• 제목/요약/키워드: randomized controlled trial(RCT)

검색결과 138건 처리시간 0.035초

만성 어깨 통증의 한약 추출 외용 젤 치료에 대한 임상연구 (A Randomized Controlled Clinical Trial of Topical Herbal Gel Treatment for Chronic Shoulder Pain)

  • 조수정;최영두;장진택;김갑성;이승덕
    • Journal of Acupuncture Research
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    • 제31권4호
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    • pp.1-9
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    • 2014
  • Objectives : The aim of this study is to evaluate the efficacy of a topical herbal gel application for the treatment of chronic shoulder pain. Methods : We compared the effects of Dapureo gel, which contains several herbal medicines known to improve shoulder pain, with those of placebo gel by double-blind method. 30 participants were randomized - 15 were assigned to treatment group and the other 15 were assigned to control group. Either Dapureo gel(treatment group) or placebo gel(control group) was applied topically by themselves, once a day for 2 weeks. Primary outcome was daily visual analogue scale(VAS) changes for shoulder pain which was self-reported for 2 weeks. Secondary outcome was the difference in the total shoulder pain and disability index(SPADI) which was measured at a baseline and 2 weeks after the treatment. Results : Primary outcome: Subjects of treatment group showed statistically significant improvement in VAS compared to control subjects continuously from the second day(p <0.05) to the fifteenth day(p <0.001). The treatment group showed 31% of pain reduction on the fifteenth day, while the control group showed only 7%. Secondary outcome: In terms of SPADI changes, the treatment group showed improvement compared to the control group(p <0.01). Conclusions : These results suggest that the topical herbal gel treatment used in this study is effective in improving chronic shoulder pain.

방기황기탕의 유전자 다형성에 따른 비만 치료 효과 : 무작위 배정, 이중 맹검, 위약-대조군 임상시험 (Impact of GNB3, ADRB3, UCP2, and PPAR${\gamma}$-Pro12Ala polymorphisms on Boiogito response in obese subjects : A randomized, double-blind, placebo-controlled trial)

  • 박정현;;임지연;김호준
    • 한방비만학회지
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    • 제12권2호
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    • pp.28-43
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    • 2012
  • Objectives: The aim of the study was to investigate the efficacy of Boiogito for obesity. We examined the efficacy of Boiogito for obese patients and we expected the reaction of Boiogito would vary according to the single nucleotide polymorphism(SNPs). Methods: 111 subjects(body mass index${\geq}25m/kg^2$) were recruited and randomized to receive Boiogito(n=55) or Placebo(n=56) for 8weeks. Anthropometric factors, serum lipid profile, glucose, blood pressure(BP), pulse rate, resting metabolic rate and Korean version of obesity-related quality of life(KOQOL) scale measured at baseline and 8weeks. SNPs(${\beta}3$-adrenergic receptor(ADRB3), G protein ${\beta}3$(GNB3), peroxisome proliferator activated receptor gamma 2 gene(PPAR-${\gamma}2$), uncoupling protein(UCP2)) were conducted at baseline. Adverse reactions and safety outcome variables were also checked during trials. Results: Both groups showed significant improvement on obesity after treatment. Boiogito group decreased triglyceride than did control group and improved KOQOL. Boiogito showed a significant higher efficacy in C/T and T/T genotype of GNB3 gene / in Trp64 and Arg64 genotype of ADRB3 gene / in D/D genotype of UCP2 gene / in Pro/Pro genotype of PPAR-${\gamma}$ gene. Conclusions: Boiogito promoted obesity indexes without severe adverse reactions and proved its safety. Pharmacogenetical studies of Boiogito on obesity could be a effective method for the individualized treatment and prevention of obesity.

다이나믹 테이핑을 적용한 복합 운동프로그램이 긴장성 두통과 전방머리자세를 동반한 만성 목 통증 환자에게 미치는 효과 (Effects of a Complex Exercise Program using Dynamic Taping on Patients with Tension-Type Headache and Chronic Neck Pain with Forward Head Posture)

  • 박삼호;정승화
    • 대한통합의학회지
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    • 제10권4호
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    • pp.23-34
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    • 2022
  • Purpose : This study examined the effects of pain, neck dysfunction, psychosocial level, headache impact test (HIT), postural alignment, and trapezius muscle tone of the complex exercise program using dynamic taping in patients with tension headache and chronic neck pain with forward head posture. Methods : The design of this is a randomized controlled trial (RCT). Thirty-four patients with chronic neck pain were screened using a randomized assignment program and assigned to experimental group (n=17) and control group (n=17). Both groups underwent a complex exercise program. In addition, the experimental group dynamic taping was applied to the upper trapezius muscle. All interventions were applied three times per week for four weeks. The visual analogue scale (VAS), the neck disability index (NDI), short form-12 health survey questionnaire (SF-12), Headache impact test-6 (HIT-6), Craniovertebral angle (CVA), Cranial rotation angle (CRA), upper trapezius muscle tone were compared to evaluate the effect on intervention. Results : Both groups showed significant differences before and after the intervention in VAS, NDI, SF-12, HIT-6, and CVA, CRA (p<.05). In addition, significant differences in NDI and upper trapezius muscle tone were observed between the experimental group and control group (p<.05). Conclusion : A complex exercise program using dynamic taping for patients with tension headache and chronic neck pain with forward head posture are effective method with clinical significance in improving the function and reducing upper trapezius muscle tone.

기능성 소화불량증에 대한 추나요법의 효과 : 체계적 문헌고찰과 메타분석 (Chuna Manual Therapy for Functional Dyspepsia : A Systematic Review and Meta-analysis)

  • 허인;신병철;황의형;황만석;김병준;김소연;허광호
    • 척추신경추나의학회지
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    • 제10권1호
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    • pp.1-14
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    • 2015
  • Objectives : To evaluate the evidence supporting the effectiveness of Chuna manual therapy for functional dyspepsia. Methods : We conducted search across the 3 electronic databases (Pubmed, CAJ and Oasis) to find all of randomized controlled clinical trials(RCTs) that used Chuna manual therapy as a treatment for functional dyspepsia. The methodological quality of each RCT was assessed using the Cochrane risk of bias tool. Results : Thirteen RCTs met our inclusion criteria. The meta-analysis showed positive results for the use of Chuna manual therapy combined with medication treatments in terms of the efficacy rate when compared to medication treatments alone. Positive results were also obtained, in terms of the efficacy rate, when comparing Chuna manual therapy combined with medication plus specific electromagnetic therapy to medication treatments alone. Conclusions : Our systematic review found encouraging but limited evidence of Chuna manual therapy for functional dyspepsia. However, to obtain stronger evidence without the drawbacks of trial design and the quality of studies, we recommend sham-controlled RCTs or comparative effectiveness research to test the effectiveness of Chuna manual therapy.

웃음요법이 시설거주 노인의 우울과 수면 장애에 미치는 효과 : 체계적 고찰 및 메타분석 (Effects of Laughter Therapy on Depression and Sleep Wake Disorders of the Elderly in Residential Facilities : A Systematic Review and Meta-analysis)

  • 김은정;양진향
    • 한국엔터테인먼트산업학회논문지
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    • 제15권8호
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    • pp.291-303
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    • 2021
  • 본 연구는 최근 증가하고 있는 시설거주 노인을 대상으로 건강문제로 보고되고 있는 우울과 수면장애에 대하여 웃음요법의 적용 효과를 확인하기 위한 연구이다. 이를 위해 시설거주 노인에게 웃음요법을 적용한 국내·외 실험연구들을 대상으로 체계적 고찰을 통해 연구 특성을 파악하고, 메타분석을 통해 우울과 수면장애에 대한 전체 효과크기와 중재 변인에 따른 효과크기를 파악하는 것을 목적으로 하고 있다. 최종 선정된 12편의 실험연구를 체계적으로 고찰하고 결과 변수에 영향을 미치는 전체 효과크기를 분석한 결과, 웃음요법은 시설거주 노인의 우울 감소에 유의한 효과가 있었으며, 수면장애 감소에는 유의한 효과가 없었다. 중재 변인에 따라 분석한 결과 웃음요법은 시행 횟수 10회 미만, 중재 소요 시간 400분 미만이나 400-1,000분 미만에서 우울 감소에 효과적이었다. 수면장애의 경우 전체 효과크기는 유의하지 않았으나 중재 소요 시간 300분 미만에서 수면장애 감소에 효과적이었다. 이러한 결과는 웃음요법이 시설거주 노인의 우울 감소에 효과적이며, 이를 적용할 때 시행 횟수와 중재 소요 시간과 같은 중재 변인을 고려하는 것이 필요함을 시사한다. 시설거주 노인의 수가 증가하고 있고, 우울과 수면장애와 같은 건강문제의 발생률이 증가하고 있는 점을 감안할 때 추후 연구에서 본 연구 결과를 토대로 시설거주 노인의 우울과 수면장애 감소를 위한 적용지침이 개발될 필요가 있다.

Abiraterone for Treatment of Metastatic Castration-resistant Prostate Cancer: a Systematic Review and Meta-analysis

  • Zhou, Zhi-Rui;Liu, Shi-Xin;Zhang, Tian-Song;Xia, Jun;Li, Bo
    • Asian Pacific Journal of Cancer Prevention
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    • 제15권3호
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    • pp.1313-1320
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    • 2014
  • Introduction: Although most prostate cancers initially respond to castration with luteinizing hormonereleasing analogues or bilateral orchiectomy, progression eventually occurs. Based on the exciting results of several randomized controlled trials (RCTs), it seems that patients with metastatic castration-resistant prostate cancer (mCRPC) might benefit more from treatment withabiraterone. Therefore we conducted a systematic review to evaluate the efficacy and toxicity of abiraterone in the treatment of mCRPC. Methods: Literature was searched from Embase, PubMed, Web of Science, and Cochrane Library up to July, 2013. Quality of the study was evaluated according to the Cochrane's risk of bias of randomized controlled trial (RCT) tool, then the Grading of Recommendations Assessment, Development and Evaluation (GRADE) System was used to rate the level of evidence. Stata 12.0 was used for statistical analysis. Summary data from RCTs comparing abiraterone plus prednisone versus placebo plus prednisone for mCRPC were meta-analyzed. Pooled hazard ratios (HRs) for overall survival (OS), radiographic progression-free survival (RPFS) and time to PSA progression (TTPP); Pooled risk ratios (RR) for PSA response rate, objective response rate and adverse event were calculated. Results: Ten trials were included in the systematic review; Data of 2,283 patients (1,343 abiraterone; 940 placebo) from two phase 3 trials: COU-AA-301 and COU-AA-302 were meta-analyzed. Compared with placebo, abiraterone significantly prolonged OS (HR, 0.74; 95% confidence interval [CI], 0.66 to 0.84), RPFS (HR, 0.59; 95% CI, 0.48 to 0.74) and time to PSA progression (HR, 0.55; 95% CI, 0.43 to 0.70); it also significantly increased PSA response rate (RR, 3.63; 95% CI, 1.72 to 7.65) and objective response rate (RR, 3.05; 95% CI, 1.51 to 6.15). This meta-analysis suggested that the adverse events caused by abiraterone are acceptable and can be controlled. Conclutios: Abiraterone significantly prolonged OS, RPFS and time to progression patients with mCRPC, regardless of prior chemotherapy or whether chemotherapy-na$\ddot{i}$ve, and no unexpected toxicity was evident. Abiraterone can serve as a new standard therapy for mCRPC.

만성폐쇄성폐질환의 자가간호 중재연구(RCT) 효과에 관한 체계적 문헌고찰 (Effects of Self-Care Intervention Study on Chronic Obstructive Pulmonary Disease: Focusing on a Systematic Review of a Randomized Controlled Trials)

  • 문경미;박인희;김현주
    • 산업융합연구
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    • 제21권8호
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    • pp.97-110
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    • 2023
  • 이번 연구는 국내·외 만성폐쇄성폐질환 대상자에게 시행된 다양한 자가간호 중재 프로그램의 내용에 대한 연구결과를 통합하고 분석하기 위해 수행된 체계적 문헌고찰 연구이다. 문헌선정기준은 2000년 1월 1일부터 2022년 9월 30일까지로 PubMed, CINAHL, EMBASE, MEDLINE, RISS, DBpia, KISS 및 KMbase를 통해 검색된 무작위 대조군 실험연구로 사전-사후 설계를 적용한 논문을 채택하였다. 체계적 고찰에 포함된 연구는 총 23편으로 중재 관련 요인으로는 연구대상의 수, 중재자 유형, 중재 제공 횟수 및 기간, 중재효과 관련 요인으로는 중재효과 측정도구, 중재효과 변수 등을 분석하였다. 분석결과 만성폐쇄성폐질환 자가간호 중재 프로그램은 환자의 증상 악화 및 재입원을 예방에 도움이 될 수 있음을 확인하였다. 우리나라 만성폐쇄성폐질환자에게 적합한 자가간호 중재 프로그램 개발이 필요하며 환자의 접근성, 편의성 및 지속을 위한 동기 부여 방법 등을 고려한 중재 프로그램의 개발이 필요하다.

특발성 혈소판 감소성 자반증의 중의치료에 대한 임상연구 동향 - CNKI검색을 중심으로 (A Review of Clinical Studies for Chinese Medicine Treatment of Idiopathic Thrombocytopenic Purpura Using the CNKI Database)

  • 배지은;박재원;임준규;박미소;홍정수;김동진
    • 대한한방내과학회지
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    • 제43권6호
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    • pp.1045-1062
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    • 2022
  • Objectives: The aim of this study was to analyze the latest clinical studies on Korean medicine treatment of idiopathic thrombocytopenic purpura (ITP) in the Chinese National Knowledge Infrastructure (CNKI) database. Methods: We searched the last 6 years of clinical studies discussing Oriental medicine-based treatments for ITP in the CNKI database. A meta-analysis of 13 RCTs was performed by synthesizing the outcomes, including the measured platelet count and total effective rate. The quality of the studies was assessed using Cochrane's risk of bias (RoB) tool. RevMan 5.4.1 software was used for data analysis. Results: Of the 15 selected studies, 1 was a non-randomized controlled trial (nRCT), 2 were case series, and 12 were randomized controlled trials (RCTs). Treatments in all studies included oral herbal medicine. The most frequently used herbal decoction was the Liangxue Jiedu prescription (凉血解毒方), and the most commonly used herb was Agrimonia pilosa (仙鶴草), Astragali Radix (黃芪), Fossilia Glycyrrhizae Radix et Rhizoma (甘草), and Rehmannia glutinosa Liboschitz ex Steudel (地黃). The meta-analysis showed significantly better improvement in platelet counts and total effective rate for ITP in the treatment group than in the control group. Conclusion: Treatment with herbal medicine was effective in treating ITP. However, the significance of this conclusion is somewhat limited due to the low quality of the available studies. Multifaceted and scientifically designed clinical studies are required to develop treatments for ITP based on Korean medicine. The results of this study could be used as basic data for further ITP studies.

침구와 약침에 대한 중개연구 현황 (Current situation of Translational research on Acupuncture, Moxibustion and Pharmacopuncture)

  • 신대철;송호섭
    • Journal of Acupuncture Research
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    • 제33권2호
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    • pp.109-116
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    • 2016
  • Objectives : Our primary objective lies in understanding the current landscape of translational research on acupuncture, moxibustion and pharmacopuncture. Methods : We searched our own selection of keywords of acupuncture, moxibustion and pharmacopuncture and translational research from three overseas databases (Pubmed, Scopus, Medicine) and four domestic databases (DBpia, KISS, Riss4u, Korea Med). Results : We have chosen 41 articles in total-40 articles on acupunture, 6 article on moxibustion(5 articles were duplicated in use in each category). Origin-wise, 48.8 %/24.8 %/17.0 % of our articles pool came from USA/China/Korea, respectively. UK, Austria, Thailand and Italy contributed the rest of our article pool. For those articles written in USA and China, review articles were the most common type. For the US articles, all 10 review articles were non-systematic reviews, while, for China's contribution, one out of 4 review articles were systematic review. Type-wise, our research pool's breakdown is as follows ; 17 review articles, 11 experimental research, 2 randomized controlled trials(RCT), 1 clinical trial, 4 conference reports, 1 letter, 1 study protocol and 4 uncategorized. Topic-wise, brain-neurology was most frequently referred with 8 articles, followed by parkinson's disease (3 articles) and epilepsy (2 articles). Conclusion : 1. In terms of research submission articles, Korea appears to be lacking translational research on acupuncture, moxibustion and pharmacopuncture, compared to USA and China, in our view. 2. Unlike the cases of USA and China, most of Korean translational research is limited to doing a T1 level of translational research. In order to bring bench-to-bedside to light. we believe, there should be more studies, and thereby a certain level of activation, to the T2 level of translational research in Korea. 3. Further, in our view there should be more efforts to improve article quality at the T1 level of translational research, which eventually becomes the fundamentals of the next level of research (i.e. T2 research), as well as to increase the number of research submissions, going forward.

여성 흡연자의 금연 중재 효과: 체계적 문헌고찰 (Effects of Smoking Cessation Intervention among Female Smokers: Systematic Review)

  • 김다혜;최유현;함옥경;임보애;김나경
    • 한국보건간호학회지
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    • 제34권2호
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    • pp.263-276
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    • 2020
  • Purpose: This paper systematically reviewed the effects of smoking cessation (SC) intervention among female smokers. Methods: A systematic search was performed targeting articles published on eight electronic databases, from January 1, 2010, to February 25, 2020. Nine studies were included in the systematic review. The risk of bias (RoB) tool was used to evaluate the quality of scientific evidence. Results: A randomized controlled trial (RCT) was performed in all nine studies. Interventions were classified as exercise (n=4), cognitive behavioral counseling (n=2), motivational counseling (n=1), group counseling with self-help group (n=1), and pharmacotherapy (n=1). The SC rates were measured using a 7-days point prevalence abstinence in 55.6% of the studies. Exercise studies showed higher SC rates in the experimental groups than control groups after the intervention, but the differences were not significant. Other interventions were employed in two or fewer studies or did not conduct long-term follow-up, thus we were unable to examine effects of these interventions. Conclusion: It is necessary to develop SC programs for female smokers by carefully considering the characteristics of female smokers. Further research will be needed to confirm the effects of SC programs in certain subgroups among females. Also more experimental studies on SC intervention should be carried out with scientific rigor.