due to lack of professionals and expensive treatments, Liu et al Trials (2019) 20:810 CBT isn’t highly beneficial for the majority of patients [22]
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