• Title/Summary/Keyword: randomized controlled trials (RCTs)

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Sacral Acupuncture for Lower Urinary Tract Symptoms: A Systematic Review of Randomized Controlled Trials

  • Park, Jiwon;Chun, Se-Eun;Park, Min-Cheol;Jo, Eun-Heui
    • Journal of Acupuncture Research
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    • 제39권1호
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    • pp.1-9
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    • 2022
  • Lower urinary tract symptoms (LUTS) associated with storage, voiding, and post-micturition reduce quality of life and cause mental health problems. In traditional medicine, Baliao points have been empirically used to treat urinary system diseases. In this review, randomized controlled trials (RCTs) using sacral acupuncture on Baliao points with sham treatment, other remedies, or other acupoints were retrieved from 8 electronic databases up to June 2021. Sixteen RCTs met the inclusion criteria. The quality of the included studies was assessed using a risk-of-bias (ROB) tool. Most of the evaluation indicators used in the included RCTs showed that sacral acupuncture had a significant therapeutic effect compared with the sham control intervention groups, and other remedies. However, all studies using acupoints (other than the Baliao points) as a control intervention had a "high" ROB and only reported secondary processed information, making it difficult to evaluate the efficacy of sacral acupuncture treatment for LUTS. No serious adverse effects were reported for sacral acupuncture, and only a low number of minor side effects were observed. These results suggest that sacral acupuncture could be considered as an alternative to existing treatments, with the added benefit of low cost. Large-scale, long-term RCTs are required in the future.

Analysis of Registration Information of Randomized Controlled Clinical Trials on Suicide Attempters Based on WHO-ICTRP (자살시도자에 대한 무작위대조군연구의 등록 현황 분석: WHO-ICTRP를 중심으로)

  • Min-Ryeong Park;Ji-Won Lee;In-Jun Hwang;Chan-Young Kwon
    • Journal of Oriental Neuropsychiatry
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    • 제34권3호
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    • pp.213-234
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    • 2023
  • Objectives: To investigate current status of randomized controlled clinical trial (RCT) registration for suicide attempters. Methods: The World Health Organization International Clinical Trials Registry Platform (WHO-ICTRP) was used to search for data using 'suicide' as a search term. All registration information of RCTs registered up to April 2023 were collected. Results: Among a total of 68 RCTs registered, the United States ranked the highest in terms of quantity in this field (n=30, 46.15%), whereas Asia had only six (8.82%). A total of 62 (91.18%) RCTs involved individual interventions, while nine (13.24%) RCTs involved group interventions. Among individual interventions, 11 (16.18%) and 54 (79.41%) RCTs were on pharmacotherapy and psychotherapy, respectively. Within psychotherapy, there were a total of 17 (25%) studies utilizing digital media, with cognitive behavioral therapy (CBT) via phone being the most common approach. Among non-digital media-based studies, CBT was used the most frequently (n=11, 16.18%), followed by attempted suicide short intervention program (n=6, 8.82%). There were no studies using interventions from East Asian traditional medicine, including Korean medicine (KM). The most frequently used main outcome was the Beck scale for suicidal ideation. Conclusions: Studies on suicide attempts in Asia, especially in South Korea, are very scarce. Despite vigorous psychotherapeutic research in this field, KM psychotherapy has not been used. Thus, KM clinical trial for suicide attempters might be planned in the future based on our findings.

TheAssessment of risk of bias in randomized controlled trials published in the Korean Journal of Physical Therapy: A 2018~2022 review (한국 물리치료 학술지에 무작위대조연구의 비뚤림 위험 평가: 2018~2022년 검토)

  • Jae Hyun Lim;Chi Bok Park;Byeong Geun Kim
    • Journal of Korean Physical Therapy Science
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    • 제30권4호
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    • pp.82-91
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    • 2023
  • Background: Randomized controlled trials (RCTs) provide evidence on the effectiveness and safety of interventions and inform systematic reviews and guideline preparation for clinical application. However, methodological flaws can occur in many RCTs, and Cochrane's risk of bias version 2 (RoB2) can be used to evaluate RCTs' risk of bias (RoB). However, physical therapy RCTs in Korea did not confirm RoB. Therefore, the purpose of this study was to evaluate RoB using RoB2 in RCTs published in the Korean Physical Therapy Journal. Design: Review. Methods: The RCTs subject to evaluation were RCTs published in 11 physical therapy journals in Korea from 2018 to 2022. RoB2 evaluated a total of five domains: bias arising from the randomization process, bias due to deviations from intended interventions, bias due to missing outcome data, bias in measurement of the outcome, and bias in selection of the reported result. Results: A total of 616 RCTs were evaluated. As for bias arising from the randomization process, high risk was the highest at 555 (90.1%), followed by low risk at 41 (6.7%) and some concerns at 20 (3.2%). For bias due to deviations from intended interventions, the proportion of some concerns was the highest at 390 (63.3%), followed by high risk at 218 (35.4%) and low risk at 8 (1.3%). As for the bias due to missing outcome data, the rate of low risk was the highest at 399 (64.8%), followed by high risk at 159 (25.8%) and some concerns at 58 (9.4%). As for bias in measurement of the outcome, high risk was the highest at 294 (47.7%), followed by low risk at 224 (36.4%) and some concerns at 98 (15.9%). In the bias due to missing outcome data, the ratio of high risk was the highest at 610 (99%), followed by low risk at 4 (0.7%) and some concerns at 2 (0.3%). Conclusion: Most of the RoB evaluation results of RCTs published in the Korean Physical Therapy Journal were rated as high risk. Methodological quality of RCTs needs to be improved.

Association of Trial Registration with Reporting Biases in Randomized Controlled Trials of Acupuncture (침 무작위 대조 임상 시험에서 보고 비뚤림과 프로토콜 등록 여부의 관련성 연구)

  • Kim, Seoyeon;Won, Jiyoon;Park, Hi-Joon;Lee, Hyangsook
    • Korean Journal of Acupuncture
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    • 제35권2호
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    • pp.70-81
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    • 2018
  • Objectives : To investigate the association of trial registration status with presence of reporting bias including publication bias and outcome reporting bias in recently published randomized controlled trials (RCTs) of acupuncture. Methods : A PubMed search for RCTs of acupuncture published from March 2016 to February 2017 was conducted. Primary outcomes were identified and the direction of the results was judged as positive (i.e., statistically significant) or negative. The trial registration was identified by manually screening the trial registration number in the main text of the published article and classified into 1) prospective registration; 2) retrospective registration based on the registration date or; 3) no registration. Results : Of the 125 included RCTs, only 40 studies (32.0%) prospectively registered the study protocols. Among 65 RCTs that adequately reported the primary outcome, unregistered trials were more likely to report positive results than the registered ones (p=0.013). Of the 40 prospectively registered studies, 19 trials (47.5%) had the discrepancies between the registered and published primary outcomes and furthermore, 40% of them reported the positive findings. Conclusions : Unregistered trials were more likely to report positive results and the discrepancies between the registered and published primary outcomes were detected in about a half of the prospectively registered studies, 42.1% of which tended to report positive findings. Journal editors and researchers in this field should be alerted to various reporting biases.

Review of Randomized Controlled Trials using Herbal Remedies on Cancer Patients (한약물을 이용한 암 치료 관련 무작위 배정 임상시험에 대한 고찰)

  • Park, Bong-Ky;Wang, Jing-Hua;Cho, Jung-Hyo;Son, Chang-Gue
    • The Journal of Korean Medicine
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    • 제31권5호
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    • pp.12-32
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    • 2010
  • Objective: This study aimed to review herbal remedy-based RCTs on cancer patients in order to produce helpful information for clinical study of herbal medicine in the future. Methods: We collected all RCTs using herbal remedies on cancer patients from Pubmed and Cochrane databases until November 1st, 2009. Elementary information such as nation where performed, clinical question, design, randomization, double-blinding and allocation concealment were analyzed. Results: 153 RCTs were finally selected. 119 RCTs were conduced in China while only 2 were done in Korea. The most frequent targeted cancer was lung cancer as 29 RCTs. The main clinical questions included improvement of quality of life, elongation of survival rate and regression of tumor being 83, 62 and 55 respectively. 112 RCTs used herbal remedies with western therapy. Adequate methods for randomization and allocation concealment were found in 37% and 10% of trials respectively. Conclusions: We found that herbal remedies are used on cancer patients in aspects of both caring for the human body and tumor treatment itself. The study might provide us useful data for cancer-related clinical study using herbal remedies in the future.

Acupuncture for Premenstrual Syndrome: A Systematic Review and Meta-analysis (월경전증후군에 대한 침 치료의 효과 : 체계적 문헌고찰과 메타분석)

  • An-Na Kim;Young-Eun Kim;Eun-Hee Lee;Mi-Ju Son
    • The Journal of Korean Obstetrics and Gynecology
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    • 제36권3호
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    • pp.154-172
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    • 2023
  • Objectives: This study aimed to assess the clinical evidence supporting the use of acupuncture (AC) for premenstrual syndrome (PMS). Methods: We searched randomized controlled trials (RCTs) that used AC for PMS in 9 databases (PubMed, EMBASE, Cochrane Library, CINAHL, CNKI, CiNii, SCIENCE ON, KoreaMed, OASIS) from their inception to July 2022. Results: We identified 1,168 studies, of which 15 RCTs met the inclusion criteria. The risk of bias in the included studies was relatively unclear or high. Meta-analysis of 3 RCTs showed that the AC group had a significantly higher effective rate than the Medroxyprogesterone group (RR 1.48, 95% CI (1.23, 1.78), p<0.0001). Meta-analysis of 2 RCTs showed that there was no statistically significant difference between the AC group and the Sham AC group in the effective rate (RR 4.72, 95% CI (0.88, 25.36), p=0.07). In a review of individual studies, the AC group was more effective than the control group in terms of the effective rate, symptom scale, quality of life, adverse events, and recurrence rate. Conclusions: The AC group was more effective than general treatments groups such as sham AC, western medicine, and dietary supplements, and there were no serious adverse events. However, the evidence on the effectiveness and safety of acupuncture for PMS was inconclusive due to the small number of included studies and low quality. Therefore, systematic reviews based on more rigorously designed randomized clinical trials are needed in the future to properly evaluate the effect of AC on PMS.

A Systematic Review and Meta-Analysis of Randomized Controlled Trials on Acupuncture for Improving Post-Operative Cognitive Dysfunction (POCD) and Chemotherapy-Related Cognitive Impairment (CRCI)

  • Kim, Ju-Young;Cho, Han-Byul;Kim, Man-Gi;Koo, Byung-Su;Kim, Geun-Woo
    • Journal of Oriental Neuropsychiatry
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    • 제33권1호
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    • pp.49-78
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    • 2022
  • Objectives: This study was conducted to evaluate the efficacy of Korean Medicine Therapy (KMT) for the treatment of Chemotherapy-induced Cognitive Impairment (CICI) through systematic review and meta-analysis of randomized controlled trials (RCTs) as proceeding research to further research the efficacy of KMT for CICI patients. Methods: We conducted a systematic review and meta-analysis according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines (PRISMA). The RCTs on the efficacy of KMT for treatment of CICI were searched by structured search strategies in MEDLINE, EMBASE, Cochrane library, CAJD, KISS, NDSL, KoreaMed, and OASIS. The searched RCTs were screened by inclusion and exclusion criteria. We evaluated the quality of the method in the included studies using the Jadad score and Cochran ROB tool. The efficacy outcomes were the Visual Analogue Scale (VAS) and the Clinical total Effective Rate (CER) of CICI. They were analyzed using mean difference for continuous variable or Relative Risk (RR) for Dichotomous variable in the random-effect model. The RevMan 5.3 program was used for meta-analysis. Results: We included 19 RCTs, including 653 participants, in the systematic review and meta-analysis. There were favorable results for the KMT group after the intervention compared with the pharmacotherapy group, physiotherapy group, and combined treatment group. KMT group showed improvement using CER and VAS compared with exercises, but their heterogeneities were slightly significant. KMT was more effective compared to the Rehabilitation program in CER and the subgroup analysis results showed that KMT had a significant difference compared to other therapies in VAS, to Medication therapy in CER. Conclusions: KMT presented reasonable evidence on improving the Clinical total Effective Rate and Visual Analogue Scale in CICI patients. However, further evaluation in future research is required.

The Effect of Acupuncture combined with Conventional Rehabilitation Treatment for Cerebral palsy: A Systematic review of Randomized Controlled Trials(RCTs) (뇌성마비(Cerebral palsy) 소아의 재활치료와 재활과 침치료의 병행치료를 비교한 체계적 문헌 고찰)

  • Chang, Seok Joo;Seong, Eun Hak;Kim, Jang Hyun;Min, Sang Yeon
    • The Journal of Pediatrics of Korean Medicine
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    • 제34권3호
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    • pp.81-96
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    • 2020
  • Objectives This study aims to evaluate the effect of acupuncture combined with rehabilitation treatment for cerebral palsy in children. Methods 7 electro-database (PubMed, CENTRAL, CNKI, DBpia, KISS, OASIS, KJTK) were searched for using the keywords "cerebral palsy AND acupuncture" which study is designed in randomized controlled trials (RCTs). Results 10 out of 303 studies were included in analysis after screened. Acupuncture combined with rehabilitation treatment had a significant effect on motor function. Only 1 study reported minor adverse effects. Conclusions All of the studies have shown acupuncture combined with conventional rehabilitation treatment was effective in cerebral palsy. Additional well-designed studies are needed to justify the effectiveness of acupuncture in cerebral palsy.

The Effectiveness of Smoking Cessation Program in Adults: Systematic Review of Randomized Controlled Trials (성인 흡연자의 금연 프로그램 효과: 무작위대조군 실험연구의 체계적 문헌고찰)

  • Park, Seong-Hi;Hwang, Jeong-Hae;Choi, Yun-Kyoung;Kang, Chang-Bum
    • Korean Journal of Health Education and Promotion
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    • 제29권3호
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    • pp.1-14
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    • 2012
  • Objectives: The purpose of this study was to determine if smoking cessation programs (SCPs) are effective for adults through a systematic review of the results of such programs in large randomized controlled trials (RCTs). Methods: The PICO (Patient, Intervention, Comparator, Outcome) strategy was established, 1,160 literature from domestic and foreign electronic databases was reviewed, and 22 references were selected based on the inclusion and exclusion criteria. The quality of each reference was evaluated using the Scottish Intercollegiate Guidelines Network tool, and meta-analysis was carried out. Results: The SCPs were significantly effective for adult smokers. Smoking cessation counseling, education, and smoking cessation medications such as nicotine patch were more effective than the other interventions. However, the results showed short-term effects (within six months), and differences were observed among the SCPs. For the outcome measures for SCPs, the abstinence rate of seven days was mainly used, but differences were identified between the CO level and the cotinine-verified abstinence rate of smoking cessation. Conclusions: For a smoking cessation program for adult smokers, the strength of the evidence of the program's effectiveness in RCTs that provide the identified intervention strategies should be considered.

The Assessment of Appropriateness of Acupuncture Methodology Based on STRICTA Recommendations;The Discussion of 5 Systematic Reviews and Their Objects 58 Randomized Controlled Trials Using the New Tool (STRICTA 권장안에 기초한 침 연구방법론의 적절성 평가;새로운 평가지수를 이용한 5편 Systematic Review와 그 대상인 58편 무작위대조시험의 고찰)

  • Kim, Woo-Young;Lee, Seung-Deok;Lim, Byung-Mook;Kim, Kap-Sung
    • Journal of Acupuncture Research
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    • 제24권5호
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    • pp.151-170
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    • 2007
  • Backgraounds : Recent studies provide the evidences that the efficacy of acupuncture may be no better than placebo or inconclusive. These results are very different from those of the actual clinical situations in many acupuncture medical institutions. Objectives : The present study was designed to evaluate the influencing factors which affect the efficacy of acupuncture scale(FEAS) as the methodological assessment tool of acupuncture for examining acupuncture interventions and to demonstrate the importance of it in randomized controlled trials of acupuncture. Data sources : Electronic data were retrieved from NDSL, Pubmed, sciencedirect, LWW, OVID, Black-Well Synergy, Wiley Interscience, EBSCO HOST, springer, PML, and Kluwer. No electronic data were collected from MEDLIS and MEDLAS. Study selection : The inclusion criteria were five systematic reviews included in Alberta study and all randomized controlled trials obtained from their references. Study analysis : The acupuncture rationale, methods of stimulation, treatment regimen, and the practitioner's background were rated by FEAS, and the scores were compared with those by other methodological assessment tools. Results : The number of positive conclusions of high-rank RCTs by FEAS was the same as or higher than that of high-rank RCTs by other methodological assessment tools. Conclusions : We have analysed 5 systematic reviews and their objectives 58 RCTs using FEAS. Practitioner's background has been described slightly in some reviews and studies. It may directly influence the effectiveness of acupuncture negatively in the systematic reviews.

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