• 제목/요약/키워드: Randomized controlled trials

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항암화학요법 유발 백혈구감소증에 대한 한약치료의 효과 : 체계적 고찰 및 메타분석(2007-2017) (Clinical Effectiveness of Traditional Herbal Medicine in the Treatment of Chemotherapy-induced Leukopenia: A Systematic Review and Meta-analysis of Randomized Clinical Trials)

  • 김민서;정유진;홍상훈
    • 대한한방내과학회지
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    • 제39권4호
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    • pp.520-549
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    • 2018
  • Objectives: We performed a systematic review and meta-analysis to explore the recent clinical research trends regarding the effects of traditional herbal medicine (THM) on chemotherapy-induced leukopenia. Methods: Randomized controlled trials that verified effects of herbal medicine treating chemotherapy induced leukopenia were included in the study. A literature search was performed in the English, Chinese, and Korean databases for papers published from January 1, 2007, to September 1, 2017. The selected literature was assessed by Cochrane's Risk of Bias (RoB). Results: Forty-two of 232 randomized controlled trials met the inclusion criteria. The most commonly used herbal prescriptions called '升白湯 (shengbai decoction)' which means elevating the numbers of White blood cells (WBCs). And the mostly included herbs such as Astragali Radix, Angelicae Gigantis Radix, Atractylodis Rhizoma Alba, Codonopsis Pilosulae, Glycyrrhizae Radix, Ligustri Lucidi Fructus are commonly used to elevate qi, blood and yin. The count of WBC in peripheral blood, the level of leukopenia presented in WHO (World Health Organization), and clinical symptoms were used to evaluate the treatments. The effective rate was 68.6-98.18% and the effectiveness was significantly higher in the intervention group than in the control group in 38 articles (p<0.05). No serious adverse events were reported. Only five articles (5/42, 11.9%) were rated as having adequate methodological quality with a low level of bias. Conclusion: Some traditional herbal medicines may be effective as therapeutic treatments for chemotherapy-induced leukopenia, but the majority of reviewed studies were of poor quality. The present findings need to be confirmed by rigorously conducted high-quality trials, including pharmacokinetic studies, to confirm the absence of interactions between traditional herbal medicine agents and chemotherapy.

임상에서 흔히 접하는 외상성 손상에 대한 봉독약침요법의 체계적 문헌고찰 (Systematic Review of Bee Venom Therapy for Traumatic Injury)

  • 이재은;이치호;이은정;이정민;오민석
    • 한방재활의학과학회지
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    • 제26권3호
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    • pp.67-77
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    • 2016
  • Objectives To evaluate the evidence supporting the effectiveness of Bee Venom therapy for traumatic injury. Methods We conducted search across 3 electronic databases (Pubmed, CAJ and Oasis) to find clinical trials that used Bee Venom therapy as treatment for traumatic injury. The methodological quality of RCTs (Randomized controlled clinical trials) were assessed using the Cochrane Risk of Bias (RoB) tool, while NRCTs (Non-Randomized controlled clinical trials) were assessed using the Cochrane Risk of Bias Assessment tool for Non-randomized Study (RoBANS) tool. Results Among 87 articles that were searched, 10 RCTs and 19 NRCTs were finally selected. Among 19 selected studies, all studies showed that Bee Venom therapy has significant effect on traumatic injury. Conclusions Our systematic review found encouraging but limited evidence of Bee Venom therapy for traumatic injury. We recommend clinical trials which compare the effectiveness of Bee Venom therapy with other pharmacopuncture therapies to clarify the effectiveness of Bee Venom therapy from other pharmacopuncture therapies.

뇌졸중 후 중추성 통증 및 시상증후군에 대한 한약치료의 효과 : 체계적 고찰 및 메타분석 - 중의학 저널을 중심으로 (Clinical Effectiveness of Traditional Herbal Medicine in the Treatment of Central Post-Stroke Pain and Thalamic Syndrome: a Systemic Review and Meta-analysis of Randomized Clinical Trials Based on Traditional Chinese Medicine Journals)

  • 정유진;강은진;홍상훈
    • 대한한방내과학회지
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    • 제40권3호
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    • pp.295-311
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    • 2019
  • Objectives: This research aimed to investigate Chinese clinical studies on the treatment of central post-stroke pain (CPSP) and thalamic syndrome after stroke with traditional herbal medicine (THM). Methods: Randomized controlled trials verifying the effects of herbal medicine on treating CPSP and thalamic syndrome after stroke were included in the study. Electrical and hand search were conducted in the China National Knowledge Infrastructure (CNKI), National Discovery for Science Leaders (NDSL), Research Information Sharing Service (RISS), Oriental Medicine Advanced Searching Integrated System (Oasis) for CPSP and thalamic syndrome after stroke. A literature search was performed in the Chinese and Korean databases for papers published from January 1, 2010 to October 1, 2018. The selected literature was assessed by Cochrane's risk of bias. Results: Twelve reports on randomized controlled trials met the inclusion criteria from the 227 identified reports. Effective rate, comparison of visual analogy scale, present pain intensity, pain grading index, recurrence rate, follow-up, and a 36-item short form survey instrument were used to evaluate the treatments. The effective rate of the treatment group was significantly higher than that of the control group in all papers. Side effects occurred less frequently in the treatment group than in the western medicine control group. Conclusions: The treatment of CPSP and thalamic syndrome after stroke with THM was shown to be highly effective. Additional well-designed clinical trials are needed. This study can be used as a basis for further research on the treatment of CPSP and thalamic syndrome after stroke.

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

  • 김정헌
    • 재활치료과학
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    • 제9권2호
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    • pp.27-38
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    • 2020
  • 서론 : 본 연구는 무작위 대조군 실험(Randomized control trial: 이하 RCT) 연구에서 치료의향분석(Intention-to-treat analysis)의 올바른 활용에 대해서 고찰하고자 한다. 본론 : 치료의향분석은 RCT 연구에서 무작위 분배 이후에 모든 대상자의 데이터를 결과에 포함하는 분석방법이다. RCT 연구의 결과는 일반화에 있어서 매우 높은 타당성을 갖는다. 이런 측면에서 중도 탈락을 포함한 모든 대상자의 데이터를 결과 분석에 포함하여야 그 결과를 실제 임상에 적용했을 때 중재의 효과가 예측 가능하기 때문이다. 이런 이유로 RCT 연구에 대한 질평가 도구들은 치료의향분석 실시여부를 확인하고 있다. 그럼에도 많은 연구자들은 치료의향분석의 이해도가 낮아 잘못 활용하고 있거나 활용하지 않는 경우가 많다. 결론 : 본 고찰 연구를 통해 국내 많은 연구자들이 치료의향분석방법을 정확하게 이해하고 올바르게 활용하여 RCT 연구에 반영할 것을 기대한다.

한약을 이용한 chemotherapy-induced peripheral neuropathy (CIPN) 치료 관련 무작위 배정 임상 시험에 대한 고찰 (A review of herbal medicines for chemotherapy induced peripheral neuropathy)

  • 박봉기
    • 대한암한의학회지
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    • 제21권2호
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    • pp.51-61
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    • 2016
  • Background : Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect in cancer patients who were exposed to chemotherapy. CIPN impacts on the quality of life and could delay chemotherapy. The aim of this review was to assess the therapeutic effectiveness of herbal medicine in CIPN patients. Methods : Randomized controlled trials (RCTs) were included in this review. We searched MEDLINE, Cochrane database, EMBASE, CNKI, Wanfang and four Korean databases without restrictions on time or language. The risk of bias was assessed using the Cochrane risk of bias tool. Results : Eleven RCTs involving 706 patients met the inclusion criteria. Eleven different herbal medicines were examined in the included trials. Almost RCTs showed insufficiency in the reporting randomization method and allocation concealment. One trial used allocation concealment and a double-blinding method. Five studies reported that participants dropped out of RCTs and conducted an 'as-treated analysis'. One trials reported adverse effects of herbal medicine. In ten of the eleven trials, the use of herbal medicine had shown significant differences in clinical symptoms or nerve conduction velocity. Conclusions : The use of herbal medicines for CIPN showed significant improvements in the management of CIPN. However, conclusions cannot be drawn because of the generally low quality of methodology and low quantity of data for each single herbal medicine. Further rigorous trials are needed.

중풍 후 강직의 침구치료에 대한 계통적 연구 (A Systematic Review of Clinical Trials on Acupuncture on the Post-stroke Muscle Spasticity)

  • 서병관;백용현;박동석
    • Journal of Acupuncture Research
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    • 제27권6호
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    • pp.1-10
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    • 2010
  • Objectives : The aim of this systematic review was to assess the efficacy of acupuncture and its relevant modality on post-stroke muscle spasticity Methods : We included 7 randomized controlled trials(RCTs) and 1 crossover study on acupuncture on the post-stroke muscle spasticity. Articles searches were performed in various databases in October 2009. Eight studies from 38 articles met the inclusion criteria and were used to assess the quality of clinical trials by means of Jadad scale, STRICTA, CONSORT statement and cochrane-handbook for systematic reviews of interventions. Results : Electrical stimulation such as electroacupuncture and TENS on acupoints was used in five studies. Repeatition of electroacupuncture showed significant decrease of the post-stroke muscle spasticity and persistence of the effect. Only three studies were assessed high quality as the methodological assessment tool(Jadad scale) and none of the studies matched STRICTA recommendations. Conclusions : This systematic review shows that there is beneficial effects of electroacupuncture on the post-stroke muscle spasticity. Further study of large population with high methodological quality will be needed.

화장품 임상시험 프로토콜 개발을 위한 체계적 문헌 고찰 (A Systematic review for the development of cosmetic clinical trial protocol)

  • 조가원;황충연;홍석훈;김남권
    • 한방안이비인후피부과학회지
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    • 제26권1호
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    • pp.104-117
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    • 2013
  • Objective : The aim of this review is to development of clinical trial protocol for against cosmetics as a treatment of dry skin condition. Methods : We searched the literature from 2002 through April 2012 using 5 databases. We included randomized controlled trials(RCTs) in which human participants with dry skin condition as chief complaint were treated with cosmetics. The methodological quality of all RCTs was using the Jadad score. Results : Nine RCTs met the inclusion criteria. Cosmetic types included cream (7 trials), lotion (1 trial), oil (1 trial) and body wash (1 trial). The methodological quality of the trials was generally low (Jadad score: mean 1.78; range, 1 to 3). Conclusions : The evidence for cosmetics as an effective treatment for dry skin condition(xerosis) is currently scarce and of poor quality, and is therefore inconclusive. More rigorous studies are warranted.

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.

A Systematic Review of Acupuncture for Tennis Elbow

  • Oh, Ji Hye;Lee, Yun Kyu;Kim, Jae Soo;Lee, Hyun Jong;Lim, Sung Chul
    • Journal of Acupuncture Research
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    • 제36권4호
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    • pp.211-219
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    • 2019
  • This review analyzed randomized controlled trials and case reports to identify the effectiveness, and level of evidence showing that acupuncture treatment aids the recovery of patients with tennis elbow. A literature search was performed between $1^{st}$ to $10^{th}$ September, 2019 which used PubMed, the Cochrane library, the Korean databases Oriental Medicine Advanced Searching Integrated System, Korean Studies Information Service System to retrieve Korean and international studies. Amongst the 243 articles retrieved there were 9 randomized controlled trials and 18 case reports. The level of evidence for the recovery of patients with tennis elbow, for efficacy and safety of acupuncture was low. It was observed that the studies had a high risk of bias, missing acupuncture details, multiple combinations of treatments rather than a single treatment, insufficient indicators of assessment, and lacked robustness. Compliance with international standards such as using consolidated standards of reporting trials, will improve the quality of evidence.

수술 후 환자의 수면 개선에 대한 한의치료 임상연구 동향 -한약, 침, 뜸 치료를 중심으로- (Research Trends of Korean Medicine Treatments for Postoperative Sleep Improvement: Focusing on Herbal Medicine, Acupuncture, and Moxibustion)

  • 조준희;김보경;임정화
    • 동의신경정신과학회지
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    • 제33권4호
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    • pp.425-451
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    • 2022
  • Objectives: To review trends of clinical trials on Korean medicine treatments for postoperative sleep improvement. Methods: We searched randomized controlled trials (RCTs) on Korean medicine treatments for postoperative sleep improvement from ten domestic and foreign databases. Sample sizes, diseases, types of operation, diagnosis tools, pattern identification, interventions, outcome measurements, and main results of included studies were extracted and analyzed. Results: A total of 20 RCTs were selected. Most studies were published in China. The most common target disease was cancer, followed by cardiovascular disease. Most studies lacked detailed description regarding participants such as onset, duration of sleep disturbance, and preoperative sleep issues. Herbal medicine was the most frequently used in 12 studies. The most commonly used prescription was Suanzaoren decoction. The effectiveness of Korean medicine treatment on improving postoperative sleep was found to be significant in most studies. Conclusions: Korean medicine treatments might be effective in postoperative sleep improvement. However, the quality of included studies was low. Therefore, further well-designed research studies are needed to provide high quality clinical evidence on Korean medicine treatments for postoperative sleep improvement.