• Korean Journal of Clinical Pharmacy
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• v.29 no.2
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• pp.71-78
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• 2019

Objective: This study aimed to provide efficacy and safety information on the use of erenumab for prevention of episodic and chronic migraines. Methods: The keywords "Erenumab and migraine" were used to search the PubMed database to then compile efficacy and safety data for erenumab. Data from relevant Phase 2 and Phase 3 clinical trials were analyzed, using RevMan for statistical analysis. Results: Three clinical trials (one Phase 2 and two Phase 3 studies) were retrieved. All three trials used the same primary endpoint (change from baseline in monthly migraine days (CBMD)) to evaluate efficacy and safety of erenumab use for prevention of episodic and chronic migraines. Subcutaneous doses of erenumab (70 or 140 mg) were administered monthly in each trial, for 3 months (Studies 2, and 3) or 6 months (Study 1). The mean differences in CBMD in the 70 mg and 140 mg erenumab arms were -1.36 and -1.98, respectively, compared to that in the placebo arm. Some adverse events, such as nasopharyngitis and upper respiratory tract infection, were reported, but no differences in safety between erenumab and placebo were found to be significant. Conclusions: Erenumab showed superior efficacy in prevention of migraines compared to placebo. However, additional information regarding the long-term safety of erenumab should be collected. Therefore, post-marketing surveillance for adverse events is needed.

• The Korean Journal of Applied Statistics
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• v.33 no.2
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• pp.137-145
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• 2020

Phase I clinical trials (Dose Finding Studies) are the first step in administering new drugs developed through animal experiments or in vitro experiments to humans. An important area of interest in designing Phase I clinical trials is determining the dose that provides the greatest efficacy and acceptable safe dose to the patient. In this paper, we propose a method to determine the maximum tolerated dose considering efficacy and safety using Biased coin design and stopping rule. The proposed method is compared with existing methods through simulation.

• 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.

• The Journal of Pediatrics of Korean Medicine
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• v.29 no.3
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• pp.1-11
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• 2015

Objectives : The purpose of this study is to analyze the trends in foreign clinical trials for pediatric asthma in complementary and alternative medicine (CAM). Methods : We reviewed 31 randomized controlled trials (RCT) for pediatric asthma treatment in CAM published from 2005 to 2015 in PubMed and analyzed their treatments, compounds of herbal medicines, acupoints, methods of assessment, and treatment results. Results : The treatments used in the studies were herbal medicines, acupuncture, acupoint application, breathing training, supplement, normocaloric diet, yoga, massage therapy, and art therapy. The frequently used herbs were Asari Herba Cum Radix (細辛). Ephedrae Herba (麻黃), Astragali Radix. The most common acupoints were Feishu (肺兪, BL13). The methods of assessment in pediatric asthma were symptom scale, questionnaire of Quality of Life, lung function test, laboratory studies, and medication usage. In 28 out of 31 studies, treatment group gets better than non-treated group. Conclusions : This study shows that CAM is effective in treating pediatric asthma. More clinical studies using objective outcome measures are needed to prove its efficacy clearly.

• The Journal of Internal Korean Medicine
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• v.41 no.1
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• pp.59-68
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• 2020

Objectives: The purpose of this study was to investigate the current state of clinical trials for acupuncture treatment of Parkinson's disease (PD) using neuroimaging methods. Methods: We searched for clinical trial studies of acupuncture treatment for Parkinson's disease that used neuroimaging methods in the MEDLINE (PubMed) database. The identified studies were then selected manually based on inclusion criteria. We subsequently analyzed the characteristics of the selected articles and reviewed the neural substrates of acupuncture treatment in PD. Results: Eight studies were included. The most frequently applied modality for PD was functional MRI. The most frequently selected acupoint for PD was GV34. Several studies showed that acupuncture treatment could improve the symptoms of PD. Through the analysis, we demonstrated that the neuroimaging method could capture the neural substrates associated with PD and that acupuncture treatment may affect the activation of brain areas that are impaired in PD in a different way than sham acupuncture. Conclusions: Applying a neuroimaging method could be helpful in clinical trials of acupuncture treatment for PD, and more efforts should be made in this area.

• Journal of Korean Medicine Rehabilitation
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• v.33 no.1
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• pp.13-29
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• 2023

Objectives To evaluate the evidence supporting the effectiveness of acupuncture for facet joint syndrome. Methods We conducted search across 9 electronic databases (PubMed, EMBASE, Cochrane CENTRAL (CENTRAL), KoreaMed, Kmbase, Koreanstudies Information Service System (KISS), ScienceOn, China National Knowledge Infrastructure (CNKI), and Wanfang) to find clinical trials that used acupuncture as treatment for facet joint syndrome. The methodological quality of randomized controlled clinical trials (RCTs) were assessed using the Cochrane Risk of Bias (RoB) tool, while non-randomized controlled clinical trials (nRCTs) were assessed using the Cochrane Risk of Bias Assessment tool for Non-randomized Study (RoBANS) tool. Results Nine RCTs and one nRCT met our inclusion criteria. Fire needle was more effective than medial branch block in terms of visual analogue scale (VAS) after 1 month (p=0.02). Also, Fire needle was more effective than Ibuprofen in terms of VAS and oswestry disability index (ODI) (p<0.05). However, in the rest of the study results, the intervention group did not show a statistically significant difference than the control group. Conclusions Although our review found encouraging but limited evidence of acupuncture for facet joint syndrome, most of the studies included in the analysis were evaluated as methodologically high risk of bias. From now on further well-designed RCTs should be encouraged.

• Journal of Physiology & Pathology in Korean Medicine
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• v.37 no.6
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• pp.185-192
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• 2023

The purpose of this study is to analyze trends in domestic and international clinical research studies on pharmacopuncture treatment for fractures. We searched five online databases (PubMed, CNKI, RISS, KISS, and OASIS), and selected a total of 13 clinical research studies from Korea and China. Selected studies were analyzed according to publication year, subject, intervention, treatment method, evaluation scale, adverse event, risk of bias, etc. A total of 10 case studies and 3 randomized controlled trials were included. The study subjects were more often female, and the most common type of fracture was vertebral compression fracture. In Korea, herbal medicine preparations and bee venom were used for pharmacopuncture solution, whereas in China, both herbal medicine preparations and Western medicine preparations were used. All studies commonly used local acupoint needling, and in most cases, the treatment period for case study was less than 1 month, and the observation period of randomized controlled trials was diverse. The most frequently used evaluation scale was numeric rating scale, adverse events were mentioned in only three studies, and no adverse events were reported. Overall risk of bias of all included randomized controlled trials was judged "some concerns". According to this study, pharmacopuncture treatment for fractures was found to be relatively effective and safe, but research that complements the limitations of this study is needed.

• The Korean Society of Law and Medicine
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• v.21 no.2
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• pp.163-207
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• 2020

Korea has been positioned as the leading country in the industry of clinical trials as the clinical trail of Korea has developed for the recent 10 years. Clinical trial has plays a significant role in the development of medicine and the increase of curability. However, it has inevitable risk as the purpose of the clinical trial is to prove the safety and effectiveness of new drugs. Therefore, the clinical trial should be controlled properly to protect the health of the subjects of clinical trial and to ensure that they exercise a right of self-determination. In this context, the fiduciary duties of doctors who conduct clinical trials is especially important. The Pharmaceutical Affairs Act and the relevant regulations define several duties of doctors who conduct clinical trials. In particular, the duty to protection of subjects and the duty to provide information constitute the main fiduciary duties to the subjects. Those are essentially similar to the fiduciary duties of doctors in usual treatment from the perspective of the values promoted by the law and the content of the law. Nonetheless, clinical trials put more emphasis on the duties to provide explanation than in usual treatment. Further research and study are required to establish the concrete standard for the duty of care. However, if the blind pursuit of higher standards for the duty of care or to pass the burden of proof to doctors may result in disrupting the development of clinical trials, limiting the accessibility of patients to new treatment and even violating the principle of sharing damage equally and properly. In addition to these duties, the laws of clinical trials define several duties of doctors. Any decision on whether the violation of the law constitutes the violation of the fiduciary duty and justifies the demand for compensation of damages should be based on whether relevant law aims to protect the safety and benefit of subjects, even if in an incidental way, the degree to which such violation breaches the values promoted by the law and the concrete of violation of benefit of law, the detailed acts of such violation. The legal interests of the subjects can be protected effectively by guaranteeing compliance with those duties and establishing judicial and administrative controls to ensure that the benefit of subjects are protected properly in individual cases.

• Biomaterials Research
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• v.22 no.4
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• pp.303-310
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• 2018

Background: Photodynamic therapy (PDT) is photo-treatment of malignant or benign diseases using photosensitizing agents, light, and oxygen which generates cytotoxic reactive oxygens and induces tumour regressions. Several photodynamic treatments have been extensively studied and the photosensitizers (PS) are key to their biological efficacy, while laser and oxygen allow to appropriate and flexible delivery for treatment of diseases. Introduction: In presence of oxygen and the specific light triggering, PS is activated from its ground state into an excited singlet state, generates reactive oxygen species (ROS) and induces apoptosis of cancer tissues. Those PS can be divided by its specific efficiency of ROS generation, absorption wavelength and chemical structure. Main body: Up to dates, several PS were approved for clinical applications or under clinical trials. $Photofrin^{(R)}$ is the first clinically approved photosensitizer for the treatment of cancer. The second generation of PS, Porfimer sodium ($Photofrin^{(R)}$), Temoporfin ($Foscan^{(R)}$), Motexafin lutetium, Palladium bacteriopheophorbide, $Purlytin^{(R)}$, Verteporfin ($Visudyne{(R)}$), Talaporfin ($Laserphyrin^{(R)}$) are clinically approved or under-clinical trials. Now, third generation of PS, which can dramatically improve cancer-targeting efficiency by chemical modification, nano-delivery system or antibody conjugation, are extensively studied for clinical development. Conclusion: Here, we discuss up-to-date information on FDA-approved photodynamic agents, the clinical benefits of these agents. However, PDT is still dearth for the treatment of diseases in specifically deep tissue cancer. Next generation PS will be addressed in the future for PDT. We also provide clinical unmet need for the design of new photosensitizers.

• Bulletin of the Korean Chemical Society
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• v.33 no.2
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• pp.433-442
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• 2012

The promise of stem cell therapy for various clinical applications seems getting realistic. An increasing number of researchers, from virtually every discipline of natural sciences, are flocking into this new world. Only ten years ago, gene therapy was the medicine for the 21st century. The possibility was endless. Although the science itself underlying gene therapy was very young, the field was exploding under the optimism that this new medicine would revolutionize both the basic and clinical sciences. For many reasons, the initial target was cancer. Here, we will focus on the results of cancer gene therapy clinical trials using liposome or nonviral gene carrier, hoping that the lesson from here will be a guideline for the new generation of cell-based therapies.