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1.
J Virol ; 98(6): e0046824, 2024 Jun 13.
Article in English | MEDLINE | ID: mdl-38780244

ABSTRACT

The antiviral role of the tripartite motif-containing (TRIM) protein family , a member of the E3-ubiquitin ligase family, has recently been actively studied. Hepatitis B virus (HBV) infection is a major contributor to liver diseases; however, the host factors regulated by cytokine-inducible TRIM21 to suppress HBV remain unclear. In this study, we showed the antiviral efficacy of TRIM21 against HBV in hepatoma cell lines, primary human hepatocytes isolated from patient liver tissues, and mouse model. Using TRIM21 knock-out cells, we confirmed that the antiviral effects of interferon-gamma, which suppress HBV replication, are diminished when TRIM21 is deficient. Northern blot analysis confirmed a reduction of HBV RNA levels by TRIM21. Using Luciferase reporter assay, we also discovered that TRIM21 decreases the activity of HBV enhancers, which play a crucial role in covalently closed circular DNA transcription. The participation of the RING domain and PRY-SPRY domain in the anti-HBV effect of TRIM21 was demonstrated through experiments using deletion mutants. We identified a novel interaction between TRIM21 and hepatocyte nuclear factor 4α (HNF4α) through co-immunoprecipitation assay. More specifically, ubiquitination assay revealed that TRIM21 promotes ubiquitin-mediated proteasomal degradation of HNF4α. HNF1α transcription is down-regulated as a result of the degradation of HNF4α, an activator for the HNF1α promoter. Therefore, the reduction of key HBV enhancer activators, HNF4α and HNF1α, by TRIM21 resulted in a decline in HBV transcription, ultimately leading to the inhibition of HBV replication.IMPORTANCEDespite extensive research efforts, a definitive cure for chronic hepatitis B remains elusive, emphasizing the persistent importance of this viral infection as a substantial public health concern. Although the risks associated with hepatitis B virus (HBV) infection are well known, host factors capable of suppressing HBV are largely uncharacterized. This study elucidates that tripartite motif-containing protein 21 (TRIM21) suppresses HBV transcription and consequently inhibits HBV replication by downregulating the hepatocyte nuclear factors, which are host factors associated with the HBV enhancers. Our findings demonstrate a novel anti-HBV mechanism of TRIM21 in interferon-gamma-induced anti-HBV activity. These findings may contribute to new strategies to block HBV.


Subject(s)
Hepatitis B virus , Hepatocyte Nuclear Factor 4 , Hepatocytes , Interferon-gamma , Ribonucleoproteins , Virus Replication , Humans , Hepatitis B virus/physiology , Animals , Mice , Interferon-gamma/pharmacology , Interferon-gamma/metabolism , Hepatocytes/virology , Hepatocytes/metabolism , Hepatocyte Nuclear Factor 4/metabolism , Hepatocyte Nuclear Factor 4/genetics , Ribonucleoproteins/metabolism , Ribonucleoproteins/genetics , Hepatitis B/virology , Hepatitis B/metabolism , Hep G2 Cells , Cell Line, Tumor
2.
PLoS One ; 18(6): e0286449, 2023.
Article in English | MEDLINE | ID: mdl-37363912

ABSTRACT

This cross-sectional, retrospective, observational study aimed to analyze the distribution and healthcare usage patterns of patients with atopic dermatitis using the 2010-2018 Health Insurance Review and Assessment Service data. Patients diagnosed with atopic dermatitis in Korea between January 2010 and December 2018 and registered in the Health Insurance Review and Assessment national database were identified, and 270,008 patients who used healthcare services at least once during this period were evaluated to ascertain the healthcare usage patterns and treatment methods for atopic dermatitis. The number of patients with atopic dermatitis plateaued during the study period, while the number of claims and total expenses increased by a small margin. Atopic dermatitis prevalence was the highest among patients aged <5 years (31.4%), followed by those aged 5-14 years (23.53%) and 15-24 years (15.33%). However, the prevalence in these age groups showed a decreasing trend over time. The most used Western medicine treatments were injections and oral medications involving topical corticosteroids, antihistamine agents, and oral steroids, while it was acupuncture therapy in Korean medicine. The frequency of the most frequently prescribed medication, topical corticosteroid, showed a decreasing trend over time. The findings in this study will inform healthcare policy makers and clinicians across different countries on the usage trends of Western medicine and Korean medicine treatment.


Subject(s)
Dermatitis, Atopic , Dermatologic Agents , Humans , Dermatitis, Atopic/therapy , Dermatitis, Atopic/drug therapy , Retrospective Studies , Cross-Sectional Studies , Delivery of Health Care , Insurance, Health , Glucocorticoids/therapeutic use , Dermatologic Agents/therapeutic use , Patient Acceptance of Health Care
3.
J Mass Spectrom ; 58(3): e4912, 2023 Mar.
Article in English | MEDLINE | ID: mdl-36916476

ABSTRACT

A pyrolyzer gas chromatography/mass spectrometry (GC/MS) method eliminates toxic solvents that burden our environment and can address the crucial problem of the solvent extraction GC/MS method. The purpose of this study is to establish an efficient quantitative analysis method for 10 phthalates that are regulated by the several governments. A change of concentrations over time for phthalates and internal standards was measured to verify the feasibility of using an auto sampler that facilitates analyzing multiple samples. Both standards maintained constant concentrations over the appropriate time for analysis. A certified reference material under the auspices of the Korea Research Institute of Standards and Science was used to verify the calibration curve obtained by the pyrolyzer GC/MS method, and a deviation was considered similar to the solvent extraction GC/MS method. Then, the limit of detection and limit of quantitation values were confirmed for various consumer products. To verify the reliability of the method, a comparative test with several accredited testing institutes was conducted, and the results were within the standard deviations of the results provided by the institutes. These results indicate that the pyrolyzer GC/MS method can be used in not only screening but also in accurate quantitative analysis.

4.
Healthcare (Basel) ; 10(8)2022 Aug 16.
Article in English | MEDLINE | ID: mdl-36011204

ABSTRACT

Given the increasing prevalence of tinnitus and expenditure related to its treatment, it is important to identify the efficacy of different treatment methods used for its diagnosis and treatment. To this end, this study analyzed the trends of medical service utilization for tinnitus in adult patients from 2010 to 2018 based on a national sample of medical claims data from the Health Insurance Review and Assessment Service National Patient Samples database. A total of 94,323 patients with tinnitus were identified in Korea between 2010 and 2018. The results confirmed that the number of patients, claim numbers, and expenditures steadily increased during the nine-year period. Blood circulation agents were the most commonly used drug therapy; however, the frequency of their use gradually decreased, whereas that of tinnitus and vertigo medicines gradually increased. Total and average expenditure per patient nearly doubled in this period. The study showed that medication trends are changing from blood circulation agents to tinnitus or vertigo medicines. The findings of this study may be helpful for clinicians and researchers in the study, treatment, and management of tinnitus.

5.
Article in English | MEDLINE | ID: mdl-35378908

ABSTRACT

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

6.
Explore (NY) ; 18(6): 676-682, 2022.
Article in English | MEDLINE | ID: mdl-35246396

ABSTRACT

INTRODUCTION: Intranasal low-level laser therapy (LLLT) has already proven its immunosuppressive effects on allergic rhinitis (AR) in experimental studies; however, there is a dearth of clinical evidence supporting its effects in treating AR. The aim of this study was to assess the safety and effectiveness of intranasal LLLT in the treatment of AR compared with acupuncture. METHODS: A total of 80 patients with AR participated and were randomly assigned to the intranasal LLLT or acupuncture treatment (AT) group. They were given each treatment for 20 min 3 times a week for 4 weeks. RESULTS: Both groups improved the total nasal symptom score (TNSS), rhinoconjunctivitis quality of life questionnaire (RQLQ) score, and nasal endoscopy index in patients with AR after 4 weeks of treatment, and these effects extended 4 weeks after the end of treatment. Intranasal LLLT was noninferior to AT in regard to the TNSS. The estimated outcome difference between baseline and the 5th week was -0.38 points (upper 97.5% confidence limit 1.06 points), which was within the noninferiority margin of 2 points. The effect size of the TNSS at the 5th week was 0.19, which was close to Cohen's small effect size. There were no significant differences between two groups regarding the RQLQ, nasal endoscopy index, total serum immunoglobulin E level or absolute eosinophil count. CONCLUSION: This study showed that intranasal LLLT is noninferior compared to AT in terms of the TNSS; thus, it may be used as an alternative or adjunctive treatment option for relieving symptoms of AR. TRIAL REGISTRATION: This study was registered at the Korean National Clinical Trial Registry, Clinical Research Information Service (KCT0004079).


Subject(s)
Acupuncture Therapy , Low-Level Light Therapy , Rhinitis, Allergic , Humans , Quality of Life , Rhinitis, Allergic/therapy , Rhinitis, Allergic/diagnosis , Surveys and Questionnaires , Treatment Outcome
7.
Clin Mol Allergy ; 19(1): 20, 2021 Oct 11.
Article in English | MEDLINE | ID: mdl-34635115

ABSTRACT

BACKGROUND: There has been little investigation on how guidelines for allergic rhinitis (AR) treatment are applied in current clinical practice. We aimed to analyze prescription trends and patterns for AR treatment according to patient characteristics over a 9-year period in Korea. METHODS: We used cross-sectional data from the Korean Health Insurance Review & Assessment Service National Patient Sample from 2010 to 2018. We analyzed 1,719,194 patients with AR as the principal diagnosis. Prescription rates of antihistamines, steroids, and other drugs; combination prescriptions; and first-choice prescriptions were analyzed. RESULTS: The prescription rate of first-generation antihistamines decreased over the years (2010: 29.13; 2018: 23.41). By contrast, the prescription rate of systemic steroids (2010: 23.60; 2018: 28.70), nasal steroids (2010: 9.70; 2018: 14.67), and leukotriene receptor antagonists (LTRAs) (2010: 11.13; 2018: 26.56) increased. The prescription rate of steroids was lower in patients aged 0-5 years and ≥ 65 years than in other age groups and that of LTRAs was the highest in patients aged 0-5 years. The rate of combination prescribing antihistamines and nasal steroids increased (2010: 7.99; 2018: 12.09). The rate of first-choice prescriptions with antihistamines and nasal steroids also increased (2010: 4.72; 2018: 7.24). CONCLUSIONS: The results confirmed a decrease in antihistamine prescriptions, especially with first-generation, and an increase in steroid and LTRA prescriptions in patients with AR in Korea. Regarding prescription patterns, steroids were increasingly prescribed in combination with antihistamines. However, the trend was opposite in the 0-5 years and ≥ 65 years groups.

8.
Medicine (Baltimore) ; 99(30): e20835, 2020 Jul 24.
Article in English | MEDLINE | ID: mdl-32791671

ABSTRACT

INTRODUCTION: Allergic rhinitis (AR) is an immunoglobulin E (Ig E)-mediated inflammatory disease. Intranasal phototherapy is a promising treatment modality because it has a profound immunosuppressive effect, but the available evidence of its use for AR is insufficient. Therefore, rigorously designed randomized controlled trials (RCTs) are needed. Our objective is to describe the protocol for a feasibility trial to assess the effects and safety of intranasal phototherapy for the treatment of AR. METHODS AND ANALYSIS: This is a study protocol for a single-center, randomized, double-blind, parallel, placebo-controlled, investigator-initiated pilot study. A total of 40 patients with AR will be randomly assigned to the medical device or sham device group in a 1:1 ratio. The participants will receive intranasal phototherapy with a medical or sham device for 20 min 5 times a week for 2 weeks. The primary outcome will be the mean change in the Total Nasal Symptom Score (TNSS) from baseline to 2 weeks. The secondary outcomes will include the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score, Nasal Endoscopy Index, total serum Ig E level, and eosinophil count. DISCUSSION: The findings of this study will provide the basis for subsequent large-scale definitive RCTs to confirm the effects and safety of intranasal phototherapy for the treatment of nasal symptoms in patients with AR who do not respond well to conventional therapy. This study may assist in the development of noninvasive treatment for patients with AR. TRIAL REGISTRATION: This study was registered at the Korean National Clinical Trial Registry, Clinical Research Information Service (KCT0003253).


Subject(s)
Phototherapy , Rhinitis, Allergic/therapy , Double-Blind Method , Humans , Pilot Projects , Randomized Controlled Trials as Topic
9.
Medicine (Baltimore) ; 99(30): e21183, 2020 Jul 24.
Article in English | MEDLINE | ID: mdl-32791692

ABSTRACT

INTRODUCTION: Allergic rhinitis (AR) is an immunoglobulin E (Ig E)-mediated inflammatory disease. Intranasal phototherapy is a promising treatment modality because it has a profound immunosuppressive effect, but the evidence of its use for AR is insufficient. Therefore, rigorously designed randomized controlled trials (RCTs) are needed. Our objective is to describe the protocol for an RCT to assess the effects and safety of intranasal phototherapy for the treatment of AR. METHODS AND ANALYSIS: This is a study protocol for a single-center, randomized, parallel (acupuncture-controlled), open-label, investigator-initiated, pilot study. A total of 80 patients with AR will be randomly assigned to the intranasal phototherapy or acupuncture group at a 1:1 ratio. The participants will receive intranasal phototherapy with medical or acupuncture treatment for 20 minutes, 3 times a week for 4 weeks. The primary outcome will be the mean change in the total nasal symptom score (TNSS) from baseline to 4 weeks. The secondary outcomes will include the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score, Nasal Endoscopy Index, total serum immunoglobulin E (Ig E) level and eosinophil count. DISCUSSION: The findings of this study will provide the basis for the design and implementation of RCTs investigating the effects and safety of intranasal phototherapy for AR. Additionally, it will provide preliminary evidence of intranasal phototherapy for use in AR. TRIAL REGISTRATION: This study was registered at the Korean National Clinical Trial Registry, Clinical Research Information Service (KCT0004079).


Subject(s)
Eosinophils , Low-Level Light Therapy , Rhinitis, Allergic/therapy , Acupuncture Therapy , Humans , Immunoglobulin E/blood , Leukocyte Count , Low-Level Light Therapy/adverse effects , Nasal Cavity , Pilot Projects , Quality of Life , Randomized Controlled Trials as Topic , Rhinitis, Allergic/blood , Severity of Illness Index , Single-Blind Method
11.
ACS Appl Bio Mater ; 3(1): 263-272, 2020 Jan 21.
Article in English | MEDLINE | ID: mdl-35019442

ABSTRACT

Microalgal lipid-derived biofuels have been regarded as promising candidate materials to replace fossil fuels, but their production cost, especially for lipid extraction, still must be lowered substantially for field application. Although lipid extraction from concentrated wet microalgae using a nonpolar solvent is considered as a feasible method, an effective recovery method to regain the nonpolar solvent with microalgal lipid from the emulsified extraction mixture has not yet been addressed significantly. In this study, microalgal lipid is cost-efficiently recovered in continuous manner directly from the emulsified, highly concentrated extraction mixture by utilizing a surface-modified filter. The surface of a highly porous sponge filter is modified conformally by an oil-absorbing but water-repellent polymer coating via an initiated chemical vapor deposition (iCVD) process. Concentrated wet Schizochytrium sp. ABC101 microalgal cells are disrupted, and the microalgal lipid components are extracted out by adding n-hexane in the aqueous disrupted microalgae. The surface-modified filter is capable of selective permeation of the n-hexane phase with microalgal lipid while blocking the water-phase permeation simply by immersing the filter into the emulsified extraction mixture. The absorbed n-hexane phase is recovered in a continuous manner by pumping it out. The continuous filter-based recovery system shows a high recovery yield of 95% and an extremely high permeation flux of 2640 L m-2 h-1. Moreover, the recovery performance is maintained for more than 24 h without any filter-cleaning step. Techno-economic analysis of the method developed in this study with the conventional phase recovery methods shows that the rapid but highly cost-efficient filter-based recovery method will be a useful platform for scalable, continuous microalgae lipid production.

12.
Clin Otolaryngol ; 44(6): 997-1003, 2019 11.
Article in English | MEDLINE | ID: mdl-31468673

ABSTRACT

OBJECTIVES: The aim of the current study was to investigate the effectiveness and clinical feasibility of Biyeom-go for the treatment of nasal symptoms associated with rhinitis. DESIGN: Prospective observational study. SETTING: This study was conducted at the Woosuk Korean Medicine Medical Center in South Korea. PARTICIPANTS: Fifty-eight patients with rhinitis participated in this study. All patients received Biyeom-go treatment >3 times daily for a total of 4 weeks. MAIN OUTCOME MEASURES: The primary outcome was the total nasal symptom score. Mini-rhinoconjunctivitis quality of life questionnaire, nasal endoscopy index, total serum immunoglobulin E levels and immunologic factors in nasal lavage fluid were also measured. RESULTS: Biyeom-go administration was associated with significant improvements in total nasal symptoms scores (P < .0001) and mini-rhinoconjunctivitis quality of life questionnaire scores (P < .0001) in a time-dependent manner. The nasal endoscopy index also significantly improved at weeks 2 (P = .0049), 3 (P < .0001) and 4 (P = .0001) after Biyeom-go treatment. Significantly, increased interleukin-2 levels (P = .005) and decreased interleukin-8, chemokine (C-C motif) ligand (CCL) 5, chemokine (C-X-C motif) ligand (CXCL) 9, CCL2 and CXCL10 levels were observed in the nasal lavage fluid. CONCLUSIONS: The present findings suggest that Biyeom-go may be beneficial for the management of rhinitis symptoms and rhinitis-associated quality of life. Further well-designed randomised controlled trials are needed to evaluate the effectiveness of Biyeom-go for rhinitis.


Subject(s)
Anti-Allergic Agents/therapeutic use , Phytotherapy , Plant Extracts , Rhinitis/complications , Rhinitis/therapy , Administration, Intranasal , Adolescent , Adult , Female , Humans , Male , Middle Aged , Nasal Sprays , Ointments , Prospective Studies , Young Adult
13.
Bioprocess Biosyst Eng ; 42(9): 1447-1455, 2019 Sep.
Article in English | MEDLINE | ID: mdl-31076866

ABSTRACT

While lipid extraction from wet microalgae has attracted attention as an economical method for microalgal biofuel production, few studies have focused the actual separation of extract phase from the emulsified extraction mixture. Here, a novel approach which utilizes hydrophobic/oleophilic filter was developed for the efficient solvent recovery. The filter was surface-modified by coating a functional polymer via initiated vapor deposition for the selective solvent permeability. While acid-treated Chlorella sorokiniana HS1 and n-hexane was stirred for lipid extraction, tubular filter module was immersed into the mixture for separation. The mixture was kept stirred during the separation to inhibit the buildup of cell debris on the filter by inducing crossflow on the filter. Extract phase was separated directly from the raffinate phase with high separation efficiency (> 98.3%) while maintaining permeation flux. The place-, space- and energy-efficient strategy reported here could be a useful tool for the solvent extraction process.


Subject(s)
Chlorella/chemistry , Filtration/instrumentation , Lipids/isolation & purification , Liquid-Liquid Extraction , Microalgae/chemistry , Hydrophobic and Hydrophilic Interactions , Lipids/chemistry , Solvents/chemistry
14.
Medicine (Baltimore) ; 98(11): e14526, 2019 Mar.
Article in English | MEDLINE | ID: mdl-30882619

ABSTRACT

RATIONALE: Psoriasis is a common chronic, immune-mediated inflammatory skin disease. Here, we describe 2 patients who presented with psoriasis to illustrate the potential efficacy of Korean medicine treatment combined with phototherapy. PATIENT CONCERNS: A 33-year-old female (Case 1) and a 37-year-old male (Case 2) presented at the clinic with symptoms of itching, erythema, and scaliness. DIAGNOSIS: Both patients were diagnosed with psoriasis based on the locations of erythema, as well as the appearance of circumscribed scaly papules and plaques. INTERVENTIONS: Patients underwent 5 months (Case 1) and 8 months (Case 2) of treatments with acupuncture, herbal medicine, probiotics, and phototherapy. OUTCOMES: After treatment, the patients improved in Psoriasis Area and Severity Index score from 7 to 1.2 (Case 1), and 23.2 to 2.2 (Case 2). LESSONS: These outcomes suggest that Korean medicine therapies combined with phototherapy may be effective for resolution of psoriasis; however, further research is needed to confirm these findings.


Subject(s)
Phototherapy , Phytotherapy , Psoriasis/therapy , Acupuncture Therapy , Adult , Combined Modality Therapy , Female , Humans , Liver Function Tests , Male , Medicine, Korean Traditional , Plant Preparations/therapeutic use , Probiotics/therapeutic use , Severity of Illness Index
15.
Medicine (Baltimore) ; 97(34): e11812, 2018 Aug.
Article in English | MEDLINE | ID: mdl-30142767

ABSTRACT

INTRODUCTION: Socheongryong-tang (SCRT) is an herbal medicine with anti-inflammatory and anti-allergic properties, commonly used in East Asian countries to reduce rhinitis symptoms. There have been several clinical studies of its effects on allergic rhinitis (AR), but no trials comparing it with conventional treatment. We present the protocol for a feasibility trial to assess the safety and clinical effectiveness of SCRT in AR in comparison with cetirizine. METHODS AND ANALYSIS: This is a randomized, open-label, cetirizine-controlled clinical trial. A total of 30 AR patients who have signed informed consent forms will be recruited and randomly assigned to SCRT or cetirizine groups at a 1:1 ratio. The participants will visit the clinical research center every week and receive SCRT granules or cetirizine tablets. SCRT will be taken twice daily, cetirizine will be taken once daily, and treatment medication will be taken for 2 weeks. Data will be collected at baseline, at week 2, and at week 4 after random allocation. The primary outcome will be the mean change in the total nasal symptom score from baseline to week 2. Secondary outcome measures will include the mini Rhinoconjunctivitis Quality of Life Questionnaire and total serum immunoglobulin E. To assess the safety of SCRT, a liver and renal function test will be conducted before and after treatment, and the participants will be asked about any occurrence of adverse events at every visit. The recruitment rate, completion rate, and medication adherence will also be calculated to assess feasibility. DISCUSSION: The findings of this study are expected to provide the basis for a full-scale randomized controlled trial to confirm the safety and effectiveness of SCRT for the treatment of nasal symptoms in patients with AR patients not controlled by conventional therapy. TRIAL REGISTRATION: This study has been registered at the Korean National Clinical Trial Registry, Clinical Research Information Service (KCT0002380).


Subject(s)
Anti-Allergic Agents/administration & dosage , Cetirizine/administration & dosage , Drugs, Chinese Herbal/administration & dosage , Rhinitis, Allergic/drug therapy , Adult , Anti-Allergic Agents/therapeutic use , Cetirizine/therapeutic use , Drug Administration Schedule , Drugs, Chinese Herbal/therapeutic use , Feasibility Studies , Female , Humans , Immunoglobulin E/blood , Male , Middle Aged , Rhinitis, Allergic/blood , Rhinitis, Allergic/immunology , Treatment Outcome , Young Adult
16.
Medicine (Baltimore) ; 97(25): e11196, 2018 Jun.
Article in English | MEDLINE | ID: mdl-29924041

ABSTRACT

INTRODUCTION: A herbal formula, Galgeun-tang-ga-cheongung-sinyi (GGTCS), is traditionally used for the treatment of rhinosinusitis in East Asian countries. However, there is a dearth of clinical evidence supporting the effects of this medication. Here, we describe the protocol for a randomized controlled study designed to investigate the efficacy and safety of GGTCS for the treatment of chronic rhinosinusitis (CRS). METHODS AND ANALYSIS: To investigate the clinical efficacy and safety of GGTCS for the treatment of CRS, a randomized, double-blind, placebo-controlled, parallel group, clinical trial has been designed. A total of 58 participants with CRS will be recruited and randomly allocated to a GGTCS or placebo group in a 1:1 ratio. The participants will be administered GGTCS or placebo granules 3 times a day for 8 weeks. Data will be collected from the participants at baseline and at 1, 2, 4, and 8 weeks after random allocation. The primary outcome measure will be the mean change in the Sino-Nasal Outcome Test-22 score from baseline to 8 weeks. The secondary outcomes will include the Total Nasal Symptom Score, EuroQoL 5 Dimensions 5 Levels score, Nasal Endoscopy Index, Lund-Mackay score, and total serum immunoglobulin E level. DISCUSSION: The key elements for conducting a high-quality randomized clinical trial have been addressed in this protocol. In summary, the findings of this study are expected to provide a base for large-scale randomized controlled trials to confirm the safety and efficacy of GGTCS for the treatment of CRS and may consequently serve to improve future treatment strategies for this condition. TRIAL REGISTRATION: This study has been registered at the Korean National Clinical Trial Registry, Clinical Research Information Service (KCT0002835).


Subject(s)
Drugs, Chinese Herbal/pharmacology , Rhinitis/drug therapy , Sinusitis/drug therapy , Adult , Chronic Disease , Clinical Protocols , Drugs, Chinese Herbal/administration & dosage , Endoscopy/methods , Asia, Eastern/epidemiology , Female , Humans , Immunoglobulin E/blood , Male , Middle Aged , Treatment Outcome
17.
BMJ Open ; 6(5): e010556, 2016 05 13.
Article in English | MEDLINE | ID: mdl-27178973

ABSTRACT

INTRODUCTION: Manual therapy is the non-surgical conservative management of musculoskeletal disorders using the practitioner's hands on the patient's body for diagnosing and treating disease. The aim of this study is to systematically review trial-based economic evaluations of manual therapy relative to other interventions used for the management of musculoskeletal diseases. METHODS AND ANALYSIS: Randomised clinical trials (RCTs) on the economic evaluation of manual therapy for musculoskeletal diseases will be included in the review. The following databases will be searched from their inception: Medline, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Econlit, Mantis, Index to Chiropractic Literature, Science Citation Index, Social Science Citation Index, Allied and Complementary Medicine Database (AMED), Cochrane Database of Systematic Reviews (CDSR), National Health Service Database of Abstracts of Reviews of Effects (NHS DARE), National Health Service Health Technology Assessment Database (NHS HTA), National Health Service Economic Evaluation Database (NHS EED), CENTRAL, five Korean medical databases (Oriental Medicine Advanced Searching Integrated System (OASIS), Research Information Service System (RISS), DBPIA, Korean Traditional Knowledge Portal (KTKP) and KoreaMed) and three Chinese databases (China National Knowledge Infrastructure (CNKI), VIP and Wanfang). The evidence for the cost-effectiveness, cost-utility and cost-benefit of manual therapy for musculoskeletal diseases will be assessed as the primary outcome. Health-related quality of life and adverse effects will be assessed as secondary outcomes. We will critically appraise the included studies using the Cochrane risk of bias tool and the Drummond checklist. Results will be summarised using Slavin's qualitative best-evidence synthesis approach. ETHICS AND DISSEMINATION: The results of the study will be disseminated via a peer-reviewed journal and/or conference presentations. TRIAL REGISTRATION NUMBER: PROSPERO CRD42015026757.


Subject(s)
Musculoskeletal Diseases/therapy , Musculoskeletal Manipulations/economics , Cost-Benefit Analysis , Disability Evaluation , Humans , Musculoskeletal Diseases/diagnosis , Musculoskeletal Diseases/economics , Musculoskeletal Manipulations/methods , Pain Measurement , Randomized Controlled Trials as Topic , Systematic Reviews as Topic
18.
BMC Complement Altern Med ; 13: 330, 2013 Nov 25.
Article in English | MEDLINE | ID: mdl-24274317

ABSTRACT

BACKGROUND: Moisturisers prevent and treat dry skin. They can also protect sensitive skin, improve skin tone and texture, and mask imperfections. Herbal medicines or their extracts have been available as topical formulations and cosmetics. Arctium lappa L. (Asteraceae) has been used to treat inflammatory disorders and various skin problems. It could be a candidate herbal medicine for treating dry skin condition.This study aims to establish the efficacy and safety of a proposed herbal moisturising cream containing Arctium lappa L. seed extract, which has been approved by the Korean Ministry of Food and Drug Safety for use in cosmetics. METHODS/DESIGNS: This study is a randomised, double-blind, placebo-controlled study with two parallel groups (proposed herbal moisturising cream vs. placebo cream). We will recruit 66 healthy male and female participants, aged 20 to 65 years, who have been diagnosed with dry skin conditions. Participants will be randomly allocated to receive either the proposed herbal moisturising cream or a placebo cream for four weeks. Each participant will be examined for signs and symptoms before and after using the cream. Skin hydration, sebum (oily secretion) levels and transepidermal water loss (TEWL; constitutive loss of water from the skin surface) will be assessed. Participants will also be asked to fill out a health-related quality of life questionnaire. Safety will be assessed using blood tests, urine analysis, a pregnancy test, and the assessment of vital signs. DISCUSSION: This trial will utilise high-quality methodologies in accordance with both consolidated standards for reporting trials guidelines and the guidelines for clinical trials of cosmetics products that are aimed at expressions and advertisement approval in Korea. It will evaluate the clinical efficacy and safety of a proposed herbal moisturising cream containing Arctium lappa L. seed extract to treat dry skin conditions and provide itch relief. Moreover, we will also employ health-related quality of life questionnaires to assess changes in the quality of life. The results of this study will be used to present the evidence needed to request advertising/display allowances, in compliance with the recently amended Cosmetics Act for advertisement in Korea. TRIAL REGISTRATION: Current Controlled Trials ISRCTN46216631.


Subject(s)
Arctium/chemistry , Plant Extracts/administration & dosage , Adult , Aged , Analysis of Variance , Double-Blind Method , Female , Humans , Male , Middle Aged , Plant Extracts/adverse effects , Pruritus/drug therapy , Skin Cream/administration & dosage , Skin Cream/adverse effects , Skin Diseases/drug therapy , Surveys and Questionnaires , Treatment Outcome
19.
BMC Complement Altern Med ; 12: 97, 2012 Jul 17.
Article in English | MEDLINE | ID: mdl-22805113

ABSTRACT

BACKGROUND: Complementary and alternative medicine (CAM) has frequently been used to treat tinnitus, and acupuncture is a particularly popular option. The objective of this review was to assess the evidence concerning the effectiveness of acupuncture as a treatment for tinnitus. METHODS: Fourteen databases were searched from the dates of their creation to July 4th, 2012. Randomized clinical trials (RCTs) were included if acupuncture was used as the sole treatment. The Cochrane risk of bias tool was used to assess the risk of bias. RESULTS: A total of 9 RCTs met all the inclusion criteria. Their methodological quality was mostly poor. Five RCTs compared the effectiveness of acupuncture or electroacupuncture with sham acupuncture for treating tinnitus. The results failed to show statistically significant improvements. Two RCTs compared a short one-time scalp acupuncture treatment with the use of penetrating sham acupuncture at non-acupoints in achieving subjective symptom relief on a visual analog scale; these RCTs demonstrated significant positive effects with scalp acupuncture. Two RCTs compared acupuncture with conventional drug treatments. One of these RCTs demonstrated that acupuncture had statistically significant effects on the response rate in patients with nervous tinnitus, but the other RCT did not demonstrate significant effects in patients with senile tinnitus. CONCLUSIONS: The number, size and quality of the RCTs on the effectiveness of acupuncture for the treatment of tinnitus are not sufficient for drawing definitive conclusions. Further rigorous RCTs that overcome the many limitations of the current evidence are warranted.


Subject(s)
Acupuncture Therapy , Tinnitus/therapy , Acupuncture Points , Complementary Therapies , Humans , Randomized Controlled Trials as Topic
20.
BMC Complement Altern Med ; 11: 68, 2011 Aug 23.
Article in English | MEDLINE | ID: mdl-21861896

ABSTRACT

BACKGROUND: Atopic Dermatitis is a chronic relapsing eczematous skin disease with increasing prevalence and rising costs. It has a clear impact on a patient's quality of life. Many patients are worried about the use of usual care techniques, such as corticosteroids and antihistamine due to the widespread fear of adverse effects. Complementary and alternative medical approaches have been employed to relieve symptoms of Atopic Dermatitis. Hwangryunhaedoktang is among the most strongly preferred and widely used herbal medicines for Atopic Dermatitis in Korea, as it causes very few serious adverse effects.We aim to establish basic clinical efficacy and safety data for Hwangryunhaedoktang, which is approved as an herbal medication by the Korean Food and Drug Administration, in adult patients with Atopic Dermatitis. METHODS/DESIGNS: This study is a randomised, double blind, placebo-controlled, two-centre trial with two parallel arms (Hwangryunhaedoktang and a placebo). The diagnosis of Atopic Dermatitis will be made according to the criteria of Hanifin and Rajka by two different Oriental medicine doctors. We will include participants experiencing typical conditions of intermittent or continuous Atopic Eczema for six or more months. Participants will receive Hwangryunhaedoktang or a placebo-drug for eight weeks. The total duration of each arm is eleven weeks. Each participant will be examined for signs and symptoms of Atopic Dermatitis before and after taking medication. A follow-up to evaluate the maintenance of safety will be performed two weeks after the final administration of medication. DISCUSSION: This trial will utilize high quality trial methodologies in accordance with consolidated standards of reporting trials guidelines. It will provide evidence for the clinical efficacy and safety evaluation of Hwangryunhaedoktang in adult patients with Atopic Dermatitis. Moreover, we will also employ health-related quality of life questionnaires to assess the changes in quality of life.


Subject(s)
Clinical Protocols , Dermatitis, Atopic/drug therapy , Plant Extracts/therapeutic use , Adult , Double-Blind Method , Female , Herbal Medicine , Humans , Male , Plant Extracts/adverse effects , Quality of Life , Republic of Korea
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