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

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Effect of Electrical Stimulation on Upper Extremity Function in Stroke Patients: A Systematic Review Based on Randomized Controlled Trials (뇌졸중 환자의 상지 기능에 기능적 전기 자극이 미치는 영향: 무작위대조군연구에 기초한 체계적 고찰)

  • Hwang, Su-jin;Seo, Yeon-ju
    • PNF and Movement
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    • v.20 no.2
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    • pp.147-156
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    • 2022
  • Objective: Electrical stimulation is an assistive technology used to aid the recovery of upper limb use after stroke. The purpose of this systematic review was to determine the effects of electrical stimulation on upper extremity function in individuals with hemiparetic stroke and to develop an evidence base that supports the use of electrical stimulation for upper limb recovery after stroke. Design: A systematic review based on randomized controlled trials (RCTs). Methods: Studies published before April 20 2021 were collected for this review by searching PubMed, four other databases, and RCTs that reported the effects of electrical stimulation on upper extremity function in individuals with the characteristic stroke type. Information on the following parameters was extracted from each study: surname of first author, published year, country, participants, intervention, intervention's intensity, comparison, outcomes, additional therapy, and summary of results. This review also evaluated the bias within each study, including any selection bias, performance bias, detection bias, attrition bias, and reporting bias. Results: This review included five RCTs, and 208 stroke patients were included in the analysis. Stroke patients who underwent electrical stimulation showed significantly improved grip and pinch strengths, wrist range of motion, and basic daily living compared to those in the control group; however, there was no improvement in upper extremity function. Of the selected papers, 60% showed a "high risk" of performance bias, and 20% showed a "high risk" of detection bias. Conclusions: The results of this systematic review suggest that electrical stimulation provides some benefits to stroke patients, such as improved hand strength and range of motion. However, future studies are needed to provide clinical evidence of the effects of electrical stimulation on upper extremity function in stroke patients.

Review of Randomized Controlled Trials Research of Gyejibongnyeong-hwan and Gyejibongnyeong-hwan gagam for Chronic Pelvic Inflammatory Disease (만성 골반 염증성 질환의 계지복령환 및 계지복령환 가감방 투여에 대한 중의학 연구 동향 : 무작위 대조군 임상 연구를 중심으로)

  • Yeon-Soo Jung;Young-Jin Yoon;Hee-Yoon Lee;Jang-Kyung Park
    • The Journal of Korean Obstetrics and Gynecology
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    • v.36 no.3
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    • pp.78-94
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    • 2023
  • Objectives: The purpose of this study is to review the trends of clinical trials of traditional herbal medicine Gyejibongnyeong-hwan for chronic pelvic inflammatory disease in CNKI. Methods: We searched relevant studies using Chinese National Knowledge Infrastructure (CNKI). Data retrieval was carried out by December 20th, 2021. We analyzed characteristics of study subjects, treatment period, composition of prescription, outcome and adverse event of selected studies and the risk of bias was assessed by using Cochrane's risk of bias tool. Results: Among the total 988 studies, 10 studies met the inclusion criteria. All of the studies were randomized controlled studies and written in Chinese. In all studies, Gyejibongnyeong-hwan was effective in improving chronic pelvic inflammatory disease. Conclusions: This study suggests that Gyejibongnyeong-hwan can be effective in treating chronic pelvic inflammatory disease compared to antibiotics treatment. Further large and well-established randomized placebo controlled trials will be needed.

A Review of Randomized Controlled Trials of Catgut Embedding Therapy for Urinary Incontinence (요실금의 매선 치료에 대한 무작위 대조군 연구의 문헌고찰)

  • Hyun-Joo Lee;Hee-Yoon Lee;Jang-Kyung Park;Young-Jin Yoon
    • The Journal of Korean Obstetrics and Gynecology
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    • v.37 no.2
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    • pp.58-74
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    • 2024
  • Objectives: This study aims to evaluate the efficacy of urinary incontinence treatment using catgut embedding therapy. Methods: Using electronic databases including Pubmed, EMBASE, and CAJ, we looked for randomized controlled trials that treated urinary incontinence with catgut embedding that were published between January 2000 and December 2023. The chosen clinical studies' interventions and outcomes were examined. Results: Ultimately, eight randomized controlled trials met the inclusion and exclusion criteria. Treatment group was treated with catgut embedding alone in 3 studies, and with Biofeedback Electrical Stimulation Therapy (Biofeedback EST), Kegel exercises, Herbal Medicine and Acupuncture Injection in 5 studies. Control group was treated with Biofeedback EST, Kegel exercises, Herbal Medicine, Vitamin B, Electroacupuncture (EA), Denitine Tolterodine Tartrat with Bladder Drill, Tension-free Vaginal Tape Obturator (TVT-O) and Acupoint Injection Therapy. Outcome measures are total efficacy rate, Urine pad test, Urinary frequency, Maximum bladder capacity, VRP, POP-Q, etc. 關元 (CV4) was the most frequently used acupoint in catgut embedding therapy. In all of 8 studies, treatment group was more effective for urinary incontinence than the control group. Conclusions: According to this study, catgut embedding may be useful in enhancing the therapeutic outcome for urine incontinence, either by itself or in conjunction with standard medical treatment.

Traditional Asian Medicine Treatment for Childhood Cancer - Review of Controlled Clinical Studies (소아암의 한의약치료 임상 동향 - 대조군 임상연구를 중심으로)

  • Kim, Younhwan;Kim, Hanseul;Oh, Jeongmyeong;Lee, Hyeyoon;Min, Yuri;Yun, Youngju
    • Journal of Society of Preventive Korean Medicine
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    • v.24 no.2
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    • pp.17-30
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    • 2020
  • Objectives : To find treatment techniques and design clinical studies, this study reviewed controlled clinical studies on traditional Asian medicine treatment for childhood cancer. Methods : Literature searches were performed on four databases, such as NDSL, OASIS, PubMed, and CNKI. Studies were categorized and analyzed according to the treatment goal and we also assessed the quality of the randomized controlled trials (RCT) using Van Tulder Scale. Results : Twenty-seven studies met our inclusion criteria: 21 RCTs, 4 controlled trials, 2 Cohort studies, however only 6 among the 21 RCTs got the scores of high quality. Various interventions were used, such as herbal medicine, acupuncture, acupressure, and chuna. 7 studies were focused on cure of leukemia or solid cancer. 11 studies were performed to alleviate chemotherapy induced nausea and vomiting. 9 studies were focused on other complications of chemotherapy. Conclusions : Most of the studies reported significant effectiveness of traditional medicine treatment compared to controlled group. However we could not made a definite conclusion because of the low quality and heterogeneity of the studies included. More studies should be performed to introduce traditional Asian medicine to childhood cancer treatment.

Analysis of Recent Clinical Studies to Establish Korean Herbal Medicine Clinical Trial Guidelines for the Common Cold (감기 임상시험 가이드라인 제정을 위한 최신 임상시험 연구 분석)

  • Kim, Kwan-il;Lee, Ho-jung;Lee, Beom-joon;Jung, Hee-jae;Jung, Sung-ki;Lee, Jun-hee
    • The Journal of Internal Korean Medicine
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    • v.37 no.1
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    • pp.109-134
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    • 2016
  • Objectives: The aim of this study was to help develop a guideline for the common cold. We searched recent clinical studies of the common cold in Western medicine and reviewed their objectives, inclusion and exclusion criteria, primary outcome, secondary outcome, and assessment tools to establish evidenced-based guideline.Methods: We searched electronic databases (Cochrane Library, MEDLINE, EMBASE) to identify eligible randomized controlled trials (RCTs) about the common cold for the last 10 years. We included 29 RCTs and showed their research summary via their objectives, participants, interventions, control, treatment duration, and results. We also analyzed the definition of the common cold presented in the article, inclusion and exclusion criteria, primary and secondary outcomes, and assessment tools.Results: We reported the aforementioned areas in detail. At first, the definition of the common cold was confused across the articles. Second, herbal medication clinical trials for the common cold have been extensively studied recently. Third, the eligibility criteria frequently included the Jackson Symptom score. Fourth, validated assessment tools (i.e., the Wisconsin Upper Respiratory Symptom Survey-21) have only been used in a few recent studies.Conclusions: Our research will be helpful to establish Korean herbal medicine clinical trial guidelines for the common cold.

Citalopram and Escitalopram for Management of Hot Flashes: A Review of Recent Clinical Trials in Humans (Citalopram과 Escitalopram의 안면홍조 증상개선효과에 대한 최근 연구 고찰)

  • Lee, Yu-Jeung
    • Korean Journal of Clinical Pharmacy
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    • v.21 no.4
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    • pp.376-382
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    • 2011
  • The results from eight clinical studies demonstrate that citalopram and escitalopram could be an effective option in the treatment of hot flashes with tolerable adverse effects. However, there are limitations in the above studies. The inclusion criteria of 2 studies reviewed in this paper was breast cancer patients, so it's hard to apply the results to the general population in clinical practice. Also 4 studies had less than 50 subjects included, and the duration of study was 8 weeks or less in 7 studies reviewed in this paper. Moreover, only 4 studies were randomized, placebo-controlled trials (3 for citalopram and 1 for escitalopram). Therefore, further randomized, double-blind, placebo-controlled studies with the general population should be needed to use citalopram and escitalopram for the treatment of hot flashes in clinical practice.

Review of Intention-to-Treat Analysis in Randomized Controlled Trials (무작위 대조군 실험 연구에서 치료의향분석 (Intention-to-treat analysis)에 대한 고찰)

  • Kim, Junghun Aj
    • Therapeutic Science for Rehabilitation
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    • v.9 no.2
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    • pp.27-38
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    • 2020
  • Introduction : This review aims to introduce an intention-to-treat analysis(ITT) method and demonstrate the importance of rigorous utilization of this method to researchers in Korea. Discussion : ITT analysis includes all data as results in randomized control trials (RCT). Thereby the result of RCT is high validated to adapt in the real-world so that the result should be expected at clinical practice. Therefore, many RCT quality assessment tools include the question of the utilization of ITT analysis in individual trials. However, many researchers omit to report ITT, not utilize ITT or use ITT incorrectly. Conclusion : Through this review, more Korean researchers may understand and utilize ITT which is expected to enhance the quality of RCT papers.

Chuna Manual Therapy for Adhesive Capsulitis : A Systematic Review and Meta Analysis (유착성 관절낭염에 대한 추나요법의 효과: 체계적 문헌고찰과 메타분석)

  • Cho, Ju-Chan;Heo, In;Park, Sun-Young;Shin, Byung-Cheul
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.14 no.2
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    • pp.1-14
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    • 2019
  • Objectives : To evaluate the effectiveness of Chuna Manual Therapy for adhesive capsulitis by a systematic review manner. Methods : Five foreign electronic databases (Pubmed, Ovid-medline, Embase, Cochrane library, Chinese Academic Journals (CAJ)) and two Korean medical electronic databases (Oriental Medicine Advanced Searching Integrated System (OASIS) and Research Information Sharing Service (RISS)) were searched to find all randomized controlled trials (RCTs) using Chuna Manual Therapy as a treatment for adhesive capsulitis. The methodological quality of each RCT was assessed using the Cochrane risk of bias tool. Results : Twenty-one RCTs met our inclusion criteria. The meta-analysis showed positive results on the use of Chuna Manual Therapy combined with acupuncture or exercise therapy in terms of the efficacy rate and pain using the Visual Analogue Scale (VAS), compared to acupuncture or exercise alone [SMD-1.81 (95% CI & -2.54, -1.08), P<0.001, RR 1.19 (95% CI 1.14, 1.23), P<0.001)]. Positive results in terms of efficacy rate were also obtained comparing Chuna Manual Therapy to acupuncture alone [RR 1.10 (95% CI 1.02, 1.18), P=0.01]. Conclusions : Our systematic review found favorable results on the effectiveness of Chuna Manual Therapy for pain and efficacy rate of adhesive capsulitis. However, evidence was limited due to the lack of well-designed RCTs. More qualified clinical trials are needed to obtain stronger evidence.

Placebo Control and Placebo Effect in Acupuncture Medicine (침구의학에서 플라시보 대조군과 플라시보 효과)

  • Chae, Younbyoung;Enck, Paul
    • Korean Journal of Acupuncture
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    • v.35 no.2
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    • pp.47-55
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    • 2018
  • Objectives: Clinical improvements can be observed following placebo administrations in clinical trials. Randomized controlled trials have been conducted to disentangle the specific effects of therapeutic interventions over the past decade. In acupuncture trials, non-penetrating placebo needles offer the opportunity to determine the specific effects of needling. Methods: The present review provides an overview of the concept of the placebo effect and the characteristics of the placebo needles. Results: Placebo control can contribute to minimize for bias and the contextual and psychological components of therapeutic interventions. Placebo control should meet two criteria: blinding efficacy (indistinguishable from active treatment) and physiological inertness. In the case of acupuncture, however, it is difficult to meet both criteria simultaneously. The dilemma of placebo needles suggests that placebo needles do not constitute proper control in acupuncture research. Considering the characteristics of placebo needles, patients are more likely to perceive placebo needles as active treatment in acupuncture trials compared to placebo pills in pharmaceutical trials. Placebo response might be observed more frequently to placebo needles than to placebo pills. When acupuncture treatments are utilized in clinical use, placebo effects can be enhanced by exploiting patients' expectations in the contextual or environmental cues that surround medical intervention. Conclusions: We have to consider these unique characteristics of placebo needles in order to avoid drawing premature conclusions that acupuncture itself is just a placebo.

근거 중심 치의학 - 2. 근거 수준과 비판적 평가

  • Hong, Soon-Min
    • The Journal of the Korean dental association
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    • v.45 no.3 s.454
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    • pp.169-181
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    • 2007
  • In this second part of series report on evidence-based dentistry, the level of evidence and the methods for critical appraisal are discussed. The epidemiologic studies, namely clinical studies have some bias per se, and the degree of bias is somewhat predetermined by the study design. The level of evidence can be defined as the reliability of the clinical study and it is dependent on the degree of bias. Thus, it is important to determine the type of the study and to understand its structure before critically appraising them. Systematic reviews of primary studies, randomized controlled trials, nonrandomized clinical trials, cohort studies, case-control studies, and case reports / series constitute the clinical studies and the level of evidence follows the order of the studies listed above. Critical appraisal is the most important procedure in evidence-based dentistry. It is done to determine the credibility of research papers and their usefulness in the clinician s own practice. Critical appraisal is consisted of multiple questions that are helpful for evaluating validity and usefulness of the studies concerning therapy, diagnosis, prognosis, and causation.

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