• Journal of Magnetics
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• v.19 no.2
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• pp.161-169
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• 2014

The aim of this study is to investigate the efficacy of pulsed electromagnetic field (PEMF) on the alleviation of lumbar myalgia. This is a randomized, real-sham, double blind pilot study. 38 patients were divided into the PEMF group and the Sham group, each of which was composed of 19 patients (1 patient dropped out in the Sham group) of randomized allocation. The PEMF group was treated by using the PEMF device and the Sham group by using a sham device on the lumbar muscle and acupuncture points, three times a week for a total of two weeks. Evaluations of Visual Analogue Scale for bothersomeness (VASB), Visual Analogue Scale for pain intensity (VASP), Oswestry Disability Index (ODI), 36-Item Short Form Health Survey Instrument (SF-36), EuroQol-5Dimension (EQ-5D), Beck's Depression Inventory (BDI) and Roland-Morris Disability Questionnaire (RMDQ), etc. before and 1 week after treatment were carried out. The primary outcome measure was the VASB, measured 1 week after the end of the pulsed electromagnetic therapy. VASB scores for the PEMF group changed by $-2.06{\pm}2.12$ from the baseline, and that for the Sham group changed by $-0.52{\pm}0.82$ (p < 0.05). VASP scores for the PEMF group were reduced by $-2.10{\pm}2.12$ from the base line, and that for the Sham group was reduced by $-0.53{\pm}1.50$ (p < 0.05). PEMF group showed significant improvements in all VASB, VASP, ODI, SF-36, EQ-5D, BDI and RMDQ scores, while the Sham group showed significant improvements in all scores, except the VASP score. However, the VASB, VASP and RMDQ scores of the PEMF group were much lower than those of the Sham group. The two groups showed no significant difference in ODI, SF-36, EQ-5D and BDI. This study demonstrates the effectiveness of PEMF treatment for alleviating lumbar myalgia.

• The Journal of Korean Medicine
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• v.28 no.1 s.69
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• pp.105-116
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• 2007

Objectives : Mahuang (Ephedra sinica), well known as an herbal medicine in the East and West, contains a relatively high percentage of ephedrine known as sympathomimetic alkaloid. We investigated the effects of Mahuang on sympathetic nervous system with heart rate variety (HRV). Time and frequency domain analysis of HRV is a noninvasive technique capable of providing information on autonomic modulation of the sinus node. Methods : We investigated 57 healthy volunteers consisting of 37 subjects in the Mahuang group and 20 subjects in the placebo group. Study form was a randomized, placebo-controlled, double-blind clinical trial. The 37 subjects in the Mahuang group took 3 Mahuang capsules (1 capsule equivalent to 2g herb Mahuang) twice a day at 10 a.m. and 2 p.,., while the 20 subjects in the placebo group took 3 placebo-capsules filled with glutinous rice powder at the same times. Mahuang medicine and placebo medicine were made into opaque capsules. We measured HRV at 3 p.m. 1 or 2 days before medication and at 3 p.m. after medication. Results : Mean-RR and SDNN of the Mahuang group significantly decreased compared with that of the placebo group, but the heart rate of the Mahuang group significantly increased compared with the placebo. HRV-Index, RMSSD and SDSD of the Mahuang group significantly decreased compared with that of the placebo group, but PNN50 of the Mahuang group significantly increased compared with placebo. Ln(TP), Ln(VLF), Ln(LF) and Ln(HF) of the Mahuang group significantly decreased compared with those of the placebo group. There were no significant differences in normalized LF, normalized HF and LF/HF ratio between the Mahuang and placebo groups. Conclusion : The results suggest that Mahuang in healthy adults tends to reduce the autonomic nervous system within the normal range.

• Journal of Acupuncture Research
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• v.23 no.5
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• pp.127-144
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• 2006

Background and Purpose : Though there were many clinical studies of acupuncture effects they didn't have appropriate control group. So we didn't say it was true acupuncture effect, though subjects in clinical study improved. To investigate the possibility of sham acupuncture application, we examined how well subjects distinguished real acupuncture from sham acupuncture. Methods : We investigate the possibility of sham acupuncture application as the following 3 kinds of methods. 1. The public (n=60) and Oriental Medicine Doctors (n=20) looked at the appearance of acupuncture and then were treated with randomly allocated acupuncture and judged it as real or sham. 2. The public (n=60) and Oriental Medicine doctors (n=20) were treated with randomly allocated acupuncture, then they looked at the appearance of acupuncture and judged it as real or sham. 3. The public (n=60) were treated with randomly allocated acupuncture (right-real-left-sham), (right-sham-left-real), (left-real-right-sham), (left-sham-right-real), then they judged it as real or sham. Results : 1. When the public (n=60) looked at the acupuncture appearance, the correct judgement ratio was 63.3%. After they were treated with acupuncture, the correct judgement ratio was 50.0%. 2. When Oriental Medicine doctors (n=20) looked at the acupuncture appearance, the correct judgement ratio was 25.0%. After they were treated with acupuncture, the correct judgement ratio was 45.0%. 3. When the public (n=60) were treated with acupuncture, the correct judgement ratio was 50.0%. After they looked at the acupuncture appearance, the correct judgement ratio was 63.3%. 4. When Oriental Medicine doctors (n=20) were treated with acupuncture, the correct judgement ratio was 65.5%. After they looked at the acupuncture appearance, the correct judgement ratio was 65.0%. 5. After the public (n=60) were treated with randomly allocated sham or real acupuncture as (right-real-left-sham), (right-sham-left-real), (left-real-right-sham), or (left-sham-right-real). the correct judgement ratio was 66.7% in looking at the acupuncture appearance group, and in not looking at 60.0%. Conclusion : These results indicated that Kim Sham Acupuncture could apply to the double blind clinical study of acupuncture effect. And more continuous studies are needed on Sham Acupuncture apparatus.

• Journal of Gastric Cancer
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• v.17 no.2
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• pp.120-131
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• 2017

Purpose: Tumor bleeding is a major complication in inoperable gastric cancer. The study aim was to investigate the effects of proton pump inhibitor (PPI) treatment for the prevention of gastric tumor bleeding. Materials and Methods: This study was a prospective double-blind, randomized, placebo-controlled trial. Patients with inoperable gastric cancer were randomly assigned to receive oral lansoprazole (30 mg) or placebo daily. The primary endpoint was the occurrence of tumor bleeding, and the secondary endpoints were transfusion requirement and overall survival (OS). Results: This study initially planned to enroll 394 patients, but prematurely ended due to low recruitment rate. Overall, 127 patients were included in the analyses: 64 in the lansoprazole group and 63 in the placebo group. During the median follow-up of 6.4 months, tumor bleeding rates were 7.8% and 9.5%, in the lansoprazole and placebo groups, respectively, with the cumulative bleeding incidence not statistically different between the groups (P=0.515, Gray's test). However, during the initial 4 months, 4 placebo-treated patients developed tumor bleeding, whereas there were no bleeding events in the lansoprazole-treated patients (P=0.041, Gray's test). There was no difference in the proportion of patients who required transfusion between the groups. The OS between the lansoprazole (11.7 months) and the placebo (11.0 months) groups was not statistically different (P=0.610). Study drug-related serious adverse event or bleeding-related death did not occur. Conclusions: Treating patients with inoperable gastric cancer with lansoprazole did not significantly reduce the incidence of tumor bleeding. However, further studies are needed to evaluate whether lansoprazole can prevent tumor bleeding during earlier phases of chemotherapy (ClinicalTrial.gov, identifier No. NCT02150447).

• Journal of Ginseng Research
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• v.44 no.5
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• pp.697-703
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• 2020

Background: GS-3K8 and GINST, both of which are modified ginseng extracts, have never been examined in terms of their effectiveness for the prevention of acute respiratory illness (ARI) in humans. We conducted a pilot study to assess the feasibility of performing a large-scale, randomized, controlled trial. Methods: This study was a randomized, double-blind, placebo-controlled, pilot study at a single center from October 2014 to March 2015. The 45 healthy applicants were randomly divided into the GS-3K8 (n = 15), GINST (n = 15), and placebo groups (n = 15). The study drug was administered as a capsule (500 mg/cap and 3000 mg/day). GS-3K8 contained 6.31 mg/g of Rg1, 15.05 mg/g of Re, 30.84 mg/g of Rb1, 15.02 mg/g of Rc, 12.44 mg/g of Rb2, 6.97 mg/g of Rd, 1.59 mg/g of Rg3, 3.25 mg/g of Rk1, and 4.84 mg/g of Rg5. GINST contained 7.54 mg/g of Rg1, 1.87 mg/g of Re, 5.42 mg/g of Rb1, 0.29 mg/g of Rc, 0.36 mg/g of Rb2, 0.70 mg/g of Rd, and 6.3 mg/g of compound K. The feasibility criteria were the rates of recruitment, drug compliance, and successful follow-up. The primary clinical outcome measure was the incidence of ARI. The secondary clinical outcome measures were the duration of symptoms. Results: The rate of recruitment was 11.3 participants per week. The overall rate of completed follow-up was 97.8%. The mean compliance rate was 91.64 ± 9.80%, 95.28 ± 5.75%, and 89.70 ± 8.99% in the GS-3K8, GINST, and placebo groups, respectively. The incidence of ARI was 64.3% (9/14; 95% confidence interval [CI], 31.4-91.1%), 26.7% (4/15; 95% CI, 4.3-49.0%), and 80.0% (12/15; 95% CI, 54.8-93.0%) in the GS-3K8, GINST, and placebo groups, respectively. The average days of symptoms were 3.89 ± 4.65, 9.25 ± 7.63, and 12.25 ± 12.69 in the GS-3K8, GINST, and placebo groups, respectively. Conclusion: The results support the feasibility of a full-scale trial. GS-3K8 and GINST appear to have a positive tendency toward preventing the development of ARI and reducing the symptom duration. A randomized controlled trial is needed to confirm these findings.

• The Journal of Internal Korean Medicine
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• v.30 no.1
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• pp.144-152
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• 2009

Background : Ephedra (Ephedra sinica) has been widely used to treat respiratory disease in traditional medicine of East Asia for over a hundred years. Despite safety concerns raised by some, the use of ephedra in traditional medicine is documented over more than 1,800 years. It is well established that ephedra is one of the central medicines in Korean 'Seseng constitution' medicine. In Sasang constitution medicine, all humans can be divided into one of four types: Soeumin, Soyangin, Taeumin or Taeyangin, and each constitution type has their own typical characteristics. Accordingly, it is hypothesized that the adverse effects of ephedra differ depending on the Sasang constitution classification. Objectives : The aim of this study was to determine adverse effects of ephedra which is classified as a Taeumin herb, and to observe whether the response differs or not. according to Sasang constitution classification. Methods : The study design was a double-blind randomized controlled trial. The subjects were healthy adults 20 - 50 years old who agreed to participate in this study. They were allocated through randomization to either ephedra group (N=55) or placebo group (N=24). where ephedra extract (6 g of dried ephedra) and placebo with similar opaque capsules were given twice for one day. To compare the adverse events of ephedra according to Sasang constitution classification, we analyzed blood pressure (systolic and diastolic), pulse rate, the morning questionnaire, and patient's global assessment scale score for well known adverse events: palpitation, headache, sweating, tiredness, dyspepsia, and dry mouth. Results : After ingestion of ephedra, the pulse rate had a significant increase in all constitution types. The changes of diastolic pressure in Soeumin and the changes of pulse rate in Soeumin, Soyangin and Taeumin had a significant increase in the ephedra over the control group. In the ephedra group, the palpitation and dyspepsia score of the patients' global assessment scale had a significant increase in Soeumin, with palpitation and sweating score increasing in Soyangin. Others observations were insignificant results. Conclusion : The results of this study may confirm that the physical responses or adverse effects of herbs differ for each type of Sasang constitution. Future studies using other herbs will be required to ascertain the herbal drug reaction of Sasang constitutions.

• The Journal of Internal Korean Medicine
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• v.41 no.3
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• pp.326-338
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• 2020

Background: Alzheimer's disease (AD) is a chronic neurodegenerative disease that causes disorientation, mood swings, problems with language, and difficulty remembering recent events. Acetylcholinesterase inhibitors (AchEIs) and memantine have been used to slow the course of the disease, but they can neither modify its progression nor prevent disease onset. Previous studies have suggested that Kami-guibi-tang (KGT) could be beneficial for supporting cognitive function in AD patients, but few clinical trials have been published. This pilot study aimed to evaluate the effect of KGT in improving cognitive function in AD patients. Methods: The study will be a randomized, placebo-controlled, double-blind, single-center trial conducted using subjects diagnosed with mild AD by neurologists. Study subjects will be randomly assigned to either a treatment or control group. The treatment group will receive KGT granules for 24 weeks, while the control group will receive placebo granules. AchEI administration will be maintained in both groups during the entirety of the study. Subjects will be assessed using the following exams: the Seoul Neuropsychologic Screening Battery (SNSB) for cognitive function; brain magnetic resonance imaging (MRI) for brain metabolite, neurotransmitter, and cerebral blood flow (CBF) measurements; the Korean version of Quality of Life-Alzheimer's Disease (KQol-AD) for quality of life; the Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI) for neurobehavioral symptoms; blood tests for amyloid and tau proteins and general blood parameters; and electrocardiography (ECG) before and after taking the medication. Discussion: Our findings will provide insight into the feasibility of large-scale trials to consolidate evidence for the efficacy of KGT for dementia treatment. Registration ID in CRIS: KCT0002904 (Clinical Research Information Service of the Republic of Korea).

• Journal of Ginseng Research
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• v.29 no.1
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• pp.27-36
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• 2005

In East-South Asia it has been said that ginseng(Panax ginseng) induces flushing and epistaxis, whereas American ginseng(Panax quinquefolius) dosen't. This study was designed to find out if ginseng really could increase flushing and epistaxis, compared with American ginseng. Double-blind randomized controlled trials on general symptom, such as flushing and epistaxis, of ginseng and American ginseng in Koreans and Chinese were performed by questionnaire. There was no significant accident or improvement in Koreans. But in Chinese dried mouth was significantly observed in placebo group and chest discomfort was significant in placebo group and American ginseng(4 years) group. In addition in Chinese chest discomfort was significantly observed in American ginseng(4 years) group and American ginseng(6 years) group. It was revealed that ginseng might not increase flushing and epistaxis.토양환경학회 홈페이지 ( http://www.kossge.or.kr ) 을 참조하십시오.

• Pediatric Gastroenterology, Hepatology & Nutrition
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• v.24 no.5
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• pp.423-431
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• 2021

Purpose: To assess the effect of combination probiotic Saccharomyces boulardii CNCM-I 3799 and Bacillus subtilis CU-1 in outpatient management of acute watery diarrhea in children. Methods: A randomized double-blind placebo-controlled study was conducted in 180 participants aged six months to five years with acute mild to moderate diarrhea. All were enrolled from six centers across India and centrally randomized to receive S. boulardii CNCM-I 3799 and B. subtilis CU-1 or a placebo along with oral rehydration salts and zinc supplementation. Each participant was followed up for three months to assess recurrence of diarrhea. Results: The mean duration of diarrhea in the probiotic and placebo groups were 54.16 hours and 59.48 hours, respectively. The difference in the duration of diarrhea in those administered with probiotic or placebo within 24 hours of diarrhea onset was 25.21 hours. Furthermore, the difference in duration of diarrhea was 13.84 hours (p<0.05) for participants who were administered with probiotics within 48 hours. There were no significant differences in the stool frequencies between the two arms. After three months, 15% in the probiotic group and 18.5% in the placebo group reported episodes of diarrhea. The mean duration of diarrhea was considerably lower in the probiotic group, 31.02 hours versus 48 hours in placebo (p=0.017). Conclusion: S. boulardii CNCM-I 3799 and B. subtilis CU-1 combination was effective in reducing the duration of diarrhea when administered within 48 hours of diarrhea onset. Similarly, it reduced recurrence of diarrhea and its intensity in the subsequent three months.

• Journal of Nutrition and Health
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• v.52 no.3
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• pp.258-267
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• 2019

Purpose: Upper respiratory tract infections are major causes of the common cold throughout the world. Cordyceps militaris (C. militaris) is a well-known functional food for its anti-fatigue and immunomodulating activities. On the other hand, there are no reports on the protective effect against upper respiratory tract infections (URI). This study was a 12 week randomized, double-blind, and placebo-controlled trial in healthy volunteers. Methods: A total of 100 subjects 20 ~ 70 years of age with a history of at least two colds in the year were enrolled in the study. The participants were required to record any adverse events and rate any cold-related incidents in a diary during the investigation period. The efficacy end point was the symptoms and incidence of URI, and changes in cytokines, IgA and natural killer (NK) cell activity. Results: The Cordyceps militaris group over 12 weeks showed no significant impact on the incidence and symptomatology of URI compared to the placebo group. On the other hand, the experimental group showed significantly higher NK cell activity (p = 0.047) and IgA level (p = 0.035) compared to the placebo group. The NK-cell activity and IgA level were increased significantly by Cordyceps militaris over 12 weeks. Conclusion: The results suggest the possible beneficial immunomodulating effects, but the protective effects on URI could not be demonstrated under these conditions. Additional research will be needed to determine the efficacy and mechanisms of Cordyceps militaris function.