• Journal of Gastric Cancer
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• v.6 no.2
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• pp.69-75
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• 2006

Purpose: We aimed to investigate the effect of oral Saccharomyces cerevisiae Hansen CBS 5926 therapy (Saccharomyces boulardii) on gastrointestinal symptoms and nutrition in gastrectomized patients. Materials and Methods: Ninety patients who underwent a gastrectomy due to early gastric cancer were randomly divided into case and control (placebo) groups and were given medicine or placebos for 12 weeks. The gastrointestinal symptom rating and the nutritional status were evaluated by using double blind methods at 4, 16, and 20 weeks after discharge. Results: The ratio of males to females was 2.3 : 1, and the mean age was $56.3{\pm}10.2$ years. The numbers of subtotal gastrectomies and total gastrectomies were 69 and 21, respectively. Fourteen (15.6%) patients dropped, of whom 5 belonged to the case group. Of the remaining 76 patients, those in the case group had higher levels of serum albumin (P=0.046). For patients who underwent subtotal gastrectomy (n=57), the case group had higher level of serum albumin (P=0.049). Conclusion: This double blind study showed that oral Saccharomyces boulardii therapy could improve the postoperative nutrition of gastrectomized patients because gastrectomized patients with oral Saccharomyces boulardii therapy had higher levels of serum albumin than the control group.

• Journal of Oriental Neuropsychiatry
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• v.29 no.1
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• pp.35-46
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• 2018

Objectives: The aim of this trial is to evaluate the efficacy and safety of Yukwool-tang (Liuyu-tang) for the treatment of major depression in women by comparing the Yukwool-tang (Liuyu-tang)-treated group with the placebo-treated group and assessing the association of various biological factors related to depression through various outcome measures. Methods: This study is a single-center, randomized, double-blind, placebo-controlled, parallel-design clinical trial. The subjects to be selected are women between the ages of 19 and 65, and the registered subjects are to be randomly assigned to treatment with Yukwool-tang or the placebo control. The Yukwool-tang group will take 1 bottle of Yukwool-tang (30 mg) for 8 weeks, 3 times a day, before meals. The control group will take the placebo in the same way. The primary outcome to be examined will be the change between the total score after 8 weeks and the total score before the start of the study of the K-HDRS score. Secondary outcomes are assessed by the change in total score after 12 weeks of K-HDRS, K-HDRS remission rate, K-HDRS improvement rate, BDI-K, PITD, KSCL-95, ISI, STAI-K, EQ-5D, VAS, Emotional Stimulation Test, BDNF test, inflammatory cytokine and tumor necrosis factor test, intestinal microbiome test, dietary report and Beck's hopelessness scale. Results: This protocol has been approved by the IRB of Dunsan Korean Medicine Hospital of Daejeon University and is registered in the CRIS, and it is made public in advance to ensure transparency of the research process and conduct ethical clinical trials. Conclusions: Based on this protocol, when the trial is completed, its data can be used to access the validity and safety of Yukwool-tang for major depression in women, and it is also expected to be helpful in the study of the correlation between future treatment of Korean medicine for depression and related biological factors, and quality of life.

• Journal of Nutrition and Health
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• v.39 no.1
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• pp.35-43
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• 2006

This study aimed to evaluate the effect of dietary fiber supplementation with snack type on functional constipation. We conducted a double blind case-control study with 3 groups; placebo, low dose group (LD: insoluble fiber 7 g/d + soluble fiber 1.2 g/d) and high dose group (HD: insoluble fiber 14 g/d + soluble fiber 2.4 g/d) , which were randomly assigned out of subjects with functional constipation, defined by modified Rome II criteria. We measured anthropometric parameters and evaluated the bowel movement frequency, stool type, straining, sense of complete evacuation, abdominal discomfort/pain, abdominal inflation, relief and colon transit time before, during the supplementation. Both LD and HD groups had significant improvement in straining, sense of complete evacuation and satisfactory relief compared with placebo group (p < 0.05). When subdivide by baseline colon transit time (less than 24 hrs/ 24 hrs or more and less than 72 hrs / 72 hrs or more), only HD group had significantly improvement; colon transit time recovered near by 24 hrs in subjects of 'less than 24 hrs' (from $7.57{\pm}1.40$ hrs to $25.2{\pm}3.91$ hrs, p < 0.01) and reduced in those of '24hr or more and less than 72 hr' (from $47.0{\pm}3.36$ hrs to $31.3{\pm}4.31$ hrs, p < 0.01) and '72 hr or more' (from $106.7{\pm}10.7$ hrs to $85.0{\pm}13.1$ hrs, P < 0.05) subjects. Particularly, positive effect of fiber supplementation on straining and sense of complete evacuation in test groups seemed to be greater in subjects of '24 hrs or less' and '24 hrs or more and less' than 72 hrs' than those of '72 hrs or more'. In conclusion, subjects with functional constipation, particularly those having colon transit time less than 72 hrs can significantly improve, at least in part, symptom related to constipation by fiber supplementation of snack type without serious side effects.

• 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.

• 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 Pharmacopuncture
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• v.25 no.3
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• pp.233-241
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• 2022

Objectives: Asthma is a chronic disease, and the demand for herbal medicines in this field has increased in recent years. The new findings highlight the role of the gut-lung axis in the pathophysiology of asthma. Hence, this study will evaluate the safety and efficacy of Glasthma syrup, an herbal formula based on Persian medicine, in improving asthma and regulating intestinal permeability. The formula consists of five herbal ingredients that have anti-inflammatory effects on the respiratory tract, also known as gut tonics. Methods: The study will be conducted as a placebo-controlled, triple-blind, randomized trial. It will consist of a 4-week intervention followed by a 4-week follow-up period. The target sample size is 20 patients with moderate asthma aged 18 to 60 years. Eligible participants will be randomly assigned to either the experimental group or the control group in equal numbers. Patients in the experimental group will take Glasthma syrup (7.5 mL, twice a day), while patients in the control group will take a matching placebo. Both groups will receive a 4-week combination of a long-acting beta2 agonist and a leukotriene modulator as standard of care. Inhaled corticosteroids can be used as rescue medication as needed. Results: The primary outcomes are asthma symptom scale, lung function, and intestinal permeability. Secondary outcomes include quality of life, symptom recurrence rates, and blood tests. A safety assessment will also be conducted during the trial. Conclusion: In this trial, the effects of Glasthma syrup in patients with moderate asthma will be examined. The study will also assess the effects of the formulation on the gut-lung axis by simultaneously monitoring the gut permeability index, asthma symptoms, and lung function.

• Physical Therapy Rehabilitation Science
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• v.1 no.1
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• pp.33-39
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• 2012

Objective: The objective of this study is to investigate the effect of treadmill training with real optic flow scene on functional recovery of balance and balance self-efficacy in stroke patients. Design: Single blind, Randomized controlled trial. Methods: Nine patients following stroke were divided randomly into the treadmill with optic flow group (n=3), treadmill with virtual reality group (n=3), and control group (n=3). Subjects in the treadmill with optic flow group wore a head-mounted display in order to receive a speed modulated real optic flow scene during treadmill training for 30 minutes, while those in the treadmill with virtual reality group and control group received treadmill training with virtual reality and regular therapy for the same amount of time, five times per week for a period of three weeks. Timed up and go test (TUG) and activities-specific balance confidence scale (ABC scale) were evaluated before and after the intervention. Results: TUG in the treadmill training with optic flow group showed significantly greater improvement, compared with the treadmill training with virtual reality group and control group (p<0.05). Significantly greater improvement in the ABC scale was observed in the treadmill training with optic flow group and the tread mill training with virtual reality group, compared with the control group (p<0.05). Conclusions: Findings of this study demonstrate that treadmill training with real optic flow scene can be helpful in improving balance and balance self-efficacy of patients with chronic stroke and may be used as a practical adjunct to routine rehabilitation therapy.

• Korean Journal of Adult Nursing
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• v.13 no.3
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• pp.420-430
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• 2001

This study was designed to verify the effect of aromatherapy on menstrual cramps and dysmenorrhea by a quasi experiment (nonequivalent control group pretest-posttest design), from March to October, 2000. The subjects of this experiment consisted of 45 college women with menstrual cramps and dysmenorrhea. They were randomized by 25 for the experimental group and 20 for the control group. Their mean age was 20.6 years, mean menstrual period 28.7 days, mean menstrual cramps(VAS) 7.25, mean dysmenorrhea (Dysmenorrhea Scale) was 27.34. As treatment, aromatherapy was to give effleurrage of the abdomen with lavender, clary sage and rose as aroma oil, almond oil as carrier oil. For the control group, abdominal massage was given with only almond oil. Data collection included menstrual cramps, dysmenorrhea, the change of symptoms(low abdominal pain, lumbago, headache, nausea, fatigue, edema). Menstrual cramps, dysmenorrhea and general, menstrual characteristics of subjects were measured the first day of the pre menstrual period before treatment (pre-test), menstrual cramps, dysmenorrhea, the change of symptoms were measured the first and second day of post menstrual period after treatment (posttest). Data were analyzed by t-test, $\chi^2$- test, repeated measures ANOVA, Cronbach's ${\alpha}$ with SAS Program. The results of this study was as follows; 1. Menstrual cramps was significantly lower in the experimental group(p = .001). 2. Dysmenorrhea was significantly lower in the experimental group(p = .027). 3. Less women in the experimental group complained about the six symptoms than women in the control group after treatment on the first day of the menstrual period(p < 0.05, p < 0.01) In conclusion, these findings indicate that aromatherapy with lavender, clary sage, and rose could be effective to decrease menstrual cramps, and dysmenorrhea. So, aromatherapy could be applied to women suffering with menstrual cramps, dysmenorrhea periodically as an nursing intervention.

• Journal of Acupuncture Research
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• v.26 no.5
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• pp.77-83
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• 2009

Objectives : We investigated the effects of Mahuang-Chuanwu Pharmacopuncture Treatment in Obese Patients by analysing Body mass index(BMI), waist measurement and weight. Methods : We investigated on 52 volunteers consisted of 24 subjects in experiment(Mahuang-Chuanwu Pharmacopuncture) group and 28 subjects in control(Normal Saline) group. The Study form was a single-blind and placebo-controlled clinical trial. 24 subjects in experiment group were injected Mahuang-Chuanwu Pharmacopuncture with additional common treatment and 28 subjects in control group were injected Normal Saline with additional common treatment with Dietic Theraphy and Exercise. We measured BMI, waist measurement and weight on 3 times : before 1st session, after first 5 sessions, and after 10 sessions. The SPSS 13.0 for Windows was used to analyze the data and the wilcoxon signed ranks test (in group), mann Whitney u t-test(between two groups) and ${\chi}^2$-test(description of number) were used to verify the result. Results : In experiment group. BMI, waist measurement and weight were significantly low at the period of after first 5 sessions and after 10 sessions. In control group, BMI, waist measurement and weight were significantly low at the period of after 10 sessions but weren't significantly low at the period of after first 5 sessions. The changes of BMI, waist measurement and weight in experiment group were significantly more than that in control group. Conclusions : The Results suggest that Mahuang(Ephedra sinica Stapf)-Chuanwu(Aconitum carmichaeli Debx) Pharmacopuncture is effective on the treatment of obesity, compared to Normal Saline.

• Journal of Oriental Neuropsychiatry
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• v.25 no.3
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• pp.235-242
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• 2014

Objectives: The purpose of this research is to examine effects of acupuncture treatment on the autonomic nervous systems of Hwa-byung patients with insomnia. Methods: The study was performed through a patient-assessor blind, randomized, placebo-controlled trial in which the volunteers, data collectors, and analysts were unaware of which individuals were receiving the treatment. A total of thirty-seven volunteers were divided into 2 groups. Eighteen subjects were placed into a trial group and 19 subjects into a control group using a randomization table. The trial group was treated with bilateral Shigu, Ahnmyun, B62 (Shinmaek), and K6 (Chohae), while the control group was not given any other treatment. The ISI (Insomnia Severity Scale) was measured as the first evaluative instrument, and then a comparative analysis was conducted by comparing the results with those measured by ANS (BVP/HR, respiration rate, peripheral temperature, skin conductance, EMG). Results: In the BVP/HR, statistically significant decreases were found in those from the trial group compared to those of the control group. Skin conductance was found to be significantly increased in the trial group, as compared to the control group. However, there were no significant differences between the groups with respect to peripheral temperature, respiration rate, and EMG. Conclusions: The results suggest that acupuncture treatment is effective in the treatment of hwa-byung patients who suffer from insomnia due to their autonomic nervous systems.