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Efficacy and safety of Kami-guibi-tang for mild cognitive impairment: a pilot, randomized, double-blind,
Hee-Yeon Shin1, Ha-Ri Kim1, Geon-Ho Jahng2
1Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, 26, Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
Background:
Mild 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.
Methods:
This 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.
Results:
A 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.
Conclusions:
KGT 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 Registration:
Korean Clinical Trial Registry, ID: KCT0002407; Registered on March 30, 2017, http://cris.nih.go.kr/.
Insights
Kami-guibi-tang (KGT) improved cognitive function in patients with amnestic mild cognitive impairment (aMCI) over 24 weeks. This traditional Korean medicine showed significant benefits in memory and dementia rating scales with no adverse effects, suggesting a potential treatment for aMCI.
Area of Science:
- Neuroscience
- Gerontology
- Pharmacology
Background:
- Mild cognitive impairment (MCI) is a transitional stage to dementia, with amnestic MCI (aMCI) often progressing to Alzheimer's disease (AD).
- Currently, no FDA-approved medications offer symptomatic or preventive benefits for MCI.
- Kami-guibi-tang (KGT), a traditional Korean herbal formula, is used for amnesia and may enhance acetylcholine levels.
Purpose of the Study:
- To evaluate the efficacy and safety of Kami-guibi-tang (KGT) in patients diagnosed with amnestic mild cognitive impairment (aMCI).
- To assess KGT's potential as a therapeutic option for preventing cognitive decline in the prodromal stage of Alzheimer's disease.
Main Methods:
- A single-center, randomized, double-blind, placebo-controlled pilot study.
- Participants with aMCI received either KGT or placebo granules for 24 weeks.
- Efficacy was measured by changes in the Seoul Neuropsychological Screening Battery (SNSB) and Clinical Dementia Rating-Sum of Boxes (CDR-SB) scores. Safety was monitored through adverse events and clinical/laboratory assessments.
Main Results:
- The KGT group showed a significant improvement in CDR-SB scores (p=0.010), while the placebo group showed worsening.
- A significant difference in CDR-SB scores was observed between groups post-intervention (p=0.045).
- KGT significantly improved total SNSB-D and memory domain scores compared to baseline, unlike placebo. No significant differences in adverse events or safety markers were found between groups.
Conclusions:
- Kami-guibi-tang (KGT) demonstrates potential as a safe and effective treatment for amnestic mild cognitive impairment (aMCI).
- Further research with larger sample sizes is warranted to confirm these findings and establish KGT's role in managing aMCI.
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