• 제목/요약/키워드: Controlled clinical trials, randomized

검색결과 783건 처리시간 0.031초

손목터널증후군에 사용된 침 치료 보고의 질 평가 (A Systematic Review on the Reporting Quality of Acupuncture Treatment for Carpal Tunnel Syndrome)

  • 현지윤;신주은;임채정;박지연
    • Korean Journal of Acupuncture
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    • 제37권3호
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    • pp.131-144
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    • 2020
  • Objectives : The aim of this study is to analyze the details of acupuncture treatment methods and the reporting quality of acupuncture on Carpal Tunnel Syndrome (CTS). Methods : Search was conducted in Pubmed, EMBASE, and Cochrane Library for acupuncture studies on CTS. The reporting quality of acupuncture treatment was assessed using the following guidelines: Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) for analyzing the method of acupuncture treatment, Consolidated Standards of Reporting Trials (CONSORT) for analyzing study design and study process, and Risk of Bias (ROB) for analyzing bias. The number of reported items was calculated and evaluated as a proportion. The reported proportion of each study was classified into three grades: Grade A (% score ≥75), Grade B (50≤ % score <75), and Grade C (% score <50). Results : A total of 9 Randomized Controlled Trials (RCTs) were included in this study. All trials reported 12 items (66.67%) on average in STRICTA guidelines. Five studies were conducted with manual acupuncture and 3 studies were conducted with electroacupuncture. PC7 (Daereung) was most frequently used to treat CTS. In STRICTA guideline evaluation, 3 studies were classified as Grade A, 5 studies were classified as Grade B, and 1 study was classified as Grade C. In the CONSORT statement assessment, all trials reported an average of 20.56 items. Of the 9 RCTs, 6 studies were classified as Grade B and 3 studies were classified as Grade C. In ROB assessment, most studies showed a low (63.49%) or unclear (26.98%) risk of bias. The selective reporting bias and the incomplete outcome data bias were found to have the lowest risk of bias, and the allocation concealment of selection bias was found to have the most unclear risk of bias. Conclusions : Recent acupuncture studies on CTS showed moderate reporting quality. However, more detailed reports on acupuncture are still needed to establish more solid evidence of acupuncture treatment.

메타분석을 이용한 간호 대학생의 학업 관련 만족도 중재프로그램의 효과 (A Meta-analysis of the effects of Academic-related Satisfaction Intervention Programs for Nursing Students in Korea)

  • 김미나;김영아
    • 한국산학기술학회논문지
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    • 제20권10호
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    • pp.218-228
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    • 2019
  • 본 연구는 국내 간호 대학생을 대상으로 수행된 학업 관련 만족도 중재프로그램을 고찰하고 메타분석하여 근거기반 자료를 제공하기 위해 수행되었다. 메타분석에 포함된 자료는 2001년부터 2018년 7월까지 발표된 25편의 실험연구로서 연구의 설계는 무작위 대조군 연구가 1편, 비무작위 대조군 연구가 24편이었다. 연구대상자는 간호학과 1~4학년 재학생으로, 이론수업 및 실습수업에서 중재프로그램이 수행되었다. 표본크기는 실험군 1182(평균 47.3), 대조군 1137(평균 45.5)명이었고, 중재프로그램의 구성은 1~16주/1~16회/1회기 당 7~240분으로 이루어졌다. 결과변수로는 전공만족도, 학습만족도, 교내실습만족도, 임상실습만족도가 있었으며, 교내실습만족도(Hedges' g=0.876[95% CI: 0.405, 1.346])와 임상실습만족도(Hedges' g=0.515[95% CI: 0.312, 0.718]) 및 전체 학업 관련 만족도(Hedges' g=0.630[95% CI: 0.371, 0.889])는 통계적으로 유의미한 중간 수준 이상의 효과크기가 확인되었다. 본 연구의 결과는 간호 대학생들의 학업 관련 만족도 중재프로그램을 다룬 선행연구들을 통합적으로 정리하여 객관적 결과를 확인하였다는데 의의가 있다.

Effect of Chlorhexidine Mouthrinse on Prevention of Microbial Contamination during EBUS-TBNA: A Study Protocol for a Randomized Controlled Trial

  • Kim, Na Young;Park, Jae Hyeon;Park, Jimyung;Kwak, Nakwon;Choi, Sun Mi;Park, Young Sik;Lee, Chang-Hoon;Cho, Jaeyoung
    • Tuberculosis and Respiratory Diseases
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    • 제84권4호
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    • pp.291-298
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    • 2021
  • Background: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a standard diagnostic method for mediastinal and hilar lymphadenopathy. Although rare, fatal infectious complications can occur following EBUS-TBNA. However, to date, there is a lack of effective preventive strategies to reduce these complications. We started a trial to investigate the effect of chlorhexidine mouthrinse on the prevention of microbial contamination during EBUS-TBNA. Methods: This study is a single-center, parallel-group, assessor-blinded randomized controlled trial (RCT). We will enroll 112 adult participants undergoing EBUS-TBNA using a convex probe, and randomly assign them to two groups at a 1:1 ratio. The intervention group will gargle for 1 minute with 100 mL of 0.12% chlorhexidine gluconate before EBUS-TBNA, while the control group will have no mouthrinse before the procedure. Immediately after completion of EBUS-TBNA on all targeted lesions with an aspiration needle, a needle wash sample will be taken by instilling 5 mL of sterile saline into the used needle. The primary outcome is colony forming unit (CFU) counts in aerobic cultures of the needle wash samples. Secondary outcomes are CFU counts in anaerobic cultures, fever within 24 hours after EBUS-TBNA, and infectious complications within 4 weeks after EBUS-TBNA. Conclusion: This trial was designed as the first RCT to investigate the effect of chlorhexidine mouthrinse on the prevention of microbial contamination during EBUS-TBNA. Results from this trial can provide clinical evidence for a simple, safe, and cost-effective strategy to prevent infectious complications following EBUS-TBNA (ClinicalTrials.gov ID: NCT04718922, registered on 22 January 2021).

경항통에 침치료를 시행한 무작위대조군연구(RCT)들에 대한 계통적 연구 (A Systematic Review of Randomized Controlled Trials on Acupuncture Treatment for Neck Pain)

  • 김현욱;김성수;강정아;남동우;김은정;홍권의;김성철;이재동;김갑성;이건목
    • Journal of Acupuncture Research
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    • 제26권2호
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    • pp.103-123
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    • 2009
  • Objectives : The aim of this study is to review RCTs of acupuncture treatment for neck pain and to establish standards of acupuncture treatment for neck pain. Methods : We searched articles in Pubmed using ICD 10. Study quality was assessed using the FEAS and Jadad score. Results and Conclusions : Three review studies and nineteen clinical trials were searched and reviewed. Among the nineteen clinical trials reviewed, positive outcome was reported in thirteen studies. Most frequently used meridians were GB, BL, SI, GV and LI, The most frequently used acupuncture points were $GB_{20}$, $GB_{21}$, $LI_4$, $BL_{10}$, $GV_{14}$ and $SI_3$. More than two needles were inserted in the studies and needle retention time was more than 10 minutes. The most frequently used needle length was 40mm, and diameter was 0.25mm and 0.30mm. The mean number of treatment sessions were more than 10 times. Frequency of treatment was more than once a week, And treatment duration was more! than 5 weeks. The total FEAS scores ranged from 3 to 15.5, and the mean value was 9.39. Jadad score ranged from 2 to 5, and the mean value was 3.42. The number of studies scoring over three points on the Jadad scale was sixteen.

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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.

기능성 소화불량증에 대한 추나요법의 효과 : 체계적 문헌고찰과 메타분석 (Chuna Manual Therapy for Functional Dyspepsia : A Systematic Review and Meta-analysis)

  • 허인;신병철;황의형;황만석;김병준;김소연;허광호
    • 척추신경추나의학회지
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    • 제10권1호
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    • pp.1-14
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    • 2015
  • Objectives : To evaluate the evidence supporting the effectiveness of Chuna manual therapy for functional dyspepsia. Methods : We conducted search across the 3 electronic databases (Pubmed, CAJ and Oasis) to find all of randomized controlled clinical trials(RCTs) that used Chuna manual therapy as a treatment for functional dyspepsia. The methodological quality of each RCT was assessed using the Cochrane risk of bias tool. Results : Thirteen RCTs met our inclusion criteria. The meta-analysis showed positive results for the use of Chuna manual therapy combined with medication treatments in terms of the efficacy rate when compared to medication treatments alone. Positive results were also obtained, in terms of the efficacy rate, when comparing Chuna manual therapy combined with medication plus specific electromagnetic therapy to medication treatments alone. Conclusions : Our systematic review found encouraging but limited evidence of Chuna manual therapy for functional dyspepsia. However, to obtain stronger evidence without the drawbacks of trial design and the quality of studies, we recommend sham-controlled RCTs or comparative effectiveness research to test the effectiveness of Chuna manual therapy.

Integrated Rehabilitation for Children with Cerebral palsy: A Prospective Observational Study

  • Lee, Hye-Yoon;Yun, Young-Ju;Shin, Yong-Beom;Kim, Soo-Yeon;Han, Jun-hee;Yu, Sun-ae
    • 대한한의학회지
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    • 제42권4호
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    • pp.61-74
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    • 2021
  • Objectives: This study aimed to analyse: 1) the clinical effectiveness and safety of traditional Korean Medicine (TKM) and frequency of TKM therapies used and their relationship with conventional treatments. Methods: This prospective observational study enrolled children with cerebral palsy (CP) aged 6-78 months (n=126). The children who used herbal medication for >30 days or acupuncture treatment >12 sessions within 6 months were defined as the integrated rehabilitation (IR) group; the remaining participants were included in the conventional rehabilitation (CR) group. Results: Changes in the Gross Motor Function Measure-66 (GMFM-66) were greater in the IR group (6.4±6.1) than in the CR group (4.6±5.8). The reduction in the number of other health problems was greater in the IR group than in the CR group. The GMFM-66 improvement was greatest in gross motor function classification system level 1. There was no between-group difference in the frequency of rehabilitation therapy (10.9±6.6 and 12.0±9.9 in the IR and CR groups, respectively). Conclusion: TKM may offer additional benefits in terms of the GMFM-66 score and other health problems. However, there is a need for further randomized controlled trials involving a restricted CP type and a controlled treatment type and intensity to confirm these findings.

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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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.

Role of Balloon Guide Catheter in Modern Endovascular Thrombectomy

  • Chueh, Ju-Yu;Kang, Dong-Hun;Kim, Byung Moon;Gounis, Matthew J.
    • Journal of Korean Neurosurgical Society
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    • 제63권1호
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    • pp.14-25
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    • 2020
  • Proximal flow control achieved with a balloon guide catheter (BGC) during endovascular treatment of acute ischemic stroke is reviewed in this article. In clinical practice, BGCs offer a multi-faceted approach for clot retrieval by creating proximal flow arrest, reducing embolic burden, and shortening procedure time. Evaluation of frontline thrombectomy procedures with BGCs revealed advantages of combined use over the conventional guide catheter (CGC), notably in the significant reduction of distal emboli to both the affected and previously unaffected territories. Recently, new measures of early and complete reperfusion at first thrombectomy pass have been identified as independent predictors of improved outcomes, which were consistently demonstrated with use of BGC as a safe and effective option to minimize number of passes during intervention. Prior randomized controlled trials reported the positive correlation between BGC-treated patients and a lower risk of mortality as well as shortened procedure time. While BGC use is more common in stent retriever-mediated mechanical thrombectomy, preliminary data has shown the potential benefit of device application during contact aspiration thrombectomy to achieve successful recanalization. However, the question of which major endovascular strategy reigns superior as a frontline remains to be answered. Along with clinical case assessments, BGC performance during in-vitro simulation was analyzed to further understand mechanisms for optimization of thrombectomy technique.