• Title/Summary/Keyword: Randomized controlled trial (RCT)

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Integrative Review of Sex Education for School Age Children (학령기 아동의 성교육에 대한 통합적 고찰)

  • Lee, Jaeyoung;Je, Minji
    • Journal of the Korean Society of School Health
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    • v.30 no.3
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    • pp.251-265
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    • 2017
  • Purpose: This study is an integrative review to analyze articles about sex education for school age children in Korean journals. This study explored the year, methods, major variables and key findings of previous studies. Methods: Five electronic databases and eleven journals of nursing in Korean language were searched to find studies done until 2017. 75 papers published from 1995 to 2017 were selected (43 were survey studies and 32 were intervention studies). Results: Among the intervention studies, there was no Randomized Controlled Trial (RCT) study. Most intervention studies were conducted to change sexual knowledge and sexual attitudes. Among the survey studies, Q methodology and content analysis were used. The subjects' sexual knowledge and sexual consciousness were measured low in some studies. The sex education for school age children was composed of elementary school students' perception, understanding and needs related to sex. In addition, sex education was carried out to improve students' informational aspects such as sexual knowledge, prevention of sexual violence and secondary sexual character as well as emotional aspects such as sexual attitude. However, research on sexual consciousness, sexual values and sexual identity was insufficient. Conclusion: In order to develop an effective sex education program for school age children, it is necessary to consider the degree of their perception, understanding and needs and reflect both the social and cultural aspects as well as the informational and emotional aspects.

Chuna Manual Therapy for Tourette's Syndrome: A Systematic Review and Meta-Analysis (뚜렛 장애에 대한 추나요법의 효과: 체계적 문헌 고찰 및 메타분석)

  • Kim, Hyeon-Ji;Lee, Eun-Byeol;Kim, Chae-Young;Ahn, Hee-Duk
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.17 no.1
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    • pp.21-33
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    • 2022
  • Objectives To assess the effectiveness of Chuna manual therapy in patients with Tourette's syndrome. Methods We queried nine electronic databases using the keywords "Tourette's Syndrome" and "tuina OR chuna" to identify RCTs that investigated the effectiveness of Chuna manual therapy in patients with Tourette's syndrome. Results Thirteen RCTs were selected according to the inclusion criteria. A systematic review showed that Chuna manual therapy can have a curative effect on patients with Tourette's syndrome. Conclusions In this study, 13 RCTs reported that Chuna manual therapy was effective for Tourette's syndrome. These findings provide a basis for its clinical use. However, all studies involved populations belonging to the same country. Many studies lacked details of the research methodology. Therefore, further studies are required to produce high-quality evidence.

Study on the Significance of Health Services Research Methods for Studying Traditional Korean Medicine (한의학 연구에 있어 의료서비스연구가 갖는 의의 고찰)

  • Park, Yu-Ri;Seo, Sang-Rok;Kim, Young-Jin;Kim, Yu-Lee;Kim, Jae-Hyo;Ahn, Seong-Hun;Sohn, In-Chul
    • Korean Journal of Acupuncture
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    • v.27 no.2
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    • pp.79-94
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    • 2010
  • Objectives : Many researchers in western societies raised questions on methodological limitations of randomized controlled trial (RCT) for studying Complementary and Alternative Medicine (CAM), and they have tried to find alternatives to RCT. Some of them recently have interest in health service research as one of the alternatives. Discussing the significance of health services research in CAM studies will be helpful to guide the researchers in Korea who are also interested in developing an appropriate research methodology for traditional Korean medicine. Methods : Previous studies on methodological issues of studying CAM and health service researches published in western societies until 2009 were searched mainly from Pubmed. The definition, main research domains, and research methods of health service research and the significance of it for researches on CAM were summarized. Results & Conclusions : Health service researches are important in two aspects. First, health service researches evaluate the actual practice of CAM, including the individualized diagnosis as well as treatment and interaction between practitioners and patients. Second, when evaluating the outcomes, they put an emphasis on subjective evaluation by patients as well as objective evaluation by doctors. Thus, it can reflect the treatment goals of CAM which is improving the overall quality of life and the physical and psychological health. Therefore, health services researches such as descriptive studies, qualitative studies, outcomes studies including economic evaluation, and whole systemic research should be more utilized in order for studying traditional Korean medicine.

An Analysis of Clinical Research Trends on Interventions of Oriental Medicine for Postpartum Disease and Postpartum Care (산후병 및 산후관리에 대한 국내 한의학 임상 연구 동향 분석)

  • Kim, Nu-Ree;Lee, Eun-Hee
    • The Journal of Korean Obstetrics and Gynecology
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    • v.35 no.1
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    • pp.34-58
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    • 2022
  • Objectives: This study was performed to analyze the interventions of Oriental Medicine which had been commonly used for postpartum disease and postpartum care. Methods: We searched research on the interventions for postpartum disease and postpartum care in 4 domestic search engines. After that, we conducted eligibility screening based on inclusion and exclusion criteria. Results: 1. We selected total 50 studies. There were 2 randomized controlled trial (RCT), 5 non-RCT, 35 case reports, 8 case series within the 6~8 weeks after childbirth. 2. Of the 35 case reports, several interventions were used : acupuncture (22), moxibustion (11), cupping therapy (7), pharmacopuncture (5), chuna manipulation (4), herbal medicine (34). The most common symptoms were musculoskeletal symptoms (8), followed by postpartum depression (7). Various prescriptions and acupoints of oriental medicine were used depending on the diseases or symptoms. 3. Of the 8 case series, 382 subjects in 5 case series had taken Saenghwa-tang-gagam. And Acupuncture, moxibustion, cupping therapy (5), pharmacopuncture (1) were used as an intervention. 4. The most commonly used acupoint is 腎兪 (BL23) in the pain including postpartum back pain and 三陰交 (SP6), 關元 (CV4) in the postpartum care. 關元 (CV4) is the most commomly used moxibustion point not only the postpartum disease but also the postpartum care. Conclusions: In clinical studies of oriental medicine related to postpartum disease and postpartum care, pain-related clinical studies that belong to or progress to Sanhupung were the most common (30%), and among them, postpartum low back pain studies were the most common (20%). Based on this, we believe that large-scale clinical studies with high quality using oriental interventions including chuna and pharmacopuncture are needed to establish guidelines for the management of pain treatment including postpartum back pain.

The Study on the Effectiveness of Acupuncture in Stroke Rehabilitation (중풍(中風) 재활(再活)의 침치료(鍼治療) 효과(效果)에 대한 고찰(考察) -최근 RCT(Randomized controlled trial) 논문을 중심으로-)

  • Kim, Eun-jung;Lee, Jae-dong;Kang, Sung-keel
    • Journal of Acupuncture Research
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    • v.22 no.1
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    • pp.211-221
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    • 2005
  • Objective : The aim of this study is to review clinical trials on the effectiveness of acupuncture in stroke rehabilitation. Methods : Computerized literature searches was carried out on three electronic databases, and hand-searching on some chinese medical journals in library of Kyung Hee Medical Center. Results : 1) Sixteen articles of clinical trials were collected and reviewed. Among these articles, randomized controlled trials were achieved in nine articles. 2) In three articles, statically significant results in improvement of mobile abilities, activities of daily life and Quality of life were reported after acupuncture treatment applied as a part of stroke rehabilitation. In three articles no statically significant changes were reported. 3) Among two articles about spasticity, One about the upper limbs and the results showed statically significant improvement of the spasticity after acupuncture treatment as stroke rehabilitation, and the other was about the lower limbs and the results showed no statically significant changes. 4) One article about acupuncture and postural control showed statically significant results suggesting that acupuncture promotes normalization of postural control after stroke.

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Comparison of the Effects of Topical Nasal Application on Allergic Rhinitis between Korean and Western Medicine : A Systematic Review of Randomized Controlled Trials (알레르기성 비염에 대한 한약 및 양약 국소비강외용제의 효과 비교 : 체계적 문헌 고찰)

  • Jo, Hyo-Rim;Oh, Se-Hee;Kim, Seon-Hye;Sung, Won-Suk;Hong, Seung-Ug;Kim, Eun-Jung
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.32 no.4
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    • pp.62-89
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    • 2019
  • Objectives : The purpose of this study is to evaluate the effectiveness and safety of topical nasal application of Herbal medicine compared with Western medicine in the treatment of Allergic Rhinitis(AR). Methods : Electronic databases including Cochrane library, PubMed, EMBASE, CNKI, KMBASE, KISS, NDSL, OASIS, KISS and KJTK(Korean Traditional Knowledge Portal) were searched by the keywords such as 'allergic rhinitis', 'nasal sprays', 'herbal medicine', 'plant extracts', and 'external application'. The quality of each RCTs was assessed by Cochrane Collaboration of 'Risk of bias(RoB) Tool'. Results : 19 RCTs were finally selected from 1419 references screened. 19 RCTs were compared with the effects of topical nasal application of Herbal medicine and Western medicine. Based on the symptom scores from 13 RCTs, topical nasal application of herbal medicine generally has a better effect on relief of AR. The two treatments have similar effects on improving the level of specific factors like IgE, IgG, IL-13, $uLTD_4$ in blood and urine. 8 RCTs showed adverse effects(AEs) in both groups and severe AEs were not reported. Conclusions : This study shows that topical nasal application of herbal medicine can improve symptoms and related factors of allergic rhinitis. Well-designed RCT studies with low risk of bias should be conducted to confirm these findings.

Analysis of Food Intake and Physical Activity in Randomized Controlled Trials on Herbal Medicine for Treatment of Human Obesity (비만 치료 한약 무작위 대조 임상시험에서의 음식 섭취량과 운동량 실태분석)

  • Kim, Doo-Hee;Shin, Woo-Suk;Park, Won-Hyung;Cha, Yun-Yeop;Song, Yun-Kyung;Ahn, Min-Youn;Ko, Seong-Gyu
    • Journal of Korean Medicine for Obesity Research
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    • v.13 no.2
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    • pp.58-65
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    • 2013
  • Objectives: The objective of this study was to analyse the methods being used to control food intake and physical activity in RCTs of human obesity. Methods: A total of 21 randomized controlled trials (RCTs) were investigated. Nine of which were domestic studies from "http://oasis.kiom.re.kr" and the other of which were foreign studies from systematic reviews of RCTs on herbal medicine for treatment of human obesity. Results: According to domestic studies, "low calorie diet" were recommended in five cases of the domestic studies, "maintain current dietary habit" were recommended in two and no information on diet was two. Considering the seven cases where the information on diet was available, patients' food intake were checked at every visit in six cases. Only two cases among the six had been dropped owing to the violation of dietary habit by patients. Exercises were prohibited in two cases, "maintain current level of phisical activity" were recommended in three cases and, from the rest, no information was available. The level of physical activity were not strictly controlled by any means hence no drop out. According to foreign studies, "low calorie diet" were recommended in two cases, "very low calorie diet (less than 700 kcal/day)" in one case, "maintain current dietary habit" in two cases, "do not eat fat" in two cases and no information was available in the rest five cases. Exercises which concerns spending about 300 kcal/day was recommended in one case, "moderate exercise" were recommended in three cases, "maintain current level of physical activity" were recommended in three cases and no information available in the rest five cases. Conclusions: In order to improve the accuracy of RCT, for the dietary side, researchers should record patient food intake at every visit by means of 24-hour dietary recall methods. This can be supplemented by multiple choice survey that are designed to help patients to diagnose themselves more accurately leading to less bias. For the exercise side, it is highly recommended to confine the exercises to walking only so as to quantify the amount of physical activity more easily by using pedometer.

Efficacy and Safety of COVID-19 Vaccines in Adolescents: Systematic Review of Randomized Controlled Studies and Observational Studies

  • Soo-Han Choi;Su-Yeon Yu;Jimin Kim;Miyoung Choi;Youn Young Choi;Jae Hong Choi;Ki Wook Yun;Young June Choe
    • Pediatric Infection and Vaccine
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    • v.31 no.1
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    • pp.12-24
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    • 2024
  • The number of pediatric coronavirus disease 2019 (COVID-19) cases worldwide are increasing compared to the early phase of the pandemic, along with highly transmissible severe acute respiratory syndrome coronavirus variant and the increase in adult COVID-19 vaccination. We conducted a rapid systematic review and meta-analysis of published randomized clinical trials (RCTs) of the COVID-19 vaccines and the observational retrospective studies on adverse events after COVID-19 vaccination in adolescents. Seventeen studies were finally included in this systematic review. Meta-analysis showed that although vaccination in adolescents was significantly effective to prevent COVID-19 infection in retrospective studies (risk ratio [RR], 0.29; 95% confidence interval [CI], 0.22-0.37; I2 =100%), however the effect of preventing COVID-19 infection was lower than in RCTs (RR, 0.05; 95% CI, 0.01-0.27). In five retrospective studies, the pooled estimated proportion of participants with myocarditis and/or pericarditis was 2.33 per 100,000 of the population (95% CI, 0.97-5.61 per 100,000). Sub-group analysis with sex and vaccine doses showed that male (5.35 per 100,000) and the second dose (9.71 per 100,000) had significantly higher incidence of myocarditis and/or pericarditis than female (1.09 per 100,000) and the first dose (1.61 per 100,000), respectively. Our study showed that mRNA COVID-19 vaccines in adolescent recipients were favorable and effective against COVID-19 in RCT as well as observational studies. The safety findings of BNT162b2 vaccine in adolescents were explored and we found the difference of safety according to sex and vaccine doses. The occurrence of adverse events after mRNA COVID-19 vaccination should be monitored.

Herbal Medicine for the Treatment of Viral Hepatitis B and C: A Systematic Review of Randomized Controlled Trials (B형 및 C형 간염에 대한 한약 치료의 효과 - 체계적 고찰 연구)

  • Kim, Seung-mo;Lee, Yu-ri;Cho, Na-kyung;Choi, Hong-sik;Kim, Kyung-soon
    • The Journal of Internal Korean Medicine
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    • v.42 no.4
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    • pp.455-474
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    • 2021
  • The aim of this study was to perform a systematic review and meta-analysis of randomized controlled trials (RCTs) that applied herbal medicine to treat viral hepatitis B and C in order to determine the therapeutic efficacy of herbal medicine. EMBASE, Pubmed, NDSL, KMBASE, KISS, KISTI, Koreamed, Koreantk, and Oasis databases were searched to identify RCTs. The selected studies were assessed by the Cochrane group's risk of bias tool. A total of 15 RCTs were selected, and the hepatitis B virus (HBV) DNA reduction was significantly higher in patients treated with herbal medicine combined with Western medicine than in patients treated with herbal medicine. Herbal medicine combined with Western medicine was also superior to Western medicine alone in achieving hepatitis B e-antigen (HBeAg) and alanine aminotransferase [ALT] reduction. Only herbal medicine alone was not superior to Western medicine treatments in achieving HBV DNA, HBeAg, and ALT reduction.

Orally Administered Korean Herbal Medicine Medications of Randomized Controlled Trials Published in the Journal of Korean Medicine and Related Journals: A Narrative Analysis using CONSORT-CHM 2017 (CONSORT-CHM 2017 지침에 근거한 대한한의학회지 및 회원학회지에 투고된 경구투여 한약 중재를 활용한 무작위 배정 비교 임상 연구(RCT)의 양적, 질적 평가 연구)

  • Se-hun Moon;Jung-ho Jo;Seung-kwan Choi;Yun-hee Han;Hyeon-jun Woo;Byeong-hyeon Jeon;Won-bae Ha;Jung-han Lee
    • The Journal of Internal Korean Medicine
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    • v.44 no.6
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    • pp.1212-1242
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    • 2023
  • Objectives: This study aims to explore the current usage status of orally administered Korean herbal medicine in randomized controlled trials (RCTs) published in the Journal of Korean Medicine and member journals using the CONSORT-Chinese Herbal Medicine Formulas 2017 (CONSORT-CHM 2017) checklist. Methods: We searched the OASIS, RISS, and KMBASE archives as well as the websites of the Journal of Korean Medicine and 45 member journals to identify RCTs that used herbal interventions. Two independent researchers searched and categorized the RCTs and performed a quantitative evaluation by journal, study design, and target disease, as well as qualitative evaluation of the literature using CONSORT-CHM 2017. Results: After the search, 66 articles were selected. The quantitative evaluation resulted in 13 articles (19.6%) that were published in the Journal of Korean Medicine and 12 articles (18.1%) in the Journal of Internal Korean Medicine. In terms of study design, 62 articles (93.9%) were parallel, 4 articles (6%) were crossover, and 2-arm parallel study designs were the most common in 45 articles (68.2%). In terms of the study participants, physiological characteristics and mechanisms in healthy individuals were the most common in 21 studies (31.8%) and obesity in 9 studies (13.6%). In terms of assessing completeness in the CONSORT-CHM 2017 items, 29 articles were rated high, 31 were rated moderate, and 6 were rated low. Items 4a, 6a, and 7a had low reporting rates (≤ 30%), while items 2a, 2b, and 12a were completely reported in all studies. Conclusion: Future RCTs using orally administered Korean herbal medicine need to be reported completely, and the CONSORT-CHM 2017 checklist can be a helpful tool for this purpose.