Publications by authors named "So-Young Jung"

105 Publications

Alitretinoin Compliance in Patients with Chronic Hand Eczema.

Ann Dermatol 2021 Feb 30;33(1):46-51. Epub 2020 Dec 30.

Department of Dermatology, Busan Paik Hospital, College of Medicine, Inje University, Busan, Korea.

Background: Oral alitretinoin is effective in the treatment of chronic hand eczema (CHE), and ≥12 weeks of alitretinoin treatment has been shown to be effective in Korean patients. However, in the real world, a considerable number of patients discontinue alitretinoin, which leads to treatment failure.

Objective: To evaluate the compliance rate of alitretinoin treatment and explore common reasons for poor compliance in patients with CHE in the real world.

Methods: We retrospectively reviewed the electronic medical records of CHE patients treated with alitretinoin. We defined 'poor-compliance' as subjects who were treated with alitretinoin for <12 weeks and 'good-compliance' as subjects who were treated with alitretinoin for ≥12 weeks. We reviewed the demographics, dose, and duration of alitretinoin usage, efficacy, and reasons for poor compliance.

Results: A total of 137 subjects were enrolled, and 77 (56.2%) did not complete the 12-week treatment with alitretinoin. Among them, the non-improvement rate was significantly higher in the poor-compliance group than in the good-compliance group (<0.01). The main reasons for the alitretinoin cessation in the poor-compliance group were insufficient response (40.8%), followed by high cost (34.7%), and adverse events (24.5%).

Conclusion: Alitretinoin appears the preferred long-term treatment option for CHE. Although there are complaints about late efficacy, cost, and side effects, following proper explanation, these should not justify discontinuation. Physicians need to recognize the reasons for poor compliance with alitretinoin for each patient and suggest continuing alitretinoin for the successful treatment of CHE.
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http://dx.doi.org/10.5021/ad.2021.33.1.46DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7875224PMC
February 2021

Validity of Diagnostic Codes for Identification of Psoriasis Patients in Korea.

Ann Dermatol 2020 Apr 11;32(2):115-121. Epub 2020 Mar 11.

Department of Dermatology, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Korea.

Background: Recently, the number of nationwide medical researches on psoriasis using the National Health Insurance Service database has been on the rise. However, identification of psoriasis using diagnostic codes alone can lead to misclassification. Accuracy of the diagnostic codes and their concordance with medical records should be validated first to identify psoriasis patients correctly.

Objective: To validate the diagnostic codes of psoriasis (International Classification of Diseases, 10th Revision L40) and to find the algorithm for the identification of psoriasis.

Methods: We collected medical records of patients who received their first diagnostic codes of psoriasis during 5 years from five hospitals. Fifteen percent of psoriasis patients were randomly selected from each hospital. We performed a validation by reviewing medical records and compared 5 algorithms to identify the best algorithm.

Results: Total of 538 cases were reviewed and classified as psoriasis (n=368), not psoriasis (n=159), and questionable (n=11). The most accurate algorithm was including patients with ≥1 visits with psoriasis as primary diagnostic codes and prescription of vitamin D derivatives. Its positive predictive value was 96.5% (95% confidence interval [CI], 93.9%~98.1%), which was significantly higher than those of the algorithm, including patients with ≥1 visits with psoriasis as primary diagnostic codes or including ≥1 visits with diagnostic codes of psoriasis (primary or additional) (91.0% and 69.8%). Sensitivity was 90.8% (95% CI, 87.2%~93.4%) and specificity was 92.5% (95% CI, 86.9%~95.9%).

Conclusion: Our study demonstrates a validated algorithm to identify psoriasis, which will be useful for the nationwide population-based study of psoriasis in Korea.
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http://dx.doi.org/10.5021/ad.2020.32.2.115DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7992553PMC
April 2020

Effectiveness and Safety of Polydioxanone Thread Embedding Acupuncture Compared to Physical Therapy in the Treatment of Patients with Non-Specific Chronic Neck Pain: An Assessor-Blinded, Randomized, Controlled, Clinical Trial.

J Pain Res 2021 28;14:201-211. Epub 2021 Jan 28.

Department of Acupuncture & Moxibustion Medicine, College of Korean Medicine, Daejeon University, Daejeon, Republic of Korea.

Background: Thread embedding acupuncture (TEA) has recently been used as a conservative treatment method for non-specific chronic neck pain (CNP). The objective of this study was to evaluate the effectiveness and safety of TEA compared to physical therapy (PT) for treating patients with CNP.

Methods: A total of 128 patients diagnosed with CNP were randomly assigned to a TEA group and a PT group at a 1:1 ratio. The TEA group received four sessions of TEA, while the PT group received eight sessions of PT over 4 weeks. Outcomes were assessed using Neck Pain and Disability Scale (NPDS), clinically important difference (CID), cervical spinal angle, Beck Depression Inventory II (BDI-II), Beck Anxiety Inventory (BAI), Patient Global Impression of Change (PGIC), and EuroQol Five-Dimension (EQ-5D) at baseline and 5, 9, and 13 weeks.

Results: The TEA group showed significant improvement in NPDS compared to the PT group at 5, 9, and 13 weeks. Proportions of patients with decreased NPDS scores of more than 11.5 points (minimal CID) were significantly higher in the TEA group at 5, 9, and 13 weeks. There were significant differences between the two groups at 5, 9, and 13 weeks for BDI-II, and at 5 and 9 weeks for BAI. For EQ-5D, the TEA group showed significant improvement at 5, 9, and 13 weeks. There was no significant difference in cervical spinal angle between the two groups. For PGIC, better improvement was observed at 9 and 13 weeks in the TEA group. Adverse events associated with interventions were mostly temporary and mild.

Conclusion: For patients with CNP, TEA treatment was found to be more effective than PT treatment for improving their pain and dysfunction, quality of life, and psychological distress. Despite some post-treatment discomfort, TEA treatment can be considered as a useful treatment method for patients with CNP.

Trial Registration: This trial has been registered 5 April 2019 in Clinical Research Information Service of South Korea (CRIS- KCT0003720).
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http://dx.doi.org/10.2147/JPR.S276941DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7850897PMC
January 2021

Multicentre randomised controlled clinical trial of electroacupuncture with usual care for patients with non-acute pain after back surgery.

Br J Anaesth 2021 Mar 16;126(3):692-699. Epub 2020 Dec 16.

Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, South Korea. Electronic address:

Background: The purpose of this study was to investigate the effectiveness and safety between electroacupuncture (EA) combined with usual care (UC) and UC alone for pain reduction and functional improvement in patients with non-acute low back pain (LBP) after back surgery.

Methods: In this multicentre, randomised, assessor-blinded active-controlled trial, 108 participants were equally randomised to either the EA with UC or the UC alone. Participants in the EA with UC group received EA treatment and UC treatment twice a week for 4 weeks; those allocated to the UC group received only UC. The primary outcome was the VAS pain intensity score. The secondary outcomes were functional improvement (Oswestry Disability Index [ODI]) and the quality of life (EuroQol-5-dimension questionnaire [EQ-5D]). The outcomes were measured at Week 5.

Results: Significant reductions were observed in the VAS (mean difference [MD] -8.15; P=0.0311) and ODI scores (MD -3.98; P=0.0460) between two groups after 4 weeks of treatment. No meaningful differences were found in the EQ-5D scores and incidence of adverse events (AEs) between the groups. The reported AEs did not have a causal relationship with EA treatment.

Conclusions: The results showed that EA with UC treatment was more effective than UC alone and relatively safe in patients with non-acute LBP after back surgery. EA with UC treatment may be considered as an effective, integrated, conservative treatment for patients with non-acute LBP after back surgery.

Clinical Trial Registration: KCT0001939.
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http://dx.doi.org/10.1016/j.bja.2020.10.038DOI Listing
March 2021

Intratympanic administration of alpha-lipoic acid-loaded pluronic F-127 nanoparticles ameliorates acute hearing loss.

Nanomedicine 2021 02 10;32:102329. Epub 2020 Nov 10.

Department of Medical Life Sciences and Department of Biomedicine & Health Sciences, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea; Catholic Photomedicine Research Institute, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. Electronic address:

We used antioxidant-containing nanoparticles (NPs) to treat acute hearing loss. Alpha-lipoic acid (ALA) served as the antioxidant; we employed Pluronic F127 to fabricate NPs. In vitro, ALA-NPs protected cells of the organ of Corti in HEI-OC1 mice, triggering nuclear translocation of NRF2 and increases in the levels of antioxidant proteins, including Nrf2, HO-1, SOD-1, and SOD-2. In vivo, the hearing of mice that received ALA-NP injections into the middle ear cavity was better preserved after induction of ototoxicity than in control animals. The cochlear Nrf2 level increased in test mice, indicating that the ALA-NPs protected hearing via the antioxidant mechanism observed in vitro. ALA-NPs effectively protected against acute hearing loss by activating the Nrf2/HO-1 pathway.
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http://dx.doi.org/10.1016/j.nano.2020.102329DOI Listing
February 2021

Monitoring in clinical trials of complementary and alternative medicine.

Integr Med Res 2021 Jun 23;10(2):100666. Epub 2020 Sep 23.

Korean Medicine Clinical Trial Center, Korean Medicine Hospital, Kyung Hee University, Seoul, South Korea.

Background: Clinical trial monitoring is an essential activity for quality assurance (QA) to ensure the protection of human rights and the reliability and transparency of the data collection process. The purpose of this article is to enhance the understanding of monitoring process and major findings in clinical trials of complementary and alternative medicine (CAM).

Methods: Based on International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use (ICH-GCP), we summarized main concept of monitoring process. Personal experiences on monitoring for CAM studies were also narratively described.

Results: In this brief article, the basic concept of QA and quality control (QC), various monitoring activities during the study process, and major findings regarding clinical trials of CAM are suggested in an effort to improve understanding of monitoring in clinical research on CAM.

Conclusion: When performing clinical trials for CAM-related interventions, the monitoring recommended in GCP is needed to be recognized as a mandatory element in the course of CAM research.
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http://dx.doi.org/10.1016/j.imr.2020.100666DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7510525PMC
June 2021

Acupuncture for dry eye syndrome after refractive surgery: A randomized controlled pilot trial.

Integr Med Res 2021 Mar 24;10(1):100456. Epub 2020 Jun 24.

Future Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.

Background: Dry eye syndrome is the most common complication of refractive surgery. Acupuncture is widely used for the treatment of ophthalmologic diseases, but to date, few have explored the effects of acupuncture for the treatment of this condition following refractive surgery. The objective of this study is to assess the feasibility of a study design for evaluating the effectiveness of acupuncture treatment along with usual care compared with usual care only for dry eye syndrome after refractive surgery.

Methods: A total of 18 patients with dry eye syndrome occurring after refractive surgery participated in this study. For 4 weeks, the acupuncture plus usual care and usual care only groups received treatment three times a week. A series of assessments, namely the ocular surface disease index (OSDI), visual analog scale for ocular discomfort, quality of life, tear film break-up time, Schirmer 1 test, and fluorescein-stained corneal-surface photography, along with other general assessments were carried out.

Results: Although preliminary, changes in OSDI from the baseline values were significantly different between the two groups at week 5 ( = 0.0003). There was a significant difference in the trends of OSDI changes between the acupuncture plus usual care and the usual care only groups ( = 0.0039). No serious adverse events were reported during the study.

Conclusion: Four weeks of acupuncture treatment in addition to usual care is a feasible treatment for dry eye syndrome after refractive surgery. A full-scale randomized controlled trial is needed to confirm the clinical effectiveness of acupuncture.
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http://dx.doi.org/10.1016/j.imr.2020.100456DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7452177PMC
March 2021

Coxsackievirus A6-induced Hand-Foot-and-Mouth Disease Mimicking Stevens-Johnson Syndrome in an Immunocompetent Adult.

Infect Chemother 2020 Dec 27;52(4):634-640. Epub 2020 Jul 27.

Division of Infectious Disease, Department of Internal Medicine, Chungnam National University Sejong Hospital, Sejong, Korea.

Hand-foot-and-mouth disease, a highly contagious viral infection, occurs more common in children than in adults. However, there was a recent outbreak of Coxsackievirus A6-induced infection with an atypical presentation among the adult population. Stevens-Johnson syndrome is a severe mucocutaneous disease characterized by extensive necrosis and detachment of the epidermis, and this condition is commonly caused by medications. Herein, we describe a 30-year-old male patient taking allopurinol for the management of gout. The patient presented with numerous erythematous papules, vesicles, and patches with mucosal eruptions on the whole body, oral mucositis, and fever, and he was finally diagnosed with hand-foot-and-mouth disease.
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http://dx.doi.org/10.3947/ic.2020.52.4.634DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7779988PMC
December 2020

Comparative Effectiveness of Cheonwangbosimdan (Tian Wang Bu Xin Dan) Versus Cognitive-Behavioral Therapy for Insomnia in Cancer Patients: A Randomized, Controlled, Open-Label, Parallel-Group, Pilot Trial.

Integr Cancer Ther 2020 Jan-Dec;19:1534735420935643

Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.

Cancer patients have a 2 times higher prevalence of insomnia than healthy populations and cancer-related insomnia has received minimal attention while insomnia can aggravate the rehabilitation of cancer patients. Cheonwangbosimdan is a Korean herbal medicine generally used to relieve sleep deprivation, however, few studies presented the effects of Cheonwangbosimdan on cancer-related insomnia. The purpose of study is to examine the feasibility of Cheonwangbosimdan treatments for cancer patients. Twenty-two participants were allocated into a Cheonwangbosimdan or cognitive-behavioral therapy for insomnia (CBT-I) control group by equal number. The intervention group took Cheonwangbosimdan liquid once in a day and attend visits once a week for 4 weeks. The CBT-I group underwent individualized behavioral therapy 4 times in 4 weeks. The primary outcome is changes in the Insomnia Severity Index (ISI) from baseline to the end of the trial. Responses to the Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), Zung Self-Rating Anxiety Scale (SAS), Brief Fatigue Inventory (BFI), Euroqol-5 Dimensions-5 Levels (EQ-5D-5L), and Eastern Cooperative Oncology Group Performance Status (ECOG-PS) were secondary outcomes used to evaluate the quality of sleep. Outcomes were measured at a follow-up visit (visit 5) in the fifth week of the trial. There is no difference between 2 groups, but both groups showed tendency to alleviate cancer insomnia symptoms. SAS-K showed significant difference between the 2 groups (P < .001), as treatment group score was highly lowered than control group score. The study can contribute to more attentive care for insomnia in cancer patients.
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http://dx.doi.org/10.1177/1534735420935643DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7338643PMC
July 2020

Effects of the Immobilization of the Upper Extremities on Spatiotemporal Gait Parameters during Walking in Stroke Patients: A Preliminary Study.

Biomed Res Int 2020 2;2020:6157231. Epub 2020 Jun 2.

Department of Physical Therapy, College of Medical Sciences, Jeonju University, Jeonju, Republic of Korea.

Background: The purpose of this study was to investigate the effects of upper extremity immobilization and consequent walking speed on spatiotemporal gait parameters in stroke patients with hemiparesis.

Methods: The following variables were assessed or measured in 29 stroke patients: age, height, weight, disease duration, Korean version of the Mini-Mental State Examination (MMSE-K), Berg balance scale (BBS-K), functional gait assessment (FGA-K), cause of the disease (type of lesion), and hemiparetic side. The measurement of gait was performed using two pressure plates of 1.5 m to create a 3 m walking distance and leaving 1.5 m of extension at both start and end, to ultimately create a 6 m walking distance that the patient could walk through. The following gait patterns were randomly selected based on card draws: self-selected walk speed (SW), self-selected walk speed with immobilized upper extremities (SWI), fast walking (FW), and fast walking with immobilized upper extremities (FWI). Each patient was assessed for four different gait patterns, with three measurements per pattern (12 gait measurements in total).

Results: While there were significant differences in the stride length, step width, velocity, and step length of the paretic side between self-selected walk speed (SW) and SWI, FWI did not show significant changes in any of the tested parameters.

Conclusions: Immobilization of the upper extremities may affect walking at self-selected walk speeds. A comprehensive training program including upper extremity movement should be established for gait rehabilitation. . This trial is registered at http://cris.nih.go.kr/cris.
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http://dx.doi.org/10.1155/2020/6157231DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7288199PMC
March 2021

Cilastatin Preconditioning Attenuates Renal Ischemia-Reperfusion Injury via Hypoxia Inducible Factor-1α Activation.

Int J Mol Sci 2020 May 19;21(10). Epub 2020 May 19.

Division of Nephrology, Department of Internal Medicine, College of Medicine, Kyung Hee University, Seoul 02447, Korea.

Cilastatin is a specific inhibitor of renal dehydrodipeptidase-1. We investigated whether cilastatin preconditioning attenuates renal ischemia-reperfusion (IR) injury via hypoxia inducible factor-1α (HIF-1α) activation. Human proximal tubular cell line (HK-2) was exposed to ischemia, and male C57BL/6 mice were subjected to bilateral kidney ischemia and reperfusion. The effects of cilastatin preconditioning were investigated both in vitro and in vivo. In HK-2 cells, cilastatin upregulated HIF-1α expression in a time- and dose-dependent manner. Cilastatin enhanced HIF-1α translation via the phosphorylation of Akt and mTOR was followed by the upregulation of erythropoietin (EPO) and vascular endothelial growth factor (VEGF). Cilastatin did not affect the expressions of PHD and VHL. However, HIF-1α ubiquitination was significantly decreased after cilastatin treatment. Cilastatin prevented the IR-induced cell death. These cilastatin effects were reversed by co-treatment of HIF-1α inhibitor or HIF-1α small interfering RNA. Similarly, HIF-1α expression and its upstream and downstream signaling were significantly enhanced in cilastatin-treated kidney. In mouse kidney with IR injury, cilastatin treatment decreased HIF-1α ubiquitination independent of PHD and VHL expression. Serum creatinine level and tubular necrosis, and apoptosis were reduced in cilastatin-treated kidney with IR injury, and co-treatment of cilastatin with an HIF-1α inhibitor reversed these effects. Thus, cilastatin preconditioning attenuated renal IR injury via HIF-1α activation.
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http://dx.doi.org/10.3390/ijms21103583DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7279043PMC
May 2020

Acupotomy versus Manual Acupuncture for the Treatment of Back and/or Leg Pain in Patients with Lumbar Disc Herniation: A Multicenter, Randomized, Controlled, Assessor-Blinded Clinical Trial.

J Pain Res 2020 1;13:677-687. Epub 2020 Apr 1.

Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea.

Background: Acupotomy, which involves the addition of a scalpel function to the conventional acupuncture treatment, has recently been applied as a conservative treatment method for lumbar disc herniation (LDH). This study investigated the effectiveness and safety of acupotomy, compared to manual acupuncture, for the treatment of patients with LDH.

Methods: A total of 146 patients diagnosed with LDH were randomly assigned to either the acupotomy group or the manual acupuncture group at a 1:1 ratio. Participants in both groups received four sessions of each intervention over 2 weeks. Outcome assessments based on the visual analog scale (VAS), Roland Morris Disability Questionnaire (RMDQ), Modified-Modified Schober Test (MMST), EuroQol Five Dimensions (EQ-5D), clinically important difference (CID), and patient global impression of change (PGIC) were conducted at baseline and at 2, 4, and 6 weeks post-randomization.

Results: The acupotomy group showed significant improvement in VAS and MMST at 2, 4, and 6 weeks than did the manual acupuncture group. RMDQ was significantly different between the two groups at 2 and 6 weeks. In EQ-5D, there was no significant difference between the two groups. The proportion of patients with ≥15 mm decrease on the VAS (minimal CID) was significantly higher in the acupotomy group at weeks 2 and 4. Better improvement in the PGIC at week 4 was also observed in the acupotomy group. Post-intervention muscle pain was reported, but there was no serious adverse event related to interventions.

Conclusion: In this study, four sessions of acupotomy treatment were found to be effective in improving the pain intensity and range of motion of the lumbar region in patients with LDH. Despite post-treatment muscle pain, acupotomy treatment can be considered a preferred treatment method over manual acupuncture.

Trial Registration: This trial has been registered 24 April 2018 in Clinical Research Information Service of South Korea (CRIS-KCT0002824).
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http://dx.doi.org/10.2147/JPR.S234761DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7131997PMC
April 2020

Jakyakgamcho-tang in the relief of delayed-onset muscle soreness in healthy adults: study protocol for a randomized, double-blind, placebo-controlled, crossover design clinical trial.

Trials 2020 Feb 21;21(1):211. Epub 2020 Feb 21.

Clinical Medicine Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daro, Yuseong-gu, Daejeon, 34054, Republic of Korea.

Background: Muscle soreness after exercise, called delayed-onset muscle soreness (DOMS), may cause significant changes in muscle function and may increase the risk of sports injuries. Therefore, various therapeutic strategies have been studied to help recovery after exercise. Jakyakgamcho-tang (JGT) is a widely prescribed herbal medicine to treat muscle pain and cramps in traditional Eastern medicine. The aim of this study is to evaluate the effect of JGT for reducing pain and improving muscle damage after exercise.

Methods: This study is a randomized, double-blind, placebo-controlled, crossover design clinical trial. A total of 30 healthy male adults will be recruited. Subjects who voluntarily wish to participate in this study will be hospitalized for 4 days. On the first day, the subjects will perform a standardized treadmill exercise for 1 h to induce DOMS. After the exercise, the subjects will take either JGT or a placebo for 3 days. After a more than 1 week wash-out period, the subjects will repeat the same process with the other drug. Pain intensity, calf circumference, and pain threshold will be measured as outcome measures. Blood tests and blood pressure will be measured as safety assessments. In addition, blood tests for muscle damage and inflammation markers, such as creatine kinase, interleukin-6, and C-reactive protein, will be analyzed.

Discussion: This will be the first trial to assess the effect of JGT on exercise-induced muscle soreness. Our findings will provide valuable data to determine the clinical effects of JGT on DOMS.

Trial Registration: Clinical Research Information Sevice, KCT0003457. Registered on 29 January 2019.
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http://dx.doi.org/10.1186/s13063-020-4119-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7035661PMC
February 2020

Effect of Daesiho-tang on obesity with non-alcoholic fatty liver disease: a study protocol for a randomised, double-blind, placebo-controlled pilot trial.

Trials 2020 Jan 31;21(1):128. Epub 2020 Jan 31.

Liver-Immune Research Center, Dunsan Hospital of Daejeon University, Daejeon, Republic of Korea.

Background: The high prevalence of obesity and non-alcoholic fatty acid disease has become an important public health problem. Daesiho-tang (DST) is an herbal medicine widely used to treat obesity, metabolic syndrome and liver diseases. This pilot study will assess the feasibility of using DST in obese patients with a non-alcoholic fatty liver disease (NAFLD) prior to undertaking a full-scale clinical trial.

Methods/design: This is a study protocol for a randomised, double-blind, parallel-group, stratified, placebo-controlled pilot trial. We will recruit a total of 60 participants with NAFLD who have a body mass index ≥ 25 kg/m. They will take either DST or placebo (3 g, three times daily) for 12 weeks with a 4-week follow-up period. The effects of DST will be evaluated by the mean change in body weight as the primary measurement and other secondary parameters (body composition, anthropometric measurements, blood tests, hepatic fat quantification through transient elastography and a physical symptoms questionnaire). Faecal samples will be collected before and after the intervention for a gut microbial analysis.

Discussion: In anticipation of conducting further large-scale trials, in this study we will explore the effect of DST on weight loss and obesity-related markers, along with NAFLD-related clinical parameters, in obese patients with NAFLD. Furthermore, it will provide insight into the DST pharmacological mechanism of action through a gut microbiome analysis.

Trial Registration: Korean Clinical Trial Registry, KCT0003554. Registered on 25 February 2019.
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http://dx.doi.org/10.1186/s13063-020-4068-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6995056PMC
January 2020

α-Lipoic acid prevents against cisplatin cytotoxicity via activation of the NRF2/HO-1 antioxidant pathway.

PLoS One 2019 26;14(12):e0226769. Epub 2019 Dec 26.

Department of Otolaryngology, Daejeon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Daejeon, Republic of Korea.

The production of reactive oxygen species (ROS) by cisplatin is one of the major mechanisms of cisplatin-induced cytotoxicity. We examined the preventive effect of α-lipoic acid (LA) on cisplatin-induced toxicity via its antioxidant effects on in vitro and ex vivo culture systems. To elucidate the mechanism of the antioxidant activity of LA, NRF2 was inhibited using NRF2 siRNA, and the change in antioxidant activity of LA was characterized. MTT assays showed that LA was safe at concentrations up to 0.5 mM in HEI-OC1 cells and had a protective effect against cisplatin-induced cytotoxicity. Intracellular ROS production in HEI-OC1 cells was rapidly increased by cisplatin for up to 48 h. However, treatment with LA significantly reduced the production of ROS and increased the expression of the antioxidant proteins HO-1 and SOD1. Ex vivo, the organs of Corti of the group pretreated with LA exhibited better preservation than the group that received cisplatin alone. We also confirmed the nuclear translocation of NRF2 after LA administration, and that NRF2 inhibition decreased the antioxidant activity of LA. Together, these results indicate that the antioxidant activity of LA was through the activation of the NRF2/HO-1 antioxidant pathway.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0226769PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6932784PMC
April 2020

Exploring the effects of expert-led qigong and self-practice qigong on blood pressure.

Integr Med Res 2019 Dec 12;8(4):271-272. Epub 2019 Nov 12.

Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.

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http://dx.doi.org/10.1016/j.imr.2019.11.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6879980PMC
December 2019

Clinical Anatomy of the Puboprostatic Ligament for the Safe Guidance for the Prostate Surgery.

Urology 2020 Feb 12;136:190-195. Epub 2019 Nov 12.

Department of Anatomy, Yonsei University College of Medicine, Seoul, South Korea. Electronic address:

Objective: To provide the anatomy of the puboprostatic ligament and related structures to save urogenital competence after prostatectomy.

Materials And Methods: Pelvic areas of 31 adult cadavers were dissected to figure out the shape, number, and location of the puboprostatic ligaments.

Results: The puboprostatic ligament was the most important support structure between the pubic bone and prostate gland. Puboprostatic ligaments were bilaterally single (61.3%), bilaterally double (19.4%), or mixed (19.4%). Ligaments were mostly I-shaped (53.8%). If ligaments had extra attachment to or from the arcuate line, the ligaments were λ-shaped (36.3%), or Y-shaped (8.8%). In one case, the ligament had a central fusion with an irregular shape. I-shaped puboprostatic ligaments were observed more frequently in specimens with double ligaments, while λ-shaped puboprostatic ligaments were observed more frequently in the cases with single ligaments. The average distance between both puboprostatic ligaments was 8.1 mm at the pubic site and 14.2 mm at the prostate site. The distance was narrower when the specimen had double puboprostatic ligaments on both sides. The neurovascular bundle ran beneath the puboprostatic ligament. If the ligament was the λ-shaped type, the neurovascular bundle frequently pierced the lateral band of the ligament.

Conclusion: Puboprostatic ligaments hold and stabilize the prostate against the pubic bone. It is believed that a pelvis with bilateral, double puboprostatic ligaments would have advantages in urogenital competence. The morphologic data of the shape, multiplicity, and location of the PPLs would help to make a plan to approach the prostate.
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http://dx.doi.org/10.1016/j.urology.2019.10.015DOI Listing
February 2020

Treating nasal symptoms associated with rhinitis using the intranasal herbal ointment Biyeom-go: A prospective observational study.

Clin Otolaryngol 2019 11 29;44(6):997-1003. Epub 2019 Oct 29.

Deptartment of Ophthalmology, Otolaryngology, and Dermatology, College of Korean Medicine, Woo-Suk University, Jeonju-si, Korea.

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.
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http://dx.doi.org/10.1111/coa.13425DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6916331PMC
November 2019

Effectiveness and safety of polydioxanone thread embedding acupuncture compared to physical therapy in the treatment of patients with non-specific chronic neck pain: Study protocol for an assessor-blinded, randomized, controlled, clinical trial.

Medicine (Baltimore) 2019 Aug;98(32):e16768

Clinical Medicine Division, Korea Institute of Oriental Medicine.

Background: As the number of patients who suffer from non-specific chronic neck pain (CNP) is increasing in the Republic of Korea, conservative treatments for patients with CNP have been spotlighted. Although several studies on thread embedding acupuncture (TEA) treatment have been published for the treatment of such patients, no randomized controlled trial has been reported that investigates the effectiveness and safety of the TEA treatment compared with other conservative treatments for the treatment of patients with CNP. Therefore, the purpose of this trial is to compare the effectiveness and safety of TEA to those of physical therapy (PT) for the treatment of patients with CNP.

Methods/design: This study is planned as a parallel design, randomized, controlled, assessor-blinded, clinical study. One hundred twenty-eight patients diagnosed with CNP will be randomly assigned to either the TEA group or the PT group in a 1:1 ratio. Participants in the TEA group will receive 4 sessions of TEA treatment, while those in the PT group will receive 8 sessions of PT treatment over 4 weeks. An assessment of effectiveness based on the outcomes of the Neck Pain and Disability Scale (NPDS), cervical spinal angle, Beck Depression Inventory II (BDI-II), Beck Anxiety Inventory (BAI), Patient Global Impression of Change (PGIC), EuroQol-Five Dimension 3 level version (EQ-5D-3L), and Pressure Pain Threshold (PPT) will be conducted at baseline, and at 5, 9, and 13 weeks. The primary outcome is the mean change in the NPDS at 9 weeks. Adverse events (AEs) will be recorded at every visit.

Discussion: The results of this study will be expected to provide useful information for the effectiveness and safety of TEA treatment compared to PT treatment for patients with CNP.

Trial Registration: Clinical Research Information Service of Republic of Korea (CRIS- KCT0003720), April 5, 2019.
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http://dx.doi.org/10.1097/MD.0000000000016768DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6709075PMC
August 2019

Nonsurgical integrative inpatient treatments for symptomatic lumbar spinal stenosis: a multi-arm randomized controlled pilot trial.

J Pain Res 2019 28;12:1103-1113. Epub 2019 Mar 28.

Department of Anesthesiology, Division of Pain Medicine, Mayo Clinic, Rochester, MN, USA,

Background: Lumbar spinal stenosis (LSS) is a chronic condition that causes low back pain and neurogenic claudication, often resulting in significant limitation of daily activities. In this open-label randomized controlled pilot study, we assessed the safety and feasibility of 4-week novel integrative inpatient treatments for LSS.

Methods: Thirty-six symptomatic LSS patients were randomly and equally allocated to one of the three groups: Mokhuri Chuna treatment 1 (MT1) group, Mokhuri Chuna treatment 2 (MT2) group, or conventional management treatment (CMT) group. MT1 patients were treated with herbal medication, Mokhuri Chuna, and acupuncture, and received daily physician consultation; MT2 patients were treated with Mokhuri Chuna and acupuncture without any herbal medication, and received daily physician consultation; and CMT patients received conventional pain management therapy that included epidural steroid injection, oral NSAID, and muscle relaxant medication, along with daily physiotherapy. The primary outcome of this pilot study was safety as measured by the type and incidence of adverse events (AEs). The secondary outcome measures included VAS score for low back pain and leg pain, Oswestry Disability Index, Oxford Claudication Score (OCS), walking capacity on a 50 m flat track and treadmill, and EuroQol-5D score. Magnetic resonance imaging was also performed up to 6 months after treatment cessation.

Results: Thirty-four treated patients were included in the analysis, based on the modified intention-to-treat principle. No serious AEs were observed or reported. Compared to the CMT group, the MT1 and MT2 groups did show significant improvement at 3 and 6 months in various domains, including pain (VAS score for leg and back pain) and function (OCS and treadmill walking).

Conclusion: These novel multimodal integrative treatments for LSS are both clinically safe and logistically feasible. Larger, adequately powered randomized controlled trials will be necessary to assess comparative efficacy and thoroughly analyze the cost-effectiveness of each treatment approach.

Clinical Trial Registration Number Cris: KCT0001218.
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http://dx.doi.org/10.2147/JPR.S173178DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6445233PMC
March 2019

Linear focal elastosis: A case report and institutional case series of 22 patients.

Australas J Dermatol 2019 Aug 27;60(3):e261-e263. Epub 2018 Dec 27.

Department of Dermatology, Inje University Busan Paik Hospital, Busan, Korea.

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http://dx.doi.org/10.1111/ajd.12976DOI Listing
August 2019

Efficacy and safety of thread embedding acupuncture for chronic low back pain: a randomized controlled pilot trial.

Trials 2018 Dec 12;19(1):680. Epub 2018 Dec 12.

Clinical Research Division, Korea Institute of Oriental Medicine, Daejeon, 34054, Republic of Korea.

Background: We investigated the efficacy and safety of thread-embedding acupuncture (TEA) for chronic low back pain (LBP) in a randomized controlled pilot trial with the aim of laying the foundation for a large-scale randomized controlled trial on this topic.

Methods: Forty participants were recruited for this two-arm, assessor-blinded randomized controlled pilot trial. The participants were randomly allocated to a TEA group (experimental group) or an acupuncture group (control group). The TEA group received TEA once every 2 weeks for 8 weeks (four sessions in total), while the acupuncture group received acupuncture twice per week for 8 weeks (16 sessions in total). The primary outcome was the visual analog scale (VAS) score for pain and the secondary outcomes were short-form McGill Pain Questionnaire (SF-MPQ) and Oswestry Disability Index (ODI) scores. Assessments were performed at screening and at 2, 4, 6, 8, and 10 weeks after treatment initiation (the 10-week assessment was conducted at 2 weeks after treatment cessation).

Results: Of the 40 participants, 36 completed the study and four dropped out. Both the TEA group and the acupuncture group showed significant improvements in VAS, SF-MPQ, and ODI scores in a time-dependent manner. Furthermore, with regard to ODI, a significant interaction between group and time was observed, with the two groups exhibiting a different pattern of change at 8 weeks according to contrast analysis with Bonferroni's correction. No serious adverse event occurred, and hematological and biochemical test findings were within normal limits.

Conclusion: This pilot study has provided basic data for a larger clinical trial to demonstrate the efficacy and safety of TEA for chronic LBP.

Trial Registration: Clinical Research Information Service of the Korea National Institute of Health, ID: KCT0001819 . Registered on 15 February 2016.
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http://dx.doi.org/10.1186/s13063-018-3049-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6291972PMC
December 2018

Efficacy and safety of polydioxanone thread embedded at specific acupoints for non-specific chronic neck pain: a study protocol for a randomized, subject-assessor-blinded, sham-controlled pilot trial.

Trials 2018 Dec 6;19(1):672. Epub 2018 Dec 6.

Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Daejeon University, 62, Daehak-ro, Dong-gu, Daejeon, 34520, Republic of Korea.

Background: This study aims to evaluate the efficacy and safety of thread-embedding acupuncture (TEA) with polydioxanone thread embedded at various acupoints, compared with sham TEA, for the treatment of non-specific chronic neck pain.

Methods/design: This study will be an 8-week-long, two-armed, parallel, randomized, subject-assessor-blinded, sham-controlled pilot trial. Fifty eligible patients will be randomly allocated into the real TEA group or the sham TEA group. The real TEA group will receive TEA treatment at 14 fixed acupoints in the neck region. The sham TEA group will receive the same treatment as the real TEA group, but with a sham device with the thread removed. Both groups will receive treatment once a week for a total of four sessions. The primary outcome will be the mean change in the visual analog scale (VAS) from baseline to week 6 (2 weeks post intervention). Clinical relevance (ratio of the number of patients with decreases on the VAS of ≥15 mm or with percentiles ≥ 30% and ≥ 50% relative to baseline to the total number of patients), Neck Disability Index, pressure pain threshold, the Hospital Anxiety and Depression Scale, EuroQol 5-Dimensions questionnaire, Patient Global Impression of Change, blinding test, and adverse events will be used to assess secondary outcomes.

Discussion: The results of this study will provide valuable data for a large-scale clinical trial to evaluate the clinical effects of polydioxanone TEA in the treatment of patients with non-specific chronic neck pain.

Trial Registration: Clinical Research Information Service (CRIS), Republic of Korea, KCT0002452 . Registered on 6 September 2017.
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http://dx.doi.org/10.1186/s13063-018-3058-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6282385PMC
December 2018

The efficacy and safety of the herbal medicine geonchildan for patients with active rheumatoid arthritis: study protocol for a randomized, double-blind, placebo-controlled, parallel pilot trial.

Trials 2018 Sep 3;19(1):471. Epub 2018 Sep 3.

Department of Acupuncture & Moxibustion Medicine, Kyung Hee University Korean Medicine Hospital, 23 Kyunghee dae-ro, Dongdaemun-gu, Seoul, 02447, South Korea.

Background: This study aims to assess the efficacy and safety of geonchildan, a Korean traditional herbal medicine, for patients with active rheumatoid arthritis (RA) and evaluate the feasibility of a large-scale confirmatory clinical trial.

Methods/design: This is a randomized, double-blind, placebo-controlled, parallel two-arm pilot trial in Seoul, Korea. Altogether, 30 patients diagnosed with RA for at least 3 months and with a Disease Activity Score for 28 joints (DAS28) ≥ 3.2 will be enrolled. Participants are randomly assigned to one of two groups, the experimental group or the placebo group, in a 1:1 ratio and will make four scheduled visits. The participants will be administered geonchildan or a placebo three times per day for 12 weeks. The change in DAS28 will be examined as the primary efficacy outcome. The secondary efficacy outcomes include the proportion of patients achieving ACR20, ACR50, ACR70, and EULAR responses; the DAS28 sub-items; the consumption of medication; Korean Health Assessment Questionnaire scores; inflammatory parameters; and the Korean medical diagnostic pattern indicator. Adverse events and laboratory test results will be recorded to evaluate safety. The process, resources used, and management of the study will also be assessed to determine the feasibility of a large-scale trial.

Discussion: This is the first clinical trial to explore the efficacy and safety of geonchildan in patients with active RA. If the superiority of geonchildan versus the placebo is demonstrated and the study design is feasible, this study could form the foundation for a large-scale clinical trial. The results will be published in a peer-reviewed journal.

Trial Registration: Clinical Research Information Service, KCT0001943 . Registered on 14 June 2016.
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http://dx.doi.org/10.1186/s13063-018-2849-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6122614PMC
September 2018

Effectiveness and safety of acupotomy for treating back and/or leg pain in patients with lumbar disc herniation: A study protocol for a multicenter, randomized, controlled, clinical trial.

Medicine (Baltimore) 2018 Aug;97(34):e11951

Department of Acupuncture and Moxibustion Medicine, Daejeon University Dunsan Korean Medicine Hospital, Daejeon Department of Acupuncture and Moxibustion Medicine, Daejeon University Cheonan Korean Medicine Hospital, Cheonan Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.

Background: As the number of patients suffering from back and/or leg pain due to lumbar disc herniation (LDH) is increasing in Korea, conservative treatments for patients with LDH have been spotlighted. Although several studies have been published on the use of acupotomy for the treatment of such patients, most of them are only case studies. Therefore, the purpose of this study is to compare the effectiveness and safety of acupotomy to those for manual acupuncture for the treatment of patients with LDH.

Methods/design: This study is planned as a multicenter, parallel design, randomized, controlled, clinical study. One hundred forty-six patients diagnosed with LDH will be randomly assigned to either the acupotomy group or the manual acupuncture group at a 1:1 ratio. Participants in both groups will receive a total of 4 interventions over 2 weeks. An effectiveness assessment based on the outcomes on the visual analog scale (VAS), Roland Morris Disability Questionnaire (RMDQ), Modified-Modified Schober Test (MMST), EuroQol Five Dimensions (EQ-5D), and Patient Global Impression of Change (PGIC) will be conducted at baseline and at 2, 4, and 6 weeks postrandomization. The primary outcome will be the mean change in the VAS for back and/or leg pain 4 weeks postrandomization. Adverse events will be recorded at every visit.

Discussion: The results of this study will provide evidence for the effectiveness and safety of acupotomy treatment for patients with LDH.

Trial Registration: Clinical Research Information Service of South Korea (CRIS- KCT0002824), April 24, 2018.
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http://dx.doi.org/10.1097/MD.0000000000011951DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6112943PMC
August 2018

Socheongryong-tang for improving nasal symptoms associated with allergic rhinitis: A study protocol for a randomized, open-label, cetirizine controlled, clinical trial.

Medicine (Baltimore) 2018 Aug;97(34):e11812

Korea Institute of Oriental Medicine, Yuseong-gu, Daejeon Department of Korean Preventive Medicine, College of Korean Medicine, Graduate School, Kyung Hee University, Dongdaemun-gu, Seoul Korean Medicine Life Science, University of Science and Technology, Yuseong-gu, Daejeon Department of Ophthalmology and Otolaryngology and Dermatology, Woo-Suk University Korean Medicine Hospital, Wansan-gu, Jeonju-si, Jeollabuk-do, Republic of Korea.

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).
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http://dx.doi.org/10.1097/MD.0000000000011812DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6112955PMC
August 2018

Impact of Time Delay in Processing Blood Sample on Next Generation Sequencing for Transcriptome Analysis.

Osong Public Health Res Perspect 2018 Jun;9(3):130-132

Division of Biobank for Health Sciences, Center for Genome Science, Korea National Institute of Health, Korea Centers for Disease Control and Prevention, Cheongju, Korea.

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http://dx.doi.org/10.24171/j.phrp.2018.9.3.09DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6037398PMC
June 2018

Efficacy and treatment-related adverse events of gemcitabine plus nab-paclitaxel for treatment of metastatic pancreatic cancer "in a Korean" population: A single-center cohort study.

Semin Oncol 2017 Dec 12;44(6):420-427. Epub 2018 Jan 12.

Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea. Electronic address:

Pancreatic cancer has poor prognosis because of its rapid progression and treatment resistance. Based on the results of the Metastatic Pancreatic Adenocarcinoma Clinical Trial (MPACT), a combination regimen of gemcitabine with nab-paclitaxel is currently used as standard therapy for the treatment of metastatic pancreatic cancer. However, because studies in Asian populations are lacking, we investigated the treatment efficacy and safety of this combination therapy in Korean population. Patients with metastatic pancreatic cancer (n=81) treated with gemcitabine and nab-paclitaxel (1,000 and 125 mg/m, respectively) as the first-line chemotherapy from January 2016 were identified using the Severance Hospital Pancreatic Cancer Cohort Registry. Treatment efficacy and treatment-related adverse events (AEs) were analyzed. The median follow-up period was 10.7 months (range, 1.5-23.3 months). Median overall survival, progression-free survival, and objective response rates were 12.1 months (95% confidence interval [CI], 10.7-not estimable), 8.4 months (95% CI, 5.0-11.8), and 46.9%, respectively. The incidence of grade ≥3 neurotoxicity and neutropenia were 18.5% and 46.9%, respectively. Febrile neutropenia and grade ≥3 gastrointestinal AEs occurred in 13 (16.0%) and 16 (19.8%) patients, respectively. Dose reductions because of AEs were required in 60.5% of patients. The combination of gemcitabine with nab-paclitaxel is an effective anti-cancer regimen in Korean population of patients with metastatic pancreatic adenocarcinoma. However, careful monitoring and management are required because of occurrence of treatment-related AEs.
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http://dx.doi.org/10.1053/j.seminoncol.2018.01.001DOI Listing
December 2017

Safety and efficacy of Galgeun-tang-ga-cheongung-sinyi, a herbal formula, for the treatment of chronic rhinosinusitis: A study protocol for a randomized controlled trial.

Medicine (Baltimore) 2018 Jun;97(25):e11196

Korea Institute of Oriental Medicine Korean Medicine Life Science, University of Science & Technology, Daejeon Department of Ophthalmology & Otolaryngology & Dermatology, Woo-Suk University Korean Medicine Hospital, Jeonju-si, Jeollabuk-do, Republic of Korea.

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).
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http://dx.doi.org/10.1097/MD.0000000000011196DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6023643PMC
June 2018