• Journal of the Korean Society of Physical Medicine
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• v.18 no.2
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• pp.1-11
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• 2023

PURPOSE: This study examined the immediate effects of applying ankle eversion taping using kinesiology tape in chronic stroke patients-design: a randomized cross-over trial. METHODS: Seventeen stroke patients underwent three interventions in random order. The subjects were initially assigned randomly to an ankle eversion taping, placebo taping, or no taping for each intervention. Ankle eversion taping was used for mechanical correction and was involved in ankle dorsiflexion and eversion. The tape was stretched by 30-40%. Placebo tapping was applied in the same form as eversion tapping but was not stretched. The balance ability was assessed using the Y-balance test. The gait ability was assessed by maximum foot pressure and time of stance phase, and gait speed was assessed using a 10 m walk test (10MWT). All measurements were performed immediately after the intervention. RESULTS: The results showed that the dynamic balance and stance phase time in chronic stroke patients was improved after ankle eversion taping. The ankle eversion taping conditions increased significantly (p < .05) compared to the placebo and no taping conditions. CONCLUSION: The application of ankle eversion taping that uses kinesiology tape instantly increased the gait ability of chronic stroke patients. On the other hand, more research will be needed to identify the long-term effects of ankle eversion taping.

• The Journal of Korean Obstetrics and Gynecology
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• v.26 no.2
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• pp.138-150
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• 2013

Objectives: To observe randomized controlled trials(RCTs) related to investigating the effects of acupoint treatments on nausea and vomiting in pregnancy to establish the basis of korean medical treatments, and suggest the problems of future clinical research. Methods: After searching for national and international papers published after 2000 and restricting the parameters to 'clinical trial', 'controlled clinical trial', 'randomized controlled trial', then comparing the subjects, methods, research tools, and results to understand the effects and re-comparing the conflicting results to assume the cause. Results: Of the 9 research papers that applied acupressure, four of them used control and experimental groups, and three(75%) research papers indicated significant reduction in vomiting and nausea, and of the seven research papers that utilized the experimental and placebo groups, five(71.4%) reported significant reducing effects. Of the four research papers the used acupuncture treatments, four research papers using control and placebo groups, two showed improvements in symptoms but did not have significant results compared to sham acupuncture groups, and two showed significant reduction of symptoms compared to the control groups. The one research paper that used electrical stimulation showed significant results in the reduction of vomiting and nausea compared to the control group. Conclusions: Acupressure and electrical stimulation showed efficacy reducing the symptoms. Acupuncture treatments did not indicate efficacy some experiments. Therefore it is thought that future acupuncture treatments should use methods that resemble actual clinical medicine to establish efficacy to produce significant results.

• Journal of Periodontal and Implant Science
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• v.51 no.3
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• pp.199-212
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• 2021

Purpose: This randomized clinical placebo-controlled trial was conducted to evaluate the effectiveness of Lactobacillus reuteri as a probiotic in guided pocket recolonization (GPR) for the treatment of chronic periodontitis (CP) adjunctive to scaling and root planing (SRP). Methods: Forty-eight CP patients were randomly assigned to 3 treatment groups: group 1 (SRP+placebo), group 2 (SRP+single application of probiotic), and group 3 (SRP+incremental application of probiotic). Clinical parameters were evaluated at baseline and at 8, 12, and 24 weeks, whereas biochemical parameters were measured at baseline and 12 weeks. Results: At 24 weeks, the probing pocket depth and clinical attachment level improved in all 3 groups from baseline with no significant intergroup differences; however, a statistically significant difference was observed in localized plaque and gingival scores between groups 1 and 3 (P<0.05). At 12 weeks, matrix metalloproteinase-8 (MMP-8), nitric oxide (NO), and gingipains-R (Rgps) levels improved in all 3 groups, with statistically significant differences between groups 1 and 3 for MMP-8 and NO (P<0.05), but no difference for Rgps levels. Conclusions: Within its limitations, the results of this study show that incremental 3-time application of L. reuteri as a probiotic led to improvements in clinical and biochemical parameters. This protocol can be a useful adjunct to SRP in the non-surgical management of CP.

• The Journal of Internal Korean Medicine
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• v.28 no.2
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• pp.363-376
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• 2007

Objectives : This study was undertaken to learn what should be considered in a good clinical trial investigating a herbal medicine as an antidepressant. Methods : Five well-designed clinical trials published from 2000 to 2006 investigating SJWE in depressive disorder were selected. The trials were reviewed and compared in terms of methodology such as trial design, patient selection, efficacy & safety evaluation, and so on. On the basis of this review of the trials and the regulations and guidelines of KFDA, we suggest some points to be considered for a good clinical trial of a herb for depression. Results : Although every trial had its own unique design, procedure, objectives and so on, all trials used randomizing and double blinding methods. If there is no ethical problem, a placebo-controlled design should be considered in a herbal antidepressant clinical trial for depression. Conclusions : Some points to be considered in an optimal & good clinical trial for an antidepressive herbal medicine were suggested as follows: 1) randomizing and double blinding manner is essential, 2) if there is no ethical problem, placebo control design should be considered, 3) the trial period should be 6 weeks, 4) out-patients will be recruited as subjects, 5) investigators will be well-trained psychiatrists or medical doctors, 6) the number of subjects should be calculated by statistical methods, 7) subjects should be diagnosed by DSM-IV criteria, 8) subjects who have current risk of committing suicide should be excluded, etc.

• The Journal of Korean Medicine
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• v.31 no.1
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• pp.1-13
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• 2010

Objective: Functional dyspepsia is a prevalent disease. It impedes subjective quality of life. The purpose of this study was to examine the equivalent effect of herb medicine treatment (DA-9701) for functional dyspepsia. Methods: In this randomized, single-blinded, placebo-controlled study, we compared a herb medicine (DA-9701) with standard treatment (mosapride) and placebo for the treatment of functional dyspepsia. 42 volunteers who satisfied the requirements were enrolled in study. Severity of dyspepsia was measured by Nepean Dyspepsia Index (NDI) and Functional Dyspepsia Quality of Life (FD-QOL) before and after treatments. Results: 1. In the DA-9701 group, total key symptoms score was significantly lower and improve rate of key symptoms was higher than in the mosapride and placebo groups, but there were no statistically significant differences between three groups. 2. In the DA-9701 and mosapride groups, "nausea" and "bad breath" were significantly lower compared with the placebo group. 3. In the DA-9701 group, NDI Quality of Life scores were significantly higher, but there were no [other] statistically significant differences between the three groups. 4. In the DA-9701 and mosapride groups, FD-QOL scores were higher compared with the placebo group, but there were no statistically significant differences between the three groups. Conclusion: Herb medicine treatment (DA-9701) is effective to improve the symptoms and quality of life in patients with functional dyspepsia.

• Journal of Ginseng Research
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• v.46 no.4
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• pp.601-608
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• 2022

Background: Various treatments are used to relieve menopausal symptoms for women. However, herbal substances are frequently used as complementary and alternative therapies as other treatments can increase ovarian and breast cancer risk. While the herbal substances' therapeutic effect is essential, the safety of their use is considered more important. This study aims to confirm the safety of red ginseng and herb extract complex (RHC), which are used to relieve menopausal symptoms. Methods: This randomized, double-blind, placebo-controlled clinical study recruited and divided 120 women experiencing menopausal symptoms into the RHC and placebo groups (60 women per group). Subjects were administered with 2 g RHC or placebo daily for 12 wk. Adverse reactions, female hormonal changes, and uterine thickness were observed and recorded on wk 0, 6, and 12. Hematologic and blood chemistry tests were also conducted. Results: The reactions of the subjects who received RHC or placebo at least once were analyzed. A total of six adverse reactions occurred in the RHC group, while nine occurred in the placebo group; common reactions observed in both groups were genital, subcutaneous tissue, and vascular disorders. However, there was no statistically significant difference between the administration groups (p = 0.5695), and no severe adverse reactions occurred in both groups.

• Physical Therapy Rehabilitation Science
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• v.6 no.2
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• pp.59-64
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• 2017

Objective: Elderly people with dementia experience not only cognitive dysfunction but also motor function deficits, such as balance and gait impairments. Recently, transcutaneous electrical nerve stimulation (TENS) has been used to reduce pain as well as to control muscle spasm, spasticity and motor performance in various types of subjects. The purpose of this study determined the effect of a single trial TENS on balance and gait function in elderly people with dementia. Design: A randomized controlled trial. Methods: Twenty-two subjects with dementia were assigned to the TENS group (n=12) and ten subjects were assigned to the control group (n=10) randomly. Subjects were classified into two groups: the TENS group (n=12) and the placebo-TENS group (n=10). The TENS group had electrical stimulation applied on the calf muscle for 15 minutes, while the placebo-TENS group had not received real electrical stimulation. The timed up and go test (TUG) and functional reach test (FRT) were used to measure the balance function, and the 10 meters walk test (MWT) and 6MWT were used to assess gait ability. All tests were performed before and after intervention under a single-blinded condition. Results: After intervention, there were significant improvements in TUG, FRT, 10MWT, and 6MWT results in the TENS group (p<0.05), while the placebo-TENS group did not show significant changes in all outcome measurements. There were also differences in all tests between the two groups at post-measurements (p<0.05). Conclusions: This study demonstrated that a single trial TENS application on the calf may be used to improve balance and gait function in elderly people with dementia.

• The Korea Journal of Herbology
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• v.34 no.1
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• pp.13-21
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• 2019

Objectives : This clinical trial is performed to investigate the effect of improving the hypersensitivity reaction and the safety of powdered ethanol extract Codonopsis lanceolata (S. et Z.) Trautv. for allergic patients. Methods : This study was randomized, double blinded, placebo-controlled clinical trial. 60 allergic rhinitis subjects were randomly assigned to Treatment group(n=30) and Control group(n=30). They were received the test substance or placebo in their $1^{st}$ and $2^{nd}$ visit, and took it once a day, 1 powder bag per 1 time, for 8 weeks. The freeze dried powder of Codonopsis lanceolata (S. et Z.) Trautv. was mixed with 30% ethanol and the filtrate was collected thrice with constant stirring of the mixture. The placebo was prepared in the same form as the test substance by replacing with corn starch. Total Nasal Symptom Score(TNSS) questionnaires and laboratory tests were performed at the screening and last visit to evaluate the efficacy. And to assess safety, vital signs and adverse events were confirmed at every visit. Statistical analysis about the result was performed using SAS 9.4. Results : In treatment group, there was a significant decrease in B cell after taking the test substance(p<0.005). And there was a statistically significant difference between groups(p<0.005). Changes in nasal symptoms were not statistically significant between groups, and both groups showed statistically significant differences before and after the test(p<0.0001). Also there were no adverse events associated with the clinical trial product. Conclusions : This clinical trial showed that Codonopsis lanceolata (S. et Z.) Trautv. extract was helpful in improving the hypersensitivity reaction in allergic patients without significant side effects.

• Preventive Nutrition and Food Science
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• v.8 no.2
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• pp.145-148
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• 2003

Many antibiotic monographs cite the induction of vaginal infections as a possible side effect. Invariably, this is believed to be due to Candide albicans, and empirical therapy is given. However, recent studies raise the question of the extent to which yeast do infect the host after antibiotic use. A double-blind, randomized, placebo-controlled study was undertaken on female patients to determine how many yeast infections occurred following 10 days antibiotic use. In addition, the study was designed to examine whether oval use of probiotic lactobacilli can reduce the risk of vaginal infection. Twenty four patients diagnosed with respiratory, oval or throat infections received one of several types of antibiotic for 10 days, and two capsules containing 10$^{9}$ dried Lactobacillus rhamnosus GR-1 and L. fermentum RC-14 from the day of commencement of antibiotic therapy for 21 days. The most commonly prescribed antibiotic was biaxin (clarithromycin). All but one patient had lactobacilli in the vagina upon entry to the study, and none developed yeast vaginitis or diarrhea during treatment or 20 days after completion of antibiotics. The mean Nugent score was higher in the placebo than the lactobacilli group (4.1 versus 2.4), and three cases of bacterial vaginosis arose (25 % incidence compared to 0% in the lactobacilli group) in the placebo group (2 receiving cefuroxime, 1 on biaxin). The study suggested that current antibiotic use is not necessarily associated with either diarrhea or yeast infection, as is often surmised. Nevertheless, daily use of probiotics was safe and could potentially reduce the risk of patients developing bacterial vaginosis after antibiotic use.

• The Korean Journal of Pain
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• v.18 no.1
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• pp.43-47
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• 2005

Background: The optimal management of pain using magnetic irradiation modalities continues to attract considerable debate. Therefore, we conducted a randomized, double-blind, placebo-controlled clinical trial to determine the effectiveness of pulsed electromagnetic therapy for the treatment of chronic lower back pain. Methods: Fifteen-minute sessions of active (n = 20) or placebo (n = 20) electromagnetic therapy were repeated 3 times a week for 3 weeks. Patients were assessed using the 11-point numerical rating scale and the revised Oswestry disability scores for up to 4 weeks after therapy. Results: The active magnetic group showed significantly more pain reduction than the placebo group immediately after therapy and one and four weeks after therapy (P < 0.05). At 4 weeks after therapy percentage changes in NRS from baseline were $22{\pm}24%$ and $38{\pm}11%$ in the placebo and magnetic groups, respectively. The revised Oswestry disability percentage in the active magnetic group was also significantly improved (P < 0.05). Conclusions: Pulsed electromagnetic therapy provided pain relief and ameliorated disability in patients with chronic lower back pain. According to our results, pulsed electromagnetic therapy should be considered an important potential therapeutic tool for the conservative therapy of chronic lower back pain.