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Effects of different acupuncture treatment methods on mild cognitive impairment: a study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Mild cognitive impairment (MCI) is an intermediate state between normal aging and Alzheimer's disease, which is the world's most common form of dementia. It is important to identify early and easily available interventions to delay the progression of MCI to Alzheimer's disease. Acupuncture has been reported to improve the clinical outcomes of MCI treatment. Acupuncture is a complex intervention, involving both specific and non-specific factors associated with therapeutic benefits. Therefore, we intend to obtain basic data for developing an optimal acupuncture treatment for MCI by comparing the effects of different acupuncture treatment methods on cognitive function in MCI patients. METHODS:This study will be a prospective, outcome-assessor-blinded, parallel-arm, single-center (DongShin University Gwangju Korean Medicine Hospital, Republic of Korea), randomized controlled clinical trial. Thirty-two participants with MCI will be randomized in equal numbers to four groups (basic acupuncture (BA), acupoint specificity (AS), needle duration (ND), or electroacupuncture (EA)) and receive acupuncture treatment once per day, 3 days/week for 8 weeks. The BA and ND groups will receive acupuncture treatment for 30 and 20?min, respectively, at Baihui (GV20), Sishencong (EX-HN1), Fengchi (GB20), and Shenting (GV24). The EA group will receive electroacupuncture treatment at the same acupoints for 30?min. The AS group will receive acupuncture treatment at GV20, EX-HN1, GB20, GV24, and Taixi (KI3) for 30?min. The outcome measured will be scores on the Korean version of the Alzheimer's Disease Assessment Scale-cognitive subscale, the Korean version of the Montreal Cognitive Assessment, the Center for Epidemiological Studies Depression scale, the Korean Activities of Daily Living scale, the Korean Instrumental Activities of Daily Living scale, and the European Quality of Life Five Dimension Five Level scale. All scores will be recorded before intervention, 8 weeks after the first intervention, and 12 weeks after completing the intervention. DISCUSSION:Four acupuncture protocols will be assessed and compared as potential MCI treatments. This study is expected to provide data to be used in developing an optimal acupuncture method for MCI treatment. TRIAL REGISTRATION:Clinical Research Information Service, KCT0003430 . Registered on 16 January 2019. http://cris.nih.go.kr ).

SUBMITTER: Kim JH

PROVIDER: S-EPMC6727424 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Effects of different acupuncture treatment methods on mild cognitive impairment: a study protocol for a randomized controlled trial.

Kim Jae-Hong JH Cho Myoung-Rae MR Park Gwang-Cheon GC Lee Jeong-Soon JS

Trials 20190904 1

<h4>Background</h4>Mild cognitive impairment (MCI) is an intermediate state between normal aging and Alzheimer's disease, which is the world's most common form of dementia. It is important to identify early and easily available interventions to delay the progression of MCI to Alzheimer's disease. Acupuncture has been reported to improve the clinical outcomes of MCI treatment. Acupuncture is a complex intervention, involving both specific and non-specific factors associated with therapeutic benef ...[more]

PMID: 31484559

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Project description:BackgroundMild cognitive impairment (MCI) is known as a transitional status between normal cognitive function and Alzheimer's disease (AD). Acupuncture and Chinese herbal medicines (CHMs) are considered to be beneficial to patients with cognitive impairment. However, it is still unknown whether the combination of the two therapies could optimize the therapeutic effect for MCI. This trial is aimed to evaluate the therapeutic effects of acupuncture and the herbal formula Yishen Granule (YSG) for elderly patients with MCI.Methods/designThis is a multi-sited, patient-blinded, randomized controlled trial (RCT). Two hundred and forty eligible patients will be randomly divided into four groups: A. acupuncture with YSG, B. acupuncture with placebo herbal medicine, C. sham acupuncture with YSG or D. sham acupuncture with placebo herbal medicine. Acupuncture treatment will be given twice a week for 8 weeks and then once a week for 4 weeks. The herbal treatment patients will be given granules daily for 12 weeks, 8 weeks of standard-dose followed by 4 weeks of mid-dose. The primary outcome is scored by the Montreal Cognitive Assessment (MoCA). The secondary outcomes will be scored by the Mini-Mental State Examination (MMSE) and event-related potential (ERP). All the assessments will be conducted at baseline, and at the eighth and 12th week after intervention starts. The follow-up assessments will be performed with the MoCA in the 12th, 24th, and 36th weeks after intervention ends. Intention-to-treat (ITT) analysis will be used in this RCT.DiscussionThis RCT will provide us information on the effect of treating MCI patients with only acupuncture, herbal formula as well as the combination of both. The additive effect or synergistic effect of acupuncture and Chinese herbal formula will then be analyzed.Trial registrationThis trial is registered with ChiCTR-INR-17011569 on 5 June 2017, and has been approved by the Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine (2017SHL-KY-05).

Project description:BackgroundMild cognitive impairment (MCI) is generally regarded as the borderline between cognitive changes of aging and very early Alzheimer's disease (AD). It is important to develop easily available interventions to delay the progression of MCI to AD. We investigated factors contributing to the cognitive improvement effects of acupuncture to obtain data for developing optimized acupuncture treatments for MCI.MethodsThis outcome assessor-blinded, randomized controlled trial included a full analysis for comparing the efficacy of different acupuncture methods. Thirty-two participants with MCI (i.e., fulfilling the Peterson diagnostic criteria for MCI, K-MMSE scores of 20-23, and MoCA-K scale scores of 0-22) were randomly assigned to basic acupuncture (BA; GV20, EX-HN1, GB20, and GV24 for 30 min), acupoint specificity (AS; adding KI3 to BA), needle duration (ND; BA for 20 min), or electroacupuncture (EA; electrical stimulation to BA) groups (n=8/group) via 1:1:1:1 allocation and administered acupuncture once daily, three times a week for 8 weeks. The measured outcomes included scores on the Korean version of the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-K-cog), Korean version of the Montreal Cognitive Assessment scale (MoCA-K), Center for Epidemiological Studies-Depression Scale, Korean Activities of Daily Living scale, Korean Instrumental Activities of Daily Living scale, and European Quality of Life Five Dimension Five Level Scale. Outcome measurements were recorded at baseline (week 0), intervention endpoint (week 8), and 12 weeks after intervention completion (week 20).ResultsTwenty-five patients with MCI completed the trial (BA group, 8; AS group, 6; ND group, 5; EA group, 6). MoCA-K scores were significantly increased in the BA group compared with the ND (p=0.008, week 8-week 0) and EA groups (p=0.003, week 8-week 0; p=0.043, week 20-week 0). ADAS-K-cog scores were significantly decreased in the BA group compared with the ND group (p=0.019, week 20-week 0).ConclusionsThe BA group showed significant improvement in cognitive function compared to the ND and EA groups. Electrical stimulation and needle duration may contribute to the cognitive improvement effects of acupuncture in patients with MCI.Trial registrationClinical Research Information Service; URL:cris.nih.go.kr .; unique identifier: KCT0003430 (registration date: January 16, 2019).

Project description:BackgroundMild cognitive impairment (MCI) is defined as a decline in cognitive state with preservation of activities of daily living. Medications such as donepezil and rivastigmine have been commonly prescribed for MCI, but their use is controversial. Acupuncture has been widely used in Korea and has been shown to improve cognitive function. The aim of this study is to evaluate the efficacy of acupuncture for MCI and investigate the effect of acupuncture on structural and functional brain changes in patients with MCI.MethodsThis study is a randomized, assessor-blinded, sham-controlled trial. Fifty participants with MCI will be randomly assigned to the acupuncture group (n = 25) or sham acupuncture group (n = 25). The acupuncture group will receive acupuncture treatment at nine acupuncture points (GV20, EX-HN1, bilateral LI4, and ST36) twice a week for 12 weeks. The sham acupuncture group will receive sham acupuncture treatment at the same points with non-penetrating sham needles. Both groups will be restricted from all other treatments for the improvement of cognitive function. The primary outcome measure is the Digit Span Test (DST). The secondary outcome measures are the Digit Symbol Substitution Test (DSST), Korean version of Montreal Cognitive Assessment (MoCA-K), Seoul Neuropsychological Screening Battery-II (SNSB-II), Beck Depression Inventory-II (BDI-II), State-Trait Anxiety Inventory (STAI), working memory (WM) task performance score, and structural/functional brain changes. Outcomes will be assessed at screening, baseline, 4 and 8 weeks, and after the end of treatment. We will also observe adverse events. In the statistical analysis, a full analysis set and per-protocol analysis will be performed.DiscussionThis randomized clinical trial aims to examine the efficacy of acupuncture treatment for MCI. Neuropsychological tests, psychological inventories for measuring depression and anxiety, and magnetic resonance imaging will be performed to investigate the underlying neurological mechanisms and the association between cognition, emotion, and brain networks following acupuncture treatment. The results of the trial will provide evidence supporting the efficacy of acupuncture and also add to the neurobiological understanding of acupuncture treatment for MCI.Trial registrationClinical Research Information Service, KCT0002896 . Registered on 25 May 2018.

Project description:BackgroundMild cognitive impairment (MCI) is defined as an intermediate stage between normal aging and Alzheimer's disease (AD), and early and easily available interventions to delay the progress of MCI to AD are necessary. Feasible complementary and alternative therapies such as electroacupuncture (EA), exercise, and cognitive training have shown some beneficial effects on MCI and AD. Here we report the protocol for a randomized controlled trial of the efficacy and safety of EA combined with computer-based cognitive rehabilitation (EA-CCR) for the treatment of MCI.MethodsThe study will be a prospective, outcome assessor-blinded, parallel-arm, single-center (DongShin University Gwangju Korean Medicine Hospital, Republic of Korea), pilot randomized controlled clinical trial with a 1:1 allocation ratio. Participants with MCI will be randomized to a computer-based cognitive rehabilitation (CCR) or an EA-CCR group (n = 18 each). The CCR group will receive RehaCom cognitive rehabilitation once (30 min) a day, 3 days per week (excluding Saturday and Sunday) for 8 weeks. The EA-CCR group will receive EA at Baihui (GV20), Sishencong (EX-HN1), Fengchi (GB20), and Shenting (GV24) in addition to RehaCom cognitive rehabilitation once (EA:30 min, CCR:30 min) a day, 3 days per week (excluding Saturday and Sunday) for 8 weeks. The primary outcome will be an improvement in cognitive function assessed using the Korean version of the Alzheimer's Disease Assessment Scale-cognitive subscale. Scores for the Korean version of the Montreal Cognitive Assessment scale, Center for Epidemiological Studies Depression Scale, Korean Activities of Daily Living scale, Korean Instrumental Activities of Daily Living scale, and European Quality of Life Five Dimension Five Level Scale will be recorded as secondary outcome measures. All scores will be recorded at baseline (before intervention), 8 weeks after the first intervention (i.e., at the end of the intervention), and 12 weeks after completion of the intervention.DiscussionThe study is expected to provide preliminary evidence regarding the efficacy, safety, and usefulness of EA-CCR for the treatment of MCI.Trial registrationKorea Clinical Information Service, cris.nih.go.kr, KCT0003415 . Registered on 4 January 2019. Retrospectively registered, http://cris.nih.go.kr .

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Effects of different acupuncture treatment methods on mild cognitive impairment: a study protocol for a randomized controlled trial.

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Effects of different acupuncture treatment methods on mild cognitive impairment: a study protocol for a randomized controlled trial.

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