Dataset Information

Efficacy and safety of Hominis placenta pharmacopuncture on mild cognitive impairment: Randomized, double blind, placebo-controlled, multi-center trial.

ABSTRACT:

Introduction

Mild cognitive impairment (MCI) is cognitive decline which can be observed in a wide range of cognitive domains. It is considered as a prodromal stage of dementia; therefore, strategies for treatment are necessary, but current evidence is limited. Combining the memory enhancing effect of Hominis placenta (H placenta) and acupuncture elucidated separately in previous studies, efficacy of H placenta pharmacopuncture for treating MCI is anticipated.

Methods

Thirty participants will be recruited. Male and female adults aged 50 to 80 who voluntarily participate in the trial, are diagnosed with MCI according to diagnostic and statistical manual of mental disorders-5 criteria, and have a Clinical Dementia Rating score 0.5 will be enrolled. Participants who meet the criteria will be randomly allocated to either pharmacopuncture group or control group. Participants will undergo H placenta pharmacopuncture or saline pharmacopuncture in GV20, ST36, and CV12 twice weekly for 8 weeks and will be evaluated a month after the last treatment. Primary outcome will be difference in mean change of Korean version of Montreal Cognitive Assessment scores between intervention group and control group. Cognition, mood, sleep quality and quality of life will be also assessed using other neuropsychological tests and questionnaires regarding depression, anxiety, sleep and quality of life.

Discussion

Evaluating the efficacy and safety data obtained by assessing diverse aspects of patients with MCI will broaden the scope of MCI management and prevention of dementia progression.

Trial registration

Clinical Research Information Service (KCT0005368), Registered 02 Sep 2020, https://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=16425.

SUBMITTER: Kim Y

PROVIDER: S-EPMC7668472 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Publications

Efficacy and safety of Hominis placenta pharmacopuncture on mild cognitive impairment: Randomized, double blind, placebo-controlled, multi-center trial.

Kim Yunna Y Lee Jae Hyok JH Jung In Chul IC Eom Yoon Ji YJ Cho Seung-Hun SH

Medicine 20201101 46

<h4>Introduction</h4>Mild cognitive impairment (MCI) is cognitive decline which can be observed in a wide range of cognitive domains. It is considered as a prodromal stage of dementia; therefore, strategies for treatment are necessary, but current evidence is limited. Combining the memory enhancing effect of Hominis placenta (H placenta) and acupuncture elucidated separately in previous studies, efficacy of H placenta pharmacopuncture for treating MCI is anticipated.<h4>Methods</h4>Thirty partic ...[more]

PMID: 33181659

Similar Datasets

Project description:BackgroundMild cognitive impairment (MCI) is considered an intermediate phase between normal aging and dementia. As the majority of cases of amnestic MCI (aMCI) progress to Alzheimer's disease (AD), it is considered the prodromal stage of AD, and a treatment target for prevention of further cognitive decline. However, no medications have been shown to have symptomatic or preventive benefits in MCI. Kami-guibi-tang (KGT) is a traditional herbal formula used in Korean medicine to treat amnesia, which is reported to increase acetylcholine levels via activation of choline acetyltransferase. The objective of this study was to evaluate the efficacy and safety of KGT in patients with aMCI.MethodsThis study was designed as a single-center, randomized, double-blind, placebo-controlled pilot study. Participants diagnosed with aMCI were randomized to receive either KGT or placebo granules for 24 weeks. The efficacy measure was a change in the Seoul Neuropsychological Screening Battery (SNSB) score. The safety measures included the occurrence of adverse events and abnormalities in vital signs and blood chemistry, electrocardiogram (ECG), and brain magnetic resonance imaging (MRI) findings.ResultsA total of 16 patients in the KGT group and 14 patients in the placebo group were investigated in the study. The mean score of Clinical Dementia Rating-Sum of Boxes (CDR-SB) significantly improved from 1.53 (0.64) points to 1.13 (0.62) points in the KGT group (p = 0.010), whereas it worsened from 1.61 (0.88) points to 1.75 (0.94) points in the placebo group. There was a significant difference in the CDR-SB scores between the two groups after the intervention (p = 0.045). The total SNSB-D scores and the scores in the memory domain after the treatment were significantly higher than the baseline values in the KGT group, but not in the placebo group. The frequency of adverse events was not significantly different between the two groups, and there were no abnormalities in vital signs or blood test, ECG, and brain MRI findings after the intervention.ConclusionsKGT may provide a safe and effective treatment option for patients with aMCI. Further studies with a larger sample size are needed to validate the findings.Trial registrationKorean Clinical Trial Registry, ID: KCT0002407; Registered on March 30, 2017, http://cris.nih.go.kr/.

Dataset Information

Efficacy and safety of Hominis placenta pharmacopuncture on mild cognitive impairment: Randomized, double blind, placebo-controlled, multi-center trial.

Introduction

Methods

Discussion

Trial registration

Publications

Efficacy and safety of Hominis placenta pharmacopuncture on mild cognitive impairment: Randomized, double blind, placebo-controlled, multi-center trial.

Similar Datasets

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