• 한방안이비인후피부과학회지
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• 제27권4호
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• pp.1-15
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• 2014

Objective : This study was carried out to analyze the quality and quantity of Clinical Trials that have been published in the journal of korean medical ophthalmology, otolaryngology, dermatology(JKOOD). Methods : We analyzed 25 clinical trials that published in JKOOD from 1988 to 2014. We excluded case reports, protocol and retrospective studies and classified searched papers into three categories; Randomized Clinical Trials(RCT), Non Randomized Clinical Trials(NRCT), Before After Study(BAS) by using study Design Algorithm for Medical literature of Intervention(DMAI). All articles were analyzed according to diagnosis, statistics program and intervention period. The bias of RCTs were evaluated by Cochrane Risk of Bias(RoB). Result : 1. The number of searched journals is 25 papers; 13 RCT, 2 NRCT, 10 BAS 2. Distribution of clinical trial; 'Atopic dermatitis' ranked the highest(44%) in disease, 'External application' raked the highest(71%) in treatment method. 3. 'allocation sequence' and 'prevention of allocated intervent to patients and therapists' are graded 'Low' but 'incomplete outcome date' and 'selective outcome' are graded 'Uncertain'. Conclusions : It is necessary to study more RCT. It will be helpful to study systematic reviews and meta analysis in JKOOD.

• Nutrition Research and Practice
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• 제15권3호
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• pp.309-318
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• 2021

BACKGROUD/OBJECTIVES: Data regarding the effects of poly-γ-glutamic acid (γ-PGA) on sleep status are limited. This study aimed to test whether γ-PGA and vitamin B₆ (VitB6) supplements improve sleep duration and quality. SUBJECTS/METHODS: A factorial randomized, double-blinded, placebo-controlled crossover study included 47 adults (25 men and 22 women) who were free of chronic disease. Stratified randomized allocation considered age and gender for three interventions, group A (supplementation with γ-PGA 600 mg; n = 16), group B (supplementation with VitB6 100 mg; n = 14), and group C (dual supplementation of both γ-PGA 600 mg and VitB6 100 mg; n = 17). Participants underwent a 1-mon intervention period, followed by a 1-mon washout period, and then a second 1-mon intervention period. Differences (mean ± SD) in nighttime sleep status before and after supplementation were compared between the placebo and intervention groups using nonparametric tests. RESULTS: Significant changes in sleep duration (0.27 ± 0.98 h, P < 0.05) and the Pittsburgh Sleep Quality Index global score (-0.52 ± 1.58, P < 0.05) indicating improved sleep status were observed in the intervention compared with the placebo of group C while no significant changes were observed in groups A and B. No statistical significance was detected between the intervention and the placebo; however, there was a greater increase in the group C intervention (4.59 ± 38.5 ng/mL) in serum serotonin concentrations than the groups A and B interventions. No side effects were observed. CONCLUSIONS: On the basis of these findings, the dual supplementation of γ-PGA and VitB6 may be effective as functional food components to improve nighttime sleep status.

• 한방재활의학과학회지
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• 제31권1호
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• pp.137-147
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• 2021

Objectives Domestic acupuncture research is being actively conducted in various fields. The aim of this study is to systematically analyze the current acupuncture randomized controlled trials (RCTs) conducted on healthy volunteers. Methods We searched RCTs by the search terms of (acupuncture & random & healthy) in 10 electronic databases and related journals. Then, we analyzed the characteristics and assessed the risk of bias by Cochrane tool. Results Finally, 49 acupuncture RCTs on health volunteers were included in our analysis. The purpose of research could be classified into five major categories: (1) checking the effects on physiological function, (2) comparing the effects of different acupuncture/acupuncture methods, (3) a study confirming improvement after inducing a specific condition, (4) a sham acupuncture study, and (5) a comparison of acupuncture sense. The Cochrane risk of bias was generally high, especially only 1 trial adopted allocation concealment (1/49, 2.0%) and 9 ones with assessor blinding (9/49, 18.4%). Conclusions Acupuncture RCTs in healthy subjects have confirmed various effects in various age/sex groups. However the research quality should be updated for future clinical research and to draw clear conclusion within rigorous methodology.

• 한방재활의학과학회지
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• 제33권4호
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• pp.61-78
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• 2023

Objectives This systematic review aimed to analyze the effectiveness, safety and the reporting quality of scalp acupuncture (SA) treatment for musculoskeletal disease (MSD). Methods Eleven databases were systematically searched up to July 12th 2023. Randomized controlled trials (RCTs) of SA treatment for MSD were selected manually by the inclusion criteria. The risk of bias of RCTs was assessed using the Cochrane's Risk of Bias (RoB) 1.0 and the reporting quality of studies was evaluated using Consolidated Standards of Reporting Trials (CONSORT) 2010 statement and Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) 2010 checklist. Results Ten clinical studies were met the inclusion criteria. Most of studies reported SA treatment significantly alleviated pain and functional disability of MSD patients and no serious adverse effects were reported. In RoB assessment, blinding of participants and personnel was found to have the highest RoB and allocation concealment was found to have the most unclear RoB. In CONSORT 2010 statement evaluation, all studies reported 15.3 items (41.4%) on average. In STRICTA 2010 checklist evaluation, all studies reported 11.2 items (65.9%) on average. Conclusions The systematic review found that SA treatment may alleviate pain and functional disability of MSD patients and have little severe adverse effect. The reporting quality of included studies was mainly low, therefore, further studies with strict adherence to the CONSORT and STRICTA checklist should be encouraged.

• 인간행동과 음악연구
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• 제10권2호
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• pp.1-33
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• 2013

본 연구는 소아환자대상 최근의 음악치료 및 음악을 사용한 임상연구들에 대한 체계적인 문헌고찰(Systematic Review)을 위해 실시되었다. 이를 위해 13개 데이터베이스를 이용하여 2000년부터 2012년 사이에 영어로 발표 된 무작위 임상 및 교차설계 연구들을 자료로 수집하였고, 최초 검색 되었던 1023개의 논문 중 선정 및 제외기준에 따라 영어문헌 15건을 선별하였다. 선별 결과 연구 대상자는 1개월에서 만 18세까지의 아동 및 청소년으로 11명에서 150명 까지 표본크기가 다양했으며 전체 연구 참여자는 987명으로 집계되었다. 선별된 연구들은 음악요법 및 음악치료 연구로 분류되어 전반적인 유형, 연구절차와 방법론, 임상접근법, 측정도구 및 연구결과에 대해 체계적으로 분석되었다. 총 7건의 음악요법과 8건의 음악치료로 분류된 연구들은 7개영역의 종속변수를 36종류의 측정도구를 사용하여 측정하였는데 음악의 임상적 사용에 있어 음악의 선택, 종류 및 임상접근방법에 큰 차이가 있음이 나타났다. 연구절차와 방법론의 분석 결과 다수의 연구들이 주요 연구절차에 대한 기술이 충분치 않고 특히 무작위배정(Randomization), 배정순서 은폐(Allocation Concealment), 이중 또는 부분은폐(double or partial blinding) 및 참여자 감소율(Attrition Rate)과 같은 방법론적 표준에 미치지 못함이 도출되었다. 전반적인 연구결과가 통계적으로 유의하거나 긍정적 결과가 보고된 바 있으나, 연구 방법론적 문제들과 임상접근법들의 이질성으로 인해 그 결과가 편향에 의해 오염되거나 신뢰성에 문제가 있음을 확인할 수 있다. 그 결과 음악이 소아 환자들의 신체 및 사회 심리적 필요를 다루는 도구로 임상적 가치가 있음을 제안할 수는 있지만 이에 대한 과학적인 근거로서는 절차와 접근법이 보다 엄격하고 균일하여 추후 재현이 가능한 연구들이 다수 요구됨을 알 수 있다.

• 한방재활의학과학회지
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• 제24권4호
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• pp.49-60
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• 2014

Objectives The purpose of this study is to research current trends of acupuncture treatment of lumbar herniated intervertebral disc using the PubMed database. Methods We set up the search strategy and investigated clinical trials on acupuncture treatment of lumbar herniated intervertebral disc through PubMed search. This study analyzed previous researched papers published from January 1st, 2000 to April 30th, 2014, and classified them by publication year, journal names, types of literature, treatment methods and evaluation scales. To assess the quality of the reviewed literature, randomized controlled trial (RCT) studies were assessed by Cochrane's risk of bias (ROB) tool and non-RCT studies were assessed by risk of bias for non-randomized studies (RoBANS). Results We found 35 studies on the acupuncture treatment of lumbar herniated intervertebral disc. Papers on this topic have been published, on average, three to four times annually in 9 journals since the mid-2000's. The journal with the largest number of publications was Chinese Acupuncture & Moxibustion, and most of articles were classified as RCT. Acupuncture treatment was performed individually or together with other treatments. The most frequently used pain evaluation index was visual analogue scale (VAS). The index of effective rate was used frequently but there was a lack of objectivity. In regards to the quality of the studies, outcome assessment in RCT showed that random sequence generation, allocation concealment, and the blinding of participants and personnel increase potential of risk of bias. For non-RCT assessment, outcome showed that confounding variable, measurement of intervention were at high risk of bias. Conclusions In order to obtain objective clinical evidence of acupuncture treatment of lumbar herniated intervertebral disc, further clinical studies should be designed to minimize the risk of bias, using STRICTA with larger sample sizes.

• Journal of Dental Anesthesia and Pain Medicine
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• 제20권1호
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• pp.29-37
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• 2020

Background: This study evaluated the efficacy of three intraoral topical anesthetics in reducing the injection needle prick pain from local anesthetic among children aged 7-11 years old. Methods: It is a prospective, Interventional, parallel design, single-blind, randomized clinical trial in which subjects (n=90) aged 7-11 years were included in the study based on an inclusion criteria. Subjects were divided into three groups based on computer-generated randomization with an allocation ratio of 1:1:1. Groups A, B, and C received benzocaine 20% jelly (Mucopain gel, ICPA health products Ltd, Ankleshwar, India), cetacaine anesthetic liquid (Cetylite Industries, Inc, Pennsauken, NJ), and EMLA cream (2% AstraZeneca UK Ltd, Luton, UK), respectively, according to manufacturer's instructions, for 1 minute prior to local anesthetic injection. After application of topical anesthetic agent, for all the groups, baseline pre-operative (prior to topical anesthetic administration) and post-operative scores (after local anesthetic administration) of pulse rate was recorded using Pulse oximeter (Gibson, Fingertip Pulse Oximeter, MD300C29, Beijing Choice Electronic). Peri-operative (i.e., during the administration of local anesthesia) scores were recorded using Face, Legs, Activity, Cry, Consolability (FLACC) Scale, Modified Children hospital of Eastern Ontario Pain Scale (CPS) behavior rating scale, and Faces Pain Scale (FPS-R) - Revised (For self-reported pain). Direct self-reported and physiological measures were ascertained using FPS-R - Revised and Pulse oximeter, respectively, whereas CPS and FLACC scales assessed behavioral measures. To test the mean difference between the three groups, a one way ANOVA with post hoc tests was used. For statistical significance, a two-tailed probability value of P < 0.05 was considered as significant. Results: The Cetacaine group had significantly lower pain scores for self-report (P < 0.001), behavioral, and physiological measures (P < 0.001) than the other two groups. However, there was no significant difference between the Benzocaine group and EMLA group during palatal injection prick. Conclusion: Cetacaine can be considered as an effective topical anesthetic agent compared to benzocaine 20% jelly (Mucopain gel) and EMLA cream.

• Asian Pacific Journal of Cancer Prevention
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• 제16권17호
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• pp.7517-7522
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• 2015

Onion (Allium cepa) consumption has been remarked in folk medicine which has not been noted to be administered so far as an adjunct to conventional doxorubicin-based chemotherapy in breast cancer patients. To our knowledge, this is the first study aimed to investigate the effects of consuming fresh yellow onions on hepatic enzymes and cancer specific antigens compared with a low-onion containing diet among breast cancer (BC) participants treated with doxorubicin. This parallel design randomized controlled clinical trial was conducted on 56 BC patients whose malignancy was confirmed with histopathological examination. Subjects were assigned in a stratified-random allocation into either group received body mass index dependent 100-160 g/d of onion as high onion group (HO; n=28) or 30-40 g/d small onion in low onion group (LO; n=28) for eight weeks intervention. Participants, care givers and laboratory assessor were blinded to the assignments (IRCT registry no: IRCT2012103111335N1). The compliance of participants in the analysis was appropriate (87.9%). Comparing changes throughout pre- and post-dose treatments indicated significant controls on carcinoembryonic antigen, cancer antigen-125 and alkaline phosphatase levels in the HO group (P<0.05). Our findings for the first time showed that regular onion administration could be effective for hepatic enzyme conveying adjuvant chemotherapy relevant toxicity and reducing the tumor markers in BC during doxorubicin-based chemotherapy.

• 대한치과교정학회지
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• 제51권5호
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• pp.346-354
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• 2021

Objective: To compare the effectiveness of ibuprofen, acetaminophen, and chewing gum for orthodontic pain relief and to assess if chewing gum can be a non-pharmacological alternative for orthodontic pain relief. Methods: The study enrolled 106 patients of both sexes, aged ≥ 12 years, with body weight > 50 kg, and mild-to-moderate dental crowding in the upper arch. After randomization and allocation concealment, the intervention groups were either administered with ibuprofen (400 mg) or acetaminophen (500 mg) or chewed sugar-free chewing gum immediately after initial archwire placement and every 6 hours for 1 week if the pain persisted. The control group did not receive any pain relief. The pain was assessed on a 100-mm visual analog scale at rest and while biting down at T1 (2 hours), T2 (24 hours), T3 (2 days), T4 (3 days), T5 (7 days), and T6 (21 days). Statistical analyses were performed using the Kruskal-Wallis and post-hoc Mann-Whitney U tests (α = 0.05). Results: The chewing gum group experienced more pain relief than the ibuprofen group at while biting down at T3 (p = 0.04) and at rest at T4 (p < 0.001). The chewing gum group reported more pain relief than the acetaminophen and control groups while biting down at T3 (p = 0.03 and p = 0.0006, respectively) and T4 (both p < 0.001). Conclusions: Chewing gum can be a non-pharmacological alternative for orthodontic pain relief at 2 and 3 days after initial archwire placement.

• 임상간호연구
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• 제26권3호
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• pp.365-373
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• 2020

Purpose: The purpose of this study was to evaluate the effect of preoperative warming to prevent hypothermia in surgery for patients undergoing total hip replacement arthroplasty under spinal anesthesia. Methods: A randomized experimental study was conducted. Data were collected at an S University hospital in Gyeonggido from December 3, 2019 to March 31, 2020. A random allocation program was used to randomize participants into intervention and control groups. A total of 90 participants were assigned to the study: 30 people were randomized to a pre-warming group using Bair Hugger forced-air warming blankets(Model 505) 30 minutes before surgery, 30 to a pre-warming group 15 minutes before surgery, or 30 to a control group. The findings from 88 participants were analyzed. For data analysis, χ2 test and ANOVA were used utilizing the SPSS 21.0 program. Results: The pre-warming group 30 minutes before surgery had significantly higher body temperature than the control group, from 30 minutes after inducing anesthesia to the end of anesthesia. Body temperature over anesthesia time showed significant differences among the three groups, but there were no statistically significant differences in interactions between time and groups. Conclusion: Warming patients' body for 30 minutes before surgery was effective in maintaining normal body temperature while preventing intraoperative hypothermia.