The Opioid-Sparing Effect of Acupuncture After Abdominal Surgery: A Systematic Review and Meta-Analysis Protocol.

Purpose: Routine overprescribing of postoperative opioid analgesics may induce side effects and correlate with chronic opioid use following surgery. This review aims to evaluate the effectiveness and safety of acupuncture for opioid-sparing effects in patients who underwent abdominal surgery. Methods: Eleven databases in different languages, including English (Ovid MEDLINE, CENTRAL, EMBASE, CINAHL), Chinese, Korean, and Japanese, will be searched. Randomized controlled trials using acupuncture for postoperative pain control in adult patients undergoing abdominal surgery will be screened. All randomized controlled trials comparing acupuncture with no treatment, sham acupuncture, and conventional treatments will be included. The Cochrane risk of bias tool will be used to assess the risk of bias. The primary outcome will consist of a cumulative opioid consumption. Additionally, the number of cumulative opioid analgesic demands/requests, the time to initial opioid analgesic usage, postoperative pain, opioid-related side effects, and adverse events of acupuncture will be assessed. The mean differences or risk ratios with a 95% confidence interval will be calculated to estimate the pooled effect of acupuncture when it is possible to conduct a meta-analysis. Results: This study could confirm the effect of opioid-sparing on acupuncture after abdominal surgery. Conclusion: This study would evaluate the evidence on the effectiveness of acupuncture after abdominal surgery with a focus on opioid intake. It provides evidence to support decision-making on applying acupuncture for postoperative management. Registration Number: CRD42022311155.

Treatment of nausea and vomiting associated with cerebellar infarction using the traditional herbal medicines banhabaekchulcheonma-tang and oryeong-san: Two case reports (CARE-complaint).

RATIONALE: Metoclopramide is commonly used to treat nausea and vomiting. However, long-term administration of metoclopramide is associated with various adverse effects, and its therapeutic effects are short-lasting. Hence, traditional East Asian medicine has received increasing attention as a short-term strategy for treating these symptoms. PATIENT CONCERNS: The present report discusses the cases of a 71-year-old man and an 80-year-old woman diagnosed with cerebellar infarction. Both patients reported nausea and vomiting, which appeared during hospitalization following cerebellar infarction. DIAGNOSES: One patient was diagnosed with a left cerebellar infarction and hemorrhagic transformation, while the other was diagnosed with a bilateral cerebellar infarction. INTERVENTIONS: Both patients took Banhabaekchulcheonma-tang (BT) and Oryeong-san (OS) extracts. OUTCOMES: The patient in Case 1 experienced a rapid decrease in nausea from day 5 of BT and OS administration, and metoclopramide was discontinued on day 7. The patient in Case 2 experienced a clear decrease in the number of vomiting episodes from day 6 of BT and OS administration and did not take metoclopramide thereafter. LESSONS: Other than drugs used to mitigate symptoms, there are no suitable treatments available for nausea and vomiting caused by cerebellar infarction. In the present cases, nausea and vomiting remained unresolved even after 3 weeks of treatment with conventional therapies; however, these symptoms significantly improved after administration of the traditional East Asian herbal medicines BT and OS, and there were no recurrences. These cases demonstrate that traditional herbal medicine can reduce the side effects associated with long-term administration of metoclopramide and help patients resume their daily lifestyle. In addition, BT and OS treatment can facilitate administration of other drugs, highlighting its potential to aid in the treatment of stroke. Further research including relevant clinical trials is required to obtain more conclusive evidence.

Use of traditional, complementary and alternative medicine in nine countries: A cross-sectional multinational survey.

OBJECTIVES: Traditional, complementary, and alternative medicine (TC&AM) play an exceptional role in health care around the world as many patients has sought a holistic approach. SETTING: In this study, a multinational survey was developed and administered to obtain experience, attitude, and promotion information with regard to the international use of TC&AM among nine countries: Germany, United States, Japan, China, Malaysia, Vietnam, Russia, Kazakhstan, and United Arab Emirates (UAE). The survey was administered via online to members of SurveyMonkey Audience, a proprietary panel of respondents who were recruited from a diverse population worldwide. RESULTS: A total of 1071 participants has completed the survey. The participants were in favor of the treatments and therapies as well as expressed positive attitudes and also have used herbal medicine treatment more than acupuncture therapy and also used the modalities to promote metabolism rather than treating musculoskeletal diseases. Moreover, participants mentioned that TC&AM should be applied for treating and managing infectious diseases, such as COVID-19. Additionally, participants recommended using Facebook channel to promote its treatments and therapies. CONCLUSION: Based on the results, this study provides initial insights on TC&AM that may influence the non-users globally and perhaps inspire a need for further research including more countries in different continents.

Factors influencing use of conventional and traditional Korean medicine-based health services: a nationwide cross-sectional study.

BACKGROUND: In Korea, conventional medicine (CM) and traditional Korean medicine (KM) are run as a dual healthcare system; however, the backgrounds and characteristics of the users of both medical services have not yet been compared. This study aimed to identify the differences in factors determining the use of CM and KM health services. METHODS: A secondary data analysis of a nationwide cross-sectional survey was conducted in this study. The Survey on the Experience with Healthcare Services 2017 asked participants about their most recent outpatient visit to a health service. Initially, a descriptive analysis was performed on respondents who visited the CM or KM health service in the last 12 months. Then, logistic regression analysis using Andersen's behavioral model was performed, to identify the factors affecting health service selection, by classifying demographic variables into predisposing, enabling, and need factors. Respondents who replied they did not frequently use CM/KM and those with missing data were excluded. RESULTS: Of the total 11,098 respondents, 7,116 (64.1%) reported to have used CM/KM: 2,034 (18.3%), 4,475 (40.3%), and 607 (5.5%) for hospital CM, clinic CM, and KM, respectively. In logistic regression analysis, of the 2,723 (24.5%) respondents analyzed, 822 (7.4%) went to a hospital, 1,689 (15.2%) to a clinic, and 212 (1.9%) opted for KM service. Respondents with a higher number of chronic diseases were less likely to use KM (one disease, odds ratio: 0.52, 95% confidence interval: 0.36-0.76; two diseases: 0.51, 0.31-0.85; three to five diseases: 0.26, 0.10-0.69). Respondents with a high income were likely to go to the hospital (4Q vs. 1Q: 1.92, 1.35-2.72) and less likely to go to the clinic (4Q vs. 1Q: 0.49, 0.35-0.68). CONCLUSIONS: Significant differences were observed on the enabling factor (income) for CM and need factors (number of chronic diseases) for KM. Our analysis suggests that through the healthcare policy, we should consider stratifying user backgrounds and needs for each medical service.

A Time-Dependent Analysis of Association between Acupuncture Utilization and the Prognosis of Ischemic Stroke.

This study investigated the time-dependent characteristics of acupuncture and analyzed the association between acupuncture utilization and mortality rates, readmission rates, and complications among ischemic stroke patients. Data from the National Health Insurance Service-National Sample Cohort 2.0 from South Korea were used to track patients with subacute and chronic ischemic stroke, who had survived more than one month after onset, between 2010 and 2013. A total of 2299 patients were followed up until 2015. At baseline, the acupuncture group (n = 195) and the control group (n = 2104) had similar ages (acupuncture group: 69.0 ± 11.1 years; control group: 68.5 ± 11.8 years), but the acupuncture group had more comorbidities (Charlson comorbidity index; acupuncture group: 4.7 ± 2.1, control group: 4.3 ± 2.4). According to time-dependent Cox regression survival analysis, acupuncture treatment was associated with low hazard ratios (HR) for death (HR: 0.32; 95% confidence interval (CI): 0.18-0.60), fewer composite complications (HR: 0.34; 95% CI: 0.21-0.53), and reduced urinary tract infection (HR: 0.24; 95% CI: 0.11-0.54). Many acupuncture session sensitivity analyses were performed to assess the robustness using different criteria to define the acupuncture group, and the results were consistent with those of the main analysis. Therefore, acupuncture treatment might be associated with lower mortality rates and the prevention of complications after ischemic stroke.

Combined Korean medicine therapies in children with allergic rhinitis: A multi-center, observational explanatory registry trial: A study protocol.

INTRODUCTION: Allergic rhinitis (AR) is the third most prevalent disease in early and middle adolescence in South Korea and one of the most common allergic diseases worldwide. Due to the ineffectiveness and frequent side effects of conventional medications for AR (such as antihistamines, corticosteroids) complementary and alternative medical (CAM) therapies have been in the spotlight. Although previous clinical trials conducted on AR with CAM showed efficacy and safety, these research results have limitations in that they did not estimate the effectiveness of combining multiple interventions. In this respect, this study aims to investigate the efficacy and safety of combined Korean medicine therapy by establishing an observational registry study at 13 Korean medical clinics that specialize in treating pediatric rhinitis. METHODS: This is a prospective, observational, registry study of adolescent patients with AR. After screening, eligible subjects will be allocated to the registry. The patients will undergo a 4-week treatment and a 4-week post-treatment follow-up. The primary outcome will be the change in the average total nasal symptom score evaluated from baseline to the end of treatment. The secondary outcomes will include the numerical range scale, quality of life questionnaire in Korean children with AR, and the Pediatric Allergic Disease Quality of Life Questionnaire. KiFDA 3.0 will be measured for explanatory application on adolescents. Medical cost data and characteristics of patients such as weight, height, and sex will be collected by researchers. DISCUSSION: This is the first multi-center observational registry study to compare combined Korean medicine treatment for AR. The results of this study will shed light on the effectiveness and safety of Korean medicine treatments for the treatment of patients with AR. TRIAL REGISTRATION: KCT0006625 (2021.09.30)/IRB approval: Kyung-hee University Institutional Review Board (approval number: KHSIRB-21-358-1 [NA]).Trial Status: Protocol version 1.2(2021.09.16).

Successful treatment of restless leg syndrome with the traditional herbal medicines Dangguijakyak-san and Shihogyeji-tang: A case report (CARE-compliant).

RATIONALE: Dopamine replacement is currently the standard treatment for restless leg syndrome (RLS); however, various adverse effects are associated with long-term therapy, and the benefits disappear upon discontinuation. To overcome these limitations, interest in traditional East Asian medicine has increased. PATIENT CONCERNS: A 72-year-old Asian woman originally admitted for an intracerebral hemorrhage presented with complaints of an unpleasant sensation throughout the body that appeared at night. DIAGNOSES: The patient was diagnosed with chronic persistent RLS based on the 2012 Revised International Restless Leg Syndrome Study Group Diagnostic Criteria. INTERVENTIONS: The patient was treated with extracts of the traditional herbal medicines Dangguijakyak-san (DS) and Shihogyeji-tang (ST). After 47 days of therapy, all herbal medicines were discontinued, and symptoms had not returned by the last follow-up 244 days after the initial treatment. OUTCOMES: One week after initiating herbal treatment with DS and ST, the RLS symptoms began to improve, and the total hours of sleep had increased from 2 to 9 hours by day 21, with a Korean version of the international restless legs scale score of 11 points. On day 36, ST was discontinued, given the continued improvement of symptoms. On day 47, symptoms had disappeared (Korean version of the international restless legs scale score: 0), and sleep disturbances caused by RLS had completely resolved. After day 47, DS was also discontinued. There were no adverse effects associated with the administration of DS and ST, and the symptoms had not recurred by the last follow-up on day 244. LESSONS: In this case, RLS related symptoms, which had been present for approximately 60 years, were improved using only the traditional herbal medicines DS and ST (without dopamine replacement), and no symptoms recurred for 244 days. This case suggests that if replacement therapy is difficult or not desired, herbal medicinal therapies may be an effective alternative. This also suggests that the effect of herbal medicine on RLS might be semi-permanent. Further investigations, including clinical trials, are needed to confirm these effects.

How Suppressed Anger Can Become an Illness: A Qualitative Systematic Review of the Experiences and Perspectives of Hwabyung Patients in Korea.

Background: In the clinical field, anger has generally been studied in terms of aggressive behavior. However, in Asians, anger suppression is more common than anger expression. Hwabyung is a culture-related anger syndrome in Korea and is known to occur due to the continued repression of anger. Investigating Hwabyung should lead to a better understanding of the multiple dimensions of anger. To explore Hwabyung patients' experiences and perspectives, a meta-aggregation approach was used to conduct a systematic review and a qualitative synthesis. Methods: A systematic search was conducted in MEDLINE/PubMed, EMBASE, Allied and Complementary Medicine Database (AMED), Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycARTICLES, and four Korean databases [Korean Medical Database (KMbase), Korean Studies Information Service System (KISS), National Digital Science Library (NDSL), and Oriental Medicine Advanced Searching Integrated System (OASIS)] in September 2020. Studies were included if they collected and analyzed qualitative data from Hwabyung patients. Qualitative research findings on the experiences and perspectives of Hwabyung patients in Korea were critically appraised and synthesized using the Joanna Briggs Institute methodology. Results: Seven eligible studies were included. The findings from those studies (i.e., theme or subtheme of qualitative research) were aggregated into categories (a group of similar findings) and synthesized findings (a group of categorized findings). Ultimately, 116 findings were aggregated into 15 categories. Finally, four synthesized findings were derived from the 15 categories: (i) anger arousal, (ii) blame, (iii) uncontrollable physical and emotional symptoms, and (iv) compromise and temporary coping. Conclusions: Patients with Hwabyung experience chronic anger through the complex cognitive processes involved in blame. Hwabyung negatively affects patients' physical, psychological, and social functions. Because Hwabyung patients feel as if they are losing control, due to emotional dysregulation and physical symptoms, professional support should be provided to facilitate their coping strategies. Further studies on Hwabyung can serve as a new model of pathological anger.

Traditional East Asian herbal medicines for the treatment of poststroke constipation: A protocol for systematic review and meta analysis.

BACKGROUND: Post-stroke constipation is a major complication of stroke and increases the incidence of poor neurological outcomes and infectious complications and, therefore, warrants active and prompt treatment. In East Asian countries, several types of herbal medicines have been used for the treatment of post-stroke constipation because they are considered safer than existing pharmacotherapies. However, no systematic review has investigated the efficacy and safety of traditional East Asian herbal medicine in the treatment of post-stroke constipation. With this systematic review and meta-analysis, we aimed to evaluate the efficacy and safety of traditional East Asian herbal medicines for the treatment of post-stroke constipation. METHODS AND ANALYSIS: Eight electronic databases will be searched for relevant studies published from inception to April 2021. Only randomized controlled trials (RCTs) that assess the efficacy and safety of traditional East Asian herbal medicines for the treatment of post-stroke constipation will be included in this study. The methodological qualities, including the risk of bias, will be evaluated using the Cochrane risk of bias assessment tool. After screening the studies, a meta-analysis of the RCTs will be performed, if possible. RESULTS: This study is expected to generate high-quality evidence of the efficacy and safety of herbal medicines to treat post-stroke constipation. CONCLUSION: Our systematic review will provide evidence to determine whether herbal medicines can be effective interventions for patients with post-stroke constipation. ETHICS AND DISSEMINATION: Ethical approval is not required, as this study was based on a review of published research. This review will be published in a peer-reviewed journal and disseminated electronically and in print. TRIAL REGISTRATION NUMBER: Research registry reviewregistry1117.

Bibliometric Analysis of Integrative Medicine Studies from 2000 to 2019.

Integrative medicine has become a vital component of patient care. It provides patient-centered care that is focused on prevention and overall well-being. As there has been a growing number of patients favoring a blend of conventional, complementary and alternative approaches, integrative medicine has exceeded beyond the evaluation of complementary therapies. However, it is noteworthy that there has been a dilemma of providing substantial evidence supporting the efficacy of some complementary and alternative therapies. This study's goals were to analyze publication trends, most productive journals, most productive funding agencies, most productive authors, most relevant keywords, and countries in the field of integrative medicine research. Additionally, science mapping included country collaboration analysis and thematic evolution analysis. The findings from this study showed a constant rise in annual growth of publications from 2000 to 2019; the United States was dominant in various analysis categories. In conclusion, a comprehensive review of the evolution of research of integrative medicine will help healthcare providers understand an overview of the present status while encouraging more evidence-based research for the betterment of integrative patient care.

Adverse events from pharmacopuncture treatment in Korea: A protocol for systematic review and meta analysis.

BACKGROUND: Pharmacopuncture is a combination of acupuncture and herbal medicine, which involves the injection of herbal extracts into acupuncture points (acupoints). Pharmacopuncture has become one of the major therapeutic tools used in Korea; however, safety is one of the major concerns associated with it. We aim to systematically review clinical studies on the adverse events of pharmacopuncture in Korea. METHODS: To collect data on the incidence and characteristics of adverse events (AEs) and to evaluate pharmacopuncture safety, 2 or more researchers will conduct a comprehensive search of pertinent English and Korean databases using the keywords "pharmacopuncture" and "adverse events." Regardless of the participants' conditions or treatment types, we will include clinical studies on the AEs of pharmacopuncture. Studies that were not conducted in Korea, and acupoint injections containing Western medications, vitamins, or autologous serum will be excluded from this study. The severity of AEs will be classified using the common terminology criteria for adverse events, and the causality between pharmacopuncture and AEs will be assessed using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) causality scale. The quality of identifying and reporting the AEs will be assessed using the McHarm scale. The risk of selection bias will be assessed using the Cochrane risk of bias and the risk of bias for non-randomized studies tools. Studies will be assessed for heterogeneity utilizing Higgins's I2 statistics, and the risk of publication bias will be assessed and expressed in the form of a contour-enhanced funnel plot. RESULTS AND CONCLUSION: Comprehensive investigation of all types of clinical studies in Korea will provide clearer evidence of the safety of pharmacopuncture. The results of this study will be useful for traditional medical doctors and patients who use such treatments and interventions.Systematic Review Registration: Open Science Foundation (osf.io/umhyz).

Trends for weight control strategies in Korean adults using the Korea National Health and Nutrition Examination Survey from 2007 to 2017.

BACKGROUND: Obesity is an increasing global health problem and is associated with various diseases including stroke, respiratory diseases, diabetes mellitus, and hypertension. Various weight control strategies such as exercise, calorie-restricted diet, anti-obesity medication, herbal medicine, and functional food are being used. The present study aimed to investigate the trends of weight control strategies in Korean adults METHODS: This was a cross-sectional study that used data from the Korea National Health and Nutrition Examination Survey from 2007 to 2017. A total of 64,207 participants were analyzed. The body mass index (BMI), subjective judgment of body appearance, practice of weight control, and methods to control weight were analyzed according to year and sex. RESULTS: The prevalence rate of obesity in men based on a BMI of 25 or higher was slightly increased from 37.0% in 2007 to 41.1% in 2017. Among the weight control strategies, use of exercise decreased from 83.8% to 80.5% in men, and from 73.4% to 69.5% in women, reduction in the amount of food consumed increased from 47.1% to 60.5% in men and from 65.1% to 70.6% in women, consumption of functional food increased from 3% to 6.2% in men and from 3.2% to 8.7% in women, and rate of skipping meals increased from 6.1% to 12.0% in men and from 11.5% to 14.0% in women. CONCLUSION: The present study showed that exercise has decreased and dietary control and functional food consumption have increased as weight control strategies in Korean adults during the past decade.

Acupuncture as an adjuvant therapy for management of treatment-related symptoms in breast cancer patients: Systematic review and meta-analysis (PRISMA-compliant).

BACKGROUND: Although randomized controlled trials have revealed the considerable effectiveness of acupuncture in breast cancer patients, there have been no studies exploring current acupuncture research trends for treatment induced various symptoms in breast cancer patients. This review evaluated the effectiveness of acupuncture for treatment-induced symptoms in breast cancer patients. METHODS: We performed a systematic review and meta-analysis of the literature regarding acupuncture to treat symptoms associated with breast cancer therapies. The following databases were searched for relevant RCTs published before June 2018: MEDLINE, EMBASE, the Cochrane Library, AMED, CINAHL, OASIS, CNKI, and CiNii. RESULTS: Among the 19,483 records identified, 835 articles remained after screening titles and abstracts. A total of 19 RCTs were included in this qualitative synthesis. Among the studies, 8 explored climacteric symptoms, 4 explored pain, 2 explored lymphedemas, 2 explored nausea and vomiting and 3 investigated miscellaneous symptoms.explored miscellaneous symptoms due to cancer treatments. Most of the studies reported that acupuncture can alleviate various symptoms of breast cancer treatment. However, there is a lack of evidence as to whether accupuncture can alleviate chemotherapy associated side effects CONCLUSIONS:: Acupuncture may alleviate the treatment-related symptoms of breast cancer; however, further studies are necessary to obtain conclusive evidence of the effectiveness of acupuncture in treating breast cancer. REGISTRATION NUMBER: CRD42018087813.

Evaluation of efficacy and safety of single and multiple therapy of herbal medicine/Chuna therapy on non-specific chronic low back pain: A study protocol for multicenter, 3-arm, randomized, single blinded, parallel group, incomplete factorial design, pilot study.

INTRODUCTION: Chronic non-specific low back pain is one of the common health issues which reduce the quality of life and in working population. While combined therapeutic treatment method is widely used for musculoskeletal related disorders in Korea, well-developed trials on the efficacy of single or combine therapy on herbal medicine and Chuna manual therapy (CMT) are scarce. OBJECTIVE: This study aims to evaluate the clinical efficacy and safety of herbal medicine, Sogyeonghwalhyeol-tang (SGHH) on work related chronic low back pain patients. The primary aim is to determine the efficacy of a combined multidisciplinary approach using SGHH with CMT compared to SGHH alone. The secondary aim is to examine the naïve direct comparison between SGHH and placebo. METHOD: This trial is designed as a multicenter, randomized, controlled, clinical trial. A total of 150 participants who have with chief complaint of low back pain in Korean medicine rehabilitation center will be randomly assigned to 1 of 3 treatments with a ratio of 1:1:1. Eligible participant will be randomized to treatment arm A receive single treatment of Sogyeonghwalhyeol-tang, in treatment Arm B Sogyeonghwalhyeol-tang and Chuna manual therapy are administered concurrently, in treatment arm C, where individuals receive placebo with Chuna manual therapy. They will receive assigned treatment in 4 weeks and follow-up for 4 weeks. The primary endpoint is to assess the change in severity of low back pain from baseline. The secondary endpoints are the following: the changes in disability and health related quality of life. Adverse events will also be reported. DISCUSSION: The study result will provide the valuable information for efficacy and safety of monotherapy and multiple therapy of herbal medicinal extract and Chuna manual therapy on chronic non-specific low back pain. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03132974.

Korean medicine registry for low back pain - A study protocol for prospective observational multi-center study (KLOS).

BACKGROUND: Low back pain (LBP) is a major burden in Korea. Despite its high prevalence, the government and the public health sector do not address the specific evidences of symptom control and prevention of LBP to reduce long-term healthcare costs and increase the quality of life. Thus, the Korean medicine sector encourages to collection and analysis of the medical utilization pattern of patients with LBP in Korea to provide evidences of LBP control strategy as well as political decisions. METHODS: KLOS, a prospective, multi-center, patient registry pilot study will collaborate with 7 traditional Korean medicine hospitals and recruit patients with LBP into the registry. A total of 150 eligible patients with new episodes of LBP, who visit a Korean hospital without any other treatment history, will be enrolled in the registry. After enrollment, we will collect the individual characteristics of each patient, such as pain intensity, LBP-related daily disability, anthropometrics, and Health-Related Quality of Life (HRQoL) at baseline and FU1 and FU2. We will also access the patients' clinical and administrative electronic records to analyze the pattern of patients' resource utilization. Overall, the aims of KLOS are to (1) explore the general characteristics of patients with new episodes of LBP and (2) evaluate the efficacy and safety of various Korean medicine treatments for LBP, based on nationwide registry outcome collecting process. DISCUSSION: The first pilot study of prospective, multi-center registry of newly diagnosed LBP patients in traditional Korean medicine hospitals. The result of this study may show the current status of LBP patients who receive Korean medicine treatments and provide evidences for reasonable decision-making on Korean medicine healthcare policy in the future. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT02418286.

Exploring the efficacy and safety of herbal medicine on Korean obese women with or without metabolic syndrome risk factors: A study protocol for a double-blind, randomized, multi-center, placebo-controlled clinical trial.

BACKGROUND: The prevalence of obesity among women is increasing. Obesity is associated with various metabolic syndromes; conventional treatments are limited and may induce serious adverse events due to polytherapy regimens. Currently, demands for complementary and alternative medicine that has a proven safety profile for the treatment of obesity with or without metabolic risk factors are increasing.Our team of preclinical experts reported a significant anti-obesity effect of the Korean herbal medicine, Galgeun-tang (GGT). Thus, we designed this trial to explore the effects of GGT among obese women to accumulate optimal clinical evidence.Obesity is not only a component of metabolic syndrome and a factor associated with an increased risk of cardiovascular disease but is also related to insulin resistance. Previous research has confirmed that an increasing body mass index is highly related with increased risk of metabolic syndrome among overweight and obese individuals. The effectiveness of the Korean medicine herbal formula, GGT on obesity has been previously reported. The objective of this study is to assess the efficacy and safety of GGT for weight loss among obese Korean women with or without high risk for metabolic syndrome. METHODS/DESIGN: This study is a randomized, double-blinded, placebo-controlled, multi-center clinical trial. A total of 160 participants will be randomly distributed in 2 groups, the GGT group or the placebo group in a 1:1 ratio using a web-based randomization system. Each group will be administered GGT or placebo 3 times a day for 12 weeks. The primary endpoint is to assess the change in weight from baseline. The secondary endpoints are the following: the changes in body composition measurements, anthropomorphic measurements, obesity screening Laboratory tests, patient self-reported questionnaires, and economic evaluation outcomes. Adverse events will also be reported. DISCUSSION: The findings of this study will confirm methodologies regarding the efficacy and safety of GGT for weight loss among obese Korean women with or without metabolic risk factors.

Utilization of traditional medicine in primary health care in low- and middle-income countries: a systematic review.

This paper reports the findings from the first systematic review of the utilization of traditional medicine (TM) in primary health care (PHC) in low- and middle-income countries (LMICs). PHC is an important component of health care and essential for achieving universal health coverage (UHC). For countries where there is a gap in PHC, TM plays a vital role. It is widely used and has the potential to increase the coverage of PHC and UHC. Hence in situations where TM is recognized in a considerable magnitude, there are scarce evidence and minimal regulation on it and TM practitioners (TMPs). This study aims to identify the current situation in the utilization of TM in PHC or UHC in LMICs. A systematic review and thematic synthesis of qualitative and quantitative studies have been conducted. A total of 56 articles met the criteria and were included in the review. In all, 14 analytic themes have been developed including the current use of TM in PHC, higher accessibility of TM, medical pluralism, national health system, national health policy and national health insurance to include TM, including TMPs in the referral system, utilizing TMPs as community health workers, the needs of scientific research on TM and the need for training both TMPs and conventional medical staffs for better collaboration. The study concluded that it is necessary to further focus on TM in the macro level on strengthening the referral system by including TM to establish a comprehensive service delivery network under UHC and in the micro level to focus on training the TMPs and conventional medicine health workers on both areas to attain more in-depth understanding of each other, which can lead to better collaboration and quality patient care.

Efficacy and safety of ucha-shinki-hwan on korean patients with cold hypersensitivity in the hands and feet: Study protocol clinical trial (SPIRIT Compliant).

BACKGROUND: Cold hypersensitivity in the hands and feet (CHHF) is a common complaint in Asian female population especially in Korea. Due to the symptoms of CHHF the quality of individual's daily life can be degraded. Ucha-Shinki-Hwan (UCHA) is widely used in the treatment of various diseases including CHHF by harmonizing Yin and Yang, and improving the vitality of whole body. However, the efficacy of UCHA as a treatment option of CHHF has not been assessed in trials. Thus, we aimed to investigate the efficacy and safety of UCHA in Korean women with CHHF through this trial. METHODS: This study will be an exploratory, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. Korean women aged 19 to 59 years who complaint with CHHF will be enrolled from 5 university affiliated Korean medicine hospitals. A total of 164 subjects will be randomly assigned to a treatment group (UCHA) or a placebo group at a 1:1 ratio. The subjects will receive 2.5 g of either UCHA or placebo three times a day for 8 weeks. The primary outcome will be evaluated with the visual analog scale score of CHHF. The secondary outcome measures will be changes in skin temperature in extremities as measured by using a thermometer and the Korean version of the World Health Organization Quality of Life Scale Abbreviated Version. DISCUSSION: This study will be the first trial to explore the efficacy and safety of UCHA for CHHF patient. This will provide meaningful clinical information on herbal medicine treatment of CHHF and a clinical evidence for planning a full randomized clinical trial. DISCLOSURES AND ACKNOWLEDGMENTS: The authors report no competing interests. TRIAL REGISTRATION: This study is registered at ClinicalTrials.gov, ID: NCT03790033. Registered on (31 December 2018) PROTOCOL VERSION:: The final approved version of the trial protocol is V1.3. (25 January 2019).

A pilot study exploring the efficacy and safety of herbal medicine on Korean obese women with metabolic syndrome risk factors: Double blinded, randomized, multicenter, placebo controlled study protocol clinical trial.

BACKGROUND: Obesity is associated with metabolic syndrome, a condition that increases one's risk for heart disease and other conditions. The prevalence of obesity and associated diseases have steadily increased among Korean adults. The effect of the herbal medicines Daesiho-tang (DSHT) and Chowiseungcheng-tang (CST) on obesity have been reported. The purpose of this study is to evaluate the efficacy and safety of Daesiho-tang and Chowiseungcheng-tang on obese Korean women with high risk for metabolic syndrome. METHODS/DESIGN: This study is a randomized, double-blinded, placebo-controlled, multi-center, 3-arm, parallel group clinical trial. A total of 120 participants will be enrolled and randomly assigned to the Daesiho-tang group, the Chowiseungcheng-tang group, or the placebo group in a 1:1:1 ratio using an internet-based randomization system at visit 2. Each group will be administered DSHT, CST, or placebo 3 times per day for 12 weeks. The primary outcome is to evaluate the changes in mean body weight of participants in the DSHT and CST groups and compare with those in the placebo group, and determine their statistical significance, if any, after 12 weeks. The secondary outcomes are the following: changes in body fat percentage and body fat mass, changes in waist circumference, waist-to-hip ratio, and body mass index, changes in serum lipids, fasting blood sugar, blood pressure, and C-reactive proteins (CRP) levels between visit 1 and visit 5 measurements. Changes in visceral fat volume determined through abdominal computed tomography, patient-reported health outcomes surveys-the Korean version of the Obesity-related Quality of Life and the Korean version of Eating Attitudes Test. DISCUSSION: This study will provide research methodologies for evaluating the efficacy and safety of Daesiho-tang and Chowiseungcheng-tang on obese Korean women with high risk for metabolic syndrome. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02651454. Registered on 11 January 2016.Protocol version: The final approved version of the trial protocol is V1.3.(2017.11.10).