• Title/Summary/Keyword: Randomized Clinical Trials

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Is Axillary Dissection Necessary for Breast Cancer in Old Women? A Meta-analysis of Randomized Clinical Trials

  • Zhang, Pei-Zhen;Chong, Le;Zhao, Ye;Gu, Jing;Tian, Jin-Hui;Yang, Ke-Hu
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.2
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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.

A Review of Clinical Researches for Acupuncture Treatment on Tourette Syndrome (투렛장애 (Tourette syndrome)의 침 치료에 대한 중의학 임상 연구 고찰)

  • Kim, Boram;Choi, Il Shin;Kim, Ki Bong;Cheon, Jin Hong
    • The Journal of Pediatrics of Korean Medicine
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    • v.36 no.2
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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.

Analysis of Existing Guidelines and Randomized, Controlled, Clinical Trials for Development of [Guideline of Clinical Trial on Herbal Medicinal Product for Liver Cancer] (간암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 무작위배정 대조군 임상시험 고찰)

  • Han, Ga-jin;Kim, Dong-hun;Park, Eun-joo;Seong, Sin;Kim, Sung-su;Leem, Jung-tae
    • The Journal of Internal Korean Medicine
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    • v.40 no.1
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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."

Research Trends of Randomized Clinical Trial for Insomnia Using the Network Analysis (네트워크 분석을 이용한 불면의 무작위임상시험 해외 연구 동향)

  • Baek, Younghwa;Jin, Hee-Jeong
    • The Journal of the Korea Contents Association
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    • v.13 no.12
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    • pp.1036-1047
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    • 2013
  • In this study, we applied the time series analysis to the randomized controlled trial (RCT) researches related to insomnia for finding international trends. The data used in the analysis of 379 of ClinicalTrials, Web of Science was the of 132 by several keyword related with 'Insomnia' and 'Randomized Clinical Trial'. In ClinicalTials, RCT studies for insomnia, drug, cognitive behavioral therapy, depression were the key words make up the main network. In WOS, 'melatonin' key word was added in the main network. In addition to, we found the characteristic that the elderly and female subjects were steady studied.

The Analysis of Incidence and Type of Adverse Events in Acupuncture & Moxibustion Clinical Trials (침구임상시험에서 나타난 이상반응 발생률 및 유형 분석)

  • Jung, Hee-Jung;Park, Ji-Eun;Liu, Yan;Kim, Ae-Ran;Choi, Sun-Mi
    • Korean Journal of Acupuncture
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    • v.29 no.3
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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.

Review of Randomized Controlled Trials on Pharmacopuneture Treatment for Musculoskeletal Diseases (무작위대조군연구(RCT)를 중심으로 한 근.골격계 질환의 약침 치료에 관한 고찰)

  • Jang, Min-Ki;Yoon, Eun-Hye;Jung, Chan-Yung;Kim, Eun-Jung;Lee, Seung-Deok;Hwang, Min-Seop;Kim, Kap-Sung
    • Journal of Acupuncture Research
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    • v.26 no.3
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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.

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Outcomes of epidural steroids following percutaneous transforaminal endoscopic discectomy: a meta-analysis and systematic review

  • Song, Yinghao;Li, Changxi;Guan, Jingjing;Li, Cheng;Wu, Haisheng;Cheng, Xinzhi;Ling, Bingyu;Zhang, Jinglang
    • The Korean Journal of Pain
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    • v.35 no.1
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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.

Review on Clinical Study of Oriental Medical Treatment for Cancer in Korea (국내 한의학 암치료 임상연구 논문에 대한 고찰)

  • Kim, Jong-Han;Park, Dong-Suk;Kim, Yong-Suk;Lee, Jae-Dong
    • Journal of Acupuncture Research
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    • v.29 no.3
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    • pp.19-28
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    • 2012
  • Objectives : The aim of this study is to evaluate present clinical evidence of oriental medical treatment for cancer in Korea. Method : A search was performed in the Korean Studies Information, Korea Institute of Science and Technology Information, KoreaMed, Oriental Medicine Advanced Searching Integrated System, National Assembly Library, RISS4u, DBPIA, and Oasis using the keyword 'cancer', 'leukemia', 'malignant tumor', 'lymphoma', 'multiple myeloma', 'melanoma'. The search period spanned between Jan 1, 1980~June 30, 2011 and the results were analyzed and evaluated according to the publication date, journal, method of treatment, type of study, and the primary outcome. Randomized clinical trials (RCTs) and Non randomized clinical trial(NRCT) were reviewed separately. Result : The results yielded 133 trials during the period of Jan 1, 1980~June 30, 2011. Most of the trials were concerned with lung cancer and 94 of the trials were simple case studies or case series studies. 61 trials used herbal Formula/herbal medicine as the primary method of treatment. A total of 4 RCTs existed compared to only one NRCT. Conclusion : The use of oriental medicine for the treatment of cancer is gaining popularity in the field of medical scientific research. However most of the studies that have been published up to date are mostly case studies or case series studies, and RCT/NRCT are rare. In order to provide appropriate evidence regarding the effectiveness of oriental medicine in the treatment of cancer, more rigorous and well-designed studies are warranted.

Trends in Clinical Research of Herbal Medicine Treatment for Functional Gastrointestinal Disorders in Children - Focused on Randomized Controlled Trials in traditional Chinese medicine (소아 기능성 위장 장애의 한약 치료에 대한 임상연구 동향 - 중의학 무작위 대조군 임상시험을 중심으로)

  • Lee, Jihong;Lee, Sun Haeng;Chang, Gyu Tae
    • The Journal of Pediatrics of Korean Medicine
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    • v.35 no.3
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    • pp.67-88
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    • 2021
  • Objectives The purpose of this study is to analyze randomized clinical trials (RCTs) on traditional Chinese medicine to summarize its efficacy and safety for the treatment of functional gastrointestinal disorders (FGIDs) in children. Methods We searched literatures published up to March 19, 2021 using two Chinese electronic databases. Data regarding patients, interventions, results, and adverse events were extracted from RCTs of herbal medicine for children with FGIDs. Results A total of 34 RCTs were included: 16 trials on functional dyspepsia, 7 trials on functional constipation, 6 trials on functional abdominal pain, 4 trials on irritable bowel syndrome, and 1 trial on functional diarrhea. 26 of 29 trials that reported total effective rate, the treatment group showed a significant improvement compared to the control group. Most of other evaluation indicators, such as symptom score, symptom disappearance time, and recurrence rate also demonstrated statistically significant improvement. Of the 16 studies which reported safety, 5 studies reported no adverse reactions in either group, and 4 studies reported no statistically significant differences in the incidence of adverse events between two groups. Also, reported adverse events were mostly mild. Conclusions Herbal medicine may help improve symptoms of FGIDs in children. However, due to limited types of studies on sub-diseases of FGIDs and small sample sizes in each study, additional large scale clinical studies on various other FGIDs are necessary.