• Title/Summary/Keyword: randomized clinical trial

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

  • Nam, Dong-Woo;Lee, Jae-Dong;Choi, Do-Young
    • Journal of Acupuncture Research
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    • v.24 no.1
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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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A Clinical Trial of Acupuncture Treatment for Frozen Shoulder (Frozen Shoulder의 침치료에 대한 임상연구)

  • Hong, Kwon-Eui;Kim, Young-Il;Yim, Yun-Kyoung;Ahn, Taek-Won;Kang, Wee-Chang;Choi, Sun-Mi;Lee, Hyun
    • Journal of Acupuncture Research
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    • v.23 no.1
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    • pp.165-177
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    • 2006
  • Objectives : 1. Clinical trial for the efficacy evaluation of Korean acupuncture techniques in treating frozen shoulder. 2. Development of the standard clinical guidelines of the acupuncture treatment for the frozen shoulder. 3. Development of the new clinical protocol for the acupuncture treatments. 4. Verification of the hypothesis that treating at both the remote and the nearby acupoints according to the meridian theory is more effective than treating at only the nearby acupoints. Methods : 1. Research designed as Single blind, Randomized, Sham acupuncture controlled clinical Trial. 2. Assignment of 86 patients to one of three groups treated at nearby acupoints(group A), remote & nearby acupoints(group B), and sham points(group C) respectively. 3. Trial conducted at KIOM CRC of Dunsan oriental medical hospital, Daejeon Univ. 4. Estimation of the recovery rate of the frozen shoulder in subjects aged over 40. 5. Efficacy evaluation using VAS, SPADI, ROM and Improvement rate. Results : 1. There was no significant difference in VAS among the three groups. 2. Pain related scores in SPADI of the group B were significantly lower than those of the group A. 3. There was no significant difference in disability related scores of SPADI among the three groups. 4. External rotation of upper arm in the group B was significantly improved in comparison with that in the group C. 5. Abduction of upper arm in group A was improved with weak statistical significance in comparison with that in the group C. Conclusion : Acupuncture at both the remote and the nearby acupoints according to the meridian theory is effective to improve external rotation of frozen shoulder, and acupuncture at the nearby acupoints is effective to improve adduction of frozen shoulder. However it is not clear that acupuncture treatment at both the remote and the nearby acupoints according to the meridian theory is more effective than treating at only the nearby acupoints in the treatment of frozen shoulder. Since our study was a short term trial, a long term trial for a more precise evaluation of acupuncture treatment for frozen shoulder will be needed in the future.

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Effects of Acupuncture with a Combination of GV20 and EX-HN1 Acupoints on CO2 Reactivity in the Anterior and Middle Cerebral Arteries during Hypercapnia in Normal Subjects: A Randomized Crossover Trial

  • Park, Hojung;Moon, Sang-Kwan;Lee, Han-Gyul;Kwon, Seungwon;Cho, Seung-Yeon;Park, Seong-Uk;Jung, Woo-sang;Park, Jung-Mi;Ko, Chang-Nam;Cho, Ki-Ho
    • The Journal of Internal Korean Medicine
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    • v.43 no.4
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    • pp.582-595
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    • 2022
  • Objectives: To investigate the effects of acupuncture at GV20 and EX-HN1 on cerebral blood flow (CBF) velocity and cerebrovascular reactivity (CVR) in the middle cerebral arteries (MCA) and anterior cerebral arteries (ACA) and to compare the effects to acupuncture at GV20. Methods: The study was a randomized, crossover trial that included 10 healthy men aged 20 to 29 years who underwent acupuncture treatment four times with a washout period of one week. The CBF velocity and CVR were measured by transcranial Doppler sonography (TCD) on both MCAs at the first and second visits, and both ACAs at the third and fourth visits. Participants were randomly assigned to one of two groups (A and B) before the first and third visits. Group A received two phases of acupuncture intervention at a single GV20 point and a combination of GV20 and EX-HN1 acupoints. Group B received the same interventions, but in the reverse order. Results: The increase in CO2 reactivity was significantly higher for the combination acupoints of GV20 and EX-HN1 than for the GV20 single acupoint in both MCAs (Right: 136 to 178, p=0.017; Left: 127 to 191, p=0.017) and ACAs (Right: 133 to 158, p=0.013; Left: 122 to 168, p=0.025). No significant change was noted in the corrected velocity at PETCO2 40 mmHg, blood pressure, or heart rate. Conclusions: The findings suggest that improvement of the CBF in the MCA and ACA after GV20 acupuncture increases when acupuncture is also performed at EX-HN1. These results clinically support the combined use of EX-HN1 and GV20 to treat disorders of MCA and ACA circulation.

Effect of Chlorhexidine Mouthrinse on Prevention of Microbial Contamination during EBUS-TBNA: A Study Protocol for a Randomized Controlled Trial

  • Kim, Na Young;Park, Jae Hyeon;Park, Jimyung;Kwak, Nakwon;Choi, Sun Mi;Park, Young Sik;Lee, Chang-Hoon;Cho, Jaeyoung
    • Tuberculosis and Respiratory Diseases
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    • v.84 no.4
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    • pp.291-298
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    • 2021
  • Background: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a standard diagnostic method for mediastinal and hilar lymphadenopathy. Although rare, fatal infectious complications can occur following EBUS-TBNA. However, to date, there is a lack of effective preventive strategies to reduce these complications. We started a trial to investigate the effect of chlorhexidine mouthrinse on the prevention of microbial contamination during EBUS-TBNA. Methods: This study is a single-center, parallel-group, assessor-blinded randomized controlled trial (RCT). We will enroll 112 adult participants undergoing EBUS-TBNA using a convex probe, and randomly assign them to two groups at a 1:1 ratio. The intervention group will gargle for 1 minute with 100 mL of 0.12% chlorhexidine gluconate before EBUS-TBNA, while the control group will have no mouthrinse before the procedure. Immediately after completion of EBUS-TBNA on all targeted lesions with an aspiration needle, a needle wash sample will be taken by instilling 5 mL of sterile saline into the used needle. The primary outcome is colony forming unit (CFU) counts in aerobic cultures of the needle wash samples. Secondary outcomes are CFU counts in anaerobic cultures, fever within 24 hours after EBUS-TBNA, and infectious complications within 4 weeks after EBUS-TBNA. Conclusion: This trial was designed as the first RCT to investigate the effect of chlorhexidine mouthrinse on the prevention of microbial contamination during EBUS-TBNA. Results from this trial can provide clinical evidence for a simple, safe, and cost-effective strategy to prevent infectious complications following EBUS-TBNA (ClinicalTrials.gov ID: NCT04718922, registered on 22 January 2021).

Designing Clinical Studies and Keeping Research Ethics (임상연구의 설계 및 연구윤리)

  • Chang, Jae Seung;Lee, Sunny;Ha, Tae Hyon;Yoon, In-Young;Ha, Kyooseob
    • Korean Journal of Biological Psychiatry
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    • v.19 no.4
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    • pp.172-178
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    • 2012
  • Data from clinical studies are needed for psychiatrists to make quick and scientific decisions based on the best available evidence in clinical settings. Various methods of clinical studies are useful for clinicians to have reliable answers to unmet clinical needs. Although randomized controlled trials may provide high-quality information about major issues, well-designed, naturalistic and observational studies often give us unbiased explanation for real-world phenomena. Adequate selection of clinical variables and appropriate number of participants are key factors of well-designed clinical studies. Statistical methods can add an extra dimension to initial design of clinical studies. Given ethical issues in clinical studies on psychiatric disorders, special regards should be paid to participants' ability to provide informed consents. New strategies of clinical studies need to be developed to meet clinical needs and protect the rights and welfare of study participants.

The Study of the Sham Acupuncture for Acupuncture Clinical Trials (침 임상시험 논문에 적용한 Sham Acupuncture에 대한 고찰)

  • Jung, Chan-Yung;Jang, Min-Gee;Cho, Jae-Yong;Kim, Eun-Jung;Park, In-Shik;Kim, Kap-Sung
    • Journal of Acupuncture Research
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    • v.25 no.6
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    • pp.77-93
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    • 2008
  • Objectives : Though there were many clinical studies of acupuncture effects they didn't have appropriate control group or use another therapy for control group. So, we didn't say it was true acupuncture effect, though subjects in clinical study improved. Recently several sham needles for control group were developed and validated. This study aimed at summarizing the validation studies of these needles and evaluating the control group of the acupuncture clinical study. Methods : Computerized literature searches were performed using 'acupuncture' and 'placebo or sham' with a limitation of the results to RCTs in Pubmed, Sciencedirect, NDSL, KISS, RISS. Data were extracted regarding study design, sample size, acupuncture point, stimulation form, credibility testing. And We have examined 106 acupuncture clinical studies published by Pubmed from January 1, 2005 to April 30, 2008. Data were extracted author's country, subject of study, type of study groups, type of control groups, type of blinding, difference between the results in the control groups. Results : Streitberger's placebo needle, Fink's sham needle, Park sham needle, Kim sham needle were developed. They were validated at domestic and abroad. But the results were deviation depending on the each of the researcher. They has shown that sample, acupuncture points, experiences or knowledge of acupuncture dependent on the results. Recent three years, acupuncture clinical trial had different results. Significant differences between Study group and control group emerged from using other therapy or non-treatment for control group. Many study has no significant differences using sham acupuncture for control groups. Conclusions : Acupuncture clinical studies need to meet several requirements. First of all, they require the basics of randomized controlled clinical studies such as blinding and the accurate implementation and description of randomization. And also need to research the unique circumstances of these studies such as the development of sham acupuncture and blinding method which differs from other clinical trials.

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Methodologic Lessons Learned from Multicenter, Randomized, Controlled Clinical Trial of Acupuncture for Hot Flashes in Peri- and Postmenopausal Women (갱년 및 폐경 후 여성의 안면홍조에 대한 침 치료 다기관 임상연구 : 수행보고 및 방법론적 교훈)

  • Kim, Kun-Hyung;Kim, Dong-Il;Hwang, Deok-Sang;Lee, Jin-Moo;Kim, Hyung-Jun;Yoon, Hyun-Min;Jung, Hee-Jung;Kang, Kyung-Won;Lee, Myeong-Soo;Choi, Sun-Mi
    • The Journal of Korean Obstetrics and Gynecology
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    • v.23 no.1
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    • pp.42-52
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    • 2010
  • Purpose: This report aims to administer methodologic issues around recently conducted multicenter study for evaluating the effects of acupuncture on menopusal hot flashes and discuss practical issues for further implementation of acupuncture clinical trial for hot flashes. Methods: Study process were mentioned, and issues related to avoiding risk of bias, designing appropriate control group, optimal outcome measurement, potential different effects of menopausal status on study outcomes, and suggestions for developing future clinical trials are discussed. Results: Shortcomings of our multicenter study include lack of allocation concealment and assessor blinding, subjective outcome measurement, short-term follow-up, and fixed acupuncture regimen despite pragmatic purpose of this study. Improving trial design, using objective or validated outcomes, assessing long-term effects of acupuncture, and individualizing acupuncture regimen are needed in future clinical trials. Conclusion: We expect these practical discussions to enable researchers to plan and develop future well-designed clinical trials for evaluating the effects of acupuncture on hot flashes or other women's health issues.

Assessment of Double-blindness at the Conclusion of the $\beta-Blocker$ Heart Attack Trial

  • Byington Robert P.;Curb J. David;Mattson Margaret E.
    • 대한예방의학회:학술대회논문집
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    • 1994.02b
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    • pp.293-296
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    • 1994
  • At the conclusion of a double-blinded, randomized clinical trial of propranolol hydrochloride, but before un blinding, the patients and clinic personnel were asked to guess the treatment group assignment of each patient. While 79.9% of the patients receiving propranolol correctly Identified their treatment group assignment, 57.2% of the patients receiving placebo incorrectly guessed that they were aiso in the propranolol group. No specific mechanism was identified to explain why more patients receiving propranolol were better able to guess' their group assignment. Clinic physicians correctly identified the group assignment of 69.9% of the patients receiving propranolol and 68.8% of the patients receiving placebo. Clinic coordinators correctly identified the group assignment of 67.1% of the patients receiving propranolol and 70.6% of the patients receiving placebo. For clinic personnel, heart rate level and heart rate change seem to be the mechanisms employed to Identify their patients' treatment assignment.

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Chuna Manual Therapy for Nocturnal Crying; A Systematic Review (소아 야제에 대한 추나요법 효과; 체계적 문헌고찰)

  • Hwang, Man-Suk;Shin, Byung-Cheul;Heo, Kwang-Ho;Heo, In;Kim, Byung-Jun;Kim, Ki-Bong;Cheon, Jin-Hong;Park, Jae-Hong;Hwang, Eui-Hyoung
    • Journal of Korean Medicine Rehabilitation
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    • v.25 no.3
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    • pp.51-57
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    • 2015
  • Objectives To evaluate the evidence supporting the effectiveness of Chuna manual therapy for nocturnal crying. 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 nocturnal crying. The methodological quality of each RCTs was assessed using the Cochrane Risk of Bias tool and nRCTs was assessed using the Cochrane Risk of Bias Assessment tool for Non-randomized Study tool. Results Two RCTs and three nRCTs met our inclusion criteria. The meta-analysis showed positive results for the use of Chuna manual therapy 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 acupoint application therapy to Chuna manual therapy alone, but was not statistically significant. Conclusions Our systematic review found encouraging but limited evidence of Chuna manual therapy for nocturnal crying. We recommend clinical trials which compare the effectiveness of Chuna manual therapy with usual care to obtain stronger evidence without the demerits of trial design.

Effect of Debriefing Based on the Clinical Judgment Model on Simulation Based Learning Outcomes of End-of-Life Care for Nursing Students: A Non-Randomized Controlled Trial (임상판단모델에 근거한 디브리핑 적용이 임종간호 학습성과에 미치는 효과: 비무작위 대조시험설계)

  • Jeong, Kyung In;Choi, Ja Yun
    • Journal of Korean Academy of Nursing
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    • v.47 no.6
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    • pp.842-853
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    • 2017
  • Purpose: This study was conducted to identify effects of debriefing based on the clinical judgment model for nursing students on their knowledge, skill performance, clinical judgment, self-confidence and learner satisfaction during simulation based end-of-life care (ELC) education. Methods: Simulation based ELC education was developed in six steps as follows: selection of learning subjects and objects, development of learning tools, a trial run of simulation-based education, students' skill training, and evaluators' training. Forty-eight senior nursing students (25 in the experimental group and 23 in the control group) participated in the simulation-based ELC education using a high-fidelity simulator. Debriefing based on the clinical judgment was compared with the usual debriefing. Results: ANCOVA showed that there were differences in knowledge (F=4.81, p=.034), skill performance (F=68.33, p<.001), clinical judgment (F=18.33, p<.001) and self-confidence (F=4.85, p=.033), but no difference in satisfaction (t=-0.38, p=.704) between the experimental and control groups. Conclusion: This study found that debriefing based on the clinical judgement model is effective for supporting nursing students for reflecting on clinical judgment and improving their diverse competencies in complex clinical settings such as ELC.