• Title/Summary/Keyword: Electronic Clinical Trial

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Literature Review of Korean Medicine Studies for Fibromyalgia Syndrome (FMS) (섬유근통 증후군의 한의학적 연구에 대한 문헌 조사: 국내 논문을 대상으로)

  • Lee, Jung-Min
    • Journal of Korean Medicine Rehabilitation
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    • v.27 no.2
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    • pp.55-66
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    • 2017
  • Objectives This study aimed to review studies in Korean medicine for fibromyalgia syndrome (FMS). Methods We conducted search across 3 electronic databases (Korean traditional knowledge portal, RISS, Oasis) to find studies for FMS in Korean medicine. Studies of Korean medicine for FMS were included and analysed. Results 15 studies were included. 2 studies were reviews and 13 studies were case reports. Total numbers of patients in case studies were 15. In case studies, acupuncture (100%), herbal medicine (76.9%), Korean physical therapy (69.2%), pharmacopuncture (53.8%), Chuna (46.1%) and moxibustion (30.7%) etc. were used. BL23 in acupuncture and CV12 in moxibustion were most frequently used. Gamisoyo-san in herbal medicine and visual analogue scale (VAS) in outcome measure were most frequently used. Conclusions This systematic review found encouraging but limited evidence of Korean medicine for FMS. I expect various trials such as randomized clinical trial or animal experimentation and more case reports. And systemic review for FMS in other national journals is needed.

Chuna Manual Therapy for Rheumatoid Arthritis : A Systematic Review and Meta-analysis (류마티스 관절염에 대한 추나요법의 효과 : 체계적 문헌고찰과 메타분석)

  • Heo, In;Han, In-Sik;Cha, Yun-Yeop
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.13 no.1
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    • pp.1-10
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    • 2018
  • Objectives: To evaluate the evidence supporting the effectiveness of Chuna manual therapy for rheumatoid arthritis. Methods: We conducted a search across 9 electronic databases to find all randomized controlled clinical trials (RCTs) that used Chuna manual therapy as a treatment for rheumatoid arthritis. The methodological quality of each RCT was assessed using the Cochrane risk of bias tool. Results: Our inclusion criteria were met by 5 RCTs. The meta-analysis showed positive results for the use of Chuna manual therapy combined with oriental usual care (UC) in terms of the efficacy rate, pain, and duration of morning stiffness when compared to western UC. Positive results were also obtained in terms of the efficacy rate, when Chuna manual therapy combined with medication was compared to medication treatments alone. Conclusions: Our systematic review found encouraging, but limited evidence of Chuna manual therapy for rheumatoid arthritis. However, to obtain stronger evidence without the drawbacks of trial design and the quality of studies, we recommend a comparative research to test the effectiveness of Chuna manual therapy.

Chinese Medicine including Chuna Manual Therapy for Osteoarthritis : A Systematic Review (골관절염에 대한 추나요법을 포함한 중의학치료의 효과 : 체계적 문헌 고찰)

  • Kim, Han-Kyul;Gwon, Tae-U;Kim, Byung-Jun
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.13 no.1
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    • pp.11-21
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    • 2018
  • Objectives: To evaluate the evidence supporting the effectiveness and safety of Chinese medicine, including Chuna manual therapy, for the treatment ofosteoarthritis. Methods: We conducted a search of 8 electronic databases(Pubmed, Web of Science, EMBASE, Cochrane Library, CAJ, KISTI, NDSL, and RISS) to find all randomized controlled clinical trials that discuss Chuna manual therapy forosteoarthritis till May 2018. Results: Our inclusion criteria selected 7eligible RCTs involving 633 participants. The meta-analysis of 6 studies showed positive results for the useof Chinese medicine, including Chuna manual therapy, for treating knee osteoarthritis. There was no evidence of worsening symptoms or any adverse events. Conclusions: Our systematic review found favorable evidence regardingthe effectiveness of Chinese medicine, including Chuna manual therapy, for treating knee osteoarthritis. However, our systematic review had several limitations owingto the low quality of original articles andadditionalclinical trials would be necessary for stronger evidence.

Estimating survival distributions for two-stage adaptive treatment strategies: A simulation study

  • Vilakati, Sifiso;Cortese, Giuliana;Dlamini, Thembelihle
    • Communications for Statistical Applications and Methods
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    • v.28 no.5
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    • pp.411-424
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    • 2021
  • Inference following two-stage adaptive designs (also known as two-stage randomization designs) with survival endpoints usually focuses on estimating and comparing survival distributions for the different treatment strategies. The aim is to identify the treatment strategy(ies) that leads to better survival of the patients. The objectives of this study were to assess the performance three commonly cited methods for estimating survival distributions in two-stage randomization designs. We review three non-parametric methods for estimating survival distributions in two-stage adaptive designs and compare their performance using simulation studies. The simulation studies show that the method based on the marginal mean model is badly affected by high censoring rates and response rate. The other two methods which are natural extensions of the Nelson-Aalen estimator and the Kaplan-Meier estimator have similar performance. These two methods yield survival estimates which have less bias and more precise than the marginal mean model even in cases of small sample sizes. The weighted versions of the Nelson-Aalen and the Kaplan-Meier estimators are less affected by high censoring rates and low response rates. The bias of the method based on the marginal mean model increases rapidly with increase in censoring rate compared to the other two methods. We apply the three methods to a leukemia clinical trial dataset and also compare the results.

Chuna Manual Therapy for Tourette's Syndrome: A Systematic Review and Meta-Analysis (뚜렛 장애에 대한 추나요법의 효과: 체계적 문헌 고찰 및 메타분석)

  • Kim, Hyeon-Ji;Lee, Eun-Byeol;Kim, Chae-Young;Ahn, Hee-Duk
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.17 no.1
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    • pp.21-33
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    • 2022
  • Objectives To assess the effectiveness of Chuna manual therapy in patients with Tourette's syndrome. Methods We queried nine electronic databases using the keywords "Tourette's Syndrome" and "tuina OR chuna" to identify RCTs that investigated the effectiveness of Chuna manual therapy in patients with Tourette's syndrome. Results Thirteen RCTs were selected according to the inclusion criteria. A systematic review showed that Chuna manual therapy can have a curative effect on patients with Tourette's syndrome. Conclusions In this study, 13 RCTs reported that Chuna manual therapy was effective for Tourette's syndrome. These findings provide a basis for its clinical use. However, all studies involved populations belonging to the same country. Many studies lacked details of the research methodology. Therefore, further studies are required to produce high-quality evidence.

Chuna Manual Therapy for Postpartum Hypogalactia: A Systematic Review and Meta-Analysis (산후 유즙분비부전에 대한 추나 치료: 체계적 문헌 고찰 및 메타분석)

  • Kim, Chae-Young;Lee, Eun-Byeol;Kim, Hyeon-Ji;Ahn, Hee-Duk
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.17 no.1
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    • pp.1-10
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    • 2022
  • Objectives To evaluate the effectiveness of Chuna manual therapy (CMT) for postpartum hypogalactia. Methods Using nine electronic databases, we selected 13 randomized controlled trials (RCTs) that applied CMT for postpartum hypogalactia and conducted a meta-analysis. The risk of bias was assessed using the Cochrane risk of bias tool. Results Meta-analysis showed statistically significant results for CMT in terms of effective rate and breast filling degree compared to the other treatment groups (p<0.05). Conclusions Our study showed clinical evidence of CMT efficacy for postpartum hypogalactia. Further studies are required to support our findings.

Chuna Manual Therapy for Premature Infants: A Literature Review (조산아의 추나 치료에 대한 문헌 고찰)

  • Ju-Chan Cho;Hye-Jin Park;In Heo
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.18 no.2
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    • pp.23-29
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    • 2023
  • Objectives This study aimed to explore literature evidence regarding Chuna manual therapy for premature infants and determine its applicability. Methods Eight electronic databases were searched, and randomized control trials (RCTs) applying Chuna manual therapy to premature infants were sought. The Cochrane risk of bias tool was employed to assess the methodological quality of each RCT. Results Two RCTs met the inclusion criteria and were subjected to analysis. Each study compared the usual care group with the pediatric Chuna group. The results indicated improvements in nutritional status, a reduction in hospitalization days, and enhancements in growth indicators. Conclusions Chuna manual therapy is worth applying to premature infants. However, evidence is limited due to a lack of well-designed RCTs. More qualified clinical trials are needed to obtain stronger evidence.

Development and Evaluation of Ontology for Diagnosis in Oriental Medicine (한의진단 Ontology 구축과 평가)

  • Shin Sang-Woo;Jung Gil-San;Park Kyung-Mo;Kim Seon-Ho;Park Jong-Hyun
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.20 no.1
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    • pp.202-208
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    • 2006
  • The goal of this study is to develop knowledge representation method for the construction and evaluation of ontology for diagnosis in oriental medicine. To develop the expert system for decision making on diagnosis and treatment, the systematic and structural knowledge which can be processible in EMR(Electronic Medical Record) must be precedent, and the Computational Process which control the system as well. This study set up an ontology as a trial model to represent the oriental medical knowledge into the machine processible one. Protege 2.1 has been used to build the ontology, and the serialization format of our ontology is the XML document based on OWL. The components of oriental medical diagnosis was arranged with the combination of symptoms which belong to the certain symptom patterns. Then natural language which expresses the oriental medical diagnosis components were converted into the logical sentence, and individual characteristic symptoms into each values of specific properties. In addition to the study, the diagnosis software for oriental medicine was developed and it used the ontology which we developed. Sequently, we tested the software to confirm the appropriateness of ontology. The result of the test shows that diagnostic questions are automatically formulated according to the diagnosis components of this ontology and that as such diagnostic results are induced. Therefore, the ontology system in this study will be efficient to develop the diagnosis program and useful as a tool for doctors to make decision. But, it is not recommendable to apply the system to the clinical environment until the clear diagnosis standards are introduced, and the more reliable diagnosis program can be developed based on the more appropriate ontology mentioned above.

The Assessment of Risk of Bias on Clinical Trials of Korean Medicine for Alopecia (탈모증의 한약제제 임상연구에 대한 비뚤림 위험 평가)

  • Ryu, Deok-hyun;Roh, Seok-sun
    • Journal of Haehwa Medicine
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    • v.24 no.1
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    • pp.25-36
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    • 2015
  • Objective : This study 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 herbs to alopecia and provides the newest reason of effectiveness of herbs to alopecia. Methos : Data were collected through electronic database including NDSL, KISS, KMBASE, Koreantk, OASIS, KoreaMed, KISTI, Pubmd, Cochrane CENTRAL and CINAHL. Two experts in Oriental Medince 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 trials, 13 non-randomized controlled trials and 3 case reports. This study evaluates 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. Conclusion : We must try to specify concretely methods of allocation concealment after planning and practicing it for reducing a selection bias in randomized controlled trials. Also report a reason of missing value and blinding outcome assessments. And we have to agonize and mention methods of blinding of researchers for reducing a detection bias in non-randomized controlled trials.

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Retrospective Pharmacotherapeutic Evaluation of Dutasteride not Approved by US FDA for Androgenetic Alopecia in Korea (미국 식품의약국 미승인 두타스테라이드의 국내 남성형 탈모증 약물요법 적용에대한 후향적 평가)

  • Cheon, Young Ju;Kim, Jung Tae;Lim, Sung Cil
    • Korean Journal of Clinical Pharmacy
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    • v.25 no.3
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    • pp.171-177
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    • 2015
  • Background: Androgenetic alopecia (AGA), one of alopecias, requires continuous treatment in order to prevent or stop it, and patient's compliance is very important. Currently, only two drugs (finasteride, minoxidil) have been approved for AGA by Food and Drug Administration of United States (US FDA). However, another ${\alpha}-2$ reductase inhibitor, dutasteride, is approved by Korea Ministry of Food and Drug Safety (MFDS) through a phase III trial. For treatment, pharmacotherapy of AGA usually combines topical minoxidil 7% with one of oral <${\alpha}-2$ reductase inhibitor. Objectives: We evaluated the comparative efficacy and adverse effect between topical minoxidil 7%/finasteride 1 mg and topical minoxidil 7%/dutasteride 0.5 mg pharmacotherapy for outpatients with AGA. Also we evaluated the relationship between therapeutic effect and regular hospital visit. Method: This study was performed retrospectively based on electronic medical record (EMR) data of total 98 patients (topical minoxidil 7% with dutasteride 0.5 mg ($Avodart^{(R)}$) or finasteride 1 mg ($Alopecia^{(R)}$, $Propecia^{(R)}$) with diagnosis of AGA from department of dermatology at a secondary hospital from January $1^{st}$, to May $31^{st}$, 2014. Results: The efficacy and adverse event of topical minoxidil 7%/dutasteride 0.5 mg (DUTA group) were 100% and 45.7%, and of topical minoxidil 7%/finasteride 1 mg (FINA group) were 92.1% and 33.3%, respectively. The mean onset time of responses and adverse events in the FINA group were 3.86 months and 4.43 months. Those in the DUTA group were 3.97 months and 5.06 months. Conclusion: Both FINA and DUTA group were highly effective, but the DUTA group showed higher efficacy and adverse effects than those in the FINA group. Dutasteride may be another alternative in AGA treatment.