Background: Insomnia is a common but frequently overlooked sleep disorder after stroke, and there are limited effective therapies for insomnia following stroke. Traditional Chinese medicine (TCM), including acupuncture and the Chinese herbal medication (CHM) Suanzaoren decoction (SZRD), has been reported as an alternative option for insomnia relief after stroke in China for thousands of years. Here, this study aims to investigate the efficacy and safety of electroacupuncture (EA) in combination with SZRD in the treatment of insomnia following stroke.
Methods: A total of 240 patients with post-stroke insomnia will be included and randomized into four groups: the EA group, SZRD group, EA & SZRD group, and sham group. The same acupoints (GV20, GV24, HT7, and SP6) will be used in the EA group, EA & SZRD group, and sham group, and these patients will receive the EA treatment or sham manipulation every other day for 4 consecutive weeks. SZRD treatments will be given to participants in the SZRD group and EA & SZRD group twice a day for 4 consecutive weeks. The primary outcome measures include Pittsburgh Sleep Quality Index scores and polysomnography. Secondary outcome measures include the Insomnia Severity Index, the National Institutes of Health Stroke Scale, the Hospital Anxiety and Depression Scale, brain magnetic resonance imaging, functional magnetic resonance imaging, and nocturnal melatonin concentrations. The primary and secondary outcomes will be assessed at baseline (before treatment), during the 2nd and 4th weeks of the intervention, and at the 8th and 12th weeks of follow-up. Safety assessments will be evaluated at baseline and during the 4th week of the intervention.
Discussion: This study will contribute to assessing whether the combination of these two therapies is more beneficial for post-stroke insomnia than their independent use, and the results of this clinical trial will improve our understanding of the possible mechanisms underlying the effects of combination therapies.
Trial Registration: Chinese Clinical Trials Register ChiCTR2000031413 . Registered on March 30, 2020.
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http://dx.doi.org/10.1186/s13063-021-05399-y | DOI Listing |
Medicine (Baltimore)
October 2023
Department of Clinical Psychology, Hangzhou Hospital of Traditional Chinese Medicine, Hangzhou, China.
Background: Cognitive impairment and insomnia are common complications for stroke patients, and often coexist without effective therapy. Modified Suanzaoren decoction (M-SZRD), derived from a famous classic prescription, has been used as an alternative treatment for these patients. The objective of this study is to investigate the effectiveness of M-SZRD in treating post-stroke cognitive impairment with comorbid insomnia symptoms.
View Article and Find Full Text PDFZhongguo Zhong Yao Za Zhi
December 2022
School of Traditional Chinese Materia Medica, Shanxi University of Chinese Medicine Taiyuan 030619,China.
To explore the mechanism of Suanzaoren Decoction(SZRD) in improving the insomnia rat model induced by DL-4-chlorophenylalanine(PCPA). The insomnia model was established by single intraperitoneal injection with PCPA(400 mg·kg~(-1)), UPLC-Q-TOF-MS/MS was used to analyze the profile of metabolites in rat hippocampus samples, combined with multivariate statistical analysis and screening of differential metabolites, and related metabolic pathways were constructed with MetaboAnalyst 5.0.
View Article and Find Full Text PDFEur Rev Med Pharmacol Sci
November 2022
Department of First College of Clinical Medicine, Shandong University of Traditional Chinese Medicine, Jinan, Shandong Province, China.
Objective: Suanzaoren decoction (SZRD) in Traditional Chinese Medicine is a common prescription for chronic insomnia. This study systematically and accurately evaluated the safety and efficacy of SZRD in the treatment of chronic insomnia, thus providing a reference for its clinical application.
Materials And Methods: From the establishment of the corresponding database until May 2022, we systematically queried EMbase, PubMed, Cochrane Library, Web of Science, CNKI, VIP, and Wanfang Database.
Trials
July 2021
College of Traditional Chinese Medicine, China Three Gorges University & Yichang Hospital of Traditional Chinese Medicine, Yichang, 443003, Hubei, China.
Background: Insomnia is a common but frequently overlooked sleep disorder after stroke, and there are limited effective therapies for insomnia following stroke. Traditional Chinese medicine (TCM), including acupuncture and the Chinese herbal medication (CHM) Suanzaoren decoction (SZRD), has been reported as an alternative option for insomnia relief after stroke in China for thousands of years. Here, this study aims to investigate the efficacy and safety of electroacupuncture (EA) in combination with SZRD in the treatment of insomnia following stroke.
View Article and Find Full Text PDFChin Med
January 2021
School of Basic Medicine, Hubei University of Chinese Medicine, Wuhan, 430065, Hubei, China.
Background: Suan-Zao-Ren Decoction (SZRD) has been widely used to treat neurological illnesses, including dementia, insomnia and depression. However, the mechanisms underlying SZRD's improvement in cognitive function remain unclear. In this study, we examined SZRD's effect on APP/PS1 transgenic mice and mechanisms associated with SZRD's action in alleviating neuroinflammation and improving synaptic plasticity.
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