• Title/Summary/Keyword: Randomized Clinical Trials

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Analysis of Registration Information of Randomized Controlled Clinical Trials on Suicide Attempters Based on WHO-ICTRP (자살시도자에 대한 무작위대조군연구의 등록 현황 분석: WHO-ICTRP를 중심으로)

  • Min-Ryeong Park;Ji-Won Lee;In-Jun Hwang;Chan-Young Kwon
    • Journal of Oriental Neuropsychiatry
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    • v.34 no.3
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    • pp.213-234
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    • 2023
  • Objectives: To investigate current status of randomized controlled clinical trial (RCT) registration for suicide attempters. Methods: The World Health Organization International Clinical Trials Registry Platform (WHO-ICTRP) was used to search for data using 'suicide' as a search term. All registration information of RCTs registered up to April 2023 were collected. Results: Among a total of 68 RCTs registered, the United States ranked the highest in terms of quantity in this field (n=30, 46.15%), whereas Asia had only six (8.82%). A total of 62 (91.18%) RCTs involved individual interventions, while nine (13.24%) RCTs involved group interventions. Among individual interventions, 11 (16.18%) and 54 (79.41%) RCTs were on pharmacotherapy and psychotherapy, respectively. Within psychotherapy, there were a total of 17 (25%) studies utilizing digital media, with cognitive behavioral therapy (CBT) via phone being the most common approach. Among non-digital media-based studies, CBT was used the most frequently (n=11, 16.18%), followed by attempted suicide short intervention program (n=6, 8.82%). There were no studies using interventions from East Asian traditional medicine, including Korean medicine (KM). The most frequently used main outcome was the Beck scale for suicidal ideation. Conclusions: Studies on suicide attempts in Asia, especially in South Korea, are very scarce. Despite vigorous psychotherapeutic research in this field, KM psychotherapy has not been used. Thus, KM clinical trial for suicide attempters might be planned in the future based on our findings.

Clinical Research of the Effect of Traditional Herbal Medicine with In Vitro Fertilization and Embryo Transfer in Pubmed (체외 수정과 한약 치료 중재에 대한 임상연구 동향 - Pubmed를 중심으로 -)

  • Lee, Mi-Joo;Son, Sung-Se;Park, Seung-Hyeok;Park, Kyoung-Sun;Hwang, Deok-Sang;Lee, Jin-Moo;Jang, Jun-Bock;Lee, Chang-Hoon
    • The Journal of Korean Obstetrics and Gynecology
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    • v.31 no.4
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    • pp.89-109
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    • 2018
  • Objectives: The purpose of this systematic review is to assess the effects of herbal medicine with in vitro fertilization-embryo transfer (IVF-ET) based on the current evidence. Methods: Eligible randomized controlled trials (RCT) searched from Pubmed which compared a combination of herbal medicine and IVF with IVF alone were included. Results: Sixteen trials, in which 2025 women involved, were included in this review. The review results showed that the effect of traditional herbal medicine can improve the clinical pregnancy rate (herbal medicine intervention: 30.36~63.64%, Control: 9.38~47.5%) and rate of high quality oocytes and embryos. The mechanism may be through regulating follicular fluid to improve microenvironment for oocytes which would lead to a successful embryo implantation. Conclusions: This analysis showed that combination of IVF and traditional herbal medicine used in the included trials improve clinical pregnancy rate and IVF success. During in vitro fertilization, TCM can regulate the microenvironment in the follicular fluid to mature the oocyte, improve the quality of the embryo, and help the development and implantation of the embryo. Further large randomized placebo controlled trials are needed to confirm the effectiveness of traditional herbal medicine with concurrent IVF.

Pros and Cons of Various Research Designs in Clinical Psychiatry (정신과 연구에서 다양한 임상연구방법의 장단점)

  • Ha, Ra Yeon;Cho, Hyun-Sang
    • Korean Journal of Biological Psychiatry
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    • v.19 no.4
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    • pp.159-163
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    • 2012
  • An appropriate research design for hypotheses and purposes leads to a good quality of research results. In this review article, we summarized the types of research methods and described the characteristics of clinical trials. Research designs are categorized into observational studies and experimental ones, depending on data collecting methods. In an observational study, there are cross-sectional, cohort and case-control studies. Parallel groups design and crossover trial studies are representative designs in a randomized controlled trial study, a kind of experimental study. Clinical researchers should understand the characteristics of clinical research designs including advantages and disadvantages and choose the suitable design according to their study purposes and the nature of collected data or subjects.

A Review of the Korean Traditional Medicine Treatment for Meniscus Injury (반월상 연골판 손상의 한의학적 치료에 대한 국내외 최신 연구 동향 분석)

  • Han, Sihoon;Oh, Taeyoung;Oh, Minseok
    • The Journal of Korean Medicine
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    • v.43 no.1
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    • pp.154-170
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    • 2022
  • Objectives: The purpose of this study was review the current clinical studies about the effect of Korean traditional medicine treatment for meniscus injury. Methods: Clinical studies on Korean traditional medicine treatment of meniscus injury were searched through 11 online databases. We analyzed the authors, publication year, country, study design, subjects, treatment methods, treatment effects, evaluation tools and adverse events of the selected studies. Results: 23 studies which included 9 randomized controlled trials, 8 case reports, 4 retrospective observational studies, 2 non-randomized controlled trials were selected through the databases. A total of 9 Korean traditional medicine treatments were used, among them, acupuncture treatment was the most used. The most commonly used outcome was effective rate. Conclusions: Through this study, we could confirm that Korean traditional medicine is an effective treatment for meniscus injury. It was suggested that various clinical studies on the effects of Korean traditional medicine for meniscus injury are needed and it is necessary to establish more scientific evidence through studies with a high level of evidence.

Trends in Chinese Clinical Research on Herbal Medicine Treatment in Adolescent Polycystic Ovary Syndrome - Focusing on Randomized Controlled Clinical Trials - (청소년 다낭성 난소증후군 한약치료에 대한 중의학 임상연구 동향 -무작위 대조군 임상연구를 중심으로-)

  • Kim Hyo Eun;Jang Su Bi;Kim Ki Bong;Cheon Jin Hong
    • The Journal of Pediatrics of Korean Medicine
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    • v.38 no.2
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    • pp.53-67
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    • 2024
  • Objective This study aimed to assess the trend of randomized clinical trials conducted in China involving oral herbal medicine for treating adolescent polycystic ovary syndrome (PCOS). Methods We used the China National Knowledge Infrastructure as our primary resource and conducted a search using keywords such as "PCOS", "多囊卵巢" and "多囊卵巢综合征". We identified and analyzed seven RCTs. Results 1. The group receiving herbal medicine treatment demonstrated significant improvements in total efficiency, sex hormone levels, and ultrasound-measurable values compared to the control group. 2. Epimedii Herba (淫羊藿), Alviae Miltiorrhizae Radix (丹參), and Angelicae Gigantis et Acutilobae Radix (當歸) were among the most used herbs in Traditional Chinese medicine decoctions for treating PCOS. Conclusions The findings suggest that oral herbal medicine is an effective treatment for patients with PCOS. This study provides a foundation for future research on the use of oral herbal medicine in PCOS treatment.

A Systematic Review of Acupuncture-Moxibution Treatment for Functional Dyspepsia (기능성 소화불량증에 사용된 침구치료방법에 대한 체계적 문헌고찰)

  • Kim, Bo-Young;Seo, Bok-Nam;Park, Ji-Eun;Yang, Chang-Sop;Kim, Ick-Tae;Im, Ji-Won;Kim, Young-Eun
    • Korean Journal of Acupuncture
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    • v.34 no.1
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    • pp.8-36
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    • 2017
  • Objectives : The aim of this study is to review the methodology of clinical trials conducted with the acupuncture and moxibustion treatment on functional dyspepsia. Methods : We searched four international databases and three Korean databases including English, Korean and Chinese, through March 2016 for randomized controlled trials(RCT) and non-randomized case-control trials(CCT) that evaluated the effects of the acupuncture and moxibustion on functional dyspepsia. We abstracted the designs of the trials and the method of acupuncture and moxibustion treatment according to the Standards for Reporting Interventions in Clinical Trials of Acupuncture. Results : A total 117 papers were reviewed. The 106 studies were conducted in China. There were 111 RCTs(95%), and 6 CCTs(5%). Sixty eight studies(59%) were conducted with the manual acupuncture, 29 studies of electro-acupuncture(25%), 11 studies of moxibustion(9%), 5 studies of acupoints embedding therapy(4%), 4 studies of acupoint injection therapy(3%) were conducted. ST36, CV12, ST25 were most frequently used for acupoints to treat functional dyspepsia. In 59 studies(50%), western medication was used in the control group, and the effects of acupuncture and moxibustion were evaluated with the symptoms in most studies. Conclusions : These results suggest that it is necessary to develop more detailed reporting standards about acupuncture and moxibustion treatment method as the method of acupuncture and moxibustion is getting more diverse, and more objective tools are needed in evaluating functional dyspepsia.

Meta-analysis of Six Randomized Control Trials of Chemotherapy Plus Anti-HER Monoclonal Antibody for Advanced Gastric and Gastroesophageal Cancer

  • Luo, Huai-Qing;Han, Li;Jiang, Yan
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.13
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    • pp.5343-5348
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    • 2014
  • Background: A meta-analysis was performed to examine the benefit/risk ratio for the addition of anti- HER MoAbs to chemotherapy in patients with advanced gastric and gastroesophageal cancer from six randomized phase II/III trials. Materials and Methods: We searched relative trials from Pubmed, EMBASE, Cochrane library databases, China National Knowledge Infrastructure databases, Google Scholar and the NIH ClinicalTrials. Primary outcomes were overall response rate (ORR), progression-free survival (PFS), overall survival (OS). Secondary outcomes were toxicities. All analyses were performed using STATA 12.0. Results: This meta-analysis included six randomized controlled trials (RCTs) with 2, 297 patients and we demonstrated that the anti-HER MoAbs arm did have a positive effect on ORR in the anti-HER MoAbs arm (OR 1.28, 95% CI 1.00-1.64, p=0.01). There was an increasing benefit regarding OS (HR 0.74, 95% CI 0.60-0.88, p<0.05) and PFS (HR 0.72, 95% CI 0.60-0.84, p<0.05) in the anti-HER2 subgroup, but a reduction of OS (HR 1.11, 95% CI 0.87-1.36, p<0.05) and PFS (HR 1.13, 95% CI 0.98 -1.28, P<0.05) in anti-EGFR subgroup. Some grade 3-4 toxicity had a significantly higher incidence in the anti-HER MoAbs arm. There was no significant publication bias for all endpoints. Conclusions: The addition of trstuzumab MoAb to chemotherapy for gastric and gastroesophageal cancer significantly improved outcome of OS and PFS endpoints, while other MoAbs led to no improvement in results. Some adverse events were increased in anti-HER MoAbs arm compared with the control.

Research Trends of Randomized Controlled Trials on Herbal Medicine Treatment for Atopic Dermatitis-Focusing on CNKI (아토피 피부염의 한약 치료에 대한 무작위대조군연구 중심의 연구 동향 - CNKI를 중심으로)

  • Yang, Geum-Jin;Jo, Eun-hee;Kang, Su-Jin;Hong, Jieun;Shim, Yu-Hwa;Lee, Ju-Hyun;Park, Min-cheol
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.34 no.2
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    • pp.102-116
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    • 2020
  • The purpose of this study was to analyze the research trends of randomized controlled trials on herbal medicine treatment for atopic dermatitis in China for the last 5 years. We searched for randomized controlled trials with the intervention of herbal medicine for the treatment of atopic dermatitis in the CNKI (China National Knowledge Infrastructure) from January 2014 to December 2018. For the screening of the paper, we used '特应性皮炎' and '异位性皮炎' which mean atopic dermatitis and search was limited to three areas within Medicine & Public Health: Traditional Chinese Medicine, Traditional Chinese Medicinal Herbs, Combination of Traditional Chinese Medicine with Western Medicine. Among the 136 searched studies, we selected a total of 34 studies and analyzed a year of publication, subject characteristics, study design and intervention, prescribed herbal medicine and herbs, pattern identification, evaluation criteria, and outcomes. Longmu decoction (龍牡湯) and Polia Sclerotium (茯笭) was the most frequently prescribed medicine and herb. The most commonly used pattern identification was Blood deficiency and Wind-dryness (血虛風燥), and among them, the most frequently prescribed herb is Rehmanniae Radix (生地黃). In most studies using the total effectiveness and SCORAD index as an outcome measure, the herbal medicine treatment group showed statistically better results than the control group. As a result of the safety assessment, the herbal medicine treatment group was reported having significantly fewer side effects compared to the control group. Hence, it was confirmed that the intervention including herbal medicine had a significant effect on atopic dermatitis. This study would be able to provide the basis of clinical research on atopic dermatitis and applied to the treatment of atopic dermatitis.

Preoperative chemoradiotherapy versus postoperative chemoradiotherapy for stage II-III resectable rectal cancer: a meta-analysis of randomized controlled trials

  • Song, Jin Ho;Jeong, Jae Uk;Lee, Jong Hoon;Kim, Sung Hwan;Cho, Hyeon Min;Um, Jun Won;Jang, Hong Seok;Korean Clinical Practice Guideline for Colon and Rectal Cancer Committee
    • Radiation Oncology Journal
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    • v.35 no.3
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    • pp.198-207
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    • 2017
  • Purpose: Whether preoperative chemoradiotherapy (CRT) is better than postoperative CRT in oncologic outcome and toxicity is contentious in prospective randomized clinical trials. We systematically analyze and compare the treatment result, toxicity, and sphincter preservation rate between preoperative CRT and postoperative CRT in stage II-III rectal cancer. Materials and Methods: We searched Medline, Embase, and Cochrane Library from 1990 to 2014 for relevant trials. Only phase III randomized studies performing CRT and curative surgery were selected and the data were extracted. Meta-analysis was used to pool oncologic outcome and toxicity data across studies. Results: Three randomized phase III trials were finally identified. The meta-analysis results showed significantly lower 5-year locoregional recurrence rate in the preoperative-CRT group than in the postoperative-CRT group (hazard ratio, 0.59; 95% confidence interval, 0.41-0.84; p = 0.004). The 5-year distant recurrence rate (p = 0.55), relapse-free survival (p = 0.14), and overall survival (p = 0.22) showed no significant difference between two groups. Acute toxicity was significantly lower in the preoperative-CRT group than in the postoperative-CRT group (p < 0.001). However, there was no significant difference between two groups in perioperative and chronic complications (p = 0.53). The sphincter-saving rate was not significantly different between two groups (p = 0.24). The conversion rate from abdominoperineal resection to low anterior resection in low rectal cancer was significantly higher in the preoperative-CRT group than in the postoperative-CRT group (p < 0.001). Conclusions: As compared to postoperative CRT, preoperative CRT improves only locoregional control, not distant control and survival, with similar chronic toxicity and sphincter preservation rate in rectal cancer patients.

A Review on Clinical Studies of Acupuncture and Moxibustion Therapy for Acute Herpes Zoster (급성기 대상포진의 침구치료에 대한 임상 연구 문헌 고찰)

  • Choi, Yoo Min;Kim, Seok Hee;Kim, Ju Yong;Park, Sang Hun;Yook, Tae Han;Kim, Jong Uk
    • Journal of Acupuncture Research
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    • v.32 no.3
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    • pp.147-161
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    • 2015
  • Objectives : The purpose of this study was to review the effectiveness of acupuncture and moxibustion therapy for the treatment of acute herpes zoster. Methods : Data was collected by two researchers. Clinical trials on PubMed were retrieved using MeSH terms including "herpes zoster" combined with "acupuncture therapy", "moxibustion", "bloodletting", "electroacupuncture", and related keywords. We excluded irrelevant studies and included randomized and non-randomized controlled trials, case series and case reports. Finally, we selected a total of thirteen studies and conducted a literature analysis and an object quality assessment. Results : Twelve of thirteen studies were about acupuncture and moxibustion combined therapy. Only one study suggested that a single acupuncture therapy is expected to be equally as effective as a common western medicine therapy. There was some evidence related to the effectiveness of moxibustion, venesection and electroacupuncture, but it dealt with combining therapy and was insufficient, and with an inclusion of potential risk factors. Only one study was conducted under approval from an institutional review board. No severe treatment-related adverse events were observed. A quality assessment suggested that there was some weakness in the areas of blinding and concealment. Conclusions : There is some evidence that suggests the effectiveness and safety of acupuncture and moxibustion combined therapy as a treatment for acute herpes zoster.