• Title/Summary/Keyword: RCTs Review

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The Systematic Review of Clincal Trial(s) Intervening Traditional Korean Herbal Medicine: Extension of Developing Clinical Guideline for Hwa-byung (화병 진료지침 개발을 위한 한약 임상시험 방법론 연구)

  • Kim, Seok-Hwan;Park, Bo-Ra;Choi, Keum-Ae;Lim, Hyun-Ju;Lee, Sang-Ryong;Jung, Dae-Gyu;Kim, Rak-Hyung;Kim, Tae-Hun;Kim, Kyung-Ok;Jung, In-Chul
    • Journal of Oriental Neuropsychiatry
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    • v.20 no.2
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    • pp.163-176
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    • 2009
  • Objectives : To address most probable and suitable method for designing clinical trial intervening Traditional Korean Herbal Medicine on hwa-byung. Study Design : A systematic review of research studies of complementary and/or alternative medical(CAM) treatment of depression, and of domestic clinical trials of Traditional Korean Medicine, and of Chinese clinical trials of Traditional Chinese Medicine. Methods : Randomized, controlled trials(RCTs) of treatment of depression intervening herbal medicine were searched through MEDLINE, Cochrane Library, and CNKI databases. Also, domestic RCTs intervening Traditional Korean Herbal Medicine were searched through Korean Traditional Knowledge Portal and Korean studies Information Service System(KISS). Studies were evaluated using Iadad scale and self-designed tool for this study. Results : Thirty four RCT studies( 10 from MEDLINE, 16 from CNKI, 8 domestic studies) of herbal medicine met inclusion criteria. Mean Jadad score of studies published in English was 2.8${\pm}$0.79, in Chinese 1.94${\pm}$0.77, and in Korean 2.75${\pm}$0.71. Twenty one percent of studies included pattern differentiation in their inclusion criteria. Twenty nine percent of studies used combined treatment of herbal and conventional medicine. Among studies on depression, 9% included Complementary Medical assessing tools. Conclusions : There is shortage of domestic clinical trial involving herbal medicine. In China, studies tend to focus on investigating effect of Combined treatment of herbal and conventional medicine on depression. Clinical trial(s) of hwa-byung should provide good internal validity by describing methodology for randomization, double-blinding, and attrition. Also, specific guideline for clinical trial, including Traditional Korean Medical aspects across inclusion criteria, and assessing tools is needed.

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A Systematic Review on the Reporting Quality of Acupuncture Treatment for Carpal Tunnel Syndrome (손목터널증후군에 사용된 침 치료 보고의 질 평가)

  • Hyun, Ji-Yoon;Shin, Joo-eun;Im, Chae-Jeong;Park, Ji-Yeun
    • Korean Journal of Acupuncture
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    • v.37 no.3
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    • pp.131-144
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    • 2020
  • Objectives : The aim of this study is to analyze the details of acupuncture treatment methods and the reporting quality of acupuncture on Carpal Tunnel Syndrome (CTS). Methods : Search was conducted in Pubmed, EMBASE, and Cochrane Library for acupuncture studies on CTS. The reporting quality of acupuncture treatment was assessed using the following guidelines: Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) for analyzing the method of acupuncture treatment, Consolidated Standards of Reporting Trials (CONSORT) for analyzing study design and study process, and Risk of Bias (ROB) for analyzing bias. The number of reported items was calculated and evaluated as a proportion. The reported proportion of each study was classified into three grades: Grade A (% score ≥75), Grade B (50≤ % score <75), and Grade C (% score <50). Results : A total of 9 Randomized Controlled Trials (RCTs) were included in this study. All trials reported 12 items (66.67%) on average in STRICTA guidelines. Five studies were conducted with manual acupuncture and 3 studies were conducted with electroacupuncture. PC7 (Daereung) was most frequently used to treat CTS. In STRICTA guideline evaluation, 3 studies were classified as Grade A, 5 studies were classified as Grade B, and 1 study was classified as Grade C. In the CONSORT statement assessment, all trials reported an average of 20.56 items. Of the 9 RCTs, 6 studies were classified as Grade B and 3 studies were classified as Grade C. In ROB assessment, most studies showed a low (63.49%) or unclear (26.98%) risk of bias. The selective reporting bias and the incomplete outcome data bias were found to have the lowest risk of bias, and the allocation concealment of selection bias was found to have the most unclear risk of bias. Conclusions : Recent acupuncture studies on CTS showed moderate reporting quality. However, more detailed reports on acupuncture are still needed to establish more solid evidence of acupuncture treatment.

A Review on Domestic Study Trends on Hot Flush in Menopausal Women with Traditional Korean Medicine (갱년기 여성의 안면홍조 증상에 대한 국내 한의학 연구 동향 분석)

  • Hong, Noo-Ri;Jang, Yeong-Suk;Yang, Su-Hyeon;Choi, Yun-Young;Oh, Da-Yoon;Lee, Soo-Jin;Namgoong, Jin;Kim, Jin-Hwan
    • The Journal of Korean Obstetrics and Gynecology
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    • v.33 no.1
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    • pp.86-103
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    • 2020
  • Objectives: The purpose of this study is to analyse the domestic trends of Traditional Korean Medicine on Hot flush in menopausal women. Methods: We searched six databases and selected relevant papers according to the criteria. Results: 12 papers included case report, literature review, randomized controlled clinical trials (RCTs), Non-RCTs, and retrospective chart analysis study design. 1. The daily diary, Kupperman's Index, Menopause Rating Scale, Menopause-specific Quality of Life Questionnaire, Digital Infrared Thermographic Imaging were used as a measure of the symptoms of hot flush. 2. There were significant correlations between Thermographic images, Pulse energy, Lifestyle Habits, Low frequency power/High frequency power (LF/HF) ratio and certain items of Menopausal Symptoms Measurement. 3. The case report using Er-Xian decoction and Hwangryunhaedoktang-Gamibang showed significant effect. 4. Domestic RCT studies using herbal or acupuncture treatments showed a significant value of 3.4 on average in the quality assessment conducted in the study. However, the number of domestic studies included was five, which is not enough compared to foreign countries. Conclusions: This study examined domestic research trends on hot flushes of menopausal women and found that various evaluation tools and diagnostic methods were applied. It is necessary to conduct various RCT studies in Korea, where the number of studies is insufficient compared to overseas.

Current Research Trends on Prevalence, Correlates with Cognitive Function, and Intervention on Sarcopenia in Community-dwelling Older Adults: Systematic Review (지역사회 거주 노인의 근감소증 유병률, 인지기능과의 관계 및 중재연구 동향: 체계적 문헌고찰)

  • Ahn, Soojung;Chu, Sang Hui;Jung, Hyejeong
    • 한국노년학
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    • v.36 no.3
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    • pp.727-749
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    • 2016
  • This systematic review was performed to investigate relationship between sarcopenia and cognitive function among community-dwelling older adults. Studies which reported prevalence rates of sarcopenia in community-dwelling older adults, relationships between sarcopenia and cognitive dysfunction, or effective interventions in alleviated symptoms of sarcopenia were selected. Of 43 studies reviewed, prevalence rate of sarcopenia ranged from 2.5-42.4% in 25 studies, and 4 studies revealed a significantly positive correlation between sarcopenia and cognitive dysfunction. Among 12 randomized-control trials (RCTs), exercise intervention was used in 2 studies; nutrition intervention in 6; and 4 studies included both the exercise and nutrition interventions. All interventional studies reported positive effects on muscle mass, muscle strength, or physical function. However, only 6 studies met the high quality criteria of Risk of Bias, and there was no study which evaluated cognitive function as an outcome measure. Therefore, this study draws attention to the lack of high-quality RCTs and exclusion of cognitive function as an outcome measure in the research of sarcopenia. A comprehensive and sustained system including standardized sarcopenia screening, assessments of cognitive functioning, and evidence-based intervention programs is needed in order to prevent and manage sarcopenia amongst older adults in the community.

Systematic Review on Presbycusis Treated by Herbal Medicine Focusing on Kidney Deficiency (노인성 난청의 한약 치료에 대한 체계적 문헌고찰: 신허(腎虛)을 중점으로)

  • Lim, Hui-yeong;Jin, Han-Sol;Ko, Woo-Shin;Yoon, Hwa-Jung
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.34 no.4
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    • pp.49-70
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    • 2021
  • Objectives : This study was conducted to approve the effectiveness and safety of herbal medicine on presbycusis with kidney deficiency. Methods : We searched randomized controlled trials(RCTs) on presbycusis patients diagnosed with kidney deficiency through 10 electronic databases from the start to Sep 7, 2021. Study collection and data extraction, and evaluation of risk of bias were conducted by two independent collaborator. The evaluation of the risk of bias in included RCTs was carried out by using Cochrane risk-of-bias tool. And the data synthesis was conducted by using Review Manager(RevMan, ver.5.4). Results : 1. The treatment group which used herbal medicine(HM) alone was more effective than the control group which used only western medicine(WM) on effective rate of hearing loss. 2. In 3 studies comparing the HM-WM combination treatment group with the control groups using the same WM treatment, the effective rate was statistically significantly higher in the HM-WM combination treatment group. 3. Of the 5 studies that reported adverse reactions, one study reported mild nausea and dizziness, but the difference between the HM treatment group and the WM control group was not statistically significant, and no side effects occurred in other 3 studies. 4. In studies comparing HM and WM, the HM treatment group improved hearing loss, whole blood viscosity, serum TNF-𝛼, IL-1𝛽, IL-6, and oxidative stress indicators better than the WM control group, and there was no significant difference. 5. In studies comparing the HM-WM treatment group with the WM control group, the severity of tinnitus, quality of life, and feelings of anxiety and depression were better in the treatment group than the control group. Conclusions : This study shows that the herbal medicine can improve symptoms of presbycusis with kidney deficiency.

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

  • Ji-eun Bae;Jae-won Park;Jun-kyu Lim;Mi-so Park;Jeong-su Hong;Dong-jin Kim
    • The Journal of Internal Korean Medicine
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    • v.43 no.6
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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.

Cardiovascular Outcomes of Sodium-Glucose Cotransporter-2 Inhibitors Therapy in Patients With Type 2 Diabetes Mellitus and Chronic Kidney Disease: A Systematic Review and Updated Meta-Analysis

  • Nicole Felix;Mateus M. Gauza;Larissa Teixeira;Maria Eduarda S. Guisso;Alleh Nogueira;Caroline S. Dagostin;Amanda Godoi;Sandro A. G. Ribeiro;Juan C. Duque;Jose A. Moura-Neto;Rhanderson Cardoso
    • Korean Circulation Journal
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    • v.54 no.9
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    • pp.549-561
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    • 2024
  • Background and Objectives: The efficacy of sodium-glucose cotransporter-2 inhibitors (SGLT2i) may depend on renal function, and this raises theoretical concern over its effects on cardiovascular outcomes in patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD). Methods: This systematic review and updated meta-analysis of randomized controlled trials (RCTs) compared cardiovascular outcomes of patients with T2DM and CKD treated with SGLT2i to placebo. PubMed, Embase, and Cochrane were systematically searched. Prespecified subgroup analyses were performed in strata of estimated glomerular filtration rate (eGFR) of <45 mL/min/1.73 m2 and 45 to 59 mL/min/1.73 m2. Results: Nine RCTs comprising 29,146 patients were selected. Average follow-up ranged from 0.75 to 4.2 years. SGLT2i were shown to reduce the risk of all-cause mortality (hazard ratio [HR], 0.88; 95% confidence interval [CI], 0.79-0.97; p=0.01), the composite of cardiovascular mortality or hospitalizations for heart failure (HHF: HR, 0.71; 95% CI, 0.65-0.78; p<0.001), cardiovascular mortality (HR, 0.86; 95% CI, 0.76-0.98; p=0.02), HHF (HR, 0.62; 95% CI, 0.55-0.71; p<0.001), major adverse cardiovascular events (HR, 0.85; 95% CI, 0.77-0.94; p=0.002), stroke (HR, 0.76; 95% CI, 0.59-0.97; p=0.03), and myocardial infarction (HR, 0.78; 95% CI, 0.67-0.91; p=0.001). These findings were consistent over strata of eGFR, albeit with a lower incidence of stroke in patients treated with SGLT2i with eGFR <45 mL/min/1.73 m2 (p-value for interaction=0.04). Conclusions: Compared with a placebo, patients with T2DM and CKD treated with SGLT2i experience a reduction in all-cause mortality, cardiovascular mortality, and HHF.

Clinical Research Trends on Mindfulness Meditation in Korea (마음챙김 명상관련 국내 임상연구 동향 분석)

  • Yang, Yeong-Pil;Song, Ick-Soo;Moon, Jin-Seok;Han, Chang-Hyun;Park, Ji-Ha;Lee, Sang-Nam
    • Korean Journal of Oriental Medicine
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    • v.16 no.2
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    • pp.57-64
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    • 2010
  • Background : Meditation is one of the healing therapies used to prevent and cure ailments and to improve health through regular practice. Although Meditation is within the paradigm of modern Western medical science, effects on the human body could be possible. Objectives : This study performed a systematic review of the literature published in Korea focused on mindfulness meditation (MM), which is being applied as mind-body therapy around the USA lately. Method : Three hundred sixty six articles were found after searching with keyword, 'mindfulness meditation (MM)' in 6 journals and web databases. Ninety papers related MM were analyzed trend, Seventeen randomized controlled trials (RCTs) and 38 controlled clinical trials (CCTs) were researched by systematic review. Result : Most of them were studies about relationship between MM and syndrome such as stress, depression, anxiety and MM was also applied to some disease like hypertension, temporomandibular joint disorder in some cases. In 55 studies, It was shown that MM has positive effects on various symptoms and sometimes the effect of MM showed at post and follow-up study although there was no significant difference between control group and experimental group in some cases according to outcome measurement. Interestingly, there was no study reported about side effects of MM after the application. Conclusions : MM is being clinically applied at both western and oriental hospital in Korea, but more clinical trials with the high quality are needed to support its scientific basis.

A Literature Review of Studies on Disaster Training for Nursing Students and Nurses (간호대학생 및 간호사 대상 재난교육 연구에 대한 문헌고찰)

  • Hong, Eun-Joo
    • Journal of Convergence for Information Technology
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    • v.10 no.5
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    • pp.60-74
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    • 2020
  • The purpose of this study is to review articles related to disaster training for nursing students and nurses by investigating the contents and effects of research. Electronic databases, including CINAHL, Pubmed and RISS were searched. Papers published only in English or Korean were included. Twelve studies were selected from the 3,588 references screened. Most training programs took less than 8 hours, focusing mostly on the response phase of disaster. Intervention methods included simulation, debriefing, action learning, role play, problem based learning and so on. It was found that disaster training programs have significant positive effects on disaster management competency, disaster knowledge, disaster nursing related self-confidence, and disaster response competency. It was also revealed that multidisciplinary practice would help learners enhance cooperation and collaboration with other team members and foster a positive professional identity. Among the selected articles, the randomized controlled trial(RCT) study was just one. Therefore, RCTs are further needed to verify the effects of such an disaster training. Also, further studies considering the characteristics of department and nursing interventions based on all phases of disaster are needed.

Effectiveness of Deep Breathing Exercise for Postoperative Pulmonary Complications Prevention: A Systematic Review (수술 후 폐 합병증 예방을 위한 심호흡 운동의 효과에 대한 체계적 고찰)

  • Lee, Worlsook;Yang, You Lee;Oh, Eui Geum
    • Journal of Korean Academy of Fundamentals of Nursing
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    • v.21 no.4
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    • pp.423-432
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    • 2014
  • Purpose: This study was done to evaluate effectiveness of deep breathing exercise as a postoperative intervention to prevent pulmonary complications. Methods: A search of databases from 1990 to 2012 was done including MEDLINE, EMBASE, CINAHL, Cochrane Library and eight Korean databases. Ten studies met eligibility criteria. Researchers trained in systematic review, independently assessed the methodological quality of selected studies using the Cochrane's risk of bias tool. Data were analyzed using RevMan 5.2 program. Results: Among ten RCTs in four studies, deep breathing exercise was compared with an instrument using interventions such as incentive spirometry, in the other four studies deep breathing exercise was compared with non-intervention, and in last two studies bundles of interventions including coughing and early ambulation were assessed. A significant difference was found between deep breathing exercise group and non-intervention group. The odds ratio (OR) of occurrence of pulmonary complications for deep breathing exercise versus non-intervention was 0.30. However, there was no significant difference between deep breathing exercise group and incentive spirometry group (OR=1.22). Conclusion: Deep breathing exercise is vital to improving cost-effectiveness and efficiency of patient care in preventing postoperative pulmonary complications. For evidence-based nursing, standardized guidelines for deep breathing in postoperative care should be further studied.