• Title/Summary/Keyword: Controlled clinical trials, randomized

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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."

A Systematic Review from the Journals of the Korean Oriental Medical Society. (대한한의학회지 및 대한한의학회 산하 정회원 학회의 학술진흥재단 등재지에 대한 천식 임상연구의 체계적 고찰)

  • Choi, Jun-Yong;Bang, Ji-Hyung;Shen, Feng-Yan;Jung, Hee-Jae;Jung, Sung-Ki
    • The Journal of Korean Medicine
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    • v.31 no.1
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    • pp.14-22
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    • 2010
  • Objectives: This study aimed to evaluate any clinical research regarding asthma published by the Korean Oriental Medical Society and its sub-societies for future rigorous clinical research. Methods: Every article relevant to asthma was initially obtained from journals in the Korean Oriental Medical Society and its sub-societies by electronic search at journal web sites or manual search. Journals were limited to those registered by the Korea Research Foundation. From initial findings, two independent reviewers selected clinical articles and these articles were further analyzed separately into predefined criteria according to prospective and retrospective studies. For prospective studies, quality assessment was also conducted. Results: From 99 articles initially obtained, 19 were finally analyzed. 14 were prospective whereas 5 were retrospective. Among the prospective articles, there were no randomized controlled trials and the non-randomized studies had no control groups, with several problems of quality regarding pre-calculated study size and unbiased assessment. None of the retrospective studies described asthma diagnosis objectively and outcome measures were either non-relevant to asthma or non-validated. Conclusions: Well-designed randomized controlled studies for asthma are needed and more rigorous non-randomized controlled studies should be conducted.

Systematic Review of Selection of Acupoints in Domestic Clinical Studies Related to Nuchal Pain (국내 경항통 연구에서의 경혈 선정에 관한 계통적 연구)

  • Lee, Hyung Eun;Lee, Eun Jung;Oh, Min Seok
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.27 no.6
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    • pp.698-704
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    • 2013
  • The purpose of this study is to figure out which acupoints are selected to treat nuchal pain and attempt to analyze the meaning of those acupoints in current clinical trials. We searched ten electronic databases and manually checked related Korean journals and references. We included randomized controlled trials(RCT), clinical controlled trials(CCT), case reports/series, and literature reviews using acupojnts to treat nuchal pain. We investigated the frequency of selected acupoints. We included 31 articles in this study. The most frequently adopted acupoints were GB20(77.41%), followed by GB21(61.29%). In distribution according to meridian system, BL was the most(25.60%), followed by Extra points of Dong-Shi(12.19%). Selected acupoints for treat nuchal pain were considered to be affected by flow of meridian system. It is necessary for more studies to provide clinical guideline of acupoint selection.

Respiratory Review of 2014: Pulmonary Thromboembolism

  • Lee, Jae Seung
    • Tuberculosis and Respiratory Diseases
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    • v.77 no.3
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    • pp.105-110
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    • 2014
  • Venous thromboembolism (VTE), which includes pulmonary embolism and deep vein thrombosis, is an important cause of morbidity and mortality. The aim of this review is to summarize the findings from clinically important publications over the last year in the area of VTE. In this review, we discuss 11 randomized controlled trials published from March 2013 to April 2014. The COAG and the EU-PACT trials indicate that pharmacogenetic testing has either no usefulness in the initial dosing of vitamin K antagonists or marginal usefulness in the Caucasian population. Recent clinical trials with novel oral anticoagulants (NOACs) have demonstrated that the efficacy and safety of rivaroxaban, apixaban, edoxaban, and dabigatran are not inferior to those of conventional anticoagulants for the treatment of VTE. The PEITHO and ULTIMA trials suggested that rescue thrombolysis or catheter-directed thrombolysis may maximize the clinical benefits and minimize the bleeding risk. Lastly, riociguat has a proven efficacy in treating chronic thromboembolic pulmonary hypertension. In the future, NOACs, riociguat, and catheter-directed thrombolysis have the potential to revolutionize the management of patients with VTE.

Review on Clinical Trials of Catgut Embedding for Obesity Treatment (비만치료에 응용되는 매선요법의 최근 연구 동향 고찰)

  • Song, Mi-Young;Kim, Ho-Jun
    • Journal of Korean Medicine for Obesity Research
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    • v.12 no.2
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    • pp.1-7
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    • 2012
  • Objectives: The purpose of this report was to review the clinical trials of the catgut embedding for obesity treatment. Methods: We searched the clinical trial papers with key words of obesity and catgut embedding via searching Pubmed, Scopus and KISS etc. Results: We reviewed 8 searched articles, 7 articles were conducted in China and only 1 article was published in Korea. Most of Chinese articles used acupuncture as a control group and revealed the equality or superiority of catgut embedding in body weight loss. The only Korean article, which was uncontrolled, implanted catgut in localized fat area, it had changes partially in fat thick, body size. Conclusions: The acupoint catgut embedding has the efficacy of body weight loss, but to confirm the efficacy of localized fat loss, more randomized controlled trials are needed.

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.

The Clinical Effect on Acupuncture Treatment of Postpartum Hypogalactia: A Systematic Review of Randomized Controlled Trials (산후 유즙분비부전에 대한 침 치료 효과 : 체계적 문헌 고찰)

  • Kim, Yu-Jeong;Park, Kyung-Sun;Hwang, Deok-Sang;Lee, Jin-Moo;Jang, Jun-Bok;Lee, Chang-Hoon
    • The Journal of Korean Obstetrics and Gynecology
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    • v.30 no.3
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    • pp.79-91
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    • 2017
  • Objectives: The purpose of this systematic review is to overview and evaluate the effect on postpartum hypogalactia after acupuncture treatment. Methods: Relevant randomized controlled trials (RCTs) were identified by database searches in Embase, Pubmed, CENTRAL, CNKI, KISS. Searching keywords were "Hypogalactia" or "Hypolactaion" and "Acupuncture". After searching qualified articles, we independently assessed the risk of bias according to the Cochrane Rob criteria. Results: Among the 81 articles five RCTs were finally selected. Four of the selected were statistically significant. One of them was not statistically significant because it was comparative study of chinese medicine and acupuncture treatment. The quality of the evidence for specific comparisons ranged from low to high. Conclusions: Our systematic review found encouraging. Acupuncture treatment would be effective way to increase insufficient milk supply on postpartum hypogalactia.

An Overview of Clinical Studies for Pompholyx in Traditional Chinese Medicine - Literature Review based on Randomized Controlled Trials - (한포진 치료의 중의학 임상연구 동향 - 무작위 대조군 임상연구를 중심으로 -)

  • Woo, Jeong A;Park, Beom Chan;Choi, Il Shin;Kim, Kibong;Cheon, Jin Hong
    • The Journal of Pediatrics of Korean Medicine
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    • v.35 no.4
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    • pp.82-95
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    • 2021
  • Objectives The purpose of this study is to analyze clinical studies on the effectiveness of TCM (traditional Chinese medicine) for pompholyx treatment and provide evidence for Korean medicine use. Methods Randomized controlled trials (RCT) which used TCM as a treatment for pompholyx were searched in China National Infrastructure (CNKI) platform. The risk of bias of studies was assessed by using Cochrane risk of bias (RoB) 2.0 tool. Results The selected 10 RCTs showed that the experimental group treated with either TCM alone or with a combination of TCM and Western medicine showed more significant therapeutic effect compared to the control group which Western medicine alone. Conclusions Based on the studies from China, TCM may be an effective treatment for pompholyx. This provides evidence for Korean medicine use, and its possible effectiveness in treating pompholyx

Review of Clinical Research for Herbal Medicine in the Treatment of Influenza Compared with Oseltamivir (Oseltamivir를 투약한 양성대조군과 비교한 인플루엔자의 한약 치료 효과 - RCT 연구를 중심으로 -)

  • Jang, Eun Ha;Min, Sang Yeon;Kim, Jang Hyun
    • The Journal of Pediatrics of Korean Medicine
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    • v.33 no.3
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    • pp.1-14
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    • 2019
  • Objectives The purpose of this study is to analyze clinical studies on effectiveness of herbal medicine in influenza compared with Oseltamivir. Methods We searched the randomized controlled trials (RCTs) with herbal medicine treatment on influenza compared to Oseltamivir from the Pubmed, CNKI, OASIS, NDSL, J-stage, and CiNii. Results 14 out of 717 studies were selected and analyzed. The herbal medicine treatment had a significant effects on the alleviation of fever, cough, sore throat than the Oseltamivir control treatment. Herbal medicine had same therapeutic effectiveness like Oseltamivir on duration of influenza-like symptoms and viral shedding. No serious adverse reactions were reported from the herbal medicine treatment. Conclusions The results of these trials showed that the herbal medicine may be more effective than the Oseltamivir in the treatment of influenza. Well-designed RCTs for domestic herbal medicine treatment on influenza are needed to prove its efficacy clearly.