• Journal of Oriental Neuropsychiatry
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• v.26 no.4
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• pp.383-406
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• 2015

Objectives: People with tension-type headache generally take pain relievers, but long term dependency causes problems as well as side effects. The present study aimed to provide clinical evidence of herbal medicine for tension-type headache by systematic review of randomized controlled trials on the effect of herbal medicine for tension-type headache. Methods: Randomized or quasi-randomized controlled trials that verified effects of herbal medicine intervention on patients with tension-type headache were included in the study. A literature search of English, Japanese, Chinese, Korean databases was performed. The selected literature were assessed by Jadad scale and Risk of Bias. Results: Herein, 40 reports were selected from a total of 157. Meta-analyses of 2 trials indicated that the effective rate was significantly higher in the herbal medicine treatment group, as compared to the placebo control (risk ratio: 1.49, 95% confidence interval (CI): 1.23 to 1.80, p<0.0001, I²=0%). Four trials that compared herbal medicine with routine care with routine care only group showed a significantly higher effective rate of benefits for herbal medicine with routine care, as compared to routine care only (RR: 1.57, 95% CI: 1.18 to 2.10, p=0.002, I²=0%). Conclusions: The effective rate was significantly higher than control and adverse events were less in the treatment group. Pattern analysis (辨證) indicated that the studies on wind-fire pattern (風火證) were highest. Yougeun-bang (柔筋方) in prescription and Paeoniae Radix Alba (白芍藥) in medicinal herbs were most used. This finding could be widely utilized in future clinical practice and form the basis for the development of clinical practice guidelines in advance.

• Journal of Aquaculture
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• v.21 no.3
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• pp.190-195
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• 2008

We investigated the changes in growth, digestive enzymes activities, nucleic acids contents and RNA/DNA ratio of flounder Paralichthys olivaceus larvae (C for Paracyclopina nana, A for Artemia, and M for Mix of C and A) for 14 to 28 DAH. Body length of flounder larvae showed the best in the C trial at 28 DAH. The change of nucleic acids contents showed faster in C and M trials than A trial. And RNA/DNA ratio showed the significantly faster changes in C trial than A trial. High metamorphosis rates were also observed in C and M trial. $\alpha$-amylase activities increased gradually up to 28 DAH in all trials. Total alkaline protease (TAP) activities of A trial showed the highest value to 9 mU/larvae at 26 DAH. But others trials showed lower to $5{\sim}6$ mU/larva than A trial. TAP:$\alpha$-amylase activity ratio did not significantly changed to $0.025{\sim}0.053$ in A trial during the experiments. But, C and M trials tended to gradually decrease from $0.078{\sim}0.083$ (initial) to $0.013{\sim}0.018$ (final). Therefore, it shown the ratio gradually decreased of TAP:$\alpha$-amylase activity, stability of TAP activity, and rapid change of nucleic acids in trials grown positively. Thus, because P. nana could continuously supply the optimal nutrients for flounder larvae, we suggested the supplement of the copepod to an efficient feed of the flounder larvae.

• Journal of Genetic Medicine
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• v.8 no.1
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• pp.28-34
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• 2011

Most clinicians understand clinical trials as the evaluation process for new medicine before their use. However, clinical trials can also be applied to laboratory diagnostic tests (LDTs) to verify diagnostic accuracy and efficacy before their clinical laboratory implementation for patients. The clinical trial of LDT has two distinctive characteristics that are different from the case of pharmaceuticals and thus worth special consideration. One of them is the level of evidence. The well-designed randomized controlled trials (RCTs) are known to provide the best evidence to prove the clinical efficacy of any pharmaceutical products. However, RCTs lose practicality when applied to LDTs due to various issues including ethical complications. For this reason, comparative study format is considered more feasible approach for LDTs. In addition pharmaceuticals and LDTs are different in that the user's intervention is not required for the former but critical to the latter. Moreover, in the case of pharmaceuticals, end-products are produced by manufacturers before being used by clinicians. However, in LDTs, once reagents and instruments are provided by manufacturers, they are first utilized by clinical laboratories to produce test results in order for clinicians to use them later. In other words, when it comes to LDTs, clinical laboratories play the role of manufacturers, providing reliable test results with improved quality assurance. Considering the distinctive characteristics of LDTs, we would like to offer detailed suggestions to successfully perform clinical trials in LDTs, which include analytical performance measures, clinical test performance measures, diagnostic test accuracy measures, clinical effectiveness measures, and post-implementation surveillance.

• Journal of Nutrition and Health
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• v.50 no.5
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• pp.437-446
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• 2017

Purpose: This meta-analysis aimed to evaluate the effect of cassia cinnamon (Cinnamomum. cassia and C. aromaticum) on the glycemic response with a focus on the preparation of dehydrated powder and water extract. Methods: We searched Pubmed, Cochrane, EMBASE, Science Direct, and the Korean Studies Information Service System (KISS) through May 2017. In the meta-analysis for the preparation of powder, eight trials reporting fasting blood glucose (FBG), four trials reporting HbA1c, and three trials reporting the postprandial glycemic response were included. For the water extract, six trials reporting FBG and four trials reporting HbA1c were eligible for this study. A random-effects model was used to calculate the pooled effect size. Results: Cassia cinnamon powder intake significantly lowered FBG by -1.55 mmol/L (95% CI, -2.45, -0.64; p = 0.001) and the AUC of postprandial blood glucose level by $-51.8mmol/L{\cdot}min$ (95% CI, -85.5, -18.1; p = 0.003). There was a significant difference in FBG between water extract of cinnamon and placebo of -0.76 mmol/L (95% CI, -1.09, -0.43; p = 0.000). However, blood HbA1c level was not significantly altered by any preparation of cinnamon. No statistical heterogeneity was observed for any analysis except in the case of FBG for cinnamon powder. Results of funnel plots and Egger's regression suggest a low likelihood of publication bias in all biomarkers (p > 0.05). Conclusion: According to this meta-analysis, there was possible evidence to support a relationship between cassia cinnamon intake and fasting glucose in both preparation of powder and water extract. Furthermore, new evidence of the health benefits on postprandial glucose regulation of cinnamon powder was obtained.

• Korean Journal of Acupuncture
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• v.37 no.3
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• pp.131-144
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• 2020

Objectives : The aim of this study is to analyze the details of acupuncture treatment methods and the reporting quality of acupuncture on Carpal Tunnel Syndrome (CTS). Methods : Search was conducted in Pubmed, EMBASE, and Cochrane Library for acupuncture studies on CTS. The reporting quality of acupuncture treatment was assessed using the following guidelines: Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) for analyzing the method of acupuncture treatment, Consolidated Standards of Reporting Trials (CONSORT) for analyzing study design and study process, and Risk of Bias (ROB) for analyzing bias. The number of reported items was calculated and evaluated as a proportion. The reported proportion of each study was classified into three grades: Grade A (% score ≥75), Grade B (50≤ % score <75), and Grade C (% score <50). Results : A total of 9 Randomized Controlled Trials (RCTs) were included in this study. All trials reported 12 items (66.67%) on average in STRICTA guidelines. Five studies were conducted with manual acupuncture and 3 studies were conducted with electroacupuncture. PC7 (Daereung) was most frequently used to treat CTS. In STRICTA guideline evaluation, 3 studies were classified as Grade A, 5 studies were classified as Grade B, and 1 study was classified as Grade C. In the CONSORT statement assessment, all trials reported an average of 20.56 items. Of the 9 RCTs, 6 studies were classified as Grade B and 3 studies were classified as Grade C. In ROB assessment, most studies showed a low (63.49%) or unclear (26.98%) risk of bias. The selective reporting bias and the incomplete outcome data bias were found to have the lowest risk of bias, and the allocation concealment of selection bias was found to have the most unclear risk of bias. Conclusions : Recent acupuncture studies on CTS showed moderate reporting quality. However, more detailed reports on acupuncture are still needed to establish more solid evidence of acupuncture treatment.

• Journal of Science and Technology Studies
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• v.18 no.3
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• pp.1-45
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• 2018

South Korea has recently emerged as one of the leading countries conducting clinical trials. Seoul, for instance, is now ranked at the top of the list among the cities in the world. This paper examines the rapid growth of research involving human subjects in Korea, not just from the economic perspective (e.g., the growth of global pharmaceutical markets and the subsequent increase in the demand for clinical trials), but from the policy perspective (e.g., the government?s drive to support and promote this field as a new industry). The industrialization of clinical trials in Korea has manifested itself in the rise of international Contract Research Organizations (CRO) doing their business in Korea. They are, figuratively speaking, invited to Korea by the government. This paper intends to uncover and discuss the bioethical issues concerning research on human subjects, the issues that tend to be set aside merely as procedural ones like ??workable documents??. To this end, it investigates the practice of clinical trials by collecting hitherto unherad voices from patient-volunteers, physician-researchers, CRO employees, and government officials. This paper also explores the themes of ??ethical variability?? and ??biocapital?? in order to compare and constrast the case in Korea with those in other countries.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.36 no.4
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• pp.122-144
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• 2023

Objectives : The purpose of this study is to evaluate the effects of herbal medicine treatment in patients with cold urticaria. Methods : We searched randomized controlled trials(RCTs) reporting the effects of herbal medicine for cold urticaria through domestic and international databases from their inception to September 2023. The results were summarized in tables. We assessed the risk of bias in included RCTs through Cochrane risk of bias tool and the data synthesis was conducted through RevMan version 5.4. Results : A total of 12 RCTs were included in this review and all trials compared herbal medicine alone treatment(treatment group) with western medicine alone treatment(control group). The total effective rate(TER) of treatment group was statistically higher than that of control group(RR: 1.49, 95% CI: 1.38 to 1.62, p<0.00001, I²=65%). On the other hand, when comparing except for 1 trial with different evaluation period, the TER of treatment group was statistically higher than that of control group and heterogeneity was very low(RR: 1.36, 95% CI: 1.26 to 1.47, p<0.00001, I²=0%). And when comparing 8 trials using the total symptom score(TSS) change index as an indicator of TER, the TER of treatment group was statistically higher than that of control group and heterogeneity was very low(RR: 1.38, 95% CI: 1.26 to 1.51, p<0.00001, I²=0%). The treatment group showed more statistically significant decrease compared to the control group in TSS(MD: -2.51, 95% CI: -2.63 to -2.40, p<0.00001, I²=99%). The relapse rate of treatment group was statistically lower than that of control group(RR: 0.19, 95% CI: 0.10 to 0.40, p<0.00001, I²=0%). Mild adverse events such as sleepiness, dizziness were reported in control group and gastric discomfort was reported in treatment group. In the risk of bias assessment, many cases were evaluated as 'Unclear risk'. Conclusions : This review found that herbal medicine alone treatment could more effective and safe than western medicine alone treatment for cold urticaria. But further well-designed researches are needed because of heterogeneity between trials and the quality of the included trials.

• 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.

• Proceedings of the Microbiological Society of Korea Conference
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• 2005.05a
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• pp.140-142
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• 2005

• 대한예방의학회:학술대회논문집
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• 1993.10a
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• pp.14-15
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• 1993