• Asian Pacific Journal of Cancer Prevention
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• v.13 no.12
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• pp.6337-6342
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• 2012

Background: Clinical trials on cancer subjects have one of the highest dropout rates. Barriers to recruitment range from patient-related, through institutional-related to staff-related factors. This paper highlights the low response rate and the recruitment barriers faced in our Qigong exercises trial. Materials and Method: The Qigong trial is a three-arm trial with a priori power size of 114 patients for 80% power. The University Malaya Medical Centre database showed a total of 1,933 patients from 2006-2010 and 751 patients met our inclusion criteria. These patients were approached via telephone interview. 131 out of 197 patients attended the trial and the final response rate was 48% (n=95/197). Results: Multiple barriers were identified, and were regrouped as patient-related, clinician-related and/or institutional related. A major consistent barrier was logistic difficulty related to transportation and car parking at the Medical Centre. Conclusions: All clinical trials must pay considerable attention to the recruitment process and it should even be piloted to identify potential barriers and facilitators to reduce attrition rate in trials.

• Asian Pacific Journal of Cancer Prevention
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• v.14 no.5
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• pp.2789-2800
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• 2013

Background: The aim of this systematic review was to investigate whether stem cells could be effectively applied in targeted therapy of breast cancer. Material and Method: A systematic literature search was performed for original articles published from January 2007 until May 2012. Results: Nine studies met the inclusion criteria for phase I or II clinical trials, of which three used stem cells as vehicles, two trials used autologous hematopoetic stem cells and in four trials cancer stem cells were targeted. Mesenchymal stem cells (MSCs) were applied as cellular vehicles to transfer therapeutic agents. Cell therapy with MSC can successfully target resistant cancers. Cancer stem cells were selectively targeted via a proteasome-dependent suicide gene leading to tumor regression. $Wnt/{\beta}$-catenin signaling pathway has been also evidenced to be an attractive CSC-target. Conclusions: This systematic review focused on two different concepts of stem cells and breast cancer marking a turning point in the trials that applied stem cells as cellular vehicles for targeted delivery therapy as well as CSC-targeted therapies. Applying stem cells as targeted therapy could be an effective therapeutic approach for treatment of breast cancer in the clinic and in therapeutic marketing; however this needs to be confirmed with further clinical investigations.

• Journal of Acupuncture Research
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• v.30 no.3
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• pp.51-59
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• 2013

Objectives : This study was designed to evaluate clinical evidence of acupuncture treatment for peripheral facial palsy in South Korea. Methods : All process was independently proceeded by two investigators. Literature search was performed in 9 databases from their inception to February 2013. Searched reports was twice excluded for title, abstract and body. And then, data extract and analysis was done before assessing risk of bias by Cochrane Handbook. Results : 10 randomized controlled trials(RCT) were finally included. 4 RCT handled postauricular pain with facial palsy. All articles at least used in combination with two treatments. Interventions like pharmacopuncture, electroacupuncture, scalp acupuncture etcetera were conducted as treatment to evaluate efficacy, and some study reported advantageous effects of treatment group compared to baseline or control group. Adverse events didn't referd to in any studies. In assessing risk of bias, indefinite and uncertain information made all included trials to have a high risk of bias. Conclusions : Because of methodological deficit, there is no sufficient evidence to allow any conclusion about the efficacy of acupuncture for peripheral facial palsy. Therefore, well designed trials with high quality is needed from now on.

• Journal of Dental Anesthesia and Pain Medicine
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• v.21 no.4
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• pp.269-282
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• 2021

This review aimed to assess and compare the outcomes of the anesthetic efficacy of inferior alveolar nerve block (IANB) and Gow-Gates mandibular nerve block (GGMNB) in patients with symptomatic irreversible pulpitis. A descriptive systematic review of quantitative research was conducted wherein the "Preferred Reporting Items for Systematic Reviews (PRISMA)" was adopted, and the Problem/Patient/Population, Intervention/Indicator, Comparison, Outcome (PICO) criteria were used to structure the research question. A literature search was performed using PubMed/Medline, Cochrane Library, Google Scholar, and Ovid. Selection criteria were applied for populations over nine years of age, of either sex, with irreversible pulpitis, and articles published in English regarding conventional IANB or IANB and Gow-Gates techniques between 2009 and 2019. Prospective randomized clinical trials or randomized controlled trials were included in the review, in which anesthetic efficacy or success was measured. After screening, four articles were included. Three studies were randomized clinical trials, and two were randomized controlled trials. The validity and reliability of the individual studies were examined. There was evidence of the higher efficacy of the GGMNB technique than that of the IANB technique. However, both techniques can be mastered through training.

• BMB Reports
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• v.56 no.9
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• pp.488-495
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• 2023

Mitochondrial transplantation is a promising therapeutic approach for the treatment of mitochondrial diseases caused by mutations in mitochondrial DNA, as well as several metabolic and neurological disorders. Animal studies have shown that mitochondrial transplantation can improve cellular energy metabolism, restore mitochondrial function, and prevent cell death. However, challenges need to be addressed, such as the delivery of functional mitochondria to the correct cells in the body, and the long-term stability and function of the transplanted mitochondria. Researchers are exploring new methods for mitochondrial transplantation, including the use of nanoparticles or CRISPR gene editing. Mechanisms underlying the integration and function of transplanted mitochondria are complex and not fully understood, but research has revealed some key factors that play a role. While the safety and efficacy of mitochondrial transplantation have been investigated in animal models and human trials, more research is needed to optimize delivery methods and evaluate long-term safety and efficacy. Clinical trials using mitochondrial transplantation have shown mixed results, highlighting the need for further research in this area. In conclusion, although mitochondrial transplantation holds significant potential for the treatment of various diseases, more work is needed to overcome challenges and evaluate its safety and efficacy in human trials.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.31 no.2
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• pp.40-59
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• 2018

Objectives : We report on the contents and reviews of the guidelines for clinical trials of herbal medicine for psoriasis. Methods : After reviewing the existing reports, the guidelines were drafted by the writing committee on guidelines for Korean medicine clinical trial center in Kyung Hee university Korean medicine hospital. Since then, the guidelines have been consulted by the experts in diseases, clinical trials and pharmaceuticals. In addition, the guidelines have been certified by the Korean medicine clinical trial center association and Korean Medicine Ophthalmology & Otolaryngology & Dermatology Society. Results : The guidelines for clinical trials are divided into 8 categories: (1) general contents, (2) evaluation standards of effectiveness, (3) outcome valuables, (4) selection of study participants, (5) designs of clinical trials, (6) safety evaluations, (7) combination therapies in psoriasis treatment and (8) Korean medical considerations. Conclusions : There are 3 major contents for discussion: (1) obscurity of Korean medical considerations to differentiate from existing guidelines, (2) the absence of Korean version of PASI and DLQI, which are validity parameters and (3) realistic institutional problem using the herbal medicine.

• Journal of Korean Medical classics
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• v.23 no.4
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• pp.63-102
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• 2010

Purpose : To propose various types of clinical research which is feasible for botanical new drug (IND) development processes, and suggest essential steps to development of study protocol for IND. Methods : Literature-based discussions and one research group's experience is given regarding domestic act, regulation, and system. Results : In order to get an approval of IND for botanical drug in Korea there are several types of clinical research to conduct. In quality control steps for standardized medicinal herbs, case reports or case series can be conducted, and for good manufacturing practice(GMP) steps, we can conduct case reports, case series, and retrospective cohort studies. In addition, as long as we gathered good laboratory practice(GLP) data we can conduct up to quasi-experimental studies and clinical trials including investigator initiated trials. In order to conduct these studies development of study protocol is essential. First, we obtain historical evidence including target disease and indication, efficacy, safety, and endpoints by reviewing medical classics. Second, we obtain clinically and statistically important data by conducting non-clinical studies, observation studies, and quasi-experimental studies. Third, we generate research hypotheses and purposes and explore methodologies, endpoints, clinical practice guidelines, cost-effectiveness, and commercial potential. Finally, we develop study protocol with aid of biostatistician or expert in contract research organization. Discussions and conclusions : This study have obvious limitations in that most thoughts, suggestions, and proposes are from one research group's experience. Therefore, we hope to see various types of research in this topic and process from other research group as well.

• The Journal of Internal Korean Medicine
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• v.28 no.3
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• pp.519-530
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• 2007

Objectives : The purpose of this study was to develop outcome indicators in clinical trials of herbal drugs effective for asthma. cough and sputum. To accomplish the objective, this study collected outcome indicators developed and used according to conventional medical concepts. Methods : Our research group reviewed SCI papers concerned with developing outcome indicators to evaluate amelioration of asthma, cough and sputum. We also reviewed clinical trials of herbal drugs effective for them. Results : To evaluate asthma, objective as well as subjective methods were chosen according to the purpose of each trial. Objective methods were PEF, FEVl, serum IgE, peripheral eosinophil counts, and so on. Subjective methods were symptom scores, symptom diaries, quality of life measures, etc. To evaluate cough and sputum, objective and subjective methods were also chosen. Objective methods were tussigenic challenges, sputum induction and computerized methodology, and subjective methods were similar to the methodology evaluating asthmatic symptoms. Conclusions : It is desirable for a clinical trial evaluating herbal drugs for asthma, cough and sputum to use objective and subjective outcome indicators together. However, biological outcome indicators, a kind of objective methods, can not be chosen as the purpose of trial. Valid and reliable subjective outcome indicators are needed to develop good clinical trials of herbal drugs effective for asthma, cough and sputum.

• The Korea Journal of Herbology
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• v.24 no.4
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• pp.205-213
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• 2009

Objectives : Cancer incidence is increasing in all countries and chemotherapy-induced peripheral neuropathy (CIPN) in patients undergoing chemotherapeutic agents have been a clinically serious problems. So far therapeutic options for CIPN patients are limited and no confirmed methods have yet been established for dealing with peripheral neuropathy. Therefore this review is to provide an evidence-based summary of oriental medicine and CAM (complementary and alternative medicine) neuroprotective and treatment therapies which have gone through clinical trials. Methods : An overview of the domestic and international papers of adult clinical trials relating management of only CIPN symptoms through 1990 to present were searched by electronic databases. Search key words were chemotherapy-induced neurotoxicity, chemotherapy-induced peripheral neuropathy, chemotherapy toxicity & herb, chemotherapy toxicity & acupuncture, chemotherapy toxicity & CAM. Only English and Korean written papers were reviewed. Total 25 papers were reviewed in this study, 18 papers were retrieved by electronic search. Results : Clinical studies of managing CIPN were rare, two acupuncture clinical studies and four herb medicinal studies were found. Rest of 19 papers were about other CAM clinical studies. Total 25 papers were analyzed, and all interventions were focused on their pain control efficacy. Other 24 trials of potential therapies except one proved to be effective for CIPN, however some described to be inadequate positive or sufficient negative. Conclusions : As most of the studies were pilot studies, interventions for the prevention and treatment of CIPN have to go through prospective confirmatory studies, such as larger scale randomized, double-blinded, placebo controlled clinical trials must be done for the safe and effective use of proposed therapies. Also standard measurement scales have to be developed for the better clinical study of CIPN.

• Asian Pacific Journal of Cancer Prevention
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• v.13 no.4
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• pp.1159-1166
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• 2012

Research on radiation oncologists has indicated that there is a shortage in supply of specialist workers in this field internationally, and also within Australia. However, there are no current estimates as to what the future Australian radiotherapy workforce will look like. This paper aims to review the current status and capacity of the three main disciplines that make up the radiation oncology workforce in Australia and project the workforce supply and demand for 2014 and 2019. Using data on the workforce from a survey of all radiotherapy facilities operating in Australia in 2008 a workforce model was constructed. This study found that there will be a future shortfall of radiation oncologists, radiation therapists and radiation oncology medical physicists working in radiation oncology treatment. By 2014 there will be 109 fewer radiation oncologists than what will be demanded, and by 2019 this figure will increase to a shortfall of 155 radiation oncologists. There was a projected shortfall of 612 radiation therapists by 2014, with this figure slightly decreasing to a shortfall of 593 radiation therapists in 2019. In 2014, there was projected to be a deficit of 104 radiation oncology medical physicists with a persisting shortfall of 78 in 2019. This future projected shortage highlights the need for radiation oncology workforce planning.