• Title/Summary/Keyword: non-randomized controlled trial

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A Systematic Review and Meta-analysis of Acupuncture Trials in Republic of Korea that Used Sham Acupuncture as a Control Group (거짓침을 대조군으로 사용한 국내 침 임상시험에 대한 체계적 고찰과 메타분석)

  • Kim, Jung-Eun;Kang, Kyung-Won;Kim, Tae-Hun;Lee, Seung-Hoon;Kim, Joo-Hee;Baek, Seung-Min;Choi, Sun-Mi
    • Journal of Acupuncture Research
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    • v.28 no.6
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    • pp.1-17
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    • 2011
  • Objectives : This study aimed to review randomized controlled trials of acupuncture performed in South Korea that used sham acupuncture as a control group. Methods : The following databases were searched through the end of September 2011: Koreanstudies information service system (KISS), Korean medical database (KMbase), national discovery OR science leaders (NDSL), oriental medicine advance searching integrated system (OASIS), and research information service system (RISS). The following search terms were used: acupuncture AND (sham or placebo). The reference lists of searched articles and Korea institute of oriental medicine (KIOM) reports(2005~2009) were identified. The following data were extracted: year/first author, disease, number of participants, blinding, intervention, outcome, and result. Where appropriate, we performed meta-analysis. The methodological quality was assessed according to the Jadad scale and 'risk of bias' by Cochrane Handbook procedure. Results : Twenty-nine studies were included in this review. In eighteen studies, penetrating sham controls were used as the control intervention, whereas the remaining eleven studies adopted non-penetrating sham controls such as the Park Sham Device or blunt auricular acupuncture. Nine studies showed statistically significant difference in outcomes. Twelve studies concerning insomnia after stroke, chronic tension-type headache, idiopathic Parkinson's disease, Hwa-Byung, and smoking cessation were included in meta-analysis. A meta-analysis of insomnia after stroke only found significant difference(MD -4.31, 95% Cl -6.19 to -2.42, $p$<0.00001). In general, all of the studies showed low methodological quality(Jadad score: mean 2.1). Risk of bias by Cochrane Handbook procedure varied. Conclusions : The results of this study could not suggest conclusive evidence that acupuncture is more effective than sham acupuncture in several diseases. In the future, more studies with rigorous acupuncture trials using sham controls should be conducted.

A Meta-analysis of the effects of Academic-related Satisfaction Intervention Programs for Nursing Students in Korea (메타분석을 이용한 간호 대학생의 학업 관련 만족도 중재프로그램의 효과)

  • Kim, Mina;Kim, Young A
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.20 no.10
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    • pp.218-228
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    • 2019
  • This study was conducted to review and analyze the academic-related satisfaction intervention programs for Korean nursing students and to provide evidence-based data. The data included in the meta-analysis were 25 studies published from 2001 to July 2018, and the design of the study consisted of 1 randomized controlled trial and 24 non-randomized controlled trials. The study subjects were nursing students from 1st to 4th grade, and the intervention program was conducted in theoretical and practical classes. The sample size was 1182 (mean: 47.3) in the experimental group and 1137 in the control group (mean: 45.5). The intervention program consisted of 1~16 weeks/1~16 sessions/7~240 minutes per session. Dependent variables were as follows: major satisfaction, learning satisfaction, satisfaction with the classroom practice, and satisfaction with the clinical practice. Satisfaction with the classroom practice (Hedges' g=0.876[95% CI: 0.405, 1.346]), satisfaction with the clinical practice (Hedges' g=0.515[95% CI: 0.312, 0.718]), and overall academic-related satisfaction (Hedges' g=0.630[95% CI: 0.371, 0.889]) were statistically significant and above intermediate levels in the meta-analysis. The study results are significant in that the objective results were confirmed by integrating the previous studies dealing with the academic-related satisfaction intervention program of nursing students.

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.

Effects of Transcranial Direct-Current Stimulation Therapy on Primary Chronic Insomnia: A Proof-of Concept Clinical Trial (일차성 만성불면증 환자에서 경두개 직류전기자극법 치료 효과: 개념 증명 연구)

  • Jun, Jin-Sun;Kim, Tae-Joon;Koo, Sun A;Park, Ji-Sook;Kim, Keun Tae;Yang, Tae-Won;Lim, Jung-Ah;Byun, Jung-Ick;Sunwoo, Jun-Sang;Jung, Ki-Young
    • Journal of Sleep Medicine
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    • v.15 no.2
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    • pp.37-42
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    • 2018
  • Objectives: To assess the effect and safety of transcranial direct-current stimulation (tDCS) in primary chronic insomnia. Methods: A one-month, double-blind, randomized, sham-controlled trial was performed. A total of 7 patients with primary chronic insomnia received tDCS using anodal (n=3), cathodal (n=2), or sham stimulation (n=2). They were followed up at 1 week and 1 month after treatment. The primary outcome measures included improvement in total sleep time (TST), sleep latency (SL), and sleep efficiency (SE) at 1 month follow-up. Results: TST and SE were improved with tDCS at 1 month follow-up in all patients (100%) of the anodal group, one (50%) of the cathodal group, and one (50%) of the sham group. tDCS improved SL at 1 month follow-up in two patients (67%) of the anodal group, one (50%) of the cathodal group, and none (0%) of the sham group. With respect to adverse events, transient itching sensation occurred in one patient of the anodal group. None of the other groups reported adverse events. Conclusions: Our results suggest that tDCS may be effective and safe for treatment of primary chronic insomnia. A larger controlled study needs to be further investigated.

Literature Review on clinical studies for cold hypersensitivity of hands and feet -Focusing on journals published in Korea (수족냉증의 임상연구에 관한 문헌적 고찰 - 국내에 출판된 논문을 중심으로 -)

  • Lee, Hye-Sol;Han, In-Sik;Sun, Seung-Ho;Kim, Geun-yeob;Go, Ho-Yeon;Kim, Tae-Hoon;Lee, Jin-Moo;Jang, Jun-Bok;Song, Yun-Kyung;Ko, Seong-Gyu;Choi, You-Kyung;Jeong, Jong-Jin;Ko, Youme;Jeong, Keum Ran;Jeon, Chan-Yong
    • Journal of Society of Preventive Korean Medicine
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    • v.21 no.1
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    • pp.83-93
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    • 2017
  • Objectives : This study's aim is to investigate clinical studies of cold hypersensitivity of hands and feet (CHHF) published in Korea and to explore the direct of future research. Methods : We searched clinical studies of CHHF using the database, such as DBpia(http://www.dbpia.co.kr/), NDSL(www.ndsl.kr), OASIS(http://oasis.kiom.re.kr), and RISS(www.riss.kr). The search words were 'cold hypersensitivity(冷症)' and 'syncope(厥證)'. Inclusion criteria were randomized controlled trials (RCTs), non RCTs, Before and after clinical study (B&A) about CHHF. Selection journals and data extraction were conducted by HS Lee and SH Sun independently. Results : Total twenty-one articles were selected finally. RCTs, non-RCTs, and B&A were 3, 12, and 6, respectively. The topics for CHHF were classified into three categories: effect of treatment (n=2) characteristics (n=11), and diagnosis (n=8). Conclusions : This results showed that RCT about CHHF and treatment effect of cold hypersensitivity of hands and feet were small in number. Further systemic and larger studies about CHHF will be needed.

Current situation of Translational research on Acupuncture, Moxibustion and Pharmacopuncture (침구와 약침에 대한 중개연구 현황)

  • Sin, Dae Chul;Song, Ho Sueb
    • Journal of Acupuncture Research
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    • v.33 no.2
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    • pp.109-116
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    • 2016
  • Objectives : Our primary objective lies in understanding the current landscape of translational research on acupuncture, moxibustion and pharmacopuncture. Methods : We searched our own selection of keywords of acupuncture, moxibustion and pharmacopuncture and translational research from three overseas databases (Pubmed, Scopus, Medicine) and four domestic databases (DBpia, KISS, Riss4u, Korea Med). Results : We have chosen 41 articles in total-40 articles on acupunture, 6 article on moxibustion(5 articles were duplicated in use in each category). Origin-wise, 48.8 %/24.8 %/17.0 % of our articles pool came from USA/China/Korea, respectively. UK, Austria, Thailand and Italy contributed the rest of our article pool. For those articles written in USA and China, review articles were the most common type. For the US articles, all 10 review articles were non-systematic reviews, while, for China's contribution, one out of 4 review articles were systematic review. Type-wise, our research pool's breakdown is as follows ; 17 review articles, 11 experimental research, 2 randomized controlled trials(RCT), 1 clinical trial, 4 conference reports, 1 letter, 1 study protocol and 4 uncategorized. Topic-wise, brain-neurology was most frequently referred with 8 articles, followed by parkinson's disease (3 articles) and epilepsy (2 articles). Conclusion : 1. In terms of research submission articles, Korea appears to be lacking translational research on acupuncture, moxibustion and pharmacopuncture, compared to USA and China, in our view. 2. Unlike the cases of USA and China, most of Korean translational research is limited to doing a T1 level of translational research. In order to bring bench-to-bedside to light. we believe, there should be more studies, and thereby a certain level of activation, to the T2 level of translational research in Korea. 3. Further, in our view there should be more efforts to improve article quality at the T1 level of translational research, which eventually becomes the fundamentals of the next level of research (i.e. T2 research), as well as to increase the number of research submissions, going forward.

Four-Week Comparative Effects of Abdominal Drawing-In and Diaphragmatic Breathing Maneuvers on Abdominal Muscle Thickness, Trunk Control, and Balance in Patients With Chronic Stroke

  • Kim, Su-kyung;Kang, Tae-woo;Park, Dong-hwan;Lee, Ji-hyun;Cynn, Heon-seock
    • Physical Therapy Korea
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    • v.24 no.3
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    • pp.10-20
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    • 2017
  • Background: Patients with chronic stroke often shows decreased trunk muscle activity and trunk performance. To resolve these problems, many trunk stabilizing techniques including the abdominal drawing-in maneuver (ADIM) and the diaphragmatic breathing maneuver (DBM) are used to improve trunk muscle strength. Objects: To compare the effects of the ADIM and the DBM on abdominal muscle thickness, trunk control, and balance in patients with chronic stroke. Methods: This was a randomized controlled trial. Nineteen patients were randomly allocated to the ADIM ($n_1=10$) and DBM ($n_2=9$) groups. The ADIM and DBM techniques were performed three times per week for 4 weeks. The thicknesses of the transversus abdominis (TrA), internal oblique muscle, and external oblique muscles on the paretic and non-paretic sides, Trunk Impairment Scale (TIS) score, and Berg Balance Scale (BBS) score were used to assess changes in motor development after 4 weeks of training. Results: After the training periods, the TrA thickness on the paretic side, TIS score, and BBS score improved significantly in both groups compared to baseline (p<.05). TIS score was significantly greater in the DBM group than in the ADIM group (p<.05). Conclusion: This study demonstrated that ADIM and DBM are beneficial for improving TrA muscle thickness in the paretic side, trunk control, and balance ability. Intergroup comparison revealed that TIS score was significantly improved in the DBM group versus the ADIM group. Thus, DBM may be an effective treatment for low trunk muscle activity and performance in patients with chronic stroke.

Effects of Active Mandibular Exercise for Mouth Opening Limitation Patients after Maxillomandibular Fixation Release: A Non-Randomized Controlled Trial (악간고정 제거후 개구장애 환자에게 적용한 능동적 하악운동의 효과: 비무작위 대조군 설계)

  • Jang, Hyo Jin;Kim, Myung Hee
    • Journal of Korean Academy of Nursing
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    • v.48 no.1
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    • pp.26-37
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    • 2018
  • Purpose: The aim of this study was to evaluate the effects of active mandibular exercise (AME) in patients with limited mouth opening after maxillomandibular fixation (MMF) release. Methods: The study used a quasi-experimental, nonequivalent control group and a pre test-post test design. Sixty-two patients with Maxillomandibular Fixation Release were assigned to the experimental (n=31) or control group (n=31). The AME was performed in the experimental group for 4 weeks. The exercise AME consisted of maximal mouth opening, lateral excursion and protrusive movement. These movements were repeated ten times a day. After the final exercise of the day, the number of tongue blades used for mouth opening was noted. The effect of AME was evaluated after MMF release at different time intervals: a) immediately, b) after 1 week, c) after 2 weeks, d) after 4 weeks, and e) after 12 weeks. The exercise was assessed using the following criteria: a) mandibular movements, b) pain scores associated with maximal mouth opening, c) discomfort scores associated with range of movement, and d) daily life activities that involve opening the mouth. Results: The experimental group showed significant improvement regarding the range of mandibular movements (maximal mouth opening (F=23.60, p<.001), lateral excursion to the right side (F=5.25, p=.002), lateral excursion to the left side (F=5.97, p=.001), protrusive movement (F=5.51, p=.001)), pain score (F=39.59, p<.001), discomfort score (F=9.38, p<.001). Daily life activities that involve opening the mouth were more favorable compared to those in the control group. Conclusion: The AME in patients after MMF release is helpful for increasing mandibular movement range, decreasing pain and discomfort, and improving day life activities that involve opening the mouth. Therefore, AME is highly recommended as an effective nursing intervention.

Influence of the Supplementary Ki-hap Technique and Verbal Encouragement on Abdominal Muscle Activation during Crunch Exercise in Healthy Subjects: A Pilot Randomized Controlled Trial (크런치 운동 시 부수적인 기합 기법과 청각적 격려 적용이 정상인의 복부 근육 활성도에 미치는 영향 : 무작위 대조 예비 연구)

  • Kim, Hyung-Kun;Kim, Chang-Yong;Kang, Jeong-Hyeon;Kim, Hyeong-Dong
    • Journal of the Korean Society of Physical Medicine
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    • v.11 no.2
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    • pp.53-62
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    • 2016
  • PURPOSE: The purpose of this study was to investigate the effects of a supplementary Ki-hap technique and verbal encouragement on the activation of abdominal muscles during performance of crunch exercise in healthy subjects. METHODS: 93 subjects were randomly allocated to three group, crunch exercise group (CG), crunch exercise with Ki-hap group (CKG), and crunch exercise with Ki-hap and verbal encouragement group (CKVG), with 31 subjects in each group, respectively. The interventions were conducted over three trials in each group, and measurements were performed on each subject by one examiner in three trials. The activation of rectus abdominis (RA), external oblique (EO), and internal oblique (IO) muscles were evaluated using electromyography (EMG) during performance of crunch exercise with non-Ki-hap, Ki-hap and Ki-hap combined with verbal encouragement. RESULTS: Our results showed a significantly greater increase in the EMG patterns of all muscles during performance of crunch exercise in the CKG (p<0.05) compared to the CG and CKVG. The results also showed that there were significantly greater increase in the activation of EO and IO muscles in those of the CKVG (p<0.05) compared with the CG. CONCLUSION: These findings demonstrated that addition of the Ki-hap technique and verbal encouragement during performance of crunch exercise, at the same time, would suggest positive evidence for improving activation of abdominal muscles.

Neuroprotective Effects of Lacosamide in Experimental Peripheral Nerve Injury in Rats : A Prospective Randomized and Placebo-Controlled Trial

  • Demiroz, Serdar;Ur, Koray;Bengu, Aydin Sukru;Ulucan, Aykut;Atici, Yunus;Erdogan, Sinan;Cirakli, Alper;Erdem, Sevki
    • Journal of Korean Neurosurgical Society
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    • v.63 no.2
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    • pp.171-177
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    • 2020
  • Objective : To evaluate the neuroprotective effects of lacosamide after experimental peripheral nerve injury in rats. Methods : A total of 28 male wistar albino rats weighing 300-350 g were divided into four groups. In group I, the sciatic nerve exposed and the surgical wound was closed without injury; in group II, peripheral nerve injuries (PNI) was performed after dissection of the nerve; in group III, PNI was performed after dissection and lacosamide was administered, and in group IV, PNI was performed after dissection and physiological saline solution was administered. At 7 days after the injury all animals were sacrificed after walking track analysis. A 5 mL blood sample was drawn for biochemical analysis, and sciatic nerve tissues were removed for histopathological examination. Results : There is low tissue damage in lacosamide treated group and antioxidant anzymes and malondialdehyde levels were higher than non-treated and placebo treated group. However there was no improvement on clinical assessment. Conclusıon : The biochemical and histological analyses revealed that lacosamide has neuroprotective effect in PNI in rats. This neuroprotective capacity depends on its scavenger role for free oxygen radicals by increasing antioxidant enzyme activity.