• Title/Summary/Keyword: randomized clinical controlled trial

Search Result 659, Processing Time 0.034 seconds

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
    • /
    • v.13 no.1
    • /
    • pp.103-110
    • /
    • 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 The selection contents were to identify all published and unpublished RCTs that compared neoadjuvant chemotherapy and surgery with surgery alone for resectable esophageal carcinoma.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.

Current Status of N-of-1 Trials for Herbal Medicine -Literature Review (한약에 대한 N-of-1 임상시험의 현황 - 문헌 고찰)

  • Jeung, Chang-woon;Jeon, Sun-woo;Jo, Hee-Geun
    • The Journal of Korean Medicine
    • /
    • v.41 no.1
    • /
    • pp.107-116
    • /
    • 2020
  • Objectives: To overcome the limitations of randomized controlled trials, many other trials design is tested. The n-of-1 trial is a promising research method in the field of Korean medicine because of this methodology can examine the optimal treatment for each patient strictly. Therefore, we reviewed the status of N-of-1 studies on herbal medicine. Methods: A systematic literature review was conducted based on the pubmed database. The search term were 'N-of-1 Trial', 'Chinese Medicine', 'Herbal Medicine', 'Kampo'. There was no restriction in year. Results: Four clinical trials have been identified to demonstrate the effectiveness of herbal medicines for Kidney-yin-deficiency syndrome, bronchiectasis and gastric cancer. These studies suggest that the N-of-1 design is a study that encourages patient involvement, demonstrates the effectiveness of herbal medicines and helps reduce unnecessary medication. Conclusion: The N-of-1 clinical trial may be a rigorous methodology suitable for the clinical setting and may help the development of evidence-based Korean medicine. Attention is also needed in this research method in Korea.

Research Trends on the Thread Embedding Therapy of Low back pain in Traditional Chinese Medicine - Focusing on published articles in China (요통에 대한 매선 임상연구의 중국 현황 분석 - 중국 내(內) 출판 저널을 중심으로)

  • Jun, Purumea;Liu, Yan;Park, Ji-Eun;Jung, So-Young;Han, Chang-Hyun
    • Journal of Physiology & Pathology in Korean Medicine
    • /
    • v.31 no.1
    • /
    • pp.25-35
    • /
    • 2017
  • About 60% to 90% of a total population experience low back pain at least once of life, and about 35% to 79% among them experience a recurrent and chronic low back pain. thread-embedding therapy is mainly used to improve appearance or treat obesity in early stage, but recently it is also used to treat musculoskeletal pain. This study aimed to search Chinese study using thread-embedding therapy on low back pain and to analyse their methodology. Three Chinese database(CNKI(www.cnki.net), WANFANG(www.wanfangdata.com), WEIPU(www.cqvip.com)) were searched for clinical study of thread-embedding therapy up to March 2016. The characteristics of included studies and regimen of thread-embedding in those studies were analyzed. The total 21 studies (4 case studies, 16 non-randomized controlled trials, 1 randomized controlled trial) were included. All studies on thread embedding treatment of low back pain reported that its effectiveness was very good. The most frequently used acupoints was Ashi acupoints and acupoints on bladder meridian(BL) or governor vessel(GV). Thread-embedding therapy is considered very useful for low back pain in Traditional Chinese medicine. Further studies are needed to investigate the effect of thread-embedding therapy and to expand its application. This study is limited in that the literature search in the Chinese database were restricted.

The effects of Sa-am Acupuncture Simpojeongkyeok Treatment on Hwa-byung : Randomized, patient-assessor blind, placebo-controlled acupuncture, pilot clinical trial (화병에 대한 사암침 심포정격의 치료 효과 : 환자-평가자 눈가림, 무작위배정 대조군 임상시험)

  • Choi, Woo-Jin;Lee, Seung-Gi;Son, In-Bong;Sun, Seung-Ho
    • Journal of Oriental Neuropsychiatry
    • /
    • v.22 no.2
    • /
    • pp.1-13
    • /
    • 2011
  • Objectives : The purpose of this research is to examine the effects of Sa-am acupuncture Simpojeongkyeok treatment on Hwa-byung. Methods : The study was performed through a patient-assessor blind, randomized, placebo-controlled trial in which the volunteers, data collector and analyst were unaware of individuals which were receiving the treatment. Fifty volunteers were divided into a trial and a control group, each of which consisted of 25 subjects. The trial group was treated with Sa-am acupuncture Simpojeongkyeok, while needle insertion at non-acupoints was given to the control group. The Likert scale for major symptoms of Hwa-byung was measured as the 1st evaluative instrument, and then a comparative analysis was conducted by comparing the results with those measured by of STAXI-K, STAI-K and BDI-K. Results : In the Likert scale comparison of major symptoms, total scores in both groups were decreased after treatment. However, a more significant decrease was found in those of trial group compared to those of the control group from a statistical perspective. The results measured by BDI scores also decreased significantly in the trial group after treatment. In comparison of STAXI and STAI scores, there were no significant differences found between the groups. Conclusions : The results suggest that Sa-am Acupuncture Simpojeongkyeok treatment is effective in the treatment of Hwa-byung.

The Effects of Acupuncture Treatment on Hwa-byung patient's Insomnia: Patient-assessor blind, Randomized, Placebo-controlled Clinical trial (화병환자의 불면증상에 대한 침치료 유효성 평가연구: 환자-평가자 눈가림, 무작위배정, 일반대조군 임상시험)

  • Lee, Go-Eun;Kim, Nam-Kwon;Kim, Hang-Yi;Kang, Hyung-Won
    • Journal of Oriental Neuropsychiatry
    • /
    • v.23 no.1
    • /
    • pp.31-48
    • /
    • 2012
  • Objectives: The purpose of this research is to examine the effects of acupuncture treatment on Hwa-byung patient's insomnia. Methods: The study was performed through a patient-assessor blind, randomized, placebo-controlled trial in which the volunteers, data collectors and analysts were unaware of individuals who were receiving the treatment. A total of thirty-seven volunteers were divided into 2 groups. 18 subjects were placed into a trial group and 19 subjects into a control group by a randomization table. The trial group was treated on bilateral Shigu, Ahnmyun, B62 (Shinmaek), and K6 (Chohae), while the control group was not given any other treatment. The ISI(Insomnia Severity Scale) was measured as the 1st evaluative instrument, and then a comparative analysis was conducted by comparing the results with those measured by a Likert scale for major symptoms of Hwa-byung, PSQI, Hwa-byung scale, BDI, STAI, and STAXI. Results: In the ISI, PSQI, and the Likert scale regarding major symptoms of Hwa-byung, Hwa-byung scale, BDI, and STAI, more significant decreases were found in those concerning the trial group compared to those of the control group from a statistical perspective. However, in the STAXI, regarding the trial group, there was no significant decrease compared to the control group. Conclusions: The results suggest that acupuncture treatment is effective in the treatment regarding Hwa-byung patients who suffer from insomnia.

The Effect of Virtual Reality Based Rehabilitation Program on Balance of Patient with Stroke: A Meta-analysis of Studies in Korea (가상현실기반 재활프로그램이 뇌졸중환자의 균형에 미치는 영향 : 국내연구에 대한 메타분석)

  • Roh, Jung-suk
    • Journal of Korean Physical Therapy Science
    • /
    • v.24 no.1
    • /
    • pp.59-68
    • /
    • 2017
  • Purpose : The aims of this study was to conduct a systematic literature review with meta-analysis to investigate the effect of virtual reality based rehabilitation program on balance of patient with stroke in Korean studies. Method : The studies for analysis were searched in electronic databases(Research Information Sharing Service; RISS, Korean Studies Information Service; KISS, DBpia, e-articles, National Assembly Library). The key words for search were 'virtual reality', 'stroke', and 'balance' and only randomized controlled trials and clinical controlled trials were included. Of 40 studies identified in the search, 20 studies met the criteria of this study and included in this meta-analysis. Result : The results were as follows: 1) The overall effect size of virtual reality based rehabilitation program was 0.557(95% critical interval; 0.340~0.774). 2) In the analysis of sub-categorical variables, effect size was as follows; the commercial game type(0.621) > virtual environment type(0.335); the dynamic balance measurement(0.750) > static balance measurement(0.226); randomized controlled trial(0.653) > clinical controlled trial(0.275); and thesis type(0.706) > article of journal type(0.339). 3) In the analysis of sub-continuous variables, as time of program(per session) increased, the balance increased(p<0.05). Conclusion : The results of this study showed that virtual reality based rehabilitation program moderately improves the balance of stroke patient. Further studies are recommended to investigate the effect of sub-variables related to virtual reality programs on motor functions of patient with stroke.

  • PDF

Evaluation of the clinical and radiographic effectiveness of treating peri-implant bone defects with a new biphasic calcium phosphate bone graft: a prospective, multicenter randomized controlled trial

  • Jae-Hong Lee;Hyun-wook An;Jae-Seung Im;Woo-Joo Kim;Dong-Won Lee ;Jeong-Ho Yun
    • Journal of Periodontal and Implant Science
    • /
    • v.53 no.4
    • /
    • pp.306-317
    • /
    • 2023
  • Purpose: Biphasic calcium phosphate (BCP), a widely used biomaterial for bone regeneration, contains synthetic hydroxyapatite (HA) and β-tricalcium phosphate (β-TCP), the ratio of which can be adjusted to modulate the rate of degradation. The aim of this study was to evaluate the clinical and radiographic benefits of reconstructing peri-implant bone defects with a newly developed BCP consisting of 60% β-TCP and 40% HA compared to demineralized bovine bone mineral (DBBM). Methods: This prospective, multicenter, parallel, single-blind randomized controlled trial was conducted at the periodontology departments of 3 different dental hospitals. Changes in clinical (defect width and height) and radiographic (augmented horizontal bone thickness) parameters were measured between implant surgery with guided bone regeneration (GBR) and re-entry surgery. Postoperative discomfort (severity and duration of pain and swelling) and early soft-tissue wound healing (dehiscence and inflammation) were also assessed. Data were compared between the BCP (test) and DBBM (control) groups using the independent t-test and the χ2 test. Results: Of the 53 cases included, 27 were in the test group and 26 were in the control group. After a healing period of 18 weeks, the full and mean resolution of buccal dehiscence defects were 59.3% (n=16) and 71.3% in the test group and 42.3% (n=11) and 57.9% in the control group, respectively. There were no significant differences between the groups in terms of the change in mean horizontal bone augmentation (test group: -0.50±0.66 mm vs. control groups: -0.66±0.83 mm, P=0.133), postoperative discomfort, or early wound healing. No adverse or fatal complications occurred in either group. Conclusions: The GBR procedure with the newly developed BCP showed favorable clinical, radiographic, postoperative discomfort-related, and early wound healing outcomes for peri-implant dehiscence defects that were similar to those for DBBM.

Review of Clinical Studies for Herbal Medicine Treatment on Childhood Obesity - Focusing on Studies from the China Academic Journal (CAJ) - (중의학 데이터베이스 (CAJ)를 이용한 소아 비만의 한약치료에 대한 임상 연구 동향)

  • Kim, Seo Hyeong;Ryu, Hyang;Kim, Kibong;Cheon, Jin Hong
    • The Journal of Pediatrics of Korean Medicine
    • /
    • v.32 no.3
    • /
    • pp.26-43
    • /
    • 2018
  • Objectives The purpose of this study was to analyze recent traditional Chinese medicine clinical studies for treatment of childhood obesity. Methods We analyzed 11 clinical studies from January, 2000 to March, 2018 about childhood obesity from the China Academic Journal (CAJ) and China National Knowledge Infrastructure (CNKI). All selected studies were Randomized Controlled Trials and analyzed in order of publication year, demographic information, treatment method, evaluation methods, results, adverse reactions and relapse after treatment discontinuation. Results The main Traditional Chinese Medicine (TCM) treatment was the herbal decoctions, granules and pills. In most studies, the total efficacy of the treatment group was reported to be higher than that of the control group. Adverse reactions were found in small number of studies. Frequently used medical herbs were Crataegi Fructus (山?), Atractylodis Rhizoma (蒼朮), Citri Pericarpium (陳皮), Poria (茯?), and Nelumbinis Folium (荷葉). Also, Water-draining and swelling-dispersing medicinal (利水退腫藥), Qi-regulating medicinal (理氣藥), Resolving dampness with aroma medicinal (芳香化濕藥), Blood-activating and stasis-dispelling medicinal (活血祛瘀藥), Qi-tonifying medicinal (補氣藥), and Digestant medicinal (消食藥) were commonly used. Conclusions This study showed that traditional Chinese medicine, especially herbal medicine treatment can be effective and safe option for treating childhood obesity. These research results can be utilized in other clinical studies as well as in treatment of childhood obesity. Additional well-designed randomized controlled trials and systematic reviews are need to confirm the conclusion.

Review of Clinical Research on Effect of Traditional Chinese Medicine for Febrile Seizure (열성 경련에 대한 중의학 임상 연구 동향 - RCT를 중심으로 -)

  • Lee, Bo Ram;Lee, Eun Ju;Lee, Ji Hong;Chang, Gyu Tae
    • The Journal of Pediatrics of Korean Medicine
    • /
    • v.30 no.3
    • /
    • pp.78-96
    • /
    • 2016
  • Objectives The purpose of this study is to provide clinical evidence of Korean medicine for febrile seizure by review of randomized controlled trials on the effect of TCM (traditional Chinese medicine) for febrile seizure. Methods We searched randomized controlled trials about TCM treatment of febrile seizure from the China National Knowledge Infrastructure (CNKI) (January 2008 to June 2016). The selected literatures were assessed by Jadad scale. Results 40 papers were selected from 160 studies. Analyses of selected studies indicated that the TCM treatment group has significantly higher cure rate for febrile seizure than first aid or western medicine group. The most commonly used herbs were Gardeniae Fructus (梔子), Uncariae Ramulus cum Uncis (鉤藤), Cornus Gazeliae (羚羊角), Margarita (珍珠), Scutellariae Radix (黃芩), Glycyrrhizae Radix (甘草). The most commonly used acupoints were GV26 (人中), LI4 (合谷), KI1 (湧泉), GV20 (百會). There were no serious adverse events reported from the TCM treatment group during the treatment period. Conclusions TCM has been shown as not only effective but also safe treatment on febrile seizure. This finding can be widely utilized in clinical practice and can form the basis for development of clinical practice guidelines in future.

Effects of an electric toothbrush combined with 3-color light-emitting diodes on antiplaque and bleeding control: a randomized controlled study

  • Kwon, Chakyoung;Lee, Jae-Mok;Suh, Jo-Young;Seo, Seung-Jun;Lee, Youngkyun;Kim, Yong-Gun
    • Journal of Periodontal and Implant Science
    • /
    • v.50 no.4
    • /
    • pp.251-259
    • /
    • 2020
  • Purpose: This randomized controlled study aimed to evaluate the effects of an electric toothbrush with 3 colors of light-emitting diodes (LEDs) on antiplaque and bleeding control. Methods: This randomized, placebo-controlled, double-blinded, parallel-group clinical trial included 50 healthy adults with gingivitis, who were randomly assigned to 2 groups. The experimental group used electric toothbrushes with 3 colors of LEDs and the control group used the same electric toothbrush as the experimental group, but with LED sources with one-hundredth of the strength. The subjects used the electric toothbrush 3 times a day for 4 minutes each time. As clinical indices, bleeding on marginal probing (BOMP), the Löe-Silness gingival index (GI), and the Turesky-Quigley-Hein plaque index (QHI) were assessed at baseline, at 3 weeks, and at 6 weeks. Results: There were significant decreases in all clinical indices (BOMP, GI, QHI) in both the experimental and control groups compared to baseline at 3 weeks and at 6 weeks. In a comparison between the experimental and control groups, no statistically significant differences were observed for any clinical indices at 3 weeks (P>0.05). However, at 6 weeks, statistically significant differences were observed between the experimental and control groups in BOMP and GI, which are indicators of gingival inflammation (P<0.05). Conclusions: This study demonstrated that an electric toothbrush combined with 3-color LEDs reduced gingival bleeding and inflammation after 6 weeks.