• The Korean Journal of Applied Statistics
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• v.32 no.1
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• pp.1-13
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• 2019

An adaptive seamless Phase II/III clinical trial design enables a reduction in the sample size (in comparison to a conventional design) that also shortens the clinical development time. It is also very effective in clinical trials since it can have higher statistical power than Phase III alone. In this study, we use extensive simulation studies to compare several multiple hypothesis testing methods that can help select the best doses in a Phase II study along with several methods to combine p-values of the Phase II and Phase III study.

• Journal of Korean Medicine Rehabilitation
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• v.26 no.3
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• pp.79-84
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• 2016

Objectives To evaluate the evidence supporting the effectiveness of Chuna manual therapy for primary insomnia. Methods The researcher conducted search across the 3 electronic databases (Pubmed, CAJ and Oasis) to find all of randomized controlled clinical trials(RCTs) that used Chuna manual therapy as a treatment for primary insomnia. Results Four RCTs met inclusion criteria. The meta-analysis showed positive results for the use of Chuna manual therapy in terms of the PSQI when compared to medication treatments alone. Positive results were also obtained, in terms of the PSQI, when comparing Chuna manual therapy combined with acupuncture therapy to acupuncture therapy alone, but was not statistically significant. Conclusions The review found encouraging but limited evidence of Chuna manual therapy for primary insomnia. We recommend clinical trials which compare the effectiveness of Chuna manual therapy with usual care to obtain stronger evidence without the demerits of trial design.

• 대한예방의학회:학술대회논문집
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• 1994.02b
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• pp.261-264
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• 1994

This paper proposes a new method for planning randomized clinical trials. This method is especially suited to comparison of a best standard or control treatment with an experimental treatment. Patients are allocated into two groups by a random or chance mechanism. Patients In the first group receive standard treatment; those in the second group are asked if they will accept the experimental therapy; if they decline. they receive the best standard treatment. In the analyses of results. all those in the second group. regardless of treatment. are compared with those in the first group. Any loss of statistical efficiency can be overcome by Increased numbers. This experimental plan is indeed a randomized clinical trial and has the advantage' that, before providing consent, a patient will know whether an experimental treatment is to be used.

• Proceedings of the Ginseng society Conference
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• 2002.10a
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• pp.424-455
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• 2002

Diabetes mellitus is reaching epidemic proportions worldwide. The insufficiency of medication to cope with this burden has coincided with a dramatic rise in the prevalence of use of complementary and alternative therapies, especially herbal treatments. This surge in demand presents a challenge to prove the safety and efficacy of these treatments in diabetes. Korean red ginseng (steam treated Panax ginseng C.A. Meyer) is a strong candidate to succeed. It has been shown to possess a multitude of hypoglycemic effects and improve metabolic disturbances related to diabetes in in vitro and animal models. Data in humans is also emerging to support these benefits. Whether these results can be replicated in a rigorous clinical testing program is unclear. We therefore investigated the antidiabetic effects of Korean red ginseng in a series of 2 acute and 1 longterm randomized, double-blinded, placebo-controlled clinical trials. This paper provides the rationale for this program of study, expanding on the problem of diabetes, its management, and the possible role for Korean red ginseng. It then describes the design and expected findings.

• Journal of Haehwa Medicine
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• v.15 no.1
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• pp.41-45
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• 2006

Aims: This overview summarizes the existing evidence on acupuncture for cancer-related pain. Methods: Literature searches were conducted in 7 databases. All clinical studies of acupuncture, electroacupuncture, ear acupuncture and transcutaneous electrical nerve stimulation (TENS) in cancer patients with the main outcome measure of pain were included. Results: Of the 8 studies included, one high quality randomized clinical trial (RCT) of ear acupuncture showed statistically significant pain relief in comparison with placebo ear acupuncture. All the other studies were either non-blinded (n = 2) or uncontrolled clinical trials (n = 5). Most investigations suffered from methodological flaws such as inadequate study design, poor reporting of results, small sample size and overestimation of the results. Conclusions: The current evidence does not support the use of acupuncture as an adjunctive analgesic method for cancer patients. Only one high quality RCT showed promising results thus warranting further investigation into this under-researched area.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.37 no.2
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• pp.14-26
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• 2024

Objectives : The purpose of this study is to assess the feasibility of conducting a study on traditional Korean medicine treatments for periodontal diseases, specifically gingivitis and mild periodontitis. Methods : This study will employ a randomized, controlled, parallel-group design. Subjects with gingivitis and mild periodontitis will be recruited in one university hospital. In total, 45 subjects will be randomized into three arms (Acupuncture therapy group, herbal mouthwash group and usual care group), and will be followed up for 4 weeks. We will assess clinical variables such as, pocket depth, bleeding on probing, gingival index, plaque index, visual analog scale, uroqol-5 dimensions-5 levels to analyze changes in microbial flora before and after the intervention. Results : The protocol for this study was approved by the Institutional Review Board (IRB) of Dongguk University Ilsan Oriental Medicine Hospital, and registered with the Korean Clinical Trial Registry on March 29, 2024. Conclusions : This study is the first clinical research on periodontal diseases conducted in a Korean traditional medicine institution. The research aims to broaden the scope of traditional Korean medicine and is expected to serve as crucial data for future large-scale studies.

• Herbal Formula Science
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• v.28 no.2
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• pp.199-209
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• 2020

Objectives : The purpose of this systematic review is to confirm whether Gwibitang is beneficial in chronic fatigue syndrome (CFS). Methods : Clinical trials were searched from databases including Pubmed, Embase, Central Cochrane, CNKI, Wanfang, CQVIP, CiNii, OASIS, Koreamed, and NDSL. The eligible study design was limited into randomized controlled trial, quasi-randomized controlled trial and controlled clinical trial. The outcomes included general effectiveness as nominal scale, and fatigue severity, insomnia severity and quality of life as interval or ratio scale. The meta-analysis and assessment of risk of bias was performed based on the data extracted from the selected trials. Results : The results of eight randomized controlled trials (n=596) were included in the meta-analysis. The results of the synthesis showed Gwibitang is beneficial substantially for relieving and managing the general symptoms, and its heterogeneity was not in important level (RR 0.26 [95% CI 0.17, 0.39], Z=6.47, P<0.00001, I²=0%). Gwibitang was beneficial for alleviating fatigue (SMD -0.78 [95% CI -1.27, -0.30], Z=3.17, P=0.002), but its certainty was low. In case of insomnia, too few trials had been found and their risk of bias was substantial, so no conclusions had been brought to. Conclusions : We found an evidence that Gwibitang could be beneficial for managing and alleviating main symptoms in CFS patients.

• The Journal of Korean Medicine
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• v.41 no.3
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• pp.247-259
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• 2020

Objectives: This review aims to investigate clinical studies related to bee venom pharmacopuncture for cancer patients and to analyze the research trend for further study. Methods: We searched for clinical studies using bee venom pharmacopuncture therapy on patients with cancer through the electronic databases including Pubmed, Cochrane library, OASIS, KISS, NDSL, and KMBASE. There was no restriction on language and publication date, and after selection/exclusion process, the study design, target disease, intervention details including acupoints, treatment frequency and period, outcomes, study results and adverse events were extracted. Results: Thirteen clinical studies were finally selected. There were a randomized controlled trial RCT about the effect of sweet bee venom pharmacopuncture on cancer-related pain, and three case series about chemotherapy-induced peripheral neuropathy. In case reports, there were nine studies about oligodendroglioma, plexiform neurofibroma, breast cancer, prostate cancer, lung cancer, urachal adenocarcinoma, malignant melanoma, and atypical squamous cells of undetermined significance. The bee venom therapy affected the improvement of outcomes such as symptoms, quality of life, tumor response, and lab findings. Conclusions: The present study found that bee venom therapy is applicable to the treatment of cancer patients, and showed some effect on various symptoms. However, due to insufficient number and quality of studies, well designed and high-quality clinical trials are necessary to confirm the effectiveness and safety of bee venom pharmacopuncture therapy in patients with cancer.

• Communications for Statistical Applications and Methods
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• v.25 no.3
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• pp.321-328
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• 2018

In clinical trials with repeated measurements, the time-averaged difference (TAD) may provide a more powerful evaluation of treatment efficacy than the rate of changes over time when the treatment effect has rapid onset and repeated measurements continue across an extended period after a maximum effect is achieved (Overall and Doyle, Controlled Clinical Trials, 15, 100-123, 1994). The sample size formula has been investigated by many researchers for the evaluation of TAD in two treatment groups. For the evaluation of TAD in multi-arm trials, Zhang and Ahn (Computational Statistics & Data Analysis, 58, 283-291, 2013) and Lou et al. (Communications in Statistics-Theory and Methods, 46, 11204-11213, 2017b) developed the sample size formulas for continuous outcomes and count outcomes, respectively. In this paper, we derive a sample size formula to evaluate the TAD of the repeated binary outcomes in multi-arm trials using the generalized estimating equation approach. This proposed sample size formula accounts for various correlation structures and missing patterns (including a mixture of independent missing and monotone missing patterns) that are frequently encountered by practitioners in clinical trials. We conduct simulation studies to assess the performance of the proposed sample size formula under a wide range of design parameters. The results show that the empirical powers and the empirical Type I errors are close to nominal levels. We illustrate our proposed method using a clinical trial example.

• Journal of Korean Physical Therapy Science
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• v.27 no.1
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• pp.9-17
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• 2020

Background: This study aimed to examine the repeatability of hamstring strength during maximal voluntary contractions (MVCs) and to examine the sex difference. Design: Quasi-experiment design. Methods: The study recruited 23 healthy young individuals as participants. Hamstring flexibility was measured before and after MVCs by active knee extension test. Five trials of MVCs were performed, and hip extension forces were measured using a strain gauge during MVCs. Repeatability was confirmed by intraclass correlation coefficient (ICC) and coefficient of variation, and the difference between male and female participants was confirmed by independent samples t-test. Results: The forces measured during MVCs were significantly different between men and women over five trials. We observed the minimum and maximum force production at the first and fifth trial of MVCs in both men and women. Excellent to moderate reliability of the hamstring strength during MVCs was found in men (ICC range, 0.70-0.98) and women (ICC range, 0.66-0.90). There was no significant difference in hamstring flexibility between men and women. Conclusion: In clinical settings, we recommend excluding the first trial of MVCs in both men and women. Additionally, performing at least three trials of MVCs would be useful to improve the reliability of the baseline measures in women.