RESUMO
Background: Mild cognitive impairment (MCI), the early stage of dementia, requires effective intervention for symptom management and improving patients' quality of life (QoL). Jujadokseo-hwan (JDH) is a Korean herbal medicine prescription used to improve MCI symptoms, such as memory deficit. This study evaluates the improvement in QoL through JDH. Alongside a clinical trial, it estimates the cost-effectiveness of JDH, compared to placebo, for MCI over 24 weeks. Methods: Changes in QoL were measured using the EuroQol-5 Dimensions (EQ-5D) and Korean version QoL-Alzheimer's Disease (KQOL-AD). Direct medical and non-medical costs were surveyed and incremental cost-effectiveness ratios (ICER) per QALY for JDH were produced. Results: In total, 64 patients were included in the economic evaluation (n = 35 in JDH, n = 29 in placebo). In the JDH group, EQ-5D and KQOL-AD improved by 0.020 (p = .318) and 3.40 (p = .011) over 24 weeks, respectively. In the placebo group, they increased by 0.001 (p=.920) and 1.07 (p=.130), respectively. The ICER was KRW 76,400,000 per QALY and KRW 108,000 per KQOL-AD for JDH, compared to the placebo group. Conclusion: JDH is not considered a cost-effective treatment option compared with placebo; however, it positively affects QoL improvement in patients with MCI.
RESUMO
BACKGROUND: Mild neurocognitive disorder (mNCD) is one of the degenerative diseases that results in memory deficit, and can progress to dementia. The effectiveness of drug therapy for mNCD is still debatable, but treatment of this disease has important implications for postponing or preventing dementia. Jujadokseo-hwan (JDH) is a traditional herbal medicine formulation that exhibits improvement in cognitive abilities and neuroprotective effects. In this study, we will evaluate the safety and efficacy of JDH compared to placebo in mNCD patients. METHODS AND DESIGN: This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical trial. After obtaining informed consent from all participants and performing the screening process, the participants will be equally divided into an experimental group and a control group. Each participant will visit the trial center 7 times during the 12 weeks of intervention. The follow up study will be conducted 12 weeks after the intervention ends. The primary outcome is the variance in Seoul verbal learning test-elderly's version (SVLT-E) score from baseline to 12 weeks. Secondary outcomes include scores/values for the following variables: SVLT-E, Rey complex figure test, Digit span test, Korean-Boston naming test, calculation ability, controlled oral word association test, Korean-color word stroop test, digit symbol coding, Korean-trail making test-elderly's version, Korean version of mini mental state examination for dementia screening, euro-qol-5 dimension, pattern identifications tool for cognitive disorders, Korean version of Montreal cognitive assessment, Korean quality of life-Alzheimer disease, computerized tongue image analysis system, blood pressure pulse analyzer, bioelectrical impedance analyzer, wearable electroencephalogram device, functional near-infrared spectroscopy system, and cost analysis. DISCUSSION: This is the first trial evaluating the efficacy of JDH for mNCD. We expect this trial will provide strong support for wide use of JDH for mNCD and lead to further research on herbal medicine treatments for mNCD. TRIAL REGISTRATION NUMBER: KCT0003570 (Registered in Clinical Research Information Service of the Republic of Korea, https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=12669).