• 제목/요약/키워드: Randomized controlled trials

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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
    • 대한한의학회지
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    • 제42권4호
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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.

Effects of Nature-Based Programs for Workers in Korea: A Systematic Review

  • Shin, Jong-Yeon;Shin, Won-Sop
    • 인간식물환경학회지
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    • 제23권2호
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    • pp.125-138
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    • 2020
  • The aim of this study was to review previous literature to determine the effects of nature-based program for workers. This systematic review was conducted in accordance with National Evidence-based Healthcare Collaborating Agency's guidance for undertaking systematic reviews for intervention. Literature search was performed using National Assembly Digital Library, Korean Studies Information Service System, and Korea Education & Research Information Service for literature published until March 2019. The participants were full-time workers, and intervention of nature-based programs was conducted in the outdoor, indoor, and indirect nature contact exposures, with comparators in the control group who did not receive the treatment. The results showed that the programs were effective in physical, psychological, and social health. The methodological quality of randomized controlled trials (RCT) was assessed using the Cochrane Risk of Bias(RoB) tool, while non-randomized controlled trials (N-RCT) were assessed using the Cochrane Risk of bias assessment tool for non-randomized studuies (RoBANS). A total of 16 studies were selected for assessment: two RCTs, 10 N-RCTs, and four one-group pretest-posttest designs. Most interventions were provided at the workplace and in the community. There were many kinds of nature-based interventions, and forest therapy and horticultural therapy programs were most common. Various interventions for workers effectively improved job stress, depression, serum cortisol and stress-response. However, the included studies lacked methodological rigor. Future research is needed to evaluate the long-term effectiveness of nature-based programs for workers using rigorous research designs.

암(癌)에 대한 침치료(鍼治療)의 연구(硏究) 동향(動向) (Study Trends on Acupuncture Treatment of Cancer)

  • 남동우;이재동;최도영
    • Journal of Acupuncture Research
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    • 제24권1호
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    • pp.209-216
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    • 2007
  • Objectives : To review and summarize the existing evidence on acupuncture treatment for cancer and cancer related symptoms. Methods: Literature searches were made through domestic and international databases. Data were extracted according to pre-defined criteria. The methodological quality was assessed using the Modified Jadad scale. Results: Seven studies were included. Two of the studies were high in methodological quality. One study concerning acupuncture treatment for cancerous dyspnea reported insignificant differences between the treatment group and placebo group. The other study concerning auricular acupuncture for cancer related pain showed significant pain relief compared with the control group. All the other studies were non-blinded or uncontrolled trials. Conclusion : The hypothesis that acupuncture may be effective for the treatment of cancer is not supported by the data in recent clinical trials. More accurately designed randomized control trials (RCT) are needed.

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산후 우울증의 한방 치료에 대한 무작위대조군연구 중심의 연구 동향 (Research Trends of Randomized Controlled Trials on Traditional Korean Medicine Treatment for Postpartum Depression)

  • 최석영;박경선;황덕상;이진무;이창훈;장준복
    • 대한한방부인과학회지
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    • 제31권3호
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    • pp.1-19
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    • 2018
  • Objectives: The purpose of this study was to analyze the research trends of randomized controlled trials on Traditional Korean Medicine treatment for postpartum depression in women. Methods: In order to investigate the effect of Traditional Korean Medicine on postpartum depression, randomized controlled trials on postpartum depression were searched using domestic and foreign search engines and a total of 11 studies were selected. Results: 1. There were 6 studies comparing Traditional Korean Medicine treatment methods with western medicine: fluoxetine hydrochloride (4), paroxetine (1), and mirazapine (1). 2. There were 5 studies comparing methods of Traditional Korean Medicine or sham acupuncture: 1 study evaluated the efficacy of Balance Acupuncture and Guipi Decoction, 1 study compared the effects of conventional acupuncture and Dispersing Liver Regulating Spirit Acupuncture, 1 study evaluated the efficacy of acupuncture and Heat-sensitive Moxibustion, 1 study compared the effects of conventional acupuncture and Musical Electroacupuncture, and 1 study compared the effects of conventional acupuncture and non-invasive sham acupuncture. 3. Postpartum depression is closely related to Heart and Liver, and there were many studies using acupoints Taichong (LR3) and Shenmen (HE7). Cranial acupoints Baihui (DU20) and Yintang (EX-HN3) were also frequently used. 4. Xiaoyaosan and Guipi Decoction were used in herbal medicine treatment for postpartum depression. 5. Novel treatment methods such as Heat-sensitive Moxibustion and Musical Electroacupuncture were used to treat postpartum depression. Conclusion: Traditional Korean Medicine treatment is a good treatment option for postpartum depression. Further systematic studies are needed to establish the basis for Traditional Korean Medicine treatment for postpartum depression.

침 임상연구에 사용된 거짓침의 분석 (Review and Analysis of Sham Acupuncture in Acupuncture Clinical Trials)

  • 장진영;김소정;김남식;남상수;김용석
    • Journal of Acupuncture Research
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    • 제28권5호
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    • pp.29-38
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    • 2011
  • Objectives : Recent well-designed randomized controlled trials(RCTs) and their meta-analysis have been published on the efficacy of acupuncture in different condition. In most of them, real acupuncture is compared with sham acupuncture including invasive and non-invasive sham methods. But it is not clear how active sham methods are. These results tend to lead the conclusion that acupuncture has no more effective than sham acupuncture. In order to investigate that sham acupuncture is appropriate as a control, we reviewed several acupuncture trials using different sham acupuncture as a control. Methods : We searched Cochrane researches of acupuncture, reviewed and analyzed 25 RCTs in 42 Cochrane reviews. And especially we compared the effect of acupuncture according to the type of sham acupuncture. Results : Invasive sham acupunctures are used in 12 RCTs and non-invasive types are used in the rest. The majority of studies(19 RCTs) fail to show effects beyond a sham acupuncture. Streitberger's sham needle is a validated sham acupuncture of non-invasive type that was used in 8 trials and also no significant group differences are shown except one trial. Conclusions : Acupuncture is a complex intervention. Clinical trials of acupuncture need to be reexamined and redesigned to remove several bias. Especially, sham acupuncture as a control might be investigated for physiological effects as well as validation test including patient-blinding and de qi sensation. Other research need to be investigated and developed for acupuncture trials.

족저근막염의 침치료에 대한 국내외 연구동향 분석 (Acupuncture Treatment of Plantar Fasciitis: A Literature Review)

  • 고낙용;김창곤;고연석;이정한
    • 한방재활의학과학회지
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    • 제25권2호
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    • pp.97-110
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    • 2015
  • Objectives Plantar fasciitis is one of the most common causes of heel pain. Plantar fasciitis can be managed with acupuncture, but the evidence for its effectiveness is uncertain. The aim of this review was to assess the effectiveness of acupuncture for plantar fasciitis. Methods I searched specific Korean and foreign electronic databases (KCI, RISS, NDSL, OASIS, KTKP, National Assembly Library, KMbase, PubMed, The Cochrane Library and China National Knowledge Infrastructure). The key search terms were 'heel pain', 'plantar fasciitis' and 'acupuncture'. Twenty-seven trials were included; eleven case reports, fourteen randomized controlled trials (RCTs) and two non-randomized controlled trials (NRCTs). Results Twenty-seven studies reported that acupuncture treatment reduced plantar fasciitis pain. However, the evidence provided by the case reports was regarded as weak because the methodological quality was poor, and the placebo effect of acupuncture was not accounted for in the RCTs and NRCTs. Overall, the methodological quality of the RCTs and NRCTs was weak. Conclusions There is some evidence for the effectiveness of acupuncture for plantar fasciitis. However, in order to reinforce the evidence for acupuncture's effectiveness, additional placebo-controlled trials with well-designed methodologies are required.

Consolidated Standards of Reporting Trials의 소개: 무작위 대조군 연구의 보고 지침 (Consolidated Standards of Reporting Trials: The Reporting Guideline for Randomized Controlled Trials)

  • 정회인;김희은
    • 치위생과학회지
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    • 제14권3호
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    • pp.269-275
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    • 2014
  • 세계 유수의 의학관련 연구 저널의 편집자들은 제출된 원고의 질을 관리하기 위하여 연구진행의 가이드라인 역할을 할 수 있는 보고 지침을 개발하여 평가에 적용하고 있다. 따라서 본 연구는 RCTs를 위한 보고 지침인 CONSORT의 2010년 개정판 내용과 특징을 소개함으로써 치위생 연구의 계획 및 수행에 도움을 주고 더 나아가 EBP의 활성화에 기여하고자 하였다. CONSORT는 시험 보고의 질을 향상시킬 수 있도록 논문 저자들에게 보고 지침을 제공한다. 이 보고 지침은 RCTs 보고서에 반드시 포함되어야 할 필수 항목인 25개의 체크 리스트와 연구 과정의 도식화를 위한 순서도를 제시한다. 저자들은 연구 설계 시점부터 CONSORT의 각 항목을 참고함으로써 연구의 질을 향상시킬 수 있다. 따라서 우리 치위생계에서도 이러한 보고지침을 준수함으로써 치위생 연구의 타당성을 높이고, 이러한 연구 결과를 질 높은 근거 기반적 치위생 실무로 접목시켜 발전시킬 수 있을 것으로 생각된다.

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

  • 김서연;원지윤;박히준;이향숙
    • 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.

족관절 염좌의 봉독 약침 치료에 대한 체계적 문헌 고찰 (A Systematic Review of Bee Venom Acupuncture for Ankle Sprain)

  • 구지향;이옥진;조동찬;이은정
    • 한방재활의학과학회지
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    • 제28권3호
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    • pp.55-66
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    • 2018
  • Objectives To evaluate the evidence supporting the effectiveness of bee venom acupuncture for ankle sprain. Methods We conducted search across 11 electronic databases (Pubmed, EMBASE, Cochrane CENTRAL [CENTRAL], KoreaMed, Kmbase, Koreanstudies Information Service System [KISS], National Digital Science Library [NDSL], Korea Institute of Science and Technology Information [KISTI], China National Knowledge Infrastructure [CNKI], Wanfang and Chinese Scientific Journals Database [VIP] database) to find clinical trials that used bee venom acupuncture as treatment for ankle sprain. The methodological quality of randomized controlled clinical trials (RCTs) were assessed using the Cochrane Risk of Bias (RoB) tool, while non-randomized controlled clinical trials (NRCTs) were assessed using the Cochrane Risk of Bias Assessment tool for Non-randomized Study (RoBANS) tool. Results Four RCTs and one nRCT met our inclusion criteria. Almost studies showed that bee venom acupuncture has positive effect on ankle sprain. 4 studies of same intervention and control included in the meta-analysis. When comparing bee venom acupuncture and acupuncture with acupuncture, the effect size of standardized mean difference (SMD) was -0.19 (95% confidence interval [CI]: -1.95~1.56, Z=0.55, p=0.83). And when comparing bee venom acupuncture with acupuncture, the effect size of SMD was -0.17 (95% CI: -0.65~0.31, Z=0.71, p=0.48). Conclusions Although our systematic review found encouraging but limited evidence of bee venom acupuncture for ankle sprain, most of the studies included in the analysis were evaluated as methodologically high risk of bias. From now on further well-designed RCTs should be encouraged.