• Journal of the Korean Statistical Society
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• 제14권1호
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• pp.48-55
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• 1985

In clinical trials subjects are avalible sequentially and must be assigned to treatments immediately. Completely randomized procedure for the allocation of treatments to each subject may result in severe imbalance among the number of subjects in treatment groups, especially for small experiments or interim analyses of large experiments. In this study, restricted randomization methods such as biased coin designs (Efron, 1971), permuted block design, and truncated binomial design are compared to teh completely randomized design in the presence of selection and/or accidential bias by Monte Carlo simulations.

• Asian Pacific Journal of Cancer Prevention
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• 제14권2호
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• pp.947-950
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• 2013

Background: We performed this meta-analysis to assess the effectiveness and safety of axillary dissection in old women. Methods: The Cochrane Library, PubMed, EMBASE and Chinese Biomedical Literature Database were searched and all randomized controlled trials of axillary dissection in old women (at least 60 years old) were considered. Meta-analyses were completed using RevMan5.1. Results: Three eligible randomized controlled trials (RCTs) including 5,337 patients were considered. There was weak evidence in favour of axillary dissection (AD) in old women. The meta-analysis showed that the overall survival (OS) after 1, 3, 5 and 7 years and the disease free survival (DFS) after 1, 3 and 5 year were not statistically significantly different between AD and no AD groups. However, there was a difference in the 7 year DFS. Conclusions: Axillary dissection did not provide survival benefit to the old women with breast cancer analysed. Therefore, axillary dissection is not well-indicated in old women with breast cancer.

• 대한한방소아과학회지
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• 제36권2호
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• pp.13-25
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• 2022

Objective This study aimed to analyze randomized controlled trials of the effect of acupuncture on Tourette syndrome and to evaluate the efficacy of the treatment. Methods Based on the China National Knowledge Infrastructure (CNKI) and Pubmed search with the key search terms of 'Tourette syndrome, acupuncture', dated from 2000 to 2021, ten randomized controlled trials were identified and analyzed for this study. Results 1. The most commonly used acupoints were Taechung (LR3), Sinmun (HT7), Hapgok (LI4), Pungji (GB20) and Backhoe (GV20). 2. The most commonly used meridians were Bladder Meridian, Stomach Meridian and Gallbladder Meridian. 3. Acupuncture treatment was found to be significantly more or equally effective than western medicine such as haloperidol and tiapride. Conclusions Based on the results of the randomized controlled trials analyzed in this study, acupuncture was found to be effective in the treatment of Tourette syndrome. However, more clinical studies are needed to prove the effectiveness of acupuncture in Tourette syndrome.

• Clinical Nutrition Research
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• 제12권1호
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• pp.54-64
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• 2023

A systematic review and meta-analysis were designed to summarize studies conducted on the effects of raspberry and blackcurrant consumption on blood pressure (BP). Eligible studies were detected by searching numerous five online databases including PubMed, Scopus, Web of Science, Cochrane Library, and Google Scholar, until December 17, 2022. We pooled the mean difference and its 95% confidence interval (CI) by applying a random-effects model. Overall, the impact of raspberry and blackcurrant on BP was reported in ten randomized controlled trials (RCTs) (420 subjects). Pooled analysis of six clinical trials revealed that raspberry consumption has no significant reduction in systolic blood pressure (SBP) (weighted mean differences [WMDs], -1.42; 95% CI, -3.27 to 0.87; p = 0.224) and diastolic blood pressure (DBP) (WMD, -0.53; 95% CI, -1.77 to 0.71; p = 0.401), in comparison with placebo. Moreover, pooled analysis of four clinical trials indicated that blackcurrant consumption did not reduce SBP (WMD, -1.46; 95% CI, -6.62 to 3.7; p = 0.579), and DBP (WMD, -2.09; 95% CI, -4.38 to 0.20; p = 0.07). Raspberry and blackcurrant consumption elicited no significant reductions in BP. More accurate RCTs are required to clarify the impact of raspberry and blackcurrant intake on BP.

• 대한한방내과학회지
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• 제40권1호
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• pp.89-116
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• 2019

Objective: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer," by analyzing existing guidelines and clinical trials. Methods: Committee for the development of a guideline, consisting of 6 Korean medicine doctors, reviewed guidelines and clinical trials on using herbal medicine for treating liver cancer. The trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparators, outcomes, and trial design. We then compared the results of our analysis with the guidelines to identify issues we must to consider when following the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer." Several guidelines for antitumor agents and clinical trials on herbal medicine were obtained from the Ministry of Food and Drug Safety homepage, etc. The search terms were as follows: "liver neoplasms"; "herbal medicine"; "medicine, Korean traditional"; and "medicine, Chinese Traditional.". Results: Ten articles were obtained from pubmed and Embase. There was no guideline for clinical trials on using herbal medicine for treating liver cancer. All the participants in the reviewed articles had primary liver cancer, and the type of intervention varied (e.g., decoction, patches, and capsules. The comparators included placebos and conventional treatments such as chemotherapy. The outcome assessment methods were tumor response, quality of life, survival, and liver function tests. Adverse events occuring during the trial were also evaluated. Conclusion: Findings were derived by reviewing existing guidelines and comparing them with clinical trials on liver cancer and herbal medicinal products. These results will be utilized in the development of the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer."

• 한국콘텐츠학회논문지
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• 제13권12호
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• pp.1036-1047
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• 2013

본 연구는 불면과 관련된 무작위임상시험의 해외 연구 동향을 살펴보기 위하여 시계열적 키워드 비교 분석 및 네트워크 분석을 실시하였다. 분석에 사용된 자료는 'Insomnia'와 'Randomized Clinical Trial'의 연관 키워드를 사용하여 ClinicalTrials의 379건, Web of Science의 132건을 선정하였다. 분석 결과, ClinicalTrials에서는 불면과 약물요법을 중심으로 인지행동요법, 우울 등의 키워드가 네트워크를 이루고 있었다. WOS에서는 ClinicalTrials의 결과에 멜라토닌 키워드가 추가적으로 나타났다. 또한, 연구 대상자 중 특징적으로 노인과 여성에 대한 연구가 꾸준히 진행되는 것으로 파악되었다.

• Korean Journal of Radiology
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• 제25권2호
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• pp.123-125
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• 2024

• Korean Journal of Acupuncture
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• 제29권3호
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• pp.421-430
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• 2012

Objectives : We investigated the incidence rate and type of adverse events associated with RCTs(Randomized Controlled Trials) of acupuncture and moxibustion. Methods : This study included 949 patients who received acupuncture or moxibustion or usual care from 8 RCTs. We collected data including gender and age of patients, intervention, treatment frequency and type of adverse events in clinical trials from their case report forms. Results : Among the 949 patients, 83 patients(8.7%) suffered at least one adverse event throughout the clinical trials. Types of adverse event in acupuncture & moxibustion clinical trials are common cold, skin changes, pain, dizziness, bruise, gastrointestinal diseases, changes of blood chemistry, burn. Adverse events were significantly correlated to patients' age, intervention, body mass index and treatment group. Conclusions : A Guide-line for collecting and managing adverse events of acupuncture & moxibustion clinical trials are needed.

• Journal of Acupuncture Research
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• 제26권3호
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• pp.149-163
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• 2009

Objectives : The purpose of this study is to review RCTs on pharmacopuncture treatment for musculoskeletal diseases and to establish standards of pharmacopuncture treatment model. Methods : We searched articles up to date of March 2009 via computerized databases of Pubmed, The Journal of Korean Acupuncture & Moxibustion, Journal of Korean institute of Herbal Acupuncture, Journal of Oriental Rehabilitation and Journal of Korean Oriental Medicine. Only Randomized Controlled Trials (RCT) concerning the effects of pharmacopuncture on musculoskeletal diseases. The pharmacopuncture treatment methods were assessed based on STRICTA and items considering the feature of pharmacopuncture. And the methodological quality of the trials was assessed by FEAS and modified Jadad score. Results : Eighteen trials of pharmacopuncture on musculoskeletal diseases were analyzed. Except for 4 trials comparing the effect of SBV and BV, positive outcome was reported in ten trials. Among eighteen trials; most of the trials were about Bee Venom acupuncture, and most of the trials used about five acupuncture points, mainly local acupuncture points. But, the amount of injection to each point and total injection were various. And most of trials were lack in the information about method of stimulation. The adjusted FEAS score ranged from 0 to 12, and modified Jadad scoreranged from 1 to 5. Conclusions: To standardize pharmacopuncture treatment, we need more well-designed, high quality clinical trials. And methodological assessment tools designed for pharmacopuncture treatment are also needed.

• The Korean Journal of Pain
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• 제35권1호
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• pp.97-105
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• 2022

Background: Percutaneous transforaminal endoscopic discectomy (PTED) has been widely used in the treatment of lumbar degenerative diseases. Epidural injection of steroids can reduce the incidence and duration of postoperative pain in a short period of time. Although steroids are widely believed to reduce the effect of surgical trauma, the observation indicators are not uniform, especially the long-term effects, so the problem remains controversial. Therefore, the purpose of this paper was to evaluate the efficacy of epidural steroids following PTED. Methods: We searched PubMed, Embase, and the Cochrane Database from 1980 to June 2021 to identify randomized and non-randomized controlled trials comparing epidural steroids and saline alone following PTED. The primary outcomes included postoperative pain at least 6 months as assessed using a visual analogue scale (VAS) and the Oswestry Disability Index (ODI). The secondary outcomes included length of hospital stay and the time of return to work. Results: A total of 451 patients were included in three randomized and two non-randomized controlled trials. The primary outcomes, including VAS and ODI scores, did not differ significantly between epidural steroids following PTED and saline alone. There were no significant intergroup differences in length of hospital stay. Epidural steroids were shown to be superior in terms of the time to return to work (P < 0.001). Conclusions: Intraoperative epidural steroids did not provide significant benefits, leg pain control, improvement in ODI scores, and length of stay in the hospital, but it can enable the patient to return to work faster.