• 제목/요약/키워드: Randomized controlled trials

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화병의 한의학적 치료에 대한 연구동향 (Current Trends in Intervention Studies of Hwabyung in Korean Medicine)

  • 서효원;최은지;김상호;김동희;김락형;김종우;이재혁;임재환;최우진;정선용
    • 동의신경정신과학회지
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    • 제27권4호
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    • pp.261-274
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    • 2016
  • Objectives: To determine the general characteristics of clinical studies about Hwabyung and assess their limitations and alternatives. Methods: Clinical studies that examined the effects of traditional Korean medicine intervention on Hwabyung were included in this study. A systematic search of English, Chinese, Japanese, and Korean databases was performed. The characteristics of included articles were described and those articles were assessed by Risk of Bias (RoB) tool or Risk of Bias for Nonrandomized Studies (RoBANS) tool. Results: Sixteen articles were selected from 1,826 articles. Most clinical studies about Hwabyung were published in Korea. The number of conducted trials was insufficient. The prevailing study design was randomized controlled trial. Traditional Korean medicine intervention used in the trials were acupuncture, herbal medicine, counselling, meditation, emotional freedom technique (EFT), music therapy, art therapy, and multi intervention program. Herbal medicine study used placebo as control while non-pharmacological intervention study mostly used no treatment as control. Most of the trials were supported by the government. Therefore, financial conflict of interest might not exist for results. We judged that some studies had a high risk of bias. In general, most of the studies with a high risk of bias were non-pharmacological intervention studies, and the risk of bias was mainly due to lack of blinding. Conclusions: More clinical studies of Hwabyung are needed. There are some issues about a suitable comparison and effective blinding strategy for non-pharmacological study. Improving methodological quality is required.

갱년 및 폐경 후 여성의 안면홍조에 대한 침 치료 다기관 임상연구 : 수행보고 및 방법론적 교훈 (Methodologic Lessons Learned from Multicenter, Randomized, Controlled Clinical Trial of Acupuncture for Hot Flashes in Peri- and Postmenopausal Women)

  • 김건형;김동일;황덕상;이진무;김형준;윤현민;정희정;강경원;이명수;최선미
    • 대한한방부인과학회지
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    • 제23권1호
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    • pp.42-52
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    • 2010
  • Purpose: This report aims to administer methodologic issues around recently conducted multicenter study for evaluating the effects of acupuncture on menopusal hot flashes and discuss practical issues for further implementation of acupuncture clinical trial for hot flashes. Methods: Study process were mentioned, and issues related to avoiding risk of bias, designing appropriate control group, optimal outcome measurement, potential different effects of menopausal status on study outcomes, and suggestions for developing future clinical trials are discussed. Results: Shortcomings of our multicenter study include lack of allocation concealment and assessor blinding, subjective outcome measurement, short-term follow-up, and fixed acupuncture regimen despite pragmatic purpose of this study. Improving trial design, using objective or validated outcomes, assessing long-term effects of acupuncture, and individualizing acupuncture regimen are needed in future clinical trials. Conclusion: We expect these practical discussions to enable researchers to plan and develop future well-designed clinical trials for evaluating the effects of acupuncture on hot flashes or other women's health issues.

Effectiveness and Safety of Pemetrexed Versus Docetaxel as a Treatment for Advanced Non-small Cell Lung Cancer: a Systematic Review and Meta-analysis

  • Di, Bao-Shan;Wei, Kong-Ping;Tian, Jin-Hui;Xiao, Xiao-Juan;Li, Yan;Zhang, Xu-Hui;Yu, Qin;Yang, Ke-Hu;Ge, Long;Huang, Wen-Hui;Zhang, Fang-Wa
    • Asian Pacific Journal of Cancer Prevention
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    • 제15권8호
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    • pp.3419-3424
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    • 2014
  • Background: Our aim was to conduct a meta-analysis to compare the efficacy and safety of pemetrexed and docetaxel for non-small cell lung cancer (NSCLC). Materials and Methods: We systematically searched the Cochrane Library, PubMed, Embase, China Biology Medicine Database for randomized controlled trials (RCTs) comparing the efficacy and toxicities of pemetrexed versus docetaxel as a treatment for advanced NSCLC. We limited the languages to English and Chinese. Two reviewers independently screened articles to identify eligible trials according to the inclusion and exclusion criteria and assessed the methodological quality of included trials, and then extracted data. The meta-analysis was performed using STATA12.0. Results: Six RCTs involving 1,414 patients were identified. We found that there was no statistically significant differences in overall response rate, survival time, progression-free survival, disease control rate, and 1-2yr survival rate (p>0.050) but it is worthy of mention that patients in the pemetrexed arms had significantly higher 3-yr survival rate (P=0.002). With regard to the grade 3 or 4 hematological toxicity, compared with docetaxel, pemetrexed led to lower rate of grade 3-4 febrile neutropenia, neutropenia, and leukocyts toxicity (p<0.001). There was no significant difference in anemia between the two arms (p=0.08). In addition, pemetrexed led to higher rate of grade 3-4 thrombocytopenia toxicity (p=0.03). As for the non-hematological toxicities, compared with docetaxel, pemetrexed group had lower rate of grade 3-4 diarrhea and alopecia. Conclusions: Pemetrexed was almost as effective as docetaxel in patients with advanced NSCLC. At the same time, pemetrexed might increase the 3-yr survival rate. As for safety, pemetrexed led to lower rate of grade 3-4 febrile neutropenia, neutropenia, leukocytes, diarrhea and alopecia toxicity. However, it was associated with a higher rate of grade 3-4 thrombocytopenia.

Chicken Egg Yolk Antibodies (IgY) for Prophylaxis and Treatment of Rotavirus Diarrhea in Human and Animal Neonates: A Concise Review

  • Thu, Hlaing Myat;Myat, Theingi Win;Win, Mo Mo;Thant, Kyaw Zin;Rahman, Shofiqur;Umeda, Kouji;Nguyen, Sa Van;Icatlo, Faustino C. Jr.;Higo-Moriguchi, Kyoko;Taniguchi, Koki;Tsuji, Takao;Oguma, Keiji;Kim, Sang Jong;Bae, Hyun Suk;Choi, Hyuk Joon
    • 한국축산식품학회지
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    • 제37권1호
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    • pp.1-9
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    • 2017
  • The rotavirus-induced diarrhea of human and animal neonates is a major public health concern worldwide. Until recently, no effective therapy is available to specifically inactivate the rotavirion particles within the gut. Passive immunotherapy by oral administration of chicken egg yolk antibody (IgY) has emerged of late as a fresh alternative strategy to control infectious diseases of the alimentary tract and has been applied in the treatment of diarrhea due to rotavirus infection. The purpose of this concise review is to evaluate evidence on the properties and performance of anti-rotavirus immunoglobulin Y (IgY) for prevention and treatment of rotavirus diarrhea in human and animal neonates. A survey of relevant anti-rotavirus IgY basic studies and clinical trials among neonatal animals (since 1994-2015) and humans (since 1982-2015) have been reviewed and briefly summarized. Our analysis of a number of rotavirus investigations involving animal and human clinical trials revealed that anti-rotavirus IgY significantly reduced the severity of clinical manifestation of diarrhea among IgY-treated subjects relative to a corresponding control or placebo group. The accumulated information as a whole depicts oral IgY to be a safe and efficacious option for treatment of rotavirus diarrhea in neonates. There is however a clear need for more randomized, placebo controlled and double-blind trials with bigger sample size to further solidify and confirm claims of efficacy and safety in controlling diarrhea caused by rotavirus infection especially among human infants with health issues such as low birth weights or compromised immunity in whom it is most needed.

허파암 수술 전과 후에 적용한 운동의 효과: PubMed 내 연구에 대한 체계적 문헌고찰 (Effects of Exercise-Based Intervention Before and After Lung Cancer Surgery: A systematic review in pubmed database)

  • 오보람;김희수;박수경
    • 대한통합의학회지
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    • 제11권2호
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    • pp.23-35
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    • 2023
  • Purpose : Lung cancer induces a decrease in physical activity and a deterioration of respiratory ability. Exercise is an effective treatment to reduce side effects of anti-cancer treatments, also influence the survival and successful rehabilitation in lung cancer patients. However, there is insufficient evidence to show which period is the most effective to apply exercise for lung cancer patients. Therefore, this study was conducted to evaluate the efficacy of exercise-based interventions before and after surgery. Methods : Clinical trials (CTs) and randomized controlled trials (RCTs) reported in PubMed database were investigated. The trials investigated in this study were published for 10 years before August 20, 2022. The risk of bias was judged according to the Cochrane guideline. The materials included in this meta-analysis were 6-minute walk test (6MWT), pulmonary function, and quality of life (QOL). Results : 1 CT and 9 RCTs were selected in current study. In the meta-analysis, exercise increased 6MWT in preoperation (mean difference [MD] 29.49; 95 % confidence interval [CI] .99 to 57.99; p=.04; I2=0 %), 3 months postoperation (MD 54.97; 95 % CI 31.85 to 78.09; p<.001; I2=45 %) and 6 months postoperation (MD 85.59; 95 % CI 45.06 to 126.12; p<.001; I2=47 %). Exercise, also enhanced the lung function such as FEV1/FVC (%) in postoperation (MD 7.64; 95 % CI 6.26 to 9.02; p<.001; I2=19 %). Additionally, exercise improved QOL, such as preoperative EORTC-QLQ-C30-LC13 in mental function (MD 3.21; 95 % CI .64 to 5.79; p=.01; I2=0 %) and postoperative SF-36 in mental component summary (MD 9.24; 95 % CI 4.94 to 13.54; p<.001; I2=0%). Conclusion : These results indicate that exercise-based intervention can elevate the ability to exercise and the mental componentof QOL within 3 months.

심적환$^{(R)}$이 흉통 흉민에 대하여 미치는 영향에 대한 다기관 무작위배정 이중맹검 임상연구 (Effect of Cardiotonic Pills$^{(R)}$ on Chest Pain and Discomfort: A Multi-center Double-blind Randomized Controlled Trial.)

  • 장인수;고창남;이인;박정미;김세현;김상우
    • 대한한의학회지
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    • 제26권2호
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    • pp.95-104
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    • 2005
  • Objectives: This was a double blinded, randomized, placebo-controlled clinical study for evaluation of safety and effective dose finding of Cardiotonic Pills$^{(R)}$ in patients with chest pain and discomfort. Cardiotonic Pills$^{(R)}$ are composed of Salviae Miltiorrhizae Radix (丹蔘), Notoginseng Radix (三七根) and Borneolum (龍腦). Major effects of Salviae Miltiorrhizae Radix and Notoginseng Radix are vasodilatation, sedation and analgesic action. Borneolum has an antibacterial effect, and can stimulate the central nervous system. All of these substances are oriental herbs that have been used for a long time in east Asia. Cardiotonic Pills fi received Investigational New Drug (IND) approval from the Food and Drug Administration (FDA) in the USA and 40 million people in the world take this pill. We performed a phase IV clinical study to confirm its efficacy and safety in patients who have probable cardiogenic or psychogenic chest pain or chest stifling. Methods: This study was planned for a multi-center clinical trial including four university hospitals of oriental medicine in Korea. This was the first time to evaluate the 'planning treatment according to diagnosis (辨證施治)' of chest pain or chest discomfort according to oriental medical guidelines. The patients who were included in this trial were adult volunteers from 20 to 70 years old who had chest pain or chest discomfort more than twice during a recent month, and we received written consent to participate in this study from all of them. After administration of Cardiotonic Pills$^{(R)}$ for 8 weeks, number of occurrences, duration, appearance and degree of chest pain or chest discomfort was observed and degree of symptoms (severity of illness, global improvement) were measured using a patient's global assessment composite scale. Results: In the patient's global assessment scale, the severity of illness of the Cardiotonic Pills$^{(R)}$ group (n=25) was 14/25=0.56 but of the placebo group (n=25) was 7/25=0.28 (p-value=0.0449). This result indicates Cardiotonic Pills$^{(R)}$have a positive effect on the symptoms of chest pain and discomfort. However, the global improvement of the Cardiotonic Pills$^{(R)}$group was 23/25=0.92, and of the placebo group was 22/25=0.88 (p-value=0.6374). The total symptom score of the Cardiotonic Pills$^{(R)}$ group was $1.68\pm20.06$, and of the placebo group was $16.76\pm72.l4$(p-value=0.2285). The number of symptom events of the Cardiotonic Pills$^{(R)}$ group was $72\pm29.78$, and of the placebo group (n=25) was $10.80\pm38.42$ (p­value=0.3660). We could not find any effects on the other factors examined besides the severity of illness, beyond the difference of standard deviations. Conclusions: Cardiotonic Pills$^{(R)}$ significantly reduced chest pain and chest discomfort in patients. Therefore, we expect that Cardiotonic Pills$^{(R)}$ will be helpful for patients with chest pain and chest discomfort not only caused by heart disease but also by other diseases.

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한국 학령기 ADHD 아동을 위한 인지행동중재의 효과 연구: 메타분석 (Effects of Cognitive Behavioral Therapy on Attention Deficit Hyperactivity Disorder among School-aged Children in Korea: A Meta-Analysis)

  • 박완주;박신정;황성동
    • 대한간호학회지
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    • 제45권2호
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    • pp.169-182
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    • 2015
  • Purpose: This study was a meta-analysis designed to identify effects of Cognitive Behavioral Therapy (CBT) interventions in alleviating main symptoms of Attention Deficit Hyperactivity Disorder (ADHD) among school-aged children in Korea. Methods: Examination of several databases including Research Information Sharing Service, Korean Studies Information Service System, Data Base Periodical Information Academic and hand-searched article references, resulted in identification of 1,298 studies done between 2000 and 2013 of which 21 met the inclusion criteria. Comprehensive Meta-Analysis version 2.0 was used to analyze effect sizes, explore possible causes of heterogeneity, and check publication bias with a funnel plot and its trim-and-fill analysis. Results: Overall effect size of CBT intervention was large (g=1.08) along with each outcome of self-control (g=1.26), lack of attention (g=1.02), social skills (g=0.92), and hyperactivity (g=0.92). For heterogeneity, moderator analysis was performed, but no significant differences were found between the RCT (Randomized Controlled Trials) group and the NRCT (Non RCT) group. Also, meta-regression was performed using sample size, number of sessions, and length of session as predictors, but no statistically significant moderators were found. Finally, a funnel plot along with trim-and-fill analysis was produced to check for publication bias, but no significant bias was detected. Conclusion: Based on these findings, there is clear evidence that CBT intervention has significant positive effects on the main symptoms of school-aged children suffering ADHD. Further research is needed to target diverse age groups with ADHD along with more RCT studies to improve the effectiveness of the CBT intervention.

만성 근골격계 통증환자에 대한 태극침법의 임상적 유효성: 후향적 의무기록 분석 연구 (Taegeuk Acupuncture for Patients with Chronic Musculoskeletal Pain: A Retrospective Analysis of Medical Records)

  • 김재규;김건형;노승희;김유리
    • Journal of Acupuncture Research
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    • 제31권2호
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    • pp.145-152
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    • 2014
  • Objectives : This study aimed to assess the effectiveness and safety of Taegeuk acupuncture for patients with chronic musculoskeletal pain. Methods : A retrospective analysis of the electronic medical records of Pusan National University Korean Medicine Hospital from March 2012 to March 2013 was performed. Eligible cases were outpatients who had received at least six sessions of Taegeuk acupuncture for their pain and had agreed to the use of their medical records for research purposes. Pain levels, heart rate variability, and patients' perceptions of the safety of acupuncture were investigated through the medical records and follow-up telephone interviews. Results : Fifteen cases were selected for analysis. All had suffered from musculoskeletal pain for at least one year. After six sessions of Taegeuk acupuncture, the average score on the pain numeric rating scale decreased from $6.7{\pm}2.0$ to $2.9{\pm}2.2$(a 43 % reduction). Follow-up telephone interviews revealed that patients experienced no adverse event after Taegeuk acupuncture. Conclusions : Patients with chronic musculoskeletal pain showed a reduction of more than half of the baseline pain after six sessions of Taegeuk acupuncture. However, the beneficial effects observed in this retrospective analysis should be interpreted with caution due to selection and recall bias. Further randomized controlled trials of Taegeuk acupuncture for chronic musculoskeletal pain are warranted.

침구와 약침에 대한 중개연구 현황 (Current situation of Translational research on Acupuncture, Moxibustion and Pharmacopuncture)

  • 신대철;송호섭
    • Journal of Acupuncture Research
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    • 제33권2호
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    • pp.109-116
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    • 2016
  • Objectives : Our primary objective lies in understanding the current landscape of translational research on acupuncture, moxibustion and pharmacopuncture. Methods : We searched our own selection of keywords of acupuncture, moxibustion and pharmacopuncture and translational research from three overseas databases (Pubmed, Scopus, Medicine) and four domestic databases (DBpia, KISS, Riss4u, Korea Med). Results : We have chosen 41 articles in total-40 articles on acupunture, 6 article on moxibustion(5 articles were duplicated in use in each category). Origin-wise, 48.8 %/24.8 %/17.0 % of our articles pool came from USA/China/Korea, respectively. UK, Austria, Thailand and Italy contributed the rest of our article pool. For those articles written in USA and China, review articles were the most common type. For the US articles, all 10 review articles were non-systematic reviews, while, for China's contribution, one out of 4 review articles were systematic review. Type-wise, our research pool's breakdown is as follows ; 17 review articles, 11 experimental research, 2 randomized controlled trials(RCT), 1 clinical trial, 4 conference reports, 1 letter, 1 study protocol and 4 uncategorized. Topic-wise, brain-neurology was most frequently referred with 8 articles, followed by parkinson's disease (3 articles) and epilepsy (2 articles). Conclusion : 1. In terms of research submission articles, Korea appears to be lacking translational research on acupuncture, moxibustion and pharmacopuncture, compared to USA and China, in our view. 2. Unlike the cases of USA and China, most of Korean translational research is limited to doing a T1 level of translational research. In order to bring bench-to-bedside to light. we believe, there should be more studies, and thereby a certain level of activation, to the T2 level of translational research in Korea. 3. Further, in our view there should be more efforts to improve article quality at the T1 level of translational research, which eventually becomes the fundamentals of the next level of research (i.e. T2 research), as well as to increase the number of research submissions, going forward.

요추 척추관 협착증에 대한 침구치료의 국내 임상근거: 체계적 문헌고찰 (Acupuncture for Lumbar Spinal Stenosis in Korean Literature: a Systematic Review)

  • 김건형;노승희;이병렬;김재규;양기영
    • Journal of Acupuncture Research
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    • 제28권6호
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    • pp.93-105
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    • 2011
  • Objectives : This study aims to evaluate currently available clinical evidence for the use of acupuncture in patients with lumbar spinal stenosis in the context of Republic of Korea. Methods : Five Korean databases were searched for all clinical studies employing acupuncture for patients with lumbar spinal stenosis. The exceptions were case reports and series involving less than 10 patients from their inception to September 2011. Only studies reported in Korean databases were searched. Results : Five retrospective audits among 22 initially identified studies were eligible for analysis in this review. There was no randomized controlled trial for this topic. The number of patients varied between 15 and 119 in each audit, and all the patients analyzed were inpatients. In all the included studies, acupuncture was conducted in combination with other concomitant treatments, including moxibustion, cupping, herbal remedies, acupoint injection, Chuna, and various physical therapies. All the included audits reported symptomatic and/or functional improvements compared to baseline. None of the included audits indicated whether any adverse events were reported. Conclusions : Current evidence for the use of acupuncture in patients with lumbar spinal stenosis in the context of South Korea is based solely on five retrospective audits that are very likely prone to a high risk of bias. Thus, further prospective and methodologically sound clinical trials to overcome this huge gap between clinical practice and the available evidence for the use of acupuncture in patients with lumbar spinal stenosis are needed.