• Title/Summary/Keyword: Randomized Clinical Trial

Search Result 915, Processing Time 0.039 seconds

The Effects of Cervi Pantotrichum Cornu Pharmacopuncture and Bovis calculus.Fel Ursi Pharmacopuncture on the Heart Rate Variability (녹용약침과 웅담.우황(BU)약침이 정상인의 심박변이도(HRV)에 미치는 영향)

  • Lee, Hwi-Yong;Lee, Jin-Bok;Cho, Yi-Hyun;Song, Beom-Yong;Yook, Tae-Han
    • Journal of Acupuncture Research
    • /
    • v.27 no.1
    • /
    • pp.65-74
    • /
    • 2010
  • Objectives : This study was to investigate the effects of Cervi Pantotrichum Cornu Pharmacopuncture and Bovis calculus Fel Ursi Pharmacopuncture on autonomic nervous system with Heart Rate Variability(HRV). Purpose of the trial was to observe what influence Cervi Pantotrichum Cornu Pharmacopuncture and Bovis calculus Fel Ursi pharmacopuncture have on the autonomic nervous system. Methods : 40 healthy male volunteers were divided into two experimental groups, such as Cervi Pantotrichum Cornu Pharmacopuncture group and Bovis calculus Fel Ursi Pharmacopuncture group. Study design was a randomized, double-blind clinical trial. 20 subjects in one experimental group were injected Cervi Pantotrichum Cornu Pharmacopuncture, 20 subjects in other experimental group were injected hydrolyzed Bovis calculus Fel Ursi Pharmacopuncture at GB21(Kyonjong). We measured HRV 7 times : baseline measurement and every 5 minutes for 30 minutes after injection. The SPSS 15.0 for Windows was used to analyze the data by the paired t-test(in group) and independent sample t-test(between the groups). Results A. Time Domain Analysis 1. Analysis of Mean HRV, SDNN and Complexity After injection of Cervi Pantotrichum Cornu Pharmacopuncture, Mean HRV was significantly decreased all the times after injection. SDNN was significantly increased at immediate and 25 minute after injection. Complexity was significantly decreased only at 15 minute after injection. After injection of Bovis calculus Fel Ursi Pharmacopuncture, Mean HRV was significantly decreased all the times after injection. Complexity was significantly decreased at 15 minutes after injection. 2. Analysis of HRV index, pNN50 After injection of Cervi Pantotrichum Cornu Pharmacopuncture, HRV index was significantly increased immediately after injection. pNN50 was significantly decreased at immediately, 20 and 25 minutes after injection. After injection of Bovis calculus Fel Ursi Pharmacopuncture, HRV index was significantly increased immediately after injection. pNN50 was significantly decreased at immediate and 25 minutes after injection. B. Frequency Domain Analysis 1. Analysis of Ln(TP), Ln(HF), Ln(LF), Ln(VLF) After injection of Cervi Pantotrichum Cornu Pharmacopuncture, Ln(TP) was significantly increased at immediate and 25 after injection. Ln(HF) was significantly increased all the times after injection. Ln(LF) was significantly increased at 15, 20 and 25 minutes after injection. Ln(VLF) was significantly increased at immediate and 25 minutes after injection. After injection of Bovis calculus Fel Ursi Pharmacopuncture, Ln(TP) was significantly increased at immediately and 25 after injection. Ln(LF) was significantly increased at 20 and 25 minutes after injection. Ln(VLF) was significantly increased at immediate and 25 minutes after injection. Conclusions : We results suggest that Cervi Pantotrichum Cornu Pharmacopuncture and Bovis calculus Fel Ursi Pharmacopuncture in healthy adult men tend to activate the autonomic nervous system and sympathetic nervous system within normal range.

Effects of Transcranial Direct-Current Stimulation Therapy on Primary Chronic Insomnia: A Proof-of Concept Clinical Trial (일차성 만성불면증 환자에서 경두개 직류전기자극법 치료 효과: 개념 증명 연구)

  • Jun, Jin-Sun;Kim, Tae-Joon;Koo, Sun A;Park, Ji-Sook;Kim, Keun Tae;Yang, Tae-Won;Lim, Jung-Ah;Byun, Jung-Ick;Sunwoo, Jun-Sang;Jung, Ki-Young
    • Journal of Sleep Medicine
    • /
    • v.15 no.2
    • /
    • pp.37-42
    • /
    • 2018
  • Objectives: To assess the effect and safety of transcranial direct-current stimulation (tDCS) in primary chronic insomnia. Methods: A one-month, double-blind, randomized, sham-controlled trial was performed. A total of 7 patients with primary chronic insomnia received tDCS using anodal (n=3), cathodal (n=2), or sham stimulation (n=2). They were followed up at 1 week and 1 month after treatment. The primary outcome measures included improvement in total sleep time (TST), sleep latency (SL), and sleep efficiency (SE) at 1 month follow-up. Results: TST and SE were improved with tDCS at 1 month follow-up in all patients (100%) of the anodal group, one (50%) of the cathodal group, and one (50%) of the sham group. tDCS improved SL at 1 month follow-up in two patients (67%) of the anodal group, one (50%) of the cathodal group, and none (0%) of the sham group. With respect to adverse events, transient itching sensation occurred in one patient of the anodal group. None of the other groups reported adverse events. Conclusions: Our results suggest that tDCS may be effective and safe for treatment of primary chronic insomnia. A larger controlled study needs to be further investigated.

Cognitive Function Effects of Acupuncture Treatment for Mild Cognitive Impairment : Systematic Literature Review and Meta-Analysis (경도인지장애 침치료 인지기능효과 : 체계적 문헌고찰 메타분석)

  • Won Soon Kim
    • Journal of Society of Preventive Korean Medicine
    • /
    • v.28 no.2
    • /
    • pp.151-164
    • /
    • 2024
  • Objectives : Using MMSE and MoCA cognitive tools, this study tried to measure the effect of acupuncture differing by cognitive types. Through the method of PRISMA literature review, this study aimed to understand and improve the acupuncture's effectiveness in its application. Methods : The research method was a literature review and Cochrane meta-analysis of papers on the effectiveness of acupuncture treatments for mild cognitive impairment conducted from 2012 to 2023. The Cochrane risk of bias (RoB) tool was used as a quality analysis tool, and the meta-analysis tool was Cochrane RevMan V5.4.1 software. Results : As a result of the study, a total of 967 subjects were used for analysis, and 16 papers on randomized acupuncture trials were analyzed. The results are as follows: As a result of meta-analysis of acupuncture intervention for mild cognitive impairment, the MMSE score had an average of 1.61 with a 95% confidence interval ranging from 0.14 to 3.07, and a statistically significant result with p<0.001. The Z-score was 2.15, which corresponded to a p-value of 0.03. The MoCA score had an average range between 0.39 and 2.49, also showing statistical significance with p<0.001, and a Z-score of 2.70 (p=0.007). The effect of acupuncture in subjects with mild cognitive impairment was significant. Conclusion : The suggestions and conclusion indicate that acupuncture intervention has a significant effect on mild cognitive impairment. This study propose future experimental research on various types of acupuncture interventions for mild cognitive impairment. The significance of this study is that it presented basic data for the development of a preventive convergence cognitive intervention program for patients with mild cognitive impairment in the community.

A Randomized Phase III Study of Patients With Advanced Gastric Adenocarcinoma Without Progression After Six Cycles of XELOX (Capecitabine Plus Oxaliplatin) Followed by Capecitabine Maintenance or Clinical Observation

  • Guk Jin Lee;Hyunho Kim;Sung Shim Cho;Hyung Soon Park;Ho Jung An;In Sook Woo;Jae Ho Byun;Ji Hyung Hong;Yoon Ho Ko;Der Sheng Sun;Hye Sung Won;Jong Youl Jin;Ji Chan Park ;In-Ho Kim;Sang Young Roh;Byoung Yong Shim
    • Journal of Gastric Cancer
    • /
    • v.23 no.2
    • /
    • pp.315-327
    • /
    • 2023
  • Purpose: Oxaliplatin, a component of the capecitabine plus oxaliplatin (XELOX) regimen, has a more favorable toxicity profile than cisplatin in patients with advanced gastric cancer (GC). However, oxaliplatin can induce sensory neuropathy and cumulative, dose-related toxicities. Thus, the capecitabine maintenance regimen may achieve the maximum treatment effect while reducing the cumulative neurotoxicity of oxaliplatin. This study aimed to compare the survival of patients with advanced GC between capecitabine maintenance and observation after 1st line XELOX chemotherapy. Materials and Methods: Sixty-three patients treated with six cycles of XELOX for advanced GC in six hospitals of the Catholic University of Korea were randomized 1:1 to receive capecitabine maintenance or observation. The primary endpoint was progression-free survival (PFS), analyzed using a two-sided log-rank test stratified at a 5% significance level. Results: Between 2015 and 2020, 32 and 31 patients were randomized into the maintenance and observation groups, respectively. After randomization, the median number of capecitabine maintenance cycles was 6. The PFS was significantly higher in the maintenance group than the observation group (6.3 vs. 4.1 months, P=0.010). Overall survival was not significantly different between the 2 groups (18.2 vs. 16.5 months, P=0.624). Toxicities, such as hand-foot syndrome, were reported in some maintenance group patients. Maintenance treatment was a significant factor associated with PFS in multivariate analysis (hazard ratio, 0.472; 95% confidence interval, 0.250-0.890; P=0.020). Conclusions: After 6 cycles of XELOX chemotherapy, capecitabine maintenance significantly prolonged PFS compared with observation, and toxicity was manageable. Maintenance treatment was a significant prognostic factor associated with PFS.

Review of the Radiation Risk and Clinical Efficacy Associated with Computed Tomography Cancer Screening (암의 조기발견을 위한 CT촬영에서의 임상적 효능과 방사선위해에 대한 고찰)

  • Kim, Hyun Ja
    • Journal of Radiation Protection and Research
    • /
    • v.38 no.4
    • /
    • pp.214-227
    • /
    • 2013
  • Computed tomographic scan as a screening procedures in asymptomatic individuals has seen a steady increase with the introduction of multiple-raw detector CT scanners. This report provides a brief review of the current controversy surrounding CT cancer screening, with a focus on the radiation induced cancer risks and clinical efficacy. 1. A large study of patients at high risk of lung cancer(the National Lung Screening Trial[NLST]) showed that CT screening reduced cancer deaths by 20%(1.33% in those screened compared with 1.67% in those not screened). The rate of positive screening tests was 24.2% and 96.4% of the positive screening results in the low-dose CT group were false-positive. Radiation induced lung cancer risk was estimated the most important in screening population because ERR of radiation induced lung cancer does not show the decrease with increasing age and synergistic connection between smoking and radiation risk. Therefore, the radiation risk may be on the same order of magnitude as the benefit observed in the NLST. Optimal screening strategy remain uncertain, CT lung cancer screening is not yet ready for implementation. 2. Computed tomographic colonography is as good as colonoscopy for detecting colon cancer and is almost as good as colonoscopy for detecting advanced adenomas, but significantly less sensitive and specific for smaller lesions and disadvantageous for subsequent therapeutic optical colonoscopy if polyps are detected. The average effective dose from CT colonography was estimated 8-10 $mS{\nu}$, which could be a significant dose if administered routinely within the population over many years. CT colonography should a) achieve at least 90% sensitivity and specificity in the size category from 6 and 10 mm, b) offer non-cathartic bowl preparation and c) be optimized and standardized CT parameters if it is to be used for mass screening. 3. There is little evidence that demonstrates, for whole-body scanning, the benefit outweighs the detriment. This test found large portion of patient(86~90.8%) had at least one abnormal finding, whereas only 2% were estimated to have clinically significant disease. Annual scans from ages 45 to 75 years would accrue an estimated lifetime cancer mortality risk of 1.9%. There is no group within the medical community that recommends whole-body CT. No good studies indicate the accuracy of screening CT, at this time. The benefit/risk balance for any of the commonly suggested CT screening techniques has yet to be established. These areas need further research. Therefore wild screening should be avoided.

Optimal Scheme of Postoperative Chemoradiotherapy in Rectal Cancer : Phase III Prospective Randomized Trial (직장암의 근치적 수술 후 화학요법과 방사선치료의 순서)

  • Kim Young Seok;Kim Jong Hoon;Choi Eun Kyung;Ahn Seung Do;Lee Sang-Wook;Kim Kyoung-Ju;Lee Je Hwan;Kim Jin Cheon;You Chang Sik;Kim Hee Cheol
    • Radiation Oncology Journal
    • /
    • v.20 no.1
    • /
    • pp.53-61
    • /
    • 2002
  • Purpose : To determine the optimal scheme of postoperative chemoradiotherapy in rectal cancer by comparing survival, Patterns of failure, toxicities in early and late radiotherapy groups using a Phase III randomized prospective clinical trial. Materials and Methods : From January 1996 to March 1999, 307 patients with curatively resected AJCC stage II and III rectal cancer were assigned randomly to an 'early (151 patients, arm 1)' or a 'late (156 patients, arm II)' and were administered combined chemotherapy (5-FU $375\;mg/m^2/day$, leucovorin $20\;mg/m^2$, IV bolus daily, for 3 days with RT, 5 days without RT, 8 cycles with 4 weeks interval) and radiation therapy (whole pelvis with 45 Gy/25 fractions/5 weeks). Patients of arm I received radiation therapy from day 1 of the first cycle of chemotherapy and those of arm II from day 57 with a third cycle of chemotherapy. The median follow-up period of living patients was 40 months. Results : Of the 307 patients enrolled, fifty patients did not receive scheduled radiation therapy or chemotherapy. The overall survival rate and disease free survival rate at 5 years were $78.3\%\;and\;68.7\%$ in arm I, and $78.4\%\;and\;67.5\%$ in arm II. The local recurrence rate was $6.6\%\;and\;6.4\%$ (p=0.46) in arms I and II, respectively, no significant difference was observed between the distant metastasis rates of the two arms ($23.8\%\;and\;29.5\%$, p=0.16). During radiation therapy, grade 3 diarrhea or more, by the NCI common toxicity criteria, was observed in $63.0\%\;and\;58.2\%$ of the respective arms (p=N.S.), but most were controlled with supportive care. Hematologic toxicity (leukopenia) greater than RTOG grade 2 was found in only $1.3\%\;and\;2.6\%$ of patients in each respective arm. Conclusion : There was no significant difference in survival, patterns of failure or toxicities between the early and late radiation therapy arms. Postoperative adjuvant chemoradiation was found to be a relatively safe treatment but higher compliance is needed.

The effect of Light Emitting Diode electric toothbrush on gingivitis: a randomized controlled trial (발광 다이오드(Light Emitting Diode) 전동칫솔의 치은염에 대한 효과: 무작위 배정 임상시험)

  • Lee, Sung-Jo
    • Journal of Dental Rehabilitation and Applied Science
    • /
    • v.33 no.2
    • /
    • pp.119-126
    • /
    • 2017
  • Purpose: The aim of the present study was to compare clinical antiplaque and antigingivitis effect between Light Emitting Diode (LED) electronic toothbrush and electronic toothbrush without LED for gingivitis and mild periodontitis patients. Materials and Methods: 30 patients included in this study. 15 patients in experimental group used LED electronic tooth brush which has red and white LED within its head, and other 15 patients in control group used same product which specially modified that function without LED. Clinical parameters ($L{\ddot{o}}e-Silness$ gingival index (GI), Quigley-Hein plaque index (PI)) were measured at the baseline, 2 weeks and 4 weeks later. Wilcoxon signed rank test and Mann-Whitney test were used for statistical analysis. Results: Compare of GI change between experimental and control group with time, both groups showed that reduced GI, but lower GI values detected at 2 weeks and 4 weeks later in experimental group than control group. And lower PI values detected at 4 weeks later in experimental group than control group, but not statistically significant. Conclusion: Based on these results and within the limits of this study, the electronic toothbrush with LED could reducing gingivitis in a short period and infer that decreasing plaque accumulation in a long period.

Chunghyul-dan for the Prevention of Stroke Progression in Silent Brain Infarction (무증후성 뇌경색 환자에 대한 청혈단(淸血丹)의 중풍예방효과)

  • Cho Ki-Ho;Ji Nam-Gue;Jung Woo-Sang;Park Seong-Uk;Moon Sang-Kwan;Ko Chang-Nam;Kim Young-Suk;Bae Hyung-Sup
    • The Journal of Korean Medicine
    • /
    • v.26 no.2 s.62
    • /
    • pp.77-84
    • /
    • 2005
  • Objectives: Chunghyul-dan is a combinatorial herbal medicine, and previous studies reported it had therapeutic effects for microangiopathy, which is a major part. in the progression of stroke, as well as having anti-hypertensive, anti-hyperlipidemic, anti-apoptotic, anti-oxidative, and anti-inflammatory activities, Therefore, we examined the inhibitory effect of Chunghyul-dan on stroke occurrence in patients with silent brain infarction. Methods: We prescribed Chunghyul-dan at 600 mg a day to patients with silent brain infarction confirmed by brain MRI, and monitored stroke occurrence, drug compliances, and adverse effects for 1 year, We then performed follow-up brain MRI to detect new vascular lesions after 1 year of Chunghyul-dan medication. As for the subjects lost to follow-up, we assessed their prognosis after 1 year by telephone. Results: There were twenty-one subjects who were treated with Chunghyul-dan for more than 1 year, None of them experienced new clinical syndromes characterized by rapidly developing clinical symptoms and signs of focal and at times global loss of brain function, which could be accompanied with evidence of stroke occurrence, or any adverse effects during the Chunghyul-dan medication period. These results might be explained by various biochemical effects of Chunghyul-dan on microangiopathy, which is closely related with cell cycle progression, hypertension, hyperlipidemia, vascular inflammation, and oxidative damage. Of the 10 subjects lost to follow-up, six were reached; two of them had stroke occurrence. Conclusions: We suggest Chunghyul-dan could be useful for prevention of stroke occurrence in patients with silent brain infarction by preventing the progression of microangiopathy. Further study with a randomized controlled trial is needed to confirm this suggestion.

  • PDF

A Crossover Clinical Trial to Determine the Effect of Siguan(Four Gates) Points on Gastrointestinal Motility Suppressed by Loperamide Administration (Loperamide로 억제된 위장관 운동에 대한 사관혈의 자침효과: 무작위배정, 단일눈가림, 교차설계, 대조 임상시험)

  • Oh, Dal-Seok;Jung, So-Young;Kim, Ae-Ran;Kang, Wee-Chang;Park, Ji-Eun;Koo, Chang-Mo;Choi, Jun-Yong;Jung, Hee-Jung;Choi, Sun-Mi;Son, Chang-Gue
    • The Journal of Korean Medicine
    • /
    • v.29 no.1
    • /
    • pp.1-6
    • /
    • 2008
  • Objective : To investigate the therapeutic effect of manual acupuncture at Siguan (four gates, bilateral LI4 and LR3) on suppression of gastrointestinal motility. Methods : A single blind, randomized, sham-acupuncture controlled, crossover study was conducted. Twenty healthy male subjects were admitted at hospital, and gastrointestinal motility suppression was induced by loperamide administration. Just after intake of 20 radio-markers, four gates or sham acupoint treatments were administered every 12 hours, 4 times over 48 hours. Gastrointestinal motility was evaluated by radiographic distribution of the radiomarkers at stomach or ileum, ascending, transverse, descending colon, sigmoid/rectum, and outside body at serial time points (0, 6, 12, 24, and 48 h). Results : Four gates acupuncture activated gastrointestinal movement as evidenced by significantly changed distributionof radio-makers at 6, 12, and 48 hours (P < 0.0001, P = 0.001, and P = 0.03, respectively) in Cochran-Mantel-Haenszel statistics. No serious adverse events occurred in either group. Conclusions : This study showed a scientific clinical relevance of four gates acupuncture to gastrointestinal disorders.

  • PDF

Effect of Hanwoo Diets Containing Linseed on Plasma Cholesterol Levels of Humans to Beef Consumption and Change in n-6/n-3 Fatty Acid of Loin Fat (아마씨앗 첨가 한우사료가 등심 지방의 n-6/n-3 변화 및 이를 섭취한 사람의 혈중 콜레스테롤 함량에 미치는 영향)

  • Park, Sang-Oh;Park, Byung-Sung;Yuh, In-Suh;Hwangbo, Jong;Bang, Han-Tae
    • Journal of the Korean Applied Science and Technology
    • /
    • v.31 no.2
    • /
    • pp.265-276
    • /
    • 2014
  • The purpose of this study was to evaluate the effect on lowering blood LDL-C in an adult human, by taking n-6/n-3 balanced Hanwoo beef and reducing n-6/n-3 in loin of Hanwoo beef. The randomized complete block design was used to conduct an experiment with a total of 20 castrated Hanwoo cattles, which were divided into two groups. Each group had 10 cattles, and the control group consisted of absence of linseed, while n-3 treatment group (n-3 group) had linseed. The results showed that n-6/n-3 in loin and blood was decreased to under 4:1 in n-3 group, while oleic acid as an monounsaturated fatty acid was increased by 52.79% compared to the control group. In above 70% of the clinical subjects who ate the balanced Hanwoo beef, the blood triglyceride, total cholesterol, and LDL-C were decreased by 25.35, 5.22, and 17.59%. However, in the subjects who ate the imported beef, and not the common Hanwoo beef, the same parameters were increased by 9.05, 8.21, and 21.70%, respectively. When the balanced Hanwoo beef were eaten, HDL-C were increased by 6.07% but the imported beef and common Hanwoo beef had those values decreased by 14.46 and 11.46%, respectively. The blood glucose was decreased by 6.42 and 11.82% in the subjects who ate balanced Hanwoo beef and common Hanwoo beef, respectively but the subjects who ate the imported beef had an increase by 15.19%.