Establishment of a Dataset for the Traditional Korean Medicine Examination in Healthy Adults.

We established a protocol for the traditional Korean medicine examination (KME) and methodically gathered data following this protocol. Potential indicators for KME were extracted through a literature review; the first KME protocol was developed based on three rounds of expert opinions. The first KME protocol's feasibility was confirmed, and data were collected over four years from traditional Korean medicine (KM) hospitals, focusing on healthy adults, using the final KME protocol. A literature review identified 175 potential core indicators, condensed into 73 indicators after three rounds of expert consultation. The first KME protocol, which was categorized under questionnaires and medical examinations, was developed after the third round of expert opinions. A pilot study using the first KME protocol was conducted to ensure its validity, leading to modifications resulting in the development of the final KME protocol. Over four years, data were collected from six KM hospitals, focusing on healthy adults; we obtained a dataset comprising 11,036 healthy adults. This is the first protocol incorporating core indicators of KME in a quantitative form and systematically collecting data. Our protocol holds potential merit in evaluating predisposition to diseases or predicting diseases.

Exploring Traditional Medicine Diagnostic Classification for Parkinson's Disease Using Hierarchical Clustering.

INTRODUCTION: Personalized diagnosis and therapy for Parkinson's disease (PD) are needed due to the clinical heterogeneity of PD. Syndrome differentiation (SD) in traditional medicine (TM) is a diagnostic method for customized therapy that comprehensively analyzes various symptoms and systemic syndromes. However, research identifying PD classification based on SD is limited. METHODS: Ten electronic databases were systematically searched from inception to August 10, 2021. Clinical indicators, including 380 symptoms, 98 TM signs, and herbal medicine for PD diagnosed with SD, were extracted from 197 articles; frequency statistics on clinical indicators were conducted to classify several subtypes using hierarchical clustering. RESULTS: Four distinct cluster groups were identified, each characterized by significant cluster-specific clinical indicators with 95% confidence intervals of distribution. Subtype 2 had the most severe progression, longest progressive duration, and highest association with greater late-stage PD-associated motor symptoms, including postural instability and gait disturbance. The action properties of the herbal formula and original SD presented in the data sources for subtype 2 were associated with Yin deficiency syndrome. DISCUSSION/CONCLUSION: Hierarchical clustering analysis distinguished various symptoms and TM signs among patients with PD. These newly identified PD subtypes may optimize the diagnosis and treatment with TM and facilitate prognosis prediction. Our findings serve as a cornerstone for evidence-based guidelines for TM diagnosis and treatment.Eine personalisierte Diagnose und Therapie des Morbus Parkinson (MP) ist angesichts der ausgeprägten klinischen Heterogenität des MP unerlässlich. Die Syndromdifferenzierung (SD) ist in der traditionellen Medizin (TM) eine diagnostische Methode für eine maßgeschneiderte Therapie, bei der verschiedene Symptome und systemische Syndrome umfassend analysiert werden. Es liegen jedoch nur begrenzt Forschungsergebnisse in Bezug auf eine SD-basierte Klassifikation des MP vor.Zehn elektronische Datenbanken wurden systematisch durchsucht, von der Einrichtung bis zum 10. August 2021. Klinische Indikatoren einschließlich von 380 Symptomen, 98 TM-Zeichen sowie pflanzlichen Heilmitteln für mittels SD diagnostiziertem MP wurden aus 197 Artikeln extrahiert, und Häufigkeitsstatistiken der klinischen Indikatoren wurden erstellt, um mittels hierarchischem Clustering eine Reihe von Subtypen zu klassifizieren.Vier verschiedene Cluster-Gruppen wurden identifiziert, die jeweils durch signifikante, Cluster-spezifische klinische Indikatoren mit 95% Konfidenzintervall der Verteilung gekennzeichnet waren. Subtyp 2 hatte den schwersten Verlauf, die längste Progressionsdauer und die stärkste Assoziation mit einem höheren Ausmaß von motorischen Symptomen des MP im Spätstadium, darunter Haltungsinstabilität und Gangstörungen. Die Wirkungseigenschaften der pflanzlichen Formulierung sowie die ursprüngliche SD, die in den Datenquellen für Subtyp 2 genannt wurden, waren mit Yin-Mangel-Syndrom assoziiert.Die hierarchische Clustering-Analyse hob verschiedene Symptome und TM-Zeichen bei Patienten mit MP hervor. Die neu identifizierten MP-Subtypen könnten die Diagnose und Behandlung mittels TM optimieren und zur Prognoseerstellung beitragen. Unsere Ergebnisse sind ein Fundament für eine evidenzbasierte Leitlinie für die TM-Diagnostik und -Therapie.

Traditional Medicine Classification Based on the Nature and Location of Disease in Parkinson's Disease: A Clustering Study Using Pattern Identification Disassemble Presented in Clinical Studies.

Objectives: The purpose of this study was to investigate a traditional medicine (TM) classification based on the nature and location of disease for pattern identification (PI) in Parkinson's disease (PD). This study also aimed to present evidence regarding the pathogenesis of PD and provide a basis for establishment of individualized treatment strategies with TM. Methods: An electronic search was conducted in three core databases, three Korean databases, and four Chinese databases. A hierarchical clustering analysis was conducted based on the nature and location of the disease for PD, and the analysis findings were compared with PI in the existing literature. Results: A total of 79 different types of PI were confirmed in 189 PD cases. Cluster analysis using the nature and location of disease disassembled from PI identified 7 groups: group 1 (wind, blood stasis) comprised 15 studies; group 2 (fire-heat, phlegm-retained fluid) comprised 7 studies; group 3 (liver, Qi stagnation) comprised 5 studies; group 4 (kidney, Yang deficiency) comprised 10 studies; group 5 (liver-kidney, Yin deficiency) comprised 93 studies; group 6 (Qi deficiency, blood deficiency) comprised 18 studies; and group 7 (meridian and collateral) comprised 9 studies. Conclusions: The findings provide evidence for the pathogenesis of PD and have the potential to translate into more specific TM patterns for PD. The authors hope that their study results will be used as a foundation for development of traditional medical diagnostic methods and treatments tailored to PD.

Efficacy of herbal medicine treatment based on syndrome differentiation for Parkinson's disease: A systematic review and meta-analysis of randomized placebo-controlled clinical trials.

Background: Parkinson's disease (PD), the second most common progressive neurodegenerative disease, causes heterogeneous clinical symptoms. Patients experience a range of motor and non-motor symptoms, and personalized diagnosis and treatment are needed. In traditional East Asian medicine, syndrome differentiation (SD) is a diagnostic approach for customized therapy that uses a comprehensive analysis and varies for the same disease. We aimed to evaluate the efficacy of herbal medicine (HM) prescribed according to the SD of PD. Methods: Ten electronic databases were searched from inception to August 2021 without language limitations. All randomized controlled trials (RCTs) involving HM for SD of PD were included. Assessment of Cochrane's risk of bias and meta-analysis and Grading of Recommendations Assessment, Development, and Evaluation was also performed. Effect measurement was summarized using the mean difference (MD) with 95% confidence interval, through a meta-analysis. Results: Thirteen RCTs involving 843 participants were included. The overall risk of bias was either low or unclear. Compared with the placebo, a combined therapy of HM and Western medicine (WM) significantly improved the total Unified Parkinson's Disease Rating Scale (UPDRS) (MD = -8.03, [-10.27, -5.79], p < 0.00001; I2 = 0%) and was more beneficial, as assessed using the UPDRS (I-III), the Parkinson's Disease Questionnaire-39, and the Non-Motor Symptoms Scale. Adverse events did not differ between the groups. Conclusion: The findings suggest that the combined treatment of WM and HM based on SD diagnosis has additional benefits in PD treatment. However, the methodological quality of the included RCTs was suboptimal. Nevertheless, this systematic review is the first to investigate the efficacy of HM treatment according to the SD diagnosis in PD. The clinically meaningful improvement in HM according to SD in PD needs to be tested in further studies with rigorous designs and longer follow-up periods. Systematic Review Registration: [https://inplasy.com/inplasy-2021-10-0020/], identifier [INPLASY2021100020].

Effectiveness of Sopoongsan for chronic upper body pruritus in patients with atopic or seborrheic dermatitis: A pilot study protocol for a randomized, double-blind, placebo-controlled, parallel trial.

INTRODUCTION: Chronic pruritus persists for > 6 weeks and is known to decrease patients' quality of life. Due to the complex pathological mechanism of chronic pruritus, there is still a lack of satisfactory therapeutic agents; therefore, complementary therapies are required to improve itching symptoms. In the Republic of Korea, Sopoongsan, an herbal formula, has been used to treat itching, dizziness, and skin paralysis. To our knowledge, this is the first study to evaluate whether Sopoongsan improves chronic pruritus and to identify Sopoongsan-related changes in the immune response in patients with chronic upper body pruritus. METHODS: A randomized, double-blind, placebo-controlled parallel trial will be conducted to assess 20 patients with chronic upper body pruritus for 3 months who have been diagnosed with allergic atopic dermatitis or seborrheic dermatitis. The patients will be randomly allocated to either the placebo-control (n = 10) or treatment (n = 10) group. The total study period will be 8 weeks (i.e., administration of Sopoongsan or placebo drugs for 4 wk and follow-up for 4 wk). Participants will be allowed to receive external treatment, except for antipruritic medications administered orally, throughout the study period. The primary outcome measure will be the numeric rating scale results for itching, whereas the secondary outcome measures will be questionnaire survey (Dermatological Life Quality Index and Epworth Sleepiness Scale) findings and the immune response index, including interferon gamma, interleukin-4, immunoglobulin E, thymic stromal lymphopoietic protein, and histamine, to investigate the biological mechanisms underlying chronic pruritus. DISCUSSION AND CONCLUSIONS: We expect that the results of this study will provide important clinical evidence regarding the effectiveness of Sopoongsan on itching symptoms, quality of life, sleep disturbance, and changes in the immune response. The findings will help elucidate the mechanism underlying the therapeutic effect of Sopoongsan for chronic pruritus and lay the foundation for further studies in this area.

Efficacy of Traditional Herbal Medicine Treatment Based on Pattern Identification for Idiopathic Parkinson's Disease: A Protocol for Systematic Review and Meta-Analysis.

Parkinson's disease (PD), the second most common progressive neurodegenerative disease, is characterized by various clinical symptoms and reduced quality of life. The standard dopaminergic therapy for PD has limitations such as drug wear-off, drug-related side effects, and drug-resistant PD symptoms. Traditional oriental medicine, which is a personalized approach based on pattern identification (PI), has been reported to relieve symptoms, halt disease progression, and improve the quality of life in patients with PD. This comprehensive systematic review will be conducted to gather clinical studies related to complementary traditional herbal therapies based on PI for idiopathic PD and assess its effectiveness. Clinical studies, including randomized controlled trials in English, Korean, and Chinese databases related to the efficacy of herbal medicine based on PI for PD will be searched in computer retrieval. In addition, the subdivided PI for each clinical manifestation of PD will be investigated. Two researchers will independently screen and select studies, extract data, and assess bias risk. The risk of bias will be evaluated using the Cochrane risk-of-bias assessment tool. After screening the studies, a meta-analysis will be performed. The primary outcome will be the unified Parkinson's disease rating scale to measure clinical symptom reduction. Secondary outcomes will consist of other validated scales to evaluate the improvement of PD, including improvement of clinical symptoms and quality of life. The quality of evidence will be evaluated through the Grading of Recommendations, Assessment, Development, and Evaluation pro. Complementary traditional medicine is a personalized medicine that classifies individual states based on PI. We expect that the results of this review will provide evidence for the efficacy of traditional herbal medicine based on PI for the treatment of PD. This protocol has been registered in the International Platform of Registered Systematic Review and Meta-Analysis Protocols (INPLASY) 2021 (registration number INPLASY2021100020).

Efficacy and safety of acupuncture on oligomenorrhea due to polycystic ovary syndrome: An international multicenter, pilot randomized controlled trial.

BACKGROUND: Polycystic ovary syndrome (PCOS) is one of the most common disorders of reproductive endocrinology affecting women of reproductive age. Our study aims to explore the feasibility of a full-scale trial to evaluate the efficacy and safety of acupuncture for PCOS. METHODS: This study is a two-armed, parallel, multi-country, multi-center, pilot randomized controlled trial (RCT) for PCOS with oligomenorrhea. We will recruit 60 women aged 20 to 40 years with oligomenorrhea due to PCOS. The participants will be randomly assigned to acupuncture and control groups. The acupuncture group will undergo a total of 40 sessions for 16 weeks with usual care. The control group will be managed with usual care (regular meals, sufficient sleep, and appropriate exercise) only. The primary clinical outcome is mean change in menstrual frequency from baseline to 16 weeks and 32 weeks (follow-up) after the start of the trial. The secondary outcomes are menstrual period, levels of estradiol, luteinizing hormone (LH), follicle-stimulating hormone (FSH), and total testosterone, LH/FSH ratio, antral follicle count and ovarian volume, body mass index, waist hip ratio, acne severity, and health-related quality of life questionnaire scores at 16 and 32 weeks after the start of the trial. DISCUSSION: This is the first protocol for multi-country, multi-center RCTs for PCOS in Korea and China. The control group in this study will be subjected to usual care (regular meals, enough sleep, and appropriate exercise). The results of this study will provide evidence for future clinical decisions and guidelines.This trial has been registered at ClinicalTrials.gov (Identifier: NCT04509817).

Traditional Chinese Medicine and Traditional Indonesian Medicine: A Comparative Review of Herbal Medicines Restricted in Pregnancy.

The decline in birth rates has become a very serious problem in various parts of the world. Many countries have implemented national programs for increasing birth rates, one of which involves the use of traditional medicine as an alternative solution. Among the fast-growing traditional medicines, traditional Chinese medicine (TCM) and traditional Indonesian medicine (TIM) have attracted a lot of demand globally. Here, we analyzed and compared the herbal medicines from TCM and TIM that must be avoided by pregnant women for preventing miscarriage and maintaining safety during pregnancy and the postpartum period. This review uses data from official reports from the respective government and national and international electronic databases for analysis. Although TCM and TIM have their own characteristics of treatment, they also have some similarities in concept and treatment, especially those related to herbal medicines. This review can be used as a reference base to help pregnant women consume herbal medicines at appropriate conditions and doses.

Efficacy and safety of thread embedding acupuncture on knee osteoarthritis: A randomized, controlled, pilot clinical trial.

INTRODUCTION: Although there are various therapeutic methods for the treatment of knee osteoarthritis, each has its advantages and shortcomings, and a definitive treatment method is yet to be determined. This pilot study is designed to obtain basic data for a further large-scale trial as well as provide information about the feasibility of thread embedding acupuncture (TEA) with polydioxanone thread in knee osteoarthritis patients. METHODS AND ANALYSIS: This study is a clinical trial to evaluate the efficacy and safety of TEA for knee osteoarthritis. Forty participants will be recruited at the hospital and after randomization into 2 groups of 20 (experimental and control); they will be treated for 6 weeks. The experimental group will receive TEA treatment 6 times (1 time/week) in 6 weeks on 14 defined knee areas, and the control group, acupuncture treatments 12 times (2 times/week) in 6 weeks on 9 defined acupuncture points. The visual analogue scale (VAS) will be used for the primary efficacy assessment and Short-form McGill Pain Questionnaire (SF-MPQ), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used for the secondary efficacy assessment. The follow-ups before clinical trial, 3 weeks after procedure, 6 weeks after procedure, and 4 weeks after the end of procedure will be done to compare the degree of pain with the control group, which received the acupuncture treatment. CONCLUSION: The trial based on this study will provide clinical information on the efficacy and safety of TEA treatment on knee osteoarthritis. TRIAL REGISTRATION NUMBER: KCT0004844.