Drug trials are more likely to disclose full placebo control information than non-drug trials: A cross-sectional study of participant information leaflets of placebo-controlled trials

Won, Jiyoon,Han, Ji-Yeon,Ji, Yu-jin,Ha, Dohyung,Han, Bong Jae,Lee, Hyangsook 한국한의학연구원 2024 Integrative Medicine Research Vol.13 No.2

Background: This study aimed to investigate whether placebo control is differently disclosed in drug and non-drug randomised clinical trial (RCT) participant information leaflets (PILs) and how this might affect participant blinding and direction of study outcomes. Methods: PILs were obtained from trials registered in the International Standard Randomised Controlled Trial Number database via email. Placebo descriptions in PILs were categorised as Full Disclosure (FD), Partial Disclosure (PD), or Missing Information (MI). Associations between intervention type (drug or non-drug)/placebo disclosure (FD or PD/MI) and participant blinding success/trial outcome direction (positive or non-positive) were examined using a two-sided Fisher's exact test. Results: Of 116 collected PILs, 56 % were for drug trials and 44 % were for non-drug trials. Among them, 88 PILs had the corresponding publications available and 68 reports specified primary outcomes. Drug trials were more likely to fully disclose placebo information than non-drug trials (92.3 % vs. 74.5 %, p < 0.05). However, the success rate of blinding was only reported in 3 out of 88 trial publications (3.4 %), precluding further analysis. Furthermore, there was no significant association between the direction of trial results and the type of intervention or placebo disclosure. Conclusion: Our study findings suggest that drug and non-drug RCTs might differ in the way they reveal placebo control information. Further research is warranted to understand what leads to more common PD of placebo information in non-drug trials than drug trials and to determine the optimal placebo control disclosure in specific trial context.

Robustness of meta-analysis results in Cochrane systematic reviews: A case for acupuncture trials

Jiyoon Won 한국한의학연구원 2022 Integrative Medicine Research Vol.11 No.4

Introduction Fragility index (FI) refers to the smallest value that change statistical significance of study results. Meta-analyses of Cochrane systematic reviews are considered as the best evidence for stake holders because they enable effect size estimation that cannot be derived by individual studies, particularly in the field of complementary and integrative medicine (CIM). Thus, this study aimed to evaluate robustness of meta-analysis in Cochrane systematic reviews of acupuncture, one of the most used CIM treatment, using FI of meta-analysis. Methods Meta-analyses of acupuncture Cochrane systematic reviews with binary benefit outcome measures were searched in PubMed, Embase, and CENTRAL and subject to analysis. Randomized clinical trials (RCTs) or quasi RCTs adopted penetrating needles as treatment and compared with controls such as sham acupuncture, usual care, and active control were included. FI of meta-analyses was calculated in web (https://clinicalepidemio.fr/fragility_ma/); and fragility quotient (FQ) was calculated by dividing FI by total sample size of meta-analysis. Results Of 248 retrieved studies, 12 Cochrane systematic reviews with 48 meta-analyses were analyzed. The median FI for statistically significant and non-significant meta-analyses was 7 [interquartile range: 3 - 12] and 6 [interquartile range: 3 - 10]. FQ was similar irrespective of statistical significance. Among controls, meta-analyses adopting sham acupuncture displayed the widest range of FI and FQ. Conclusion Robustness of meta-analyses in Cochrane systematic reviews for acupuncture was similar irrespective of statistical significance. Impact of control intervention cannot be determined in this study. As FI enables intuitive interpretation, applications for CIM field can be useful.

중년 남성에서 접골탕 투여 후 개선된 골밀도에 관한 증례 보고

원지윤(Jiyoon Won),최영진(Youngjin Choi),이병철(Byung-Cheol Lee),이향숙(Hyangsook Lee) 대한한의학회 2021 대한한의학회지 Vol.42 No.2

개원의중심연구망에서 수행된 보완통합의학 관련 연구 현황: 체계적 문헌고찰

원지윤 ( Jiyoon Won ),한가진 ( Gajin Han ),김예진 ( Yejin Kim ),박재량 ( Jae Rang Park ),노은영 ( Eunyoung Noh ),지유진 ( Yu-jin Ji ),아담스존 ( Jon Adams ),이향숙 ( Hyangsook Lee ) 경락경혈학회 2020 Korean Journal of Acupuncture Vol.37 No.4

Objectives : Practice-Based Research Networks (PBRNs), collaborations of practitioners and academic researchers, have provided platforms for conducting research to address clinical questions generated from daily routine care. This review aimed to critically analyse articles from PBRNs that are related to complementary and integrative medicine (CIM) and to suggest future directions for a PBRN which is appropriate for Korean Medicine (KM). Methods : PubMed, PBRN registries in Agency for Healthcare Research and Quality and relevant PBRN websites were searched up to November 2019 for research articles from PBRNs that focused on CIM regardless of study design. Methodological quality of the included studies was assessed. The included studies were read in full, classified and summarised according to their topics. Results : A total of 51 articles published from 1998 through 2020 were included in this review. They were categorised into three principal themes based on research questions and findings: health services research (embracing researches examining characteristics of patients and CIM practitioners/practices, and communication between patients and practitioners); effectiveness and safety of CIM practices/interventions; and feasibility studies of instruments and interventions in PBRN settings. The study designs varied including surveys (n=30), prospective observational studies (n=6), 2ndary analyses of existing studies (n=7), protocols (n=7), retrospective chart review (n=1) and qualitative study (n=1). Quality of the included studies greatly varied. Conclusions : PBRNs can serve as a feasible platform for conducting practice-relevant research on KM and CIM. Considering growing demands on evidence-base for routine practice of KM amid various stakeholders, a PBRN in KM community and further researches nested within PBRN designs are warranted.

The Factors Affecting Longitudinal Course of Posttraumatic Stress Disorder Symptoms in Sexual Assault Victims

Jaewon Lee,Jiyoon Shin,Soohyun Chae,Jeeyoung Chun,Jae-Won Choi,Ju-Yeon Lee,Tae-Won Park,Kyoung Min Kim,Kihyun Kim,Jae-Won Kim 대한신경정신의학회 2023 PSYCHIATRY INVESTIGATION Vol.20 No.11

Objective This study aimed to identify the factors affecting posttraumatic stress disorder (PTSD) symptom remission prospectively through a 1-year follow-up of sexual assault (SA) victims.Methods A total 65 female SA victims who visited the crisis intervention center were included. Self-administered questionnaires regarding PTSD symptoms and PTSD related prognostic factors were conducted at both recruitment (T1) and 1 year after recruitment (T2). The multivariate analyses were used to determine the significant predictors of PTSD remission/non-remission state 1 year after SA.Results In logistic regression analysis, both anxiety and secondary victimization were identified as significant factors explaining the results on PTSD remission/non-remission state at T2 (Beck’s Anxiety Inventory [BAI], p=0.003; Secondary Victimization Questionnaire, p=0.024). In a linear mixed analysis, both depression and anxiety were found to be significant variables leading to changes in Posttraumatic Diagnostic Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition from T1 to T2 (BAI, p<0.001; Center for Epidemiological Studies Depression Scale, p<0.001).Conclusion Depression, anxiety symptoms, and secondary victimization after SA were associated with PTSD symptom non-remission 1 year after SA.

A Brief Depression and Anxiety Rating Scale for Sexual Violence Victims

Soohyun Chae,Jiyoon Shin,Dajung Ji,Jae-Won Choi,Ju-Yeon Lee,Minha Hong,Tae-Won Park,Kyoung Min Kim,Sunhwa Lee,Soo Yeon Kim,Kihyun Kim,Jae-Won Kim 대한신경정신의학회 2021 PSYCHIATRY INVESTIGATION Vol.18 No.2

Objective This study aimed to develop a brief self-report measure of depressive and anxiety symptoms in victims of sexual violence. Methods The sample, which consisted of 215 victims and 255 healthy controls, was recruited between December 2016 and November 2018 from eight Sunflower Centers. Eligible items were selected from existing scales of depression (CES-DC and CES-D) and anxiety (SAI-C and BAI) symptoms by item-total correlation coefficients and item response theory (IRT) analysis. Internal consistency coefficients were computed and the receiver operating characteristics curve was inspected to assess the validity of the brief scale and determine optimal cutoff scores. Results The brief scales showed high internal consistency across all age groups. The optimal cutoff score of brief depression scale was 1.5 for children, 2.5 for adolescents, and 2.5 for the adults. That of brief anxiety scale was 8.5, 6.5, and 3.5, respectively. Conclusion The results underscore the need for age-appropriate screening measures of depressive and anxiety symptoms in victims of sexual violence.

Profiling Patterns of Volatile Organic Compounds in Intact, Senescent, and Litter Red Pine (Pinus densiflora Sieb. et Zucc.) Needles in Winter

( Won-sil Choi ),( Seung-ok Yang ),( Ji-hyun Lee ),( Eun-ji Choi ),( Yun-hee Kim ),( Jiyoon Yang ),( Mi-jin Park ) 한국목재공학회 2020 목재공학 Vol.48 No.5

This study was aimed to investigate the changes of chemical composition of the volatile organic compounds (VOCs) emitted from red pine needles in the process of needle abscission or senescence. The VOCs in intact, senescent, and litter red pine needle samples were analyzed by headspace-solid phase microextraction gas chromatography-mass spectrometry (HS-SPME-GC/MS). And then, multivariate statistical interpretation of the processed data sets was conducted to investigate similarities and dissimilarities of the needle samples. Principal component analysis (PCA) and orthogonal partial least squares discriminant analysis (OPLS-DA) were used to investigate the dataset structure and discrimination between samples, respectively. From the data preview, the levels of major components of VOCs from needles were not significantly different between needle samples. By PCA investigation, the data reduction according to classification based on the chlorophyll a / chlorophyll b (Ca/Cb) ratio were found to be ideal for differentiating intact, senescent, and litter needles. The following OPLS-DA taking Ca/Cb ratio as y-variables showed that needle samples were well grouped on score plot and had the significant discriminant compounds, respectively. Several compounds had significantly correlated with Ca/Cb ratio in a bivariate correlation analysis. Notably, the litter needles had a higher content of oxidized compounds than the intact needles. In summary, we found that chemical compositions of VOCs between intact, senescent, and litter needles are different each other and several compounds reflect characteristic of needle.

A Study on the Diffusion Strategies of Wood Culture Using Analytic Hierarchy Process (AHP)

( Jiyoon Yang ),( Myungsun Yang ),( Yeonjung Han ),( Myungkil Kim ),( Won Joung Hwang ) 한국목재공학회 2023 목재공학 Vol.51 No.6

The diffusion strategies of wood culture were established using the analytic hierarchy process, to prepare a diffusion plan of wood culture and wood utilization in response to climate change due to global warming. ‘Standardization of wood culture’, ‘Valuation of wood culture’, and ‘Habituation of wood culture’ were set as three major implementation strategies and priorities were evaluated. As a result, it was analyzed in the following order: ‘Development of systematic education programs for each age group for rational and efficient use of eco-friendly wood materials and development of wood education standard guidelines linked to the curriculum’, ‘Preparation of scientific basis data on human compatibility and eco-friendliness of wood to ensure the reliability of wood and wood products’, and ‘Establishment of monitoring and improvement plan through the designation as a model school’. Through this, it was determined that an educational environment, changes in public attitudes through publicity, and expanding opportunities to use wood and wood products were necessary for wood culture diffusion. The results of this study can be used as basic data to derive the diffusion strategies of wood culture and establish a roadmap and policy implementation strategy to revitalize wood culture.

Anti-Inflammatory Effect of Essential Oils Extracted from Wood of Four Coniferous Tree Species (침엽수 4종 목부 정유의 항염증 효과 평가)

( Jiyoon YANG ),( Won-Sil CHOI ),( Jae-Woo KIM ),( Sung-Suk LEE ),( Mi-Jin PARK ) 한국목재공학회 2019 목재공학 Vol.47 No.6

The aim of this study was to evaluate the anti-inflammatory effects of essential oils extracted from the wood of Chamaecyparis obtusa, Pinus densiflora, Pinus koraiensis, and Larix kaempferi. Essential oils were extracted by hydrodistillation, and their chemical components were determined by GC/MS. Major chemical components of these essential oils were α-cadinol (19.25%), τ-muurolol (14.20%), and α-pinene (13.74%) in C. obtusa; α-pinene (47.16%), longifolene (14.31%), β-phellandrene (11.78%), and β-pinene (11.02%) in P. densiflora; α-pinene (13.49%) and longifolene (10.79%) in P. koraiensis, and geranyl linalool (23.58%) and α-pinene (18.57%) in L. kaempferi. To evaluate the anti-inflammatory effects of essential oils, lipopolysaccharide (LPS)-induced RBL-2H3 mast cells were treated with these essential oils; then, the changes in the mRNA expression level of the cytokines IL-4 and IL-13 were examined. Further, degranulation was evaluated by measuring β-hexosaminidase release. After LPS-induced RBL-2H3 mast cells were exposed to 10-7% of all types of essential oils, the gene expression levels of IL-4 and IL-13 within the cells remarkably decreased. The relative mRNA expression level of IL-4 was 69.6% in P. densiflora, 63.2% in P. koraiensis, 55.1% in C. obtusa, and 45.8% in L. kaempferi compared with that in the group treated with LPS. The mRNA expression level of L-13 should a similar trend. The inhibitory rate of IL-13 mRNA expression of P. densiflora, P. koraiensis, C. obtusa, and L. kaempferi was 57.8%, 57.1%, 51.1%, and 34.5%, respectively. β-Hexosaminidase release significantly decreased following the treatment with the four types of essential oils. The rate of β-hexosaminidase release were 38.1% C. obtusa; 33.0% P. densiflora; 27.4% P. koraiensis; and 9.1% L. kaempferi. Among all types of essential oils, that extracted from P. densiflora wood showed the highest anti-inflammatory activity. These results show that the tested essential oils exert an anti-inflammatory effect through the inhibition of degranulation and expression of cytokines.

Verification of Liver Regeneration Using Vascularized Hepatic Microtissue Spheroids Fabricated by Bioprinting

( Jiyoon Byeon ),( Minji Park ),( Jae-hun Kim ),( Soraya Salas-silva ),( Tae Hun Kim ),( Dokyoung Lee ),( Jin-hyung Shim ),( Won-soo Yun ),( Songwan Jin ),( Ji Hyun Shin ),( Dongho Choi ) 대한간학회 2024 춘·추계 학술대회 (The Liver Week) Vol.2024 No.1