• Clinical Nutrition Research
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• 제12권4호
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• pp.257-268
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• 2023

Migraine is a common neurological disease correlated with oxidative stress and lipid profile disorders. The present study was designed to determine the effects of Coenzyme Q10 (Co-Q10) supplementation on oxidative status and lipid profile in migraine individuals. This clinical trial was conducted on 84 females aged 18-50 years, diagnosed for episodic migraine according to the International Headache Society. Subjects were randomized to receive either Co-Q10 supplement (400 mg/day) or placebo for 12 weeks. Lipid profile and oxidative stress indices including malondialdehyde (MDA) and total antioxidant capacity (TAC) were measured before and after intervention in both groups. Also, anthropometric indices, dietary intakes, and clinical features were collected. Data analysis was conducted using SPSS version 16. Seventy-seven of the participants, with mean age of 33.70 ± 7.75 years, completed the study. After 12-week intervention, Co-Q10 led to a significant decrease in MDA levels compared to placebo (p = 0.009), with no effect on TAC levels (p = 0.106). A significant increase in serum Co-Q10 concentration and high-density lipoprotein cholesterol (HDL-C) level in Co-Q10 group was observed, but no significant differences were found in other lipid profile variables (low-density lipoprotein cholesterol, triglycerides and total cholesterol). Among anthropometric variables, Co-Q10 only caused a significant reduction in body fat percentage (BFP), but we did not find any significant changes in others. A 12-week Co-Q10 supplementation led to significant improvement in clinical features, BFP, and HDL-C level among migraine individuals.

• 대한예방의학회:학술대회논문집
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• 대한예방의학회 1994년도 교수 연수회(역학)
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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.

• 대한한의학회지
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• 제28권4호
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• pp.86-94
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• 2007

Objective : Kuesu point is a newly discovered point, it is located in 3-cun from the centre of sacrum laterally, paralleled to the 4th foramen on the sacrum. This controlled trial was to evaluate the superior effect of Kuesu point on back pain which radiated to lower extremities. Methods : Randomized Controlled Trial (RCT) and Single Blind in patient was designed. Patients (n=31) were randomized to two groups, Kuesu-point acupuncture group (Group A, n=16) and non Kuesu point acupuncture group (Group B, n=15). Group A was acupunctured on B25 (大腸兪), B26 (關元兪) and B60 (崑崙) with Kuesu point. Group B was acupunctured on the same points without Kuesu point. The clinical subjects were female patients. Beside acupuncture, the other therapies were excluded. Clinical period was three weeks total. Each group was treated 4-5 times per week for 3 weeks. The outcome measurements were The Estimation Index of Backache (quality of life), Pain Rating Scale (pain intensity) and other physical examinations (ROM, SLR, etc.). Results : 31 patients (Group A: n=16, Group B: n=15) were Randomized, 6 of them dropped out. Eventually 25 patients (Group A: n=15, Group B: n=10) were included in the analysis. Group A acupunctured on Kuesu point scored more significant Estimation Index of Backache and lower PRS (Pain Rating Scale) than Group B acupunctured without Kuesu point (p=0.003/2). It turned out that the group acupunctured on Kuesu point show meaningful high improvement index. And other examination's results showed that the treatment effects of Group A are twice as better as Group B. Conclusion : These results suggest that Kuesu point acupuncture was more effective on lower back pain and improved the life quality of patients, being compared with non Kuesu point acupuncture.

• 대한한방내과학회지
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• 제37권1호
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• pp.109-134
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• 2016

Objectives: The aim of this study was to help develop a guideline for the common cold. We searched recent clinical studies of the common cold in Western medicine and reviewed their objectives, inclusion and exclusion criteria, primary outcome, secondary outcome, and assessment tools to establish evidenced-based guideline.Methods: We searched electronic databases (Cochrane Library, MEDLINE, EMBASE) to identify eligible randomized controlled trials (RCTs) about the common cold for the last 10 years. We included 29 RCTs and showed their research summary via their objectives, participants, interventions, control, treatment duration, and results. We also analyzed the definition of the common cold presented in the article, inclusion and exclusion criteria, primary and secondary outcomes, and assessment tools.Results: We reported the aforementioned areas in detail. At first, the definition of the common cold was confused across the articles. Second, herbal medication clinical trials for the common cold have been extensively studied recently. Third, the eligibility criteria frequently included the Jackson Symptom score. Fourth, validated assessment tools (i.e., the Wisconsin Upper Respiratory Symptom Survey-21) have only been used in a few recent studies.Conclusions: Our research will be helpful to establish Korean herbal medicine clinical trial guidelines for the common cold.

• 한방재활의학과학회지
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• 제20권4호
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• pp.197-213
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• 2010

Objectives : The clinical trial was designed to investigate the safety and effects of Taeeumjowui-tang(Taiyintiaowei-tang) extracts on the change of the weight, body compositions, serum in obese patients. Methods : This was a 12-weeks, randomized, double blind, placebo-controlled clinical trial. Patients with a body mass index of either greater than $30kg/m^2$ or between 27 and $30kg/m^2$ with controlled hypertension, diabetes, hyperlipidemia were considered eligible. Participants of 41 obese patients were randomized either to Taeeumjowui-tang(Taiyintiaowei-tang)(23) or placebo(18). After 12 weeks of treatment, we measured anthropometric factors(weight, height, waist circumference, BMI(body mass index) etc.), abdominal fat area by CT(computed tomography)scanning, serum lipid(total cholesterol, tryglyceride, HDL-cholesterol, LDL-cholesterol), blood lever of variety(AST, ALT, BUN, creatinine etc.). Adverse events also evaluated. Results : After 12 weeks of treatment mean weight, waist-circumference, total cholesterol, LDL-cholesterol and score of KEAT-26 were significant changed in Taeeumjowui-tang(Taiyintiaowei-tang). There were no serious adverse events in either groups. Conclusions : There were limited in this study that is conducted within a short period of 12 weeks. but its weight and WC(waist circumference), WHR(waist hip ratio), total cholesterol, LDL-cholesterol and score of KEAT-26 loss effect was significant and it had few adverse events.

• Journal of the Korean Association of Oral and Maxillofacial Surgeons
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• 제46권1호
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• pp.41-48
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• 2020

Objectives: One of the most common complications of bilateral sagittal split ramus osteotomy (BSSRO) is neurosensory impairment of the inferior alveolar nerve (IAN). Accurate preoperative determination of the position of the IAN canal within the mandible using cone-beam computed tomography (CBCT) is recommended to prevent IAN dysfunction during BSSRO and facilitate neurosensory improvement after BSSRO. Materials and Methods: This randomized clinical trial consisted of 86 surgical sites in 43 patients (30 females and 13 males), including 21 cases (42 sides) and 22 controls (44 sides). Panoramic and lateral cephalographs were obtained from all patients. In the experimental group, CBCT was also performed from both sides of the ramus and mandibular body. Neurosensory function of the IAN was subjectively assessed using a 5-point scale preoperatively and 7 days, 1 month, 3 months, 6 months, and 12 months post-surgery. Data were analyzed using Fisher's test, Spearman's test, t-test, linear mixed-model regression, and repeated-measures ANCOVA (α=0.05, 0.01). Results: Mean sensory scores in the control group were 1.57, 2.61, 3.34, 3.73, and 4.20 over one year and were 1.69, 3.00, 3.60, 4.19, and 4.48 in the CBCT group. Significant effects were detected for CBCT intervention (P=0.002) and jaw side (P=0.003) but not for age (P=0.617) or displacement extent (P=0.122). Conclusion: Preoperative use of CBCT may help surgeons to practice more conservative surgery. Neurosensory deficits might heal faster on the right side.

• 대한예방한의학회지
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• 제26권3호
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• pp.97-108
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• 2022

Objectives : The purpose of this study is to confirm the efficacy and safety of Gongjin-dan and Ssanghwatang for chronic fatigue. Methods : A total of 90 people, between 19 and 65 years old, will be recruited to participate in a randomized, double-blind, and placebo-controlled a clinical trial. Participants in the Gongjin-dan group will take one pill of Gongjin-dan along with three packs of placebo oral liquid Ssanghwa-tang per day for 4 weeks. Participants in the Ssanghwa-tang group will take three packages of liquid Ssanghwa-tang and one placebo Gongjindan pill per day for 4 weeks. In the placebo group, participants will take one pill of placebo Gongjin-dan and three packs of placebo liquid Ssanghwa-tang per day, for 4 weeks. Outcomes will be measured at the baseline, 4^th week, and 6^th week. The primary outcome is the change in the Fatigue Severity Scale (FSS). Secondary outcomes are the change of Multidimensional Fatigue Inventory-20 (MFI-20), Chalder Fatigue Scale (CFQ), Short-Form 36 Health Survey (SF-36), Korean Version of Schedule of Fatigue and Anergy/General Physician (SOFA/GP), Glucose, Lactate, Ammonia, Free Fatty Acid (FAA), d-ROMs&BAP, Selenium, and Cortisol. Results : This trial was approved by the institutional review board of Pusan National University Korean Medicine Hospital (registry number: PNUKHIRB 2021-10-005). Recruitment opened in November 2021 and is supposed to be completed by December 2022. Conclusions : This trial will provide clinical information to determine the efficacy and safety of Gongjindan and Ssanghwa-tang for chronic fatigue.

• Journal of Acupuncture Research
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• 제33권4호
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• pp.33-38
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• 2016

Objectives : To identify potential correlation between patients' expectations and clinical outcome in a randomized control study of acupuncture. Methods : In a clinical trial of acupuncture for hypertension, 60 participants with pre and mild hypertension were randomized into an acupuncture group and a control group. After randomization, all participants were asked to rate their expectation for the intervention on a scale of 0 to 10. To analyze the effect of expectation on clinical outcome, change of blood pressure was compared between high and low expectation groups. Results : There was no significant difference of baseline blood pressure between low expectation group and high expectation group. Proportion of acupuncture group and control group was also not different between low and high expectation groups (p = 0.638). The change of systolic blood pressure was -1.55 mmHg in low expectation group and -3.07 mmHg in high expectation group, and it was not significantly different (p = 0.54). There was no significant difference in the change of diastolic blood pressure between two groups (p = 0.58), with -3.24 mmHg in low expectation group and -2.34 mmHg in high expectation group. Conclusion : In this study, the expectation of intervention (including acupuncture treatment) was not associated with the effect of intervention.

• Journal of Acupuncture Research
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• 제35권4호
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• pp.149-157
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• 2018

Background: Parkinson's disease is the second most common degenerative brain disease after Alzheimer's disease. This study reviewed clinical practice of acupuncture and moxibustion treatment for Parkinson's disease to assess the future direction of these treatments. Methods: The literature search used 5 Korean Internet databases. The search terms were "Parkinson's disease." and "Parkinson (Korean)." 36 papers were selected: 27 case reports, 2 respropective studies, 3 uncontrolled clinical trials, 3 randomized controlled trial, 1 non-randomized controlled trial. Results: Filiform needles were used in most of studies. Pharmacopuncture, electro-acupuncture, and auricular acupuncture therapy were also used in combination with Filiform needles. 2. The most commonly used basic acupoints for Parkinson's disease was Saamchimbeop. The most commonly used form of pharmacopuncture involved Bee-venom. Conclusion: It is expected that treatment of Parkinson's disease with a variety of acupuncture and moxibustion therapies will continue to be studied, in addition to treatments that utilize existing Filiform needle treatments in clinical practice.

• 한방비만학회지
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• 제20권2호
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• pp.138-148
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• 2020

Objectives: The aim of this study is to evaluate the effects of Bangpungtongseong-san (Fangfengtongsheng-san, BTS) and Daesiho-tang (Dachaihu-tang, DST) on weight loss and improvement in lipid metabolism and glucose metabolism. Furthermore, we intend to develop a prediction model for drug effects through the analysis of the single nucleotide polymorphism (SNP), gut-microbiota, and the expression of immune-related biomarkers. Methods: This study is a single-center, randomized, double-blind, parallel-design clinical trial. One hundred twenty-eight participants will be assigned to the BTS group (n=64) and DST group (n=64). Both groups will be administered 4 g medication three times a day for up to 2 weeks. The primary outcomes is weight loss. The secondary outcomes include bioelectrical impedance analysis, waist circumstance, body mass index, total cholesterol, high-density lipoprotein, triglyceride, insulin resistance. The exploratory outcomes include 3-day dietary recall, food frequency questionnaire, quality of life questionnaire, gut microbiota analysis, immune biomarkers analysis, and SNP analysis. Assessment will be made at baseline and at week 4, 8, and 12. Conclusions: This protocol will be implemented by approval of the Institutional Review Board of Dongguk University. The results of this trial will provide a systematic evidence for the treatment of obesity and enable more precise herbal medicine prescriptions.