• Title/Summary/Keyword: Clinical Trials

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The Effect of Herbal Medicine for Adenomyosis patients: A Systematic Review (자궁선근증에 대한 한약의 효과 : 체계적 문헌 고찰)

  • Jung, Jae-Woong;Yoon, Young-Jin
    • The Journal of Korean Obstetrics and Gynecology
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    • v.32 no.4
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    • pp.87-101
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    • 2019
  • Objectives: The purpose of this study is to investigate the effect of herbal medicine during the Western medicine therapy in adenomyosis. Methods: The author searched 5 electronic databases and search keywords were 'Adenomyosis' and 'Herbal Medicine'. We included randomized controlled clinical trials (RCTs) using herbal medicine therapy combined Western medicine for adenomyosis patients. Results: The author selected 12 studies. The systematic review of the 12 trials indicated that herbal medicine therapy integrated Western medicine therapy was more effective than Western medicine therapy alone. Conclusions: The herbal medicine therapy combined Western medicine for adenomyosis patients seems to improve pain relief and improvement of illness from this research. However, this result should be taken cautiously by unclear risk of bias. More clinical research will be needed to standardize the results of this study through herbal medicine.

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.

Phototherapy in Allergic Rhinitis: From In Vitro Studies to Clinical Trials

  • Yoo, Shin Hyuk;Chung, Young-Jun;Bae, Jun-Sang;Mo, Ji-Hun
    • Medical Lasers
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    • v.9 no.2
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    • pp.95-102
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    • 2020
  • Phototherapy has a profound immunosuppressive effect and is widely used for the treatment of inflammatory skin diseases. Since allergic rhinitis (AR) shares several common pathologic features with atopic dermatitis, intranasal phototherapy is a novel approach for treating AR. Phototherapy reduces the antigen presenting capacity of dendritic cells, induces apoptosis of immune cells, and inhibits synthesis and release of pro-inflammatory mediators from inflammatory cells. The effectiveness of phototherapy for AR has been extensively researched: from in vitro studies to several clinical trials. Data indicates the potential of intranasal phototherapy as an alternative treatment for AR as well as other inflammatory mucosal diseases. In this review, we introduce the in vitro, in vivo studies, and clinical trials which demonstrated the effect of phototherapy on AR.

Dendritic Cell-based Immunotherapy for Rheumatoid Arthritis: from Bench to Bedside

  • Md. Selim Ahmed;Yong-Soo Bae
    • IMMUNE NETWORK
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    • v.16 no.1
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    • pp.44-51
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    • 2016
  • Dendritic cells (DCs) are professional antigen presenting cells, and play an important role in the induction of antigen-specific adaptive immunity. However, some DC populations are involved in immune regulation and immune tolerance. These DC populations are believed to take part in the control of immune exaggeration and immune disorder, and maintain immune homeostasis in the body. Tolerogenic DCs (tolDCs) can be generated in vitro by genetic or pharmacological modification or by controlling the maturation stages of cytokine-derived DCs. These tolDCs have been investigated for the treatment of rheumatoid arthritis (RA) in experimental animal models. In the last decade, several in vitro and in vivo approaches have been translated into clinical trials. As of 2015, three tolDC trials for RA are on the list of ClinicalTrial.gov (www.clinicaltrials.gov). Other trials for RA are in progress and will be listed soon. In this review, we discuss the evolution of tolDC-based immunotherapy for RA and its limitations and future prospects.

Review of Clinical Research of Korean Medicine on Postpartum Pelvic Organ Prolapse (산후 골반장기탈출증에 대한 한의학적 임상 연구 동향)

  • Park, Nam-Gyeong;Hwang, Young-Sik;Kim, Gyu-Tae;Park, Seung-Hyeok;Lee, Jin-Moo;Lee, Chang-Hoon;Jang, Jun-Bock;Hwang, Deok-Sang
    • The Journal of Korean Obstetrics and Gynecology
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    • v.33 no.4
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    • pp.93-112
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    • 2020
  • Objectives: The purpose of this study is to review the clinical research trends of postpartum pelvic organ prolapse and to recognize the efficacy of Korean medicine intervention. Methods: Based on seven domestic and foreign databases, including Research Information Sharing Service (RISS), Oriental Medicine Advanced Searching Integrated System (OASIS), Journal of Korean Obstetric and Gynecology, Cochrane Library Central, Pubmed, China National Knowledge Infrastructure (CNKI) and WangFang Med Online, we analyzed the clinical trials using Korean medicine intervention, which included acupuncture and herbal medicine. Data retrieval was carried out on May 18 to 20, 2020, and a total of 13 papers were included. Results: All papers were published in China and it contains nine randomized controlled trials, three clinical trials, and one case. The most frequently used intervention was herbal medicine, and Bupleuri Radix, Cimicifugae Rhizoma were used. The treatment group treated by Korean medicine intervention was more effective than the control group. Also, there were no significant side effects of Korean medicine. Conclusion: This study shows that Korean medicine can be effective and safe medical alternatives or options for pelvic organ prolapse patients. However, to laying the foundation of clinical guidelines and applying it to the real-world clinical scene, further follow-up research is needed.

Continual Reassessment Method in Phase I Clinical Trials for Leukemia Patients (백혈병환자 대상의 제1상임상시험 연속재평가방법)

  • Lee, Joo-Hyoung;Song, Hae-Hiang
    • Communications for Statistical Applications and Methods
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    • v.18 no.5
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    • pp.581-594
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    • 2011
  • The traditional method of 3+3 standard design and model-based Bayesian continual reassessment method (CRM) are commonly used in Phase I clinical trials to identify the maximal tolerated dose(MTD) of a new drug. In this paper we review clinical examples of Phase I trials that were carried out in patients with refractory or relapsed leukemia and myelodysplastic syndrome. The recently proposed 3+1+1 design and rolling-6 design can shorten the trial duration, when a very slow accrual of patients with a simple 3+3 standard design may result in the untimely termination of trials. Too conservative approaches in determining the dose levels in Phase I clinical trials can leave clinical investigators unable to accurately determine the MTD. When determining future patient doses, the designs that use a time-to-event CRM can cooperate late toxicities by accounting for the proportion of the observation period of each enrolled patient. With the CRM design, simulations under different scenarios during the trial are important in detecting the under- or over-estimation of the initial estimate of the dose-limiting toxicity rate for each dose level. We present the advantages and drawbacks of the designs used in Phase I clinical trials for leukemia patients.

Analysis for Randomized Controlled Clinical Trials of Acupuncture-type Treatment on Gastrointestinal Dysfunction after Ceasarean Section (제왕절개술 후 발생한 위장관 기능장애에 대한 최신 RCT 연구 동향 분석 - 경혈 자극을 중심으로 -)

  • Jeong, So-Mi;Lee, Jin-Moo;Lee, Chang-Hoon;Hwang, Deok-Sang;Jang, Jun-Bock
    • The Journal of Korean Obstetrics and Gynecology
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    • v.33 no.1
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    • pp.19-35
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    • 2020
  • Objectives: The purpose of this study was to show effectiveness of Acupuncture treatment on gastrointestinal dysfunctions after Cesarean section by analyzing randomized controlled clinical trials. Methods: We searched randomized controlled clinical trials related with acupuncture treatment on gastrointestinal dysfunctions after Cesarean section through national and overseas database and analyzed them in detail. Results: 6 articles were included according to our selection criteria and 1,084 women were involved. 3 studies used TEAS (Transcutaneous Electrical Acupoint Stimulation), 2 studies used Elastic band and 1 study used Acupressure by hand. Their results were statistically more effective than control groups. The most frequently used acupoints were Neiguan (PC6), Zusanli (ST36) followed by Sanyinjiao (SP6), Hegu (IL4). Conclusions: There was significant difference in the effectiveness of the intervention including Acupuncture treatment. Based on analysis, it could be an effective way for the treatment of gastrointestinal dysfunctions after Cesarean section in clinical practice.

Pharmacological Treatment of Major Depressive Episodes with Mixed Features: A Systematic Review

  • Shim, In Hee;Bahk, Won-Myong;Woo, Young Sup;Yoon, Bo-Hyun
    • Clinical Psychopharmacology and Neuroscience
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    • v.16 no.4
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    • pp.376-382
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    • 2018
  • We reviewed clinical studies investigating the pharmacological treatment of major depressive episodes (MDEs) with mixed features diagnosed according to the dimensional criteria (more than two or three [hypo]manic symptoms+principle depressive symptoms). We systematically reviewed published randomized controlled trials on the pharmacological treatment of MDEs with mixed features associated with mood disorders, including major depressive disorder (MDD) and bipolar disorder (BD). We searched the PubMed, Cochrane Library, and ClinicalTrials.gov databases through December 2017 with the following key word combinations linked with the word OR: (a) mixed or mixed state, mixed features, DMX, mixed depression; (b) depressive, major depressive, MDE, MDD, bipolar, bipolar depression; and (c) antidepressant, antipsychotic, mood stabilizer, anticonvulsant, treatment, medication, algorithm, guideline, pharmacological. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We found few randomized trials on pharmacological treatments for MDEs with mixed features. Of the 36 articles assessed for eligibility, 11 investigated MDEs with mixed features in mood disorders: six assessed the efficacy of antipsychotic drugs (lurasidone and ziprasidone) in the acute phase of MDD with mixed features, although four of these were post hoc analyses based on large randomized controlled trials. Four studies compared antipsychotic drugs (olanzapine, lurasidone, and ziprasidone) with placebo, and one study assessed the efficacy of combination therapy (olanzapine+fluoxetine) in the acute phase of BD with mixed features. Pharmacological treatments for MDEs with mixed features have focused on antipsychotics, although evidence of their efficacy is lacking. Additional well-designed clinical trials are needed.

Success rate of nitrous oxide-oxygen procedural sedation in dental patients: systematic review and meta-analysis

  • Rossit, Marco;Gil-Manich, Victor;Ribera-Uribe, Jose Manuel
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.21 no.6
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    • pp.527-545
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    • 2021
  • The aim of this systematic review was to determine the success rate of nitrous oxide-oxygen procedural sedation (NOIS) in dentistry. A systematic digital search was conducted for publications or reports of randomized controlled trials evaluating the clinical performance of NOIS. Abstracts of research papers were screened for suitability, and full-text articles were obtained for those who met the inclusion and exclusion criteria accordingly. The quality of the studies was assessed using the revised Cochrane risk-of-bias tool (RoB 2). A total of 19 articles (eight randomized clinical trials with parallel intervention groups and 11 crossover trials), published between May 1988 and August 2019, were finally selected for this review. The studies followed 1293 patients reporting NOIS success rates, with a cumulative mean value of 94.9% (95% CI: 88.8-98.9%). Thirteen trials were conducted on pediatric populations (1098 patients), and the remaining six were conducted on adults (195 patients), with cumulative efficacy rates of 91.9% (95% CI: 82.5-98.1%) and 99.9% (95% CI: 97.7-100.0%), respectively. The difference was statistically significant (P = 0.002). Completion of treatment and Section IV of the Houpt scale were the most used efficacy criteria. Within the limitations of this systematic review, the present study provides important information on the efficacy rate of NOIS. However, further well-designed and well-documented clinical trials are required and there is a need to develop guidelines for standardization of criteria and definition of success in procedural sedation. Currently, completion of treatment is the most used parameter in clinical practice, though many others also do exist at the same time. To maximize NOIS efficacy, clinicians should strictly consider appropriate indications for the procedure.

Clinical research methodology for Traditional Korean Medicine treatment of lung cancer : Evidence-based approach (폐암(肺癌)의 한방치료 임상연구 방법론)

  • Kim, Kyung-Suk;Kim, Sme-Hyun;Eo, Wan-Kyu;Cheon, Seong-Ha;Eom, Seok-Ki;Jo, Hak-Jun
    • Journal of Korean Medical classics
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    • v.23 no.4
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    • pp.39-62
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    • 2010
  • Background : I investigated clinical research methodology of Traditional Korean Medicine(TKM) for treatment of lung cancer with Evidence Based Medicine(EBM) approach. Methods : I conducted the internet search of National Central Library, the National Assembly Library, Korea Education & Research Information Service, Korea Institute of Science and Technology Information for Korean theses and papers, and MEDLINE for the outside articles. Conclusion : In addition to outcomes of clinical trial, abundant clinician's experience and patients' preference are also considered. Pragmatic trials and quasi-experimental trials are better than clinical trials to plan clinical design of TKM for lung cancer and appropriate endpoints includes overall survival, disease-free survival, patient reporting outcome.