• Title/Summary/Keyword: Controlled clinical trials, randomized

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Whole Brain Radiotherapy Combined with Stereotactic Radiotherapy Versus Stereotactic Radiotherapy Alone for Brain Metastases: a Meta-analysis

  • Duan, Lei;Zeng, Rong;Yang, Ke-Hu;Tian, Jin-Hui;Wu, Xiao-Lu;Dai, Qiang;Niu, Xiao-Dong;Ma, Di-Wa
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.2
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    • pp.911-915
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    • 2014
  • Aim: This study was to evaluate the effect of whole brain radiation (WBRT) combined with stereotactic radiotherapy (SRS) versus stereotactic radiotherapy alone for patients with brain metastases using a meta-analysis. Materials and Methods: We searched PubMed, EMBASE, Cochrane Library from their inception up to October 2013. Randomized controlled trials involving whole brain radiation combined with stereotactic radiotherapy versus stereotactic radiotherapy alone for brain metastases were included. Statistical analyses were performed using RevMan5.2 software. Results: Four randomized controlled trials including 903 patients were included. The meta-analysis showed statistically significant lowering of the local recurrence rate (OR=0.29, 95%CI: 0.17~0.49), new brain metastasis rate (OR=0.45, 95%CI: 0.28~0.71) and symptomatic late neurologic radiation toxicity rate (OR=3.92, 95%CI: 1.37~11.20) in the combined group. No statistically significant difference existed in the 1-year survival rate (OR=0.78, 95%CI: 0.60~1.03). Conclusions: The results indicate that whole brain radiotherapy combined with stereotactic radiotherapy has advantages in local recurrence and new brain metastasis rates, but stereotactic radiotherapy alone is associated with better neurological function. However, as the samples included were not large, more high-quality, large-sample size studies are necessary for confirmation.

Analysis on the Acupuncture Contents of the Domestic Neck Pain and HIVD-Cervical Spine Clinical Studies : a literature review

  • Mo, Min Ju;Hwang, Doo Ree;Lee, Ju Hyeon;Kim, Dong Hoo;Hwang, Seon Hye;Sohn, Soo Ah;Hwang, Ji Hoo
    • Journal of Acupuncture Research
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    • v.34 no.2
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    • pp.113-125
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    • 2017
  • Objectives : Cervical herniated intervertebral disc (HIVD) are common diseases. They can be managed with acupuncture, but the evidence for effectiveness is uncertain. This review analyzed the acupuncture studies of domestic neck pain and cervical HIVD; the purpose of this study was to provide basic data useful for future research. Methods : We investigated acupuncture treatments for neck pain and cervical HIVD by searching 5 Korean Internet databases. The keywords used were "neck pain", "HIVD-cervical spine", and "nuchal pain". A total of 53 research papers (17 case reports, 16 clinical data analyses, 11 randomized controlled trials, and 9 non-randomized controlled trials) were found and analyzed according to the publication year, type of study, treatment, use of filiform needles, and type of pharmacopuncture used acupoint. The effectiveness of acupuncture treatment was determined. Results : 1. Filiform needles have been primarily used in domestic research and were used in at least half of published pharmacopuncture studies. 2. In 51 papers using filiform needles, many studies used only local acupoints; few studies used only distant acupoints. 3. All studies using pharmacopuncture were performed using local acupoints. In particular, the studies based on A-shi point, trigger point, and radiologic lesion sites were useful for multiple purposes. Conclusion : In this study, we analyzed the acupuncture contents of the domestic neck pain and HIVD-cervical spine clinical studies. This study considers the assessment of the quality and efficacy of each study, which is likely to require research that reflects the future.

The Analysis of Korean Clinical Studies on the Effect of Pharmacopuncture for Whiplash Injury after Traffic Accidents

  • Yun, Jung Min;Hur, Na Yeon;Kim, Kyeong Han
    • Journal of Pharmacopuncture
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    • v.23 no.4
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    • pp.262-272
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    • 2020
  • Objectives: Whiplash injury is one of the major diseases in recent times because of increasing traffic accidents. This review aims to analyze the overall trend of studies on pharmacopuncture for whiplash injury after traffic accidents. Methods: We searched through 4 Korean electronic databases from 2001 up to October 2020 for relevant clinical studies for whiplash injury after traffic accidents, regardless of the patients' age, gender, or race. We included studies that had an intervention group receiving pharmacopuncture therapy with or without other additional treatments, and also included studies that had a control group receiving sham treatment or active treatment such as physical therapy and herbal medication. For the clinical outcomes, we did not place any restrictions on evaluation scales if they are objective metrics. Results: We included 6 randomized controlled trials (RCTs) and 10 non-randomized controlled trials (nRCTs). 10 nRCTs were divided into 4 categories that were case-control studies, case series, case report, and retrospective observational study. In RCTs, Hwangryun-haedoktang (黃蓮解毒湯) pharmacopuncture was the most frequently used. In nRCTs, Jungsong-ouhyul (中性瘀血) pharmacopuncture, and bee venom pharmacopuncture were the most frequently used. As target points of Hwangryun-haedoktang pharmacopuncture, Ashi-points, Jianjing (GB21), and Fengchi (GB20) were the most frequently used. As target points of Jungsong-ouhyul pharmacopuncture, Ashi-points were the most frequently used. And as target points of Bee venom pharmacopuncture, Fengchi (GB20) was the most frequently used. Conclusion: Hwangryun-haedoktang pharmacopuncture, bee venom pharmacopuncture, and Jungsong-ouhyul pharmacopuncture were mainly used for whiplash injury, and their usual target points were Jianjing (GB21), Fengchi (GB20), and Ashi-points. However, a high level of evidence should be conducted through studies with systematic methodology in the future.

A Systematic Review and Meta Analysis of Randomized Controlled Trials of the Clinical Effect on Taking a Herbal Medicine on Postpartum Lactation (한약 복용이 산후 유즙분비에 미치는 효과에 대한 체계적 문헌고찰)

  • Lee, Hye-Jung;Lee, Su-Jeong;Hwang, Deok-Sang;Lee, Chang-Hoon;Jang, Jun-Bock;Lee, Jin-Moo
    • The Journal of Korean Obstetrics and Gynecology
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    • v.34 no.3
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    • pp.137-156
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    • 2021
  • Objectives: The purpose of this study is to assess the effect of taking herbal medicine for the postpartum lactation. Methods: We searched 9 databases for recent three years, that contained four english, two chinese, one japanese and two korean database from September 17, 2016 to December 31, 2020. Randomized controlled trials (RCTs) were eligible. Measurement of outcome included total curative effective rate, volume of lactation, volume of milk supplement, and serum prolactin concentration. The risk of bias was assessed by two independent authors using the Cochrane risk of bias tool. Results: Total 725 of studies was screened, 11 RCTs were finally selected. Number of participants per study ranged from 60 to 257. The treatment group of taking a herbal medicine is effective for improving total curative effective rate, volume of lactation, volume of milk supplement, and serum prolactin concentration compared with control group. Because most of the studies had considerable heterogeneity in terms of type of intervention and comparison for outcome measurement, meta analysis for quantitative analysis was impossible. Conclusions: This studies showed that taking a herbal medicine is effective on increasing volume of lactation and speeding up the start of the first breastfeeding. However, included studies suffered from incomplete reporting, high or unclear risk of bias and substantial heterogeneity between studies. In the Future, further high-quality RCTs are needed to prove effectiveness of herbal medicine for breastfeeding and reduce the risk of bias.

Utility of three-dimensional printing in the surgical management of intra-articular distal humerus fractures: a systematic review and meta-analysis of randomized controlled trials

  • Vishnu Baburaj;Sandeep Patel;Vishal Kumar;Siddhartha Sharma;Mandeep Singh Dhillon
    • Clinics in Shoulder and Elbow
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    • v.27 no.1
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    • pp.72-78
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    • 2024
  • Background: Clinical outcomes after fixation of distal humerus intraarticular fractures are directly related to the quality of reduction. The use of three-dimensional (3D)-printed fracture models can benefit preoperative planning to ensure good reduction. This review aims to determine if surgery performed with 3D printing assistance are faster and result in fewer complications and improved clinical outcomes than conventional methods. We also outline the benefits and drawbacks of this novel technique in surgical management of distal humerus fractures. Methods: A systematic literature search was carried out in various electronic databases. Search results were screened based on title and abstract. Data from eligible studies were extracted into spreadsheets. Meta-analysis was performed using appropriate computer software. Results: Three randomized controlled trials with 144 cases were included in the final analysis. The 3D-printed group had significantly shorter mean operating time (mean difference, 16.25 minutes; 95% confidence interval [CI], 12.74-19.76 minutes; P<0.001) and mean intraoperative blood loss (30.40 mL; 95% CI, 10.45-60.36 mL; P=0.005) compared with the conventional group. The 3D-printed group also tended to have fewer complications and a better likelihood of good or excellent outcomes as per the Mayo elbow performance score, but this did not reach statistical significance. Conclusions: Three-dimensional-printing-assisted surgery in distal humerus fractures has several benefits in reduced operating time and lower blood loss, indirectly decreasing other complications such as infection and anemia-related issues. Future good-quality studies are required to conclusively demonstrate the benefits of 3D printing in improving clinical outcomes.

Acupuncture Trials for Peripheral Facial Palsy in Republic of Korea: A Systematic Review (국내 말초성 안면마비의 침 임상시험에 대한 체계적 고찰)

  • Lee, Cham Kyul
    • Journal of Acupuncture Research
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    • v.30 no.3
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    • pp.51-59
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    • 2013
  • Objectives : This study was designed to evaluate clinical evidence of acupuncture treatment for peripheral facial palsy in South Korea. Methods : All process was independently proceeded by two investigators. Literature search was performed in 9 databases from their inception to February 2013. Searched reports was twice excluded for title, abstract and body. And then, data extract and analysis was done before assessing risk of bias by Cochrane Handbook. Results : 10 randomized controlled trials(RCT) were finally included. 4 RCT handled postauricular pain with facial palsy. All articles at least used in combination with two treatments. Interventions like pharmacopuncture, electroacupuncture, scalp acupuncture etcetera were conducted as treatment to evaluate efficacy, and some study reported advantageous effects of treatment group compared to baseline or control group. Adverse events didn't referd to in any studies. In assessing risk of bias, indefinite and uncertain information made all included trials to have a high risk of bias. Conclusions : Because of methodological deficit, there is no sufficient evidence to allow any conclusion about the efficacy of acupuncture for peripheral facial palsy. Therefore, well designed trials with high quality is needed from now on.

Study on Clinical Research Methodologies for Acupuncture: Based on Review of Clinical Studies on Back Pain (침 임상연구방법론 연구: 요통 임상연구 사례를 중심으로)

  • Park, Yu Lee
    • 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.

Herbal Medicine for Pediatric Epilepsy: Clinical Research Trends in Traditional Chinese Medicine

  • Kim, Sang-Ho;Kim, Da-Woon
    • 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.

Clinical Effectiveness of Acupuncture in the Treatment of Non-Alcoholic Fatty Liver Disease: A Systematic Review (비알코올성 지방간 질환에 대한 침치료의 효과 : 체계적 고찰)

  • Hyun, Joon;Lee, Joo-bok;Kim, So-yeon;Han, Chang-woo
    • The Journal of Internal Korean Medicine
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    • v.39 no.6
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    • pp.1206-1224
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    • 2018
  • Purpose: This systematic review was planned and performed in order to determine the clinical effectiveness of acupuncture for non-alcoholic fatty liver disease (NAFLD). Methods: We searched related randomized controlled trials in several medical online databases, including China National Knowledge Infrastructure (CNKI), Excerpta Medica dataBASE (EMBASE), Public/Publisher MEDLINE (PubMed), Cochrane Central Register of Controlled Trials (CENTRAL), National Digital Science Library (NDSL), and Research Information Sharing Service (RISS). NAFLD related outcomes were extracted from the included trials and meta-analyzed. Results: From the 8 included trials, the values of the following examinations were extracted: liver ultrasonography, liver CT, body fat CT, aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyltransferase (GGT), total cholesterol (TC), triglyceride (TG), low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, fasting blood sugar (FBS), hosmeostatic model assessment for insulin resistance (HOMA-IR), weight, body mass index (BMI), waist hip ratio (WHR), obesity degree, body fat mass, body fat rate, leptin, malondialdehyde (MDA), and super oxide dismutase (SOD). In the 4 outcomes, cure rate in liver ultrasonography (RR=1.56; 95%CI=1.05~2.31; P=0.03), cure rate in liver CT (RR=2.23; 95%CI=1.33~3.72; P=0.002), TC (MD=-0.78; 95%CI=-1.41~-0.15; P=0.02), and TG (MD=-2.05; 95%CI=-3.88~-0.21; P=0.03), acupuncture was more effective than the control intervention. Conclusions: In this meta-analysis, acupuncture relieved hepatic steatosis, and reduced TC, and TG in NAFLD patients. more well-planned studies are still needed due to the heterogeneity and the considerable methodological flaws in the analyzed trials.

Review on Clinical Trials of Chemotherapy Induced Toxicity with Acupuncture in PubMed Database (PubMed 검색을 통한 항암화학요법 부작용 관련 침 임상시험 현황 고찰)

  • Kim, Jong Yoon;Kim, Jin Youp;Kim, Nam Sik;Kim, So Jung;Oyungerel, Munkhgerel;Kim, Yong Suk;Choi, Do Young;Nam, Sang Soo
    • Journal of Acupuncture Research
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    • v.30 no.2
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    • pp.43-53
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    • 2013
  • Objectives : The purpose of this study is to review of Clinical trials related to the treatment of chemotherapy induced-toxicity by acupuncture therapy. Methods : We searched PubMed by using word of "chemotherapy induced, acupuncture" (Limits : Full text available, 10 years, Clinical trials, Humans, English). We analyzed 15 research paper and examined published journals, years, countries, topic, study design, their results, interventions, participants and instruments of assessment. Results : Eleven journals with fifteen papers were searched. These papers were published in USA, Germany, etc. On the topic of these clinical trials, seven of them were about nausea(vomiting), two about peripheral neuropathy, two about hot flash, two about arthralgia and one about neutropenia, one about fatigue. Six of these studies were single blinded, randomized controlled trial. Twelve studies reported significant effect. The median for number of final participants was 35.5 persons. Assessment for outcomes were versatile questionnaire, nerve conduction studies, WBC, ANC, G-CSF examination, etc. Conclusions : Their median for impact factor was 3.650 and average modified Jadad score of six RCTs was 4.33. In order to provide appropriate evidence regarding the effectiveness of acupuncture in treatment for chemotherapy-induced toxicity, more rigorous and well-designed studies are necessary.