• Title/Summary/Keyword: randomized clinical

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A Clinical Research Analysis of the Korean Medicine for Peroneal Nerve Palsy (비골신경마비에 대한 국내 한의치료 임상연구 동향 분석)

  • Hong, Su Min;Lee, Eun Jung
    • Journal of Korean Medicine Rehabilitation
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    • v.29 no.3
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    • pp.61-74
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    • 2019
  • Objectives This study aimed to review clinical studies about Korean medicine used in peroneal nerve palsy. Methods In 11 online databases (Earticle, Research Information Sharing Service, Oriental Medicine Advanced Searching Integrated System, KMbase, Korean Traditional Knowledge Portal, National Digital Science Library, MEDLINE/Pubmed, Ebscohost, Cochrane CENTRAL, EMBASE, China National Knowledge Infrastructure), we searched clinical studies about Korean medicine. Among the studies that we've searched, we excluded the studies that are not related to Korean medicine, case reports, randomized controlled trials and retrospective studies. As a result, 16 case studies and 1 randomized controlled trial are included. Results Total number of patients was 123. In these studies, acupuncture (100%), herbal medicine (58.8%), pharmacopuncture (58.8%), Korean physical therapy (58.8%), moxibustion (41.1%), cupping (41.1%) etc. were used. In acupuncture, GB34 and ST36 were most frequently used. Most of the herbal medicines used in these studies were different. Range of movement were most frequently used in outcome measure. Conclusions In this study, we reviewed studies about Korean medicine used in peroneal nerve palsy. It was difficult to clearly determine which intervention has improved the symptom. In the future, Further clinical studies will be needed to retain the evidence for the treatment of peroneal nerve palsy. And also more randomized controlled clinical trials to prove the efficacy of Korean medicine will be needed.

Localized probiotic-guided pocket recolonization in the treatment of chronic periodontitis: a randomized controlled clinical trial

  • Kumar, Vikram;Singhal, Rameshwari;Rastogi, Pavitra;Lal, Nand;Pandey, Shivani;Mahdi, Abbas Ali
    • Journal of Periodontal and Implant Science
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    • v.51 no.3
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    • pp.199-212
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    • 2021
  • Purpose: This randomized clinical placebo-controlled trial was conducted to evaluate the effectiveness of Lactobacillus reuteri as a probiotic in guided pocket recolonization (GPR) for the treatment of chronic periodontitis (CP) adjunctive to scaling and root planing (SRP). Methods: Forty-eight CP patients were randomly assigned to 3 treatment groups: group 1 (SRP+placebo), group 2 (SRP+single application of probiotic), and group 3 (SRP+incremental application of probiotic). Clinical parameters were evaluated at baseline and at 8, 12, and 24 weeks, whereas biochemical parameters were measured at baseline and 12 weeks. Results: At 24 weeks, the probing pocket depth and clinical attachment level improved in all 3 groups from baseline with no significant intergroup differences; however, a statistically significant difference was observed in localized plaque and gingival scores between groups 1 and 3 (P<0.05). At 12 weeks, matrix metalloproteinase-8 (MMP-8), nitric oxide (NO), and gingipains-R (Rgps) levels improved in all 3 groups, with statistically significant differences between groups 1 and 3 for MMP-8 and NO (P<0.05), but no difference for Rgps levels. Conclusions: Within its limitations, the results of this study show that incremental 3-time application of L. reuteri as a probiotic led to improvements in clinical and biochemical parameters. This protocol can be a useful adjunct to SRP in the non-surgical management of CP.

Analysis of Registration Information of Randomized Controlled Clinical Trials on Suicide Attempters Based on WHO-ICTRP (자살시도자에 대한 무작위대조군연구의 등록 현황 분석: WHO-ICTRP를 중심으로)

  • Min-Ryeong Park;Ji-Won Lee;In-Jun Hwang;Chan-Young Kwon
    • Journal of Oriental Neuropsychiatry
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    • v.34 no.3
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    • pp.213-234
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    • 2023
  • Objectives: To investigate current status of randomized controlled clinical trial (RCT) registration for suicide attempters. Methods: The World Health Organization International Clinical Trials Registry Platform (WHO-ICTRP) was used to search for data using 'suicide' as a search term. All registration information of RCTs registered up to April 2023 were collected. Results: Among a total of 68 RCTs registered, the United States ranked the highest in terms of quantity in this field (n=30, 46.15%), whereas Asia had only six (8.82%). A total of 62 (91.18%) RCTs involved individual interventions, while nine (13.24%) RCTs involved group interventions. Among individual interventions, 11 (16.18%) and 54 (79.41%) RCTs were on pharmacotherapy and psychotherapy, respectively. Within psychotherapy, there were a total of 17 (25%) studies utilizing digital media, with cognitive behavioral therapy (CBT) via phone being the most common approach. Among non-digital media-based studies, CBT was used the most frequently (n=11, 16.18%), followed by attempted suicide short intervention program (n=6, 8.82%). There were no studies using interventions from East Asian traditional medicine, including Korean medicine (KM). The most frequently used main outcome was the Beck scale for suicidal ideation. Conclusions: Studies on suicide attempts in Asia, especially in South Korea, are very scarce. Despite vigorous psychotherapeutic research in this field, KM psychotherapy has not been used. Thus, KM clinical trial for suicide attempters might be planned in the future based on our findings.

Neoadjuvant Chemotherapy for Resectable Esophageal Carcinoma: A Meta-analysis of Randomized Clinical Trials

  • Xu, Xiao-Hua;Peng, Xue-Hong;Yu, Ping;Xu, Xiao-Yuan;Cai, Er-Hui;Guo, Pi;Li, Ke
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.1
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    • pp.103-110
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    • 2012
  • Neoadjuvant chemotherapy for resectable esophageal carcinoma has been a focus of study, but no agreement has been reached on clinical randomized controlled trials and relevant systematic evaluation. The purpose of this study was to perform a meta-analysis on published randomized controlled trials (RCTs) that compared neoadjuvant chemotherapy and surgery with surgery alone for resectable esophageal carcinoma. Medline and manual searches was conducted in PubMed, ASCO (American Society of Clinical Oncology) meeting summary, Embase, the Cochrane Library (up to October 2010), Chinese Biomedical Literature Database, China National Knowledge Infrastructure, VIP Database, Wanfang Database. The selection contents were to identify all published and unpublished RCTs that compared neoadjuvant chemotherapy and surgery with surgery alone for resectable esophageal carcinoma. Sixteen RCTs which included 2,594 patients were selected. The risk ratio (RR) (95% confidence interval [CI]; P value), expressed as neoadjuvant chemotherapy and surgery versus surgery alone (treatment versus control), was 1.02 (0.95, 1.10; P=0.54) for 1-year survival, 1.29 (1.13, 1.47; P=0.0001) for 3-year survival, 1.31 (1.13, 1.51; P=0.0003) for 5-year survival, 1.00 (0.95, 1.04; P= 0.85) for rate of resection and 0.89 (0.64, 1.23; P=0.48) for operative mortality. The results showed that neoadjuvant chemotherapy for resectable esophageal carcinoma can raise the overall survival rate of patients with esophageal carcinoma, but it does not affect treatment-related mortality.

A randomized, double-blind, placebo-controlled pilot study to assess the effects of protopanaxadiol saponin-enriched ginseng extract and pectinase-processed ginseng extract on the prevention of acute respiratory illness in healthy people

  • Hwang, Jeong-Hwan;Park, Soo-Hyun;Choi, Eun-Kyung;Jung, Su-Jin;Pyo, Mi Kyung;Chae, Soo-Wan
    • Journal of Ginseng Research
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    • v.44 no.5
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    • pp.697-703
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    • 2020
  • Background: GS-3K8 and GINST, both of which are modified ginseng extracts, have never been examined in terms of their effectiveness for the prevention of acute respiratory illness (ARI) in humans. We conducted a pilot study to assess the feasibility of performing a large-scale, randomized, controlled trial. Methods: This study was a randomized, double-blind, placebo-controlled, pilot study at a single center from October 2014 to March 2015. The 45 healthy applicants were randomly divided into the GS-3K8 (n = 15), GINST (n = 15), and placebo groups (n = 15). The study drug was administered as a capsule (500 mg/cap and 3000 mg/day). GS-3K8 contained 6.31 mg/g of Rg1, 15.05 mg/g of Re, 30.84 mg/g of Rb1, 15.02 mg/g of Rc, 12.44 mg/g of Rb2, 6.97 mg/g of Rd, 1.59 mg/g of Rg3, 3.25 mg/g of Rk1, and 4.84 mg/g of Rg5. GINST contained 7.54 mg/g of Rg1, 1.87 mg/g of Re, 5.42 mg/g of Rb1, 0.29 mg/g of Rc, 0.36 mg/g of Rb2, 0.70 mg/g of Rd, and 6.3 mg/g of compound K. The feasibility criteria were the rates of recruitment, drug compliance, and successful follow-up. The primary clinical outcome measure was the incidence of ARI. The secondary clinical outcome measures were the duration of symptoms. Results: The rate of recruitment was 11.3 participants per week. The overall rate of completed follow-up was 97.8%. The mean compliance rate was 91.64 ± 9.80%, 95.28 ± 5.75%, and 89.70 ± 8.99% in the GS-3K8, GINST, and placebo groups, respectively. The incidence of ARI was 64.3% (9/14; 95% confidence interval [CI], 31.4-91.1%), 26.7% (4/15; 95% CI, 4.3-49.0%), and 80.0% (12/15; 95% CI, 54.8-93.0%) in the GS-3K8, GINST, and placebo groups, respectively. The average days of symptoms were 3.89 ± 4.65, 9.25 ± 7.63, and 12.25 ± 12.69 in the GS-3K8, GINST, and placebo groups, respectively. Conclusion: The results support the feasibility of a full-scale trial. GS-3K8 and GINST appear to have a positive tendency toward preventing the development of ARI and reducing the symptom duration. A randomized controlled trial is needed to confirm these findings.

Review of Clinical Researches about Korean Medicine Treatment on Language Disorder of Cerebral Palsy (뇌성마비 언어장애에 대한 한의 치료 연구 동향)

  • Kim, Lakhyung;Yu, Gyung
    • The Journal of Pediatrics of Korean Medicine
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    • v.26 no.4
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    • pp.32-37
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    • 2012
  • Objectives: The purpose of this study was to obtain some understanding about Korean medicine treatment on language disorder in cerebral palsy for future practice and the research, from the clinical studies. Methods: The literature was searched using the database-China Academic Journals (CAJ). Clinical studies of Korean medicine treatment for language disorder in cerebral palsy, including Randomized controlled trial (RCT), case control study, case series, case report were analyzed. Results: Fifteen Clinical studies met our inclusion criteria; One case study and six case series, one non-randomized controlled trial and seven RCTs. Acupuncture treatment, especially Head acupuncture, was the major treatment for language disorder of cerebral palsy in clinical studies, as it was used in fourteen studies. Acupoint massage, tuina, and acupoint injection were employed as treatment methods in the studies. Acupuncture treatment was used for language disorder of cerebral palsy combined with language therapy and other rehabilitation treatment in many studies. The effectiveness in the treatment groups, regardless of treatment methods, was higher than that of control group in all RCT studies. Conclusions: The results of this study could be used in the practice and the future study about language disorder of cerebral palsy.

Clinical Usefulness of Gastric Residual Volume as An Indicator to Provide Approximately Enteral Nutrition for Patients in Intensive Care Units: A Systematic Literature Review (중환자의 경관영양 공급 지표로서 위 잔여량의 임상적 효용성: 체계적 문헌고찰)

  • Kim, Hyunjung;Chang, Sun Ju
    • Journal of Korean Biological Nursing Science
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    • v.16 no.4
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    • pp.267-275
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    • 2014
  • Purpose: The practice of enteral nutrition with gastric residual volumes (GRVs) as a clinical indicator is poorly standardized in intensive care units. This study aims to summarize the results from studies that evaluated the clinical outcomes related to the GRVs. Methods: This systematic review study analyzed 11 studies consisting of four randomized controlled trials, one non-randomized controlled trial, and six observational studies. Results: No consistent relationship between GRV thresholds and clinical outcomes was observed. Higher GRVs were not consistently correlated with clinical outcomes such as higher gastrointestinal complications, aspiration pneumonia, or mortality. Higher GRVs significantly generate complications more often. Findings show that a single GRV more than 200 mL or two consecutive GRVs more than 150 mL should raise concern about negative consequences. Conclusion: Critical care nurses need to monitor GRVs closely during their practice of enteral nutrition. For critically ill patients receiving enteral nutrition, a GRV threshold of 200 ml would be a desirable limit to provide safe and adequate nutrition with a conservative approach.

Recent Clinical Research on Effect of Acupuncture for Autism Spectrum Disorder (자폐스펙트럼장애의 침치료에 대한 최근 임상 연구 동향 - RCT 중심으로 -)

  • Lee, Ji Na;Lee, Sun Haeng;Lee, Jin Yong
    • The Journal of Pediatrics of Korean Medicine
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    • v.29 no.4
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    • pp.119-126
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    • 2015
  • Objectives The purpose of this study is to investigate recent clinical studies on effect of acupuncture for Autism Spectrum Disorder in other countries. We have analyzed the studies on effect of acupuncture for Autism Spectrum Disorder within randomized controlled trail (RCT) for 6years (from 2010 to 2015). Methods The search database includes Medline, Embase, Cochrane library and CNKI (China National Knowledge Infrastructure). To narrow the search, the following key search terms were used: 'autism or ASD or Asperger's Syndrome or pervasive developmental disorder, acupuncture'. The search was limited to the publication date from 2010 to 2015. 7 control studies in Medlin, Embase, Cochrane library and 5 control studies in CNKI were selected for analysis. Results and Conclusions 1. The acupuncture and rehabiliation treatment is more effective than only acupuncture treatment. Especially, Retention of needling is helpful. 2. It is necessary to set up standard scale in assessment of ASD patients and serum arginine-vasopressin (AVP) can be substitution. 3. Head acupuncture and tongue acupuncture is effective for ASD.

Randomized Clinical Controlled Trials of a Herb Remedies in Korea - Systematic Review (한약을 이용한 한국에서의 무작위 임상시험 개괄적 검토)

  • Oh, Rai-Young;Seol, In-Chan;Son, Chang-Gue
    • The Journal of Korean Medicine
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    • v.31 no.4
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    • pp.1-8
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    • 2010
  • Objective: The study aimed to review all randomized controlled clinical trials (RCTs) performed in Korea with herbal medicine, to produce further useful information for herbal-drug development. Methods: All papers reporting RCT with herbal drugs were collected via public database of Korea Science and Technology Integration Services, and various Oriental medicine journals. Then, the clinical question, herbal medicine, result, RCT design, and its conductor were analyzed. Results: A total of 20 RCTs were finally selected, and most of them were performed after 2003. The main subjects of RCT were related to heart and blood circulation, dermatitis, respiration disorder, Sasang constitution, or psychiatric disorders. Eight RCTs were done with a single herb while 12 RCTs were with multiple herbal formulae. In particular, three RCTs for atopic dermatitis with three formulae showed positive results. The quality of RCT was considered as better than average. Conclusions: This study revealed the current status of RCT using herbal drugs. This result would provide helpful information for research and drug development using traditional herbal medicine.

The Trends in Clinical Trials about Effects of Acupuncture on Anxiety, Depression and Mental Stress - In Medline, Pubmedcentral & Oriental Medicine Journal since 2004 - (침치료가 불안, 우울 및 정신적 스트레스에 미치는 효과에 대한 임상시험 연구 경향 - 2004년 이후의 Medline, Pubmedcentral 논문 검색과 국내 한의학 학술지 중심으로 -)

  • Kang, Hee-Chul;Lee, Seung-Gi
    • Journal of Oriental Neuropsychiatry
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    • v.20 no.4
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    • pp.137-148
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    • 2009
  • Objectives : The purpose of this study is to review the recent trends in the clinical trial studies that have been published since 2004. Methods : We reviewed the Medline & Pubmedcentral databases by using searching word of "acupuncture". Then 20 articles were selected within total 803 articles. In oriental medicine journals in Korea, we investigated 6 journals represented Korean Oriental medicine and chose 13 articles. Results & Conclusions : 1. We found 33 articles in journals. 2. The patterns of study were as follows: Randomized Controlled Trials(18), Single case series clinical study(9), Case-Control clinical study(4), Randomized crossover Trial(1) and Prospective Clinical analysis(1). 3. The fields of study were as follows: Combined anxiety, depression & other psychiatic symptoms(18), Stress & heart rate variablity(5), The single study of anxiety(5), The single study of depression(3), Stress & pupil variablity(1), Stress and heart rate & pupil variablity(1). 4. The methods of acupuncture were as follows: Acupuncture on points of 14 meridians(24), Auricular acupuncture(3), Electro acupuncture(2) and Both Auricular & Electro acupuncture(1). 5. Stomach meridian(足陽明胃經) and ST36(足三里) were used mostly.

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