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

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The effectiveness and safety of cupping therapy for stroke survivors: A systematic review and meta-analysis of randomized controlled trials

  • Kim, Mikyung;Han, Chang-ho
    • The Journal of Korean Medicine
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    • v.42 no.4
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    • pp.75-101
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    • 2021
  • Objectives: ncluding stroke. The aim of this study was to systematically review the clinical evidence of CT for stroke. Methods: To identify randomized controlled trials (RCTs) reporting the effectiveness and/or safety of CT, seven databases including PubMed, EMBASE, and Cochrane Library were searched for articles published from January 2000 to February 2021 without language restrictions. Meta-analysis was performed using Review Manager 5.4 software and the results were presented as mean difference (MD) or standard mean difference (SMD) for continuous variables and odds ratio (OR) for diverse variables with 95% confidence intervals (CIs). Assessment of the methodological quality of the eligible trials was conducted using the Cochrane Collaboration tool for risk of bias in RCTs. Results: Twenty-two RCTs with 1653 participants were included in the final analysis. CT provided additional benefit in improving upper limb motor function (Fugl-Meyer assessment for upper limb motor function, MD 6.91, 95% CI 4.64 to 1.67, P<0.00001) and spasticity (response rate, OR 3.28, 95% CI 1.31 to 8.22, P=0.08) in stroke survivors receiving conventional medical treatment. These findings were supported with a moderate level of evidence. CT did not significantly increase the occurrence of adverse events. Conclusions: This study demonstrated the potential of CT to be beneficial in managing a variety of complications in stroke survivors. However, to compensate for the shortcomings of the existing evidence, rigorously designed large-scale RCTs are warranted in the future.

Review of Recent Clinical Trials for Depression in Traditional Chinese Medicine-Based on Randomized Controlled Trials and Systematic Reviews- (우울증 치료의 중의학 최신 임상연구 동향-무작위 대조군 임상연구와 체계적 문헌 고찰을 중심으로-)

  • Woo, Jeong A;Nam, Yu Jin;Park, Yoon Jin;Kwon, Young Kyu
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.29 no.6
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    • pp.458-466
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    • 2015
  • The purpose of this study was to review the research on treating depression in Traditional Chinese Medicine(TCM) over the last 5 years to set the foundation for further studies. We searched for and analyzed articles about depression in CNKI(China National Knowledge Infrastructure) from January 2010 to December 2014. The results were as follows : The most frequently used diagnostic criteria was CCMD-3(The Chinese Classification of Mental Disorders-3), and the most used evaluation criteria was HAMD(Hamilton Depression Rating Scale). Prescription of decoction of medical herbs was most frequently used as a therapeutic method. Acupuncture, traditional Chinese psychotherapy, and music therapy were also used for some studies. The most frequent TCM Syndrome Differentiation Type was stagnation of liver-QI. For decoction of Chinese herbs, Soyo-san(Xiaoyao-san) and Sihosogan-san(Chaihushugan-san) were most often prescribed, and Bupleuri Radix, Paeoniae Radix Alba, Curcumae Radix, Poria cocos wolf, Angelicae Gigantis Radix, Atractylodis Rhizoma Alba were mainly used for medical herbs. BaekHoi(GV20) and Yindang(Ex-HN3) were often used as acupuncture sites. Post-Stroke Depression was the most common case of intercurrent or secondary depression. According to the Jadad Quality Assessment Scale, the quality of the reports was not high as most of the reports had a score of 3 or below. Most systematic reviews on depression were conducted by Chinese researchers. The problem with Clinical research on depression, according to those reviews, was that there were no standardized criteria for the diagnosis and treatment and the trials were usually not randomized nor controlled. We found out there are various clinical methods for treating depression in TCM, and hope that this research could provide the preliminary data for designing and conducting clinical trials for depression.

The Trends in Clinical Trials about Effects of Acupuncture on Anxiety, Depression and Mental Stress - In Medline, Pubmedcentral & Oriental Medicine Journal since 2004 - (침치료가 불안, 우울 및 정신적 스트레스에 미치는 효과에 대한 임상시험 연구 경향 - 2004년 이후의 Medline, Pubmedcentral 논문 검색과 국내 한의학 학술지 중심으로 -)

  • Kang, Hee-Chul;Lee, Seung-Gi
    • Journal of Oriental Neuropsychiatry
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    • v.20 no.4
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    • pp.137-148
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    • 2009
  • Objectives : The purpose of this study is to review the recent trends in the clinical trial studies that have been published since 2004. Methods : We reviewed the Medline & Pubmedcentral databases by using searching word of "acupuncture". Then 20 articles were selected within total 803 articles. In oriental medicine journals in Korea, we investigated 6 journals represented Korean Oriental medicine and chose 13 articles. Results & Conclusions : 1. We found 33 articles in journals. 2. The patterns of study were as follows: Randomized Controlled Trials(18), Single case series clinical study(9), Case-Control clinical study(4), Randomized crossover Trial(1) and Prospective Clinical analysis(1). 3. The fields of study were as follows: Combined anxiety, depression & other psychiatic symptoms(18), Stress & heart rate variablity(5), The single study of anxiety(5), The single study of depression(3), Stress & pupil variablity(1), Stress and heart rate & pupil variablity(1). 4. The methods of acupuncture were as follows: Acupuncture on points of 14 meridians(24), Auricular acupuncture(3), Electro acupuncture(2) and Both Auricular & Electro acupuncture(1). 5. Stomach meridian(足陽明胃經) and ST36(足三里) were used mostly.

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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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    • v.31 no.5
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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.

Review of Clinical Acupuncture Research Protocols on Cancer in the USA (미국의 암 관련 침 임상 연구 프로토콜 분석)

  • Dobs, Adrian S;Lee, Sang-Hoon
    • The Journal of Korean Medicine
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    • v.28 no.3 s.71
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    • pp.116-125
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    • 2007
  • Objective : To overview the protocols of clinical acupuncture research on cancer in the USA. Methods : Using 'acupuncture' and 'cancer' as keyword search terms in Clinical Trials. gov, 28 clinical studies were found. Three studies by non-American institutions were excluded and 25 studies were analyzed. Analytic parameters were cancer condition, primary outcome, research institution, study design, and acupuncture intervention. Results : Breast cancer was the most frequent single condition in the searched protocols. Pain and quality of life were the primary outcomes in many studies. Memorial Sloan-Kettering Cancer Centerin New York has performed the largest number of acupuncture cancer studies. The majority of studies were randomized controlled trials with active controls or placebo/sham controls. Total enrollment varied between the range of 10 and 700 subjects and ages of these subjects were at least above 18 years old (except one protocol). Most protocols had strict exclusion criteria for acupuncture needling such as bleeding disorders, infection, heart disorder, and central nervous system disorder. Conclusions : Clinical acupuncture studies for cancer patients have focused on pain, quality of life, and side effects induced by anti-cancer therapies. Re-evaluation and cautions for strict exclusion criteria in foreign countries are required to perform multi-national acupuncture trials.

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Success rate of nitrous oxide-oxygen procedural sedation in dental patients: systematic review and meta-analysis

  • Rossit, Marco;Gil-Manich, Victor;Ribera-Uribe, Jose Manuel
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.21 no.6
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    • pp.527-545
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    • 2021
  • The aim of this systematic review was to determine the success rate of nitrous oxide-oxygen procedural sedation (NOIS) in dentistry. A systematic digital search was conducted for publications or reports of randomized controlled trials evaluating the clinical performance of NOIS. Abstracts of research papers were screened for suitability, and full-text articles were obtained for those who met the inclusion and exclusion criteria accordingly. The quality of the studies was assessed using the revised Cochrane risk-of-bias tool (RoB 2). A total of 19 articles (eight randomized clinical trials with parallel intervention groups and 11 crossover trials), published between May 1988 and August 2019, were finally selected for this review. The studies followed 1293 patients reporting NOIS success rates, with a cumulative mean value of 94.9% (95% CI: 88.8-98.9%). Thirteen trials were conducted on pediatric populations (1098 patients), and the remaining six were conducted on adults (195 patients), with cumulative efficacy rates of 91.9% (95% CI: 82.5-98.1%) and 99.9% (95% CI: 97.7-100.0%), respectively. The difference was statistically significant (P = 0.002). Completion of treatment and Section IV of the Houpt scale were the most used efficacy criteria. Within the limitations of this systematic review, the present study provides important information on the efficacy rate of NOIS. However, further well-designed and well-documented clinical trials are required and there is a need to develop guidelines for standardization of criteria and definition of success in procedural sedation. Currently, completion of treatment is the most used parameter in clinical practice, though many others also do exist at the same time. To maximize NOIS efficacy, clinicians should strictly consider appropriate indications for the procedure.

An Analysis of Clinical Trials for Understanding and Application of Pragmatic Clinical Trial (실용적 임상연구에 대한 이해와 적용을 위한 연구 사례 분석)

  • Yun, Young-Ju;Kang, Kyung-Won;Choi, Sun-Mi
    • Journal of Acupuncture Research
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    • v.26 no.5
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    • pp.105-116
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    • 2009
  • The use of acupuncutre has been increased worldwide, and large number of researches on acupuncture with improved quality has been conducted. Nevertheless, results of acupuncture treatment in those research tend to show mixed results, while many patients continuously seek acupuncture treatment as an adjuvant or alternatives for their health. Researchers and clinicians relevant to acupuncture are faced at this problematic discrepancy between the results of acupuncture in clinical trial including an randomized controlled trial and those of day-to-day clinical practice. The methodology of pragmatic clinical trial seems to be one of the promising research tools administering this problem especially in the area of complementary alternative medicine and traditional Korean medicine. In this study we first reviewed articles on the pragmatic clinical trial, summarized the essential concepts of 'explanatory' clinical trial 'pragmatic' clinical trial and then presented recent recommendations and arguments on this issue. We also analyzed and compared two similar pragmatic clinical trial protocols to show the readers the complexity of research designing. We hope more researchers in traditional Korean medicine will be interested in the methodology of pragmatic clinical trials and this study will serve to produce various high-quality clinical trials.

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Systematic Review of Randomized Controlled Trials on Herbal Medicine for Treatment of Human Obesity (비만 치료 한약의 무작위 대조임상시험에 대한 체계적 분석)

  • Park, Jung-Hyun;Nam, Jong-Kyung;Kwon, Dong-Hyun;Kim, Ho-Jun;Lee, Myeong-Jong
    • Journal of Korean Medicine Rehabilitation
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    • v.19 no.3
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    • pp.33-46
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    • 2009
  • Objectives : The objective of the study was to summarize randomized clinical trials(RCTs) that have assessed the effectiveness of herbal medicine on treatment of obesity and to propose better process of study. Methods : NLM Medline(pubmed), EMBASE, the Cochrane library, Science Direct, EBSCO, 4 Korean medical databases were systematically searched and 4 Korean medical journals were manually searched for clinical trials investigating the efficacy of herbal medicines on treatment of overweight or obese people from 1998 to 2008. The methodological quality was assessed using a Jadad score and validity was assessed using Oxford Pain Validity Scale(OPVS). Results : 14 RCTs met all the inclusion criteria. The methodological and ethical quality of the trials was generally low. The mean score by Jadad was 2.6 and the mean score of validity was 11.2. Complex herbal medicine was used in 8 RCTs and single herbal medicine was used in 6 RCTs. Except 1 RCT, the other RCTs reported positive effects of herbal medicine on treatment of obesity. Herbal medicines didn't seem to affect toxicity. In general adverse events relevant with the therapy were minor, but more than half of RCTs did not report about the safety or adverse events of herbal medicine, questioning their reliability. Conclusions : Although most RCTs concluded the efficacy and safety of herbal medicines on treatment of obesity, the quality of trials was low in general. Further rigorous clinical trials using complex herbal medicine should be performed.

Pros and Cons of Various Research Designs in Clinical Psychiatry (정신과 연구에서 다양한 임상연구방법의 장단점)

  • Ha, Ra Yeon;Cho, Hyun-Sang
    • Korean Journal of Biological Psychiatry
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    • v.19 no.4
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    • pp.159-163
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    • 2012
  • An appropriate research design for hypotheses and purposes leads to a good quality of research results. In this review article, we summarized the types of research methods and described the characteristics of clinical trials. Research designs are categorized into observational studies and experimental ones, depending on data collecting methods. In an observational study, there are cross-sectional, cohort and case-control studies. Parallel groups design and crossover trial studies are representative designs in a randomized controlled trial study, a kind of experimental study. Clinical researchers should understand the characteristics of clinical research designs including advantages and disadvantages and choose the suitable design according to their study purposes and the nature of collected data or subjects.

Chuna Manual Therapy for Postpartum Low Back Pain: Systematic Review (출산 후 요통에 대한 추나요법의 효과: 체계적 문헌고찰)

  • Cho, Ju-chan;Park, In-hwa;Hwang, Man-Suk;Heo, In
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.16 no.2
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    • pp.1-8
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    • 2021
  • Objectives This study aimed to evaluate the effect of chuna manual therapy (CMT) for postpartum low back pain using a systematic review. Methods We performed a literature search using 12 electronic databases up to the end of September 2021. We included randomized controlled trials (RCTs) that evaluated the effect of CMT in the treatment of postpartum low back pain. The risk of bias was evaluated using the Cochrane risk-of-bias tool. Results Four randomized controlled trials were reported statistically significant effect in pain VAS, ODI and JOA of chuna manual therapy compared with moxibution, electro acupuncture, hyperthermia or usual care. As a result of assessing the risk of bias tool, most of the contents of the evaluation items were not identified, so it was evaluated as an uncertain risk. Conclusions CMT may be effective in treating postpartum low back pain. However, evidence was limited due to the small sample size, lack of well-designed RCTs and regional bias. Further well-designed studies are required to obtain stronger evidence.