대한가정의학회지에 실린 무작위대조시험논문의 질 평가

정우빈,이경우,황인홍,김수영,이동희 대한가정의학회 2009 Korean Journal of Family Medicine Vol.30 No.8

Background: Because low quality trials may lead to wrong conclusions, quality assessments are necessary. Thus, this study scrutinizes randomized controlled trials (RCTs) in the Journal of the Korean Academy of Family Medicine (KAFM) to assess the quantity and the quality. Methods: Upon extracting randomized controlled trials from all the articles published in the Journal of the KAFM from 1980 to 2005, assessments were made on the Jadad scale and the adequacy of allocation concealment. The selections and assessments were performed independently by two researchers, and adjustment of the differences were done by a thirdparty researcher. In addition, the factors that may affect the quality levels were analyzed. Results: Twenty-three trials were included. In 1980s, there were only 1.09% of the total original articles, but in 2000s, 2.63% were RCTs. The mean total Jadad score increased from 1 point in 1980s to 2.17 in 2000s, and the "good quality" trials also increased from 0% to 33.33%. As for the adequate allocation concealment, however, only two studies were observed in 2000s. The most lacking aspect was the appropriate double-blinding. Also, studies intervened by medicine or funded or examined by Institutional Review Boards (IRBs) tended to receive higher quality assessments. Conclusion: Although RCTs consistently increased in quantity and quality, in future studies, researchers should continue to strive towards achieving adequate allocation concealment and appropriate double-blinding. In addition, researchers must become more interested in receiving funds and examination by IRBs. 연구배경: 최근의 국내 연구에선 무작위대조시험의 양적 증 가가 관찰되지만, 질이 낮은 무작위대조연구는 오히려 잘못 된 결과를 초래하므로 논문의 질 평가가 요구된다. 본 연구는 대한가정의학회지를 대상으로 질 평가를 시행하여 양적 성장 뿐만 아니라 질적 성장도 확인하고자 한다. 방법: 1980년도부터 2005년도까지 발행된 대한가정의학회 지의 원저 1,290편을 대상으로 무작위대조연구논문을 추출한 후, Jadad Quality Assessment Scale (Jadad scale)을 이용한 질 평가 와 배정 은폐 방법의 적절성 평가를 시행하였다. 논문의 추출 과 평가는 2인의 연구자가 독립적으로 시행하였고 이견은 제 3자가 조정하였다. 또한 질적 수준에 영향을 미칠 수 있는 요 인들을 분석하였다. 결과: 추출된 무작위대조시험논문은 총 23편으로 1,980년대 원저의 1.09%에서 2000년대 2.63%로 증가하였다. Jadad scale 총 점 평균은 1980년대 1점에서 2000년대 2.17점으로 증가하였 고, 높은 질로 평가받은 논문도 0%에서 33.33%로 증가하였지 만, 적절한 은닉 방법은 2000년대 들어서야 단 2편에서 관찰되 었다. 질 평가 항목 중 가장 부족한 항목은 적절한 이중 맹검이 었고, 중재가 약품이거나 특정 기관의 후원을 받은 논문 또는 임상시험 윤리위원회 심의를 받은 논문들은 그 외의 논문들 보다 높은 질적 평가를 받았다. 결론: 대한가정의학회지에 실린 무작위 대조시험 논문은 1980년도 창간호부터 2005년도까지 꾸준한 양적 성장과 질적 성장을 하였지만 아직 충분치 않으므로, 향후 연구자들은 특 히 적절한 이중 맹검과 은닉 방법이 시행될 수 있도록 노력이 필요하겠다. 또한 연구의 질적 향상을 위해 좀 더 많은 후원을 받을 수 있는 환경이 조성되어야 하고, 임상시험 윤리위원회 심의 통과에도 관심을 기울여야 할 것이다.

여성의 갱년기 증상에 대한 석류농축액의 유효성 및 안전성을 평가하기 위한 단일기관, 무작위 배정, 이중맹검, 위약대조군 임상시험

안기훈 ( Ki Hoon Ahn ),김선미 ( Sun Mee Kim ),이경욱 ( Kyong Wook Yi ),박현태 ( Hyun Tae Park ),신정호 ( Jung Ho Shin ),김영태 ( Young Tae Kim ),허준용 ( Jun Young Hur ),김선행 ( Sun Haeng Kim ),이규완 ( Kyu Wan Lee ),김탁 ( Tak 대한폐경학회 2010 대한폐경학회지 Vol.16 No.2

연구목적: 석류농축액이 폐경여성의 갱년기 장애에 어떠한 영향을 미치는지 알아보고자 하였다. 연구재료 및 방법: 2008년 5월부터 2008년 9월까지 고려대학교 병원을 방문한 증상을 가진 폐경여성환자를 대상으로 무작위, 이중맹검, 시험-대조군 임상시험으로 진행되었다. 총 112명의 환자를 대상으로 55명의 시험군과 57명의 대조군이 포함되었으며 시험군은 석류 원액 20 ml가 포함된 100 ml의 시험약물을 대조군은 석류가 섞이지 않은 대조약물을 12주간 투여하여 연구시작시점과 마지막 시점의 결과를 비교하였다. 측정을 위한 일차지표는 쿠퍼만 지표로 계산된 폐경증상의 정도였고, 이차지표는 혈중 estradiol (E2, pg/ml) 수치였다. 결과: 쿠퍼만 지표로 측정한 폐경증상을 비교하였을 때 쿠퍼만 지표점수가 첫 방문시에는 석류농축액을 투여한 군과 위약을 투여한 군에서 유의한 차이가 없었으나 12주 뒤 (P<0.0001) 마지막 방문 시에는 석류를 투여한 군에서 유의하게 폐경증상이 좋아짐을 관찰할 수 있었다. 우울감의 경우 석류투여군에서 쿠퍼만 지표의 수치가 낮은 경향을 보였으나 통계학적으로 유의하지 않았다. 혈청 E2 농도는 첫 방문 시나 마지막 방문 시 두 군간에 차이가 없었다. 결론: 석류농축액은 증상을 지닌 폐경여성에서 안전하게 전반적인 개선을 나타냈다. 석류의 폐경여성에서의 효과가 에스트로겐에 의한 것인지는 이 연구로 결론 내리기 어려우며 향후 이에 대한 추가적인 연구가 필요할 것으로 보인다. Objectives: To investigate the safety and effect of pomegranate extract on postmenopausal syndrome. Methods: One hundred twelve women participated in a randomized, double-blind, placebo-controlled trial conducted in a tertiary university hospital in Korea. Women were treated with pomegranate extract or placebo for 12 weeks. The primary end point was menopausal symptoms, which were evaluated based on the Kupperman Index. The secondary end point was the serum estradiol (E2, pg/ml) level. Statistical analysis was performed. Results: Menopausal symptoms as the Kupperman Index were significantly improved in the pomegranate group compared to placebo during the 12 weeks of intervention (P<0.0001). Melancholia did not differ between the two groups. There was also no difference in serum E2 levels. There were no differences between the two groups in age, body weight, height, systolic and diastolic blood pressures, serum white and red blood cell counts, and fasting blood glucose, hemoglobin, aspartic transaminase, alanine transaminase, total cholesterol, triglycerides, high- and low-density lipoprotein-cholesterol, creatinine, and E2 levels. The side effects of pomegranate extract were negligible. Conclusion: Pomegranate extract is safe and effective in the treatment of menopausal symptoms. Further studies on whether or not the beneficial effect of pomegranate extract is due to the estrogen component are needed.

고령 고혈압 환자에서 천일염의 혈압 감소 효과: 예비 무작위 대조시험

백승하,안주원,이혜리,조수현,김정하 대한임상건강증진학회 2015 Korean Journal of Health Promotion Vol.15 No.3

Background: High sodium and/or low mineral intake are known to be associated with elevated blood pressure. It has been reported that substituting low-sodium, mineral-rich salt for refined salt lowers blood pressure (BP). And solar salt is emerging as a low sodium high mineral salt for a healthy diet in Korea. Therefore, this double- blind, randomized, and placebo-controlled trial was conducted to explore changes in BP from substituting refined salt with solar salt among hypertensive elderly subjects. Methods: Forty-three hypertensive and institutionalized elderly individuals aged 65 years or older were enrolled. Thirty-eight subjects (88.4%) completed the study. Subjects were provided with either a solar salt- or refined salt-based diet for eight weeks. Results: Systolic BP decreased significantly in the solar salt-based diet group after 2, 4, and 8 weeks when compared to the refined salt-based diet group. And, diastolic BP was lowered significantly in the solar salt-based diet group compared to that in the refined salt-based diet group after 8 weeks. In addition, urinary sodium/potassium, and angiotension converting enzyme activity decreased significantly in the solar salt-based diet group compared to the refined salt-based group. Urinary potassium excretion was significantly increased in the solar salt-based diet group. Conclusions: These results may provide clinical evidence that solar salt has beneficial effects on BP in elderly patients. And, people such as Koreans, who do not consume enough minerals, may experience a greater anti- hypotensive effect by using solar salt. However, further large-scale studies are necessary. 연구배경: 나트륨 과다 섭취와 적은 미네랄 섭취는 혈압상승과 연관된 것으로 알려져 있으며, 정제 소금을 저염도, 고미네랄 천일염으로 대체하는 것은 혈압을 낮춘다고 보고되고 있다. 천일염은 한국에서 건강한 식습관을 위한 저염도, 고미네랄 소금으로 부상되고 있다. 따라서 정제 소금을 천일염으로 대체한 고령 고혈압 환자의 혈압 변화에 대하여 연구하기 위하여 무작위 이중 맹검 위약 대조시험을시행하였다. 방법: 43명의 65세 이상 노령 고혈압 환자가 이 실험에최초 등록되었고, 이 중 38명(88.4%)이 시험을 완료했다. 연구 대상은 실험군으로 천일염 그리고 대조군으로 정제염을섭취하는 식생활을 8주 동안 진행하였다. 결과: 천일염을 섭취하는 집단은 정제염을 섭취하는 대조집단과 비교하였을 때 수축기 혈압이 2, 4, 8주 후에 크게감소하였고, 확장기 혈압 또한 8주 후에 크게 떨어졌다. 또한 천일염을 섭취하는 집단에서는 소변 중 나트륨/칼륨과ACE 활동이 정제염을 섭취하는 집단보다 크게 감소하였다. 소변 중 칼륨 배설 또한 크게 증가하였다. 결론: 이러한 결과는 고령 환자에서 천일염이 혈압에 유익한 효과가 있다는 임상 증거를 제공하고 있으며, 한국인과 같이 충분한 미네랄 섭취가 부족한 경우에 천일염을 사용하여 더 큰 항고혈압 효과를 가질 수도 있을 것으로 보인다. 따라서 추가적인 대규모 연구가 요구된다.

급성백혈병 환자를 대상으로 구강함수제별 구내염 및 구강안위감에 대한 무작위대조시험연구

송지은(Song Chi Eun),소향숙(So Hyang Sook),주덕(Ju Deok),김은정(Kim Eun Jeong) 대한종양간호학회 2011 Asian Oncology Nursing Vol.11 No.1

Purpose: This study compared the effect of two oral care agents on preventing stomatitis and discomfort for acute leukemic patients. Methods: A total of forty patients was enrolled and randomly assigned to sodium bicarbonate or chlorhexidine group. WHO oral toxicity scale was used for measuring stomatitis and Beck’s subjective oral discomfort scale for evaluating oral comfort. Data was collected from August 2009 to February 2010. The data was analyzed using Chi-square test, Fisher’s exact test, and Mann-Whitney test. Results: Data analyzed was thirty five one. The incidence of stomatitis was 47.4%, 68.8% in sodium bicarbonate and chlohexidine group respectively. The onset of stomatitis was about the 10th and 9th day after chemotherapy initiation, and the duration was 8.0 and 8.67 day respectively. The severity of stomatitis was highest on the 21st day after chemotherapy initiation. There were no statistical differences in the status of stomatitis and the levels of oral comfort during treatment periods. Conclusion: Nurses should routinely assess oral cavity and encourage patients to do oral care actively from second to third week after chemotherapy initiation. Also sodium bicarbonate agent can be recommended to for preventing stomatitis.

낙상예방 중재로서의 태극권: 무작위 대조군 실험 연구들을 대상으로 한 심층 문헌고찰과 태권도와의 연계성 탐구

이용호,김경태 대한운동학회 2013 아시아 운동학 학술지 Vol.15 No.1

[서론] 본연구의 주목적은 낙상예방효과로서의 태극권에 대해 심층 문헌고찰연구법을 통해 그 효과를 보다 심층적으로 확인하고자 하는데 있다. 많은 수의 태극권연구들이 이루어져 왔지만 다양한 연구방법 및 태극권 방식으로 인해 연구결과에 대한 신뢰도에 의문이 있어왔다. 따라서 본 연구는 무작위 대조군 실험을 사용한 논문을 대상으로 본 연구에서 정한 기준을 적용하여 논문을 심층적으로 고찰하여 태극권의 낙상에 대한 효과를 살펴보았다. [방법] 심층 문헌고찰연구법을 사용하여 총 7개의 논문이 본 연구 기준을 충족시켜 본 연구에 포함되었고 각 논문은 본 연구가 정한 기준에 따라 심층적으로 고찰이 되었다. [결과] 앞선 선행 논문들이 밝혔듯이 본 연구에서도 태극권이 낙상 예방으로서 효능이 있는 것으로 확인 되어졌으나 중강도 이상의 태극권은 신체기능이 많이 떨어지는 노인들에게는 효능이 없거나 미미한 것으로 확인되어졌다. [결론] 태극권은 대상에 따라 강도를 조절하면 낙상예방에 큰 효능이 있는 것으로 확인 되어졌다. 그리고, 기본동작이나 움직임의 역학이 유사한 태권도 또한 낙상예방운동을서의 충분히 가능성이 있고 노인들에 맞게 개발이 되어진다면 우리나라사람에게 익숙한 태권도가 낙상예방운동으로서 큰 역할을 할 수 있을것이라 기대된다. [INTRODUCTION] Tai Chi as non-pharmaceutical approach has frequently appeared in fall prevention literature in last two decades and has been reported to have positive effects on fall prevention. While there is abundant amount of evidence as to effects of Tai Chi on falls, there are also so many variations in research design, implementation of various types of Tai Chi and outcomes of the studies in Tai Chi studies. Hence, the current study attempted to thoroughly review to examine if Tai Chi still appears to have positive effects when applying exclusive research criteria. [METHOD] In-depth literature review was employed for the current study. Total of 7 studies were selected and reviewed for the final inclusion of the study. [RESULT] The current study confirmed existing current literature that Tai Chi indeed appears to have positive impacts on fall prevention among older adults. [CONCLUSION] Thanks to similarity of Tai Chi to Taekwnodo, the current study also suggested that Taekwonodo could also be another option alternative to Tai Chi for fall prevention since Tai Chi is not commonly practiced in Korea.

일차의료에서 지질저하제 치료 후 외래방문율 개선효과에 대한 휴대폰 문자메시지와 편지 회상법간의 무작위배정 대조군 비교 임상시험

조성자,김영식,신호철,성은주,김대현,이상엽,전태희,양윤준,조충환,강희철,정유석 대한가정의학회 2010 Korean Journal of Family Medicine Vol.31 No.4

Background: In the primary care setting, compliance with lipid lowering therapy was relatively low. In order to compare the efficacy of a short messaging service (SMS) text messaging and postal reminder as means of improving attendance rates during the first 24 weeks of lipid-lowering therapy, a randomized controlled trial of 918 patients from 19 family practice clinics was conducted between February 2003 and June 2006. Methods: Patients were randomly assigned into 3 groups: SMS (327), postal (294),and control (297) group. To ascertain attendance rates, patients were followed up at 24 weeks after their treatment. Reminders were sent at 16 weeks from the coordinating center. Results: Overall attendance rate was 74.1%. This differed between groups, with 76.1% attendance for the SMS group,73.5% for the postal group, and 72.4% for the control group. According to a multivariate analysis, the SMS group had a significantly higher attendance rate (Odds ratios [OR] 1.48; 95% confidence interval [CI], 1.01 to 2.16) than the control group, but the postal group (OR, 1.15; 95% CI, 0.79 to 1.69) did not. Moreover, the cost per attendance for the SMS reminder (155 Korean Won [KRW]) was much lower than that for the postal reminder (722 KRW). Conclusion: SMS reminder may be more cost saving method to improve the attendance rate compared with the postal reminder.

임상예방의료에 필요한 과학적 증거의 평가방법

이중엽,박병주 대한의사협회 2011 대한의사협회지 Vol.54 No.10

Evaluation of scientific evidence in the medical literature is based on the research methodology, which can be the fundamental tool for medical professionals to improve their practice. Since analytic studies usually provide evidence for generating hypotheses and selecting appropriate research designs, this article aims to review the methods for evaluating the study quality in randomized controlled trials (RCTs), cohort studies, and case-control studies. Critical appraisal of systematic errors including selection bias, performance bias, attrition bias, detection bias, and publication bias are the essential elements of the evaluation. Clinical trials need to have an adequate description of sequence generation and allocation concealment, blin-ding for exposure measurement, completeness of follow-up and intention to treat analysis, and blinding for outcome evaluation. For cohort studies, like RCTs, appropriate control of confoun-ding variables is needed to prevent selection bias, and blinding and completeness of follow-up are also very important. Matching of the case group to the control group, blinding of interviewers, and proper definition of the cases and controls are important to prevent bias in a case-control study. Since the process of critical appraisal depends on the quality of reporting, there have been efforts to improve the reporting quality of the medical literature. However, reporting all of the elements necessary to avoid bias does not automatically guarantee an exclusion of bias or the quality of a study; instead, what is important is the logical connection of the elements of a study and the eventual lucid expression of the elements.

스타틴이 총 사망률에 미치는 영향

배재현 대한내과학회 2023 대한내과학회지 Vol.98 No.1

Statins are the cornerstone in primary and secondary prevention of atherosclerotic cardiovascular disease. Most benefits of statin treatment mainly come from lowering low-density lipoprotein cholesterol levels. However, statins have pleiotropic effects on vascular dysfunction, inflammation, and immunomodulation beyond cholesterol-lowering, suggesting a positive impact on various health outcomes. All-cause mortality is a commonly chosen outcome in randomized controlled trials (RCTs) of statins. Nevertheless, the effect of statin treatment on the risk of all-cause mortality remains uncertain since it has usually been evaluated as a secondary outcome or a component of the primary composite outcome. A recent meta-analysis of RCTs also failed to draw a clear conclusion on this issue. Further studies investigating all-cause mortality as a primary endpoint are needed to determine the effect of statins on all-cause mortality from the perspective of evidence-based medicine.

골다공증성 척추압박골절의 근거기반 치료법

이수범,조대철,김경태,이영석 대한의사협회 2021 대한의사협회지 Vol.64 No.3

The prevalence and medical costs of osteoporotic vertebral compression fractures (OVCFs) are on the rise. However, a concrete evidence-based treatment guideline has not yet been established. Despite that numerous randomized controlled trials (RCTs) were performed, the study design and outcome measurement were heterogeneous, and the results were not unified. The purpose of this review is to compare the results of high level-evidence studies to provide a background for evidence-based OVCF treatment. Many reports showed that vertebroplasty has better clinical outcomes than non-surgical treatment for OVCF, but the results of three double-blinded RCTs with the highest level of evidence did not show a significant difference between vertebroplasty and sham procedure. Whether undergoing surgical or non-surgical treatment, OVCF patient management should be started by managing osteoporosis first. Meanwhile, in the results of RCTs related to the comparison of conservative treatment modalities, the benefit of braces and a specific analgesic prescription protocol was also unclear. The presented results of each clinical trial were generally inconsistent and may not be appropriate in all situations. Any decision by clinicians to apply this evidence must be made considering individual patients and available resources. At present, controversy remains about the best treatment modality for OVCF. Large, multicenter, placebo/sham-controlled trials are needed to address this gap and establish strong evidence-based guidelines.

무작위 임상시험의 윤리적,법적 문제

최경석 ( Kyung Suk Choi ) 한국의료윤리학회 2008 한국의료윤리학회지 Vol.11 No.1

Human experimentation can be ethically justified when subjects participate on a voluntary basis. Informed consent is required for clinical trials, including randomized clinical trials. Nevertheless, ethical issues arise when subjects are randomly distributed to experimental and control groups in randomized clinical trials. I argue that equipoise as well as informed consent is a condition of randomized clinical trials. Benjamin Freedman distinguishes theoretical equipoise from clinical equipoise. I call the former the "individual physician equipoise" and the latter the "clinical community equipoise". Under clinical community equipoise, randomized clinical trials are ethically justified because physicians may still provide the best treatment to their patients. The above ethical principle should be applied to placebo-controlled randomized clinical trials. When experimental drugs and placebos are in clinical community equipoise, a trial may be ethically justified. In addition, placebo-controlled randomized clinical trials should be designed with double-blinding. The reason for this requirement is that physicians would cheat their patients without doubleblinding. Current FDA regulations in Korea and the US do not sufficiently reflect the above ethical points. Institutional review boards should review their protocols in light of these ethical points. In particular, IRB regulations should reflect the basic ideas of equipoise in randomized clinical trials and double-blinding in placebo-controlled randomized clinical trials.