Effect of acupuncture with donepezil based on syndrome differentiation on cognitive function in patients with mild-to-moderate Alzheimer's disease: a study protocol for a multicenter randomized controlled trial.

BACKGROUND: There has been a rapid increase in the worldwide prevalence of Alzheimer's disease (AD). Previous studies have shown that acupuncture can improve neurological and cognitive function; however, the utility of applying acupuncture in patients with AD remains unclear. This study protocol describes a clinical trial for evaluating the efficacy and safety of acupuncture based on syndrome differentiation with donepezil hydrochloride on cognitive function in patients with AD. METHODS/DESIGN: This multicenter randomized controlled trial commenced on February 1, 2019, at the Shanghai Longhua Hospital of TCM, Shanghai Huashan Hospital of Fudan University, and Shanghai Mental Health Center, and will conclude on June 30, 2022. The study will recruit 184 patients randomly divided into an acupuncture group or a control group at a 1:1 ratio. All participants will receive donepezil hydrochloride (5 mg/day), and those in the acupuncture group will receive acupuncture based on syndrome differentiation with donepezil for 12 weeks. The primary outcome will be the post-treatment change in the Alzheimer's Disease Assessment Scale-cognition score at 12 weeks. The secondary outcomes will be the efficacy scores of the Minimum Mental State Examination, Alzheimer's Disease Cooperative Research Activity-Daily Life, and Quality of Life-Alzheimer's Disease. All assessments will be performed at baseline, after treatment (week 12), and at follow-up (weeks 24 and 36). DISCUSSION: This trial may provide high-quality evidence for the efficacy of acupuncture in the treatment of AD. The results of this study will be published in peer-reviewed journals. TRIAL REGISTRATION: ClinicalTrials.gov NCT03810794 . Registered on 17 January 2019.

[Electroacupuncture at Siguan points for migraine of liver yang hyperactivity: a randomized controlled trial].

OBJECTIVE: To compare the clinical effect of electroacupuncture at Siguan points and flunarizine hydrochloride capsule on migraine of liver yang hyperactivity. METHODS: A total of 110 patients with migraine of liver yang hyperactivity were randomly divided into an electroacupuncture group (55 cases, 2 cases dropped off) and a western medication group (55 cases, 2 cases dropped off). In the electroacupuncture group, electroacupuncture was applied at Siguan points (Hegu [LI 4] and Taichong [LR 3]), with disperse-dense wave of 2 Hz/100 Hz in frequency and current intensity of 0.1-1 mA, 30 min each time, once a day, 5 times per week for 4 weeks. Flunarizine hydrochloride capsule was given orally in the western medication group, 10 mg a day for 4 weeks. The visual analogue scale (VAS) score and the migraine attack days were observed before and after treatment, during follow-up of 1, 3 and 6 months, and the migraine symptom score was observed before and after treatment in the two groups. RESULTS: After treatment, during follow-up of 1, 3 and 6 months, the VAS scores and the migraine attack days in the two groups were decreased compared with before treatment (ï¼°<0.05), and above indexes in the electroacupuncture group were lower than the western medication group (ï¼°<0.05). After treatment, the migraine symptom scores in the two groups were decreased (ï¼°<0.05), the change in the electroacupuncture group was greater than the western medication group (ï¼°<0.05). CONCLUSION: Electroacupuncture at Siguan points could effectively reduce headache intensity and migraine attack days, relieve migraine symptoms in patients with migraine of liver yang hyperactivity, and the efficacy is superior to oral flunarizine hydrochloride capsules.

Earlier Acupuncture Enhancing Long-Term Effects on Motor Dysfunction in Acute Ischemic Stroke: Retrospective Cohort Study.

Stroke is the leading fatal disease in China. This retrospective study aimed to explore the optimal acupuncture intervention time for long-term efficacy on motor dysfunction in patients suffering from acute ischemic stroke through 1-year of follow-up. Three hundred and nine patients collected at Longhua Hospital from January 2016 to December 2017 were classified into 3 groups based on the acupuncture intervention time, including groups A (within 2 days), B (within 3-7 days) and C (within 8-14 days). All patients had received standard treatment combined with acupuncture therapy. Specifically, acupuncture was performed at the acupoints including LI4 (Hegu), ST40 (Fenglong), DU20 (Baihui), and motor area of the scalp, followed by 2 electroacupuncture protocols based on different muscle tensions once a day for 5 days consecutively. The time-effect relationship was assessed using both the Fugl-Meyer Assessment (FMA) and the modified Barthel index (MBI) on the 90th day and 1st year, respectively. Meanwhile, the modified Rankin scale (mRS), high-sensitivity C-reactive protein (hs-CRP), and fibrinogen (FIB) were also measured during the 1-year follow-up. The favorable outcome rate was 74.4%. One-way univariate analysis of variance (ANOVA) revealed significant differences in FMA and MBI on the 90th day among the 3 groups ([Formula: see text] < 0.05), while no significant differences were observed in FMA, MBI or mRS at the 1st year between groups A and B. The levels of hs-CRP and FIB ([Formula: see text] < 0.05) were markedly reduced. Binary logistic regression analysis suggested that patients with atrial fibrillation (AF) (odds ratio (OR): 3.156), chronic kidney disease (CKD) (OR: 2.563), diabetes mellitus (DM) (OR: 2.174) or stroke history (OR: 1.883) were more inclined to recover poorly from nerve function deficit ([Formula: see text] < 0.05). Earlier acupuncture intervention may have a better long-term effect on motor dysfunction and inflammation during the 1-year follow-up. Moreover, acupuncture within 2 days is probably the optimal treatment time for early recovery on the 90th day.

The Prognostic Value of Traditional Chinese Medicine Symptoms in Acute Ischemic Stroke: A Pilot Study.

BACKGROUND: Stroke scales of traditional Chinese medicine (SSTCM) are promoted for use in the early prognosis. The current lines of evidence to support their performance evaluation are uneven. This pilot study aimed to investigate the correlation between traditional Chinese medicine (TCM) symptoms in the early stages of acute ischemic stroke and the prognosis of motor dysfunction through one-year of follow-up. METHODS: Three hundred and fifteen patients were retrospected at Longhua Hospital from January 2016 to December 2017. All patients had received standard treatments combined with acupuncture therapy, including both electroacupuncture and scalp acupuncture for a median course of five months. The observed outcomes were the Fugl-Meyer assessment (FMA), the modified Barthel index (MBI), and the modified Rankin scale (mRS) at one-year follow-up after stroke onset by multiple linear regression analysis combined with ROC curves. RESULTS: The favorable outcome rate was 74.3%, with the recurrence rate of 20.3% in the follow-up. In multiple linear regression, 10 TCM symptoms (MBI regression model) were related to the prognosis of MBI (DW 1.409, Ad. R 2 0.654) and 10 TCM symptoms (FMA regression model) were related to the FMA outcome (DW 1.446, Ad R 2 0.620). The two models were selected to have nine repeated symptoms (repeated model). In the ROC curves, the three models were compared with the NIHSS score, and the MBI regression model reflected the highest efficiency. CONCLUSIONS: The combination of 10 TCM symptoms, once onset occurred, including hemiplegia, restlessness, hemianesthesia, short breath, headache, constipation, night sweat, tinnitus, thirsty, and gurgling with sputum, may affect the recovery of motor dysfunction. Furthermore, the improvements of TCM symptoms dynamically after treatment would be observed in a large prospective cohort. This trial is registered with NCT01806233.

[Rasch analysis on stroke-specific quality of life (SS-QOL) scale of acupuncture intervention on stroke].

OBJECTIVE: To optimize the evaluation level of active motor threshold and the functional domain of upper limbs of stroke-specific quality of life (SS-QOL) scale with Rasch analysis. METHODS: Sixty patients with acute ischemic stroke that were in accord with research criterid were randomly divided into a test group (30 cases) and a control group (30 cases). Acupuncture treatment and routine western medicine were applied on the test group, and single treatment of routine western medicine was applied on the control group. Selected acupoints were MS 5, Fengchi (GB 20), Hegu (LI 4), etc. Active motor threshold and the functional domain of upper limbs of SS-QOL were self-tested by patients after one treating course. The characteristics of the above mentioned items were tested with Rasch model. RESULTS: The statistical result on fitness of active motor threshold and the functional domain of upper limbs of SS-QOL showed that every reference of samples and items wosin accord with the Rasch model and has well inner reliability and validity. The Infit and Outfit MnSq values of active motor threshold and the functional domain of upper limbs of SS-QOL are basically between 0.5 and 1.5. CONCLUSION: The application of Rasch analysis on the assessment of patient reported outcome (PRO) has optimized the PRO scale (the activity and upper limb function domain of SS-QOL scale) and enhanced evaluation level of active motor threshold and the functional domain of upper limbs of SS-QOL scale.

[Acupuncture treatment programs for post-stroke motor rehabilitation in community hospitals: study protocol of a multicenter, randomized, controlled trial].

BACKGROUND: Stroke is responsible for increasingly high rates of mortality and disability worldwide. Approximately two million people suffer from stroke for the first time in China each year. The high incidence (50%) of post-stroke disability brings a heavy burden to patients and their caregivers. Acupuncture has been widely used in the communities for post-stroke rehabilitation in China. The objective of this trial is to apply our acupuncture research achievement to treatment and evaluation of post-stroke hemiplegic patients in community. METHODS AND DESIGN: A multicenter, randomized, controlled trial will be performed in Longhua Hospital and a number of community health service centers in Shanghai. A total of 124 patients (estimated sample size) with post-stroke hemiplegia will be randomly divided into an acupuncture group and a control group. The patients undergoing randomization should be stratified according to National Institutes of Health Stroke Scale score at baseline. Within the acupuncture group, different acupuncture protocols are administered to patients with flaccid paralysis or spastic paralysis based on the Ashworth Scale. Patients in the acupuncture group will also be treated with comprehensive rehabilitation therapy. The control group will be treated with comprehensive rehabilitation therapy only. The primary outcome measures are the Simplified Fugl-Meyer Motor Scale, the Modified Barthel Index, and the Burden of Stroke Scale. Secondary outcome measures are the modified Rankin Scale, the modified Ashworth Scale and the Stroke Scale of Traditional Chinese Medicine. Outcome measures will be performed after 4 and 8 weeks of treatment. The patients will be followed up after 6 months. DISCUSSION: The results of this study are expected to demonstrate that our standardized acupuncture protocol for treating and evaluating post-stroke hemiplegic patients will improve motor function and lessen the burden of post-stroke patients within the communities. This will provide the evidence to support successful translation of acupuncture therapy for post-stroke hemiplegic patients in community hospital use. TRIAL REGISTRATION: This trial was registered in Chinese Clinical Trial Registry with the registration number ChiCTR-TRC-11001347.

[Studies on dynamic changes in traditional Chinese medicine syndrome patterns for stroke using data-driven and model-driven approaches: a review].

Many clinical studies showed that the traditional Chinese medicine (TCM) syndromes in stroke have been dynamically changing since the onset of the disease. The changing of TCM syndromes can be attributed to multiple correlative factors such as age, sex, area distribution, underlying diseases, and constitutional factor. Data-driven methods involving multivariate statistical methods and descriptive approach have been used to analyze the regularity of dynamically changed TCM syndromes of stroke. However, expressing non-linear relationship between symptom or correlative factors and syndrome patterns by data-driven models is challenging. Model-driven methods involving artificial neural networks and Bayesian networks are new methods for studying the changes in TCM syndromes in patients with stroke. In this review, the authors summarized the studies of dynamically changed patterns of stroke syndromes based on data-driven methods and some clinical trials on TCM syndromes based on model-driven methods. Further studies are needed to improve the understanding of the dynamically changing regularity of TCM syndromes for stroke by using model-driven methods so as to develop appropriate and timely TCM treatments.

[Influence of electroacupuncture and moxibustion and their treated mouse serum on the proliferation of the cultured splenetic CD4+ CD25+ regulatory T cells of tumor-bearing mice].

OBJECTIVE: To observe the effect of electroacupuncture (EA) and moxibustion of "Dazhui" (GV 14) on the proliferation levels of the splenetic CD4+ CD25+ regulatory T cells (Tregs) of H22 tumor-bearing mice in vitro. METHODS: Forty eight Balb/c mice were randomized into control, model, moxibustion and EA groups, with 12 cases in each. H22 tumor-bearing model was set up by hypodermic injection of H22 tumor cells (0.2 ml, 1 x 10(7) cells/ml). EA (2 Hz, 2 mA) was applied to "Dazhui" (GV 14) and left "Huantiao" (GB 30) for 20 min, and moxibustion was applied to "Dazhui" (GV 14) 2 moxa-cones every time. The treatment was given from the 2nd day on after innoculation of tumor cells, once every other day, 6 times altogether. After the treatment, the mice were killed by peeling off the eyeball and blood samples were collected to be separated into serum. Then, Tregs of the spleen tissues of Balb/c mice in different groups were isolated by using megnetic activated cell sorting (MACS) system to be cultured independently, and co-cultured with EA-treated serum and moxibustion-treated serum separately in culture fluid for 96 h, added with 3H-tritiate thymidine (TdR) in the culture-fluid 12 h before the end of culture, followed by collecting the cells and detecting their proliferation levels (count per minute, cpm) by using a lipid scintillation device. RESULTS: The proliferation level of Tregs in model group was elevated significantly compared to normal control group (P < 0.05), while in comparison with model group, those of Tregs of EA and moxibustion groups decreased considerably (P < 0.01). After separate application of the diluted acupuncture-treated serum and moxibustion-treated serum at 1 : 1 and 1 : 8 (not 1 : 16 and 1 : 32) to the cultured Tregs, their proliferation levels (cpm) in EA and moxibustion groups were obviously upregulated in comparison to those of normal control group (P < 0.05), and the cpm in EA group was significantly higher than that in model group (P < 0.05), suggesting a different action mechanism between acupuncture-moxibustion treatment and serum stimulation. CONCLUSION: EA of "Dazhui" (GV 14) and "Huantiao" (GB 30) and moxibustion of "Dazhui" (GV 14) can effectively downregulate the proliferation level of the cultured splenetic Tregs of the tumor bearing mice. EA-treated serum and moxibustion-treated serum diluted at 1 : 1 and 1 : 8 can evidently upregulate the proliferation level of Tregs in vitro.