• Title/Summary/Keyword: Adverse events

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A Case of Generalized Edema in a Patient after COVID-19 Vaccination Improved by a Combined Korean-Western Medicine Approach (COVID-19 백신 접종 후 발생한 전신 부종에 대한 한양방 복합치료 치험 1례)

  • Youngseon Lee;Somin Jung;Han-gyul Lee;Ki-ho Cho;Sang-kwan Moon;Woo-sang Jung;Seung-won Kwon
    • The Journal of Internal Korean Medicine
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    • v.44 no.5
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    • pp.957-967
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    • 2023
  • Background: According to Vaccine Adverse Events Reporting System data, generalized edema followed by the COVID-19 vaccine is uncommon, with only 333 reported cases, and of those, 224 (69%) are associated with the Pfizer-BioNTech vaccine. Case report: A 76-year-old male patient with heart failure with preserved ejection fraction presented with spontaneous generalized edema and otherwise normal cardiac exams following administration of BNT162b2 (Pfizer-BioNTech) COVID-19 vaccination that had lasted for approximately 60 days and was treated successfully using Korean medicine treatment. After the administration of Korean medicine treatment, the patient's symptoms in the bilateral limbs were dramatically controlled, without recurrence, for 2 months. As a result, generalized edema, which had been present for approximately 50 days, dramatically improved. Conclusion: This clinical case study suggests that a Korean medicine approach with Mokbangki-tang and Oryeong-san might be effective for the pleural effusion resolution of generalized edema after COVID-19 vaccination.

Cognitive function improvement effects of gintonin-enriched fraction in subjective memory impairment: An assessor- and participant-blinded placebo-controlled study

  • Rami Lee ;Han Sang Lee ;Won-Woo Kim ;Manho Kim ;Seung-Yeol Nah
    • Journal of Ginseng Research
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    • v.47 no.6
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    • pp.735-742
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    • 2023
  • Background: Gintonin is a new material of ginseng that acts through the ginseng-derived lysophosphatidic acid (LPA) receptor ligand. The gintonin-enriched fraction (GEF) inhibits amyloid plaque accumulation in the cortex and hippocampus, improves cognitive dysfunction by increasing acetylcholine levels, and promoted hippocampal neurogenesis in an animal model of Alzheimer's disease. We evaluated the effect of the GEF on the cognitive performance of subjects with subjective memory impairment (SMI). Methods: In this eight-week, randomized, assessor- and participant-blinded, placebo-controlled study, participants with SMI were assigned to three groups receiving placebo, GEF 300 mg/day or GEF 600 mg/day. The Korean versions of the Alzheimer's Disease Assessment Scale (K-ADAS), Mini-Mental State Examination (K-MMSE), and Stroop color-word test (K-SCWT) were also evaluated along with the safety profiles. Results: One hundred thirty-six participants completed the study. After eight weeks, we analyzed intergroup differences in primary or secondary outcome score changes. When we compared the GEF group with the placebo group, we observed significant improvements in the K-ADAS and K-SCWT scores. The GEF group did not show a significant improvement in K-MMSE and BDI scores compared to the placebo group. No adverse events were observed in the gintonin and placebo groups for eight weeks. Conclusion: The GEF is safe and effective in improving subjective cognitive impairment related to both the K-ADAS and K-SCWT in this study. However, further large-scale and randomized controlled studies are warranted to secure other cognitive function tests besides the K-ADAS and K-SCWT, and to confirm the findings of the current study.

Indications for Dental Floss Clip Traction During Gastric Endoscopic Submucosal Dissection by Less-Experienced Endoscopists

  • Hirosato Tamari;Shiro Oka;Takahiro Kotachi;Hajime Teshima;Junichi Mizuno;Motomitsu Fukuhara;Hidenori Tanaka;Akiyoshi Tsuboi;Ken Yamashita;Ryo Yuge;Yuji Urabe;Yasuhiko Kitadai;Koji Arihiro;Shinji Tanaka
    • Journal of Gastric Cancer
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    • v.23 no.4
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    • pp.512-522
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    • 2023
  • Purpose: Dental floss clip (DFC) traction-assisted endoscopic submucosal dissection (ESD) is widely performed owing to its simplicity. This study aimed to clarify the appropriate indications for the DFC traction method in early gastric cancer when ESD is performed by less-experienced endoscopists. Methods and Methods: We retrospectively analyzed 1,014 consecutive patients who had undergone gastric ESD performed by less-experienced endoscopists between January 2015 and December 2020. Gastric ESD was performed without DFC in all cases before December 2017 [DFC (-) group, 376 cases], and ESD was performed with DFC in all cases after January 2018 [DFC (+) group, 436 cases]. The procedure time and rates of en bloc resection, complete resection, and adverse events of the groups were compared. Results: The procedure time did not differ significantly between the 2 groups. However, when comparing lesions >20 mm, the procedure time in the DFC (+) group was significantly shorter than that in the DFC (-) group (95±46 vs. 75±31, P<0.01). The procedure time for lesions located in the greater curvature of the upper or middle stomach and lesions >20 mm located in the lesser curvature side of the stomach in the DFC (+) group was significantly shorter than that in the DFC (-) group. Conclusions: The indications for DFC during gastric ESD by less-experienced endoscopists include lesions located in the greater curvature of the upper or middle stomach, and lesions >20 mm located in the lesser curvature of the stomach.

Comparison of Effectiveness of Manual Therapy for Infant Crying: systematic review and meta-analysis of randomized controlled trials

  • Ui Jin Park;Hye In Jeong;Kyeong Han Kim
    • Journal of Pharmacopuncture
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    • v.26 no.4
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    • pp.285-297
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    • 2023
  • Objectives: The aim of this systematic review and meta-analysis is to assess and compare the effectiveness of manual therapy in alleviating infant crying, a common symptom of nocturnal crying (NC) and infantile colic (IC). Methods: Total effective rate, crying time and adverse events were used as outcome indicators. To assess the quality, the risk of bias was determined for each study by two authors, using the Cochrane Collaboration's risk of bias tool. RevMan 5.0 was used for data analysis. A total of 98 articles were identified from 6 electronic databases. Results: Among them, twenty-seven studies which included 13 NC and 14 IC were included. Meta-analysis showed favorable effects tuina therapy on total effective rate (TER) of NC (RR: 1.20 [95% CI 1.05 to 1.37], p = 0.007), chiropractic therapy on crying time change of IC (SMD: -0.83 [95% CI -1.61 to -0.06], p = 0.04) and massage on total crying time of IC (SMD: -0.86 [95% CI -1.09 to -0.63], p < 0.00001). This systematic review compares different manual therapies for the treatment of NC and IC. While tuina, chiropractic, and massage show results in alleviating symptoms, the overall evidence remains limited due to the low quality and heterogeneity of the included studies. Conclusion: Therefore, further high-quality research with unified control groups is needed to establish manual therapy as a recommended treatment option for NC and IC. Protocol registration number is CRD42022348143 01/08/2022.

Association of Arrhythmia in the Elderly Patients on Combination Therapy of CYP3A4 Substrates and Inhibitors with the Korean Claims Data (CYP3A4 기질과 억제제 약물의 병용 고령환자에서 부정맥 부작용 연관성)

  • Tae Woo Kim;Junhyuk Chang;Eunjung Choo;Rae Woong Park;Sukhyang Lee
    • Korean Journal of Clinical Pharmacy
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    • v.33 no.4
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    • pp.242-253
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    • 2023
  • Background: Arrhythmia due to QT prolongation is one of the most serious adverse events with drug interactions in the elderly. This study aimed to examine the incidence of arrhythmia in Korean elderly patients who administered both cytochrome P450 3A4 (CYP3A4) substrates and inhibitors. Methods: Patients using CYP3A4 substrate and inhibitor were selected from the 2017 elderly patient dataset (the Korean Health Insurance Review and Assessment Service - Aged Population Sample). Selection criteria were patients with a medication possession ratio over 80%, medication duration of at least 7 days, and a follow-up period of 3 months or more. The patient's basic information is age, gender, health insurance type, and comorbidities. The top 50 drug pairs and comorbidity with high-incidence arrhythmia were presented. Results: In patients with drug combinations for over 7 days, there were 981 incidences of arrhythmia, and 351 incidences in those with combinations for over 30 days. The comorbidities of congestive heart failure and myocardial infarction had a significant association with incidence of arrhythmia. Among patients with 7 days or longer, the drug pairs [substrates-inhibitors] with significant adjusted odds ratio (aOR) were [propranolol-cimetidine] (aOR, 2.25; 95% confidence interval [CI], 1.66-3.04). Among patients with 30 days or longer, the drug pairs with significant aOR were [tramadol-amiodarone] (aOR, 2.87; 95% CI, 1.97-4.19). Conclusions: In elderly patients, the incidence of arrhythmia was high with drug interactions of CYP3A4 substrates and inhibitors. The comorbidity of congestive heart failure was the risk factor.

A Case Report of Two Patients with Idiopathic Parkinson's Disease Treated with Korean Medicine Treatment and Temporomandibular Joint Balancing Therapy (Temporomandibular Joint Balancing Therapy(턱관절 균형요법)를 병행한 한의치료로 호전된 특발성 파킨슨병 환자 2례에 대한 증례보고)

  • Joo-eun Shin;Seung-ho Kim;Jun-young Hur;Young-jun Lee;In-chan Seol;Yoon-sik Kim;Horyong Yoo
    • The Journal of Internal Korean Medicine
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    • v.45 no.1
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    • pp.87-99
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    • 2024
  • Parkinson's disease (PD) is a chronic degenerative disorder of the central nervous system. It has no cure, but current treatments can relieve symptoms and maintain quality of life. As PD progresses, controlling its symptoms becomes difficult. Here, we present the treatment of two patients with idiopathic PD using traditional Korean medicine (TKM) and temporomandibular joint balancing therapy (TBT). We measured the progress of the two patients using the unified PD rating scale (UPDRS) and the Hoehn and Yahr (HY) scale. Combined treatment of TKM and TBT decreased the total UPDRS score from 52 to 26 after 21 days in case 1, while it decreased the total UPDRS score from 91 to 65 after 20 days in case 2. In both patients, the HY scale score was maintained at 3, and no adverse events were observed. Thus, the combined treatment of TKM and TBT can produce a treatment response in PD patients.

A Case Report of a Guillain-Barre Syndrome Patient Suspected of Having Acute Transverse Myelitis Treated with Korean Medicine (급성 횡단성 척수염으로 의심된 길랑바레증후군 환자에 대한 한방 치료 증례보고 1례)

  • Da-young An;Chae-eun Kim;Mi-kyung Kim;Seung-ho Sun
    • The Journal of Internal Korean Medicine
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    • v.44 no.6
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    • pp.1279-1293
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    • 2023
  • A 67-year-old female patient diagnosed with acute transverse myelitis visited our hospital in February 2023. Consultation papers indicated that she was diagnosed with acute transverse myelitis and that she complained of quadriparesis and numbness in both hands and feet. However, her spine magnetic resonance imaging (MRI) did not clearly indicate that she suffered from acute transverse myelitis. She was then sent to a high-level hospital and diagnosed with Guillain-Barre Syndrome through electromyography, cerebrospinal fluid test, and spine MRI. On March 2023, she visited our hospital again, still complaining about weakness in both hands and inability to walk. She was treated with Korean medicine, including acupuncture, electroacupuncture, pharmacopuncture, and herbal medicine such as Yanggyeoksanhwatang and Sipimijihwang-tanggami. After three months, she was discharged on cane walking. The manual muscle test (MMT) grade of her upper limbs increased from 3-/3-/3-/3- (shoulder/elbow/wrist/fingers) to 4/4/4/3+, and the MMT grade of her lower limbs increased from 2/2/2/2 (pelvis/knee/ankle/feet) to 4/4/4-/4-. Her numbness in both feet disappeared, and her numbness in both hands decreased from a numeric rating scale of 7 to 2. No adverse events were reported during treatment. This case implies the therapeutic potential of Korean medicine for Guillain-Barre Syndrome, especially for those who had delayed diagnosis and missed the opportunity to get plasma exchange.

Herbal Medicine for Sarcopenia: A Systematic Review of Randomized Controlled Trials (근감소증에 대한 한약 치료 : 체계적 문헌 고찰)

  • Se-eun Chun;Soo-hyung Lee;Yong-jeen Shin;Sun-ho Shin
    • The Journal of Internal Korean Medicine
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    • v.44 no.6
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    • pp.1118-1138
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    • 2023
  • Objectives: Sarcopenia is an age-associated skeletal muscle disorder that can profoundly impact the health of elderly people. However, the efficacy of herbal medicine in sarcopenia is uncertain. This review aims to investigate evidence of the effect of herbal medicine on sarcopenia. Methods: We systematically searched 12 electronic databases for relevant randomized controlled trials (RCTs). Only trials that met the inclusion criteria were selected, and the characteristics of the included studies were extracted and synthesized in a narrative manner. The quality of the included studies was assessed using Cochrane's Risk of Bias (RoB) 2.0 tool. Results: 7 RCTs involving 672 participants with sarcopenia met the inclusion criteria. The intervention combining herbal medicine and conventional treatment (i.e., exercise, nutritional support) had a significant therapeutic effect compared with the conventional treatment, showing improvement in muscle strength (i.e., grip strength), muscle mass (i.e., appendicular skeletal muscle mass index), and physical function (i.e., gait speed, short physical performance battery, and timed up and go test). However, the methodological quality of the included RCTs was relatively low due to their high RoB, making it difficult to evaluate the efficacy of herbal medicine in sarcopenia. In terms of safety, several adverse events were reported. Conclusion: This review suggests that herbal medicine has a positive effect on muscle strength, muscle mass, and physical performance in elderly patients with sarcopenia, but there is a clear need for further research in this area.

A Review on Female Infertility Treatment in Korean Medicine by Analyzing Case Studies Published in Korean Journal (국내 학술지에 게재된 증례 연구 분석을 통한 여성 난임의 한의학적 치료에 대한 고찰)

  • Young-Eun Kim;Hee-Yoon Lee;Su-In Hwang;Young-Jin Yoon;Jang-Kyung Park
    • The Journal of Korean Obstetrics and Gynecology
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    • v.37 no.1
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    • pp.40-59
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    • 2024
  • Objectives: Since infertility has been big social issue in Korea, this study aims to analyze the domestic study trends in Korean Medicine (KM) for female infertility treatment. Methods: Case studies applying KM treatment on female infertility were selected through 5 domestic journal databases. General characteristics, interventions, outcomes and results and the quality of the reports were analyzed. Especially, the quality assessments of studies were made using CAse REport (CARE) guideline and Joanna Briggs Institute (JBI) critical appraisal checklist. Results: 14 studies (22 cases) were finally selected for the analyzation. The mean age of the participants was 35.1 and the most common factor of female infertility in this study was Uterine factor. Herbal medicine was applied in all studies, and acupuncture was also used frequently. Most cases reported pregnancy of the participants. According to quality assessment, 'Diagnostic challenges', 'Intervention adherence and tolerability', 'Adverse and unanticipated events', 'Patient perspective' and 'Informed consent' were showed low reporting rates. Conclusions: Korean Medicine treatment for female infertility is expected to be effective. In quality evaluation, there were some items with low reporting rates. Further clinical studies have to be conducted to establish the evidence for the treatment.

Effects of Fasting versus Non-Fasting on Emetic Complications in Radiological Examinations Using Intravascular Non-Ionic Iodinated Contrast Media: A Systematic Review and Meta-Analysis

  • Hyewon Choi;Hyunsook Hong;Min Jae Cha;Soon Ho Yoon
    • Korean Journal of Radiology
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    • v.24 no.10
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    • pp.996-1005
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    • 2023
  • Objective: To compare the incidence of aspiration pneumonia, nausea, and vomiting after intravascular administration of nonionic iodinated contrast media (ICM) between patients who fasted before contrast injection and those who did not. Materials and Methods: Ovid-MEDLINE and Embase databases were searched from their inception dates until September 2022 to identify original articles that met the following criteria: 1) randomized controlled trials or observational studies, 2) separate reports of the incidence of aspiration pneumonia, nausea, and vomiting after intravascular injection of non-ionic ICM, and 3) inclusion of patients undergoing radiological examinations without fasting. A bivariate beta-binomial model was used to compare the risk difference in adverse events between fasting and non-fasting groups. The I2 statistic was used to assess heterogeneity across the studies. Results: Ten studies, encompassing 308013 patients (non-fasting, 158442), were included in this meta-analysis. No cases of aspiration pneumonia were reported. The pooled incidence of nausea was 4.6% (95% confidence interval [CI]: 1.4%, 7.8%) in the fasting group and 4.6% (95% CI: 1.1%, 8.1%) in the non-fasting group. The pooled incidence of vomiting was 2.1% (95% CI: 0.0%, 4.2%) in the fasting group and 2.5% (95% CI: 0.7%, 4.2%) in the non-fasting group. The risk difference (incidence in the non-fasting group-incidence in the fasting group) in the incidence of nausea and vomiting was 0.0% (95% CI: -4.7%, 4.7%) and 0.4% (95% CI: -2.3%, 3.1%), respectively. Heterogeneity between the studies was low (I2 = 0%-13.5%). Conclusion: Lack of fasting before intravascular administration of non-ionic ICM for radiological examinations did not increase the risk of emetic complications significantly. This finding suggests that hospitals can relax fasting policies without compromising patient safety.