• Title/Summary/Keyword: Randomized Clinical Trials

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

  • Boram Oh;Heesu Kim;Sookyoung Park
    • Journal of The Korean Society of Integrative Medicine
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    • v.11 no.2
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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.

Qu-Ji-Du-Huang-Wan for Essential Hypertension : Systemic Review and Meta-analysis (본태성 고혈압에 대한 기국지황환(杞菊地黄丸)의 효과에 관한 체계적 고찰 및 메타 분석)

  • Han, In Sik;Shin, Ji Hye;Cho, Yoon Young;Park, Hae Mo;Yang, Chang Sop;Jeong, Min Jeong;Jang, Insoo;Sun, Seung Ho
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.31 no.2
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    • pp.118-125
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    • 2017
  • The purpose of this study is to investigate the blood pressure reducing effect of Qi-Ju-Di-Huang-Wan (QJDHW) in adults with essential hypertension by using methods of systemic review and meta-analysis. Major search engines, such as PubMed, EMBASE, Cochrane library, Web of Science, CNKI, CiNii, J-STAGE, KISS, NDSL, RISS, OASIS, DBpia and so on, were used. The search period we used is from the start date of the search engine to October 30, 2016 and no language limits were placed. Randomized controlled trials using QJDHW in adults with essential hypertension were searched and extracted by two independent researchers. Meta-analysis was performed on outcome variables of the total effective rate (TER), systolic blood pressure (SBP) and diastolic blood pressure (DBP). Risk of bias (RoB) of Cochrane was used to assess methodological quality. Thirteen studies were finally selected. We observed that the combined treatment of QJDHW and antihypertensive drug had 3.6 times the odds ratio of TER for blood pressure lowering than a single use of an antihypertensive drug. Additionally, mean differences of SBP and DBP were -8.88 mmHg (95% Confidential Interval (CI) -12.77 mmHg, -5.00 mmHg, P<0.00001), -7.09 mmHg (95% CI -9.93, -4.25, P <0.00001), respectively. Single use of QJDHW did not reduce blood pressure more than an antihypertensive drug. All items of RoB were unclear and the methodological quality was low. Our analysis suggests that the combination of QJDHW and antihypertensive drugs may be more effective in reducing blood pressure than a single antihypertensive drug. But due to low methodological quality, careful interpretation will be needed and systematic long-term clinical trials will be required.

Early Result of Surgical Resection after Pre-Operative Concurrent chemoradiotherapy for N2-Positive Stage IIIA NSCLC (N2 종격동 림프절 전이가 있는 제 III A 병기 비소세포폐암에 있어 수술전 동시화학방사선요법 후 폐적출술의 조기 성적)

  • 차대원;김진국;심영목;김관민;박근칠;안용찬
    • Journal of Chest Surgery
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    • v.33 no.8
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    • pp.662-668
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    • 2000
  • Background: Many recent results of clinical trials show that pre-operative concurrent chemoradiotherapy and surgical resection could increase the survival of N2 positive stage IIIA non-small cell lung cancer. This study was performed to assess the feasibility, toxicity, and affect rates of concurrent chemoradiotherapy and surgical resection in N2 positive stage IIIA non-small cell lung cancer. Material and Method: Thirty-one patients who underwent preoperative concurrent chemoradiotherapy for N2 positive stage IIIA non-small-cell lung cancer from May 1997 to April 1999 were entered into the study. Mean age was 61 yrs(43∼70 yrs), There were 24 men and 7 women. The confirmation of N2 disease were achieved through mediastinoscopic biopsy(24) and CT scans(7). Induction was achieved by two cycles of cisplatin and etoposide(EP) plus concurrent chest radiotherapy to 45 Gy. Resections were done at 3 weeks after the complection of preoperative concurrent chemoradiotherapy. Resections were performed in 23 patients, excluding 5 refusals and 3 distant metastasis. Result: All patients were compled the thoracic radiotherapy except one who had distant metastasis. Twenty three patients were completed the planned 2 cycles of EP chemotherapy, and 8 patients were received only 1 cycle for severe side effects(6), refusal(1), and distant metastasis(1). There was one postoperative mortality, and the cause of death was ARDS. Three patients who had neutropenic fever and one patient who had radiation pneumonitis were required admission and treatment. Esophagitis was the most common acute side effect, but relatively well-tolerated in most patients. The complection rate of concurrent chemoradiotherapy was 74%, resection rate was 71%, pathologic complete remission rate was 13.6%, and pathologic down-staging rate was 68%. Conclusion: Morbidity related to each treatment was acceptable and many of the patients have benefited down staging of its disease. Further prospective, preferably randomized, clinical trials of larger scale may be warranted to confirm the actual benefit of preoperative concurrent chemoradiotherapy and surgical resection in N2-positive stage IIIA non-small cell lung cancer.

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Success and failure of endodontic microsurgery (미세 치근단 수술의 성공과 실패)

  • Song, Min-Ju;Kim, Eui-Seong
    • Restorative Dentistry and Endodontics
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    • v.36 no.6
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    • pp.465-476
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    • 2011
  • In current endodontic practice, introduction of operating microscope, ultrasonic instruments, and microinstruments has induced a big change in the field of surgical retreatment. In this study, we aimed to offer key steps of endodontic microsurgery procedure compared with traditional root-end surgery, and to evaluate factors influencing success and failure based on published articles. Endodontic microsurgery is a surgical procedure performed with the aid of a microscope, ultrasonic instruments and modern microsurgical instruments. The microscope provides magnification and illumination - essential for identifying minute details of the apical anatomy. Ultrasonic instruments facilitate the precise root-end preparation that is within the anatomical space of the canal. Modern endodontics can therefore be performed with precision and predictability, thus eliminating the disadvantages inherent in traditional periapical surgery such as large osteotomy, beveled apicoectomy, inaccurate root-end preparation and the inability to observe isthmus. Factors influencing the outcomes of endodontic microsurgery may be diverse, but standardization of procedures can minimize its range. Among patient and tooth-related factors, periodontal status and tooth position are known to be prognostic, but there are only few articles concerning this matter. High-evidence randomized clinical trials or prospective cohort studies are needed to confirm these findings.

Antispastic Effect of Electroacupuncture on Upper Extremity in Stroke Patients by T-reflex Study : A Single-Blind, Randomized Controlled, Preliminary Study

  • Cho, Min Kyoung;Lee, In;Kwon, Jung Nam;Shin, Byung Cheul;Ko, Sung Hwa;Ko, Hyun Yoon;Shin, Yong Il;Hong, Jin Woo
    • The Journal of Korean Medicine
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    • v.36 no.4
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    • pp.8-18
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    • 2015
  • Objectives: There have been several studies evaluated effect of electroacupuncture (EA) on spasticity but most studies could not assess spasticity quantitatively because they used clinical rating scales for assessment spasticity. The objective of this study is to evaluate effect of EA on poststroke spasticity quantitatively using tendon reflex (T-reflex). Methods: 29 stroke patients with upper extremity spasticity were randomized to EA group and control group. The EA group received combined EA and rehabilitation therapy 5 times a week for 3 weeks. Acupuncture treatment was given at Jian Yu (LI 15), Qu Chi (LI 11), Shao Hai (HT 3), Wai Guan (TE 5), He Gu (LI 4), Lie Que (LU 7), Hou Xi (SI 3) of the affected side, 30 minutes of electrical stimulation with a frequency of 40/13 Hz was applied at Qu Chi (LI 11), He Gu (LI 4). The control group received only rehabilitation therapy. The efficacy of treatment was assessed using T-reflex latency and amplitude, modified Ashworth scale (MAS) of biceps brachii, brachioradialis and triceps brachii. Fugl-Meyer motor function assessment (FMA) and functional independence measure (FIM) were also measured to assess motor function and functional independence. All outcomes were measured before treatment, immediately after 3 weeks of treatment and 1 week after 3 weeks of treatment. Results: No statistically significant differences were found in outcomes including T-reflex between the study groups except for FIM values immediately after 3 weeks of treatment (p=0.037). Conclusions: These results suggest that 3 weeks of EA does not reduce poststroke upper extremity spasticity electrophysiologically and clinically. However, small sample sizes and contradictory tendency between results from T-reflex and those from MAS require cautious judgement on interpretation of the results. A larger, well-designed clinical trials for quantitative evaluation of effect of EA on poststroke spasticity will be needed.

Platelet Rich Plasma Injection: Evidence Based Analysis (혈소판 풍부 혈장 주사 요법: 근거 중심의 분석)

  • Oh, Joo Han;Chung, Seok Won
    • The Journal of Korean Orthopaedic Ultrasound Society
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    • v.4 no.2
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    • pp.111-122
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    • 2011
  • Platelet rich plasma (PRP) has been widely used nowadays for several common orthopaedic-related sports medicine conditions with the theoretical basis that PRP supplies numerous autologous growth factors from concentrated platelets needed to promote the healing process of injured tissue. Even though there are many basic sciences, animal studies and some clinical studies regarding PRP injections for musculoskeletal injuries which suggested good results, it is difficult to compare these various studies due to marked methodological differences such as PRP preparation method, the timing, volume and number of injection, and the outcome measurement tool. In addition, many studies have no control groups or a limited sample size, and there are few prospective randomized controlled trials assessing the efficacy of PRP injections. Therefore, well designed high-quality randomized studies are required to confirm the preliminary results until now and provide scientific evidence to support its use, and the paucity of scientific clinical evidence suggest that the administration of PRP on humans for musculoskeletal injuries should be performed with caution.

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

  • Kim, Mina;Kim, Young A
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.20 no.10
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    • pp.218-228
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    • 2019
  • This study was conducted to review and analyze the academic-related satisfaction intervention programs for Korean nursing students and to provide evidence-based data. The data included in the meta-analysis were 25 studies published from 2001 to July 2018, and the design of the study consisted of 1 randomized controlled trial and 24 non-randomized controlled trials. The study subjects were nursing students from 1st to 4th grade, and the intervention program was conducted in theoretical and practical classes. The sample size was 1182 (mean: 47.3) in the experimental group and 1137 in the control group (mean: 45.5). The intervention program consisted of 1~16 weeks/1~16 sessions/7~240 minutes per session. Dependent variables were as follows: major satisfaction, learning satisfaction, satisfaction with the classroom practice, and satisfaction with the clinical practice. Satisfaction with the classroom practice (Hedges' g=0.876[95% CI: 0.405, 1.346]), satisfaction with the clinical practice (Hedges' g=0.515[95% CI: 0.312, 0.718]), and overall academic-related satisfaction (Hedges' g=0.630[95% CI: 0.371, 0.889]) were statistically significant and above intermediate levels in the meta-analysis. The study results are significant in that the objective results were confirmed by integrating the previous studies dealing with the academic-related satisfaction intervention program of nursing students.

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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    • v.84 no.4
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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).

Literature Review on clinical studies for cold hypersensitivity of hands and feet -Focusing on journals published in Korea (수족냉증의 임상연구에 관한 문헌적 고찰 - 국내에 출판된 논문을 중심으로 -)

  • Lee, Hye-Sol;Han, In-Sik;Sun, Seung-Ho;Kim, Geun-yeob;Go, Ho-Yeon;Kim, Tae-Hoon;Lee, Jin-Moo;Jang, Jun-Bok;Song, Yun-Kyung;Ko, Seong-Gyu;Choi, You-Kyung;Jeong, Jong-Jin;Ko, Youme;Jeong, Keum Ran;Jeon, Chan-Yong
    • Journal of Society of Preventive Korean Medicine
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    • v.21 no.1
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    • pp.83-93
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    • 2017
  • Objectives : This study's aim is to investigate clinical studies of cold hypersensitivity of hands and feet (CHHF) published in Korea and to explore the direct of future research. Methods : We searched clinical studies of CHHF using the database, such as DBpia(http://www.dbpia.co.kr/), NDSL(www.ndsl.kr), OASIS(http://oasis.kiom.re.kr), and RISS(www.riss.kr). The search words were 'cold hypersensitivity(冷症)' and 'syncope(厥證)'. Inclusion criteria were randomized controlled trials (RCTs), non RCTs, Before and after clinical study (B&A) about CHHF. Selection journals and data extraction were conducted by HS Lee and SH Sun independently. Results : Total twenty-one articles were selected finally. RCTs, non-RCTs, and B&A were 3, 12, and 6, respectively. The topics for CHHF were classified into three categories: effect of treatment (n=2) characteristics (n=11), and diagnosis (n=8). Conclusions : This results showed that RCT about CHHF and treatment effect of cold hypersensitivity of hands and feet were small in number. Further systemic and larger studies about CHHF will be needed.

Clinical Application of Focused Ultrasound in Korean Medicine (집속초음파 치료의 한의 임상 활용에 대한 고찰)

  • Yoomin Choi;Maeum Lee;Nayeon Hur;Eunhee Lee;Hyugyong Choi;Hyung-Sik Seo;Eui-Hyoung Hwang;Insoo Jang
    • Korean Journal of Acupuncture
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    • v.40 no.3
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    • pp.79-89
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    • 2023
  • Objectives : The purpose of this study is to investigate various application methods of focused ultrasound and apply them to clinical use in Korean medicine. Methods : Search was performed using the search engines of electronic databases, including PubMed, ScienceDirect, Cumulative Index to Nursing and Allied Health Literature (CINAHL), ScienceON, Oriental Medicine Advanced Searching Integrated System (OASIS), China National Knowledge Infrastructure (CNKI), Wanfang Data, Japan Science Technology Information Aggregator, Electronic (J-STAGE) and Citation Information by NII (CiNii), from inception to July 2023 without language limitation. Inclusion criteria were clinical studies including randomized controlled trials (RCTs), and animal experimental studies related with focused ultrasound treatments for acupoints or meridian sinews. Results : Total 17 papers, 7 for RCT, 6 for in vivo animal studies, and other experimental studies, were finally selected. Indications used in studies were shoulder pain, back pain, chronic back pain, and degenerative knee arthritis. In experimental studies, studies on animal models of hypoxic ischemic brain damage and hyperlipidemia were also conducted. As for the acupoints, LR3, LI4, and ST36 were used in clinical studies and, in animal experimental studies, GV20, KI1, and ST36 were used. As for the dose, 4 studies below 3 W/cm2 and 3 studies in the range of 0.625 to 5 W/cm2 in clinical studies, and all studies did not exceed 5 W/cm2. In animal experimental studies, 0.5 W/cm2, 2 W/cm2, 7.5 WW/cm2, 15 W/cm2, 10~20 W/cm2 were used. In all three studies describing the penetration depth during irradiation, it was less than 1 cm. Conclusions : We suggest that focused ultrasound is an appropriate treatment tool for stimulating the acupoints to transfer heat energy. Future studies with rigorous and well-designed RCTs for various diseases will be required to ascertain the focused ultrasound stimulate acupoints or meridian sinews.