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

검색결과 774건 처리시간 0.027초

Barriers to Participation in a Randomized Controlled Trial of Qigong Exercises Amongst Cancer Survivors: Lessons Learnt

  • Loh, Siew Yim;Lee, Shing Yee;Quek, Kia Fatt;Murray, Liam
    • Asian Pacific Journal of Cancer Prevention
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    • 제13권12호
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    • pp.6337-6342
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    • 2012
  • Background: Clinical trials on cancer subjects have one of the highest dropout rates. Barriers to recruitment range from patient-related, through institutional-related to staff-related factors. This paper highlights the low response rate and the recruitment barriers faced in our Qigong exercises trial. Materials and Method: The Qigong trial is a three-arm trial with a priori power size of 114 patients for 80% power. The University Malaya Medical Centre database showed a total of 1,933 patients from 2006-2010 and 751 patients met our inclusion criteria. These patients were approached via telephone interview. 131 out of 197 patients attended the trial and the final response rate was 48% (n=95/197). Results: Multiple barriers were identified, and were regrouped as patient-related, clinician-related and/or institutional related. A major consistent barrier was logistic difficulty related to transportation and car parking at the Medical Centre. Conclusions: All clinical trials must pay considerable attention to the recruitment process and it should even be piloted to identify potential barriers and facilitators to reduce attrition rate in trials.

아토피피부염의 침 치료 임상연구 동향 (Trend for Acupuncture treatment Clinical Trial on Atopic Dermatitis)

  • 박수연;최정화;정민영;이기현
    • 한방안이비인후피부과학회지
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    • 제33권1호
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    • pp.45-55
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    • 2020
  • Objectives : The objective of this study is to review the Trend of clinical trials conducted with the acupuncture treatment on Atopic Dermatitis. Methods : Through 4 foreign online databases(PubMed, Cochrane library, EMBASE, CNKI) and 3 domestic online databases(NDSL, RISS, OASIS), we searched for clinical studies performed acupuncture treatment for Atopic Dermatitis from 2010 to December 2019. Only randomized controlled trials(RCT) was selected and anlayzed according to the research method. Results : A total 4 studies were reviewed. LI11, ST36, SP10 were most frequently used acupoints in acupuncture treatment. Among the evaluation indexes, SCORAD, VAS, DLQI were used most. In most of the 4 studies, acupuncture treatment showed significant therapeutic effects. Conclusions : These results suggest that it is necessary to develop more detailed standards about Acupuncture treatment method as the method of acupuncture is getting more diverse, and objective tools are needed in evaluating Atopic Dermatitis.

The Effects of Blackcurrant and Raspberry Consumption on Blood Pressure: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

  • Ali Nikparast;Fatemeh Sheikhhossein;Mohammad Reza Amini;Sogand Tavakoli;Azita Hekmatdoost
    • Clinical Nutrition Research
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    • 제12권1호
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    • pp.54-64
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    • 2023
  • A systematic review and meta-analysis were designed to summarize studies conducted on the effects of raspberry and blackcurrant consumption on blood pressure (BP). Eligible studies were detected by searching numerous five online databases including PubMed, Scopus, Web of Science, Cochrane Library, and Google Scholar, until December 17, 2022. We pooled the mean difference and its 95% confidence interval (CI) by applying a random-effects model. Overall, the impact of raspberry and blackcurrant on BP was reported in ten randomized controlled trials (RCTs) (420 subjects). Pooled analysis of six clinical trials revealed that raspberry consumption has no significant reduction in systolic blood pressure (SBP) (weighted mean differences [WMDs], -1.42; 95% CI, -3.27 to 0.87; p = 0.224) and diastolic blood pressure (DBP) (WMD, -0.53; 95% CI, -1.77 to 0.71; p = 0.401), in comparison with placebo. Moreover, pooled analysis of four clinical trials indicated that blackcurrant consumption did not reduce SBP (WMD, -1.46; 95% CI, -6.62 to 3.7; p = 0.579), and DBP (WMD, -2.09; 95% CI, -4.38 to 0.20; p = 0.07). Raspberry and blackcurrant consumption elicited no significant reductions in BP. More accurate RCTs are required to clarify the impact of raspberry and blackcurrant intake on BP.

임신성 고혈압의 한약 치료에 대한 무작위 대조군 연구의 문헌고찰 (A Review on Randomized Controlled Trials of Herbal Medicine Treatment for Pregnancy-induced Hypertension)

  • 황수인;윤영진;박장경
    • 대한한방부인과학회지
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    • 제33권3호
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    • pp.119-135
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    • 2020
  • Objectives: The purpose of this study is to confirm the effectiveness and safety of herbal medicine treatment for treating pregnancy-induced hypertension. Methods: We searched for randomized controlled trials of pregnancy-induced hypertension treated with herbal medicine, through nine databases. Interventions and results of the selected clinical studies were analyzed. Results: Eleven randomized controlled trials were finally included according to the inclusion and exclusion criteria. Treatment group was treated with herbal medicine alone in two studies, and with herbal medicine and western medicine in nine studies. Control group was treated with western medicine. Taxilli Ramulus (桑寄生) (54.5%) was the most frequently used herb in herbal medicine treatment. In all of eleven studies, treatment group was more effective for pregnancy-induced hypertension than the control group. Conclusions: This study suggested that herbal medicine treatment alone or combined with western medicine treatment could be helpful in improving the therapeutic effect on pregnancy-induced hypertension and reducing side effects as well. However, in order to obtain stronger evidence of herbal medicine treatment for pregnancy-induced hypertension, more high-quality and well-designed randomized controlled trials should be conducted.

Comparison of Ligasure Versus Conventional Surgery for Curative Gastric Cancer Resection: a Meta-Analysis

  • Hu, Tian-Peng;He, Xiang-Hui;Meng, Zhao-Wei;Jia, Qiang;Tan, Jian;Li, Xue
    • Asian Pacific Journal of Cancer Prevention
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    • 제17권4호
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    • pp.2049-2053
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    • 2016
  • Background: The LigaSure vessel sealing system has been proposed to save operation time and reduce intraoperative blood loss for various surgeries. However, its usage for gastric cancer is still controversial. The aim of the present meta-analysis was to compare the effectiveness of LigaSure with conventional surgery in gastrectomy. Materials and Methods: Sources were retrieved from the Cochrane Library, MEDLINE, EMBASE, SCOPUS and Google Scholar until February, 2015. All randomized controlled trials comparing LigaSure with conventional surgery in curative gastric cancer resection were selected. After data extraction, statistics were performed by Review Manager 5.1 software. Results: Three eligible randomized controlled trials were evaluated, with a total of 335 patients. The quality of the included trials was good, yet some methodological and clinical heterogeneity existed. There were no significant differences between the LigaSure and conventional groups in operative time (weighted mean difference [WMD], -22.95 minutes; 95% confidence interval [CI], [-59.75, 13.85]; P = 0.22), blood loss (WMD, -45.8 ml; 95% CI, [-134.5, 42.90]; P = 0.31), nor the incidence of surgical complications (odds ratio, 1.18; 95% CI, [0.68, 2.05]; P = 0.54). But there was a longer duration of hospital stay in LigaSure group (WMD, 1.41 days; 95% CI, [0.14, 2.68]; P = 0.03). Conclusions: All available randomized evidence has been summarized. LigaSure does not confer significant advantage over conventional surgery for curative gastric cancer resection. The usefulness of the device may be limited in gastrectomy. But, more trials are needed for further assessment of the LigaSure system for gastric cancer.

Outcomes of epidural steroids following percutaneous transforaminal endoscopic discectomy: a meta-analysis and systematic review

  • Song, Yinghao;Li, Changxi;Guan, Jingjing;Li, Cheng;Wu, Haisheng;Cheng, Xinzhi;Ling, Bingyu;Zhang, Jinglang
    • The Korean Journal of Pain
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    • 제35권1호
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    • pp.97-105
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    • 2022
  • Background: Percutaneous transforaminal endoscopic discectomy (PTED) has been widely used in the treatment of lumbar degenerative diseases. Epidural injection of steroids can reduce the incidence and duration of postoperative pain in a short period of time. Although steroids are widely believed to reduce the effect of surgical trauma, the observation indicators are not uniform, especially the long-term effects, so the problem remains controversial. Therefore, the purpose of this paper was to evaluate the efficacy of epidural steroids following PTED. Methods: We searched PubMed, Embase, and the Cochrane Database from 1980 to June 2021 to identify randomized and non-randomized controlled trials comparing epidural steroids and saline alone following PTED. The primary outcomes included postoperative pain at least 6 months as assessed using a visual analogue scale (VAS) and the Oswestry Disability Index (ODI). The secondary outcomes included length of hospital stay and the time of return to work. Results: A total of 451 patients were included in three randomized and two non-randomized controlled trials. The primary outcomes, including VAS and ODI scores, did not differ significantly between epidural steroids following PTED and saline alone. There were no significant intergroup differences in length of hospital stay. Epidural steroids were shown to be superior in terms of the time to return to work (P < 0.001). Conclusions: Intraoperative epidural steroids did not provide significant benefits, leg pain control, improvement in ODI scores, and length of stay in the hospital, but it can enable the patient to return to work faster.

소아 틱장애의 한약치료에 대한 최신 임상연구 동향 - 중국 무작위 대조군 임상연구를 중심으로 - (Recent Trends in Clinical Research of Herbal Medicine for Tic Disorder in Children - Focused on Chinese Randomized Controlled Trials -)

  • 김재현;박용석;정윤경;장규태
    • 대한한방소아과학회지
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    • 제36권1호
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    • pp.38-56
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    • 2022
  • Objectives The purpose of this study was to analyze the trend of recent randomized controlled trials (RCTs) that used herbal medicine for the treatment of tic disorders in China and to evaluate the efficacy and safety of the treatment. Methods RCTs published from January 2017 to December 2021 were searched for using the China National Knowledge Infrastructure (CNKI). These were then analyzed using herbal medicine treatment methods and their results. Results A total of 35 randomized controlled trials were selected and analyzed. In most studies, evaluation indicators such as the Yale tic symptom scale and total effective rate were significantly improved in the herbal medicine treatment group compared to the control group. The most commonly used herb for tic disorder was Uncaria Rhynchophylla (釣鉤藤), followed by Glycyrrhizae Radix (甘草), Gastrodiae Rhizoma (天麻), Paeoniae Radix Alba (白芍藥), Batryticatus (白殭蠶), Poria (茯笭), and Bupleuri Radix (柴胡). In all studies that reported adverse events, herbal medicine was identified as a relatively safe treatment with fewer adverse reactions or no significant difference compared with the control group. Conclusions Based on the results of RCTs, herbal medicine has been shown to be safe and effective for the treatment of intellectual disability. However, additional well-designed large-scale clinical trials are needed to confirm these findings.

근골격계 질환의 두침치료에 대한 체계적 문헌 고찰과 질 평가: 무작위 배정 대조 임상연구를 중심으로 (A Systematic Review and Quality Assessment of Scalp Acupuncture for Musculoskeletal Diseases: Focused on Randomized Controlled Trials)

  • 공도훈;신병철
    • 한방재활의학과학회지
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    • 제33권4호
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    • pp.61-78
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    • 2023
  • Objectives This systematic review aimed to analyze the effectiveness, safety and the reporting quality of scalp acupuncture (SA) treatment for musculoskeletal disease (MSD). Methods Eleven databases were systematically searched up to July 12th 2023. Randomized controlled trials (RCTs) of SA treatment for MSD were selected manually by the inclusion criteria. The risk of bias of RCTs was assessed using the Cochrane's Risk of Bias (RoB) 1.0 and the reporting quality of studies was evaluated using Consolidated Standards of Reporting Trials (CONSORT) 2010 statement and Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) 2010 checklist. Results Ten clinical studies were met the inclusion criteria. Most of studies reported SA treatment significantly alleviated pain and functional disability of MSD patients and no serious adverse effects were reported. In RoB assessment, blinding of participants and personnel was found to have the highest RoB and allocation concealment was found to have the most unclear RoB. In CONSORT 2010 statement evaluation, all studies reported 15.3 items (41.4%) on average. In STRICTA 2010 checklist evaluation, all studies reported 11.2 items (65.9%) on average. Conclusions The systematic review found that SA treatment may alleviate pain and functional disability of MSD patients and have little severe adverse effect. The reporting quality of included studies was mainly low, therefore, further studies with strict adherence to the CONSORT and STRICTA checklist should be encouraged.

무릎 뼈관절염의 단파치료 효과 : 무작위임상시험의 메타분석과 체계적 고찰 (Effectiveness of Shortwave Therapy in Management of Knee Osteoarthritis : A Systematic Review and Meta-analysis of Randomized Controlled Trials)

  • 이재형;조혁신;송인영
    • The Journal of Korean Physical Therapy
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    • 제26권5호
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    • pp.331-343
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    • 2014
  • Purpose: The purpose of this study is to assess the effectiveness of short-wave therapy (SWT) for treatment of knee osteoarthritis (OA) as compared to placebo and control, and to assess the question of whether the effects are related to the mode, dosage, and application method. Methods: We searched randomized, placebo-controlled trials using electronic databases. We also manually reviewed sources in order to identify additional relevant studies. Results: Eight studies (597 participants) with OA were included in the meta-analysis. Pulse SWT had a significant effect on pain relief compared with control treatment, while did not favour compared with the placebo group. Pulse SWT had a significant effect on functional improvement compared with control and placebo treatment. Continuous SWT had no effect on pain relief and functional improvement. Capacitive SWT a significant effect on pain relief, functional improvement, and muscle strength. Continuous and capacitive SWT had increased muscle strength significantly. We found no clinical significance of all outcomes except pain and functional improvement in pulsed SWT with low dose. There was no difference in adverse events. None of the participants experienced any serious adverse events. Conclusion: Low dose pulsed SWT provided a short-term clinical benefit for pain relief and functional improvement. Pulsed SWD with low and high dose had effects on pain and function. There seems to be a placebo effect. We found significant effects on pain and function in capacitive SWT. Despite some positive findings, this analysis lacked data on how effectiveness is affected by mode, dosage, and application method of SWT. Further well-designed clinical studies are required in order to confirm the effectiveness of SWT.