• Title/Summary/Keyword: Trials

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Analysis on Recent Studies Trends of Humulus japonicus - Focusing on Research of Medical Sciences - (한삼덩굴에 대한 최근 국내외 연구 동향 분석 - 의약학 연구를 중심으로 -)

  • Jang Subi;Cheon Jin Hong;Kim Kibong
    • The Journal of Pediatrics of Korean Medicine
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    • v.38 no.3
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    • pp.97-112
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    • 2024
  • Objective The purpose of this study was to provide information on the international trends in Humulus japonicus by analyzing recently reported papers and theses. Methods Papers on the medicinal in vivo and in vitro activities of Humulus japonicus were reviewed and analyzed. Data on the publication year, research and experimental methods, and subjects were extracted and summarized. Results Twenty-eight papers with recent experimental studies and clinical trials related to Humulus japonicus were included. The following results were obtained from this study. 1. An average of 2.8 papers were published annually from 2014 to 2023. 2. There were 27 experimental studies and one clinical trials during the study period. 3. Among the studies, there were 13 in vivo, seven in vitro, and seven with both types of experiments. 4. Based on the subject area, studies on neuropsychiatric activity were the most numerous, totaling six reports. Conclusions Humulus japonicus has been studied for various activities, including neuropsychiatric, anti-inflammatory, liver function-related, digestive system-related, antibacterial, anti-obesity, anti-aging, and antioxidant effects. However, more clinical research is needed to further explore its medicinal uses.

A Review of Randomized Controlled Clinical Trials on the Effects of PC6 Stimulation on Blood Pressure - Focusing on Domestic Studies and PubMed (내관혈(PC6) 자극이 혈압에 미치는 영향에 관한 무작위 대조 임상시험 연구 검토 - 국내 연구 및 PubMed를 중심으로)

  • Chae-eun Kim;Kyung-min Baek
    • The Journal of Internal Korean Medicine
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    • v.45 no.4
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    • pp.744-759
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    • 2024
  • Objectives: This study reviewed randomized controlled trials (RCTs) investigating the effects of Neiguan (PC6) stimulation on blood pressure and suggests a better research process. Methods: We searched for RCTs for effects of Neiguan (PC6) stimulations on blood pressure published until July 2024 using six databases (PubMed, Oriental Medicine Advanced Searching Integrated System (OASIS), Korea Citation Index (KCI), Research Information Service System (RISS), Korean Studies Information Service System (KISS), and Science ON). In total, eight RCTs that met all the inclusion criteria were selected. Results: All the selected studies showed significant effects of Neiguan (PC6) stimulation on blood pressure. In most studies, Neiguan (PC6) stimulation was effective in stabilizing blood pressure and improving various indicators related to blood pressure. Conclusion: Neiguan (PC6) stimulation is an effective treatment for stabilizing blood pressure. However, the selected RCTs were short-term studies and had small number of subjects; so, long-term and large-scale studies are needed.

The Review on the Prostate Disease-related Studies with Acupuncture Therapy in PubMed (PubMed 검색(檢索)을 이용한 전립선(前立腺) 질환(疾患)의 침치료(鍼治療)관련 연구(硏究)에 대한 고찰(考察))

  • Song, Ho-Sueb
    • Journal of Pharmacopuncture
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    • v.7 no.2
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    • pp.65-73
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    • 2004
  • Objective : This study was to review on the prostate disease-related studies with Acupuncture therapy in renowned medical internet site of PubMed, and to make master plan of the study, especially, on Bee Venom Acupuncture(BVA) of Prostate disease and then to devise the idealistic therapeutic ways of it. Method : We made the internet search with the key words of bee venom(bee venom therapy, apitoxin, apitherapy, bee sting, bee sting therapy), acupuncture, prostate, prostatitis, prostrate cancer in Pubmed, from June 1st to July 1st,2004. Results : 1.25 papers were found in 19 publised jounals. of which two named'Urology'and Prostate' had three papars, two called 'JUrology' and 'Cancer Immunol Immunother' had two papers, and the others had a paper respectively. 2. In the classification by papers' types, Review papers were 8 and Original were 17 where there were 5 clinical trials, 11 experimental studies and 1 epidemiologic paper. Of 5 clinical trials, 2 belonged to Randomized Control Study, and of 11 experimental studies, 4 belonged to in vitro and 7 belonged to in vivo with in viro studies, and 1 epidemeologic belonged to meta-analysis. 3. In the classification by prostate diseases, 4 were about prostatitis, 3 were about prostate related symptoms, 16 were about prostate cancer, and two were about the others. 4. In the classification by applied treatment methods, 5 were related with Acupuncture, 10 were related with BVA(Bee Venom, Bee), and 10 were related with the others. Of 5 related with Acupuncture, 3 used general acupuncture, 1 used electrical acupuncture, and 1 used general acupuncture and electrical acupuncture at the same time. 5. In 2 RCTs of Clinical trials, Control group was set up to the group using different compatible treatment method or using meridians not related with treating prostate disease. Single or double blind methods couldn't be found. 6. In the clinical trials, IPSS, NIH, CPSI or subjective global assessment were used as the Index of Evaluation. 7. The Leg Greater Yang Bladder Meridian(B), The Leg Lesser Um Kidney Meridian(K) and Conception Vessel Meridian(CV) were used as major meridians, and B10(Taejo, Dazhu), B23(Shinsu, Shenshu), B28(Panggwangsu, Pangguangshu), B35(Hoeyang, Huiyang), B39(Wiyang, Weiyang), B40(Wijung, Weizhong), B54(chilbyon, Zhibian), K1(Yongchon, Yongquan), K10(Umgok, Yingu), CV3(Chungguk, Zhongji), CV4(Kwanwon, Guanyuan),S6(Hyopko, Jiache) were used as acupoints. Electrical acupuncture(EA) was considered to be more important and CV3(Chungguk, Zhongji), CV4(Kwanwon, Guanyuan) were mainly selected as EA applied acupoints. 8. It is mostly said that Acupuncture appeared to be a safe, effective, and durable treatment alternative in improving symptoms of patients with prostate diseases, refractory to conventional medicine. A larger controlled study was required to confirm these encouraging initial results. Conclusion : Papers about BVA of Prostate cancer or Prostatitis were not found, and low permeability of Prostate is concerned, BVA with the anti-inflammatory and anti-cancer effect can be adopted as a new alternatives of Prostate disease treatment, so it is thought that Study of how to make access to prostate, animal experiment including in vivo and in vitro and more clinical trials with using acupoints on related meridian should be followed.

Recent Topics of Clinical Trials in Obesity and Metabolic Study (비만과 대사증후군에 관한 임상시험의 최근 경향)

  • Lee, Ju-Ah;Kong, Kyung-Hwan;Ko, Ho-Yeon;Bae, Kwang-Ho;Park, Sun-Young;Park, Kyung-Moo;Song, Yun-Kyung;Park, Jung-Hyeon;Kim, Ho-Jun;Park, Sun-Jun;Park, Jeong-Su;Ko, Seong-Gyu
    • Journal of Korean Medicine for Obesity Research
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    • v.9 no.1
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    • pp.15-22
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    • 2009
  • Objectives The aim of this study is to review and analyze the status on the recent clinical trials of 'obesity' and 'metabolic syndrome'. Methods We search 'www.clinicaltrail.gov' for research trend of Obesity and metabolic syndrome. Search terms used were 'obesity' and 'metabolic syndrome'. In order to see detail review, searching was performed from 01, 01, 2007 to 05, 31, 2009 with intervention, phase III or phase IV, And we classified all the searched studies into design, intervention, purpose, end point, diseases and condition Results We could search total 232 trials. Of them, we found 32 trials with intervention, phase III or phase IV from 01, 01, 2007 to 05, 31, 2009 Also we could see various design of clinical trials. Conclusion To improve obesity and metabolic study in Traditional Korean Medicine, it is need to activate clinical trial, meta analysis, develope of clinical practice guidelines, co-works with conventional medicine and etc.

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Meta-analysis of Seven Randomized Control Trials to Assess the Efficacy and Toxicity of Combining EGFR-TKI with Chemotherapy for Patients with Advanced NSCLC who Failed First-Line Treatment

  • Xiao, Bing-Kun;Yang, Jian-Yun;Dong, Jun-Xing;Ji, Zhao-Shuai;Si, Hai-Yan;Wang, Wei-Lan;Huang, Rong-Qing
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.7
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    • pp.2915-2921
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    • 2015
  • Background: Some recent clinical trials have been conducted to evaluate a combination of EGFR- TKI with chemotherapy for advanced NSCLC patients as second-line therapy, but the results on the efficacy of such trials are inconsistent. The aim of this meta-analysis was to evaluate the efficacy and safety of combination of EGFR-TKI and chemotherapy for patients with advanced NSCLC who failed first-line treatment. Materials and Methods: We searched relative trials from PubMed, EMBASE, ASCO Abstracts, ESMO Abstracts, Cochrane Library and Clinical Trials.gov. Outcomes analyzed were overall response rate (ORR), progression- free survival (PFS), overall survival (OS) and major toxicity. Results: Seven trails eventually were included in this meta-analysis, covering 1,168 patients. The results showed that the combined regimen arm had a significant higher ORR (RR 1.76 [1.16, 2.66], p=0.007) and longer PFS (HR 0.75 [0.66-0.85], p<0.00001), but failed to show effects on OS (HR 0.88 [0.68-1.15], p=0.36). In terms of subgroup results, continuation of EGFR-TKI in addition to chemotherapy after first-line EGFR-TKI resistance confered no improvement in ORR (RR 0.95 [0.68, 1.33], p=0.75) and PFS (HR 0.89[0.69, 1.15], p=0.38), and OS was even shorter (HR1.52 [1.05-2.21], p=0.03). However, combination therapy with EGFR-TKI and chemotherapy after failure of first-line chemotherapy significantly improved the ORR (RR 2.06 [1.42, 2.99], p=0.0002), PFS (HR 0.71 [0.61, 0.82], p<0.00001) and OS (HR 0.74 [0.62-0.88], p=0.0008), clinical benefit being restricted to combining EGFR-TKI with pemetrexed, but not docetaxel. Grade 3-4 toxicity was found at significantly higher incidence in the combined regimen arm. Conclusions: Continuation of EGFR-TKI in addition to chemotherapy after first-line EGFR-TKI resistance should be avoided. Combination therapy of EGFR-TKI and pemetrexed for advanced NSCLC should be further investigated for prognostic and predictive factors to find the group with the highest benefit of the combination strategy.

Report of the 3rd Japan-Korea Workshop on Acupuncture and EBM;Protocol development for the acupuncture trial on the osteoarthritis of the knee

  • Jang, Jun-Hyouk;Kenji, Kawakita;Hahn, Seo-Kyung;Park, Hi-Joon;Lee, Seung-Deok;Kim, Yong-Suk;Norihito, Takahashi;Toshiyuki, Shichidou;Kazunori, Itoh;Eiji, Sumiya;Eiji, Furuya;Hitoshi, Yamashita;Hiroshi, Tsukayama
    • Journal of Acupuncture Research
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    • v.23 no.6
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    • pp.239-254
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    • 2006
  • The 3rd Japan-Korea Workshop on Acupuncture and EBM was held at Kanazawa on June $16^{th}$. From Korea team, 4 papers were presented. Dr. Hahn introduced a new approach of data analysis on series of n-of-1 trials using the Bayesian statistics. It offered important information for the future n-of-1 trials. Dr. Park clearly demonstrated the significance of various sham devices proposed and stressed the importance of research questions when we choose the control intervention in RCT. Dr. Lee reported the results of survey in Korean Medical Doctors (KMD) for their point selection and techniques to the distal and local points. Dr. Kim presented the results of face to face survey on the KMD with 28 items for acupuncture treatment on the knee OA. Finally, a draft of protocol was introduced by Dr. Kim. The title was "multi-center, a randomized, single blinded, two arms, parallel-group study to compare the effectiveness and safety of 'individualized acupuncture' and 'standardized minimal acupuncture' in Korean and Japanese patients with knee osteoarthritis (Phase IV)". From Japan team, 7 speakers presented their comments and proposals on the protocol. Dr. Takahashi introduced several issues regarding n-of-1 trials and pointed out the importance of obtaining generalizability from n-of-1 trials. Dr. Shichidou pointed the importance of research design, selection of outcome measures and reduction of biases. Dr. Itoh presented the results of point selection for the knee OA based on the literature survey. Dr. Sumiya introduced several differences between KMD and Japanese acupuncturists based on the questionnaire used in KMD survey. Dr. Furuya demonstrated a result of press tack needle and its sham device on shoulder stiffness. Dr. Yamashita introduced the results of literature survey regarding adverse events occurred by acupuncture on knee OA. Dr.Tsukayama stressed the importance of responsibility of Institutional Review Board (IRB) for the conduction of clinical trials. After several issues were discussed, the need of continued meeting for final protocol development was agreed, then the workshop was closed.

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Quality Assurance of Gastric Cancer Surgery (위암 수술의 질 관리)

  • Lee Hyuk-Joon;Yang Han-Kwang
    • Journal of Gastric Cancer
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    • v.5 no.2
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    • pp.79-88
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    • 2005
  • Quality assurance may be defined as the complete set of systemic actions that is required to achieve a better treatment result by standardizing treatment and by using various audit programs. In general, application of a quality assurance program in surgery is considered to be more difficult than it is in chemotherapy or radiotherapy. However, recently, the importance of quality assurance in the surgical field has been emphasized in clinical trials comparing different surgical procedures and evaluating the role of postoperative adjuvant therapy. In the case of gastric cancer surgery, excellent quality assurance programs have rarely been applied in most large prospective clinical trials. Although the quality assurance in Dutch trial was conducted very systemically and strictly, the situation is quite different from ours. On the other hand, several quality assurance programs in Japanese trials comparing D2 and D2 plus para-arotic lymph node dissection seem to be applicable to Korean clinical trials. Several factors, including selection of appropriate surgeons based on personal experience and annual number of operations, standardization of surgical procedures by education and consensus, development of a unified database program, application of standardized perioperative management, and standardization of pathologic examination, are required to guarantee a successful multi-institutional prospective clinical trial. In contrast, one needs to realize that protocols that are too strict and sophisticated can make the enrollment of patients and surgeons more difficult and can promote protocol violation during the clinical trials. (J Korean Gastric Cancer Assoc 2005;5:79-88)

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The effect of walnut (Juglans regia L.) intake on improvement of blood lipid levels and vascular health: A meta-analysis (호두의 혈중 지질 수준 및 혈관 건강 개선 기능성 평가: 메타분석)

  • Kwak, Jin Sook;Park, Min Young;Kwon, Oran
    • Journal of Nutrition and Health
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    • v.47 no.4
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    • pp.236-246
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    • 2014
  • Purpose: Walnut is known to have unique favorable fatty acids, phytochemicals, and other nutrient profiles. As a result, there has been growing interest in evaluation of its health benefit related to cardiovascular disease (CVD). Although inverse associations of nut consumption and risk factors of cardiovascular disease have been reported in many epidemiological studies and qualitative reviews, few meta-analysis studies have been reported. This meta-analysis was conducted in order to evaluate the effect of a walnut-enhanced diet on CVD risk factors. Methods: We searched Pubmed, Cochrane, Science Direct, and KISS (Korean studies Information Service System) through July 2014. A random-effects meta-analysis was conducted on 17 trials reporting total cholesterol (TC), 14 trials reporting LDL cholesterol (LDL-C), 15 trials reporting HDL cholesterol (HDL-C), 17 trials reporting triglyceride (TG), and four trials reporting flow-mediated dilation (FMD). Results: In meta-analysis, intake of a walnut-enhanced diet resulted in significantly lowered TC, LDL-C, and TG by -0.124 mmol/l (95% CI, -0.209, -0.039; p = 0.004), -0.085 mmol/lL (95% CI, -0.167, -0.004; p = l0.039), and -0.080 mmol/l (95% CI, -0.155, -0.004; p = 0.039), respectively. The overall pooled estimate of the effect on FMD was +1.313% (95% CI, 0.744, 1.882, p = 0.000). HDL-C was not affected by walnut intake. No statistical heterogeneity was observed for any analysis. Results of funnel plots and Egger's regression suggested a low likelihood of publication bias in all biomarkers (p > 0.05). Conclusion: Findings of this meta-analysis provide consistent evidence that walnut-enhanced diet intake reduces the CVD risk factors.

Efficacy and Safety of Sorafenib for Advanced Non-Small Cell Lung Cancer: a Meta-analysis of Randomized Controlled Trials

  • Wang, Wei-Lan;Tang, Zhi-Hui;Xie, Ting-Ting;Xiao, Bing-Kun;Zhang, Xin-Yu;Guo, Dai-Hong;Wang, Dong-Xiao;Pei, Fei;Si, Hai-Yan;Zhu, Man
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.14
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    • pp.5691-5696
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    • 2014
  • Background: Many clinical trials have been conducted to evaluate sorafenib for the treatment of advanced NSCLC, but the results for efficacy have been inconsistent. The aim of this study was to evaluate the efficacy and safety of sorafenib in patients with advanced NSCLC in more detail by meta-analysis. Methods: This meta-analysis of randomized controlled trials (RCTs) was performed after searching PubMed, EMBASE, ASCO Abstracts, ESMO Abstracts, and the proceedings of major conferences for relevant clinical trials. Two reviewers independently assessed the quality of the trials. Outcomes analysis were disease control rate (DCR), progression- free survival (PFS), overall survival (OS) with 95% confidence intervals (CI) and major toxicity. Subgroup analysis was conducted according to sorafenib monotherapy, in combination with chemotherapy or EGFR-TKI to investigate the preferred therapy strategy. Results: Results reported from 6 RCTs involving 2, 748 patients were included in the analysis. Compared to sorafenib-free group, SBT was not associated with higher DCR (RR 1.31 (0.96- 1.79), p=0.09), PFS (HR 0.82 (0.66-1.02), p=0.07) and OS (HR 1.01 (0.92-1.12), p=0.77). In terms of subgroup results, sorafenib monotherapy was associated with significant superior DCR and longer PFS, but failed to show advantage with regard to OS. Grade 3 or greater sorafenib-related adverse events included fatigue, hypertension, diarrhea, oral mucositis, rash and HFSR. Conclusions: SBT was revealed to yield no improvement in DCR, PFS and OS. However, sorafenib as monotherapy showed some activity in NSCLC. Further evaluation may be considered in subsets of patients who may benefit from this treatment. Sorafenib combined inhibition therapy should be limited unless the choice of platinum-doublet regimen, administration sequence or identification of predictive biomarkers are considered to receive better anti-tumor activity and prevention of resistance mechanisms.

Number of Trials for the Reliable Golf Swing Ground Reaction Force Data Collection and Its Characteristics (골프 드라이버스윙 시 지면반력 반복측정 횟수와 지면반력 특성)

  • Park, Young-Hoon;Youm, Chang-Hong;Seo, Kuk-Woong;Seo, Kook-Eun
    • Korean Journal of Applied Biomechanics
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    • v.17 no.4
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    • pp.115-125
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    • 2007
  • Grould Reaction force(GRF) is important in human movements and GRF measurements are one of the most frequently used tool in biomechanical studies. In the studies of the golf swing motion, people refer to GRF as weight transfer. A successful golf swing motion requires many segments activation sequences which are controled by the nerve system. Due to the inter- and intra-individual variability of the human movement and the movement strategies, reliability of the measurements are important in human movement studies. Previous golf researches were based on group studies and certain events' values were analyzed. The purposes of this study were to determine the number of trials for the reliable golf swing GRF data collection, to reveal the variability level of the meaningful components of the golf swing GRF, and to classify the types of the golf swing GRF patterns. Twenty three male professional golfers($26.4{\pm}6.6$ years, $174.3{\pm}5.2\;cm$, $71.3{\pm}6.5\;kg$) signed an informed consent form prior to participation in this study. GRFs of driver swings were collected with Kistler 9285 force platform and 9865A amplifier, and calculated by the KwonGRF program(Visol, Korea). Sampling frequency was 1080 Hz. GRF data were trimmed from 1.5 s prior to the impact to 0.5 s after the impact. The number of trials for the reliable GRF collection was determined when the change in floating mean overs the 25 % of the standard deviation of that variable. Variabilities of the variables were determined by the coefficient of variation(CV) of 10 %. The types of GRF patterns were determined by visual inspection of the peak GRF shapes. The minimum number of trials for the reliable golf swing GRF data collection was five. Ten-trial seems more conservative. The value of the peak GRF was more reliable than the value of the impact GRF. The CV of the peak GRF and impact GRF were 7.4 %, 15.2 %, respectively. Because of the +/- sigh of the peak GRF appearance time, it was impossible to calculate CV of the peak GRF appearance time. Golf swing GRF patterns were classified as sing peak type, double peak type, and plateau peak type. This classification suggests the presence of the different golf swing weight transfer strategies.