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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.

Introduction This study investigated the current status of the Health Promotion Programme using Traditional Korean Medicine (HaPP-TKM). A survey of public health Traditional Korean Medicine (TKM) doctors asked for suggestions on developing the system and programmes so that TKM public health doctors can practice effectively in different circumstances. Methods TKM public health doctors working in health centres in the Republic Korea were asked about the performance status of HaPP-TKM and their opinions on the programme. The questionnaire took about 20 min to complete and included basic information about the respondent, plus performance status and opinions on HaPP-TKM and the TKM public health doctor system. The survey was administered to 908 doctors through SurveyMonkey. Results The response rate was 96.2% (n = 838) of which 31.1% (n = 236) of respondents were administering HaPP-TKM. The top three programmes that TKM doctors implemented were; stroke (23.1%, n = 61), smoking cessation (20.1%, n = 53), and osteoarthritis (14.8%, n = 39). Over 50% of TKM public health doctors reported that the difficulties performing the programmes were a result of insufficient infrastructure, followed by lack of information and training on TKM health promotion programmes (32.6%, n = 86). Conclusion The study results show that TKM is in high demand and appropriate for stroke, smoking cessation, and osteoarthritis. The activation plan for TKM health promotion programmes are as follows: first, well trained human resources, spaces, facilities, and budget are essential, second, programme development and training manual development should run concurrently and last, it is necessary to consider ways to specialize the health promotion programmes and medical treatment according to specialty areas.

Infertility has long been recognized as a treatable disease, and complementary and alternative medicine treatments, such as acupuncture and moxibustion, have been used in Korea and China. This study describes female infertility treatment programs that used traditional Korean medicine (TKM) and were conducted by local governments in Korea and evaluates its effectiveness and safety.The authors officially requested related information from the report of the infertility treatment programs and related sources from 2006 to 2016 from the HealthWelfare Ministry of Korea and the Association of Korean Medicine (AKOM). Additional information was obtained from six Korean databases. Data including basic information about the programs, participant information, interventions, and outcomes were abstracted.A total of 9 reports, including multiple years of data from 6 programs (total 13 programs), were identified. In these 13 programs, a total of 1023 female subjects participated, and 205 of the 887 subjects who completed the program reported a successful pregnancy, indicating a 23.1% pregnancy rate. The programs lasted 3-9 months, and interventional elements, such as herbal medicine, acupuncture, fumigation, and massage, were identified. Significant adverse effects were not reported.This study suggests that infertility treatment programs with TKM interventions exhibited a positive effect on pregnancy in females with infertility. Thus, the infertility treatment programs with TKM interventions are expected to be useful and might serve as the primary treatment before assisted reproduction techniques.

Background: Herbal medicines have the potential to be alternative treatments for metabolic diseases. This systematic review will assess the efficacy of herbal medicines in treating metabolic diseases with blood stasis. Methods and analysis: We will search MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science, 2 Korean medical databases (OASIS, NDSL), a Chinese database (China National Knowledge Infrastructure, CNKI), and a Japanese database (J-STAGE) for relevant literature. We will include all randomized controlled trials (RCTs) or quasi-RCTs evaluating the effectiveness of herbal medicine. Participants of both sexes and of any age with clinically diagnosed metabolic disease with blood stasis will be included. Primary outcomes will include Blood-stasis syndrome score, TC, TG, HDL-C and LDL-C. Secondary outcomes will Blood pressure, FBS. ECG, prevalence rate of heart disease, and response rate. The risk of bias will be assessed using the Cochrane tool for assessing risk of bias. Discussion: The findings of this study will provide a summary of the current state of evidence regarding the effectiveness of types of herbal medicine in managing metabolic disease with blood stasis. In addition, this review will be expected to provide a base for clinical trials to confirm the efficacy of herbal medicine for treatments of metabolic disease with blood stasis. Trial registration number: PROSPERO 2018 CRD42018090179.

Background. This study aimed to investigate medical records using traditional Korean medicine (TKM) in Sewol Ferry disaster in 2014 and further explore the possible role of traditional medicine in disaster situation. Methods. After Sewol Ferry accident, 3 on-site tents for TKM assistance by the Association of Korean Medicine (AKOM) in Jindo area were installed. The AKOM mobilized volunteer TKM doctors and assistants and dispatched each on-site tent in three shifts within 24 hours. Anyone could use on-site tent without restriction and TKM treatments including herb medicine were administered individually. Results. The total of 1,860 patients were treated during the periods except for medical assistance on the barge. Most patients were diagnosed in musculoskeletal diseases (66.4%) and respiratory diseases (7.4%) and circulatory diseases (8.4%) followed. The most frequently used herbal medicines were Shuanghe decoction (80 days), Su He Xiang Wan (288 pills), and Wuji powder (73 days). Conclusions. TKM in medical assistance can be helpful to rescue worker or group life people in open shelter when national disasters occur. Therefore, it is important to construct a rapid respond system using TKM resources based on experience.

Introduction Every year, more than 6 million people die from smoking-related diseases. One method used to promote smoking cessation is acupuncture. The present study aims to assess the efficacy of acupuncture for smoking cessation by conducting a review of the currently available evidence. Methods and analysis Sixteen databases will be searched for studies conducted through March 2017. We will include randomized controlled trials (RCTs) assessing acupuncture for smoking cessation. All RCTs on acupuncture or related interventions will be included. Risk of bias will be assessed using the Cochrane risk of bias assessment tool, while confidence in the cumulative evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) instrument. Ethics and dissemination This systematic review will be published in a peer-reviewed journal and will also be disseminated electronically and in print. The review will be updated to inform and guide healthcare practices.

Supplemental Digital Content is available in the text, Introduction: Treating blood stasis is effective in treating obesity and metabolic diseases in traditional Korean medicine. The aim of this prospective observational study is to determine the effectiveness of the diagnosis index for metabolic diseases with blood stasis by analyzing clinical data and blood samples. Methods and analysis: We will perform a prospective observational study. Participants who meet the inclusion criteria will be recruited from the Dongguk university Ilsan Oriental hospital. The outcomes are resistin, serum amyloid P component, C-reactive protein, D-dimer, and blood stasis scores. In addition, the blood pressure, ankle–brachial pressure index, brachial–ankle pulse wave velocity, body mass index, waist circumference, and levels of blood lipid will be assessed. Discussion: Through this study, we could collect specific data for diagnosing metabolic diseases with blood stasis. Therefore, the findings of this study will provide a summary of the current state of evidence regarding the effectiveness of the diagnosis index in managing metabolic disease with blood stasis. Ethics and dissemination: The study was approved by the Institutional Review Board of the Dongguk University Ilsan Oriental Hospital (DUIOH-2018-09-001-007). The results will be published in a peer-reviewed journal and will be disseminated electronically and in print. Trial registration number: Clinical Research Information Service: KCT0003548

Introduction Blood stasis is defined as slowing or stagnation of blood and is regarded as a cause of metabolic disease. The aim of this study was to explore the opinions of traditional Korean medicine (TKM) doctors on blood stasis in metabolic disease. Methods An email with a link to an online survey was sent by the Association of Korean Medicine to all registered TKM doctors in October 2018. The questionnaire was developed and piloted by four Korean medicine doctors and included items on KMDs’ demographic characteristics, their perceptions on blood stasis and current treatment. Results Of the 908 TKM doctors participating in the survey, 836 (92.1 %) reported that they thought metabolic disease was highly associated with blood stasis or that blood stasis was the cause of metabolic disease. Most frequently reported to be associated with blood stasis was vascular disease (n = 405, 44.6 %). Over three quarters of respondents thought that herbal medicine combined with conventional medication was good for managing blood pressure, blood sugar, and blood lipids (n = 724, 79.7 %). The higher cost compared to conventional drugs (n = 463, n = 51.0 %) was thought to be the reason that Korean medicine was not being used for the treatment of metabolic disease. Gyejibongnyeong-hwan and Cardiotonic pills were chosen as the appropriate herbal medicines for treating metabolic diseases as they were covered under herbal medicine insurance. Conclusions This study suggests that further blood stasis research is required, particularly clinical studies in order to determine the strength of the association between blood stasis and metabolic diseases.

Supplemental Digital Content is available in the text, Background: Suoquan is widely used to treat frequent urination, enuresis, and other diseases caused by kidney qi deficiency. Many clinical trials assessing the efficacy and safety of Suoquan for the treatment of enuresis have been reported. This review will assess the clinical evidence for and against the use of Suoquan as a treatment for enuresis. Methods and analysis: Fourteen databases will be searched until 2018. We will include randomized controlled trials (RCTs) examining Suoquan decoctions for any type of enuresis. All RCTs of decoctions or modified decoctions will be included. The methodological qualities of the RCTs will be assessed using the Cochrane Collaboration tool for assessing risk of bias. Ethics and dissemination: This systematic review will be published in a peer-reviewed journal. The review will be disseminated both electronically and in print. It will be updated to inform and guide healthcare practices. Trial registration number: CRD42018087900

Supplemental Digital Content is available in the text, Background: Bojungikki-tang, a herbal medicine for strengthening the digestive system, has been widely used in East Asian countries since the Yuan Dynasty in China. Moreover, Bojungikki-tang has reportedly exhibited anti-allergy effects in many clinical trials. This systematic review will assess the effectiveness and safety of Bojungikki-tang for allergic rhinitis (AR). Methods and analysis: Eleven databases, including Asian databases, will be searched for studies conducted through October 2017. We will include randomized controlled trials (RCTs) assessing Bojungikki-tang for AR. The risk of bias will be evaluated using the Cochrane risk of bias assessment tool, and confidence in the cumulative evidence will be evaluated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) instrument. Ethics and dissemination: This systematic review will be published in a peer-reviewed journal and will also be disseminated electronically and in print. The review will be updated to inform and guide health care practices. Registration: The protocol for this systematic review has been registered in PROSPERO (https://www.crd.york.ac.uk/PROSPERO) under number CRD42017068993.

Background Obesity is a public health concern in many countries due to its increasing prevalence. Euiiyin-tang is an herbal medicine formula often used as a clinical treatment for obesity. It acts to eliminate humidity and purify the blood, the causes of obesity identified by the theoretical framework of Korean medicine. The purpose of this study is to evaluate the efficacy and safety of Euiiyin-tang in treating obesity. Methods/design This study is a randomised, double-blinded and placebo-controlled, multicentre trial. It has two parallel arms: the Euiiyin-tang group and the placebo group. A total of 160 obese adult women will be enrolled in the trial. The participants will be randomly divided at a 1:1 ratio at visit 2 (baseline). The participants will be administered Euiiyin-tang or placebo for 12 weeks. The primary endpoint is the change in weight occurring between baseline and post-treatment. The secondary outcomes include average weight reduction, changes in body fat, waist and hip circumferences, body mass index, and lipid profile, and the results of questionnaires such as the Korean version of Obesity-related Quality of Life, the Korean version of Eating Attitudes Test, the Social Readjustment Rating Scale, and the Stress Reaction Inventory. Discussion The present study will provide research methodologies for evaluating the efficacy and safety of Euiiyin-tang in patients with obesity. In addition, it will provide evidence of correlation between obesity and Sasang constitutional medicine. Trial registration ClinicalTrials.gov, NCT01724099. Registered on 2 November 2012. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2039-8) contains supplementary material, which is available to authorized users.

Background. This survey aimed to investigate the characteristics of users and nonusers of herbal medicine and the adverse events experienced due to herbal medicines in South Korea. Methods. The questionnaire consisted of safety, using experience, using type, usage and nonusage reason, purchase location, and adverse events of herbal medicine. The survey was administered by online. Results. Of the total 1,134 respondents, 726 (64.0%) considered herbal medicine safe, and 693 (61.1%) answered that they have taken herbal medicines within the past year. Most common place to purchase them was “TKM hospital or clinic” (63.6%), and most participants (72.2%) took a decoction from a TKM institution. The biggest reason for taking them was for “health improvement” (57.3%), and the reasons for not using them was “medication not necessary” (63.7%). Among those who took herbal medicines, 46 experienced adverse events, and the most frequently reported symptoms were digestive disorders (52.2%). Of the 46 participants who experienced adverse events, 20 (43.5%) were treated by TKM doctors. Conclusions. This study suggests that regulation of herbal medicines is needed in order to resolve problems related to the safety of herbal medicines.

Background There are growing interests in using various methods including traditional and complementary medicines (T&CM) for tobacco control. The study aimed to introduce how traditional Korean medicine (TKM) applied to smoking cessation programmes in Korea and to show the detail information of each programme for designing other smoke cessation programmes. Methods Reports of the smoke cessation programmes in Korea were searched on March 10th, 2016, from the webpages of the related agencies and the databases: the Ministry of Health and Welfare, the Korea Health Foundation, the Association of Korean Medicine, PubMed, Google scholar, the RISS, the KISS, the NDSL, and the OASIS. Smoking cessation programmes, projects, or services using traditional Korean medicine (TKM) were included with no language, implementation site, and year restrictions. Results The three smoking cessation programmes using TKM in South Korea were the public health centre smoking cessation programme (PHC-SCP), the Ministry of Gender Equality & Family smoking cessation programme (MOGEF-SCP), and the National Health Insurance Service smoking cessation treatment project (NHIS-SCP). All programmes included ear acupuncture and counselling. Manual acupuncture was only used in the NHIS-SCP. The MOGEF-SCP and the NHIS-SCP used herbal medicines selectively. The PHC-SCP and MOGEF-SCP provided education programme and other tools such as non-smoking doll, self-writing handbook. They were run at no cost for participants. Treatment period were different for each programmes, 3 weeks, 4 weeks, 8 to 12 weeks, respectively. Treatment frequency was twice a week for PHC-SCP and MOGEF-SCP, and dependent on each clinic for NHIS-SCP. Conclusions This study showed the summaries of the smoking cessation programme that used TKM. The three programmes and the detail information will be a reference for other countries that are going to apply T&CM to their smoking cessation programme. Though TKM integrated smoking cessation programmes had been contributed to stop smoking, persistent efforts are needed to develop more effective and various treatments. In addition, this study suggests that consistent support and systematic reporting system are needed to be successful in non-smoking strategy. Electronic supplementary material The online version of this article (doi:10.1186/s12906-016-1462-9) contains supplementary material, which is available to authorized users.

Introduction Nicotine dependence is a disease, and tobacco use is related to 6 million deaths annually worldwide. Recently, in many countries, there has been growing interest in the use of traditional and complementary medicine (T&CM) methods, especially acupuncture, as therapeutic interventions for smoking cessation. The aim of this pilot study is to investigate the effectiveness of T&CM interventions on smoking cessation. Methods and analysis The STOP (Stop Tobacco Programme using traditional Korean medicine) study is designed to be a pragmatic, open-label, randomised pilot trial. This trial will evaluate whether adding T&CM methods (ie, ear and body acupuncture, aromatherapy) to conventional cessation methods (ie, nicotine replacement therapy (NRT), counselling) increases smoking cessation rates. Forty participants over 19 years old who are capable of communicating in Korean will be recruited. They will be current smokers who meet one of the following criteria: (1) smoke more than 10 cigarettes a day, (2) smoke less than 10 cigarettes a day and previously failed to cease smoking, or (3) smoke fewer than 10 cigarettes a day and have a nicotine dependence score (Fagerstrom Test for Nicotine Dependence) of 4 points or more. The trial will consist of 4 weeks of treatment and a 20 week follow-up period. A statistician will perform the statistical analyses for both the intention-to-treat (all randomly assigned participants) and per-protocol (participants who completed the trial without any protocol deviations) data using SAS 9.1.3. Ethics and dissemination This study has been approved by the Institutional Review Board (IRB) of the Dunsan Korean Medicine Hospital of Daejeon University (IRB reference no: DJDSKH-15-BM-11–1, Protocol No. version 4.1.).The protocol will be reapproved by IRB if it requires amendment. The trial will be conducted according to the Declaration of Helsinki, 7th version (2013). This study is designed to minimise the risk to participants, and the investigators will explain the study to the participants in detail. As an ethical clinical trial, the control group will also be given conventional cessation treatments, including NRT and counselling. Participants will be screened and provided with a registration number to protect their personal information. Informed consent will be obtained from the participants prior to enrolling them in the trial. Participants will be allowed to withdraw at anytime without penalty. Trial registration number ClinicalTrials.gov (NCT02768025); pre-results.