• Journal of Oriental Neuropsychiatry
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• v.22 no.4
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• pp.31-39
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• 2011

Objectives : This study aimed to investigate frequently used herbal materials among herbal prescription for depression focusing on randomized controlled trial. Methods : Every article relevant to depression was initially obtained from China National Infrastructure(CNKI), Korean database and book hand-searching. Searching keywords were 'depression', 'herbal medicine' and 'randomized controllled trial(RCT)'. Results : Among comorbidity with depression, the most accompanied disease was that of circulatory system. Among sixty-five articles, depression with cerebral vascular disease was twenty-eight. Article about mood disorder was twenty-four. High frequently used herbal materials were Bupleuri Radix(41times), Curcumae Radix(34 times), Acori Graminei Rhizoma and Cnidii Rhizoma(24 times). Conclusions : According to this study, we could know select frequent-used herbal medicine. In a clinical treatment, herbal materials can be added herbal prescription related to depression. As these results, it can be helpful to develop new drugs.

• Translational and Clinical Pharmacology
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• v.26 no.4
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• pp.155-159
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• 2018

For regulatory approval of a new drug, the most preferred and reliable source of evidence would be randomized controlled trials (RCT). However, a great number of drugs, being developed as well as already marketed and being used, usually lack proper indications for children. It is imperative to develop properly evaluated drugs for children. And expanding the use of already approved drugs for other indications will benefit patients and the society. Nevertheless, to get an approval for expansion of indications, most often with off-label experiences, for drugs that have been approved or for the development of pediatric indications, either during or after completing the main drug development, conducting RCTs may not be the only, if not right, way to take. Extrapolation strategies and modelling & simulation for pediatric drug development are paving the road to the better approval scheme. Making the use of data sources other than RCT such as EHR and claims data in ways that improve the efficiency and validity of the results (e.g., randomized pragmatic trial and randomized registry trial) has been the topic of great interest all around the world. Regulatory authorities should adopt new methodologies for regulatory approval processes to adapt to the changes brought by increasing availability of big and real world data utilizing new tools of technological advancement.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.30 no.2
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• pp.1-18
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• 2017

Objectives : This review aims to evaluate a risk of bias by risk of bias tool and RoBANS(Risk of Bias Assessment tool for Non-randomized Study) tool for clinical trial papers proving treatment effect of Korean medicines to alopecia and provides the newest reason of effectiveness of herbs to alopecia. Methods : Data were collected through electronic database including NDSL, KISS, KMBASE, Koreantk, OASIS, KoreaMed, KISTI, Pubmed, Cochrane CENTRAL and CINAHL. Two experts in Oriental Medicine assessed risk of bias of randomized controlled trials by Cochrane group's Risk of Bias tool and non-randomized controlled trials by RoBANS tool after searching, reviewing and selecting papers. Results : Total number of selected trials is 20 including 4 randomized controlled trial, 13 non-randomized controlled trials and 3 case reports. This study evaluate the risk of bias of 17 papers including 4 randomized controlled trials and 13 non-randomized controlled trials except 3 case reports by risk of bias tool and RoBANS tool. All papers of randomized controlled trials are evaluated unclear for random sequence generation and allocation concealment as there are no word on them. And all papers of non-randomized controlled trials are evaluated unclear for blinding of outcome assessments and relatively low for others. Conclusions : Korean medicine intervention can be an effective for treatment in alopecia. It was evaluated by hair density, thickness and expert panel assessment of photographs and all results are statistically significant. But enhancing levels of evidence, we must try to reduce bias in researches and report a safety, protocol and IRB.

• Korean Journal of Acupuncture
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• v.26 no.1
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• pp.41-49
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• 2009

Objective : To make comprehensive picture of clinical trials using moxibustion and their results by today, then help a strategy for moxibustion-derived clinical studies in the future. Methods : Surveyed literatures containing randomized controled clinical trial (RCT) from PubMed and Korean journals. Analysis was performed according to distribution mainly by study subject, target diseases, study design, and its efficacy. Results : Fifty two literatures were selected according to inclusion criteria of randomized controled clinical study. Moxibustion-derived RCT have been rapidly increased from 2003 since the first was published in China in 1992. The main subjects of RCT are associated with immunity, cancer, arthritis, chronic colitis and urogenital disorders, which are connected to cold-elated pathogenesis. The average number of subjects was 94, and direct-moxibustion was mainly applied. The control groups were set up by giving conventional therapy, herbal medicine, acupuncture or only observation. The most of RCTs showed positive results. Conclusions : This study would be helpful for designing or conducting RCTs to develop the scientific development of moxibustion.

• The Journal of Korean Obstetrics and Gynecology
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• v.26 no.2
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• pp.66-87
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• 2013

Objectives: The aim of this study was to review systemically clinical trials on the trends of studies for Complementary and Alternative Medicine in the treatment of female sexual dysfunction and provide basic resource for future treatment and suggestions for improving research methods. Methods: Through medical website 'Pubmed', foreign clinical literatures about female sexual dysfunction were searched and domestic clinical literatures about female sexual dysfunction were searched using internet websites 'National assembly library', 'KISS', 'RISS', 'Korean traditional knowledge portal'. Results: Total 19 literatures were selected from January 2000 to June 2012. 15 foreign literatures were selected through medical website and 4 domestic literatures were chosen using internet websites or hand-searching. 5 literatures were published in 2008 and 13 literatures mentioned about age group of patients. FSFI is most common tool for female sexual dysfunction. 9 of 19 literatures were using Herbal medicine for treatment. 5 literatures were about CBT, 6 literatures were about Biofeedback and other one literatures are about Perineal massage. There were 14 Randomized controlled trials and 5 Non-randomized controlled trials. And randomized controlled trials were relatively low in risk of bias than non-randomized controlled trials. Conclusions: Upon these results, in similar future more clinical trials should be done and accumulate Evidence-based literatures.

• Journal of Korean Medicine Rehabilitation
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• v.27 no.3
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• pp.95-105
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• 2017

Objectives To evaluate the evidence supporting the effectiveness of Soyeom pharmacopuncture therapy for Pain. Methods We conducted search across 6 electronic databases (Pubmed, CAJ, Oasis, RISS, DBPIA and KoreanTK) and 2 journals to find clinical trials that used Soyeom pharmacopuncture therapy as treatment for pain. The methodological quality of Randomized controlled clinical trials (RCTs) was assessed using the Cochrane Risk of Bias (RoB) tool, while NRCTs (Non-Randomized controlled clinical trials) were assessed using the Risk of Bias Assessment tool for Non-randomized Study (RoBANS) tool. Results Among 75 articles that were searched, 5 RCTs and 2 NRCTs were finally selected. Among 7 selected studies, all studies showed that Soyeom pharmacopuncture therapy has significant effect on Pain. Conclusions Our systematic review found encouraging but limited evidence of Soyeom pharmacopuncture therapy for Pain. We recommend clinical trials which compare the effectiveness of Soyeom pharmacopuncture therapy with other pharmacopuncture therapies to clarify the effectiveness of Soyeom pharmacopuncture therapy from other pharmacopuncture therapies.

• Journal of Oriental Neuropsychiatry
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• v.21 no.4
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• pp.151-161
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• 2010

Objectives : This study aimed to evaluate any clinical studies regarding the herbal medicine for dementia focusing on Korean literature for future rigorous clinical research. Methods: Every article relevant to dementia was initially obtained from oriental medical related journals by electronic search at journal web sites or manual searches. Journals were limited to those registered with the Korea Research Foundation. From initial findings. two independent reviewers selected clinical articles and these articles were further analyzed separately by predefined criteria according to prospective and retrospective studies. For randomized controlled trial and non randomized controlled trial. quality assessment was also conducted. Results: From ninety seven patients initially obtained articles. twenty three patients were finally analyzed. One article was randomized controlled study. Four articles were prospective whereas eighteen patients were retrospective. In the qualitative evaluation of prospective articles. there was deduction regarding pre-calculated study size and prospective data collecting. Assessment measurement most frequently used was Mini Mental State Examination. The order of frequency of use herbs were identified. Conclusions : According to our study. the herbal medicine for dementia in general showed a positive effect in the cognitive aspects of dementia patients. Further well-designed randomized controlled studies should be conducted.

• Journal of Oriental Neuropsychiatry
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• v.33 no.4
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• pp.389-400
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• 2022

Objectives: Depression is a highly prevalent disease, and the market for antidepressant drugs continues to grow at a steady rate. Although current antidepressants are reported to be effective, because of their low remission rate and side effects, new antidepressants are needed. The use of Banhahubak-tang (BHT) to treat the symptoms of depression is supported by experimental evidence. The proposed study will evaluate the efficacy and safety of BHT in treating depression. Methods: A randomized, waitlist-controlled, parallel clinical trial will be conducted to assess the efficacy of BHT in depression. A total of 84 participants with depression will be randomized into the intervention group or waitlist-control group at a 1:1 ratio. Patients in the intervention group will be administered BHT three times a day for four weeks and followed up for four more weeks after therapy completion. Patients in the waitlist-control group will undergo the same intervention and follow-up after a four-week waiting period. The primary outcome is change in the Korean version of the Hamilton Depression Rating Scale (K-HDRS) scores for major depressive disorders after four weeks. The secondary outcomes include scores on the K-HDRS, Korean Symptom Check List 95 (KSCL-95), Insomnia Severity Index (ISI), State-Trait Anxiety Inventory-Korean version (STAI-K), State-Trait Anger Expression Inventory-Korean version (STAXI-K), and the Instrument on Pattern Identifications for Depression and EuroQol-5 Dimension (EQ-5D). Conclusions: This trial will provide high-quality clinical evidence of the efficacy and safety of BHT in the management of depression.

• Journal of Korean Medicine Rehabilitation
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• v.33 no.1
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• pp.13-29
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• 2023

Objectives To evaluate the evidence supporting the effectiveness of acupuncture for facet joint syndrome. Methods We conducted search across 9 electronic databases (PubMed, EMBASE, Cochrane CENTRAL (CENTRAL), KoreaMed, Kmbase, Koreanstudies Information Service System (KISS), ScienceOn, China National Knowledge Infrastructure (CNKI), and Wanfang) to find clinical trials that used acupuncture as treatment for facet joint syndrome. The methodological quality of randomized controlled clinical trials (RCTs) were assessed using the Cochrane Risk of Bias (RoB) tool, while non-randomized controlled clinical trials (nRCTs) were assessed using the Cochrane Risk of Bias Assessment tool for Non-randomized Study (RoBANS) tool. Results Nine RCTs and one nRCT met our inclusion criteria. Fire needle was more effective than medial branch block in terms of visual analogue scale (VAS) after 1 month (p=0.02). Also, Fire needle was more effective than Ibuprofen in terms of VAS and oswestry disability index (ODI) (p<0.05). However, in the rest of the study results, the intervention group did not show a statistically significant difference than the control group. Conclusions Although our review found encouraging but limited evidence of acupuncture for facet joint syndrome, most of the studies included in the analysis were evaluated as methodologically high risk of bias. From now on further well-designed RCTs should be encouraged.

• Journal of Physiology & Pathology in Korean Medicine
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• v.37 no.6
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• pp.185-192
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• 2023

The purpose of this study is to analyze trends in domestic and international clinical research studies on pharmacopuncture treatment for fractures. We searched five online databases (PubMed, CNKI, RISS, KISS, and OASIS), and selected a total of 13 clinical research studies from Korea and China. Selected studies were analyzed according to publication year, subject, intervention, treatment method, evaluation scale, adverse event, risk of bias, etc. A total of 10 case studies and 3 randomized controlled trials were included. The study subjects were more often female, and the most common type of fracture was vertebral compression fracture. In Korea, herbal medicine preparations and bee venom were used for pharmacopuncture solution, whereas in China, both herbal medicine preparations and Western medicine preparations were used. All studies commonly used local acupoint needling, and in most cases, the treatment period for case study was less than 1 month, and the observation period of randomized controlled trials was diverse. The most frequently used evaluation scale was numeric rating scale, adverse events were mentioned in only three studies, and no adverse events were reported. Overall risk of bias of all included randomized controlled trials was judged "some concerns". According to this study, pharmacopuncture treatment for fractures was found to be relatively effective and safe, but research that complements the limitations of this study is needed.