• Korean Journal of Acupuncture
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• v.24 no.3
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• pp.33-45
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• 2007

Background : Hot flushes are general postmenopausal symptoms which about 75% of climacteric women undergo. They affect hotness, perspirations, systemic weakness, panic disorders, insomnia. Acupuncture is effective in alleviating hot flushes in practice. Assessment effectiveness and safety of acupuncture in hot flushes would be needed through multi-center trial. Objectives : Purpose of this study is to develope the protocol of effects of acupuncture on hot flushes, a postmenopausal symptom in climacteric women. Methods & Results : It will be a multi-centered, randomized, sham controlled, comparative trial. It will be performed by Good Clinical Practice after approval of Institutional Review Board. Selection criteria will be set according those of FDA above moderate degree. There will be a notice on concomitant medication, other herbs, dietary supplements. Superficial needling on sham points will be used for control group. Treatment period will be 8 weeks with 12 weeks' follow up. Some questionnaire scale will be used as the primary and secondary outcome. Conclusions : The clinical trials based on this protocol will be performed.

• 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 Acupuncture Research
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• v.36 no.2
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• pp.100-106
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• 2019

Background: In Korean medicine, carpal tunnel syndrome is treated by stimulating the acupoints around the wrist. Although a deep understanding of anatomy and guidance is needed to stimulate these acupoints to avoid undesirable side-effects, currently there are no published guidelines for acupotomy treatment. The aim of this study is to evaluate the effectiveness and safety of fluoroscopy-guided acupotomy compared with conventional acupotomy treatment. Methods: This is a randomized, patient-assessor, patient blind, parallel clinical trial. A total of 30 patients will be enrolled at Wonkwang University Gwangju Hospital, and will be allocated to either an experimental group or a control group. The experimental group will be treated using fluoroscopy-guided acupotomy and the control group will be treated using the conventional acupotomy method. Results: The primary outcome measure will be identification of a cross-section area of the median nerve measured by ultrasonography, and the secondary outcome measure will be the alleviation of pain measured by the Visual Analogue Scale, improvement in the Nerve Conduction Study, Tinel test, Phalen's test, EuroQol 5-dimension scale, and Boston Carpal Tunnel Questionnaire score. Safety components will be measured by monitoring vital signs, electrocardiographs, blood tests, general chemical tests, urine tests and pregnancy tests. In addition, observations for adverse effects will be performed during the trial. Conclusion: This study will provide a more effective, and less harmful way of treating carpal tunnel syndrome compared with conventional acupotomy. Fluoroscopy-guided acupotomy will help practitioners to be accurate in direction and depth of the needle for treating carpal tunnel syndrome.

• Journal of Pharmacopuncture
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• v.18 no.1
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• pp.79-85
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• 2015

Objectives: A vertebral compression fracture (VCF) is characterized by back pain and fracture of a vertebral body on spinal radiography. VCFs of the thoraco lumbar spine are common in the elderly. In general, appropriate analgesics should be prescribed to reduce pain and, thus, promote early mobilization. The ideal treatment approach for VCFs has not been determined. In Korea, acupuncture and herbal medication have been used to treat VCFs for many years. There is empirical evidence that acupuncture might benefit patients with a VCF. However, no randomized, controlled, clinical trials evaluating the efficacy and the safety of acupuncture for treating a VCF have been published. Therefore, we designed a randomized, controlled, pilot, clinical trial to obtain information for the design of a further full scale trial. Methods: A five week protocol for a randomized, controlled, pilot, clinical trial is presented. Fourteen patients will be recruited and randomly allocated to two groups: a control group receiving interlaminar epidural steroid injections once a week for three weeks, and an experimental group receiving interlaminar epidural steroid injections plus acupuncture treatment (three acupuncture sessions per week for three weeks, nine sessions in total). The primary outcomes will be the pain intensity (visual analogue scale and PainVision$^{TM}$ system). The secondary outcome measurements will be the answers on the short form McGill pain questionnaire and the oswestry disability index. Assessments will be made at baseline and at one, three, and five weeks. The last assessment (week five) will take place two weeks after treatment cessation. This study will provide both an indication of feasibility and a clinical foundation for a future large scale trial. The outcomes will provide additional resources for incorporating acupuncture into existing treatments, such as nonsteroidal anti-inflammatory medications, narcotics and vertebral augmentation. This article describes the protocol.

• Asian Pacific Journal of Cancer Prevention
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• v.13 no.12
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• pp.6337-6342
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• 2012

Background: Clinical trials on cancer subjects have one of the highest dropout rates. Barriers to recruitment range from patient-related, through institutional-related to staff-related factors. This paper highlights the low response rate and the recruitment barriers faced in our Qigong exercises trial. Materials and Method: The Qigong trial is a three-arm trial with a priori power size of 114 patients for 80% power. The University Malaya Medical Centre database showed a total of 1,933 patients from 2006-2010 and 751 patients met our inclusion criteria. These patients were approached via telephone interview. 131 out of 197 patients attended the trial and the final response rate was 48% (n=95/197). Results: Multiple barriers were identified, and were regrouped as patient-related, clinician-related and/or institutional related. A major consistent barrier was logistic difficulty related to transportation and car parking at the Medical Centre. Conclusions: All clinical trials must pay considerable attention to the recruitment process and it should even be piloted to identify potential barriers and facilitators to reduce attrition rate in trials.

• Journal of Pharmacopuncture
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• v.11 no.2
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• pp.21-31
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• 2008

Objective This study was performed to investigate whether Bee Venom Pharmacopuncture(BVP) could be a more effective modality than Warm Needling(WN) in relieving pain and symptoms of knee osteoarthritis(OA). Design Prospective, randomized and controlled clinical trial. Setting Single center trial in Korea Patients 49 volunteers with knee OA participated in the study. All the participants were screened through an inclusion and exclusion criteria. 33 participants were completed the clinical trial. Intervention The subjects were randomly assigned to one of two groups. One group received BVP(n=18), while the other group received WN(n=15). Sixteen sessions of BVP or WN were given at the pain region of the problematic knee for 8 weeks. Primary outcome measure is the Korean translation of Western Ontario and McMaster Universities Osteoarthritis Index scores(Korean WOMAC, KWOMAC). Secondary outcome measure is the physical health scores based on the 36-Item Short-Form Health Survey(SF-36) and Patient Global Assessment(PGA). KWOMAC and SF-36 were measured third (baseline, 4 and 8 weeks). PGA was measured twice(4 and 8 weeks). Results BVP group showed significant decrease compared to WN group in pain, function and total scores of KWOMAC according to the Mann-Whitney U-test. In the PGA, BVP group, compared to WN group, showed a significant increase. Conclusions BVP was more effective in relieving pain of knee OA than WN. These findings suggest that BVP is a promising alternative for treating knee OA.

• 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.

• Journal of Pharmacopuncture
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• v.21 no.1
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• pp.7-13
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• 2018

Objective: Hwa-byung is one of the cultural concept of distress in Korea resulted from chronic accumulated anger. It is characterized by various symptoms like stuffy in the chest, hot or heat sensation, something pushing up in the chest, feeling of mortification, and a flush of anger. This protocol aims to explore the efficacy and safety of Huanglian-jie-du decoction on various somatic symptoms and insomnia in patients with Hwa-byung. Methods: This is study protocol for a randomized, double-blind, placebo-controlled trial. A total of 44 patients will be randomly assigned to the experimental group or the placebo group in a 1:1 ratio. All medications will be taken orally 3 times per day for 7 consecutive days. The primary outcomes are the mean changes in Patient Health Questionnaire of physical symptoms (PHQ-15) and Insomnia Severity Index (ISI) after the 7 days of administration. The secondary outcomes include the scales to assess stress response, symptoms of Hwa-byung, and state anger. Conclusion: The results of this study will provide high quality and explorative evidence to investigate the effect of Huanglian-jie-du decoction on Hwa-byung.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.11 no.11
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• pp.4395-4403
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• 2010

The aim of this study is to know about condition of alternative medicine. Methods which An literature search in Pubmed January 2000 to March, 2010 was performed. RCT(Randomized Controlled Trial), CCT(Controled Clinical Trials), and OD(efficacy studies with either a controlled or an Other than controlled Design) were included. PubMed databases were searched using key terms relating to alternative medicine. 19 clinical trials were included among 682 studies searched. RCT was 44%, CCT was 16% and OD was 40% in the review. In the all of included studies, the acupuncture and the massage was the biggest part. The using rate was 20% of pain control about Disease of the Musculoskeletal system and Connective tissue, 15% of Certain infectious and parasitic diseases, and 15% of Neoplasms. There was lack of evidence that alternative medicine was effective for progress. Future well-designed clinical trials is needed.