• Journal of Sasang Constitutional Medicine
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• v.30 no.2
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• pp.42-54
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• 2018

Objectives This study was aimed to compare effects of Yukgunja-tang (YGJT) extract granule on functional dyspepsia (FD) by sasang constitution. Methods A placebo-controlled, double-blind, randomized, two-center trial was performed. We obtained 3D face images of FD patients participating in this study using face-only scanner and classified them into two types as narrow face and wide face by 3D facial shape diagnosis system (3-FSDS). 96 subjects (48 subjects per type) were enrolled and were randomly allocated into treatment or control groups in a 2:1 ratio. YGJT extract granule or placebo were administered to each group during the 8 week treatment period. One of sasang constitutional specialist diagnosed their constitutions by referring to questionnaires and 3D face images. The primary outcome was total dyspepsia symptom scale (TDS scale), the secondary outcomes were single dyspepsia symptom scale (SDS scale), visual analog scale (VAS) and so on. This trial was registered with clinical research information service identifier: KCT0001920, 15 May, 2016. Results In the Taeeumin treatment group, the TDS scale was significantly decreased after 8 weeks compared to the control group (t=2.331, p=0.025) and the SDS scale also significantly decreased. (t=2.042, p=0.048). The specific effects of the YGJT extract granule without the placebo effect on the Taeeumin with functional dyspepsia were 30.61% in TDS scale and 28.33% in SDS scale. Conclusions The effects of Yukgunja-tang extract granule on functional dyspepsia was different according to Sasang constitution. So the constitution should be considered in randomized controlled trials using herbal extract granules.

• Journal of Korean Medicine Rehabilitation
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• v.23 no.3
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• pp.87-106
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• 2013

Objectives We will provide basic information on bee venom clinical tests and aid the practical use of bee venom in such tests, through examination of RCT research related to bee venom that was reported domestically. Methods We collected 365 articles on Bee venom study result from the OASIS system using the Keyword 'bee venom, apitoxin, apitherapy, bee sting'. The initially selected theses were primarily screened for clinical research. Out of these, case studies and non randomized controlled trial (non-RCT) were ruled out. As a result, 39 studies of randomized controlled trial (RCT) research were chosen as the subjects of study. Results RCT research related to bee venom was first presented in 2003, and 39 studies have been published until 2012. 18 studies were tests to confirm the effectiveness of bee venom, 7 studies were comparisons between SBV and BV, and 13 studies were comparisons with other types of treatment. Research conducted through appropriate randomization methods were 20 studies, and inappropriate randomization methods were used in 19 studies. In therms of Jadad score, 12 studies received 4~5 points, 15 studies received 1-3 points, and 12 studies received zero point. Conclusions In order to assure good quality RCT research, appropriate guidelines should be provided, and proper evaluation standards should be established. In-depth study is needed concerning the difference of responses to treatment according to the types of treatment received. A standardization of treatment should be reached as a result.

• The Journal of Internal Korean Medicine
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• v.28 no.2
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• pp.346-353
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• 2007

Background : Over a thousand years of clinical preparation of Ephedrain traditional Korean medicine has confirmed effectiveness and security. Recently. Ephedra-containing herbal preparations to treat obesity are common. The aim of this study is to identify effects of Ephedra on psychological anxiety. Objectives : To determine effects of Ephedraon psychoactivity and autonomic nervous system. Methods : The study design was a double-blind randomized controlled trial. The subjects of this study were healthy adults. They were allocated to either the Ephedragroup (N =66) or the placebo group (N =32), Ephedra(8 g) or a placebo in similar opaque capsules was given twice a day for 2 weeks. Anxiety score was estimated with State-Trait Anxiety Inventory before first and after last medication. 36 of the Ephedragroup and 24 of the placebo group finished the trial and were analyzed. Paired samples T-test and independent samples T-test were applied to statistical analysis. Results : The following result was obtained: After taking Ephedra. state anxiety increased significantly. In the placebo group. both state and trait anxiety increased although significance was not reached. Conclusions : It is concluded that the intake of Ephedraplays a significant role in the increase of anxiety in healthy adults. It is suggested that anxiety level change should be considered when using Ephedra in clinics.

• 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.

• Journal of Oriental Neuropsychiatry
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• v.34 no.3
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• pp.213-234
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• 2023

Objectives: To investigate current status of randomized controlled clinical trial (RCT) registration for suicide attempters. Methods: The World Health Organization International Clinical Trials Registry Platform (WHO-ICTRP) was used to search for data using 'suicide' as a search term. All registration information of RCTs registered up to April 2023 were collected. Results: Among a total of 68 RCTs registered, the United States ranked the highest in terms of quantity in this field (n=30, 46.15%), whereas Asia had only six (8.82%). A total of 62 (91.18%) RCTs involved individual interventions, while nine (13.24%) RCTs involved group interventions. Among individual interventions, 11 (16.18%) and 54 (79.41%) RCTs were on pharmacotherapy and psychotherapy, respectively. Within psychotherapy, there were a total of 17 (25%) studies utilizing digital media, with cognitive behavioral therapy (CBT) via phone being the most common approach. Among non-digital media-based studies, CBT was used the most frequently (n=11, 16.18%), followed by attempted suicide short intervention program (n=6, 8.82%). There were no studies using interventions from East Asian traditional medicine, including Korean medicine (KM). The most frequently used main outcome was the Beck scale for suicidal ideation. Conclusions: Studies on suicide attempts in Asia, especially in South Korea, are very scarce. Despite vigorous psychotherapeutic research in this field, KM psychotherapy has not been used. Thus, KM clinical trial for suicide attempters might be planned in the future based on our findings.

• Journal of Physiology & Pathology in Korean Medicine
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• v.38 no.2
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• pp.59-65
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• 2024

Rectal prolapse is a condition where the rectal wall protrudes outside the anus. While it is a rare condition, it can cause discomfort for patients due to the protrusion of the rectal structure, discharge of mucus and blood, fecal incontinence, constipation, and other inconveniences. In this review, we analyzed a randomized controlled trial (RCT) study that used the herbal medicine Bojungikgi-tang(Buzhongyiqi-tang) as a complementary therapy to improve the weaknesses and side effects of the standard treatment, surgical therapy, for rectal prolapse. The analysis included 12 RCT studies, and in all studies, the prescription involved the use of Astragali Radix at the highest dosage. Among the 11 studies that evaluated efficacy, 7 studies showed a significant effect compared to the control group. In all 3 studies that evaluating recurrence rates and all 5 studies investigating complications after surgery, the experimental group showed significant effects. Based on these findings, this study could be considered as a foundational evidence for the application of bojungikgi-tang(Buzhongyiqi-tang) in clinical practice in Korean medicine for patients with rectal prolapse. It could also serve as foundational data for future research.

• Journal of Acupuncture Research
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• v.22 no.4
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• pp.113-120
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• 2005

objectives : This study was to evaluate the effectiveness of Bee Venom acupuncture therapy for sprain of L -spine. Methods : A randomized double blinding study of bee venom acupuncture therapy was conducted on sprain of L-spine. We divided sprain of L-spine patient into 2 groups: one group with both acupuncture and saline acupuncture therapy, and another group with both acupuncture and bee venom acupuncture therapy. To estimate the efficacy of treatment that applied for two groups, we used visual analog scale(VAS) and oswestry disability index(ODI). We compared the VAS and ODI score of two groups statistically. Results : 1. As a result of evaluation by using visual analog scale(VAS) and oswestry disability index(ODI), treatment score after 5 days was marked more higher than score before treatment and treatment score after 10 days treatment was more higher than treatment score after 5 days on each groups. 2. After 10 days treatment, acupuncture and bee venom acupuncture therapy group had significant result on visual analog scale(VAS) and oswestry disability index(ODI) compared with acupuncture and saline acupuncture therapy group. Conclusion : Bee Venom acupuncture therapy can be used with acupuncture therapy for highly effective treatment for sprain of L-spine.

• The Journal of the Korea Contents Association
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• v.18 no.6
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• pp.652-666
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• 2018

The purpose of this study was to investigate systematic review and meta-analysisto identify exercise intervention effect applied to patients who underwent lung resection with lung cancer. A total of 1,322 publications were searched from 1990 to 2016 through domestic and foreign electronic databases, and the final 13 publications were selected through literature selection process. Finally, eight RCT (randomized controlled trial) and five NRCT (non-randomized controlled trial) were identified, including 925 participants. The results of the meta-analysis of the effect sizes of the intervention on the outcome variables showed that the health-related quality of life EORTC QOL-C13/30 (the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire) (MD-0.50 95 % CI -0.83-0.18) and SF-36 PCS (the Medical Outcomes 36-Item Short Form Health Survey PCS) (MD 0.75, 95 % CI 0.41-1.10) in the intervention group were significantly higher than the control group. The results of this study suggest that exercise interventions can potentially improve the quality of life of patients who underwent lung resection with lung cancer.

• Journal of Korean Medicine Rehabilitation
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• v.32 no.3
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• pp.37-53
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• 2022

Objectives This study was conducted to investigate a randomized controlled trial study on the clinical treatment of herbal medicines for avascular necrosis of the femoral head. Methods By March 2022, the China National Knowledge Infrastructure (CNKI) was reviewed about randomized controlled trial studies on the herbal treatment of avascular necrosis of the femoral head through. The publication year, evaluation criteria, treatment period, treatment method and effectiveness were analyzed for articles published from 2017 to 2022. Results 16 articles were selected and 14 kinds of herbal medicines were used. In most studies, Western medical treatments such as injection therapy, oral drug administration, traction therapy and mid-frequency electric therapy were treated alone in the control group, and a combination of Western medical treatment and herbal treatment was administered to the experimental group. Conclusions In China, there have been many studies on herbal treatment for avascular necrosis of the femoral head. In Korea, more clinical studies on the herbal treatment of avascular necrosis of the femoral head are needed. This study will be helpful for future research in Korean medicine on avascular necrosis of the femoral head.

• CELLMED
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• v.10 no.1
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• pp.8.1-8.7
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• 2020

Aim:'Itrifal-e-Sagheer', a compound Unani formulation has been indicated in disease conditions simulating dyslipidemia. The present study was done to substantiate the efficacy of 'Itrifal-e-Sagheer' in dyslipidemia on scientific parameters. Materials and methods: A randomized, single blind, controlled, clinical trial was carried out on 30 patients of dyslipidemia who were randomly allocated into test (n = 15) or control (n = 15) groups. The test drug, Itrifal-e-Sagheer and control drug, Abana® were given to respective group for 45 days along with lifestyle modification. Results: The test drug significantly alleviated the symptoms of subjective parameters (palpitation, breathlessness and weight gain) (p<0.05). There was statistically significant reduction in lipid profile of the patients in test group (p<0.05) than control drug treatment. Conclusion: The study evidenced that Itrifal-e-Sagheer is potentially effective and safe in the treatment of dyslipidemia. However, a multicentric study with robust study design is required to generalize the results.