Journal of Oriental Neuropsychiatry (동의신경정신과학회지)

The Korean Society of Oriental Neuropsychiatry (대한한방신경정신과학회)
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Effect of Hominis Placenta Pharmacopuncture for a Patient with Mild Cognitive Impairment: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial

  • Kim, Yunna (Department of Clinical Korean Medicine, Graduate School, Kyung Hee University) ;
  • Eom, Yoon Ji (Department of Clinical Korean Medicine, Graduate School, Kyung Hee University) ;
  • Kwon, Dohyung (Department of Clinical Korean Medicine, Graduate School, Kyung Hee University) ;
  • Lee, Jae Hyok (Department of Neuropsychiatry, College of Korean Medicine, Semyung University) ;
  • Jung, In Chul (Department of Oriental Neuropsychiatry, College of Korean Medicine, Daejeon University) ;
  • Cho, Eun (College of Pharmacy, Sookmyung Women's University) ;
  • Lee, Ji Eun (College of Pharmacy, Sookmyung Women's University) ;
  • Cho, Seung-Hun (College of Korean Medicine, Kyung Hee University)
  • Received : 2021.06.08
  • Accepted : 2021.06.30
  • Published : 2021.06.30
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Abstract

Objectives: Mild cognitive impairment (MCI) is condition of cognitive decline shown in transition from normal aging to dementia. Hominis placenta pharmacopuncture (HPP) is a treatment that combines effects of medication and acupuncture by injecting Hominis placenta into acupoints. The objective of this study was to evaluate the efficacy and safety of HPP for MCI. Methods: This was a randomized, double-blind, placebo-controlled, two-center clinical trial. Eligible patients were randomly allocated to either the HPP group or the placebo group. HPP or saline as placebo was administered to participants for eight weeks. Changes in symptoms were observed. The primary outcome was difference in mean change of Korean Version of the Montreal Cognitive Assessment (MoCA-K) score between the HPP group and the placebo group. Cognitive function, overall status of mood and sleep, and quality of life (QoL) were also assessed. Safety assessment and economic analysis were then conducted. Results: Thirty participants were enrolled. One participant in the placebo group dropped out. The score of MoCA-K increased after treatment. Its mean change was smaller in the HPP group than in the control group. HPP ameliorated Global Deterioration Scale and Korean Dementia Rating Scale subtests for attention, organization, and memory compared to the placebo. However, none of them was significantly different between the two groups. Mood, sleep, and QoL all improved more in the HPP group than in the placebo group, although differences between the two groups were not statistically significant. There was no adverse event probably related to the drug. HPP treatment needed KRW 345,000 more than the placebo group in improving Geriatric Quality of Life scale-Dementia score by one point for one year. Conclusions: Although HPP treatment did not significantly improve cognition, it changed behavioral and psychological symptoms in MCI.

Keywords

Acknowledgement

This research was supported by a grant from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI) funded by the Ministry of Health & Welfare, Republic of Korea (grant number: HB16C0044).

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