Dataset Information

Combination of acupuncture and Chinese herbal formula for elderly adults with mild cognitive impairment: protocol for a randomized controlled trial.

ABSTRACT:

Background

Mild 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/design

This 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.

Discussion

This 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 registration

This 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).

SUBMITTER: Chen Y

PROVIDER: S-EPMC6371495 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Publications

Combination of acupuncture and Chinese herbal formula for elderly adults with mild cognitive impairment: protocol for a randomized controlled trial.

Chen Yueqi Y Zhang Wenjing W Wu Huangan H Lao Lixing L Xu Jian J Xu Shifen S

Trials 20190211 1

<h4>Background</h4>Mild 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 (Y ...[more]

PMID: 30744676

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Project description:Mild cognitive impairment (MCI) is a multifactorial and complex central neurodegenerative disease. Acupuncture appears to be an effective method for cognitive function improvement in MCI patients. Neural plasticity remaining in the MCI brain implies that acupuncture-associated benefits may not be limited to the cognitive function. Instead, neurological alternations in the brain play a vital role in corresponding to the cognitive improvement. However, previous studies have mainly focused on the effects of cognitive function, leaving neurological findings relatively unclear. This systematic review summarized existing studies that used various brain imaging techniques to explore the neurological effect regarding acupuncture use for MCI treatment. Potential neuroimaging trials were searched, collected, and identified independently by two researchers. Four Chinese databases, four English databases, and additional sources were searched to identify studies reporting the use of acupuncture for MCI from the inception of databases until 1 June 2022. Methodological quality was appraised using the Cochrane risk-of-bias tool. In addition, general, methodological, and brain neuroimaging information was extracted and summarized to investigate the potential neural mechanisms by which acupuncture affects patients with MCI. In total, 22 studies involving 647 participants were included. The methodological quality of the included studies was moderate to high. The methods used included functional magnetic resonance imaging, diffusion tensor imaging, functional near-infrared spectroscopy, and magnetic resonance spectroscopy. Acupuncture-induced brain alterations observed in those patients with MCI tended to be observable in the cingulate cortex, prefrontal cortex, and hippocampus. The effect of acupuncture on MCI may play a role in regulating the default mode network, central executive network, and salience network. Based on these studies, researchers could extend the recent research focus from the cognitive domain to the neurological level. Future researches should develop additional relevant, well-designed, high-quality, and multimodal neuroimaging researches to detect the effects of acupuncture on the brains of MCI patients.

Project description: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 ).

Project description:Background: Dementia is a gradual decline in cognitive ability and is becoming more common in our elderly population. Mild cognitive impairment (MCI) is defined as a slight clinical deterioration of memory capacity, below the level of normal aging, but does not constitute a clinical diagnosis of dementia. To date, no interventions have been proven to cure MCI and dementia fully. Purpose: To evaluate the potential effectiveness and safety of acupuncture for mild cognitive impairment (MCI) and dementia and evaluate the methodological quality of systematic reviews (SRs). Methods: We conducted a literature search for SRs with meta-analyses in seven Chinese and international databases through October 1, 2020. The basic characteristics of the included SRs/meta-analyses and the basic information of the original included randomized controlled trials were extracted by three reviewers independently. A meta-analysis of the original randomized controlled trials from the included SRs/meta-analyses was performed using Stata 12.0 software. The Assessing the Methodological Quality of Systematic Reviews 2 was used to assess the methodological quality of the included SRs/meta-analyses, and the Grading of Recommendations, Assessment, Development, and Evaluation was used to rate the quality of evidence. Results: A total of 35 SRs/meta-analyses were included, and the majority showed that acupuncture was more effective than western medicine or conventional therapy for MCI and dementia [odds ratio =1.39; 95% confidence interval (CI): 1.24, 1.56]. There was a statistically significant difference in the Mini-Mental State Examination score (weighted mean difference = 1.23; 95% CI: 0.78, 1.68; p < 0.00001), and there was no significant improvement in the activities of daily living score (weighted mean difference = 1.58; 95% CI: -0.02, 3.18; p = 0.053). The assessment results of Assessing the Methodological Quality of Systematic Reviews 2 showed that the methodological quality of most included SRs/meta-analyses was critically low; the lowest scores were items 2, 7, and 10. For Grading of Recommendations, Assessment, Development, and Evaluation, of the 73 outcomes, 50 (68.5%) outcomes were low or very low quality, and 23 (31.5%) outcomes were moderate quality. Conclusions: Acupuncture can be considered as an alternative for the treatment of MCI and dementia when western medicine or other therapies are contraindicated. More high-quality evidence is needed to determine further the effectiveness of acupuncture.

Dataset Information

Combination of acupuncture and Chinese herbal formula for elderly adults with mild cognitive impairment: protocol for a randomized controlled trial.

Background

Methods/design

Discussion

Trial registration

Publications

Combination of acupuncture and Chinese herbal formula for elderly adults with mild cognitive impairment: protocol for a randomized controlled trial.

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