• Title/Summary/Keyword: Clinical Trials

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Effects of Bojungikgi-tang and its modifications for Anemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials (빈혈에 대한 보중익기탕 및 그 가미방의 효과: 체계적 문헌고찰과 메타분석)

  • Mikyung Kim;Chang-ho Han
    • The Journal of Korean Medicine
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    • v.44 no.2
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    • pp.181-200
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    • 2023
  • Objectives: This study aimed to evaluate the efficacy and safety of Bojungikgi-tang (BJIG) and its modifications for patients with anemia. Methods: The subject of analysis of this study was a parallel design randomized controlled trial in which BJIG or its modifications was administered orally to patients who met the World Health Organization's anemia criteria and the efficacy and safety were prospectively measured. Electronic databases were searched to retrieve eligible literature published from 1 January 2000 to 12 February 2023. A meta-analysis was conducted, and the risk of bias (RoB) and level of evidence of the included studies was assessed using the Cochrane RoB 2 tool and GRADE method, respectively. Results: Five studies were included in the meta-analysis. When BJIG or its modifications was administered to anemia patients receiving conventional treatment, additional benefits compared to the non-administered group were found in terms of an increase in red blood cell count (mean difference (MD) 0.46 × 1012/L, 95% confidence interval (CI) 0.17 to 0.74), hemoglobin concentration (MD 9.28 g/L, 95% CI 6.06 to 12.51), hematocrit (MD 2.57%, 95% CI 1.76 to 3.38), total effective rate (odds ratio 5.29, 95% CI 2.05 to 13.68), and traditional Chinese medicine symptom scores (standardized MD -1.51, 95% CI -2.79 to -0.24). Conclusions: This study demonstrated the clinical potential of BJIG and its modifications to provide additional benefits to patients with anemia receiving conventional treatment.

Can Sodium Citrate Effectively Improve Olfactory Function in Non-Conductive Olfactory Dysfunction? (Sodium Citrate가 효과적으로 비전도성 후각장애에 치료효과를 보일 수 있을지에 대한 문헌 고찰)

  • Kim, Subin;Kang, Haram;Jin, Ho Jun;Hwang, Se Hwan
    • Korean Journal of Otorhinolaryngology-Head and Neck Surgery
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    • v.62 no.2
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    • pp.75-81
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    • 2019
  • The objective of this study was to perform a systematic review of the literature for application of intranasal sodium citrate in the patients with olfactory dysfunction to help determine the sodium citrate treatments for this condition. Two authors independently searched the data base (Medline, Scopus, and the Cochrane database) for relevant studies from inception to January 2018. Included studies were randomized controlled studies published in English comparing topical sodium citrate application (treatment group) with saline (control group) in patients who had olfactory dysfunction. Outcomes of interest included the change of olfactory identification and threshold during 2 hours post-treatment. Three studies were enrolled in the meta-analysis. Compared with control group, treatment group did not increase posttreatment score of olfactory identification [standardized mean difference (SMD)=-0.03; 95% confidence interval (CI)=-0.29-0.24; I2=0%] and olfactory threshold (SMD=0.18; 95% CI=-0.09-0.45; I2=0%) significantly. In the degree of pre-post improvement of two outcomes, although treatment group statistically showed the significant improvement in olfactory threshold (SMD=0.30; 95% CI=0.05-0.55; I2=17%), the clinical significance of this outcome was meaningless. Similarly, there was no significant difference in olfactory identification between two groups (SMD=0.17; 95% CI=-0.11-0.45; I2=22%). Unlike the recent favorable results, our summated results presented the uselessness for the local application of sodium citrate in improving patient's olfactory function. However, we also had some limitation such as small sample size and inconsistent application methods. Therefore, larger trials and standardized methodology are needed to reach more stronger and exact results.

Prognosis of Unrepaired Ascending Aorta after the Surgical Replacement of Bicuspid Aortic Valves

  • Hong Ju Shin;Wan Kee Kim;Dong Kyu Kim;Ho Jin Kim;Joon Bum Kim
    • Journal of Chest Surgery
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    • v.56 no.4
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    • pp.255-261
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    • 2023
  • Background: The surgical threshold for bicuspid aortic valve (BAV)-related aortopathy is a matter of debate due to its uncertain etiology and prognosis. This study investigated the prognosis of unrepaired BAV aortopathy in patients undergoing surgical aortic valve replacement (SAVR). Methods: We retrospectively analyzed data from 720 patients (age, 60.8±11.5 years; 246 women) who underwent SAVR for BAV disease without aortic repair between 2005 and 2020 at Asan Medical Center. The clinical endpoints were defined as occurrences of sudden death, aortic dissection or rupture, and elective aortic repair. To estimate postoperative changes in the dimensions of the unrepaired aorta, the individual annual aortic expansion rate was calculated. Multiple linear regression models were used to evaluate the risk of aortic expansion. Results: The mean ascending aortic diameter was 39.5±4.6 mm, and 299 patients (41.5%) had a baseline ascending aorta diameter >40 mm. During 70.0±68.3 months of follow-up, the mean annual aortic expansion rate was 0.39±1.96 mm/yr, no aortic dissection or rupture was observed, and sudden deaths were reported in 12 patients (0.34% per person-year). Linear regression analysis revealed no significant correlation between the baseline ascending aortic diameter and postoperative aortic expansion (R2=0.004, β=-0.84, p=0.082). Conclusion: In selected patients undergoing SAVR for a BAV (<55 mm), the risk of adverse aortic events was very low. As this observation contradicts current practice guidelines advocating for proactive aortic replacement in dilated ascending aortas measuring >45 mm, the study results need further validation by studies involving larger populations or randomized controlled trials.

Case Report of Yukmijihwang-tang(Liuweidihuang-fang) on Diabetes Mellitus in Stroke Patients Diagnosed as Kidney-Yin Deficiency or Non Kidney-Yin Deficiency Syndrome (신음허(腎陰虛)로 변증(辨證)된 중풍환자(中風患者)와 신음허(腎陰虛)로 변증(辨證)되지 않은 중풍환자(中風患者)의 당뇨(糖尿)에 대한 육미지황탕(六味地黄湯)의 치험례(治驗例))

  • Jung, Woo Sang;Moon, Sang Kwan;Cho, Ki Ho;Kim, Young Suk
    • The Journal of the Society of Stroke on Korean Medicine
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    • v.11 no.1
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    • pp.82-88
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    • 2010
  • Because syndrome-differentiation is one of the major characteristics in oriental medicine, there would be a possibility that the same herbal medicine show different effects on the same disease, if syndrome differentiation is ignored. In this report, we observed different response of Yukmijihwang-tang in diabetic stroke patients according to their syndrome differentiation. One case diagnosed as 'Kidney-yin deficiency syndrome' showed remarkable improvement on diabetes mellitus, whereas the serum glucose levels of the other 4 cases diagnosed as 'non Kidney-yin deficiency syndrome' were lowered little. These results are in accordance with the oriental medical theory that Yukmijihwang-tang can treat 'Kidney-yin deficiency syndrome'. Therefore, we suggest that subsequent clinical trials on oriental medicine would have to include the concept of differentiation of syndromes in order to take out the merit of oriental medicine.

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Korean Medicine Treatment (Banhabakchulchunma-tang) for an Obese Patient With Hypothyroidism: Two Case Reports (갑상선 기능 저하증을 동반한 비만 환자에게 반하백출천마탕 투여 후 호전된 증례 2예)

  • Sang-Song Shim;In-Hye Park;Chang-Eun Park;Won-Seok Chung
    • Journal of Korean Medicine for Obesity Research
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    • v.23 no.1
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    • pp.42-50
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    • 2023
  • Obesity often develops to hypothyroidism patients because thyroid hormone is associated with changes in body weight, body temperature, and energy expenditure. Obesity is not only pointed out as the cause of various other diseases, but also can worsen thyroid function, so obesity treatment is essential for hypothyroidism patients. But there is lack of studies about obesity treatment for hypothyroidism patients in Korea. In this study, two obese patients who diagnosed hypothyroidism were treated by Korean medicine. We prescribed herbal medicine (Banhabakchulchunma-tang) for about 2 months. A total of 6.5 kg and 4.5 kg of weight loss were observed respectively, and there were no serious side effects. Further large-scale clinical trials are needed to evaluate the anti-obesity effect and the effect of thyroid function improvement.

Vagus Nerve Stimulation Through Electro-acupuncture for Inflammatory Bowel Disease (염증성 장 질환에서 전침을 중심으로 한 미주신경자극에 대한 고찰)

  • Minjeong Kim;Dongwon Kim;Chaehyun Park;Jae-Woo Park;Seok-Jae Ko
    • The Journal of Internal Korean Medicine
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    • v.44 no.3
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    • pp.455-465
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    • 2023
  • Inflammatory bowel disease (IBD) is defined as a chronic inflammatory-mediated disease that causes ulceration and inflammation in the gastrointestinal tract. Among most patients, the course of chronic inflammation repeatedly shows intermittent exacerbations and alternating remissions. However, despite the various therapeutic options to relieve symptoms, such as corticosteroids, TNF-α inhibitors, and antibiotic drugs, there is no known cure for IBD. Nonetheless, previous research has revealed that the autonomic nervous system is involved in the pathophysiology of IBD. In this study, we reviewed clinical trials confirming the therapeutic effect of vagus nerve stimulation (VNS) on IBD in vivo. We searched in vivo and human studies on Pubmed using keywords combined with "vagus nerve stimulation", "VNS", and "inflammatory bowel disease". All studies included in this review reported that direct VNS is effective in relieving symptoms of IBD and has no severe adverse effects. The most frequently stimulated site was the unilateral cervical vagus nerve area, and parameters for stimulation were set as 5-20 Hz. Based on the results, we aim to summarize the evidence for the efficacy of VNS on IBD and suggest the possibility of auricular electroacupuncture treatment as a therapeutic option for IBD.

Recent Advances in the Prevention of RSV in Neonates and Young Infants

  • Ki Wook Yun
    • Pediatric Infection and Vaccine
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    • v.30 no.1
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    • pp.1-11
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    • 2023
  • Respiratory syncytial virus (RSV) is a pathogen with a high burden of disease and social cost among infants worldwide, but the development of a vaccine has been delayed. The recent understanding of the pathogenesis of RSV, progress in reverse genetics, and successful implementation of other maternal immunizations have prompted the recent rapid development of monoclonal antibodies (mAbs) and vaccines for RSV prevention. Phase 3 clinical trials for two next-generation mAbs (nirsevimab and clesrovimab) and two maternal RSV pre-F vaccines are currently underway or have been recently completed. Soon, we might be able to protect young infants through long-acting mAbs and/or maternal immunization. Additionally, the development of live-attenuated vaccine candidates that are capable of avoiding enhanced RSV disease is ongoing. We need to gain familiarity with these newly developed strategies and collect epidemiological data on domestic RSV to adequately prepare for a new era of RSV prevention.

Biochemical Biomarkers for Alzheimer's Disease in Cerebrospinal Fluid and Peripheral Blood (뇌척수액과 말초혈액 내 알츠하이머병의 생화학적 생체표지자)

  • Lee, Young Min;Choi, Won-Jung;Park, Minsun;Kim, Eosu
    • Journal of Korean geriatric psychiatry
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    • v.16 no.1
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    • pp.17-23
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    • 2012
  • The diagnosis of Alzheimer's disease (AD) is still obscure even to specialists. To improve the diagnostic accuracy, to find at-risk people as early as possible, to predict the efficacy or adverse reactions of pharmacotherapy on an individual basis, to attain more reliable results of clinical trials by recruiting better defined participants, to prove the disease-modifying ability of new candidate drugs, to establish prognosis-based therapeutic plans, and to do more, is now increasing the need for biomarkers for AD. Among AD-related biochemical markers, cerebrospinal beta-amyloid and tau have been paid the most attention since they are materials directly interfacing the brain interstitium and can be obtained through the lumbar puncture. Level of beta-amyloid is reduced whereas tau is increased in cerebrospinal fluid of AD patients relative to cognitively normal elderly people. Remarkably, such information has been found to help predict AD conversion of mild cognitive impairment. Despite inconsistent findings from previous studies, plasma beta-amyloid is thought to be increased before the disease onset, but show decreasing change as the disease progress. Regarding other peripheral biochemical markers, omics tools are being widely used not only to find useful biomarkers but also to generate novel hypotheses for AD pathogenesis and to lead new personalized future medicine.

The Effects of Digital Therapy for Stroke Patients in Korea: Meta-analysis (국내 뇌졸중 환자를 위한 디지털 치료의 효과: 메타분석)

  • Jae-Hun Jung
    • Journal of The Korean Society of Integrative Medicine
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    • v.11 no.4
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    • pp.1-15
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    • 2023
  • Purpose : This study investigates the effectiveness of digital therapy for stroke patients in Korea. Methods : A comprehensive database search was performed using KCI, Science on, e-article, RISS, KISS and Korea OpenMed databases for randomized controlled trials (RCTs) that studied the effects of digital therapy on patients who had a stroke. This study includes RCTs published from January 2000 to July 15, 2022, which fulfilled the inclusion and exclusion criteria. A total 697 studies were screened and 30 studies were included in the final analysis. Methodological quality was assessed with the Cochrane's RoB (risk of bias) tool. Meta-analysis was performed using CMA 4.0 software. Results : A total of 56 effect sizes were calculated from the 30 selected studies. As a result of the analysis, the overall effect size of digital therapy was .59 (95 % CI=.43-.74). When classified according to type of intervention, VR (virtual reality) (g=.58, 95 % CI=.40-.75), and CACR (computer assisted cognitive rehabilitation) (g=.62, 95 % CI=.30-.95) were statistically significant. VR showed medium to large effect sizes in cognitive function (g=.78, 95 % CI=.20-1.37), psychosocial function (g=.63, 95 % CI=.20-1.07), and physical function (g=.61, 95 % CI=.38-.83). In the CACR, there was a large effect size in cognitive function (g=.84, 95 % CI=.52-1.15), but there was no significant difference in psychosocial function. Also, there was no significant difference between the two interventions in activities of daily living and no significant difference in the effect size of both interventions according to the intervention session. Furthermore, medium to large effect sizes were found for subacute and chronic stroke patients according to the duration of disease. Conclusion : This study presents evidence that digital therapy has a positive effect on various functions of stroke patients in Korea. The researchers expect to actively accept the new paradigm of digital therapy and continue to apply digital therapy in clinical practice.

Individualized Therapy to Manage Quadriplegic Spastic Cerebral Palsy with Unani Treatment Modalities

  • Fahmida Kousar;Arshiya Sultana;Shahzadi Sultana;Taseen Banu;Arfa Begum
    • CELLMED
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    • v.13 no.14
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    • pp.16.1-16.14
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    • 2023
  • Objective: Cerebral palsy (CP) is a neurodevelopment disorder attributed to an insult or injury to the developing brain with abnormalities in muscular tone, movement and motor skill. Improvement in quality of life and ameliorating symptoms can be achieved. Therefore, this case report details a distinctive approach to treating a 5-year-old male child with quadriplegic spastic cerebral palsy utilizing Unani treatment modalities. Methods: The treatment regimen commenced with 'Habb Ayarij for constipation followed by Sharbat Ustukhuddus administered orally. Notably, Sharbat Ustukhuddus was combined with Melia Azedarach L. leaves vapour bath. Subsequently, Roghan Babunna douche was performed followed by Dalk Layyin andcontinued until symptomatic improvement was observed. Majun Falasfa, Khamira Marwareed and Khameera Gauzaban were administered for 30 days. The therapeutic outcome included anthropometrical measurements, developmental milestones, spasm/reflex scale, and muscle power grading. Results and conclusion: Over the course of a 2-year follow-up, several clinical findings emerged. These included notable improvements in anthropometric measurements, developmental milestones such as improved head control and sitting ability, and a reduction in spasticity of the upper limbs, along with decreased muscle spasms. The therapeutic outcome of this individualized and holistic approach is potentially due to the multifaceted properties of medicinal plants (Musakkin wa Muharrik wa Muqawwi-i- A'sab wa Dimāgh, Munawwim, Dafi-i-Tashannuj, Muqawwi-i-Qalb-i-Ruh). Furthermore, the use of Dalk and Naṭūl was instrumental in providing nourishment to musculoskeletal cells and initiating intracellular signaling cascades. While these findings are encouraging, further research in the form of case series andrandomized controlled trials is warranted to validate the efficacy of this unique holistic approach.