• Title/Summary/Keyword: Controlled clinical trials, randomized

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A Review of Korean Medical Pathogenesis, Pattern Identification, Treatment Principle and Herbal Medicines for Allergic Conjunctivitis in Pediatric Patients (소아 알레르기 결막염의 한의학적 병인, 변증, 치법 및 한약재 선택에 대한 문헌적 고찰)

  • Kim, Ye Ji;Seo, Hae Sun;Park, Yong Seok;Park, Sul Gi;Lee, Sun Haeng;Lee, Jin Yong
    • The Journal of Pediatrics of Korean Medicine
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    • v.35 no.2
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    • pp.21-36
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    • 2021
  • Objectives We aimed to understand etiology, pattern differentiation, treatment principle, and the role of selected herbs in the treatment of Korean herbal medicine for allergic conjunctivitis (AC) in children. Methods We searched relevant literature published up to February 20, 2021 through CNKI, using search formula of (SU= '結膜炎'+'conjunctivitis') AND (SU='儿童'+'小儿'+'少儿'+'幼年') AND (SU='治療'+'中医治療'+'中藥'+'中医藥'+'顆粒'+'胶囊'+'自擬'+'湯'+'丸'+'散'+'方'). Results Among 81 searched studies, 9 randomized controlled trials and 1 case report were selected and analyzed. In all studies included, the efficacy of herbal treatment for AC was confirmed, and there was no evidence that herbal medicine treatment has higher risk of developing side effects compared to conventional eye drop treatment. As an etiology, wind (風邪) was observed the most frequently, and Saposhnikoviae Radix (防風) and Schizonepetae Spica (荊芥) were in frequent use to dispel wind (祛風). As visceral pattern identification, spleen (脾) and lung (肺) were two important keywords, and spleen deficiency (脾虛), dampness-heat in the spleen and stomach (脾胃濕熱), lung qi deficiency (肺氣虛) were main pathologic mechanisms. Else, treatments related to liver (肝) and removing dampness-heat (濕熱) were mentioned next. Conclusions This study is significant in that AC in children, which has a lack of research compared to other allergic diseases, has been studied in the contents of Korean medicine and laid foundation that can be used as basic data in the actual clinical field. Based on this study, it is hoped that clinical data of Korean herbal medicine treatment for childhood AC will be further accumulated.

A Systematic Review of effect on Heat-sensitive Moxibustion for Benign Prostatic Hyperplasia (전립선비대증에 대한 열민구(熱敏灸)의 효과에 관한 체계적 문헌 고찰)

  • Kim, MinSeok;Ju, HongMin;Kim, MinHwa;Park, SunYoung;Yun, YoungJu;Park, SeongHa
    • The Journal of Korean Medicine
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    • v.42 no.3
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    • pp.153-164
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    • 2021
  • Objectives: The aim of this study is to investigate the effect of Heat-sensitive Moxibustion on Benign Prostatic Hyperplasia Methods: We searched articles from Academic Journals(CAJ) online databases, Oriental Medicine Advanced Searching Integrated System (OASIS), Searching key words were '前列腺增生', '熱敏灸' and '열민구', '전립선비대'. The search range included randomized controlled trials (RCTs). Among the articles published to 2020, 10 articles were found. After review the title, abstract and original, 3 articles were selected finally to rule out treatment combined with completely different treatments. Result: The Heat-sensitive moxibustion at acupoints in the treatment of Benign prostatic hyperplasia were significantly superior to control group after treatment in the symptoms of patients, IPSS, QOL, PVR and Qmax(P<0.05). The Heat-sensitive moxibustion can significantly reduce the incidence of temporary urinary incontinence after Transurethral resection of the prostate(TURP) and improve life quality and satisfaction of patients(P<0.05). The individualized desensitization saturated time and amount of Heat-sensitive moxibustion is superior effective to general amount and time of traditional moxibustion in the total effective rate, IPSS, Ru and Qmax(P<0.01) for Benign prostatic hyperplasia. Conclusion: Heat sensitive moxibustion directly transfer heat to the source of a disease. So it can be considered as a good treatment for Benign prostate hypertrophy. It was also shown a better effect on BPH compared to traditional moxibustion, According to the thermo principles of tumor, if the tumor cell's death temperature of 43℃ is reached, that can cause tumor degeneration. Therefore I think Heat sensitive moxibustion can be applied to various tumor disease. The results of this study could be applied to clinical treatment of BPH. However, additional large-scale clinical researches should be conducted.

A Narrative Review of the Korean Medicine Treatments for Achilles Tendinopathy (아킬레스 건병증의 한의학적 치료에 대한 국내외 연구 동향 분석)

  • Yoon, Kyung-Young;Hwang, Dong-Wook;Bae, In-Su;Youn, Jun-Heum;Lee, Yu-Jin;Jang, Won-Suk;Yoo, Sang-Joon;Lee, Do-Hoon;Kang, Dong-Hyeob;Son, Ja-Yean;Yang, Seok-Gyu;Cho, Hyun-Woo
    • Journal of Korean Medicine Rehabilitation
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    • v.32 no.4
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    • pp.33-45
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    • 2022
  • Objectives The purpose of this review was to investigate clinical treatment trends of Achilles tendinopathy. Methods Clinical studies about Korean medicine treatments on Achilles tendinopathy were searched in 5 databases. The included studies were classified according to the authors, published years, study designs, purposes of study, methods, interventions outcome measures and adverse event. Results In 23 studies, total number of patients were 1,135. The included studies consist of 14 randomized controlled trials (RCT), 5 non-RCT, 2 retrospective study and 2 case reports. Patients were conducted with 9 kinds of treatment, which is acupuncture, electro-acupuncture, pharmacopuncture, acupotomy, moxibustion, cupping, Chuna, herbal medicine, physiotherapy. Most studies used visual analogue scale as primary outcome. Conclusions Based on the results of the collected studies, the use of Korean medicine treatment on Achilles tendinopathy seem to be effective. Despite the large number of RCTs, the level of research cannot be guaranteed, so it is considered that more rigorous researches are needed in future studies.

The Effect of Taeksa-tang for Dyslipidemia: A Systematic Review and Meta-Analysis (이상지질혈증에 대한 택사탕(澤瀉湯)의 효과 : 체계적 문헌 고찰 및 메타 분석)

  • Yeong-seo Lee;Tae-young Huh;Kyoung-min Kim
    • The Journal of Internal Korean Medicine
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    • v.44 no.3
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    • pp.485-505
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    • 2023
  • Objective: The purpose of this study is to assess the effectiveness and safety of using Taeksa-tang for dyslipidemia through a systematic review and meta-analysis of randomized controlled trials (RCTs). Methods: The search was conducted using keywords such as "dyslipidemia", "hyperlipidemia", "taeksa tang", "zexie tang", and "takusha to" in 12 databases (Pubmed, Cochrane, Embase, ScienceDirect, CNKI, Wanfang, CiNii, RISS, KISS, ScienceON, OASIS, and DBpia) on April 13, 2023. There were no limits on the publication period and language. Cochrane's risk of bias (RoB) was used to evaluate the quality of the studies. A meta-analysis was conducted according to the outcome measurements such as total effective rate (TER), total cholesterol (TC), triglyceride (TG), HDL-cholesterol (HDL-C), LDL-cholesterol (LDL-C), and adverse effects, using the Review Manager web. Results: A total of 9 RCTs were selected. In evaluating the RoB, 2 studies mentioning the random sequence generation, 1 study conducting double blindness, and 8 studies without missing values were evaluated as low risk, while 1 study without mentioning the random sequence generation was evaluated as high risk. All other parts were evaluated as unclear risk. The treatment group (Taeksa-tang or Taeksa-tang-gagam) showed more statistically significant effects compared to the control group (Western medicine or Chinese patent medicine) in TER (RR : 1.24, 95% CI 1.15 to 1.34, P<0.00001), TC (MD : -1.12, 95% CI -1.68 to -0.56, P<0.0001), TG (MD : -1.08, 95% CI -1.65 to -0.51, P=0.0002), HDL-C (MD : 0.63, 95% CI 0.34 to 0.93, P<0.0001), LDL-C (MD : -0.81, 95% CI -1.10 to -0.53, P<0.00001). In addition, the treatment group showed lower adverse effects compared to the control group (RR : 0.30, 95% CI 0.12 to 0.74, P=0.008). Conclusion: This study suggests that Taeksa-tang is effective and safe to use for treating dyslipidemia. However, due to the low quality of the included studies, more clinical studies need to be conducted in the future to increase the possibility of clinical use.

Efficacy and Safety of COVID-19 Vaccines in Adolescents: Systematic Review of Randomized Controlled Studies and Observational Studies

  • Soo-Han Choi;Su-Yeon Yu;Jimin Kim;Miyoung Choi;Youn Young Choi;Jae Hong Choi;Ki Wook Yun;Young June Choe
    • Pediatric Infection and Vaccine
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    • v.31 no.1
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    • pp.12-24
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    • 2024
  • The number of pediatric coronavirus disease 2019 (COVID-19) cases worldwide are increasing compared to the early phase of the pandemic, along with highly transmissible severe acute respiratory syndrome coronavirus variant and the increase in adult COVID-19 vaccination. We conducted a rapid systematic review and meta-analysis of published randomized clinical trials (RCTs) of the COVID-19 vaccines and the observational retrospective studies on adverse events after COVID-19 vaccination in adolescents. Seventeen studies were finally included in this systematic review. Meta-analysis showed that although vaccination in adolescents was significantly effective to prevent COVID-19 infection in retrospective studies (risk ratio [RR], 0.29; 95% confidence interval [CI], 0.22-0.37; I2 =100%), however the effect of preventing COVID-19 infection was lower than in RCTs (RR, 0.05; 95% CI, 0.01-0.27). In five retrospective studies, the pooled estimated proportion of participants with myocarditis and/or pericarditis was 2.33 per 100,000 of the population (95% CI, 0.97-5.61 per 100,000). Sub-group analysis with sex and vaccine doses showed that male (5.35 per 100,000) and the second dose (9.71 per 100,000) had significantly higher incidence of myocarditis and/or pericarditis than female (1.09 per 100,000) and the first dose (1.61 per 100,000), respectively. Our study showed that mRNA COVID-19 vaccines in adolescent recipients were favorable and effective against COVID-19 in RCT as well as observational studies. The safety findings of BNT162b2 vaccine in adolescents were explored and we found the difference of safety according to sex and vaccine doses. The occurrence of adverse events after mRNA COVID-19 vaccination should be monitored.

Effects for kangaroo care: systematic review & meta analysis (캥거루 케어가 미숙아와 어머니에게 미치는 효과 : 체계적 문헌고찰 및 메타분석)

  • Lim, Junghee;Kim, Gaeun;Shin, Yeonghee
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.17 no.3
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    • pp.599-610
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    • 2016
  • This paper reports the results of a systematic review (SR) and meta-analysis research to compare the effect of Kangaroo care, targeting mothers and premature infants. A randomized clinical trial study was performed until February 2015. The domestic literature contained the non-randomized clinical trial research without restriction according to the level of the study design. A search of the Ovid-Medline, CINAHL, PubMed and KoreaMed, the National Library of KOREA, the National Assembly Library, NDSL, KISS and RISS. Through the KMbase we searched and combined the main term ((kangaroo OR KC OR skin-to-skin) AND (care OR contact)) AND (infant OR preterm OR Low Birth Weight OR LBW), ((kangaroo OR kangaroo OR kangaroo) AND (care OR nursing care OR management OR skin contact)) was made; these were all combined with a keywords search through the selection process. They were excluded in the final 25 studies (n=3051). A methodology checklist for randomized controlled trials (RCTs) designed by SIGN (Scottish Intercollegiate Guidelines Network) was utilized to assess the risk of bias. The overall risk of bias was regarded as low. In 16 studies that were evaluated as a grade of "++", 9 studies were evaluated as a grade of "+". As a result of meta-analysis, kangaroo care regarding the effects of premature mortality, severe infection/sepsis had an insignificant effect. Hyperthermia incidence, growth and development (height and weight), mother-infant attachment, hypothermia incidence, length of hospital days, breast feeding rate, sleeping, anxiety, confidence, and gratification of mothering role were considered significant. In satisfaction of the role performance, depression and stress presented contradictory research results for individual studies showing overall significant difference. This study has some limitations due to the few RCTs comparing kangaroo care in the country. Therefore, further RCTs comparing kangaroo care should be conducted.

Polymorphisms of tumor necrosis factor-alpha promotor gene in Kawasaki disease and relation to the risk of coronary artery lesion (가와사키병에서의 TNF-alpha 유전자의 다형성 및 관상동맥 합병증과의 연관성)

  • Kim, Se-hwa;Yun, Jang-won;Lee, Young-hyuk;Cheon, Eun-jung
    • Clinical and Experimental Pediatrics
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    • v.52 no.4
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    • pp.476-480
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    • 2009
  • Purpose : The purpose of this study was to investigate the polymorphisms of the TNF-alpha promotor gene, its susceptibility to Kawasaki disease (KD) and to assess whether the TNF-alpha promotor gene polymorphism was related the risk of coronary artery lesions (CALs). Methods : From January 2003 to January 2007, 51 children (30 boys and 21 girls) with KD and 48 children forming an age-matched control group were studied. DNA from the peripheral blood of all the children was sampled, and the DNA polymorphisms of the 5' flanking regions of the TNF-alpha promoter gene at position -308 [guanine (G) to adenine (A)] were determined by polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP). Then, the relationship between KD and the TNF-alpha promotor gene polymorphisms was evaluated. Results : The A allele frequency of the -308 site of the TNF-alpha promotor gene was 17.6% (9/51) for children with KD and 6.8% (3/48) for the control group children, but this result was not statistically significant. Twenty-four patients experienced CALs within 60 days after the onset of symptoms. KD children with TNF-alpha -308 A allele had lower frequencies of CALs (12.5% versus 22.2%, P>0.05). Conclusion : The DNA polymorphism of the -308 site TNF-alpha gene was not associated with susceptibility to KD and a risk of CALs. Multicenter, large-scale randomized controlled trials are needed for further study.

Criteria for diet pattern and meal management to improve cognitive function: A systematic review (체계적 문헌 고찰을 통한 인지기능 개선에 도움을 주는 식사 관리에 대한 연구)

  • Park, Young-Sook;Lee, Hyun-Jung;Choi, Kui-Jeong;Xu, Lin;Nam, Ye-Rim;Kim, Yoon-Ha;Kim, Min-Ji;Shin, Weon-Sun
    • Korean Journal of Food Science and Technology
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    • v.52 no.5
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    • pp.450-458
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    • 2020
  • The purpose of this study was to conduct a systematic review of the current published research related to improvement in cognitive function. A systematic search was performed in three bibliographic databases (PubMed, Cochrane Library, and EMBASE) using "dementia", "memory", "food", "diet", and "nutrition" as keywords. Meal management intervention, including Dietary Approaches to Stop Hypertension (DASH) diet, Mediterranean (Med) diet, Diet Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet, and other studies, was also included in the analysis. Through extensive screening, 21 articles, out of 2101 papers retrieved, were used for the final systematic review. The methodological quality of the randomized controlled clinical trials (RCTs) was assessed using the Cochrane Risk of Bias tool. These articles recommended vegetables, fruits, whole grains, olive oil, fish, berries, nuts, and beans. In conclusion, this study suggests the potential use of meal management to improve cognitive function.

Safety and Effectiveness of Long Acting Injectable Antipsychotic Paliperidone Palmitate Treatment in Schizophrenics : A 24-Week Open-Label Study (조현병 환자에서 장기지속형 항정신병 주사제 팔리페리돈 팔미테이트의 효능과 안전 : 24주 개방형 연구)

  • Kang, Hyun-Ku;Hahm, Woong;Shon, In-Ki;Paik, In-Ho
    • Korean Journal of Biological Psychiatry
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    • v.20 no.3
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    • pp.111-117
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    • 2013
  • Objectives We investigated the effectiveness and safety when treated in schizophrenics with paliperidone palmitate, a long acting injectable antipsychotic. Methods This was a 24-week open-label study, performed at one center in Korea. The eligible patients with schizophrenia diagnosed by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria were enrolled. Patients received long-acting paliperidone palmitate injection (234 mg, baseline; 156 mg, week 1 ; then once 4 weeks flexible dosing). Effectiveness assessments were measured by the Positive and Negative Syndrome Scale (PANSS), The Clinical Global Impression Severity Scale (CGI-S), The Personal and Social Performance (PSP) at baseline, week 1, every 4 weeks untill 24 weeks or endpoint. Safety assessments were measured by The Extrapyramidal Symptom Rating Scale (ESRS), body weight (BW) and incidence of adverse events. Oral antipsychotics were stopped or tapered off within next 14 days. Results Of 20 patients recruited, 9 patients (45%) completed the study. Paliperidone palmitate produced a significant improvement in PANSS total score from baseline to endpoint. The response rate was 75% [mean change (${\pm}SD$) $-25.9{\pm}14.4$, all p < 0.001]. The CGI-S and PSP total scores significantly improved during 24 weeks (All p < 0.001). Eighty percent of patients reported adverse events and most common adverse events (${\geq}10%$) in paliperidone palmitate were anticholinergic adverse event, extrapyramidal symptoms, weight gain, akathisia, insomnia, headache, agitation, anxiety and GI trouble. ESRS score is not statistically significant, but tends to get better at the end of the study when compared to baseline. Conclusions Our study results demonstrated maintained effectiveness and safety of paliperidone palmitate treatment in schizophrenics. And provides both clinicians and patients with a new choice of treatment that can improve the outcome of long term therapy. Their potential effectiveness and safety should be better addressed by future randomized-controlled trials.

Effects of Sweet Bee Venom Pharmacopuncture Combined with Korean Medicine Treatment for Acute Low Back Pain Syndrome Patient: A Case Report (급성 요통 증후군 환자에 대해 봉독약침요법을 병행한 한의학적 치료 효과: 증례보고)

  • Bong, Sung Min;Jang, Woo Seok;Kim, Kyung Ho
    • Korean Journal of Acupuncture
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    • v.37 no.1
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    • pp.54-62
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    • 2020
  • Objectives : Acute low back pain syndrome causes pain and poor quality of life. There are various studies of SBV (Sweet bee venom) pharmacopuncture, but few have identified the therapeutic effects for patients unable to walk due to acute back pain. This case series report three cases of acute low back pain syndrome treated with SBV pharmacopuncture combined with Korean Medicine (KM) treatments. Methods : Three acute low back pain syndrome patients with no other acute abnormalities in the imaging were treated by KM treatments including SBV pharmacopuncture, acupuncture, cupping, herbal medicine and physical therapy. The improvement of symptoms was evaluated using Numerical rating scale (NRS), Oswestry disability Index (ODI), EuroQol-5 dimension index (EQ-5D) and EuroQol-visual analogue scale (EQ-VAS). Results : Patients who were unable to walk due to acute back pain were able to walk. There were significant improvements of NRS, ODI, EQ-5D and EQ-VAS after treatment. The patients experienced an average 90% decrease in low back pain after inpatient KM treatment for about 8 days. NRS decreased by an average of 78.9%, ODI decreased by an average of 49.4%, and EQ-VAS increased by an average of 92.6%. In the case 1, EQ-5D decreased in all categories, but in the case 2, it decreased in all categories except for pain/discomfort and anxiety/depression, but in the case 3, it decreased in all categories except anxiety/depression. There was no serious side effect after treatment of SBV pharmacopuncture. Conclusions : KM treatments including SBV pharmacopuncture may be effective for acute low back pain syndrome patients. However, randomized controlled trials are needed in the future to confirm the clinical effects of these interventions.