• Journal of Korean Medicine Rehabilitation
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• v.31 no.4
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• pp.157-166
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• 2021

Objectives This study is designed to evaluate the safety of Bojungikgi-tang soft extract in healthy male volunteers. Methods 12 healthy male volunteers were recruited and this study was carried out by a single center. Laboratory test results, vital signs of the volunteers were collected to evaluate safety. According to registration order, the 12 subjects were allocated by serial number. To evaluate safety, blood samples were taken and vital signs were checked 4 times - screening, pre administration, post administration and follow up-during the whole trial. The difference between pre (before medication [0 hr]) and post-administration (after medication [48 hr]) variables was summarized as mean±standard deviation. The normality test was performed using the Kolmogorov-Smirnov test and Shapiro-Wilk test. When the normality is satisfied, the paired t-test is applied. Otherwise, the non-parametric method, Wilcoxon signed rank test is applied. The significance level was p<0.05. The incidence of all adverse effects are shown in percentage. Results In the case of red blood cell, hemoglobin, hematocrit, lymphocytes, neutrophils, protein, γ-glutamyl transpeptidase values, the normality test result of the variable for the difference value before and after the dosing has a significance level <0.05. But most of values did not deviate from the normal range, and the deviation from the normal range could not be regarded as the significance associated with this clinical trial. And adverse event wasn't observed associated with the clinical trial drug. Conclusions Bojungikgi-tang soft extract were considered to be safe for healthy male volunteers.

• The Journal of Korean Medicine
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• v.31 no.5
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• pp.1-11
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• 2010

Objectives: This study aimed to evaluate any clinical studies regarding rhinitis published by the Korean Oriental Medical Society and its sub-societies for future rigorous clinical research. Methods: Every article relevant to rhinitis was initially obtained from journals of the Korean Oriental Medical Society and its sub-societies by electronic search at journal web sites or manual searches. Journals were limited to those registered with the Korea Research Foundation. From initial findings, two independent reviewers selected clinical articles and these articles were further analyzed separately by predefined criteria according to prospective and retrospective studies. For prospective studies, quality assessment was also conducted. Results: From 36 initially obtained articles, 17 were finally analyzed. 2 articles were randomized controlled studies, 6 articles were prospective whereas 9 were retrospective. In the prospective articles, there were no randomized controlled trials and the other non-randomized studies had no control group with several problems of quality regarding pre-calculated study size and unbiased assessment. None of the retrospective studies described rhinitis diagnosis objectively and outcome measures were either non-relevant to rhinitis or non-validated. Conclusions: Further well-designed randomized controlled studies for rhinitis are mandatory and more rigorous non-randomized controlled studies should be conducted.

• Journal of Pharmacopuncture
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• v.23 no.1
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• pp.8-17
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• 2020

Aim of the study: The objective of this systematic review is to critically evaluate the evidence of the effectiveness and safety of external application of herbal medicines (EAHM) for acne vurgalis (AV). Methods: English, Chinese and Korean language databases were searched up to May 2018. Randomized clinical trials (RCTs) that reported the effects of EAHM for AV were included and analysed. Results: A total of 10 randomized trials with 656 AV patients were identified. A meta-analysis of two RCTs indicated that EAHM had a significant effect on improving primary outcome 'global assessment' compared with placebo (mean difference (MD) = -2.62, confidence interval (CI) = -4.84 to -0.40, p = 0.02). Furthermore, data extracted from two RCTs showed that EAHM significantly reduce primary outcome 'inflammatory lesion count of acne' (MD = -1.25, CI = -1.68 to -0.83, p < 0.00001) and 'non-inflammatory lesion count of acne' (MD = -1.32, CI = -1.75 to -0.90, p < 0.00001). No significant difference was observed between groups in secondary outcome 'sebum of skin' (MD = -0.21, CI = -0.53 to 0.11, p = 0.20) and 'patient-reported changes in symptom' (relative risk (RR) = 2.56, CI = 0.43 to 15.22, p = 0.30). No severe adverse events (AEs) were found and no treatment was stopped due to AEs of EAHM. Conclusions: EAHM seems to have affirmative effects, but quality of evidence, and non-standardized use of EAHM make our conclusion weak. Our suggestion is rigorously designed RCTs and standardization of EAHM are required in the future.

• The Korean Journal of Medicine
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• v.91 no.1
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• pp.88-91
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• 2016

Influenza infection may be complicated by various infectious or non-infectious diseases. Among them, hemophagocytic lymphohistiocytosis (HLH) is an uncommon hyperinflammatory syndrome caused by uncontrolled proliferation and activation of macrophages and lymphocytes, and it is often life threatening. A previously healthy male patient was suspected to have HLH after influenza B infection. The diagnosis was established based on clinical diagnostic criteria suggested in the HLH-2004 trial. Despite prompt antiviral therapy, the patient expired on day 19 of hospitalization. Influenza can thus be complicated by HLH. Due to the non-specific manifestations of HLH, clinical suspicion and early diagnosis are important.

• Tuberculosis and Respiratory Diseases
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• v.85 no.1
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• pp.25-36
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• 2022

Background: Only a few studies directly compared the therapeutic efficacy and safety of two pressurized metered-dose inhalers (pMDIs) in asthma. We analyzed the asthma treatment outcomes, safety, and patient preferences using formoterol/beclomethasone (FORM/BDP), a pMDI with extra-fine particles, compared with formoterol/budesonide (FORM/BUD), another pMDI with non-extra-fine particles. Methods: In this randomized, double-blind, double-dummy parallel group study, 40 adult asthmatics were randomized to FORM/BDP group (n=18; active FORM/BDP and placebo FORM/BUD) or FORM/BUD group (n=22; active FORM/BUD and placebo FORM/BDP). During the two visits (baseline and end of 8-week treatment), subjects were asked to answer questionnaires including asthma control test (ACT), asthma control questionnaires (ACQ), and Quality of Life Questionnaire for Adult Korean Asthmatics (QLQAKA). Lung function, compliance with inhaler, and inhaler-handling skills were also assessed. Results: Ten subjects in the FORM/BDP group and 14 in the FORM/BUD group completed follow-up visits. ACT, ACQ, QLQAKA (a primary outcome), and adverse events did not differ between two groups. We found that the increase in forced expiratory volume in 1 second/forced vital capacity and forced expiratory flow at 25% to 75% of the pulmonary volume in the FORM/BDP group was higher than in the FORM/BUD group. Regarding preference, subjects responded that the flume velocity of FORM/BDP was higher, but more adequate than that of FORM/BUD. They also answered that FORM/BDP reached the trachea and bronchus and irritated them significantly more than FORM/BUD. Conclusion: The use of pMDI with extra-fine particles may relieve small airway obstruction more than the one with non-extra-fine particles despite no significant differences in overall treatment outcomes. Some asthmatics have a misconception about the adequacy of high flume velocity of pMDIs.

• The Korean Journal of Pain
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• v.35 no.3
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• pp.311-318
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• 2022

Background: Ketamine is widely used in infants and young children for procedural sedation and anesthesia. The aim of this study was to evaluate the efficacy and safety of low dose oral ketamine to control pain and distress in children during intravenous (IV) cannulation. Methods: This is a prospective, randomized, double-blind study, including children aged between 3 and 6 years requiring a non-emergent IV-line placement. Children were randomly assigned to two groups, treated either with oral ketamine or a placebo. All patients were monitored for vital signs. Pain was assessed using the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) and Wong-Baker Faces Pain Rating Scale (WBFS) scales and sedation using a 5-point sedation score. The facility of IV-line placement was measured by a 3-point scale. Adverse effects were recorded after 1 and 24 hours. Results: A total of 79 and 81 children were entered in the ketamine and placebo groups, respectively. The heart and respiratory rates increased significantly in the placebo group. The median CHEOPS 4 (95% confidence interval [CI]: 3, 4, P < 0.001) and WBFS 6 (95% CI: 4, 6, P < 0.001) scores decreased statistically in the ketamine group. IV-line placement was 50% easier in the ketamine group (95% CI: 37%, 63%, P < 0.001). No serious adverse effects were observed in all cases. Conclusions: Low dose oral ketamine effectively decreased the pain and distress during IV cannulation in children without any significant adverse reactions.

• Journal of Physiology & Pathology in Korean Medicine
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• v.27 no.5
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• pp.650-659
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• 2013

To investigate the effects of facial blood flow rates(FBFR) and facial skin temperature(FST) generated by Gagam-Jawoonaek(GJ) application(appl.) after Miso Facial Rejuvenation Acupuncture(MFRA). Ten people in their twenties to fifties with no skin diseases were recruited. We randomly divided subjects two groups(A, B) and set the GJ appl. site(group A - right side, group B - left side). MFRA was performed on both sides of their face. Immediately after acupuncture treatment(AT treat.), GJ was applied only half of the face. We measured their FBFR using Laser Doppler Perfusion Imaging(LDPI) and FST using Digital Infrared Thermal Imaging(DITI) at pre-AT treat., immediately after AT treat., twenty and sixty minutes after GJ appl.. We analyzed data using Mann-Whitney test and Wilcoxon test(p < 0.05). After MFRA treat., FBFR on both sides increased. Twenty minutes after JW appl., the changes of FBFR on GJ appl. side($122.9{\pm}43.1PU$) were bigger than GJ non-appl. side($80.9{\pm}38.4PU$), a statistically significant decrease. Sixty minutes after application, FBFR on both sides were recovered almost at the same level as that of pre-AT treat. After MFRA treat., FST on both sides increased. Twenty minutes after GJ appl., the changes of FST on GJ appl. side($1.1{\pm}0.6^{\circ}C$) were comparable to that of GJ non-appl. side($1.2{\pm}0.5^{\circ}C$). Sixty minutes after application, FST on both sides were recovered almost at the same level as that of pre-AT treat.. Gagam-Jawoonaek could decrease facial blood flow rates.

• Korean Journal of Acupuncture
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• v.30 no.2
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• pp.135-142
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• 2013

Objectives : This study aimed to investigate the general effects of low-frequency electrical stimulation of the ankle joint acupuncture points(BL62 and KI6) on the brain waves of elderly women as a pilot study to figure out the possibility of candidate non-invasive and non-chemical stimulation method for the enhancing the brain function. Methods : A randomized, controlled, double-blinded clinical trial was performed in 31 healthy women(mean age, 54.5 years) within a treatment duration of 12 sessions. In the experimental group, low-frequency electrical stimulation was applied using the maximum range of the individual insensible strength(mean current, $0.04{\mu}A$). The control group received sham stimulation. The background electroencephalographic activity was measured before and after the12 sessions. Results : After 12 sessions of stimulation, the relative power of the alpha wave increased(32 of 32 channels: significant difference in 11 channels, p<0.05); the theta(30 of 32 channels: significant difference in 10 channels, p<0.05), beta(31 of 32 channels), and gamma(30 of 32 channels: significant difference in 7 channels, p<0.05) powers were also decreased compared with the sham group. Conclusions : Electrical stimulation on the ankle joint acupuncture points(BL62 and KI6) seemed to stabilize the elderly women brain by inducing the alpha power and reducing beta, theta, and gamma powers. These results provide insight into the action mechanism of the stimulation and can assist the future developement of a non-invasive and non-chemical treatment technique for stressor related cognitive problems.

• Journal of Preventive Medicine and Public Health
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• v.32 no.4
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• pp.427-434
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• 1999

Objectives: This study was conducted to determine, by reviewing the literature, whether treatment of Helicobacter pylori infection in patients with non-ulcer dyspepsia affects symptoms. Methods: We retrieved the literature using MEDLINE search, with nonulcer dyspepsia and Hericobacter pylori and treatment as key words, which were reported from 1984 to 1998, and manual literature search. The criteria for inclusion was as follows; 1) The paper should have confirmed nonulcer dyspepsia as case definition. 2) The paper should have peformed a randomized, blind trial. 3) Confirmation of Helicobacter pylori eradication should be done 4 weeks after treatment. 4) studies with no information on measurement of symptoms after treatment were not accepted. The percentage of patients with symptom improvement after eradication therapy for Helicobacter pylori infection was calculated. Cumulative odds ratio was compared by fixed effect model and random effect model as sensitivity and funnel plot was used to evaluate publication bias. Results: The overall effect size of symptom improvement was calculated by cumulative odds ratio. Cumulative odds ratio of random effect model was 4.16(95% CI: 1.55-11.19). Before integrating each effect sizes into common effect size, the homogeneity test was conducted and random effect model was selected(Cochran's Q=41.08 (d.f=10, p<0.001)). The heterogeneity across studies was evaluated and the different methodological aspects of studies led to differences between study results Conclusions: The results suggest that the eradication of Helicobacter pylori in patients with non-ulcer dyspepsia results more symptom improvement. In studios that shows the opposite results there are methodological aspects explaining the heterogeneity.

• Korean Journal of Veterinary Research
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• v.48 no.1
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• pp.53-60
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• 2008

We have investigated efficiency of a recombinant subunit Pasteurella multocida toxin (PMT) that was mixed with a vaccine consisted of inactivated whole cells of Bordetella bronchiseptica, P. multocida (types A and D). For verification of the efficacy of the vaccine, all experimental pigs (suckling piglets, sow and gilts) in the three farms were vaccinated. Antibody titers against B. bronchiseptica and P. multocida type A of the vaccinated pigs by microplate agglutination were significantly higher than those of the control pigs (p < 0.05). Similar patterns were observed in the analysis of anti- PMT neutralizing antibody by serum neutralizing method using Vero cell (p < 0.05). Anti- P. multocida type D antibody titer of the vaccinated sows and gilts by ELISA showed significant differences with those of the non-vaccinated pigs (p < 0.05). Although antibody titers increased, it was unable to find out the difference in the clinical signs between the vaccinated and non-vaccinated pigs. However, the increase in body weight of the vaccinated piglets was observed in comparison with the non-vaccinated piglets on a farm. At slaughtering of the pigs, pathological lesions in the turbinate bones of the vaccinated pigs were significantly lower than those of the non-vaccinated pigs (p < 0.001). These results suggested that efficacy of the vaccine in pigs demonstrated to protect against atrophic rhinitis in Korea.