• Journal of Oriental Neuropsychiatry
• /
• v.23 no.4
• /
• pp.133-152
• /
• 2012

Objectives : The purpose of this study is to investigate the effect of Sihogayonggolmoryeo-tang on the anxiety of Hwa-byung. Methods : In this randomized, double blinded, placebo-controlled study, we planned to give Sihogayonggolmoryeo-tang or controlled medication for anxiety of Hwa-byung. Hamilton Anxiety Scale (HAM-A) was measured as the 1st evaluative instrument, and Korean State-Trait Anxiety Inventory (STAI-K), Likert scale for major symptom of Hwa-byung, Hwa-Byung Scale Score, Korean Beck's Depression Inventory (BDI-K), Korean State-Trait Anger Expression Inventory (STAXI-K), Insomnia severity Index (ISI), Instrument of Oriental Medical Evaluation for Hwa-Byung, WHO Quality of Life Avvreviated (WHOQOL-BREF), genral self-Efficacy Scale (GSES), Rosenberg Self-Esteem Inventory (SRE) and Heart Rate Variability (HRV) were also measured as the 2nd evaluative instrument before treatment. Results : Clinical characteristics-vital signs and demographic characteristics showed no significant difference between both groups. The characteristics of disease-chief complaint, pattern Identification, period, etiological factor, and etc, also showed similarity of distribution in both groups. The results of Chest PA, EKG and clinicopathologic examination showed no significant difference between both groups. There were no significant difference between both groups in all valuation scales; HAM-A was measured as the first evaluative instrument, and STAI-K, Likert scale for major symptom of Hwa-byung, Hwa-Byung Scale Score, BDI-K, STAXI-K, ISI, Instrument of Oriental Medical Evaluation for Hwa-Byung, WHOQOL-BREF, GSES, SRE and HRV. Conclusions : We considered that establishment of the experimental group and controlled group was objective and worth conducting this research. In addition, this methodology is expected to be applied to the subsequent research. Further, we hope to make up for this study through various study and discussion.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
• /
• v.33 no.3
• /
• pp.27-44
• /
• 2020

Objectives : The authors conducted randomized, Double-blinded, and placebo-controlled parallel-group clinical experiment study to evaluate efficacy of fermented soybean(Bio-Peptone)cream in pruritus. Methods : The research had been conducted for 4 months from the date of IRB approval(May 26 in 2017) to Sept 2017. The experiment started by randomly distributing 25 subjects with pruritus into experimental group and control group, respectively. The experimental group applied fermented soybean(Bio-Peptone)cream twice a day, in the morning and evening, for one week on itchy area. The effect of the product was evaluated by comparing the PSS(Patient subjective score), moisture level by measuring skin moisture content(Corneometer) and transepidermal water loss(Tewameter), and the Korean version of Skindex-29(index of quality of life improvement) before applying the cream, after applying the cream for one week and after stop applying the cream for one week. The control group conducted identical experiment with the experimental group, except the control group applied placebo instead of the fermented soybean(Bio-Peptone)cream. Results : Pruritus, criterion of the first validation testing, indicates fermented soybean(Bio-Peptone)cream tend to reduce pruritus compare to placebo, although the result is not statistically noticeable. Significant difference in reduction of prutitus, the second validation test was not discovered in both groups. Corneometer and life quality tend to be improved with soy cream than placebo, but not statistically effective and both groups did not show any difference in terms of Tewameter measurement. Conclusions : The result of clinical experiment didn't prove that the fermented soybean(Bio-Peptone)cream is more effective in reducing pruritus than placebo, statistically. The clinical use of soybean product for pruritus requires further studies to be verified.

• Journal of Oriental Neuropsychiatry
• /
• v.20 no.4
• /
• pp.79-89
• /
• 2009

Objectives : To address suitable method for designing clinical trial intervening Traditional Korean Herbal Medicine on General anxiety disorder through the recent clinical research in Chinese Herbal Medicine. Methods : Randomized, controlled trials(RCTs) of treatment of general anxiety disorder intervening herbal medicine were searched through CNKI databases. We examined several item of studies and evaluated using Jadad scale. We searched articles in CNKI with the key word "General anxiety disorder or 廣範性焦慮症", among them we selected the clinical trial studies related with herbal medicine except for case reports, studies of acupuncture therapy or west medicines. Results : 11 RCT studies of herbal medicine met inclusion criteria. The Studies used CCMD-3, HAMA as inclusion tool and mainly HAMA as a evaluation tool. Studies were progressed for 2-8 weeks, mostly used various positive control. Experiment medicine were mainly 理氣劑, 安神劑. In most studies, experiment group made similar or higher efficacy in comparison with control group. Mean Jadad score of studies was $1.3{\pm}0.67$, and only one study was double-blinded among 11 studies. Conclusions : RCT studies on general anxiety disorder of chinese herbal medicine tend to focus on investigating effect of herbal medicine through setting positive control group with CCMD-3 and HAMA. But, most studies had low quality of trial, for lack of pattern identification, evaluation and inclusion tool of chinese medicine. Clinical trials of general anxiety disorder should provide good quality by randomization, double-blinding, and multi-site trial.

• The Journal of Internal Korean Medicine
• /
• v.29 no.3
• /
• pp.778-786
• /
• 2008

Objectives : This study was to investigate the short time effect of caffeine on heart rate variability(HRV) and the effect of Neiguan(PC6) acupuncture stimulation on HRV. Methods : 27 healthy adult volunteers were randomly allocated to two groups: Neiguan group (N=13) or placebo group (N=14). The study was carried out under a randomized double-blinded placebo-controlled trial method. Each group orally received the same tablets with 200 mg caffeine. After 1 hour, acupuncture was applied to the Neiguan(PC6) points for the Neiguan group, and for the placebo group was applied to a non-acupuncture point. Both groups were estimated with HRV 3 times, before and after caffeine ingestion, 20 minutes after acupuncture stimulation. Results : After taking caffeine, pulse rate, mean-HRV, and pNN50(the proportion derived by dividing NN50 by the total number of NN intervals) decreased, SDNN(standard deviation of all normal-to-normal (NN) intervals), RMSSD (the root square of successive differences), TP log, HF(high frequency), and HRV index was increased. There were significant changes to the autonomic nervous system after taking caffeine. There were no significant differences between the two groups after acupuncture at Neiguan. Conclusion : Caffeine could induce general activation of the autonomic nervous system. Neiguan acupuncture stimulation may not have significant influence on the autonomic nervous system.

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

• Journal of Ginseng Research
• /
• v.38 no.4
• /
• pp.239-243
• /
• 2014

Background: To investigate the antidiabetic effects of hydrolyzed ginseng extract (HGE) for Korean participants in an 8-wk, randomized, double-blinded, placebo-controlled clinical trial. Methods: Impaired fasting glucose participants [fasting plasma glucose (FPG) ${\geq}5.6mM$ or < 6.9mM who had not been diagnosed with any disease and met the inclusion criteria were recruited for this study. The 23 participants were randomly divided into either the HGE (n = 12, 960 mg/d) or placebo (n = 11) group. Outcomes included measurements of efficacy (FPG, postprandial glucose, fasting plasma insulin, postprandial insulin, homeostatic model assessment-insulin resistance, and homeostatic model assessment-${\beta}$) and safety (adverse events, laboratory tests, electrocardiogram, and vital signs). Results: After 8 wk of HGE supplementation, FPG and postprandial glucose were significantly decreased in the HGE group compared to the placebo group. No clinically significant changes in any safety parameter were observed. Our study revealed that HGE is a potent antidiabetic agent that does not produce noticeable adverse effects. Conclusion: HGE supplementation may be effective for treating impaired fasting glucose individuals.

• Korean Journal of Acupuncture
• /
• v.29 no.1
• /
• pp.93-108
• /
• 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 Korean Journal of Food And Nutrition
• /
• v.30 no.4
• /
• pp.735-741
• /
• 2017

This study was conducted to investigate if the supplement formula may improve alcohol metabolism in healthy adult men. In a double-blinded, randomized, crossover study, subjects were administrated yeast extract mixtures (YEM, n=15), Hovenia dulcis mixtures (HDM, n=15), placebo (PLA, n=15), and control (CON, n=15) in an oral dose followed by one week washout periods. At each visit (0, 1, 2, 3, 4 week), subjects drank 450 mL, 20.1 percent alcohol after administered mixtures. Blood was drawn periodically (0, 0.25, 0.5, 1, 2, 4, 6, 15 hours). Fifteen subjects completed the protocol and were included in the analysis. Plasma ethanol concentration was lower in YEM (10 percent) and the HDM (5 percent) groups. The area under the curves (AUC) and $C_{max}$ for plasma ethanol were significantly decreased only in the YEM group, when compared with the CON group. The AUC and $C_{max}$ for plasma acetaldehyde concentration were significantly decreased in the YEM (45 and 54 percent) and the HDM (35 and 53 percent) groups respectively, when compared with PLA (p<0.01). Together, these findings validate that YEM or HDM improved alcohol metabolism and hangover syndromes, leading to reduce alcohol concentration and acetaldehyde concentration without adverse effects.

• The Korean Journal of Pain
• /
• v.32 no.4
• /
• pp.301-306
• /
• 2019

Background: Ganglion impar blockade is a reliable and effective treatment option used in patients with coccydynia. Our primary objective was to specify the role of corticosteroids in impar blockade. We compared applications of local anesthetic with the local anesthetic + corticosteroid combination in terms of treatment efficiency in patients with chronic coccydynia. Methods: Our study was a prospective randomize double-blind study. The patients were divided into 2 groups after randomization. The first group (group SL) was made up of patients where a corticosteroid + local anesthetic were used during ganglion impar blockade. In the second group (group L) we used only local anesthetic. We evaluated numeric rating scale (NRS) and Beck depression scale, which were employed before the procedure and in 1st and 3rd months after the procedure. Results: Seventy-three patients were included in the final analysis. We detected a significantly greater decrease in NRS values in the 1st month in group SL than in group L (P = 0.001). In the same way, NRS values in the 3rd month were significantly lower in the group with steroids (P = 0.0001). During the evaluation of the Beck test, we detected significantly greater decreases in the 1st month (P = 0.017) and 3rd month (P = 0.021) in the SL group than in the L group. Conclusions: Ganglion impar blockade decreases pain in the treatment of chronic coccydynia and improve depression. Addition of steroids in a ganglion impar blockade is required for treatment response that should accumulate over a long period of time.

• The Korean Journal of Pain
• /
• v.34 no.3
• /
• pp.315-321
• /
• 2021

Background: Pillar pain may develop after carpal tunnel release surgery (CTRS). This prospective double-blinded randomized trial investigated the effectiveness of extracorporeal shock wave therapy (ESWT) in pillar pain relief and hand function improvement. Methods: The sample consisted of 60 patients with post-CTRS pillar pain, randomized into two groups. The ESWT group (experimental) received three sessions of ESWT, while the control group received three sessions of sham ESWT, one session per week. Participants were evaluated before treatment, and three weeks, three months, and six months after treatment. The pain was assessed using the visual analogue scale (VAS). Hand functions were assessed using the Michigan hand outcomes questionnaire (MHQ). Results: The ESWT group showed significant improvement in VAS and MHQ scores after treatment at all time points compared to the control group (P < 0.001). Before treatment, the ESWT and control groups had a VAS score of 6.8 ± 1.3 and 6.7 ± 1.0, respectively. Three weeks after treatment, they had a VAS score of 2.8 ± 1.1 and 6.1 ± 1.0, respectively. Six months after treatment, the VAS score was reduced to 1.9 ± 0.9 and 5.1 ± 1.0, respectively. The ESWT group had a MHQ score of 54.4 ± 7.7 before treatment and 73.3 ± 6.8 six months after. The control group had a MHQ score of 54.2 ± 7.1 before treatment and 57.8 ± 4.4 six months after. Conclusions: ESWT is an effective and a safe non-invasive treatment option for pain management and hand functionality in pillar pain.