• Biomolecules & Therapeutics
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• v.28 no.1
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• pp.34-44
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• 2020

Mesenchymal stem cells (MSCs) have been proposed as an alternative therapy to be applied into several pathologies of the nervous system. These cells can be obtained from adipose tissue, umbilical cord blood and bone marrow, among other tissues, and have remarkable therapeutic properties. MSCs can be isolated with high yield, which adds to their ability to differentiate into non-mesodermal cell types including neuronal lineage both in vivo and in vitro. They are able to restore damaged neural tissue, thus being suitable for the treatment of neural injuries, and possess immunosuppressive activity, which may be useful for the treatment of neurological disorders of inflammatory etiology. Although the long-term safety of MSC-based therapies remains unclear, a large amount of both pre-clinical and clinical trials have shown functional improvements in animal models of nervous system diseases following transplantation of MSCs. In fact, there are several ongoing clinical trials evaluating the possible benefits this cell-based therapy could provide to patients with neurological damage, as well as their clinical limitations. In this review we focus on the potential of MSCs as a therapeutic tool to treat neurological disorders, summarizing the state of the art of this topic and the most recent clinical studies.

• Korean Journal of Acupuncture
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• v.29 no.1
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• pp.93-108
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• 2012

Objectives : This study aims to review randomized controlled trials on acupuncture for shoulder pain according to Jadad Scale and revised STRICTA. Methods : Seven electronic databases including PUBMED, SCOPUS, RISS were searched for randomized controlled trials (RCT) of acupuncture for shoulder pain. Results : 16 RCTs were included: 14 were published in English and 2 were published in Korean. According to Jadad scale, 15 RCTs had high quality. However, most of the studies could not meet the double blindness criteria. All RCTs meet 12.9 items on average in STRICTA. Conclusions : This systematic review shows four conclusions as follows. Traditional Chinese Medicine is often used in style of acupuncture. Spots of LI15, TE14, GB21 and LI11, stainless steel needle($0.3mm{\times}40mm$), 20 retention time, manual stimulation, $Deqi$, and 2 times a week treatment (total 12) are often used. Double-blinded clinical trials needs to be conducted. It is controversial to use minimal acupunctures on controlled groups of RCTs on acupuncture for shoulder pain. Description about practitioner's background needs clarifying.

• 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.

• Journal of the Korean Society of Marine Environment & Safety
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• v.27 no.5
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• pp.566-573
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• 2021

In this study, safety management procedures were developed based on domestic and foreign guidelines and related maritime law to ensure the safe development and implementation of smart autonomous ship technology and Samsung Heavy Industry. The safety management procedure was developed according to the guidelines for (MASS) sea trials (MSC.1/Circ.1604, Annex: Interim guidelines for MASS trials), proposed by International Maritime Organization (IMO) for the relevant authorities and stakeholders of MASS to properly conduct tests of systems and infrastructure related to safety and environmental protection. The developed safety management procedure applies to the maritime demonstration test of a system applying autonomous navigation element technology mounted as a navigation aid on a ship operating under a watch system, while complying with the environmental protection and navigation safety of the coast of Korea.

• The Journal of Internal Korean Medicine
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• v.40 no.3
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• pp.295-311
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• 2019

Objectives: This research aimed to investigate Chinese clinical studies on the treatment of central post-stroke pain (CPSP) and thalamic syndrome after stroke with traditional herbal medicine (THM). Methods: Randomized controlled trials verifying the effects of herbal medicine on treating CPSP and thalamic syndrome after stroke were included in the study. Electrical and hand search were conducted in the China National Knowledge Infrastructure (CNKI), National Discovery for Science Leaders (NDSL), Research Information Sharing Service (RISS), Oriental Medicine Advanced Searching Integrated System (Oasis) for CPSP and thalamic syndrome after stroke. A literature search was performed in the Chinese and Korean databases for papers published from January 1, 2010 to October 1, 2018. The selected literature was assessed by Cochrane's risk of bias. Results: Twelve reports on randomized controlled trials met the inclusion criteria from the 227 identified reports. Effective rate, comparison of visual analogy scale, present pain intensity, pain grading index, recurrence rate, follow-up, and a 36-item short form survey instrument were used to evaluate the treatments. The effective rate of the treatment group was significantly higher than that of the control group in all papers. Side effects occurred less frequently in the treatment group than in the western medicine control group. Conclusions: The treatment of CPSP and thalamic syndrome after stroke with THM was shown to be highly effective. Additional well-designed clinical trials are needed. This study can be used as a basis for further research on the treatment of CPSP and thalamic syndrome after stroke.

• 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 Journal of Korean Obstetrics and Gynecology
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• v.32 no.2
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• pp.50-70
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• 2019

Objectives: The purpose of this study was to show effectiveness of Korean medicine external treatment on bacterial vaginosis by analyzing randomized controlled clinical trials. Methods: We searched randomized controlled clinical trials related with Korean external treatment on bacterial vaginosis through national and overseas database and analyzed them in detail. Results: 15 articles were included according to our selection criteria and 2,176 women were involved. 1. All treatment groups were treated with intervention including Korean medicine external treatment and their results were statistically more effective than control groups. 2. External washing was the most frequently used method followed by vaginal tablet, fumigation and powder. 3. The most frequently used herbal medicine was Sophorae Radix followed by Phellodendri Cortex, Cindi Fructus, Dictamni Radicix Cortex and Kochiae Fructusa. 4. There were 4 studies reporting side effects of treatment and no significant side effects were observed. Conclusions: There was significant difference in the effectiveness of the intervention including Korean external therapy. Based on the analysis, it could be an effective way for the treatment of bacterial vaginosis in clinical practice.

• The Journal of KAIRB
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• v.3 no.1
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• pp.1-10
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• 2021

In 2004, India began investing in the clinical trial industry; the country now boasts a 20% market share with the help of a valuable resource - the world's second largest population. The Contract Research Organization has been able to generate profits efficiently conducting clinical trials via a large pool of participants, skilled researchers, and reduced developmental costs. As the demand and sheer number of global clinical trials increased, the International Council of Harmonization-Good Clinical Practice was introduced, and the need for the Institutional Review Board increased. While the clinical trial industry in India boomed, it came at the expense of the participants' civil rights. The increased media attention regarding the ethical issues forced the Indian Supreme Court to take action. Consequently, India is the only country, by law, that specifically compensates participants suffering from injury directly resulting from participation in clinical trials. This research paper will describe and compare the relevant laws of India and Korea including compensation criteria. In addition, the ethical issues and aspects of indemnity in clinical trials will be discussed. While the clear advantage of the compensation is one of the protected rights of a clinical subject, the current system is not perfect. Furthermore, laws created to redeem ethical issues can have unintended, negative consequences.

• Journal of Acupuncture Research
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• v.38 no.1
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• pp.20-31
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• 2021

The objective was to evaluate the effectiveness and safety of acupuncture for patients with rotator cuff diseases. There were 12 electronic databases and 3 trial registries searched up to November 30th, 2019. All randomized trials were eligible, regardless of language, date of publication, or settings. The primary outcomes were pain, shoulder function, and proportion of improved participants assessed within 12 weeks of randomization of the trial. The Cochrane risk of bias for the studies was assessed. Effects sizes were presented as a risk ratio, mean difference, or standardized mean difference with a 95% confidence intervals. Grading of Recommendations Assessment, Development and Evaluation approach was adopted to rate certainty of evidence. Of the 3,686 records screened, 28 randomized trials (2,216 participants) were included in this review. The types of acupuncture included manual acupuncture, dry needling, electroacupuncture, acupotomy, warm needle acupuncture, and fire needle acupuncture. All of the studies had an unclear or high risk of bias related to more than 1 domain. Significant benefits of acupuncture in terms of pain and shoulder function were observed in all comparisons, however, the proportion of improved participants was not described in 2 comparisons. There was substantial heterogeneity among meta-analyzed trials. No serious harm was observed. For primary outcomes, the overall certainty of evidence was very low. There was very low certainty of evidence for the benefits of acupuncture for patients with rotator cuff diseases. The safety of acupuncture remains unclear due to the incompleteness of reporting. Future well-designed randomized trials with transparent reporting are required.

• Journal of Ginseng Research
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• v.46 no.1
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• pp.71-78
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• 2022

Ginseng is an international herb that has been used for thousands of years. Two species most commonly applied and investigated in the ginseng family are Asian ginseng and American ginseng. The number of randomized controlled clinical trials (RCTs) has conspicuously increased, driven by the rapid development of ginseng. However, the reporting of RCT items of ginseng is deficient because of different trial designs and reporting formats, which is a challenge for researchers who are looking for the data with high quality and reliability. Thus, this study focused on providing an extensive analysis of these two species and examined the quality of the RCTs, based on the Consolidated Standards of Reporting Trials (CONSORT) guideline. Ninety-one RCTs conducted from 1980 to 2019 that were related to Asian ginseng and American ginseng used singly met our inclusion criteria. We found that the reporting quality of the two species has improved during the past 40 years. Publication date and sample size were significantly associated with the reporting quality. Rigorous RCTs designed for the species of ginseng are warranted, which can shed light on product research and development of ginseng in the future.