scholarly journals Effects of Integrative Medicine on The Post-Stroke Cognitive Impairment (PSCI) Patients: A Study Protocol for A Randomized Multicentric Controlled Trial

Author(s):  
Xinyun Li ◽  
Kelin He ◽  
Lei Wu ◽  
Weijun Zheng ◽  
Kaitao Luo ◽  
...  

Abstract Background Due to limitation of rehabilitation in cognitive impairment after stroke, as the main parts of traditional Chinese medicine, acupuncture and herbs have their advantage effect in clinical practice for post-stroke cognitive impairment (PSCI). Therefore, forming a standardized and propagable TCM project of PSCI becomes necessary. This trail will solve the above problem. Methods In total, 126 stroke patients will be recruited from the inpatient and outpatient departments of The Third Affiliated Hospital of Zhejiang Chinese Medical University (Hangzhou, China), Jiaxing Hospital of Traditional Chinese Medicine and Hangzhou Hospital of Traditional Chinese Medicine to participate in this study with randomization. All participants will continue to receive basic treatment and cognitive function regular training, while successive 12 weeks of acupuncture and herbs will be provided to patients assigned to the integrative medicine group. Montreal cognitive assessment (MOCA), mini-mental state examination, activity of daily living (ADL) score, hamilton depression scale (HAMD), functional near-infrared spectroscopy (fNIRS) and RESTing-state functional MRI (RS-fmri) will be used to measure the outcomes. Discussion This trial may provide high-quality RCT evidence regarding the clinical effectiveness and safety of acupuncture and herbs for PSCI patient. Trial registration: ClinicalTrials.gov (ID: NCT 04596072)

Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Zhe Xue ◽  
Zhen Huang ◽  
Shu-li Cheng ◽  
Xi-hong Wang ◽  
Xuan Zhou ◽  
...  

Abstract Background Depression is one of the most frequent and severe psychiatric conditions. Many chemical drugs to treat depression are associated with adverse reactions and have shortcomings. Traditional Chinese medicine is of great significance in the prevention and treatment of depression. Xiaoyao pills has achieved good results in clinical application, which has the advantages of quick effect and no obvious adverse reactions. The aim of our study is to evaluate the efficacy and safety of Xiaoyao pills on mild to moderate depression patients. Methods This study is a multi-centre, double-blinded, randomized and placebo-controlled clinical trial. A total of 108 participants are assigned to three groups: Xiaoyao pill group taking Xiaoyao pills twice daily for 4 weeks, placebo group taking placebos twice daily for 4 weeks and normal group without taking any drug. The primary and secondary outcome measures are the Hamilton Depression Scale (HAMD) and Traditional Chinese Medicine (TCM) Syndrome Scale. The assessment is at baseline (before treatment initiation), 1 week, 2 weeks 4 weeks after the first treatment. Exploratory outcome is also assessed to explore the mechanism of Xiaoyao pills at baseline and 4 weeks. Discussion The results from this study will provide clinical evidence on the efficacy and safety of Xiaoyao pills in patients with mild to moderate depression with syndrome of liver stagnation and spleen deficiency. Trial registration ClinicalTrials.gov ISRCTN12746343. Registered on September 25, 2020.


QJM ◽  
2019 ◽  
Vol 112 (6) ◽  
pp. 437-442 ◽  
Author(s):  
C -C Shih ◽  
C -C Yeh ◽  
J -L Yang ◽  
H -L Lane ◽  
C -J Huang ◽  
...  

2009 ◽  
Vol 37 (02) ◽  
pp. 207-213 ◽  
Author(s):  
Hui Zhao ◽  
Xia Wan ◽  
Jia-Xu Chen

To systematically evaluate the effectiveness of Chinese herbal medicine for treating depression in China, the electronic medical database from China National Knowledge Infrastructure (CNKI) was searched using Chinese and the date is set, from 1st January 1994 to 1st August 2008. The 18 studies that met the entry criteria along with 1,260 randomized patients were included in this review. All studies with words like "randomization" or "quasi-randomization" in their abstracts were included, whether they used blinding or not. The results showed that the Chinese medicine treated group did not decrease the scores of the self-rating depression scale (-1.02, 95% CI -2.16 ~ 0.12, p = 0.08) and the scores of the Hamilton depression scale (-0.45, 95% CI -0.98 ~ 0.08, p = 0.10). The results showed there is no evidence to support that traditional Chinese medicine for depression has improved, which may be due to the low quality in all the trials. Therefore, more qualified, randomized controlled clinical trials are warranted to assure its efficacy.


2016 ◽  
Vol 40 (3-4) ◽  
pp. 420-430 ◽  
Author(s):  
Ling Zhang ◽  
Rubo Sui ◽  
Lei Zhang ◽  
Zhuang Zhang

Background: To study morphological and metabolic changes of cerebellum with multimodality magnetic resonance imaging (MRI) and proton magnetic resonance spectroscopy (1H-MRS), respective, to explore correlation between cerebellum alteration and severity of depression in patients with post-stroke depression. Methods: 60 subjects, including 40 stroke patients and 20 healthy volunteers were enrolled. Depression of stroke patients was tested by Self-rating Depression Scale (SDS) and Hamilton Depression Scale (HAMD), based on which stroke-patients were grouped into post-stroke depression (PSD group) and without post-stroke depression (CONT group). Results: Volume of cerebellum decreased in PSD group and CONT group compared with healthy volunteer (NORM) group. White matter of cerebellum in PSD group and CONT group was disrupted; such disruption was significantly in PSD group. In addition, there was correlation between cerebellum volume and FA and HDRS scores (P<00.01). The Cho/Cr and Cho/NAA ratios in cerebellum contralateral to stroke lesion in PSD were higher than those in NORM group (P<0.05). Cho/Cr and Cho/NAA ratios in contralateral cerebellum and ratio difference of Cho/Cr in bilateral cerebellum were positively correlated with HAMD scales (P<0.05). Conclusion: Morphologic and metabolic alterations are evident in patients with post-stroke depression, indicating possible involvement of cerebellum in post-stroke-depression occurrence.


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