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BACKGROUND: Pharmacoacupuncture (PA) is an alternative injection therapy for a broad range of conditions. This meta-analysis evaluates the effectiveness and safety of PA in treating frozen shoulder (FS) and aims to standardise PA characteristics in clinical practice. METHODS: Randomized controlled trials (RCTs) assessing PA for FS were systematically reviewed from seven electronic databases up to August 31, 2023. Outcomes measured included the visual analogue scale (VAS) or numerical rating scale (NRS), effective rate, Constant-Murley Score (CMS), Shoulder Pain and Disability Index (SPADI), ROM, quality of life (QoL), and adverse events. Data analysis was conducted using RevMan 5.3, with the risk of bias in each trial evaluated using Cochrane's risk of bias tool. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) tool assessed the quality of evidence. RESULTS: Thirteen RCTs involving 1034 patients met the inclusion criteria, with eleven RCTs and 872 patients included in the meta-analysis. PA showed low-quality evidence of improvement in VAS, effective rate, CMS Total, and CMS Pain. Moderate-quality evidence indicated improvement in CMS ADL and CMS Mobility. PA was effective in four SF-36 subscales: physical function, social role function, mental health, and emotional role function. No significant difference in CMS strength was observed. One trial reported mild anaphylaxis reaction to bee venom as an adverse event. CONCLUSION: PA may offer potential benefits as an alternative injection therapy for FS patients. Further well-designed RCTs with rigorous methodology are required to substantiate its therapeutic efficacy and clinical utility. REGISTRATION: PROSPERO (CRD42023445708).
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INTRODUCTION: Total knee replacement (TKR) is a surgical procedure that is being increasingly performed as a result of population aging and the increased average human life expectancy in South Korea. Consistent with the growing number of TKR procedures, the number of patients seeking acupuncture for relief from adverse effects, effective pain management, and the enhancement of rehabilitative therapy effects and bodily function after TKR has also been increasing. Thus, an objective examination of the evidence regarding the safety and efficacy of acupuncture treatments is essential. The aim of this study is to verify the hypothesis that the concurrent use of acupuncture treatment and usual care after TKR is more effective, safe, and cost-effective for the relief of TKR symptoms than usual care therapy alone. METHODS/DESIGN: This is an open-label, parallel, assessor-blinded randomized controlled trial that includes 50 patients with TKR. After screening the patients and receiving informed consent, the patients are divided into two groups (usual care + acupuncture group and usual care group); the patients will then undergo TKR surgery and will be hospitalized for 2 weeks. The patients will receive a total of 8 acupuncture treatments over 2 weeks after surgery and will be followed up at 3, 4, and 12âweeks after the end of the intervention. The primary outcome is assessed using the Korean version of the Western Ontario and McMaster Universities Arthritis Index (K-WOMAC), and the secondary outcome is measured using the Numerical Rating Scale (NRS), Risk of Fall, and Range of Motion (ROM). Moreover, the cost per quality-adjusted life years (QALYs) is adopted as a primary economic outcome for economic evaluation, and the cost per NRS is adopted as a secondary economic outcome. ETHICS AND DISSEMINATION: This trial has received complete ethical approval from the Ethics Committee of Catholic Kwandong University International St. Mary's Hospital (IS17ENSS0063). We intend to submit the results to a peer-reviewed journal and/or conferences. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03633097.
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Terapia por Acupuntura/efeitos adversos , Artroplastia do Joelho/reabilitação , Osteoartrite do Joelho/cirurgia , Manejo da Dor/métodos , Dor Pós-Operatória/diagnóstico , Terapia por Acupuntura/economia , Idoso , Idoso de 80 Anos ou mais , Artroplastia do Joelho/efeitos adversos , Artroplastia do Joelho/economia , Terapia Combinada/efeitos adversos , Terapia Combinada/economia , Terapia Combinada/métodos , Análise Custo-Benefício , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Osteoartrite do Joelho/economia , Manejo da Dor/efeitos adversos , Manejo da Dor/economia , Medição da Dor/estatística & dados numéricos , Dor Pós-Operatória/economia , Dor Pós-Operatória/etiologia , Dor Pós-Operatória/reabilitação , Projetos Piloto , Anos de Vida Ajustados por Qualidade de Vida , República da Coreia , Resultado do TratamentoRESUMO
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.
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Medicamentos de Ervas Chinesas/uso terapêutico , Dor Lombar/terapia , Medicina Tradicional Chinesa/métodos , Manipulações Musculoesqueléticas/métodos , Humanos , Projetos Piloto , Ensaios Clínicos Controlados Aleatórios como Assunto , Método Simples-CegoRESUMO
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.
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Medicina Herbária/normas , Síndrome Metabólica/tratamento farmacológico , Obesidade/terapia , Fitoterapia/métodos , Plantas Medicinais , Adulto , Idoso , Método Duplo-Cego , Feminino , Humanos , Síndrome Metabólica/complicações , Síndrome Metabólica/epidemiologia , Pessoa de Meia-Idade , Obesidade/complicações , Obesidade/epidemiologia , Prevalência , República da Coreia/epidemiologia , Fatores de Risco , Resultado do Tratamento , Adulto JovemRESUMO
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.
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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 (nâ¯=â¯76) or the placebo group (nâ¯=â¯73). Weight reduction in the Euiiyin-tang group was significantly greater than that in the placebo group (2.50â¯kg in the Euiiyin-tang group vs. 0.82â¯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.
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Medicina Tradicional Coreana/métodos , Obesidade/tratamento farmacológico , Preparações de Plantas/uso terapêutico , Redução de Peso/efeitos dos fármacos , Adolescente , Adulto , Idoso , Método Duplo-Cego , Feminino , Medicina Herbária , Humanos , Pessoa de Meia-Idade , Qualidade de Vida , República da Coreia , Inquéritos e Questionários , Adulto JovemRESUMO
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).
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Medicina Tradicional Coreana , Síndrome Metabólica/tratamento farmacológico , Estudos Multicêntricos como Assunto , Obesidade/tratamento farmacológico , Fitoterapia , Ensaios Clínicos Controlados Aleatórios como Assunto , Adolescente , Adulto , Idoso , Fármacos Antiobesidade/uso terapêutico , Feminino , Humanos , Síndrome Metabólica/complicações , Síndrome Metabólica/epidemiologia , Pessoa de Meia-Idade , Obesidade/complicações , Obesidade/epidemiologia , Seleção de Pacientes , Projetos Piloto , República da Coreia , Fatores de Risco , Resultado do Tratamento , Adulto JovemRESUMO
INTRODUCTION: In Korea, low back pain (LBP) which is occupation-related symptom is one of the major health issues owing to rapid industrialization. Even traditional Korean medicine has the long history in pain treatment, there still has been lack of supporting evidence on herbal prescription itself. Sogyeonghwalhyeol-tang, a Korean herbal medicine prescription, has been suggested as a medication for treating chronic LBP as well as work-related pains. OBJECTIVE: This study aims to evaluate the clinical efficacy and safety of herbal medicine, Sogyeonghwalhyeol-tang on work-related chronic LBP patients. METHOD: This trial is designed as a multicenter, randomized, controlled, clinical trial. Seventy-two participants who have chief complaint of LBP in Korean medicine rehabilitation center will be randomly assigned to ether Sogyeonghwalhyeol-tang group or placebo group with a ratio of 1:1. They will receive assigned drugs in 4 weeks and follow-up for 2 weeks. DISCUSSION: The result of this study will provide the valuable information for efficacy and safety of Sogyeonghwalhyeol-tang for patients with work-related chronic LBP.
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Dor Lombar/tratamento farmacológico , Medicina Tradicional Coreana/métodos , Doenças Profissionais/tratamento farmacológico , Preparações de Plantas/uso terapêutico , Método Duplo-Cego , Humanos , Medição da Dor , Preparações de Plantas/administração & dosagem , Preparações de Plantas/efeitos adversos , Qualidade de Vida , República da CoreiaRESUMO
BACKGROUND: Cold hypersensitivity in the hands and feet (CHHF) is frequent in Asian countries including Korea. The quality of life can be degraded by the symptoms of CHHF. In particular, gynecological disorders such as menstrual pain, infertility, leucorrhea, and irregular bleeding may be related to CHHF. Sipjeondaebo-tang (SDT) is widely used in the treatment of various diseases including CHHF by balancing Yin and Yang, restoring the deterioration of physiological function, and improving immunity. However, the efficacy of SDT in the treatment of CHHF has not been assessed in clinical trials. Therefore, we aimed to investigate the feasibility of a full randomized clinical trial of SDT for the treatment of CHHF in Korean women through this trial. METHODS: This study will be a pilot, randomized, double-blind, two-arm, placebo-controlled, parallel-group, multicenter clinical trial. Women aged 19-59 years who present with CHHF will be recruited from five university hospitals. A total of 60 subjects will be randomly assigned to a treatment group (SDT) or a placebo group at a 1:1 ratio. The subjects will receive 3 g of either SDT or placebo three times daily for 8 weeks. The primary outcome measures will be the Visual Analogue Scale scores of CHHF. The secondary outcome measures will be changes in body temperature in both the hands and the feet as measured using a thermometer and the Korean version of the World Health Organization Quality of Life Scale Abbreviated Version. DISCUSSION: This will be the first trial to investigate the efficacy and safety of SDT in the treatment of CHHF. This study will provide basic clinical information regarding Korean herbal medicine treatment of CHHF and a clinical basis for designing a full randomized clinical trial. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03374345 . Registered on 15 February 2018.
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Síndromes Periódicas Associadas à Criopirina/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Adulto , Método Duplo-Cego , Medicamentos de Ervas Chinesas/efeitos adversos , Feminino , Humanos , Adesão à Medicação , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Projetos Piloto , Tamanho da Amostra , Adulto JovemRESUMO
BACKGROUND: Gumiganghwal-tang (GMGHT) is a traditional herbal medicine consisting of nine different herbs. GMGHT inhibits the mRNA expression and production of inflammatory cytokines tumor necrosis factor-α (TNF- α), interleukin-6 (IL-6), and TNF- ß on lipopolysaccharide- (LPS-) stimulated peritoneal macrophages in a dose-dependent manner. It is empirically used for the treatment of inflammatory disease, but there are few reports of clinical trials that investigate its efficacy and safety. The current study aimed to investigate the clinical efficacy and safety of GMGHT in patients with knee osteoarthritis (OA). METHODS: This was a multicenter, two-armed, double-blinded, randomized, placebo controlled study of GMGHT over 6 weeks. Eligible patients who fulfilled the American College of Rheumatology criteria for OA were randomized to receive either GMGHT or the placebo. Clinical assessments included measurement of knee pain and function using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), patient global assessment (PGA), and knee pain scores every 2 weeks. RESULTS: A total of 128 patients were enrolled (91.4% female; mean age, 58.7 ± 8.1 years). At baseline, pain visual analogue score (VAS) was 67.2 ± 1.4, resp. 71.3 ± 1.6 (treatment, resp. placebo group, p=0.84), and total WOMAC score was 55.2 ± 1.6, resp. 55.6 ± 1.5 (p = 0.84). After 6 weeks, the pain VAS was 43.0 ± 2.5, resp. 61.6 ± 2.5 (p < 0.01) and the total WOMAC score was 34.1 ± 2.4, resp. 46.9 ± 1.8 (p < 0.01). No patients withdrew because of treatment emergent adverse events. Expected adverse events including dyspepsia, liver function abnormality, and lower extremity edema were comparable between both groups. CONCLUSIONS: Treatment with GMGHT resulted in significant improvement in pain, function, and global assessment, and it was generally safe and well tolerated in patients with OA.
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BACKGROUND: This study aims to evaluate the safety, efficacy, and feasibility of a full randomized clinical trial of Ojeok-san in Korean female patients with cold hypersensitivity in the hands and feet. METHODS: This study is a multicenter, double-blinded, randomized, placebo-controlled, two-arm, parallel-group pilot clinical trial. A total of 60 participants will be enrolled and randomly assigned to the Ojeok-san treatment group or the placebo control group, in a 1:1 ratio using an Internet-based randomization system. Each group will be administered Ojeok-san or placebo three times per day for 8 weeks. The primary outcome will be the mean change in the Visual Analog Scale scores of cold hypersensitivity in the hands from baseline to week 8. Secondary outcomes will include the mean changes in the skin temperature of the extremities, recovery rate of the skin temperature of hands after cold stress test, and the score of Korean version of the WHO Quality of Life Scale abbreviated version. DISCUSSION: The findings of this study should provide meaningful information for a further large-scale, randomized controlled trial to confirm the safety and efficacy of Ojeok-san on cold hypersensitivity in the hands and feet in female patients. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03083522 . Registered on 20 March 2017.
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Temperatura Baixa/efeitos adversos , Síndromes Periódicas Associadas à Criopirina/tratamento farmacológico , Pé/fisiopatologia , Mãos/fisiopatologia , Extratos Vegetais/uso terapêutico , Adulto , Regulação da Temperatura Corporal/efeitos dos fármacos , Síndromes Periódicas Associadas à Criopirina/diagnóstico , Síndromes Periódicas Associadas à Criopirina/fisiopatologia , Método Duplo-Cego , Feminino , Humanos , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Medição da Dor , Projetos Piloto , Extratos Vegetais/efeitos adversos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , República da Coreia , Temperatura Cutânea/efeitos dos fármacos , Fatores de Tempo , Resultado do Tratamento , Adulto JovemRESUMO
BACKGROUND: Cold hypersensitivity in the hands and feet (CHHF) is a symptom patients usually feel cold in their hands and feet, but not dealt with a disease in western medicine. However, it is often appealed by patients at a clinic of Korean medicine (KM), considered to be a sort of key diagnostic indicator, and actively treated by physicians. Nevertheless, there is no standardized diagnostic definition for CHHF. Therefore, we surveyed KM experts' opinions to address the clinical definition, diagnostic criteria, and other relevant things on CHHF. METHODS: We developed a survey to assess the definition, diagnosis, causes, and accompanying symptoms on CHHF. 31 experts who work at specialized university hospitals affiliated with KM hospitals consented to participation. Experts responded to survey questions by selecting multiple-choice answers or stating their opinions. RESULTS: Vast majority of experts (83.8%) agreed with our definition on CHHF ("a feeling of cold as a symptom; that one's hands or feet become colder than those of average people in temperatures that are not normally perceived as cold"). 77.4% of experts considered subjective symptoms on CHHF were more important than medical instrument results. Constitution or genetic factors (87.1%) and stress (64.5%) were the most common causes reported for CHHF. CONCLUSIONS: This study offers an expert consensus regarding the themes, opinions, and experiences of practitioners with CHHF. Our results underscore the need for standardized definitions and diagnostic criteria for CHHF.
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OBJECTIVES: This study examined National Health Insurance claims data to investigate the epidemiology of shoulder disorders in Korea. Detailed information on medical services and related costs was assessed by major shoulder disorder category. DESIGN AND SETTING: The 2014 National Patient Sample dataset provided by the Health Insurance Review and Assessment Service was analysed. Among shoulder-related diagnosis codes, adhesive capsulitis of the shoulder (ACS), rotator cuff syndrome (RCS) and shoulder impingement syndrome (SIS) categories were of highest prevalence. Sociodemographic characteristics and medical service use, frequency and medical costs regarding common shoulder disorders were evaluated. RESULTS: The majority of patients with shoulder disorder received ambulatory care (97%). Total and per-patient expenses were highest in patients with RCS. The number of inpatients with RCS was more than twice that of the other two groups, and patients with RCS were more likely to receive surgical management compared with patients with ACS and SIS. Prevalence of shoulder disorders was highest among subjects in their 50s for all three groups. Primary care physicians treated 75.80% of patients with ACS, 56.99% of patients with RCS and 48.06% of patients with SIS, respectively, outlining the difference in medical institution usage patterns. In all three groups, the highest proportion of patients visited orthopaedic surgeons out of medical departments. In the ACS and SIS groups, cost of visits (consultations) took up the largest part of total expenses at 32.30% and 18.88%, respectively, while cost of procedure/surgery constituted the largest portion in patients with RCS (37.77%). The usage proportion of subcutaneous or intramuscular and intra-articular injections ranged between 20% and 30% for outpatients in all three groups. CONCLUSIONS: Medical service use, frequency and cost distributions relating to major shoulder disorders in Korea were assessed using nationwide claims data. These findings are expected to aid policy-makers as well as researchers and practitioners as basic healthcare data.
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Atenção à Saúde/estatística & dados numéricos , Artropatias/epidemiologia , Artropatias/terapia , Articulação do Ombro , Adulto , Idoso , Estudos Transversais , Feminino , Humanos , Seguro Saúde/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Prevalência , República da Coreia/epidemiologia , Adulto JovemRESUMO
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.
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Fármacos Antiobesidade/uso terapêutico , Medicamentos de Ervas Chinesas/uso terapêutico , Obesidade/tratamento farmacológico , Redução de Peso/efeitos dos fármacos , Adiposidade/efeitos dos fármacos , Adolescente , Adulto , Idoso , Fármacos Antiobesidade/efeitos adversos , Índice de Massa Corporal , Protocolos Clínicos , Método Duplo-Cego , Medicamentos de Ervas Chinesas/efeitos adversos , Comportamento Alimentar , Feminino , Humanos , Lipídeos/sangue , Pessoa de Meia-Idade , Obesidade/sangue , Obesidade/diagnóstico , Obesidade/fisiopatologia , Qualidade de Vida , República da Coreia , Projetos de Pesquisa , Inquéritos e Questionários , Fatores de Tempo , Resultado do Tratamento , Relação Cintura-Quadril , Adulto JovemRESUMO
BACKGROUND: In recent years, cold hypersensitivity in the hands (CHH) has become a common ailment of women in Korea. It can lead to gynecological problems such as irregular menstruation, miscarriage, and infertility. Traditionally, Korean herbal medicine has been the primary treatment method used to balance thermoregulation in the human body; however, its effectiveness has not been confirmed through systematic study. Thus, in this trial, we will investigate the feasibility of a full randomized clinical trial, Danggui-Sayuk-Ga-Osuyu-Saenggang-tang (DSGOST) in Korean women with CHH. METHODS: This study will be a pilot, multicenter, double-blind, randomized, parallel-group, two-arm, placebo-controlled clinical trial. A total of 66 participants will be randomly divided into two groups, a DSGOST treatment group and a placebo control group, in a 1:1 ratio using a web-based randomization system. Each group will take DSGOST or placebo three times daily for 6 weeks. The primary outcome will be measured using Visual Analogue Scale (VAS) scores of CHH. Secondary outcomes will include changes in skin temperature of the hands, Clinical Global Impressions (CGI) scale scores, recovery rate of skin temperature of the hands after the cold stress test, and the Korean version of the WHO Quality of Life Scale, abbreviated version (WHOQOL-BREF). DISCUSSION: This trial will be the first trial to reflect the newly defined disease range of CHH which was compiled by Korean medicine expert consensus. This study will provide considerable evidence for further large-scale trials and general clinical guidelines for CHH in the Korean medical field. TRIAL REGISTRATION: This study is registered at ClinicalTrials.gov, ID: NCT02645916 . Registered on 30 December 2015.
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Síndromes Periódicas Associadas à Criopirina/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Adulto , Protocolos Clínicos , Síndromes Periódicas Associadas à Criopirina/diagnóstico , Síndromes Periódicas Associadas à Criopirina/fisiopatologia , Método Duplo-Cego , Medicamentos de Ervas Chinesas/efeitos adversos , Estudos de Viabilidade , Feminino , Humanos , Pessoa de Meia-Idade , Projetos Piloto , Qualidade de Vida , República da Coreia , Projetos de Pesquisa , Índice de Gravidade de Doença , Temperatura Cutânea/efeitos dos fármacos , Fatores de Tempo , Resultado do Tratamento , Adulto JovemRESUMO
The herbal extract Angelica gigas (AG) has been applied as a vasodilating agent for patients suffering from vascular diseases for many years; however, the underlying mechanism has not been fully elucidated. The present study hypothesized that the antivasoconstrictive effect of AG may be effective in the treatment of abnormal coldmediated vasospasms that occur in Raynaud's phenomenon (RP). The effect of AG on the activity of ras homolog gene family member A (RhoA) was investigated in coldexposed vascular cells. Vascular cells were pretreated to AG, followed by a warm (37ËC) or cold (25ËC) incubation for 30 min and investigated with western blotting, ELISA and confocal microscopy. Cold treatment induced the activation of RhoA in pericytes and vascular endothelial cells, however this was reduced by treatment with AG. Furthermore, AG treatment reduced the endothelin1 (ET1)mediated RhoA activation in pericytes; however, coldinduced ET1 production by vascular endothelial cells was not affected by treatment with AG. In addition, AG treatment suppressed the formation of stress fibers and focal adhesion complexes, and the coldinduced phosphorylation of focal adhesion kinase, protooncogene tyrosineprotein kinase Src and extracellular signalrelated kinase. Therefore, AG treatment demonstrated an ability to reduce coldinduced RhoA activation in pericytes and vascular endothelial cells, and attenuated ET1mediated RhoA activation in pericytes. In conclusion, the present study indicated that AG may be useful for the treatment of RP.
Assuntos
Angelica/química , Extratos Vegetais/química , Proteína rhoA de Ligação ao GTP/metabolismo , Angelica/metabolismo , Adesão Celular/efeitos dos fármacos , Linhagem Celular , Endotelina-1/análise , Endotelina-1/metabolismo , Ensaio de Imunoadsorção Enzimática , MAP Quinases Reguladas por Sinal Extracelular/metabolismo , Proteína-Tirosina Quinases de Adesão Focal/metabolismo , Células Endoteliais da Veia Umbilical Humana , Humanos , Microscopia Confocal , Pericitos/citologia , Pericitos/efeitos dos fármacos , Pericitos/metabolismo , Fosforilação/efeitos dos fármacos , Extratos Vegetais/farmacologia , Temperatura , Vasodilatadores/química , Vasodilatadores/isolamento & purificação , Vasodilatadores/farmacologia , Quinases da Família src/metabolismoRESUMO
BACKGROUND: Obesity has become a major global health challenge due to its increasing prevalence, and the associated health risk. It is the main cause of various metabolic diseases including diabetes, hypertension, cardiovascular disease, stroke and certain forms of cancer. METHODS AND RESULTS: In the present study we evaluated the anti-obesity property of Daesiho-tang (DSHT), an herbal medicine, using high fat diet (HFD)-induced obese mice as a model. Our results showed that DSHT ameliorated body weight gain, decreased total body fat, regulated expression of leptin and adiponectin genes of adipose tissue and exerted an anti-diabetic effect by attenuating fasting glucose level and serum insulin level in HFD-fed animals. In addition, DSHT-treatment significantly reduced total cholesterol (TC), triglycerides (TG) and increased high density lipoprotein-cholesterol (HDL), glutamic pyruvic transaminase (GPT) and glutamic oxaloacetic transaminase (GOT) levels in serum and reduced deposition of fat droplets in liver. DSHT treatment resulted in significantly increased relative abundance of bacteria including Bacteroidetes, Bacteroidetes/Firmicutes ratio, Akkermansia Bifidobacterium., Lactobacillus, and decreased the level of Firmicutes. Using RT2 profiler PCR array, 39 (46%) genes were found to be differentially expressed in HFD-fed mice compared to normal control. However, normal gene expressions were restored in 36 (92%) genes of HFD-fed mice, when co-exposed to DSHT. CONCLUSION/MAJOR FINDINGS: The results of this study demonstrated that DSHT is an effective herbal formulation in attenuation of obesity in HFD-fed mice through alteration of gene expressions and modulation of intestinal microbiota.
Assuntos
Microbioma Gastrointestinal/efeitos dos fármacos , Regulação da Expressão Gênica/efeitos dos fármacos , Obesidade/tratamento farmacológico , Obesidade/microbiologia , Extratos Vegetais/farmacologia , Adiponectina/genética , Tecido Adiposo/efeitos dos fármacos , Tecido Adiposo/patologia , Animais , Peso Corporal/efeitos dos fármacos , Colesterol/metabolismo , Dieta Hiperlipídica/efeitos adversos , Composição de Medicamentos , Glucose/metabolismo , Homeostase/efeitos dos fármacos , Resistência à Insulina , Leptina/genética , Fígado/efeitos dos fármacos , Fígado/metabolismo , Fígado/patologia , Masculino , Camundongos , Camundongos Endogâmicos C57BL , Obesidade/metabolismo , Obesidade/patologia , Tamanho do Órgão/efeitos dos fármacos , Extratos Vegetais/química , Extratos Vegetais/uso terapêuticoRESUMO
The brain, gut, and adipose tissue interact to control metabolic pathways, and impairment in the brain-gut-adipose axis can lead to metabolic disorders, including obesity. Chowiseungcheng-tang (CST), a herbal formulation, is frequently used to treat metabolic disorders. Here, we investigated the anti-obesity effect of CST and its link with brain-gut-adipose axis using C57BL/6J mice as a model. The animals were provided with a normal research diet (NRD) or high-fat diet (HFD) in absence or presence of CST or orlistat (ORL) for 12 weeks. CST had a significant anti-obesity effect on a number of vital metabolic and obesity-related parameters in HFD-fed mice. CST significantly decreased the expression levels of genes encoding obesity-promoting neuropeptides (agouti-related peptide, neuropeptide Y), and increased the mRNA levels of obesity-suppressing neuropeptides (proopiomelanocortin, cocaine-and amphetamine-regulated transcript) in the hypothalamus. CST also effectively decreased the expression level of gene encoding obesity-promoting adipokine (retinol-binding protein-4) and increased the mRNA level of obesity-suppressing adipokine (adiponectin) in visceral adipose tissue (VAT). Additionally, CST altered the gut microbial composition in HFD groups, a phenomenon strongly associated with key metabolic parameters, neuropeptides, and adipokines. Our findings reveal that the anti-obesity impact of CST is mediated through modulation of metabolism-related neuropeptides, adipokines, and gut microbial composition.
Assuntos
Tecido Adiposo/efeitos dos fármacos , Fármacos Antiobesidade/química , Fármacos Antiobesidade/farmacologia , Encéfalo/efeitos dos fármacos , Trato Gastrointestinal/efeitos dos fármacos , Extratos Vegetais/química , Extratos Vegetais/farmacologia , Adipocinas/genética , Tecido Adiposo/metabolismo , Adiposidade/efeitos dos fármacos , Animais , Biomarcadores , Glicemia/efeitos dos fármacos , Peso Corporal/efeitos dos fármacos , Encéfalo/metabolismo , Dieta Hiperlipídica , Modelos Animais de Doenças , Metabolismo Energético/efeitos dos fármacos , Microbioma Gastrointestinal/efeitos dos fármacos , Trato Gastrointestinal/metabolismo , Regulação da Expressão Gênica/efeitos dos fármacos , Insulina/sangue , Lipídeos/sangue , Testes de Função Hepática , Masculino , Camundongos , Neuropeptídeos/genética , Obesidade/tratamento farmacológico , Obesidade/etiologia , Obesidade/metabolismo , Tamanho do Órgão/efeitos dos fármacosRESUMO
Danggui-Sayuk-Ga-Osuyu-Senggang-Tang (DSGOST), one of the traditional Chinese medicines, has long been prescribed for patients suffering from Raynaud phenomenon (RP) in Northeast Asian countries, including China, Japan and Korea. Although a previous in vitro study from our laboratory revealed that DSGOST prevents cold (25ËC)induced RhoA activation and endothelin1 (ET1) production in endothelial cells (ECs), the mechanisms by which DSGOST is able to alleviate the symptoms of RP have yet to be fully elucidated. The present study aimed to demonstrate that DSGOST regulates RhoAmediated pathways in coldexposed pericytes. In pericytes, DSGOST amplified coldinduced RhoA activation, while markedly reducing ET1induced RhoA activation. Additionally, DSGOSTmediated regulation of RhoA was closely associated with Rhoassociated, coiledcoilcontaining protein kinase 1 (ROCK1)/testisspecific kinase 1 (TESK1)/PDXP, but not with LIM domain kinase 1/2 (LIMK1/2), cofilin and myosin light chain (MLC). Thus, DSGOST activation of RhoA/ROCK1/TESK1/PDXP in coldexposed pericytes appeared to be crucial for treating vessel contraction. In addition, the DSGOST effect on the RhoAmediated pathway in coldinduced human umbilical vein endothelial cells or human dermal microvascular endothelial cells was similar to that in ET1treated pericytes, but not in coldinduced pericytes. The results of the present study further confirmed that DSGOST inhibits coldinduced contraction of the mouse tail vein in vivo. Furthermore, DSGOST treatment reduced coldinduced expression of the α2cadrenergic receptor in mouse tail vessels. Therefore, the data in the present study suggest that DSGOST may be useful for the treatment of RPlike disease.
Assuntos
Temperatura Baixa , Medicamentos de Ervas Chinesas/farmacologia , Vasoconstrição/efeitos dos fármacos , Animais , Endotelina-1/farmacologia , Células Endoteliais da Veia Umbilical Humana/efeitos dos fármacos , Células Endoteliais da Veia Umbilical Humana/metabolismo , Humanos , Camundongos , Pericitos/efeitos dos fármacos , Pericitos/metabolismo , Receptores Adrenérgicos alfa 2/metabolismo , Transdução de Sinais/efeitos dos fármacosRESUMO
Background. Obesity is associated with chronic inflammation and cytokines. However, to date, the relationship between the serum levels of cytokines in obese individuals and taking herbal drugs remains largely unexplored. Methods. Serum cytokines were assessed by multiplex cytokine profiling assay. Serum samples of obese female Korean adults (obese group; n = 20) as well as normal female Korean adults (normal group; n = 21) were collected at the start and end of study period. Twenty obese female Korean adults were randomized to receive Eui-E-In-Tang (Eui-E-In-Tang group; n = 9) at a daily dose of 9 g or a matched placebo (placebo group; n = 11) for 12 weeks. Results. According to investigating serum cytokine levels at the start point of this study, the serum C-peptide, insulin, leptin, lipocalin-2, and adipsin levels in the obese group were found to be significantly higher than in the normal group. And the investigation of serum cytokine levels at the end point of this study demonstrated that mean serum leptin of Eui-E-In-Tang group was found to be significantly reduced (P = 0.037). Conclusions. This study provides preliminary evidence that Eui-E-In-Tang may exert immunomodulatory effect via altering the circulating concentration of leptin in Korean female adults.