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

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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.

Lymphangiographic Interventions to Manage Postoperative Chylothorax

  • Jeong, Hyuncheol;Ahn, Hyo Yeong;Kwon, Hoon;Kim, Yeong Dae;Cho, Jeong Su;Eom, Jungseop
    • Journal of Chest Surgery
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    • v.52 no.6
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    • pp.409-415
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    • 2019
  • Background: Postoperative chylothorax may be caused by iatrogenic injury of the collateral lymphatic ducts after thoracic surgery. Although traditional treatment could be considered in most cases, resolution may be slow. Radiological interventions have recently been developed to manage postoperative chylothorax. This study aimed to compare radiological interventions and conservative management in patients with postoperative chylothorax. Methods: We retrospectively reviewed periprocedural drainage time, length of hospital stay, and nil per os (NPO) duration in 7 patients who received radiological interventions (intervention group [IG]) and in 9 patients who received conservative management (non-intervention group [NG]). Results: The baseline characteristics of the patients in the IG and NG were comparable; however, the median drainage time and median length of hospital stay after detection of chylothorax were significantly shorter in the IG than in the NG (6 vs. 10 days, p=0.036 and 10 vs. 20 days, p=0.025, respectively). NPO duration after chylothorax detection and total drainage duration were somewhat shorter in the IG than in the NG (5 vs. 7 days and 8 vs. 14 days, respectively). Conclusion: This study showed that radiological interventions reduced the duration of drainage and the length of hospital stay, allowing an earlier return to normal life. To overcome several limitations of this study, a prospective, randomized controlled trial with a larger number of patients is recommended.

A Multicenter Matched Case Control Study of Breast Cancer Risk Factors among Women in Karachi, Pakistan

  • Shamsi, Uzma;Khan, Shaista;Usman, Sheheryar;Soomro, Saleem;Azam, Iqbal
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.1
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    • pp.183-188
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    • 2013
  • Background: Breast cancer (BC), the most common female cancer in Pakistan, is associated with a very high mortality. However, the roles of individual risk factors for BC among Pakistani women are still controversial. To assess potential risk factors for BC, a matched case-control study was conducted in two tertiary care hospitals of Karachi, Pakistan. Materials and Methods: The study population included 297 pathologically confirmed incident cases of BC patients diagnosed between January 2009 and December 2010. 586 controls without any history of BC were matched on hospital and ${\pm}5$ years of ages. Results: Positive family history of BC (MOR=1.72; 95%CI: 1.10, 2.80 for first degree vs. none), single marital status (MOR=1.55; 95%CI: 1.10, 2.39 for single/divorced/widowed women vs. married women), older age at menopause (MOR=3.92; 95%CI: 2.52, 6.18 for menopausal women aged below 45 years, MOR=6.42; 95%CI: 3.47, 11.98 for menopausal women above 45 years of age compared with premenopausal women) conferred an increased risk of BC for women. Increasing parity decreased the risk of BC (MOR=0.90; 95%CI: 0.85, 0.97 for each live birth). Intake of Vitamin D supplements (MOR=0.30; 95%CI: 0.12, 0.81 for ${\leq}3$ years and MOR=0.27; 95%CI: 0.13, 0.56 for >3 years) was protective compared to non-users of Vitamin D. Conclusions: This study confirmed only few of the recognized risk factors in Pakistani women. The protective effect of Vitamin D is important from public health perspective and needs to be further explored through a randomized controlled trial.

Integration of Ayurvedic formulations with iron folic acid in the treatment of nutritional anaemia among school going adolescents of Dehradun District

  • Prakash, Vaidya Balendu;Prakash, Shyam;Sharma, Rajesh;Prakash, Megha;Prakash, Shikha;Parmar, Kiran
    • CELLMED
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    • v.6 no.1
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    • pp.5.1-5.5
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    • 2016
  • Combating anaemia is a global public health challenge of the developing world. Nutritional anaemia is a serious health problem faced by Indian school children. An investigation was taken up to study the effect of non iron containing Ayurvedic preparation Sootshekhar Rasa (SR) plus Sitopaladi Churna (SC) along with iron and folic acid (IFA) for improving nutritional anaemia among adolescent school going students of Dehradun district in Northern India. The blinded, controlled randomized trial comprised of 820 adolescents anaemic students aged 11 - 18 years. The anaemic students were randomly divided into 4 groups, students of group I (control) received starch, group II, III, and IV students received daily dose of (SR 250 mg + SC 400 mg), IFA and (SR 250 mg + SC 400 mg) + IFA, respectively. All the students received treatment for 90days and were followed up for next 180days. At the end of follow-up (day 270), significant increase of haemoglobin (Hb) level from the base line was recorded in all treatment groups. The maximum gain in Hb concentration was noted in group IV (10.1 ± 0.6 g/L), which was significantly higher than any other group. There were 123 drop-outs; however, no major side effect of treatment was noted in any student. We conclude that daily dose of (SR 250 mg + SC 400 mg) along with IFA can produce sustainable improvement of nutritional anaemia in adolescent students.

Laparoscopic Reinforcement Suture (LARS) on Staple Line of Duodenal Stump Using Barbed Suture in Laparoscopic Gastrectomy for Gastric Cancer: a Prospective Single Arm Phase II Study

  • Kim, Min Chan;Kim, Sang Yun;Kim, Kwan Woo
    • Journal of Gastric Cancer
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    • v.17 no.4
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    • pp.354-362
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    • 2017
  • Purpose: Laparoscopic gastrectomy is accepted as a standard treatment for patients with early gastric cancer in Korea, Japan, and China. However, duodenal stump leakage remains a fatal complication after gastrectomy. We conducted a prospective phase II study to evaluate the safety of the new technique of laparoscopic reinforcement suture (LARS) on the duodenal stump. Materials and Methods: The estimated number of patients required for this study was 100 for a period of 18 months. Inclusion criteria were histologically proven gastric adenocarcinoma treated with laparoscopic distal or total gastrectomy and Billroth II or Roux-en-Y reconstruction. The primary endpoint was the incidence of duodenal stump leakage within the first 30 postoperative days. The secondary endpoints were early postoperative outcomes until discharge. Results: One hundred patients were enrolled between February 2016 and March 2017. The study groups consisted of 65 male and 35 female patients with a mean age (years) of 62.3. Of these, 63 (63%) patients had comorbidities. The mean number of retrieved lymph nodes was 38. The mean operation time was 145 minutes including 7.8 minutes of mean LARS time. There was no occurrence of duodenal stump leakage. Thirteen complications occurred, with one case of reoperation for splenic artery rupture and one case of mortality. Conclusions: Based on the results of this prospective phase II study, LARS can be safely performed in a short operation period without development of duodenal stump leakage. A future randomized prospective controlled trial is required to confirm the surgical benefit of LARS compared to non-LARS.