Dataset Information

The effectiveness and safety of Kami Guibi-tang for mild cognitive impairment: study protocol of a pilot, randomized, placebo-controlled, double-blind trial.

ABSTRACT:

Background

Mild cognitive impairment (MCI) is an intermediate phase between normal aging and dementia. Since a majority of amnestic MCI (aMCI) cases progress to Alzheimer's disease (AD), it is considered the prodromal stage of AD and, therefore, a treatment target for the prevention of further cognitive decline. However, there is no approved treatment for MCI at present. Kami Guibi-tang (KGT) is a herbal drug used in Korean medicine to treat amnesia, insomnia, loss of appetite, and depression. We will explore the effectiveness and safety of KGT in amnestic MCI in this trial.

Methods/design

The study will be a single-center, randomized, placebo-controlled, double-blind trial. Eligible participants diagnosed with amnestic MCI will be randomly allocated to a treatment or control group. Participants will take KGT or placebo granules, three times a day, for 24?weeks. The primary outcomes will be changes in Seoul Neuropsychological Screening Battery (SNSB) scores, and magnetic resonance imaging (MRI) measurements including those of brain metabolites, neurotransmitters, and cerebral blood flow. The secondary outcomes will include the safety assessment, measured by changes in blood chemistry, changes in blood protein and cholesterol levels related to AD pathology, and a comparison of MRI changes between the two groups, using age and genotype as covariates.

Discussion

This study will be the first clinical trial to identify the therapeutic potential of Kami Guibi-tang for amnestic MCI. The findings will provide insight into the feasibility of large-scale trials to gather evidence for KGT as a treatment for MCI.

Trial registration

Korean Clinical Trial Registry, ID: KCT0002407 . Registered on 30 March 2017.

SUBMITTER: Shin HY

PROVIDER: S-EPMC6647292 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Publications

The effectiveness and safety of Kami Guibi-tang for mild cognitive impairment: study protocol of a pilot, randomized, placebo-controlled, double-blind trial.

Shin Hee-Yeon HY Kim Jeong-Hwa JH Jahng Geon-Ho GH Jung Woo-Sang WS Park Seong-Uk SU Ko Chang-Nam CN Park Jung-Mi JM

Trials 20190722 1

<h4>Background</h4>Mild cognitive impairment (MCI) is an intermediate phase between normal aging and dementia. Since a majority of amnestic MCI (aMCI) cases progress to Alzheimer's disease (AD), it is considered the prodromal stage of AD and, therefore, a treatment target for the prevention of further cognitive decline. However, there is no approved treatment for MCI at present. Kami Guibi-tang (KGT) is a herbal drug used in Korean medicine to treat amnesia, insomnia, loss of appetite, and depre ...[more]

PMID: 31331367

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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/.

Project description:BackgroundThe incidence of insomnia increases with age and is related to cognitive function in older adults; therefore, it is important to manage it actively. In this study, we report a protocol for the evaluation of the efficacy and safety of Kami Guibi-tang (KGT), a herbal prescription that has been widely used in East Asia for insomnia, forgetfulness, and depression, in older adults with insomnia.MethodsIn this single-center, double-blind, randomized controlled trial, 60 older adults with insomnia and subjective cognitive decline will be recruited and randomly assigned to the KGT or placebo group. The KGT group will take KGT granules thrice a day for 12 weeks, whereas the control group will take placebo granules in the same manner. Participants will be assessed for sleep, cognitive function, quality of life, and depression using the Pittsburgh Sleep Quality Index-Korean (PSQI-K), Insomnia Severity Index-Korean (ISI-K), Seoul Neuropsychological Screening Battery-Dement (SNSB-D), 36-item MOS Short Form Survey (SF-36) and Short version of the Geriatric Depression Scale (S-GDS) before and at the end of administration of the investigational product. The PSQI-K, ISI-K, and SF-36 will be further assessed 12 weeks after the end of medication to determine whether the effects on sleep and quality of life are sustained. The PSQI-K total score difference between the two groups at 12 and 24 weeks will be the primary outcome; all other endpoints will be secondary. Safety will be assessed by performing blood tests and electrocardiograms before taking the investigational drug, 6 weeks after taking the drug, and 12 weeks after taking the drug; any adverse events will be observed throughout the study.DiscussionThe protocol will provide a detailed process for a clinical trial to evaluate the efficacy and safety of KGT in elderly patients with insomnia. We will also investigate if changes in cognitive function correlated with improvements in insomnia.Trial registrationThis trial was registered at CRIS (Clinical Research Information Service) on April 27, 2023 (KCT0008391, version 2.0). https://cris.nih.go.kr/cris/search/detailSearch.do?seq=24811&search_page=L .

Project description:Background: Current treatment and management options for functional dyspepsia (FD) often fail to alleviate symptoms. Naesohwajung-tang (NHT) is a herbal formula frequently used to treat functional dyspepsia in traditional Korean medicine. However, few animal and case reports on the use of Naesohwajung-tang for functional dyspepsia treatment exist, and the clinical evidence remains deficient. Objectives: This study aimed to evaluate the efficacy of Naesohwajung-tang in patients with functional dyspepsia. Methods: We enrolled 116 patients with functional dyspepsia at two study sites in this 4 weeks, randomized, double-blind, placebo-controlled trial and randomly assigned them to either the Naesohwajung-tang or placebo group. To evaluate the efficacy of Naesohwajung-tang, the primary endpoint was a score on the total dyspepsia symptom (TDS) scale after treatment. The overall treatment effect (OTE), single dyspepsia symptom (SDS) scale, food retention questionnaire (FRQ), Damum questionnaire (DQ), functional dyspepsia-related quality of life (FD-QoL) questionnaire, and gastric myoelectrical activity measured using electrogastrography were evaluated as secondary outcomes. Laboratory tests were performed to confirm the safety of the intervention. Results: The 4 weeks administration of Naesohwajung-tang granules demonstrated a significantly higher reduction in the total dyspepsia symptom (p < 0.05) and a higher degree of improvement in the total dyspepsia symptom (p < 0.01) than the placebo group. Patients who underwent Naesohwajung-tang had a significantly higher overall treatment effect and a greater increase in the degree of improvement in scores such as epigastric burning, postprandial fullness, early satiation, functional dyspepsia-related quality of life, and Damum questionnaire (p < 0.05). Additionally, the Naesohwajung-tang group showed a greater effect in preventing a decrease in the percentage of normal gastric slow waves after meals than the placebo group. As a result of subgroup analyses using the degree of improvement in total dyspepsia symptom, Naesohwajung-tang was found to be more effective than placebo in female, younger patients (<65 years), with a high body-mass index (≥22), overlap type, food retention type, and Dampness and heat in the spleen and stomach systems pattern. There was no significant difference in the incidence of adverse events between the two groups. Conclusion: This is the first randomized clinical trial to verify that Naesohwajung-tang leads on symptom relief in patients with functional dyspepsia. Clinical Trial Registration:https://cris.nih.go.kr/cris/search/detailSearch.do/17613, identifier KCT0003405

Project description:PurposeTo evaluate the effectiveness of Kami Guibi-tang (KGT) in the treatment of mild cognitive impairment (MCI) using magnetic resonance imaging (MRI) on brain metabolites, neurotransmitter, and cerebral blood flow (CBF).MethodsWe randomly allocated a total of 30 MCI patients to a KGT (N = 16) or a placebo (N = 14) group and performed MRI scans before and after 24 weeks of treatment. The participants underwent brain magnetic resonance spectroscopy and MRI scans to obtain brain metabolites using Point-RESolved Spectroscopy (PRESS) single-voxel spectroscopy, gamma-aminobutyric acid (GABA) neurotransmitter using Mescher-Garwood PRESS, and CBF using pseudocontinuous arterial spin labeling sequences using a 3.0 Tesla MRI system. We analyzed metabolite and neurotransmitter levels and CBF using repeated-measure analysis of variance to evaluate between-subject group effect, within-subject treatment condition effect, and interaction of group by condition (group x condition).ResultsThe GABA+/creatine (Cr) ratio values were not significantly different between the before and after treatment conditions. The glutamate complex/Cr ratio difference before and after treatment was lower in the KGT group than in the placebo group, but was not statistically significant (p = 0.077). The result of region of interest-based CBF measurement showed that CBF values were significantly lower after treatment at Cluster 2 for the KGT group (p = 0.003) and the placebo group (p = 0.011), at hippocampus for the KGT group (p = 0.004) and the placebo group (p = 0.008), and at the fusiform gyrus for the KGT group (p = 0.002). Furthermore, the absolute CBF difference before and after treatment in the fusiform gyrus was significantly lower in the KGT group than in the placebo group (p = 0.024).ConclusionsAlthough a KGT treatment of 24 weeks showed some significant impact on the level of CBF, the Korean version of the mini-mental state examination score was not significantly different between before and after treatment conditions, indicating that there was no memory function improvement after treatment in amnestic MCI patients. Therefore, further studies should be performed with a relatively larger population and extending the duration of the KGT treatment.

Dataset Information

The effectiveness and safety of Kami Guibi-tang for mild cognitive impairment: study protocol of a pilot, randomized, placebo-controlled, double-blind trial.

Background

Methods/design

Discussion

Trial registration

Publications

The effectiveness and safety of Kami Guibi-tang for mild cognitive impairment: study protocol of a pilot, randomized, placebo-controlled, double-blind trial.

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