Efficacy and Safety of Bojungikgi-Tang for Persistent Allergic Rhinitis: A Randomized, Double-Blinded, Placebo-Controlled, Phase II Trial.

Conventional treatments for allergic rhinitis (AR) exhibit insufficiency and long-term use-related side effects. Considering the reported anti-inflammatory and immunoregulatory effects of Bojungikgi-tang (BJIGT), we aimed to assess its efficacy on persistent AR (PAR). Patients with PAR were randomly assigned in a 1:1:1 ratio into high-dose BJIGT, standard-dose BJIGT, and placebo groups, followed by 1-week run-in and 4-week treatment periods. The primary outcome included the mean change in Total Nasal Symptom Score (TNSS), with secondary outcomes encompassing the Korean Allergic Rhinitis-Specific Quality of Life Questionnaire, biomarkers, overall assessment, TNSS by AR pattern identification, and the Sasang constitution. The mean TNSS change was more improved in the BJIGT group than in the placebo group; however, no statistically significant differences were observed. Additional interaction effect analysis revealed a statistically significant improvement in the high-dose BJIGT group compared with the placebo group from weeks 1-2 to weeks 3-4. Regarding secondary outcomes, the BJIGT group exhibited similar or improved results compared with the placebo group, showing no statistically significant differences. No serious adverse effects or clinically significant changes in safety assessments were observed. Given that this study validated clinical improvement and safety, it serves as potential groundwork for pertinent future studies.

Efficacy and Safety of Yukmijihwang-Tang in the Treatment of Cough-Variant Asthma: Study Protocol for a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial.

BACKGROUND: Cough-variant asthma (CVA), a precursor of typical asthma, is the main cause of chronic cough. We hypothesize that yukmijihwang-tang (YJT), which has been used for chronic cough in traditional medicine and has been reported to have an anti-inflammatory effect, could be an adjuvant to asthma treatment. METHODS: We plan a randomized, double-blind, placebo-controlled, multicenter, phase 2 trial to investigate the efficacy and safety of YJT in CVA patients. A total of 60 patients with CVA will be recruited and randomly assigned to either a high-dose YJT group, standard-dose YJT group, or control group (placebo) in a 1:1:1 allocation ratio after a 2-week run-in period. For the run-in period, only inhaled corticosteroids (ICSs) will be used, and the investigational drug will be administered once a day with concomitant ICS for 6 weeks. Data will be collected at baseline, week 3, and week 6, and the primary outcome measure will be the mean cough symptom score (CSS) change before and after medication. The secondary outcome measures will include the Leicester cough questionnaire-Korean version (LCQ-K) score, eosinophil count and eosinophil cationic protein level, pulmonary function test, and the number of uses of rescue medication, and so on. CONCLUSION: This study aimed to evaluate the efficacy and safety of YJT in concomitant treatment with ICS in patients with CVA and to determine the optimal dosage of YJT. The results are expected to provide evidence for the use of YJT as an adjuvant treatment for CVA.Cough-Variant-Asthma (CVA), eine Frühform von typischem Asthma, ist die Hauptursache von chronischem Husten. Unserer Vermutung nach könnte Yukmijihwang-Tang (YJT), das in der traditionellen Medizin zur Behandlung von chronischem Husten eingesetzt wird und das Berichten zufolge einen entzündungshemmenden Effekt hat, unterstützend in der Asthma-Therapie wirken.en: Wir planen eine randomisierte, doppelblinde, placebokontrollierte, multizentrische Phase-2-Studie, um die Wirksamkeit und Sicherheit von YJT bei Patienten mit CVA zu untersuchen. Insgesamt werden 60 CVA-Patienten für die Studie rekrutiert und nach einer zweiwöchigen Run-in-Phase randomisiert im Verhältnis 1:1:1 einer Gruppe mit hochdosiertem YJT, einer Gruppe, die YJT in der Standarddosierung erhält oder einer Kontrollgruppe (Placebo) zugewiesen. Während der Run-in-Phase werden nur inhalative Corticosteroide (ICS) verwendet, und das Prüfpräparat wird über 6 Wochen einmal täglich gleichzeitig mit den ICS angewendet. Die Datenerhebung erfolgt bei Studienbeginn, in Woche 3 sowie in Woche 6, und das primäre Zielkriterium ist die Änderung des mittleren Hustenscores (cough symptom score, CSS) vor und nach der Anwendung der Medikamente. Zu den sekundären Zielkriterien gehören der Score des Leicester Hustenfragebogens - koreanische Version (LCQ-K), die Eosinophilenzahl und der Spiegel an eosinophilem kationischen Protein, Lungenfunktionstests sowie die Anzahl der Anwendungen von Bedarfsmedikation usw.Ziel dieser Studie ist es, die Wirksamkeit und Sicherheit von YJT bei gleichzeitiger Behandlung mit ICS bei Patienten mit CVA zu bewerten und die optimale YJT-Dosis zu ermitteln. Es wird erwartet, dass die Ergebnisse Belege für die Anwendung von YJT als adjuvante Therapie bei CVA liefern werden.WHO International Clinical Trials Registry Platform, Clinical Research Information Service (CRIS), KCT0006994, registriert am 10. Februar 2022, https://cris.nih.go.kr/cris/search/detailSearch.do/21743.

Efficacy and Safety of Bojungikgi-Tang for Persistent Allergic Rhinitis: A Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Phase II Trial.

Background: Allergic rhinitis (AR) is a common disease, and conventional medications are often insufficient for treatment. Bojungikgi-tang (BJIGT) is an herbal medicine widely used in traditional medicine and has anti-inflammatory and immunoregulatory effects. We hypothesize that BJIGT would improve nasal symptoms in patients with persistent AR (PAR). Methods: This is a randomized, double-blind, placebo-controlled, phase II trial. A total of 105 patients, identified with perennial allergens, with a history of PAR and a mean total nasal symptom score (TNSS) ≥ 5 during the run-in period will be recruited from Daejeon Korean Medicine Hospital. Participants will be randomly assigned to a high-dose BJIGT group, standard-dose BJIGT group, or control group (placebo) in a 1 : 1 : 1 allocation ratio after a week run-in period. The treatment medication will be taken three times per day for 4 weeks. The primary outcome measure is the mean change in the TNSS before and after medication. The secondary outcome measures include the Korean Allergic Rhinitis-Specific Quality of Life Questionnaire, total IgE and eosinophil count, overall assessment of AR, pattern identification questionnaire for AR, and Sasang constitution. Discussion. The aim of this study is to investigate the efficacy and safety of BJIGT in the treatment of PAR and to determine the suitable dosage of BJIGT. Therefore, we planned a randomized, controlled, phase II trial of two different doses of BJIGT compared with placebo, and the results of this study are expected to provide evidence for the use of BJIGT as a treatment of PAR. Trial Registration. The National Clinical Trial Registry Clinical Research Information Service, CRIS, KCT0006616, https://cris.nih.go.kr/cris/search/detailSearch.do/20706.

The effect of lung-conduction exercise in chronic obstructive pulmonary disease: Randomized, assessor-blind, multicenter pilot trial.

BACKGROUND: Pulmonary rehabilitation (PR) is a management modality that improves the quality of life of patients with chronic obstructive pulmonary disease (COPD); however, PR is not readily accessible. Therefore, we developed lung-conduction exercises (LCE) that can be performed easily without any limitations. The purpose of this randomized, assessor-blind, multicenter pilot trial was to compare the effects of LCE with PR and standard care (SC) in COPD patients. METHODS: Twenty-five participants who met the eligibility criteria were randomly allocated to the SC group (only medication, n = 9), LCE group (medication + LCE, 5 times a week, n = 8), or PR group (medication + PR, 5 times a week, n = 8). The 6-minute walk distance (6WMD), pulmonary function test, modified Medical Research Council dyspnea scale, COPD assessment test (CAT), and St. George Respiratory Questionnaire (SGRQ) survey were carried out before starting the trial and after 4 and 8 weeks to determine motor performance, lung function, and dyspnea. RESULTS: After 8 weeks, the pulmonary function test scores were the same. The 6MWD (PR, 28.3 ±â€Š38.5; LCE, 14.5 ±â€Š53.1; SC, 11.5 ±â€Š20.5; P = .984), modified Medical Research Council dyspnea scale (PR, 0.8 ±â€Š1.0; LCE, 0.8 ±â€Š0.8; SC, 0.3 ±â€Š0.5; P = .772), CAT (PR, 7.3 ±â€Š6.2; LCE, 4.2 ±â€Š5.2; SC, 1.0 ±â€Š2.2; P = .232), and SGRQ scores (PR, 11.5 ±â€Š15.4; LCE, 5.5 ±â€Š13.1; SC, 4.8 ±â€Š5.1; P = .358 [PR vs LCE], P = .795 [PR vs SC]) had improved in order of PR, LCE, and SC group. Although there were no statistically significant differences in the outcome measures between the groups, there were clinically significant improvements in the CAT and SGRQ scores. CONCLUSIONS: In this trial, PR showed more improvement in symptoms and quality of life than SC alone. To seek a more precise use of LCE, further full-sized studies with a long duration and additional outcome measures such as psychological assessment tools and cost-effectiveness ratio should be conducted. TRIAL REGISTRATION: KCT0004724.

Efficacy and Safety of GHX02 in the Treatment of Acute Bronchitis and Acute Exacerbation of Chronic Bronchitis: A Phase â ¡, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial.

Acute bronchitis and acute exacerbations of chronic bronchitis (AECB) have cough and sputum as the main symptoms with a high prevalence and substantial economic burden. Although the demand for bronchitis treatment increases due to causes, such as air pollution, the appropriateness of antibiotic prescriptions and the effects of current symptomatic treatments for bronchitis are unclear. GHX02, which is a combined formulation containing four herbs, and has been clinically used for bronchitis in South Korea. We conducted a phase II, randomized, double-blind, and placebo-controlled, multicenter trial to evaluate its efficacy and safety. Patients with acute bronchitis or AECB were recruited and randomized to receive high-dose GHX02 (1920 mg/day), standard-dose GHX02 (960 mg/day), or placebo for 7 days. The primary outcome measure was the change in Bronchitis Severity Score (BSS) from baseline to Day 7. The secondary outcomes were the frequency of coughing fits, Questionnaire of Clinical Symptoms of Cough and Sputum (QCSCS), Leicester Cough Questionnaire (LCQ), Integrative Medicine Outcome Scale (IMOS), and Integrative Medicine Patient Satisfaction Scale (IMPSS). A total of 117 patients were randomized to parallel groups (38 in the high-dose GHX02, 41 in the standard-dose GHX02 group, and 38 in the placebo group). The mean differences in BSS from baseline to Day 7 in the treatment groups (4.2 ± 2.0 and 4.5 ± 1.8 in the high-dose GHX02 and standard-dose GHX02 groups, respectively) were higher than the placebo group (3.8 ± 2.1), p = 0.028. The mean differences in the frequency of coughing fits from baseline to Day 7 and IMPSS were better in the GHX02 treatment group than in the placebo group (standard-dose GHX02 group vs placebo group, p = 0.036). The QCSCS, LCQ, IMOS, and GHX02 of the treatment groups also showed more improvement than the placebo group, but there were no statistically significant differences between the groups. There were no severe adverse effects during the trial. This study supports that GHX02 is effective and safe for patients with bronchitis and provides the basis for progression to a phase III study. Clinical Trial Registration: [https://cris.nih.go.kr] WHO International Clinical Trials Registry Platform, Clinical Research Information Service [KCT0003665].

Gait Disturbance Improvement and Cerebral Cortex Rearrangement by Acupuncture in Parkinson's Disease: A Pilot Assessor-Blinded, Randomized, Controlled, Parallel-Group Trial.

BACKGROUND: Parkinson's disease (PD) leads to impaired mobility and limited independence. OBJECTIVE: We investigated the effects of acupuncture on gait disturbance and analyzed hemodynamic changes caused by acupuncture in the cerebral cortex of patients with PD. METHODS: Participants (n = 26) with gait disturbance due to PD were randomly assigned to the intervention (acupuncture twice a week for 4 weeks + conventional therapy) or control (conventional therapy) groups. We analyzed gait parameters using the GAITRite system and hemodynamic responses in the cerebral cortices using functional near-infrared spectroscopy, Unified Parkinson's Disease Rating Scale (UPDRS) scores, neurotransmitter levels, as well as the immediate effects of acupuncture in patients with PD. RESULTS: The participants tended to walk with hypometric gait (high cadence, short steps) overground. After acupuncture treatment, those in the intervention group showed a significant reduction in cadence and the UPDRS scores involving "walking and balance" compared with those in the control group (P = .004 and P = .020, respectively); the stride, swing, and single support times were significantly increased (P = .006, P = .001, and P = .001, respectively). Oxyhemoglobin levels in the intervention group while walking on a treadmill were significantly increased in the prefrontal and supplementary motor areas. The oxyhemoglobin levels in the prefrontal cortex and swing time revealed significant positive correlations. CONCLUSIONS: Our findings indicated that acupuncture tended to improve hypometric gait and rearranged activation of the cerebral cortex. Thus, acupuncture may be a useful complementary treatment for gait disturbance, including hypometric gait, in patients with PD. Trial Registration Number. Clinical Research Information Service (KCT0002603), https://cris.nih.go.kr/cris/index.jsp.

The effect of lung-conduction exercise in chronic obstructive pulmonary disease: Study protocol for randomized, assessor-blind, multicenter trial.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is an irreversible disease characterized by cough, sputum production, and dyspnea, and has a high prevalence and mortality. Pulmonary rehabilitation (PR) is a management that improves the quality of life for COPD patients; however, PR is not readily accessible. Therefore, we developed lung-conduction exercises (LCE) that can be performed without any limitations. LCE consists of breathing, stretching, and tapping to relieve dyspnea in COPD patients. METHODS/DESIGN: This randomized, assessor-blind, multicenter trial aims to recruit 54 patients with moderate and severe COPD. Subjects will be randomly allocated to a control group (only medication), an LCE group (medication + LCE, 5 times a week), or a PR group (medication + PR, 5 times a week). The 6-minute walk distance, pulmonary function tests (forced expiratory volume at 1 second, forced vital capacity, and forced expiratory volume at 1 second/forced vital capacity), modified Borg scale, modified medical research council dyspnea scale, COPD assessment test, and St. George respiratory questionnaire will be measured before starting the trial and after the 4th and 8th weeks to determine motor performance, lung function, and dyspnea. CONCLUSION: We aim to demonstrate that LCE is effective in improving symptoms and psychosomatic stability in COPD patients. Therefore, this trial will play an important role in fortifying the foundation of clinical application.

Safety and efficacy of Jujadokseo-hwan for memory deficit (amnesia) in mild neurocognitive disorder: A protocol for randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical trial.

BACKGROUND: Mild neurocognitive disorder (mNCD) is one of the degenerative diseases that results in memory deficit, and can progress to dementia. The effectiveness of drug therapy for mNCD is still debatable, but treatment of this disease has important implications for postponing or preventing dementia. Jujadokseo-hwan (JDH) is a traditional herbal medicine formulation that exhibits improvement in cognitive abilities and neuroprotective effects. In this study, we will evaluate the safety and efficacy of JDH compared to placebo in mNCD patients. METHODS AND DESIGN: This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical trial. After obtaining informed consent from all participants and performing the screening process, the participants will be equally divided into an experimental group and a control group. Each participant will visit the trial center 7 times during the 12 weeks of intervention. The follow up study will be conducted 12 weeks after the intervention ends. The primary outcome is the variance in Seoul verbal learning test-elderly's version (SVLT-E) score from baseline to 12 weeks. Secondary outcomes include scores/values for the following variables: SVLT-E, Rey complex figure test, Digit span test, Korean-Boston naming test, calculation ability, controlled oral word association test, Korean-color word stroop test, digit symbol coding, Korean-trail making test-elderly's version, Korean version of mini mental state examination for dementia screening, euro-qol-5 dimension, pattern identifications tool for cognitive disorders, Korean version of Montreal cognitive assessment, Korean quality of life-Alzheimer disease, computerized tongue image analysis system, blood pressure pulse analyzer, bioelectrical impedance analyzer, wearable electroencephalogram device, functional near-infrared spectroscopy system, and cost analysis. DISCUSSION: This is the first trial evaluating the efficacy of JDH for mNCD. We expect this trial will provide strong support for wide use of JDH for mNCD and lead to further research on herbal medicine treatments for mNCD. TRIAL REGISTRATION NUMBER: KCT0003570 (Registered in Clinical Research Information Service of the Republic of Korea, https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=12669).

Efficacy and safety of oral SOCG in treatment of major depressive disorder: A protocol for a phase II, randomized, double-blind, placebo controlled, parallel-groups, dose finding exploratory study.

INTRODUCTION: Major depressive disorder (MDD) is a common condition worldwide, and leads to degradation in quality of life and large socioeconomic costs. There has been increasing demand for new therapies with fewer side effects. SOCG (SOCG tablet) is a modified prescription of So-ochim-tang, which is widely used in Traditional Korean Medicine to treat MDD. We aim to evaluate the efficacy of SOCG in treating MDD, and identify the optimum dose. DESIGN: The protocol we are following is that of a Phase II clinical trial with a randomized, double blinded, placebo controlled, and parallel design. One hundred forty-eight participants will be randomly divided into 4 groups and treated for 8 weeks. OUTCOME MEASURES: The primary outcome will be the score in the Korean Version of the Hamilton Depression Rating Scale. Scores in the Korean version of the Beck Depression Inventory-II Korean Symptom Check List-95 (KSCL-95), State Trait Anxiety Inventory-Korean version, State- Trait Anger Expression Inventory- Korean version (STAXI-K), Insomnia Severity Index (ISI), and the EuroQol-5 Dimension (EQ-5D) will be considered as secondary outcomes. DISCUSSION AND CONCLUSIONS: Demonstration of human safety and efficacy of SOCG in the present trial and identification of the appropriate dose will justify a New Drug Application and a phase III clinical trial. Further, we expect that this new antidepressant will be able to increase cure rates, and alleviate the burden of medical expenses. TRIAL REGISTRATION NUMBER: Clinical Research Information Service, Republic of Korea (KCT0002763).

Efficacy and safety of GHX02 in the treatment of acute bronchitis: protocol of a phase II, double-blind, randomised placebo-controlled trial.

INTRODUCTION: Acute bronchitis is a self-limiting infection of the large airways; cough is the primary symptom, usually lasting for about 3 weeks. Annually, approximately 5% of adults develop acute bronchitis, and its economic burden is substantial. There are also problems of antibiotic abuse in public health systems and symptomatic therapies are commonly prescribed, for which there is insufficient supporting evidence. GHX02 contains four herbs originating from gwaruhaengryeon-hwan, which has been used in the treatment of patients with acute bronchitis in Korea. The objective is to compare the GHX02 and placebo in terms of efficacy and safety, and to determine the appropriate dosage. METHODS AND ANALYSIS: We planned a phase II, multicentre, dose-finding, double-blind, randomised placebo-controlled trial of two different doses of GHX02 compared with placebo. A total of 150 patients, aged 19-75 years, with a Bronchitis Severity Score (BSS) ≥5 due to acute bronchitis starting within 2 weeks of study enrolment will be recruited from three university-affiliated hospitals across Korea. Participants will be stratified into three patterns using the Korean Standard Tool of Pattern Identifications of Cough and Sputum and randomly assigned to either a high-dose GHX02 group (1920 mg/day), standard-dose GHX02 group (960 mg/day) or placebo group according to a 1:1:1 allocation ratio. Patients will take medications three times daily for 7 days, with two visiting days. The primary outcome measure is a change in BSS from day 0 to day 7. The secondary outcomes are the Questionnaire of Clinical Symptoms of Cough and Sputum, Leicester Cough Questionnaire, frequency of coughing fits, Integrative Medicine Outcome Scale, Integrative Medicine Patient Satisfaction Scale and withdrawal rate of patients with exacerbation. Safety will be assessed by adverse events, vital signs and laboratory examinations. ETHICS AND DISSEMINATION: The study has been approved by our Institutional Review Board (No. DJDSKH-17-DR-14). The trial results will be disseminated via peer-reviewed journals and the Clinical Research Information Service. TRIAL REGISTRATION NUMBER: NCT03310385; Pre-results.

A Systematic Review on Sasang Constitutional Type-Associated Susceptibility to Disorders in Korea.

BACKGROUND/OBJECTIVE: Sasang constitutional medicine is a component of traditional Korean medicine that classifies individuals into four Sasang constitutional types (SCTs) by their physical and psychological traits. Each SCT is known to show different susceptibilities to disorders. This systematic review investigated the effect of SCT as a risk factor for various disorders. METHODS: A systematic literature survey was conducted by searching seven databases for all articles on the prevalence rates of disorders according to SCT and sex. RESULTS: From 14,272 relevant articles, 15 studies (13 disorders) were ultimately identified to verify different prevalence rates by SCT. Of the 13 disorders, 6 (prehypertension, general obesity, abdominal obesity, metabolic syndrome, diabetes mellitus, and irritable bowel syndrome [IBS]) had a significantly different prevalence by SCT. Metabolic syndrome and its associated disorders showed the highest prevalence in Taeumin-type individuals, whereas IBS was most prevalent in Soeumin-type individuals. In general, these findings were consistent with the results obtained in an analysis of male and female participants. CONCLUSIONS: This study revealed that susceptibility to disorders was affected by SCT to some extent. Further studies are needed to determine the concrete features of SCT-related susceptibility, which may be helpful in preventive medicine with Sasang constitutional practice.

A manual acupuncture treatment attenuates common cold and its symptoms: a case series report from South Korea.

OBJECTIVE: To investigate beneficial effects of manual acupuncture on common cold periods and its symptoms depended on the difference onset time of common cold, within 36 h or over than that. To prove effects of manual acupuncture on common cold, a retrospective chart review was conducted. METHODS: Chart data for patients with common cold who were treated with only manual acupuncture with fulfilling Jackson scales and satisfaction at the end of each treatment were collected via multi-centers of Oriental hospitals, Oriental medicine clinics and covalent hospital in South Korea. Totally 187 patients were divided into two groups, Group Ⅰ (115 patients, within 36 h) and Group Ⅱ (72 patients, onset time of cold over than 36 h). Finally 120 patients were observed until entire resolution of cold symptoms. RESULTS: Group Ⅰ showed significant decreases themediandurationsofcompletelyrecovery (3 days; 95% CI 3.0-4.0) as compared with Group Ⅱ (6 days; 95% CI 4.0-7.0, P < 0.001). The manual acupuncture beneficially worked for reduction rate of common cold symptoms by 50% after initial treatment, decreased cold symptoms, and reduced cold duration. CONCLUSION: Manual acupuncture beneficially affected common cold and its symptoms. Moreover it is more susceptibility on the early time of onset cold.

The comparative clinical study of efficacy of Gamisoyo-San (Jiaweixiaoyaosan) on generalized anxiety disorder according to differently manufactured preparations: multicenter, randomized, double blind, placebo controlled trial.

ETHNOPHARMACOLOGICAL RELEVANCE: Gamisoyo-San (GSS) is a well-known Traditional Korean Medicine shown to be effective on mood disorders. AIM OF THE STUDY: The purpose of this research is to examine the effect of Gamisoyo-San on generalized anxiety disorder by its differently manufactured preparations. MATERIALS AND METHODS: Multicenter, randomized, double-blinded, placebo-controlled study was set for 147 patients with generalized anxiety disorder recruited from November 1st 2009 to December 16th 2010. They were given Gamisoyo-San individual extract mixture (extraction done for each crude materia medica separately) or Gamisoyo-San multi-compound extract (extraction done for whole materia medica at once) or controlled medication. Hamilton Rating Scale for Anxiety (HAM-A), Korean State-Trait Anxiety Inventory (K-STAI), Penn State Worry Questionnaire (PSWQ), Korean Beck Depression Inventroy (K-BDI), Symptom Checklist-90-Revised (SCL-90-R), and Korean WHO Quality of Life Scale Abbreviated Version (WHOQOL-BREF) were evaluated. We also applied Pattern Identification tool for 'JingJi and ZhengChong (, Traditional Korean Medicine term which correlates with generalized anxiety disorder)' to patients to evaluate different responses among 9 patterns. RESULTS: HAM-A scores of Gamisoyo-San multi-compound extract group showed greater decrease compared to Gamisoyo-San individual extract mixture group and placebo group, but the difference was insignificant. WHOQOL-BREF scores of Gamisoyo-San multi-compound extract group showed significant increase compared to Gamisoyo-San individual extract mixture group and placebo group. In Heart blood deficiency pattern, the Gamisoyo-San multi-compound extract group showed significant decrease in K-BDI compared to the Gamisoyo-San individual extract mixture group. CONCLUSION: Gamisoyo-San did not improve anxiety level of GAD patients. However, it can be useful to improve quality of life, and reduce depressive, obsessive-compulsive, somatic symptoms of generalized anxiety disorder. Gamisoyo-San multi-compound seemed more effective than Gamisoyo-San individual extract mixture, especially in Heart blood deficiency pattern.

Reliability and validity of Leicester Cough Questionnaire Korean version.

The Leicester Cough Questionnaire (LCQ) is a self-administered questionnaire developed in England and validated for reliability. We developed a Korean translation of this questionnaire by applying a sequential forward and backward translation approach. The purpose of this study is to validate the Korean version of the LCQ (LCQ-K) in Korean patients with chronic cough. A multicenter prospective study was undertaken with 100 chronic cough patients who consented to participate in the study. The LCQ-K includes eight physical items, seven psychological items, and four social items. Visual analog scale (VAS) of cough, Borg Cough Scale (BCS), and Short Form-36 (SF-36) were used as external comparators. Participants included 52 women and 48 men with ages ranging from 18 years to 69 years. The concurrent validity comparing LCQ-K to VAS, BCS, and SF-36 yielded statistically significant Pearson correlation coefficients. The LCQ-K showed good reliability in three domains, with Cronbach's α coefficients ranging from 0.84 to 0.87 (total: 0.91). Test-retest reliability was investigated with single measure intraclass correlation coefficients, which were found to be practically and statistically significant (p = 0.005). Responsiveness was validated by effective size ranging from 1.16 to 1.40 in each domain. LCQ-K is a reliable, valid, and responsive disease-specific questionnaire for assessing symptoms and quality of life of Korean patients with chronic cough.

A traditional herbal formula, Hyangsa-Pyeongwi san (HPS), improves quality of life (QoL) of the patient with functional dyspepsia (FD): randomized double-blinded controlled trial.

ETHNOPHARMACOLOGICAL RELEVANCE: Hyangaa-Pyeongwi san is the most well known description in Traditional Chinese Medicine for treating functional gastrointestinal disorders. Functional dyspepsia (FD) is a main concern of intimidating quality of life (QoL) in recent days. Although many medicines have been developed to improve FD symptoms as well as QoL, there are no potential drugs and treatments for FD. The aim of this study is to investigate the effects of Hyangaa-Pyeongwi san (HPS) on QoL of patients with FD. METHODS: This study was designed as a randomized, double blinded, placebo controlled, and parallel group trial. Participants received either placebo or HPS (9.68g of HPS at once, three times daily) for 4-weeks, and the efficacy evaluations were performed by assessing the Nepean Dyspepsia Index (NDI) and functional dyspepsia-quality of life (FD-QoL) at 0-, 4- and 8-weeks. RESULTS: Total of 170 patients participated and were randomly allocated into placebo or HPS groups. Total symptom score of NDI decreased after 4-weeks trial in both groups (p>0.05). HPS significantly improved QoL scores, especially in the area of 'interference and eat/drink' in NDI (p=0.0031) as well as 'liveliness status', 'role-functioning status', and total score in FD-QoL (p=0.026 for liveliness status and p=0.035 for role-functioning status). This significant improvement of FD-QoL had lasted for 4-weeks. CONCLUSION: HPS treatment is markedly effective in improving QoL in patients with FD. Moreover, we observed that this improvement had lasted for 4 weeks after finishing the trial through the follow-up study.

Cancer incidence varies significantly depending on sasang constitution of traditional Korean medicine.

OBJECTIVE: Sasang constitutional medicine is a component of Traditional Korean Medicine that stresses the hereditary makeup of disease incidences or therapeutic responses. This study investigated the relationship between the incidence of cancer and Sasang constitution classification. METHODS: Five hundred and one cancer patients were classified as having one of the four types of Sasang constitutions (Taeumin, Soumin, Soyangin, Taeyangin) using Questionnaire for Sasang Constitution Classification II, then compared with data from 1423 healthy subjects. RESULTS: The Sasang constitutional distribution for the cancer patients was significantly different from that for healthy subjects: 22.8% vs 46.9% for Taeumin, 35.5% vs 24.0% for Soumin, and 41.7% vs 29.1% for Soyangin. Our results assumed that the lowest cancer incidence would be in Taeumin (around 2-fold in both sex) while the highest cancer incidence in Soumin males (2.8-fold) and Soyangin females (2.1-fold). CONCLUSION: This study identified a trend involving the frequency of cancer and the Sasang constitutional classification. We hope that this finding will provide new ideas for the study of cancer incidence and its preventive management.

The effect of Bunsimgi-eum on Hwa-byung: randomized, double blind, placebo controlled trial.

UNLABELLED: ETHNOPHAMACOLOGICAL RELEVANCE: Bunsimgi-eum (BSGE), a prescription for stagnation of the seven emotions, is being used on neuropsychiatric symptoms in clinical traditional Korean medicine. AIM OF THE STUDY: The purpose of this research is to examine the effect of BSGE on Hwa-byung's symptoms. MATERIALS AND METHODS: Randomized, double blinded, placebo-controlled study was set and patients diagnosed as Hwa-byung, were treated with Bunsimgi-eum or controlled medication. Score change of 100mm Visual Analog Scale (VAS) for chest discomfort, Likert scale for major symptom of Hwa-byung, STAXI-K, STAI-K, and BDI-K, were analyzed. RESULTS: 100mm Visual Analog Scale (VAS) for chest discomfort was measured as the 1st evaluative instrument. Experimental group showed greater inclination for score change, but there were no significance. In all other valuation scales, scores improved significantly within each group, but there were no significant difference between the groups. CONCLUSION: These data show that BSGE's effect on Hwa-byung did not exceed that of placebo.

Reliability and validity of Wisconsin Upper Respiratory Symptom Survey, Korean version.

BACKGROUND: The Wisconsin Upper Respiratory Symptom Survey (WURSS) is a self-administered questionnaire developed in the United States to evaluate the severity of the common cold and its reliability has been validated. We developed a Korean language version of this questionnaire by using a sequential forward and backward translation approach. The purpose of this study was to validate the Korean version of the Wisconsin Upper Respiratory Symptom Survey (WURSS-K) in Korean patients with common cold. METHODS: This multicenter prospective study enrolled 107 participants who were diagnosed with common cold and consented to participate in the study. The WURSS-K includes 1 global illness severity item, 32 symptom-based items, 10 functional quality-of-life (QOL) items, and 1 item assessing global change. The SF-8 was used as an external comparator. RESULTS: The participants were 54 women and 53 men aged 18 to 42 years. The WURSS-K showed good reliability in 10 domains, with Cronbach's alphas ranging from 0.67 to 0.96 (mean: 0.84). Comparison of the reliability coefficients of the WURSS-K and WURSS yielded a Pearson correlation coefficient of 0.71 (P = 0.02). Validity of the WURSS-K was evaluated by comparing it with the SF-8, which yielded a Pearson correlation coefficient of -0.267 (P < 0.001). The Guyatt's responsiveness index of the WURSS-K ranged from 0.13 to 0.46, and the correlation coefficient with the WURSS was 0.534 (P < 0.001), indicating that there was close correlation between the WURSS-K and WURSS. CONCLUSIONS: The WURSS-K is a reliable, valid, and responsive disease-specific questionnaire for assessing symptoms and QOL in Korean patients with common cold.

Effects of So-cheong-ryong-tang and Yeon-gyo-pae-dok-san on the common cold: randomized, double blind, placebo controlled trial.

AIM OF THE STUDY: So-cheong-ryong-tang (SCRT) and Yeon-gyo-pae-dok-san (YPS) extracts are widely used in treatment of the common cold. The purpose of this study is to evaluate the efficacy of SCRT and YPS on the common cold. METHODS: Four hundred eighty participants with symptoms of the common cold within 48 h were recruited for this randomized, double-blind, placebo-controlled trial. SCRT extract and YPS extract were put in gelatin capsules and orally administered 3 times a day. The pattern of participants was determined according to the Questionnaire for Common Cold Pattern Identification (QCCPI), and the severity of illness was assessed by Wisconsin Upper Respiratory Symptom Survey-21 Korean version (WURSS-21-K) every 7 days. RESULTS: The test and control groups were not significantly different in gender, age, smoking history, and baseline score of WURSS-21-K at the time of enrollment. SCRT treatment significantly decreased the total WURSS-21-K score on the 6th and 7th day (p<0.05) of the enrollment compared with the placebo group. YPS treatment decreased the total WURSS-21-K score on the 5th and 6th day (p<0.05 vs. the placebo group) of the enrollment. In the patients with Wind-cold pattern cold, SCRT significantly decreased the total WURSS-21-K score from 4th to 8th day (p<0.05), and YPS significantly decreased the total WURSS-21-K score from 4th to 6th day (p<0.05). For the Wind-heat pattern cold, neither SCRT nor YPS group showed significant difference from the placebo group. SCRT and YPS did not significantly decrease the time to complete resolution of the cold symptoms. CONCLUSIONS: SCRT and YPS have beneficial, albeit limited, effects on common cold patients, especially those with the Wind-cold pattern cold.