• Title/Summary/Keyword: Randomized controlled study

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Radiofrequency Ablation Using a Separable Clustered Electrode for the Treatment of Hepatocellular Carcinomas: A Randomized Controlled Trial of a Dual-Switching Monopolar Mode Versus a Single-Switching Monopolar Mode

  • Jae Won Choi;Jeong Min Lee;Dong Ho Lee;Jung-Hwan Yoon;Yoon Jun Kim;Jeong-Hoon Lee;Su Jong Yu;Eun Ju Cho
    • Korean Journal of Radiology
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    • v.22 no.2
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    • pp.179-188
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    • 2021
  • Objective: This study aimed to prospectively compare the efficacy, safety, and mid-term outcomes of dual-switching monopolar (DSM) radiofrequency ablation (RFA) to those of conventional single-switching monopolar (SSM) RFA in the treatment of hepatocellular carcinoma (HCC). Materials and Methods: This single-center, two-arm, parallel-group, randomized controlled study was approved by the Institutional Review Board. Written informed consent was obtained from all patients upon enrollment. A total of 80 patients with 94 HCC nodules were randomized into either the DSM-RFA group or SSM-RFA group in a 1:1 ratio, using a blocked randomization method (block size 2). The primary endpoint was the minimum diameter of the ablation zone per unit time. The secondary endpoints included other technical parameters, complication rate, technique efficacy, and 2-year clinical outcomes. Results: Significantly higher ablation energy per unit time was delivered to the DSM-RFA group than to the SSM-RFA group (1.7 ± 0.2 kcal/min vs. 1.2 ± 0.3 kcal/min; p < 0.001). However, no significant differences were observed between the two groups for the analyzed variables, including primary endpoint, regarding size of the ablation zone and ablation time. Major complication rates were 4.9% in the DSM-RFA group and 2.6% in the SSM-RFA group (p = 1.000). The 2-year local tumor progression (LTP) rates of the HCC nodules treated using DSM-RFA and SSM-RFA were 8.5% and 4.7%, respectively (p = 0.316). The 2-year LTP-free survival rates of patients in the DSM-RFA and SSM-RFA groups were 90.0% and 94.4%, respectively (p = 0.331), and the 2-year recurrence-free survival rates were 54.9% and 75.7%, respectively (p = 0.265). Conclusion: Although DSM-RFA using a separable clustered electrode delivers higher ablation energy than SSM-RFA, its effectiveness failed to show superiority over SSM-RFA in the treatment of HCC.

Review of Clinical Research for Herbal Medicine Treatment on Rhinosinusitis (비부비동염의 보완대체의학 약물치료에 대한 최신 임상 연구 동향 -RCT 연구를 중심으로 -)

  • Jang, Eun Ha;Min, Sang Yeon;Kim, Jang Hyun
    • The Journal of Pediatrics of Korean Medicine
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    • v.32 no.3
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    • pp.44-54
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    • 2018
  • Objectives The purpose of this study is to analyze clinical studies on effectiveness of herbal medicine in rhinosinusitis. Methods We searched the randomized controlled trials (RCTs) with herbal medicine treatment on rhinosinusitis from the Pubmed in recent 10 years (from 2008 to 2018). Results 11 RCTs were reviewed. In 10 out of 11 studies showed that the herbal medicine may be effective in the treatment of chronic rhinosinusitis without nasal polyp and uncomplicated acute rhinosinusitis. However, inclusion and exclusion criteria, and outcome measures were varied among different studies. No serious adverse reactions were reported from the herbal medicine treatment. Conclusions The results of these trials showed that herbal medicine may be effective in the treatment of rhinosinusitis. Well-designed RCTs for domestic herbal medicine treatment on rhinosinusitis are needed to prove its efficacy clearly.

Clinical Research Trend for Catgut-embedding Therapy on Allergic Rhinitis (알레르기 비염의 매선 치료 임상 연구 동향)

  • Kang, Jeong-In;Lee, Dong-Hyo
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.33 no.2
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    • pp.55-69
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    • 2020
  • Objectives : The purpose of this study is to analyze research trends on the effects of catgut-embedding therapy on allergic rhinitis. Methods : We searched potentially relevant randomized controlled trials using various electronic databases and extracted data using a standardized form. Results : Finally, 11 studies were selected and analyzed. All studies were conducted in China and the number of studies has increased especially in recent 3 years. 11 studies compared catgut-embedding therapy with usual care, acupuncture, sham catgut-embedding therapy. Most studies showed that catgut-embedding therapy was effective and had long lasting effect compared with comparison group. Conclusions : All studies were conducted in China and it is necessary to review its evidence for clinical application in Korea. Further studies are needed on this topic in order to demonstrate the effectiveness and safety clearly.

Trend of Clinical Trials for Intradermal Acupuncture Treatment on Dry Eye Syndrome (건성안 증후군의 피내침 치료에 대한 임상연구 동향)

  • Song, Ji-Hoon;Park, Soo-Yeon
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.33 no.2
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    • pp.12-22
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    • 2020
  • Objectives : The aim of this study is to review the trend of clinical trials conducted with the intradermal acupuncture treatment on dry eye syndrome. Methods : Through 4 foreign online databases(PubMed, Cochrane Library, EMBASE, and CNKI) and 3 domestic online databases(NDSL, RISS, and OASIS), we searched for clinical studies performed acupuncture treatment for dry eye syndrome from 2000 to 2020. Only randomized controlled trials(RCT) were selected and analyzed with the research method. Results : A total of 4 studies were reviewed. Cuanzu(攢竹, BL2), Taiyang(太陽, EX-HN5), and Sibai(四白, ST2) were the most frequently used acupoints in the studies. Among the evaluation indexes, Schirmer I test(SIT), tear film break-up time(BUT) were the most frequently used outcomes. In the most of the 4 studies, intradermal acupuncture treatment showed significant therapeutic effects for dry eye syndrome. Conclusions : These results suggest that it is necessary to develop more detailed standards for intradermal acupuncture treatment method as the method of intradermal acupuncture is getting more diverse, and objective tools are needed to evaluating dry eye syndrome.

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 Controlled Trial for Preventing Stomatitis and Discomfort among Acute Leukemic Patients (급성백혈병 환자를 대상으로 구강함수제별 구내염 및 구강안위감에 대한 무작위대조시험연구)

  • Song, Chi-Eun;So, Hyang-Sook;Ju, Deok;Kim, Eun-Jeong
    • Asian Oncology Nursing
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    • v.11 no.1
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    • pp.33-40
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    • 2011
  • Purpose: This study compared the effect of two oral care agents on preventing stomatitis and discomfort for acute leukemic patients. Methods: A total of forty patients was enrolled and randomly assigned to sodium bicarbonate or chlorhexidine group. WHO oral toxicity scale was used for measuring stomatitis and Beck's subjective oral discomfort scale for evaluating oral comfort. Data was collected from August 2009 to February 2010. The data was analyzed using Chi-square test, Fisher's exact test, and Mann-Whitney test. Results: Data analyzed was thirty five one. The incidence of stomatitis was 47.4%, 68.8% in sodium bicarbonate and chlohexidine group respectively. The onset of stomatitis was about the 10th and 9th day after chemotherapy initiation, and the duration was 8.0 and 8.67 day respectively. The severity of stomatitis was highest on the 21st day after chemotherapy initiation. There were no statistical differences in the status of stomatitis and the levels of oral comfort during treatment periods. Conclusion: Nurses should routinely assess oral cavity and encourage patients to do oral care actively from second to third week after chemotherapy initiation. Also sodium bicarbonate agent can be recommended to for preventing stomatitis.

Amiodarone Versus Propafenone to Treat Atrial Fibrillation after Coronary Artery Bypass Grafting: A Randomized Double Blind Controlled Trial

  • Nemati, Mohammad Hassan;Astaneh, Behrooz
    • Journal of Chest Surgery
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    • v.49 no.3
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    • pp.177-184
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    • 2016
  • Background: Atrial fibrillation (AF) is one of the most common complications after cardiac surgery. Several therapeutic and preventive strategies have been introduced for postoperative AF, but the treatment and prophylaxis of AF remain controversial. We aimed to compare the efficacy of intravenous amiodarone and oral propafenone in the treatment of AF after coronary artery bypass grafting (CABG). Methods: This was a randomized controlled trial performed in two hospitals in Shiraz, Iran from 2009 to 2012. We included all patients who underwent elective CABG and developed AF postoperatively. The patients were randomly assigned to receive propafenone or amiodarone. The duration of AF, the success rate of the treatment, the need for cardioversion, the frequency of repeated AF, and the need for repeating the treatment were compared. Results: The duration of the first (p=0.361), second (p=0.832), and third (p=0.298) episodes of AF, the need for cardioversion (p=0.998), and the need to repeat the first and second doses of drugs (p=0.557, 0.699) were comparable between the study groups. Repeated AF was observed in 17 patients (30.9%) in the propafenone group and 23 patients (34.3%) in the amiodarone group (p=0.704). Conclusion: Oral propafenone and intravenous amiodarone are equally effective in the treatment and conversion of recent-onset AF after CABG.

Trend for Acupuncture treatment Clinical Trial on Atopic Dermatitis (아토피피부염의 침 치료 임상연구 동향)

  • Park, Soo-Yeon;Choi, Jung-Hwa;Jeong, Min-Yeong;Lee, Gi-Hyun
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.33 no.1
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    • pp.45-55
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    • 2020
  • Objectives : The objective of this study is to review the Trend of clinical trials conducted with the acupuncture treatment on Atopic Dermatitis. Methods : Through 4 foreign online databases(PubMed, Cochrane library, EMBASE, CNKI) and 3 domestic online databases(NDSL, RISS, OASIS), we searched for clinical studies performed acupuncture treatment for Atopic Dermatitis from 2010 to December 2019. Only randomized controlled trials(RCT) was selected and anlayzed according to the research method. Results : A total 4 studies were reviewed. LI11, ST36, SP10 were most frequently used acupoints in acupuncture treatment. Among the evaluation indexes, SCORAD, VAS, DLQI were used most. In most of the 4 studies, acupuncture treatment showed significant therapeutic effects. Conclusions : These results suggest that it is necessary to develop more detailed standards about Acupuncture treatment method as the method of acupuncture is getting more diverse, and objective tools are needed in evaluating Atopic Dermatitis.

Traditional Korean Medicine Therapy for Treating Carpal Tunnel Syndrome in Patients with Wrist Pain: A Systematic Review

  • Kim, Jung Hyun;Song, Ho Sueb
    • Journal of Acupuncture Research
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    • v.32 no.2
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    • pp.59-64
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    • 2015
  • Objectives : This study aims to evaluate current clinical evidence of traditional Korean medicine treatment on wrist pain with carpal tunnel syndrome. Methods : Ten Korean databases were searched for prospective clinical trials of traditional Korean medicine therapy on wrist pain with carpal tunnel syndrome from the time of their inception to February, 2015. Studies conducted in Korean, Chinese and English were searched. Risk of bias in included non-randomized controlled trials was assessed by the Cochrane handbook procedure. Results : Four non-randomized controlled trials were included. A high risk of bias was observed in all trials. All of the included studies reported favorable effects being experienced by an intervention group compared to a baseline or control group. Included studies never described any occurrence of adverse events. Conclusions : There is no evidence that traditional Korean medicine treatments are effective for treating wrist pain associated with carpal tunnel syndrome. All of the included studies lacked appropriate methodological qualities and internal validity. Future well-designed clinical trials that evaluate the effects and safety of traditional Korean medicine treatment for patients with carpal tunnel syndrome are needed.

Acupuncture Treatment in Clinical Studies for Parkinson's Disease : A Literature Review

  • Sohn, Soo Ah;Lee, Kyoung Yun;Kim, Chang Wan;Lee, Yu Jin
    • Journal of Acupuncture Research
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    • v.35 no.4
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    • pp.149-157
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    • 2018
  • Background: Parkinson's disease is the second most common degenerative brain disease after Alzheimer's disease. This study reviewed clinical practice of acupuncture and moxibustion treatment for Parkinson's disease to assess the future direction of these treatments. Methods: The literature search used 5 Korean Internet databases. The search terms were "Parkinson's disease." and "Parkinson (Korean)." 36 papers were selected: 27 case reports, 2 respropective studies, 3 uncontrolled clinical trials, 3 randomized controlled trial, 1 non-randomized controlled trial. Results: Filiform needles were used in most of studies. Pharmacopuncture, electro-acupuncture, and auricular acupuncture therapy were also used in combination with Filiform needles. 2. The most commonly used basic acupoints for Parkinson's disease was Saamchimbeop. The most commonly used form of pharmacopuncture involved Bee-venom. Conclusion: It is expected that treatment of Parkinson's disease with a variety of acupuncture and moxibustion therapies will continue to be studied, in addition to treatments that utilize existing Filiform needle treatments in clinical practice.