• Korean Journal of Acupuncture
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• v.31 no.4
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• pp.158-167
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• 2014

Objectives : The results from randomized controlled trials on traditional medicine have been negative or ambiguous. The appropriateness of the research methodology started to be questioned. However, the research methodology appropriate for studying traditional medicine has not been well-established. This study aims to explore the appropriate research methodologies for clinical studies on acupuncture. Methods : Clinical researches evaluating the efficacy and effectiveness of acupuncture for back pain were systematically searched and evaluated focusing on research methodology. The acupuncture treatment protocol is evaluated by 9 items which is individual treatment based on diagnosis, combining proximal and distal acupoints, exact location of acupoint, De Qi, adequate stimulation, duration of acupuncture, treatment sessions, treatment interval, and establishing relationship between patients and doctors. Results : Systematic review of acupuncture researches on low back pain suggested that observational studies and pragmatic trials rather than explanatory studies could incorporate these elements. Qualitative studies also could help understanding complex characteristics of acupuncture treatment which could not be evaluated by quantitative studies. Conclusions : In designing clinical researches on acupuncture, various study designs, especially observational study and pragmatic study, should be considered according to research objectives and subjects. The efforts to incorporate the core characteristics of acupuncture practiced in everyday clinical setting are also essential.

• Journal of Oriental Neuropsychiatry
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• v.33 no.2
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• pp.181-214
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• 2022

Pediatric epilepsy, a chronic, recurrent brain disorder, is the most common neurological disorder in children. Its prevalence is increasing. Early management is very important since 30~40% of cases persist into adulthood. To provide basic data for future clinical research on pediatric epilepsy using Korean medicine treatment and cooperation between Western medicine doctors and Korean medicine doctors, we reviewed recent clinical research in traditional Chinese medicine (TCM) using herbal medicine for pediatric epilepsy. A total of 23 articles (1 clinical practice guideline, 3 systematic reviews, 15 randomized controlled trials (RCTs), and 4 non-RCTs) were reviewed in this study. The authors summarized characteristics of included studies regarding study subjects, diagnostic tools, pattern identification tools, treatment period, evaluation tools, detail of herbal medicines, treatment effects, and adverse events. Combination therapy using both herbal medicine (HM) and anti-epileptic drugs (AEDs) was performed more frequently than herbal medicine alone. Liver-pacifying medicinal, water-draining medicine, and orifice-opening medicine were frequently used. The main single HMs were Cheonma, Boglyeong, Jogudeung, and Seogchangpo. Combined therapy using HM and AEDs had significant benefits in improving total effective rate. It also appeared to be safer than AEDs. However, since the quality of clinical trials was poor and only studies in the last 10 years were included, the clinical evidence was uncertain. Finally, the authors provided limitations of this study and several suggestions for future research based on our analysis results.

• Journal of Oriental Neuropsychiatry
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• v.20 no.4
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• pp.79-89
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• 2009

Objectives : To address suitable method for designing clinical trial intervening Traditional Korean Herbal Medicine on General anxiety disorder through the recent clinical research in Chinese Herbal Medicine. Methods : Randomized, controlled trials(RCTs) of treatment of general anxiety disorder intervening herbal medicine were searched through CNKI databases. We examined several item of studies and evaluated using Jadad scale. We searched articles in CNKI with the key word "General anxiety disorder or 廣範性焦慮症", among them we selected the clinical trial studies related with herbal medicine except for case reports, studies of acupuncture therapy or west medicines. Results : 11 RCT studies of herbal medicine met inclusion criteria. The Studies used CCMD-3, HAMA as inclusion tool and mainly HAMA as a evaluation tool. Studies were progressed for 2-8 weeks, mostly used various positive control. Experiment medicine were mainly 理氣劑, 安神劑. In most studies, experiment group made similar or higher efficacy in comparison with control group. Mean Jadad score of studies was $1.3{\pm}0.67$, and only one study was double-blinded among 11 studies. Conclusions : RCT studies on general anxiety disorder of chinese herbal medicine tend to focus on investigating effect of herbal medicine through setting positive control group with CCMD-3 and HAMA. But, most studies had low quality of trial, for lack of pattern identification, evaluation and inclusion tool of chinese medicine. Clinical trials of general anxiety disorder should provide good quality by randomization, double-blinding, and multi-site trial.

• The Journal of Pediatrics of Korean Medicine
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• v.34 no.4
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• pp.59-76
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• 2020

Objectives The purpose of this study is to analyze the trends of recent clinical studies on the effect of herbal medicine for pediatric constipation in China, and to evaluate the efficacy and safety of herbal medication treatment for pediatric constipation. Methods The authors searched the clinical studies using China National Knowledge Infrastructure (CNKI) published from January 2016 to June 2020. We analyzed the literature in regards to focusing on the treatment methods and results. Results A total of 29 randomized controlled trials were selected and analyzed. In all the those studies, the total effective rate of herbal medicine treatment group in pediatric constipation was significantly higher than those of the control group. The most commonly used herbs for pediatric constipation were Atractylodis Rhizoma Alba (白朮) followed by Aurantii Immaturus Fructus (枳實), Glycyrrhizae Radix (甘草), Semen Cannabis (火麻仁), Raphani Semen (萊菔子). The recurrence rate of the herbal medicine treatment group was significantly lower than those of control group. In most studies, the adverse events from the herbal medicine treatment group were significantly less than those of the control group. Conclusions Based on the results of the analyzed clinical studies, herbal medicine treatment has been shown to be safe and effective in the treatment of pediatric constipation. Additional clinical studies are needed to solidify these findings.

• Journal of Oriental Neuropsychiatry
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• v.25 no.4
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• pp.401-410
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• 2014

Objectives: This study was intended to review the research trends of treating neuropsychiatric diseases and symptoms with Traditional Chinese Medicine containing Haematitum. Methods: Articles were obtained through the CNKI (China National Knowledge Infrastructure) by searching with 'Haematitum' as the main key word, and supportive words related with neuropsychiatric diseases and symptoms were selected. There were 61 articles related to clinical fields, which were then classified according to study design. Results: The 61 articles were categorized into the following types of study design: 3 randomized controlled trials, 1 quasi-randomized trial, 3 simple-designed clinical trials, and 54 case studies. Decoctions containing Haematitum were used to treat diseases and symptoms such as vertigo, headache, stroke, epilepsy, neurosis, globus hystericus, fishbilepoisoning, insomnia, mania, post-traumatic brain syndrome, and kinesia. All articles reported a good rate of effectiveness. There was no poor responsiveness regarding the effects of Haematitum in 9 studies, but it was not mentioned in the other 52 studies. Decoctions self-prepared by the authors were used in 28 studies. Modified Seonbokdeja-tang, modified Banhabeakchulcheonma-tang, modified Ondam-tang were used in that order of frequency. The daily dosage of Haematitum provided was 0.2~6 g in powder, and 9~60 g in decoction. Conclusions: Decoctions containing Haematitum are used restrictively in the neuropsychiatric clinical scene. While there were no reports of poor responsiveness of the effects of Haematitum, more research is needed to confirm its clinical stability.

• The Journal of Pediatrics of Korean Medicine
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• v.33 no.1
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• pp.58-77
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• 2019

Objectives The purpose of this study is to investigate clinical studies on the effect of acupuncture, moxibustion, and manual therapy in pediatric growth by analyzing randomized controlled trials conducted in China. Methods We searched the clinical studies from the China Academic Journal (CAJ) in China National Knowledge Infrastructure (CNKI) by specific key words and criteria. Selected 31 clinical studies were collected and analyzed. Results Total of 31 randomized controlled trials were selected and analyzed. In most of the studies, the effectiveness of acupuncture, moxibustion, and manual therapy on growth was significantly high. The most commonly used therapies were massage. The most commonly used massage methods were pinching spine (捏脊), pressing and kneading $Z\acute{u}s\bar{a}nl\check{i}$ (按?足三里), supplementing $P\acute{i}j\bar{i}ng$ (補脾經), supplementing $Sh\grave{e}nj\bar{i}ng$ (補腎經), rubbing Abdomen (摩腹), pushing $Y\check{o}ngqu\acute{a}n$ (推涌泉), supplementing $F\grave{e}ij\bar{i}ng$ (補肺經), kneading $T\grave{a}iy\acute{a}ng$ (?太陽), and kneading $Sh\acute{e}nqu\grave{e}$ (?神闕) etc. Conclusions Based on the results of the clinical studies from China, acupuncture, moxibustion, and manual therapy can be a valuable option for pediatric growth.

• Korean Journal of Clinical Pharmacy
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• v.26 no.2
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• pp.181-186
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• 2016

Background: There has been on increasing emphasis on the importance of monitoring the safety of participants in a clinical trial to protect patients and maintain the integrity of the trial. The independent data monitoring committee (IDMC) has become common component of randomized clinical trials in recent years. Methods: It is important to consider the implications of different approaches that are being used in various countries. IDMC guidelines in Korea, US, and Europe were reviewed and compared to provide the objective, composition and operation of IDMC in detail. Results: IDMC is a group of experts in related subject are as who perform interim data monitoring to make a recommendation to the sponsor or organizer regarding appropriateness of trial continuation and the need for modifications of the trial. Independence of IDMC is preferred in order to minimize influence of factors unrelated to scientific, medical and ethical considerations that should underlie decision-making. Conclusion: IDMC has become an increasingly important component of clinical trials in recent years. Practical operating procedures need to be developed considering the future regulatory status of data monitoring committees.

• The Journal of Internal Korean Medicine
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• v.39 no.6
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• pp.1191-1205
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• 2018

Objectives: This study was performed to review clinical research trends in the treatment of primary headache disorders with pharmacopuncture. Methods: We searched clinical studies on primary headache disorders treated with pharmacopuncture in four electronic databases including OASIS, RISS, CNKI, and Pubmed. The selected studies were analyzed with regard to study design, subject, intervention, evaluation, and result. Results: Five randomized controlled trials, one non-randomized controlled trial, one before-and-after study, and six case series were selected. Most of the studies showed that pharmacopuncture treatment was significantly effective in treating primary headache disorders; however, the quality of the randomized controlled trials was low. Conclusions: According to this study, pharmacopuncture could be a useful treatment option for primary headache disorders. Based on these results, further studies on the effectiveness and safety of pharmacopuncture for primary headache disorders should be performed in the near future.

• Journal of dental hygiene science
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• v.14 no.3
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• pp.269-275
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• 2014

Recently, there are lots methodologies to improve the quality of research in medical and public health fields. One of them is to checking a process of research with a reporting guideline before reporting paper. Especially, reporting guideline for randomized controlled trials (RCTs) is the consolidated standards of reporting trials (CONSORT). Therefore, this review describes the latest version of the CONSORT statement, CONSORT 2010, including intent, background, and contents of this. The CONSORT statement comprises a checklist of essential items that should be included in reports of RCTs and a diagram for documenting the flow of participants through a trial. This report guideline aims at providing guidance to authors about how to improve the reporting of their trials. As consulting the CONSORT, authors could be strictly reported about research methods and results. From this review, we expect to elevate the quality of such research about dental hygiene and to establish the foundation for evidence-based dental hygiene.

• 대한예방의학회:학술대회논문집
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• 1994.02b
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• pp.270-284
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• 1994

Interim analyses of randomized trials enable investigators to make more efficient use of limited research resources and to satisfy ethical requirements that a regimen be discontinued as soon as it has been established to have an inferior efficacy/toxicity profile. Unfortunately. the integrity and credibility of these trials can be compromised if inappropriate procedures are used in monitoring interim data. 'In this paper we discuss how group sequential designs provide useful guidelines that enable one to satisfy the valid objectives of interim monitoring while avoiding undesirable consequences, and we consider how flexible one can be in the way such designs are implemented. We also provide motivation for the role of data-monitoring committees in preserving study integrity and credibility in either government- or industry-sponsored trials. In our view. these committees should have multidisciplinary representation and membership limited to individuals free of apparent significant conflict of interest, and ideally should be the only individuals to whom the data analysis center provides interim results on relative efficacy of treatment regimens. Finally. we discuss some important practical issues such as estimation following group sequential testing, anal ysis of secondary outcomes after using a group sequential design applied to a primary outcome, early stopping of negative trials. and the role of administrative analyses.