A survey on Koreans' preferred type of collaboration between conventional medical and traditional Korean medicine doctors.

ABSTRACT: Although collaborative treatment by traditional Korean medicine doctors (KMDs) and medical doctors occurs, it is mainly done by referral. As no survey of the general public's preference for the type of collaboration has ever been conducted, we aimed to investigate Koreans' preferences for a collaborative treatment type.The responders were extracted by random digit dialing and then reextracted using the proportional quota sampling method by sex and age. From July to October 2017, telephone interviews were conducted and the participant responses regarding treatment history for spinal or joint diseases, experiences with collaborative treatment, and preferred type of collaborative treatment were recorded.Of the 1008 respondents, 44.64% reported a history of treatment for spinal or joint diseases at a medical institution. The concurrent collaborative treatment system, in which both KMDs and medical doctors are present in one location participating in the treatment concurrently, was the most preferred system among the respondents. Respondents who reported experience with traditional Korean medicine hospitals were more likely to prefer a one-stop treatment approach than those who did not have experience with traditional Korean medicine hospitals (adjusted odds ratio: 1.73; 95% confidence interval: 1.12-2.68). Respondents who were familiar with collaborative treatment but did not report any personal experience with it were more likely to prefer a one-stop treatment approach than those who were not familiar with collaborative treatment (adjusted odds ratio: 1.82; 95% confidence interval: 1.37-2.44).Koreans prefer a concurrent type of collaborative treatment system by KMDs and medical doctors. Therefore, efforts and support are needed to increase the application of the concurrent type of collaborative system.

The effectiveness and safety of Chuna manual therapy on scoliosis: A protocol for systematic review and meta-analysis.

BACKGROUND: Scoliosis is a spinal deformity and is diagnosed as Cobb angle being greater than 10°. Because it is accompanied with structural dysfunction, it can cause pain, worsen the patient's general health and quality of life. The prevalence of scoliosis has been increasing and many treatments, including surgical treatment and conservative treatment, such as observation, bracing, physiotherapy, and Chuna manual therapy (CMT), have been suggested. CMT is a manual therapy in Korean medicine that provides effective stimulation to the patient's body structure to treat structural dysfunction. After Korean national health insurance's coverage of CMT in 2019, the application of CMT for scoliosis has increased, and many studies have been reported. There have been attempts to elucidate the effectiveness of CMT on scoliosis; however, its effectiveness still remains unconfirmed. Therefore, the aim of this study is to evaluate the effectiveness and safety of CMT on scoliosis. METHODS: The published randomized controlled trials that evaluated the effectiveness and safety of CMT for scoliosis will be searched for in multiple electronic databases without the limitation of country and language. Data on characteristics of studies, interventions, comparators, outcome measures, results, and information for assessment of study quality will be extracted. The primary outcome will be the Cobb angle and the secondary outcomes will be the scales of pain, function, quality of life and disability, and adverse events. Data synthesis and analysis will be conducted using the Review Manager software for Windows (RevMan ver. 5.3.; Copenhagen; The Nordic Cochrane Center, The Cochrane Collaboration, 2014). Subgroup analysis to identify the differences between different CMT maneuvers will also be performed. For risk of bias assessment, the "risk of bias" tool from Cochrane Collaboration will be used. RESULTS: This study will present the clinical evidence on the effectiveness and safety of CMT on scoliosis. CONCLUSION: This study will propose useful evidence for treatment, further research, and health policies in the future.

Allomyrina dichotoma larval extract has protective effects against gut permeability of dextran sulfate sodium-fed Drosophila by E-cadherin and armadillo.

ETHNOPHARMACOLOGICAL RELEVANCE: Larvae of the rhinoceros beetle (Allomyrina dichotoma) (ADL) are used ethnopharmacologically to treat gut-related disorders in Korea and China since 1596 and are also approved as a safe novel food with high nutritional value. AIM OF THE STUDY: We investigated the protective effects of ADL extract against leaky gut disease using a Drosophila model and sought to elucidate the underlying biological mechanisms. MATERIALS AND METHODS: We examined the protective effects of ADL extract (2 mg/mL) against the leaky gut disease using a dextran sulfate sodium (DSS)-induced leaky gut Drosophila melanogaster model. RESULTS: We found that oral administration of ADL extracts significantly increase the survival rate of DSS-fed Drosophila. Under conditions of DSS-induced gut damage, ADL extract reduced gut cell apoptosis and gut permeability, resulting in the maintenance of gut tissue homeostasis. Furthermore, we observed that oral administration of ADL extract can induce high levels of E-cadherin gene expression and also restored the original membrane localization of DSS-disrupted E-cadherin contiguous with the armadillo. CONCLUSION: We concluded that ADL extract plays an important role in maintaining gut homeostasis through the up-regulation of E-cadherin and that it may have a protective effect against leaky gut syndrome.

Pharmacological Effects of Agastache rugosa against Gastritis Using a Network Pharmacology Approach.

Agastache rugosa is used as a Korean traditional medicine to treat gastric diseases. However, the active ingredients and pharmacological targets of A. rugosa are unknown. In this study, we aimed to reveal the pharmacological effects of A. rugosa on gastritis by combining a mice model and a network pharmacology method. The macrophage and gastritis-induced models were used to evaluate the pharmacological effects of A. rugosa. The results show that A. rugosa relieved mucosal damage induced by HCl/EtOH in vivo. Network analysis identified 99 components in A. rugosa; six components were selected through systematic screening, and five components were linked to 45 gastritis-related genes. The main components were acacetin and luteolin, and the identified core genes were AKT serine/threonine kinase 1 (AKT1), nuclear factor kappa B inhibitor alpha (NFKBIA), and mitogen-activated protein kinase-3 (MAPK3) etc. in this network. The network of components, target genes, protein-protein interactions, and the Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway was closely connected with chemokines and with phosphoinositide 3-kinase-Akt (PI3K/AKT), tumor-necrosis-factor alpha (TNFα), mitogen-activated protein kinase, nuclear factor kappa B, and Toll-like receptor (TLR) pathways. In conclusion, A. rugosa exerts gastro-protective effects through a multi-compound and multi-pathway regulatory network and holds potential for treating inflammatory gastric diseases.

An observational study on diagnosis index of metabolic disease with blood-stasis.

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.

Observational study on effectiveness and safety of integrative Korean medicine treatment for inpatients with sciatica due to lumbar intervertebral disc herniation.

We developed a protocol for a prospective registry to prove the effectiveness and safety of integrative Korean medicine treatment for inpatients with sciatica due to lumbar intervertebral disc herniation. We plan on recruiting 1000 inpatients receiving integrative Korean medicine treatment for lumbar intervertebral disc herniation at four spine specialized Korean medical hospitals. Patients enrolled in the registry will be evaluated at the time of hospitalization, 2 weeks after hospitalization, at discharge, and 6 months after hospitalization on predefined outcome variables such as intensity of back and leg pain, Oswestry Disability Index, quality of life, Patient Global Impression of Change, and adverse effects. The protocol of this study was registered in CRIS (KCT0003709) and Clinical trial gov (NCT03750591). This study is significant in that it cannot only be a basis for safety-related evidence of complementary alternative medicine, which has been lacking, but it also gives clear evidence on the effectiveness and validity of treatment effects such as accompaniment of stenosis, sex, age, and type of disc herniation.

Efficacy and safety of Euiiyin-tang in Korean women with obesity: A randomized, double-blind, placebo-controlled, multicenter trial.

BACKGROUND: Obesity is a global health problem and its incidence is on the rise. Euiiyin-tang is an herbal medicinal formula that is often used in the clinical treatment of obesity. The purpose of the present study was to evaluate the efficacy and safety of Euiiyin-tang in obesity treatment. METHODS: A randomized, double-blind, placebo-controlled, multicenter trial was conducted. Participants with obesity were randomly assigned to receive Euiiyin-tang or placebo 3 times daily for 12-weeks. The primary outcome was weight reduction between the baseline and 12 weeks. The secondary outcomes included the rate of weight loss compared to baseline, and changes in body mass index, lipid profiles, and questionnaires related to the quality of life and diet. Safety factors, such as vital signs and laboratory parameters, were also measured. RESULTS: A total of 149 participants were randomly distributed to either the Euiiyin-tang group (n = 76) or the placebo group (n = 73). Weight reduction in the Euiiyin-tang group was significantly greater than that in the placebo group (2.50 kg in the Euiiyin-tang group vs. 0.82 kg in the placebo group). The participant response rates of ≥3% weight loss compared to baseline was 36.8 % in the Euiiyin-tang group and 17.8 % in the placebo group. Body mass index, waist circumference, and hip circumference showed a greater change in the Euiiyin-tang group than in the placebo group (1.00, 3.23, and 2.00 in the Euiiyin-tang group vs. 0.33, 1.96, and 0.86 in the placebo group). Questionnaires, lipid profiles, and safety factors did not show significant differences between groups. CONCLUSION: The results of this study suggest that Euiiyin-tang has beneficial effects on weight loss. TRIAL REGISTRATION: Clinicaltrials.gov NCT01724099.

Efficacy and safety of Onkyeong-tang in treating cold hypersensitivity in the feet of Korean women: protocol for a double-blind, randomized, placebo-controlled, parallel-group, multicenter clinical study.

BACKGROUND: Cold hypersensitivity in the hands and feet (CHHF) commonly affects Asian women, especially Korean women, and it negatively impacts the quality of life of the affected individuals. One commonly used herbal prescription for treating CHHF is Onkyeong-tang (OKT). Although OKT is widely used clinically in treating CHHF, no randomized clinical trial has been performed to evaluate the efficacy and safety of OKT in the treatment of cold hypersensitivity in the feet (CHF). This clinical trial aims to provide objective evidence for the basis of using OKT in the treatment of CHF in Korean women. METHODS: This trial will be a double-blind, randomized, placebo-controlled, parallel-group, multicenter pilot study. A total of 112 participants will be randomly divided into an OKT treatment group or a placebo group with a 1:1 ratio via a web-based randomization system. The OKT and placebo groups will receive prescribed medications orally three times per day (3 g each time) before or between meals for 8 weeks. The primary outcome studied will be the changes in Visual Analog Scale (VAS) scores of CHF from baseline. Secondary outcomes studied will be the VAS score changes of cold hypersensitivity in the hands, changes in the skin temperature of the hands and feet, total scores of the Korean version of the World Health Organization Quality of Life Scale-abbreviated version, and the results of the cold stress test. DISCUSSION: This trial will be the first clinical trial to assess the efficacy and safety of OKT in the treatment of CHF. We anticipate that the findings of the study will provide evidence for the basis of using OKT in treating CHF symptoms and generate basic data for designing a further large-scale randomized clinical trial. TRIAL REGISTRATION: Clinical Research Information Service (CRIS): KCT0003723. Retrospectively registered on 8 April 2019.

Treatment of hypothyroidism using Korean medicine: 2 case reports.

INTRODUCTION: Hypothyroidism, the most common endocrine disease, comprises a deficiency of thyroid hormone, causing coldness, fatigue, and dysmenorrhea. Here, we report the improvement of hypothyroidism symptoms and thyroid hormone level normalization by using Korean herbal medicine and acupuncture therapy. PATIENT CONCERNS: A 30-year-old woman (Case 1) presented at the clinic with continuous seborrheic dermatitis on the scalp, accompanied by dysmenorrhea. A 55-year-old woman (Case 2) presented with symptoms of coldness of the limbs and fatigue. DIAGNOSIS: Both patients were diagnosed with "Yin deficiency and Yang hyperactivity" and hypothyroidism after serum thyroid function tests. INTERVENTIONS: Both patients received herbal medicine decoction, acupuncture, and electroacupuncture therapy. OUTCOMES: Korean medicine improved the symptoms of hypothyroidism and significantly normalized thyroid-stimulating hormone and free-thyroxine levels. CONCLUSION: These outcomes suggest that Korean medicine may be effective for resolution of hypothyroidism; however, further research is needed to confirm these findings.

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).

Prolonged Progression-Free Survival in a Patient With Malignant Pleural Mesothelioma Following Korean Herbal Medicine Treatment Alone: A Case Report.

Korean herbal medicine treatment (KHMT) involves treating with a combination of natural products, which have been used for thousands of years. Recently, it has been reported to be effective and safe in cancer patients. This case report demonstrates the efficacy of KHMT in a 49-year-old man with malignant pleural mesothelioma (MPM), a rare and highly aggressive cancer. The patient showed recurrent pleural effusion and was diagnosed with epithelioid MPM at cT3NxM0 stage III in December 2017. The multidisciplinary care team recommended multimodal treatment based on an extrapleural pneumonectomy, but he refused this because the treatment was aggressive and the effectiveness was unclear. He decided to undergo pemetrexed plus cisplatin chemotherapy if his condition worsened. He visited the Korean Medicine Cancer Center for alternative treatment options. A KHMT regimen, consisting of twice-daily Gunchil-dan and thrice-daily Bangam-tang, was initiated in December 2017. Since commencement of KHMT, computed tomography and X-ray imaging scans have shown no significant interval changes and progression. At 21 months into treatment (September 2019), no significant adverse events have occurred. Given that the median overall survival of patients with MPM is approximately 1 year, the ongoing progression-free survival of this patient for 21 months is relatively long. This case, therefore, suggests that KHMT is a potential treatment option for MPM patients.

Exploratory analysis of cold, heat, deficiency, or excess pattern distribution in women with dysmenorrhea.

OBJECTIVE: To understand the impact and implications of cold, heat, deficiency, or excess pattern identification in relation to dysmenorrhea, comparing the prevalence of these patterns between women with and without dysmenorrhea is needed. METHODS: We gathered data from the Korea Constitutional Multicenter Bank. A total of 508 patients were recruited and provided with cold, heat, deficiency, or excess pattern and dysmenorrhea questionnaires. On the basis of their responses, they were divided into the dysmenorrhea group (moderate or severe dysmenorrheic pain; n = 90) and non-dysmenorrhea group (no dysmenorrheic pain; n = 155). We analyzed the characteristics of the groups and compared the cold, heat, deficiency, or excess pattern scores. Comparisons were performed using the independent t-test. We also performed multiple comparisons of each individual symptom between the groups to explore which symptoms appear with dysmenorrhea using the Bonferroni adjustment method. RESULTS: There was a high positive correlation between deficiency pattern scores and excess pattern scores (p < 0.001). The cold, deficiency, and excess pattern scores were significantly higher in the dysmenorrhea group than in the non-dysmenorrhea group (p < 0.001). Twenty among the 76 pattern items showed significant differences between the groups (p < 0.001). Among all items, there was a large effect size only in sleep quality (mean difference 1.07, 95% confidence interval 0.75-1.39, p < 0.001). CONCLUSIONS: Women with dysmenorrhea have higher cold, deficiency, and excess pattern scores than those without dysmenorrhea. The longitudinal observation of these symptoms needs to be evaluated using a clinical prospective study design in accordance with pattern differentiation in the future.

Efficacy, safety, and cost-effectiveness analysis of adjuvant herbal medicine treatment, Palmijihwang-hwan, for chronic low back pain: a study protocol for randomized, controlled, assessor-blinded, multicenter clinical trial.

BACKGROUND: Low back pain is a common symptom and continuous or recurrent pain results in chronic low back pain (CLBP). While many patients with CLBP have tried various treatments, complementary and alternative medicine including acupuncture and herbal medicine is one of the commonly used treatments. Palmijihwang-hwan is a herbal medicine used frequently in clinical practice but there has been no report of the efficacy, safety, or cost-effectiveness analysis of Palmijihwang-hwan for CLBP. METHODS: This study is a randomized, assessor-blinded, multicenter, clinical trial with two parallel groups. Four Korean medicine hospitals will recruit 84 participants and randomly allocate them into the control or treatment group in a 1:1 ratio. The control group will receive acupuncture treatment at 11 local and 4 distal acupuncture points for 20 min twice a week for 6 weeks. The treatment group will receive the same acupuncture treatment as the control group and also take Palmijihwang-hwan for 6 weeks. The primary outcome will be the change in visual analog scale (VAS) score between baseline (visit 1) and completion of the intervention (visit 12), and secondary outcomes will be pain-related clinical relevance (minimal clinical important difference or the proportion of the participants who decrease more than 30, or 50% on VAS), disability (Roland and Morris Disability Questionnaire), quality of life (EuroQol-5D), global assessment (Patient Global Impression of Change), and economic analysis (cost-effectiveness and cost-utility analysis). Additionally, safety will be assessed. DISCUSSION: The results of our study will provide the clinical evidence about the efficacy, safety, and cost-effectiveness analysis of Palmijihwang-hwan for CLBP. There will be a chance to provide multiple subdivided influence of this treatment with various outcome measures, but lack of placebo is our limitation. TRIAL REGISTRATION: Clinical Research Information Service, KCT0002998. Registered on 12 July 2018.

Traditional Korean Medicine-Based Forest Therapy Programs Providing Electrophysiological Benefits for Elderly Individuals.

We aimed to develop forest therapy programs (FTPs) to prevent dementia and related health problems in the elderly population, with the assumption that health benefits are FTP-type specific and depend on the participant's psychophysiological traits. For this purpose, we developed two distinct FTPs, namely, a guided-breathing meditation program (BP) and a walking program (WP); we adopted the approach of Sasang constitutional (SC) medicine, which categorizes individuals into one of three SC types (SC1, SC2, or SC3) for medical care. The FTPs ran 11 sessions over 11 weeks. We recruited 29/31/28 participants who were 65 years of age or older for the BP/WP/control groups, respectively; obtained electrophysiological measurements via electroencephalogram (EEG), heart rate variability (HRV), and bioimpedance; and analyzed the intervention effects with analysis of covariance. Compared with the control, the BP and WP resulted in benefits for neural activity and parasympathetic nervous activity (PNA), respectively, and both FTPs yielded distinct beneficial effects on bioimpedance. Constitution-specific effects were also present. The SC1- and SC2-type participants gained positive effects in neural activity from the BP and WP, respectively. The SC3-type participants showed improvements in PNA from the WP. In conclusion, for older individuals, both programs conferred health benefits that would help prevent dementia, and the benefits were program-specific and constitution-specific.

Korean medicines for poor ovarian reserve in infertility: A protocol for a multicenter observational study.

INTRODUCTION: Many infertile patients have used Korean medicines (KMs) as a primary or adjuvant therapeutic method to improve in vitro fertilization success rates. The aim of this multicenter observational study is to investigate the effects of KMs on poor ovarian reserve (POR) in infertile patients. METHODS AND ANALYSIS: We will perform a prospective multicenter observational study. This study will recruit 50 women between 25 and 44 years of age with infertility caused by POR from among patients who visit the KM clinic. All participants will visit the KM clinic on the 2nd or 3rd day of menstruation to receive the KMs. KM treatment will be delivered for 3 menstrual cycles (3 months) and will include herbal decoction, acupuncture, or moxibustion on demand. Every participant will be assessed based on KM clinical symptoms, a quality of life questionnaire, and ovarian reserve test results. ETHICS AND DISSEMINATION: The study was approved by Institutional Review Board of Semyung University (SMU-IM-190501). 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: KCT0004209.

Heart rate variability in middle-aged adults: Use of Sasang typology to distinguish individuals susceptible to stress.

While stress is known to cause many diseases, there is no established method to determine individuals vulnerable to stress. Sasang typology categorizes humans into four Sasang types (So-Eum, Tae-Eum, So-Yang, and Tae-Yang), which have unique pathophysiologies because of their differential susceptibilities to specific stimuli, including stress. The purpose of this study was to determine if Sasang typology can be used identify individuals who are vulnerable to stress by evaluation of heart rate variability (HRV).This was a cross-sectional study. A total of 399 healthy men and women aged 30 to 49 years were recruited. Physical examinations for stress included HRV measurement and blood tests. The subjects also completed questionnaires about psychological stress, self-awareness, and lifestyle. HRV was analyzed using frequency-domain analysis. Subjects were divided into So-Eum (SE) and non-So-Eum (non-SE) groups according to their diagnosis.The weight and body mass index in the SE group were significantly lower than those in the non-SE group (both, P = .000). There were no significant between-group differences in any other demographic variables. In HRV analysis, the normalized high frequency (nHF) was higher (P = .008) while the normalized low frequency (nLF; P = .008) and LF:HF ratio (LF/HF; P = .002) were lower in the SE group than in the non-SE group.Although there was no difference in variables affecting HRV, HRV values were significantly different between groups. The LF/HF value for the SE group was at the lower limit of the normal range, although there were no associated clinical problems. These findings suggest that individuals with the SE type are more susceptible to stress than those with the other types. Thus, middle-aged individuals who are vulnerable to stress can be identified using Sasang typology.

Efficacy of Juglandis semen complex extract for knee osteoarthritis: A pilot study protocol for a 12-week, single-center, randomized, controlled, double-blind clinical trial.

BACKGROUND: Knee osteoarthritis (KOA) is a common disease in elderly individuals. Many medications for KOA have the potential to cause side effects. We used Juglandis semen complex extract (JCE) consisting of 4 herbs derived from Cheong-A-Won, which has been commonly used for KOA treatment. In this study, we will evaluate whether JCE improves symptoms in patients with KOA and will identify the changes in the inflammation factor. METHODS: This study will be a single-center, randomized, double-blind, and placebo-controlled trial. Three groups, JCE 1000 mg, 2000 mg, and placebo, will be randomly allocated. Total duration of the clinical trial will be 12 to 14 weeks. Study participants will be followed up every 6 weeks and the effect and safety will be assessed at the 2, 3, and 4 visit. All participants were asked to maintain a dosage schedule for this protocol. The primary outcomes will be measured using Korean Western Ontario and McMaster Universities Questionnaire and the secondary outcomes will include pain Visual analog scale score, EuroQol Five Dimensions questionnaire, Patient Global Impression of Change, and the changes in the laboratory test parameters of inflammation. Repeated-measure analysis will be used to measure primary efficacy based on full analysis set. DISCUSSION: This study has limited inclusion and exclusion criteria and a well-controlled intervention, and it will be the first randomized controlled trial to assess the efficacy and safety of JCE in patients with KOA. This study provides insights into the mechanisms that explain the therapeutic effects of JCE in KOA and will lay the groundwork for further studies.

Treatment of postpill amenorrhea with abdominal obesity by traditional Korean medicine treatment focused on pharmacopuncture and moxibustion: A case report.

RATIONALE: Hormone imbalance and menstrual irregularities are normal for postpill women. Pharmacopuncture and moxibustion can stimulate acupoints with herbal extract and heat, respectively, to regulate the function of qi and blood, expel pathogens, and support health. PATIENT CONCERNS: A 39-year-old female patient presented with amenorrhea, >6 months after she had stopped taking the oral contraceptive pill, which she had taken for more than 10 years, and possible associated infertility. Additionally, she reported sudden weight gain of approximately 12 kg in 1 year. DIAGNOSES: In this study, we examined the amenorrhea lasted more than 6 months for postpill patient. INTERVENTIONS: She refused a strong acupuncture stimulus; she underwent lower abdomen pharmacopuncture with wild ginseng complex (WGC) and moxibustion at CV4, 5 times during 1 month. As a secondary treatment, 1 g Geoseub-hwan pills were prescribed for overeating and during social events. After 5 weekly primary treatments, Geoseub-hwan was prescribed intermittently. OUTCOME: After 3 primary treatments, she began menstruation without menstrual cramps or discomfort. After 5 treatments, she exhibited improvement of body weight and body composition. At 1- and 3-month follow-up examinations, she confirmed regular menstruation without discomfort. LESSONS: Pharmacopuncture with WGC and moxibustion may be effective for the treatment of postpill amenorrhea with abdominal obesity and can be used for patients with fear of a strong acupuncture stimulus.

Potential anti-inflammatory effect of Madi-Ryuk and its active ingredient tannic acid on allergic rhinitis.

Madi-Ryuk (MDR) is a traditional Korean medicine and it has been widely used in Korea to treat arthritis and we previously reported the anti-allergic inflammatory effect of MDR in vitro model. However, therapeutic evidence of MDR on in vivo model of allergic inflammatory reaction has not yet been demonstrated. The research purpose was to investigate the efficacy of MDR and its active ingredient tannic acid (TA) in ovalbumin (OVA)-induced AR mice model. OVA-challenged AR mice orally medicated MDR or its active ingredient TA daily for ten days. In mice having a AR, MDR and TA prominently diminished number of rubs and levels of histamine, IgE, thymic stromal lymphopoietin, interleukin (IL)-1ß, IL-4, IL-5, IL-13, IL-33, and tumor necrosis factor-α. In addition, protein expression levels and activities of caspase-1 were declined by oral medication of MDR and TA. Decline in levels of macrophage inflammatory protein-2 and intercellular adhesion molecules-1 and reduction in penetrations of inflammatory cells into inflamed tissue were also noted in MDR and TA groups. Taken together, identification of MDR effect in preclinical models suggests that MDR may be a therapeutic drug for the treatment and prevention of AR.

A multicenter study on the efficacy and safety of So-Cheong-Ryong-Tang for perennial allergic rhinitis.

BACKGROUND: So-Cheong-Ryong-Tang (SCRT), also known as Xiao-Qing-Long-Tang or Sho-seiryo-to, is a mixed herbal formula that is used to treat allergic rhinitis, bronchitis, allergic asthma, and common cold in traditional Korean medicine. OBJECTIVE: To assess the efficacy and safety of the SCRT for the treatment of allergic rhinitis. METHODS: We conducted a double-blind, randomized, placebo-controlled, parallel-group, multicenter study of Korean adults with perennial allergic rhinitis. The trial consisted of a 4-week oral administration of SCRT or placebo, with two visits at 2-week intervals, and an 8-week follow-up period, with two visits at 4-week intervals. The primary outcome was a change in the total nasal symptoms score. The secondary outcomes included changes in the Rhinoconjunctivitis Quality of Life Questionnaire score, total serum immunoglobulin E (IgE), cytokines levels, and nasal endoscopy index. RESULTS: SCRT improved nasal symptoms and quality of life in patients with PAR after 4 weeks medication, and these effects did not last 8 weeks after the end of medication. The level of serum IgE, eosinophil counts, and cytokines did not alter after medication. Nasal endoscopy index did not show significant difference. No serious AEs and safety assessment changes were observed in this trial. CONCLUSION: SCRT is an effective and safe medication for patients with chronic, perennial, and moderate to severe AR. A clinical study with a >4-week period of medication use, and more participants for immune material test is needed to investigate the long-term efficacy of SCRT in relieving the symptoms of nasal obstruction and identifying the underlying mechanisms of action and indications for traditional Korean medicine.