• Journal of Pharmacopuncture
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• v.21 no.1
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• pp.7-13
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• 2018

Objective: Hwa-byung is one of the cultural concept of distress in Korea resulted from chronic accumulated anger. It is characterized by various symptoms like stuffy in the chest, hot or heat sensation, something pushing up in the chest, feeling of mortification, and a flush of anger. This protocol aims to explore the efficacy and safety of Huanglian-jie-du decoction on various somatic symptoms and insomnia in patients with Hwa-byung. Methods: This is study protocol for a randomized, double-blind, placebo-controlled trial. A total of 44 patients will be randomly assigned to the experimental group or the placebo group in a 1:1 ratio. All medications will be taken orally 3 times per day for 7 consecutive days. The primary outcomes are the mean changes in Patient Health Questionnaire of physical symptoms (PHQ-15) and Insomnia Severity Index (ISI) after the 7 days of administration. The secondary outcomes include the scales to assess stress response, symptoms of Hwa-byung, and state anger. Conclusion: The results of this study will provide high quality and explorative evidence to investigate the effect of Huanglian-jie-du decoction on Hwa-byung.

• Journal of Korean Medicine Rehabilitation
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• v.28 no.2
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• pp.73-82
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• 2018

Objectives The purpose of this study is to systematically explore the effects and safety of acupuncture treatment for upper extremity peripheral nerve injury and to review the methodology of clinical trials. Methods We searched 9 electronic databases(3 international, 1 Chinese, 5 Korean) including English, Korean and Chinese, up to December 2017 for randomized controlled trials which evaluated the effects of the acupuncture in patients with upper extremity peripheral nerve injury. We abstracted the designs of the randomized clinical trials and the method of acupuncture treatment according to the Standards for Reporting Interventions in Clinical Trials of Acupuncture(STRICTA). Results A total of 8 papers were reviewed. All randomized clinical trials were conducted in China. Of them, five studies(62.5%) were electro-acupuncture as intervention. All randomized clinical trials reported favorable effects of acupuncture treatments compared to baseline or control group with outcomes of efficacy rate. However risk of bias seemed high. LI4, LI11, SI3, PC3, PC6 were most frequently used for acupoints to treat upper extremity peripheral nerve injury. Conclusions These results suggest that it is recommended to develop more detailed reporting standards for acupuncture treatment method. In the future, well designed randomized clinical trials which evaluate the effects and safety of acupuncture treatment for upper extremity peripheral nerve injury is highly needed.

• The Journal of Internal Korean Medicine
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• v.29 no.3
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• pp.800-809
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• 2008

Objective : Although chronic prostatitis/chronic pelvic pain syndrcme(CP/CPPS) is a common disease, there is no consensus on the etiology or pathology and treatment. This was a double-blinded, placebo-controlled, randomized clinical trial, investigating the therapeutic effects of the traditional Korean medicine, Bosingunyang-tang(BSGYT). Method : Participants who met US National Institutes of Health (NIH) consensus criteria for CP/CPPS were entered after applying inclusion/exclusion criteria. They were randomized to the BSGYT or placebo group. and treated three times a day for 6 weeks. NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) was used to estimate the clinical symptoms of CP/CPPS. Prostaglandin E2 and ${\beta}$-endorphin in prostatic fluid, collected by 2-glass pre-massage and post-massage test, were analyzed as factors associated with pain and inflammation. Result : The mean decrease in NIH-CPSI total score of the BSGYT group was 11.0 points, which is 5.7 points more than the placebo group. (Mann Whitney test P=0.038) Also the BSGYT group showed three times higher response rate than the placebo group in NIH-CPSI pain subscale score. (Fisher's exact test P=0.027) In those responders, prostaglandin E2 decreased significantly. (Wilcoxon's signed-ranks test P=0.037). No specific side effects were observed. Conclusion : After a 6-week treatment period, BSGYT improved clinical symptoms of CP/CPPS patients by decreasing PGE2 level in prostatic fluid.

• Herbal Formula Science
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• v.25 no.2
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• pp.135-143
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• 2017

Objectives : This trial aimed to determine if Wasong (Orostachys japonicus) extract can enhance immune system and is safe enough to be approved as a health functional food. Methods : Total 62 people, aged 45 and older, will be recruited to participate in a randomized, double-blind, placebo-controlled clinical trial. This study will compare Wasong extract and placebo. Wasong group will take 1g of Wasong extract, once a day, for 8 weeks. Placebo group will take 1g of crystalline cellulose as placebo, once a day, for 8 weeks. Outcomes will be measured at the baseline, the end of 4th week, and 8th week. Primary outcomes are the ratio of NK cells/total lymphocytes and the ratio of T-helper cells/T-suppressor cells. Secondary outcomes are total white blood cell count, the ratio of neutrophils, lymphocytes, and monocytes in total leukocytes, the ratio of total T cells, T-helper cells, T-suppressor cells, and B cells to lymphocytes, the amount of blood IgM, IgG, IgA, and cytomegalovirus (CMV) IgG, and blood metabolite target &global analysis. Results : This trial was approved by institutional review board of Pusan National University Korean Medicine Hospital (registry number: 2016006), and registered in Clinical Research information Service, one of WHO International Clinical Trials Registry Platform (registry number: PRE20161006-002). Recruitment opened in February 2017 and is supposed to be completed by August 2017. The result is expected to be published by June 2018. Conclusion : This trial will provide clinical information to determine the efficacy and safety of Wasong in enhancing immune system of middle-aged and older people.

• Journal of Oriental Neuropsychiatry
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• v.20 no.2
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• pp.163-176
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• 2009

Objectives : To address most probable and suitable method for designing clinical trial intervening Traditional Korean Herbal Medicine on hwa-byung. Study Design : A systematic review of research studies of complementary and/or alternative medical(CAM) treatment of depression, and of domestic clinical trials of Traditional Korean Medicine, and of Chinese clinical trials of Traditional Chinese Medicine. Methods : Randomized, controlled trials(RCTs) of treatment of depression intervening herbal medicine were searched through MEDLINE, Cochrane Library, and CNKI databases. Also, domestic RCTs intervening Traditional Korean Herbal Medicine were searched through Korean Traditional Knowledge Portal and Korean studies Information Service System(KISS). Studies were evaluated using Iadad scale and self-designed tool for this study. Results : Thirty four RCT studies( 10 from MEDLINE, 16 from CNKI, 8 domestic studies) of herbal medicine met inclusion criteria. Mean Jadad score of studies published in English was 2.8${\pm}$0.79, in Chinese 1.94${\pm}$0.77, and in Korean 2.75${\pm}$0.71. Twenty one percent of studies included pattern differentiation in their inclusion criteria. Twenty nine percent of studies used combined treatment of herbal and conventional medicine. Among studies on depression, 9% included Complementary Medical assessing tools. Conclusions : There is shortage of domestic clinical trial involving herbal medicine. In China, studies tend to focus on investigating effect of Combined treatment of herbal and conventional medicine on depression. Clinical trial(s) of hwa-byung should provide good internal validity by describing methodology for randomization, double-blinding, and attrition. Also, specific guideline for clinical trial, including Traditional Korean Medical aspects across inclusion criteria, and assessing tools is needed.

• Journal of Korean Neurosurgical Society
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• v.67 no.2
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• pp.202-208
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• 2024

Objective : Failed back surgery syndrome (FBSS) is a common long-term complication following spine surgeries characterized by chronic persistent pain; different strategies of management were employed to deal with it. This clinical trial aims to compare the efficacy of Pregabalin and Gabapentin in the management of this condition. Methods : A double-blind, randomized, comparative study (clinical trial registry NCT05324761 on 11th April 2022) with two parallel arms with Pregabalin and Gabapentin were used in arms one and two, respectively. Visual analog scale was used for basal and endpoint assessment of pain. T-test and analysis of covariance were used to deal with different variables. A pairwise test was used to compare pairs of means. Results : Of 66 patients referred to the trial, 64 were eligible, with 60 patients completing the 30 days trial. Both pregabalin and gabapentin effectively reduce pain, with significant p-values of 0.001 for each group. However, the pregabalin group was superior to gabapentin in pain reduction (p=0.001). Gender was an insignificant factor (p=0.574 and p=0.445 for the pregabalin and gabapentin groups, respectively, with a non-significant reduction (p=0.393) for both groups in total. Location of stenosis before surgery and type of surgery performed show non-significant effect on pain reduction for both groups. Conclusion : Both pregabalin and gabapentin effectively and safely relieve neuropathic pain associated with FBSS; pregabalin was significantly more effective irrespective of the patients' gender.

• The Journal of Korean Medicine
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• v.41 no.1
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• pp.107-116
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• 2020

Objectives: To overcome the limitations of randomized controlled trials, many other trials design is tested. The n-of-1 trial is a promising research method in the field of Korean medicine because of this methodology can examine the optimal treatment for each patient strictly. Therefore, we reviewed the status of N-of-1 studies on herbal medicine. Methods: A systematic literature review was conducted based on the pubmed database. The search term were 'N-of-1 Trial', 'Chinese Medicine', 'Herbal Medicine', 'Kampo'. There was no restriction in year. Results: Four clinical trials have been identified to demonstrate the effectiveness of herbal medicines for Kidney-yin-deficiency syndrome, bronchiectasis and gastric cancer. These studies suggest that the N-of-1 design is a study that encourages patient involvement, demonstrates the effectiveness of herbal medicines and helps reduce unnecessary medication. Conclusion: The N-of-1 clinical trial may be a rigorous methodology suitable for the clinical setting and may help the development of evidence-based Korean medicine. Attention is also needed in this research method in Korea.

• Journal of Acupuncture Research
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• v.33 no.2
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• pp.77-87
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• 2016

Objectives : This is a pilot study for a large randomized controlled trial to investigate the efficacy and safety of a newly developed contrast therapy device-- alternating topical heat and cold -- for patients with chronic low back pain. The main objective of this study is to confirm the feasibility of the study design. Methods : The design was a randomized, 2-arm, parallel-group, single-blind, placebo controlled trial. Patients in each group received real or sham contrast therapy in an acupuncture point 10 times over four weeks. The primary outcome measure was pain intensity on a 100-mm visual analogue scale (VAS). The secondary outcomes were back-related dysfunction based on the Oswestry Disability Index (ODI), the Roland-Morris disability questionnaire (RMDQ), and range of motion of lumbar spine based on the modified Schober test (mSchober test), Finger-to-Floor distance (FTF distance), and Finger-to-Thigh distraction (FTT distraction). Results : A total of 30 subjects with chronic low back pain were randomly assigned to a contrast therapy group (n＝15) or a sham group (n＝15). A repeated-measures analysis of variance showed statistically significant group time interaction for VAS, RMDQ, mSchober test and FTF distance (p<0.05). The treatment group showed significant improvement in pain intensity and functional disability as compared to the sham group. Conclusion : Contrast therapy may be an effective and safe treatment for chronic low back pain.

• Therapeutic Science for Rehabilitation
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• v.9 no.2
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• pp.27-38
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• 2020

Introduction : This review aims to introduce an intention-to-treat analysis(ITT) method and demonstrate the importance of rigorous utilization of this method to researchers in Korea. Discussion : ITT analysis includes all data as results in randomized control trials (RCT). Thereby the result of RCT is high validated to adapt in the real-world so that the result should be expected at clinical practice. Therefore, many RCT quality assessment tools include the question of the utilization of ITT analysis in individual trials. However, many researchers omit to report ITT, not utilize ITT or use ITT incorrectly. Conclusion : Through this review, more Korean researchers may understand and utilize ITT which is expected to enhance the quality of RCT papers.

• Journal of Ginseng Research
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• v.45 no.5
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• pp.546-554
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• 2021

Background: Diabetes mellitus and hypertension often occur together, amplifying cardiovascular disease (CVD) risk and emphasizing the need for a multitargeted treatment approach. American ginseng (AG) and Korean Red Ginseng (KRG) species could improve glycemic control via complementary mechanisms. Additionally, a KRG-inherent component, ginsenoside Rg3, may moderate blood pressure (BP). Our objective was to investigate the therapeutic potential of coadministration of Rg3-enriched Korean Red Ginseng (Rg3-KRG) and AG, added to standard of care therapy, in the management of hypertension and cardiometabolic risk factors in type-2 diabetes. Methods: Within a randomized controlled, parallel design of 80 participants with type-2 diabetes (HbA1c: 6.5-8%) and hypertension (systolic BP: 140-160 mmHg or treated), supplementation with either 2.25 g/day of combined Rg3-KRG + AG or wheat-bran control was assessed over a 12-wk intervention period. The primary endpoint was ambulatory 24-h systolic BP. Additional endpoints included further hemodynamic assessment, glycemic control, plasma lipids and safety monitoring. Results: Combined ginseng intervention generated a mean ± SE decrease in primary endpoint of 24-h systolic BP (-3.98 ± 2.0 mmHg, p = 0.04). Additionally, there was a greater reduction in HbA1c (-0.35 ± 0.1% [-3.8 ± 1.1 mmol/mol], p = 0.02), and change in blood lipids: total cholesterol (-0.50 ± 0.2 mmol/l, p = 0.01), non-HDL-C (-0.54 ± 0.2 mmol/l, p = 0.01), triglycerides (-0.40 ± 0.2 mmol/l, p = 0.02) and LDL-C (-0.35 ± 0.2 mmol/l, p = 0.06) at 12 wks, relative to control. No adverse safety outcomes were observed. Conclusion: Coadministration of Rg3-KRG + AG is an effective addon for improving BP along with attaining favorable cardiometabolic outcomes in individuals with type 2 diabetes. Ginseng derivatives may offer clinical utility when included in the polypharmacy and lifestyle treatment of diabetes. Clinical trial registration: Clinicaltrials.gov identifier, NCT01578837;