• Title/Summary/Keyword: RCT(Randomized Controlled Trial)

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Quality Assessment of Randomized Controlled Trials using Herbal Remedies in Korea (국내 한약 처방을 이용한 무작위 배정 임상연구논문의 질 평가)

  • Kim, Yun-Young;Yoo, Jong-Hyang;Lee, Su-Kyung;Lee, Si-Woo
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.25 no.5
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    • pp.927-933
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    • 2011
  • This study aimed to evaluate the quality of herbal medicine-related RCT (Randomized controlled clinical trial) papers. 79 papers were searched from the domestic Hakjin paper list, and 16 papers of them were evaluated in terms of the Jadad Quality Assessment Scale and the adequacy of allocation concealment, and ethical validity. The evaluation results from Jadad Quality Assessment Scale showed that 15 papers showed high quality with the Jadad score of 3 points or higher, and none of the papers had a problem with randomization and double-blinding. The evaluation results from adequacy of allocation concealment showed that 3 of the papers were executed proper allocation concealment, and all of them had 5 points of Jadad score. IRB (Institutional Review Board) approval and written consent was investigated for the evaluation of ethical validity, and 12 papers had the IRB approval, and 14 papers had written consent. The papers published before 2005 were absent of IRB approval and written consent, and none of the papers had IRB approval number. From the above results, it is concluded that rigorous clinical research led high quality of research papers, and the ethical aspect of clinical researches are getting more important to protect the rights of research participants.

Review of Clinical Research on Effect of Traditional Chinese Medicine for Febrile Seizure (열성 경련에 대한 중의학 임상 연구 동향 - RCT를 중심으로 -)

  • Lee, Bo Ram;Lee, Eun Ju;Lee, Ji Hong;Chang, Gyu Tae
    • The Journal of Pediatrics of Korean Medicine
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    • v.30 no.3
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    • pp.78-96
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    • 2016
  • Objectives The purpose of this study is to provide clinical evidence of Korean medicine for febrile seizure by review of randomized controlled trials on the effect of TCM (traditional Chinese medicine) for febrile seizure. Methods We searched randomized controlled trials about TCM treatment of febrile seizure from the China National Knowledge Infrastructure (CNKI) (January 2008 to June 2016). The selected literatures were assessed by Jadad scale. Results 40 papers were selected from 160 studies. Analyses of selected studies indicated that the TCM treatment group has significantly higher cure rate for febrile seizure than first aid or western medicine group. The most commonly used herbs were Gardeniae Fructus (梔子), Uncariae Ramulus cum Uncis (鉤藤), Cornus Gazeliae (羚羊角), Margarita (珍珠), Scutellariae Radix (黃芩), Glycyrrhizae Radix (甘草). The most commonly used acupoints were GV26 (人中), LI4 (合谷), KI1 (湧泉), GV20 (百會). There were no serious adverse events reported from the TCM treatment group during the treatment period. Conclusions TCM has been shown as not only effective but also safe treatment on febrile seizure. This finding can be widely utilized in clinical practice and can form the basis for development of clinical practice guidelines in future.

A comprehensive quality analysis of randomized controlled clinical trials of Asian ginseng and American ginseng based on the CONSORT guideline

  • Chen, Weijie;Li, Xiuzhu;Chen, Zhejie;Hao, Wei;Yao, Peifen;Li, Meng;Liu, Kunmeng;Hu, Hao;Wang, Shengpeng;Wang, Yitao
    • Journal of Ginseng Research
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    • v.46 no.1
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    • pp.71-78
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    • 2022
  • Ginseng is an international herb that has been used for thousands of years. Two species most commonly applied and investigated in the ginseng family are Asian ginseng and American ginseng. The number of randomized controlled clinical trials (RCTs) has conspicuously increased, driven by the rapid development of ginseng. However, the reporting of RCT items of ginseng is deficient because of different trial designs and reporting formats, which is a challenge for researchers who are looking for the data with high quality and reliability. Thus, this study focused on providing an extensive analysis of these two species and examined the quality of the RCTs, based on the Consolidated Standards of Reporting Trials (CONSORT) guideline. Ninety-one RCTs conducted from 1980 to 2019 that were related to Asian ginseng and American ginseng used singly met our inclusion criteria. We found that the reporting quality of the two species has improved during the past 40 years. Publication date and sample size were significantly associated with the reporting quality. Rigorous RCTs designed for the species of ginseng are warranted, which can shed light on product research and development of ginseng in the future.

Effect of Resistance Exercise Program for Middle-Aged Women with Myofascial Pain Syndrome on Shoulder Pain, Angle of Shoulder Range of Motion, and Body Composition Randomized Controlled Trial, RCT (견갑근막 동통증후군 중년여성에게 적용한 저항운동 프로그램이 어깨 통증, 견관절 가동범위 및 주위 신체조성에 미치는 효과)

  • Kim, WonJong;Hur, Myung-Haeng
    • Journal of Korean Academy of Nursing
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    • v.50 no.2
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    • pp.286-297
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    • 2020
  • Purpose: This study aimed to identify the effects of myofascial pain syndrome on shoulder pain, range of motion, and body composition around the shoulder in middle-aged women. Methods: A total of 72 women participated in the randomized controlled trial. The subjects were grouped into an experimental group (n=39) and a control group (n=33). The experimental group received a resistance exercise program using an elastic band for 8 weeks, 3 days a week. The control group followed a normal daily for 8 weeks. Measurements were conducted three times; before the experimental treatment (pre-test), the 2nd and 8th weeks after treatment. Results: Regarding the general characteristics and homogeneity of the dependent variables, there were no significant differences between the two groups, except for the thickness of the left and right muscles and the left fat. After treatment, shoulder pain was significantly different between the two groups (F=18.54, p<.001) and the range of shoulder motion was significantly different (left, F=86.70, p<.001; right, F=98.66, p<.001). Furthermore, there were a significant differences in the thickness of muscles between the two groups (left, F=40.20, p<.001; right, F=29.57, p<.001); however, the thickness of fat was not significantly different. Conclusion: The resistance exercise program reduces shoulder pain and improves the range of motion of the shoulder joint and increases muscle mass on around the shoulder. It suggests to conduct a study to confirm the long-term exercise effect.

Effect of Self-Complex Exercise Program on Pain, Function, Psychosocial, Balance Ability, and TrA Muscle in Patients with Lumbar Instability: A Randomized Controlled Trial (허리 불안정성이 있는 허리통증 환자에게 실시한 자가-복합 운동프로그램이 통증과 기능, 심리사회적, 균형 능력 그리고 배가로근에 미치는 효과)

  • Yoon, Jong-Hyuk;Jeong, Dae-Keun;Park, Sam-Ho
    • Journal of The Korean Society of Integrative Medicine
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    • v.10 no.2
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    • pp.73-83
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    • 2022
  • Purpose : Low back pain (LBP) is reported as a risk of experiencing musculoskeletal disorders due to muscle stiffness and hypokinetics. The lumbar spine in an unstable state causes imbalance and lumbar instability. Therefore, This study examined the effects of lumbar stabilization exercise and self-complex exercise program on pain, function, psychosocial level, static balance ability, and transverse abdominal muscle (TrA) thickness and contraction ratio in patients with lumbar instability. Methods : The design of this is a randomized controlled trial (RCT). Twenty-six LBP patients participated in this study. Screening tests were performed and assigned to the experimental group (n=13) and control group (n=13) using a random allocation program. Both groups underwent a lumbar stabilization exercise program. In addition, the experimental group implemented the self-complex exercise program. All interventions were applied three times per week for four weeks. The quadruple visual analog (QVAS), the Korean version of the Oswestry disability index (K-ODI), Korean version of fear-avoidance belief questionnaire (FABQ), static balance ability, TrA thickness, and contraction ratio were compared to evaluate the effect on intervention. Statistical significance was set at 𝛼=.05. Results : Both groups showed significant differences before and after the intervention in QVAS, K-ODI, FABQ, static balance ability, and TrA thickness in contraction (p<.05). In addition, significant differences in K-ODI and FABQ were observed between the experimental group and control group (p<.05). Conclusion : A lumbar stabilization exercise and self-complex exercise program resulted in reduced dysfunctions, psychosocial stability in patients with lumbar instability. Therefore, Lumbar stabilization exercise and self-complex exercise program for patients with lumbar instability are effective method with clinical significance in improving the function and psychosocial stability.

Analysis of Main Single Medicinal Herbs for Anti-Obesity Miyoung Song, Hojun Kim Department of Oriental Rehabilitation Medicine, College of Oriental Medicine, Dongguk University Received: November (비만에 작용하는 주요 본초의 항비만 효과 분석)

  • Song, Miyoung;Kim, Hojun
    • Journal of Korean Medicine for Obesity Research
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    • v.13 no.2
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    • pp.51-57
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    • 2013
  • Objectives: This study was conducted to analyze anti-obesity effects of the main single medicinal herbs which have effects on obesity or metabolic syndrome. Methods: We selected the 8 main single medicinal herbs, and then 3 databases were searched using search words "obesity", and "each scientific name of selected 8 main herbs". Results and Conclusions: Only Ephedra sinica and Panax ginseng were analyzed through 3 methods, in vitro, animal studies and randomized controlled trial (RCT)s, Ephedra sinica was shown weight loss effects in RCTs, but Panax ginseng couldn't. Other 6 selected medicinal herbs were not verified in RCTs, all had anti-obesity effects in high fat fed mice (or rats) and the others except for Radix notoginseng and Radix puerariae had inhibitory effects on lipid accumulation in 3T3-L1 cells.

Pre-emptive analgesia efficacy of piroxicam versus tramadol in oral surgery

  • Tejdeep, Muthuluri;Siddardha Gowtam, Chandrupatla;Ritesh, Rajan;Viveka V., Reddy;Dinesh K., Jhawar;Abhinand, Potturi
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.22 no.6
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    • pp.443-450
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    • 2022
  • Background: This double-blind randomized controlled trial (RCT) was conducted to evaluate the pre-emptive analgesia and anti-inflammatory efficacy of piroxicam compared with tramadol in patients undergoing oral surgery. Methods: Seventy-eight patients who required extraction of impacted mandibular third molars were randomized into three treatment groups of 26 patients each: group I received 100 mg of tramadol, group II received 20 mg of piroxicam, and group III received a placebo. Drugs were administered intramuscularly 30 min prior to the extraction procedure. Results: Pain intensity, time to first analgesic administration, total analgesic consumption, facial edema, and trismus were the outcomes of interest. The group receiving 20 mg of piroxicam showed significantly lower pain intensity, increased time to first analgesic, and reduced edema from preoperative to postoperative day seven than those in the tramadol and placebo groups. Conclusion: The findings of this study showed that piroxicam had significant pain relief efficacy after third molar surgery compared with that in tramadol.

Chuna Manual Therapy for Premature Infants: A Literature Review (조산아의 추나 치료에 대한 문헌 고찰)

  • Ju-Chan Cho;Hye-Jin Park;In Heo
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.18 no.2
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    • pp.23-29
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    • 2023
  • Objectives This study aimed to explore literature evidence regarding Chuna manual therapy for premature infants and determine its applicability. Methods Eight electronic databases were searched, and randomized control trials (RCTs) applying Chuna manual therapy to premature infants were sought. The Cochrane risk of bias tool was employed to assess the methodological quality of each RCT. Results Two RCTs met the inclusion criteria and were subjected to analysis. Each study compared the usual care group with the pediatric Chuna group. The results indicated improvements in nutritional status, a reduction in hospitalization days, and enhancements in growth indicators. Conclusions Chuna manual therapy is worth applying to premature infants. However, evidence is limited due to a lack of well-designed RCTs. More qualified clinical trials are needed to obtain stronger evidence.

Analysis on Intervention Studies of Sasang Constitutional Diet : Participant, Intervention, Comparison, and Outcome (PICO) (사상체질 식이중재연구 현황분석 : Participant, Intervention, Comparison, Outcome (PICO)를 중심으로)

  • Kim, Ji Hwan
    • Journal of Sasang Constitutional Medicine
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    • v.33 no.1
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    • pp.90-101
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    • 2021
  • Objectives The purpose of this study was to evaluate intervention studies on Sasang Constitutional diet (SCD) through the checks of Participant, Intervention, Comparison, and Outcome (PICO) Methods Randomized controlled trial (RCT) and non-randomized study for intervention (NRSI) about SCD were searched in 4 Korean core databases and other sources, and then PICO was checked. Results 1. Total 10 studies were conducted with 1 RCT and 9 NRSIs. 2. Participants were people with no specific disease, or patients with essential hypertension, hyperlipidemia, obesity, or stroke with diabetes or hyperlipidemia. Most studies were conducted on groups of various Sasang Constitutional types except Taeyangin. 3. Two studies provided participants with meals and exercise. Three studies, instead of providing meals directly, taught participants how to eat SCD on their own. 4. NRSIs have tested the effectiveness of various outcome measures without the presentation of primary outcome, and then concluded that all outcomes were ineffective or some are effective. 5. There was no mention of adverse events. In most studies, a single doctor of Korean medicine diagnosed Sasang Constitution the QSCC II questionnaire. The intervention period ranged from three weeks to three months, and recent studies have conducted interventions for 12 weeks. Conclusions Intervention studies about SCD which were conducted so far have shown problems on the study design of PICO items. The study design and implementation that carefully consider how to maintain similarity between groups, minimize the risk of bias, set primary outcome measure, and control the diet are required.

A Review of Acupuncture and Moxibustion for the Treatment of Parkinson's Disease (파킨슨병의 침구치료 동향에 대한 고찰)

  • Lee, Eun;Kang, Ki-Wan;Kim, Lak-Hyung;Kang, Sei-Young;Sun, Seung-Ho;Han, Chang-Ho;Jang, In-Soo
    • The Journal of Internal Korean Medicine
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    • v.35 no.1
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    • pp.12-23
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    • 2014
  • Objectives : The purpose of this study was to report possibility of acupuncture or moxibustion for the treatment of Parkinson's disease (PD) by reviewing literature about its effectiveness. Methods : In this review, PubMed, SCOPUS, Science Direct and CINAHL of EBSCOhost were used to search medical journals, using keywords "Parkinson's disease and acupuncture" and "Parkinson's disease and moxibustion". The search range included randomized controlled trials (RCT) about Parkinson's disease combined with another disease and other treatments with acupuncture or moxibustion. Non-randomized controlled trial (nRCT), case study, animal experiment, human experiment, review, survey, essay, letter, and protocol for review were excluded. Results : From 311 studies, 111 were selected during the title and the screening. Finally, 16 RCTs (15 for acupuncture research and one for moxibustion) were included in this review, after scanning and matching the inclusion and exclusion criteria. The number of patients varied between 5 and 88. A total of 12 studies using electroacupuncture (EA) were classified into acupuncture studies. The body acupuncture studies numbered 4, scalp acupuncture 4, body and scarp acupuncture mixed studies 4, and bee venom, ear and abdomen acupuncture were each one study. In evaluation methods, total effective rate method was used in 9 studies, the Unified Parkinson's Disease Rating Scale (UPDRS) was used in 8, and the Webster score in 2. In addition, the Berg balance scale (BBS), 30 m walking time, steps to walk 30 m, PD motor function score, and Motor Performance Series by Schoppe (MLS) method were used for evaluation. In 15 of the 16 studies, the verum acupuncture group showed significant improvement compared with the control. In 9 studies using total effective rate method, the effective rate was reported as 80.0-97.3% in verum acupuncture groups and 52.6-86.4% in controls. Conclusions : Acupuncture may be a plausible alternative method to care for the long term symptoms and treat movement impairment of Parkinson's disease. However, to confirm this result, high quality studies including randomized, placebo-controlled double-blind trials are warranted.