Safety and efficacy of acupuncture for mild cognitive impairment: a study protocol for clinical study.

Background: Mild cognitive impairment (MCI) is an intermediary condition between typical cognitive decline that occurs owing to aging and dementia. It is necessary to implement an intervention to slow the progression from MCI to Alzheimer's disease. This manuscript reports the protocol for a clinical trial on the effect of acupuncture in patients with MCI. Methods: The trial will be a randomized, prospective, parallel-arm, active-controlled trial. Sixty-four patients with MCI will be randomized to the Rehacom or acupuncture group (n = 32 each). The participants in the acupuncture group will receive electroacupuncture at GV24 (Shenting) and GV20 (Baihui) and acupuncture at EX-HN1 (Sishencong) once (30 min) a day, twice per week for 12 weeks. The patients in the Rehacom group will receive computerized cognitive rehabilitation using RehaCom software once (30 min) daily, twice weekly for 12 weeks. The primary outcome measure is the change in the Montreal Cognitive Assessment Scale score. The secondary outcome measures are the Geriatric Depression Scale, Alzheimer's Disease Assessment Scale-Korean version-cognitive subscale-3 scores, and European Quality of Life Five Dimensions Five Level Scale. The safety outcomes will include the incidence of adverse events, blood pressure, blood chemistry parameters, and pulse rate. The efficacy outcome will be assessed at baseline and at six weeks, 13 weeks, and 24 weeks after baseline. Discussion: The findings of this protocol will provide information regarding the effects of acupuncture on MCI. Clinical trial registration: https://cris.nih.go.kr/cris/search/detailSearch.do?search_lang=E&focus=reset_12&search_page=M&pageSize=10&page=undefined&seq=25579&status=5&seq_group=25579, KCT0008861.

Development of the Blood Stasis Questionnaire for Gynecological Diseases: An Analytical Cross-Sectional Study.

OBJECTIVES: Blood stasis is the slowing or stagnation of blood and can cause metabolic, musculoskeletal, and gynecological diseases. This study developed the Blood Stasis Questionnaire for gynecological disease (BSQ-GD) by extracting clinical indicators related to gynecological diseases using the Blood Stasis Questionnaires I and II (BSQ-I and II, respectively) and analyzed the clinical data of a cross-sectional study. PATIENTS AND METHODS: In total, 103 women aged between 25 and 65 years who met gynecological disease criteria were enrolled in this study. Blood stasis scores (BSS) were evaluated using the BSQ-II and categorized into BSS and non-BSS groups. To assess the reliability of BSQ-GD, the internal consistency coefficient was employed using Cronbach's α. Furthermore, correlation analyses were conducted for the clinical symptoms related to gynecological diseases, and the discriminant validity was confirmed by comparing the two groups. The prediction accuracy was determined using logistic regression and the cut-off value of the BSQ-GD was established via the sensitivity and specificity calculations. RESULTS: The BSQ-GD showed satisfactory internal consistency (Cronbach's α coefficient = 0.71) and validity, with significant differences in mean scores between blood stasis (22.30 ± 3.34) and non-blood stasis (14.93 ± 3.49) groups. The cut-off value of the BSQ-GD score was 19 points when the Youden index (73.45) and the concordance probability (0.75) were at their maximum. The area under the receiver operating characteristic curve was approximately 96%, and the sensitivity and specificity of the diagnostic accuracy according to the cut-off value are 80.95% and 92.50%, respectively. CONCLUSION: The BSQ-GD can be an appropriate instrument to estimate blood stasis in patients with gynecological diseases; its diagnostic sensitivity according to the cut-off value is high.

Pharmacopuncture Therapy as an Adjunctive Treatment for Patients with Lumbar Spinal Stenosis: A Pragmatic Randomized Controlled Pilot Trial.

Purpose: Pharmacopuncture therapy (PPT) combines medicinal extracts with acupuncture and is widely used as an adjunct in clinical practice. This study assessed the safety and feasibility of PPT in addition to conventional Korean Medicine treatment (CKMT), including electroacupuncture, cupping and infra-red, for lumbar spinal stenosis (LSS). Patients and Methods: Forty patients diagnosed with LSS were randomly assigned to undergo PPT with CKMT (experimental group) or CKMT alone (control group) at a 1:1 ratio, receiving 10 sessions of each intervention over five weeks. The primary clinical outcome was measured using the 100-mm Visual Analog Scale (VAS) for buttock and leg pain five weeks post-treatment. Secondary outcomes included clinically important difference (CID), Zurich Claudication Questionnaire, self-reported walking capacity, Modified-Modified Schober test, EuroQol 5-dimension 5-level questionnaire, and the patient's global impression of change. The adverse events were assessed at each visit. The analysis of covariance was conducted to compare between two groups. Results: Intervention completion rates were 95% and 100% in the experimental and control groups, respectively. No statistically significant differences were found between groups regarding the primary outcome (adjusted mean difference: 8.0; 95% confidence interval: -1.4-17.4). The mean difference in the 100-mm VAS for low back pain at week 5 (adjusted mean difference: 12.9; 95% confidence interval: 2.4-23.4) and the proportion of patients who reached the minimum CID was higher in the experimental group than in the control group. However, no significant differences were observed with other secondary outcomes. One patient in the experimental group experienced a systemic skin rash that resolved the same day, whereas the adverse events in the other group were mild and transient. Conclusion: This trial demonstrated the feasibility of add-on effects and the safety of pharmacopuncture in patients with LSS. Further studies are warranted to evaluate the add-on effects of PPT in treating LSS. Trial Registration: Clinical Research Information Service (CRIS), KCT0007229; registered on April 26, 2022.

Effect and Safety of Combining Pharmacopuncture Therapy and Acupotomy in the Treatment of Patients with Degenerative Lumbar Spinal Stenosis: a Study Protocol for a Pragmatic, Assessor-Blinded, Randomized, Controlled Trial.

Background: : Pharmacopuncture therapy and acupotomy are commonly used in combination for Conventional Korean Medicine Treatments (CKMT) for the treatment of patients with lumbar spinal stenosis (LSS). The aim of this study is to evaluate the effect and safety of combining pharmacopuncture therapy and acupotomy in the treatment of LSS. Methods: : This study is designed as a pragmatic, assessor-blinded, randomized controlled trial with two parallel arms in a 1:1 ratio. A total of 104 participants diagnosed with LSS will be randomly assigned to an experimental group (pharmacopuncture therapy and acupotomy in addition to CKMT) or a control group (only CKMT). Patients in both groups will receive treatment two times weekly for 6 weeks. The primary outcome will be the mean change on the 100-mm visual analog scale (VAS) from the baseline to the end of the treatment (week 6). The secondary outcomes will include the mean change in the 100-mm VAS from baseline to week 10 and week 14, respectively. Proportion of patients who achieve the clinically important difference, Zurich Claudication Questionnaire, Roland-Morris disability questionnaire, self-reported maxium walking distance, EuroQol 5-dimension 5-level, and Patients' Global Impression of Change will also be assessed. Adverse events will be assessed at each visit. The outcomes will be measured for a total of 14 weeks, including a treatment period of 6 weeks and follow-up of 4, 8 weeks. Discussion: : The results of this trial will confirm the effect and safety of combining pharmacopuncture therapy and acupotomy in the treatment of patients with LSS.

Effects of herbal medicines (Eunkyosan/Yin qiao san and Samsoeum/Shen su yin) for treating the common cold: A randomized, placebo-controlled, multicenter clinical trial.

Background: Eunkyosan (EKS) and Samsoeum (SSE), which are called Yin qiao san and Shen su yin in Chinese, are commonly used herbal medicines for the common cold in East Asian countries. This study aimed to evaluate the effectiveness and safety of EKS and SSE for treating the common cold. Methods: A randomized, patient-assessor-blind, placebo-controlled, parallel, and multicenter clinical trial was conducted. Adult participants who had one or more cold within 48 h before screening, were randomly allocated to EKS, SSE, or placebo groups. The recruitment goal was planned to be 375 participants. They took an EKS, SSE, or placebo, thrice daily for up to 8 days. The primary outcome was the change in the total score of the Wisconsin Upper Respiratory Symptom Scale-21-Korean version (WURSS-21-K) on day 6 compared to the baseline. The secondary outcomes included visual analog scale (VAS) scores and the duration of symptoms was assessed throughout the trial. Results: A total of 128 participants were enrolled and 44, 42, and 42 were allocated to the EKS, SSE, and placebo groups, respectively. This study was prematurely terminated due to the COVID-19 pandemic, and we were unable to recruit all the planned participants (n = 375). EKS showed significant clinical effectiveness over the placebo group in the treatment of the common cold, as assessed by the total, symptom, and quality of life scores of WURSS-21-K and VAS, whereas SSE showed significant improvement over the placebo group in terms of WURSS-21-K symptom score. No severe adverse events were reported. Conclusions: Although EKS and SSE demonstrated statistically significant clinical effectiveness and safety in patients with the common cold, we failed to recruit our pre-planned number of participants. Future definitive full-scale studies are needed to confirm these results. Trial registration: ClinicalTrials. gov, registration number: NCT04073511. Registered on 29 August 2019.

Effectiveness and Safety of Adjunctive Pharmacopuncture to Acupuncture Treatment for Rotator Cuff Diseases: a Protocol for an Assessor-Blinded, Pragmatic Randomized Controlled, Pilot Trial.

Background: Shoulder pain is a common musculoskeletal disorder. Treatment can be surgical or non-surgical. Korean Medicine, including acupuncture and pharmacopuncture, is a part of conservative treatment. Pharmacopuncture, combining acupuncture with herbal medicine, has been used for musculoskeletal disorders since the 1960s, but clinical evidence on its effectiveness is lacking. Objectives: This study aims to assess the effectiveness and safety of pharmacopuncture for rotator cuff disease. Methods: A two-group, parallel, single-center, pragmatic, randomized, controlled, assessor-blinded trial will be conducted. A total of 40 patients will be recruited, starting in July 2022. All patients will be received acupuncture treatment, and pharmacopuncture will be applied to intervention group additionally. After eight treatments are delivered over four weeks, follow-up assessments will be performed. Results: Assessments will evaluate the effectiveness and safety of these treatments at baseline and at weeks 2 (2 W), 4 (4 W), and 8 (8 W). The primary outcome will be a visual analog scale (VAS) evaluation of shoulder pain levels. Assessments will include shoulder pain and disability index (SPADI), shoulder range of motion (ROM), EuroQol 5-Dimension 5-Level (EQ-5D-5L), patient global impression of change (PGIC), 'no worse than mild pain', and drug consumption rates. Conclusion: This study may offer a rationale for a future full-scale trial on the effectiveness and safety of pharmacopuncture treatment for rotator cuff disease and provide data on non-surgical treatment for the disease.

Safety and efficacy of 650 nm invasive laser acupuncture on non-specific chronic low back pain: A protocol for a multicenter randomized placebo-controlled trial.

Background: We aim to obtain clinical trial data regarding the safety, efficacy, and usefulness of invasive laser acupuncture (ILA) for non-specific chronic low back pain (NSCLBP) through a randomized placebo-controlled trial. Methods: Our clinical trial will be an assessor- and patient-blinded, prospective, parallel-arm, multi-center, randomized placebo-controlled clinical trial. One hundred and six participants with NSCLBP will be allocated evenly to the 650 ILA or control group. All participants will receive education on exercise and self-management. The 650 ILA group will undergo 650 nm ILA for 10 min, and the control group will undergo sham ILA for 10 min per visit, twice a week for 4 weeks, at bilateral GB30, BL23, BL24, and BL25. The primary outcome will be the proportion of responders (≥30% reduction in pain visual analogue scale [VAS] without increased use of painkillers) at 3 days after the intervention ends. The secondary outcomes will include changes in the scores of the VAS, European Quality of Life Five Dimension Five Level scale, and Korean version of the Oswestry Disability Index at 3 days after the intervention ends and 8 weeks after the intervention ends. Discussions: The results of our study will provide clinical evidence concerning the safety and efficacy of 650 nm ILA for the management of NSCLBP. Clinical trial registration: https://cris.nih.go.kr/cris/search/detailSearch.do?search_lang=E&focus=reset_12&search_page=M&pageSize=10&page=undefined&seq=21591&status=5&seq_group=21591, identifier KCT0007167.

Add-on Effect and Safety of Pharmacopuncture Therapy in the Treatment of Patients with Lumbar Spinal Stenosis.

Background: Recently, Korean Medicine treatment with pharmacopuncture therapy (PPT) has been increasingly used in clinical practice to improve symptoms in patients with lumbar spinal stenosis (LSS). The aim of this study is to evaluate the effectiveness and safety of PPT in addition to conventional Korean Medicine treatment (CKMT) for the treatment of patients with LSS, compared with CKMT alone. Methods: This study is designed as a pragmatic, randomized, two-armed, parallel, stratified (by sex), controlled pilot trial. Forty patients diagnosed with LSS will be randomly allocated to the PPT + CKMT group or the CKMT group. Patients in the two groups will receive treatment two times weekly for 5 weeks. The primary outcome will be the mean change in the 100-mm visual analog scale score from the baseline to the end of treatment (week 5). The secondary outcomes will include the clinically important difference, Zurich Claudication Questionnaire score, self-reported walking capacity, Modified-Modified Schober test, EuroQol 5-dimension 5-level questionnaire, and Patients' Global Impression of Change. Adverse events will be assessed at each visit. Discussion: The results of this study will provide meaningful data to evaluate the add-on effect and safety of PPT in the medical care of patients with LSS.

Comparisons of Fit Factors Between Two Quantitative Fit Testers (PortaCount vs. MT).

This study evaluated the consistency between two quantitative fit test devices with different methods of ambient aerosol counting. Three types of respirators (N95, half mask, and full facepiece) were worn by 50 participants (male, n = 25; female, n = 25), PortaCount (Pro+ 8038) and MT (05U) were connected to one probe to one mask, and fit factors (FFs) were measured simultaneously with the original and modified protocols. As a result of comparing MT FFs with PortaCount FFs as references and by applying for the pass/fail criteria (FF = 100), the consistency between the two devices for half masks and full facepieces was very high. N95 was somewhat weaker than the two type of respirators in the consistency; however, the correlation between the two devices was very strong (p < 0.0001). The results showed that an FF of 100 as measured by PortaCount was likely to be measured as 75 by the MT. Therefore, when performing the fit test for N95 using the MT and pass level of FF 100, a certain level of adjustment is necessary, whether end-user or putting a scaling factor by manufacturer.

Effectiveness and safety of herbal medicine Ukgansan for clinical symptoms in Parkinson's disease: A pilot, randomized, assessor-blinded clinical trial.

Objectives: Parkinson's disease (PD) is a neurodegenerative disease in which patients are suffering various symptoms. Previous experimental studies suggested that herbal medicine Ukgansan (UGS) could be beneficial for PD. The aim of this pilot clinical trial was to evaluate the efficacy of UGS for improving clinical symptoms in patients with PD. Methods: Sixty patients with idiopathic PD were randomly assigned to receive either UGS plus acupuncture or acupuncture alone for 6 weeks. During the trial, all anti-parkinsonian medications were maintained. Subjects were evaluated for various clinical assessments of PD, including the Movement Disorder Society-Sponsored Revision of the Unified PD Rating Scale (MDS-UPDRS) and the 39-item Parkinson's Disease Questionnaire (PDQ-39), until 12 weeks. Results: In MDS-UPDRS between the groups, no significant time x group interaction was found. In the subgroup analysis of participants with anxiety, a significant time x group interaction was found in the PDQ-39 domain of mobility (P = 0.007), activities of daily living (P = 0.042), and the PDQ-39 summary index (P = 0.048). In addition, post-hoc analysis in participants with anxiety showed a significant decrease in the domains of mobility (P = 0.001) and activities of daily living (P = 0.013) at week 7. There were no adverse events associated with UGS. Conclusion: The additional administration of UGS has the potential to significantly improve the quality of life of PD patients with anxiety. In order to create more definitive evidence, clinical trials with more rigorous methodologies should be conducted in future. Clinical trial registration: http://cris.nih.go.kr, identifier: KCT0003444.

Particulate Matter Exposure and the Changes in Immune Biomarkers: Effects of Biyeom-Go on the Nasal Mucosa of Patients with Allergic Rhinitis and a Particulate Matter-Treated Mouse Model.

This study was to investigate the effects of Biyeom-go (BYG, an herbal formula) on immune biomarkers present in the nasal mucosa of patients with allergic rhinitis under exposure to particulate matter 2.5 (PM2.5), and on changes in goblet cells and immune biomarkers in mice under exposure to Korea diesel particulate matter (KDP20). Thirty patients showing characteristic allergic rhinitis symptoms were enrolled in Jeonju-si, Korea, and treated with BYG thrice a day for four weeks. Changes in the expression of immune biomarkers (interleukin 4 (IL-4), IL-5, IL-8, IL-13, IL-33, and thymic stromal lymphopoietin (TSLP) mRNA), total nasal symptom scores (TNSS), mini-rhinitis-specific quality of life questionnaire (RQLQ) results, and visual analog scale scores were evaluated after 4 weeks of treatment. Additionally, the difference in PM2.5 concentrations in the air in Jeonju-si, Korea (November, 2019 ∼ March, 2020), was analyzed to determine the change in TNSS. KDP20 (100 µg/mL) was exposed to C57BL/6 mice for 10 days; 0.05% Nasonex (a positive control, mometasone furoate), or BYG was administrated for 5 days twice a day. The expression of inflammatory factors was detected via qRT-PCR using nasopharynx tissue samples of mice. BYG treatment was found to be associated with significant improvement in total nasal symptoms, especially itching and sneezing (p < 0.0001), and mini-RQLQ after 4 weeks. IL-8 (p < 0.01), IL-33 (p < 0.01), and TSLP (p < 0.001) expression levels decreased after BYG treatment. In mice, administration of BYG reduced the number of goblet cells increased through KDP20 treatment. KDP20-induced immune biomarkers (IL-33, TSLP, tumor necrosis factor alpha, and IL-8) were also significantly downregulated in the nasopharynx tissue after BYG treatment. Therefore, BYG may show therapeutic effects against allergic rhinitis in humans, and it was confirmed that the expression of PM-induced inflammatory factors in mice was decreased via BYG treatment.

Acupuncture for Poor Ovarian Response: A Randomized Controlled Trial.

Acupuncture is believed to improve ovarian reserve and reproductive outcomes in women undergoing in vitro fertilization (IVF). This study was conducted to evaluate the effect of network-optimized acupuncture followed by IVF on the oocyte yield in women showing a poor ovarian response. This study was an exploratory randomized controlled trial conducted from June 2017 to January 2020 at the Pusan National University Hospital. Women diagnosed with poor ovarian response were enrolled and randomly divided into two groups: IVF alone and Ac + IVF groups (16 acupuncture sessions before IVF treatment). Eight acupoints with high degree centrality and betweenness centrality were selected using network analysis. Among the participants, compared with the IVF treatment alone, the acupuncture + IVF treatment significantly increased the number of retrieved mature oocytes in women aged more than 37 years and in those undergoing more than one controlled ovarian hyperstimulation cycle. The negative correlation between the number of retrieved mature oocytes and consecutive controlled ovarian hyperstimulation cycles was not observed in the Ac + IVF group irrespective of the maternal age. These findings suggest that physicians can consider acupuncture for the treatment of women with poor ovarian response and aged > 37 years or undergoing multiple IVF cycles.

Four Subgroups of Blood Stasis Syndrome Are Identified by Manifestation Cluster Analysis in Males.

Blood stasis syndrome (BSS) is an important pathological condition in traditional East Asian medicine and is associated with ischemic heart disease, cerebral vascular accident, diabetes mellitus, chronic renal failure, severe traumatic injury, and dysmenorrhea. However, previous studies have been unable to reveal the clinical and biological characteristics or biological markers of BSS. We hypothesized that the heterogeneity among the manifestations of BSS or non-BSS could interfere with an analysis to describe the characteristics of BSS. In this study, male participants based on the severity of BSS-associated symptoms and signs were clustered and classified into four subgroups: BSS subgroups (1), (2), (3), and (4). Non-BSS core subgroup was redefined using manifestation cluster analysis. Biological characteristics of subgroups BSS(1) and BSS(2) belong to the range of the non-BSS core subgroup (1), whereas that of subgroups BSS(3) and BSS(4) are characterized by different biological parameters such as systemic inflammatory conditions and elevated D-dimer level. Our results suggested that patients in subgroups of BSS(3) and BSS(4) are more likely to be exposed in an inflammatory state than other BSS subgroups. We found the heterogeneity among the manifestations which could mask the characteristics of BSS and identified the clinical and biological profiles of the four BSS subgroups through comparisons of the redefined non-BSS and BSS subgroups. This finding could provide accurate diagnostic criteria and new approaches for BSS treatments in different subgroups.

A Study on the Development of a Korean Metabolic Syndrome Questionnaire Using Blood Stasis Clinical Data.

OBJECTIVE: The aims of this study were to extract clinical indicators related to metabolic diseases using the Blood Stasis Questionnaires I and II (BSQ-I and II) developed in 2013 and 2014, respectively, and to develop a BSQ on metabolic syndrome (BSQ-MS). METHODS: A total of 2,158 patients, comprising 1,214 from 7 traditional Korean medical hospitals in 2013 and 944 from 3 traditional Korean medical hospitals in 2014, were asked to complete the BSQ-I and BSQ-II. For the 370 patients who met the metabolic syndrome criteria, reliability and validity of the BSQ-MS were assessed using Cronbach's alpha, while prediction accuracy was determined by logistic regression. RESULTS: The BSQ-MS included a total of 15 clinical signs and symptoms. It showed satisfactory internal consistency (Cronbach's α coefficient=0.70) and validity, with significant differences in mean scores between the blood stasis (14.09±6.14) and non-blood stasis (9.09±5.60) subject groups. The cut-off value of BSQ-MS score was 9 points, the area under the receiver operating characteristic curve was approximately 77%, the sensitivity and specificity of the diagnostic accuracy according to the cut-off value were 82.9% and 49.7%, respectively, and the sensitivity and specificity of the prediction accuracy by logistic regression were 72.2% and 71.6%, respectively. CONCLUSION: These results suggest that the BSQ-MS is an appropriate instrument for estimating blood stasis in patients with metabolic syndrome, although its sensitivity for diagnosis according to the cut-off value is low.

The Optimal Cut-Off Value of Blood Stasis Syndrome Score in BSS Diagnosis in Korea.

OBJECTIVE: In the traditional oriental medicine, it is sometimes difficult to diagnose Blood Stasis Syndrome (BSS) in patients, because the diagnosis of BSS is based on the subjective signs and symptoms of patients. This study is aimed at developing the prediction tool of BSS using cut-off value for BSS score. The identification of a cut-off value for BSS score to diagnose BSS would be helpful. METHODS: A total of 887 patients admitted to six traditional Korean medical hospitals in 2013 and three hospitals in 2014. All patients have an identical pattern as a result of diagnostic decision of two experts. The cut-off value for BSS score for BSS diagnosis was determined by the receiver-operating characteristic curve. RESULTS: The area under the curve of this curve was 0.897. The optimal cut-off point for detection of BSS was 49.0. The sensitivity and specificity of this cut-off value were 80.8% and 83.2% in modelling data (2013 dataset) and 84.6% and 83.1% in validation data (2014 dataset), respectively. CONCLUSION: Our study suggests that a BSS score cut-off value of 49.0 can be used to detect BSS in the traditional Korean medical hospitals. This cut-off value for diagnosis of BSS will make up the lack of objectivity.

Evaluating the clinical application of a leaflet for clinical practice guideline in patients with lumbar herniated intervertebral discs: Randomized controlled trial.

BACKGROUND: This study aims to demonstrate the effectiveness of using clinical practice guideline (CPG) leaflets as a communication tool between doctors and patients. We evaluated the leaflets as a communication tool in the treatment of lumbar herniated intervertebral discs (HIVDs) in terms of patient and physician satisfaction and ease of treatment. METHODS: This study is a 2-parallel-arm, assessor-blinded, randomized controlled trial at Jaseng Hospital, Seoul, South Korea. We evaluated efficacy through a comparison of satisfaction and clinical outcomes in randomly allocated groups of HIVD lumbar patients visiting Jaseng Hospital of Korean Medicine. We used leaflets on the basis of Korean medicine CPG recommendations as an intervention. The intervention group received treatment and diagnosis using the leaflet, and the control group received the typical intervention, which was provided without the leaflet. RESULTS: The levels of patient satisfaction with and understanding of the doctors' explanation was 92% in the leaflet group and 64% in the nonleaflet group, which showed that, compared with patient satisfaction in the nonleaflet group, patient satisfaction was considerably higher by 28% in the leaflet group. In addition, the level of the reliability with treatment was 92% in the leaflet group and 64% in the control group. However, there were no significant differences in statistical analyses. The level of doctors' satisfaction with communicating with patients using the leaflet was 100% in the leaflet group. Given this satisfaction, the ease of persuasion of treatment was highest (84%) and followed the improvement in the patient's understanding of the treatment (16%) in the leaflet group. In addition, in the nonleaflet user group, almost all doctors thought that having a leaflet would be a more effective treatment. CONCLUSION: Although this study failed to show significant differences between the intervention and control groups, the leaflet, which included CPG information in the treatment of HIVD patients, was an effective communication tool between patients and doctors. However, further studies with larger samples should be conducted to investigate the effectiveness of the communication tool based on the CPG. TRIAL REGISTRATION NUMBER: Clinical Research Information Service: KCT0001762.

Gyejibongneyong-hwan, a herbal medicine for the treatment of dysmenorrhoea with uterine fibroids: a protocol for a randomised controlled trial.

INTRODUCTION: Gyejibongneyong-hwan (GBH), or the Guizhi Fuling Formula in Chinese, is widely used to treat uterine fibroids in East Asian countries including Korea, China and Japan. This study will assess the efficacy and safety of the GBH formula for the treatment of dysmenorrhoea. METHODS AND ANALYSIS: This study will be a randomised double-blind controlled trial with two parallel arms: the GBH group and the placebo group. This trial will recruit 38 women between 18 and 45 years of age with secondary dysmenorrhoea with uterine fibroids. The investigational drugs, either GBH or placebo, will be administered to the participants three times per day for two menstrual periods (8 weeks). The participants will be followed up for three menstrual cycles after administration of the drugs. The primary outcome will be the Numeric Rating Scale score of average menstrual pain. All analyses will be performed with SAS (V.9.1.3; SAS Institute, Cary, North Carolina, USA) by a statistician blinded to the allocation of the groups. Statistical analysis will be undertaken on the intent-to-treat (ITT) basis with a 95% CI using the last observation carried forward for missing values. The ITT analysis will include all randomised patients. ETHICS AND DISSEMINATION: This research protocol has been reviewed and approved by the institutional review boards of the trial centre (number WSOH IRB 1606-03). Written informed consent will be obtained from all study participants prior to enrolment in the study. The results will be published in a peer-reviewed journal and will be disseminated electronically and in print. TRIAL REGISTRATION NUMBER: KCT0001967.

Soshiho-Tang Aqueous Extract Exerts Antiobesity Effects in High Fat Diet-Fed Mice and Inhibits Adipogenesis in 3T3-L1 Adipocytes.

Soshiho-tang (SST; sho-saiko-to in Japanese; xiaochaihu-tang in Chinese) has generally been used to improve liver fibrosis- and cirrhosis-related symptoms in traditional Korean medicine. Although many studies have investigated the pharmacological properties of SST, its antiobesity effect has not been elucidated. Thus, our present study was carried out to evaluate the antiobesity effect of SST using a high fat diet- (HFD) induced obese mouse model and 3T3-L1 adipose cells. C57BL/6J mice were randomly divided into four groups (n = 6/group), normal diet (ND), HFD-fed group, and HFD- and SST-fed groups (S200: 200 mg/kg of SST; S600: 600 mg/kg of SST) and given HFD with or without SST extract for 8 weeks. 3T3-L1 preadipocytes were differentiated into adipocytes for 8 days with or without SST. In the HFD-fed obese mice, body weight and fat accumulation in adipose tissue were significantly reduced by SST administration. Compared with control-differentiated adipocytes, SST significantly inhibited lipid accumulation by decreasing the triglyceride (TG) content and leptin concentration in 3T3-L1 adipocytes. SST also decreased the expression of adipogenesis-related genes including lipoprotein lipase (LPL), fatty acid binding protein 4 (FABP4), CCAAT/enhancer-binding protein-alpha (C/EBP-α), and peroxisome proliferator-activated receptor-gamma (PPAR-γ). Our findings suggest that SST has potential as a nontoxic antiobesity medication.

Stroke in Traditional Korean Medicine: A Nine-Year Multicentre Community-Based Study in South Korea.

In Korea, patients with stroke are commonly treated using traditional Korean medicine (TKM). The aim of this study was to provide information on the clinical characteristics of the pattern identification (PI) of stroke used in TKM. Stroke patients admitted to 15 TKM university hospitals from April 2005 through December 2013 were evaluated. The measured variables included the following factors as they related to the PI: (a) stroke etiology; (b) distribution of symptoms/signs; (c) physical characteristics and lifestyle parameters; (d) medical history; and (e) stroke-related laboratory results. Among 4912 stroke patients, 3466 patients received the same PI by two experts with the following distribution: Qi-Deficiency pattern (n = 810), Fire-Heat (FH) pattern (n = 1031), Dampness-Phlegm (DP) pattern (n = 1127), and Yin-Deficiency pattern (n = 498). Approximately 89.9% of subjects enrolled in this study had cerebral infarction. Some of specific symptoms were related to each type of PI, and obese phenotypes and blood lipids were significantly related to DP and FH. These results showed the characteristics of each type of PI and should lead to the standardization of diagnosis for stroke in TKM.

Standardization and future directions in pattern identification research: International brainstorming session.

An international brainstorming session on standardizing pattern identification (PI) was held at the Korea Institute of Oriental Medicine on October 1, 2013 in Daejeon, South Korea. This brainstorming session was convened to gather insights from international traditional East Asian medicine specialists regarding PI standardization. With eight presentations and discussion sessions, the meeting allowed participants to discuss research methods and diagnostic systems used in traditional medicine for PI. One speaker presented a talk titled "The diagnostic criteria for blood stasis syndrome: implications for standardization of PI". Four speakers presented on future strategies and objective measurement tools that could be used in PI research. Later, participants shared information and methodology for accurate diagnosis and PI. They also discussed the necessity for standardizing PI and methods for international collaborations in pattern research.