• 제목/요약/키워드: Randomized controlled study

검색결과 1,984건 처리시간 0.027초

The efficacy of ultrasound-guided erector spinae plane block after mastectomy and immediate breast reconstruction with a tissue expander: a randomized clinical trial

  • Park, Sukhee;Park, Joohyun;Choi, Ji Won;Bang, Yu Jeong;Oh, Eun Jung;Park, Jiyeon;Hong, Kwan Young;Sim, Woo Seog
    • The Korean Journal of Pain
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    • 제34권1호
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    • pp.106-113
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    • 2021
  • Background: We aimed to investigate the analgesic efficacy of an erector spinae plane block (ESPB) in immediate breast reconstruction (IBR) with a tissue expander. Methods: Adult women undergoing IBR with a tissue expander after mastectomy were randomly assigned to either intravenous patient-controlled analgesia (IV-PCA) alone (group P) or IV-PCA plus ESPB (group E). The primary outcome was the total amount of opioid consumption during 24 hours postoperatively between the two groups. Secondary outcomes were patient satisfaction, pain score at rest and on shoulder movement using numerical rating scale, incidences of postoperative nausea and vomiting (PONV), and a short form of the brief pain inventory (BPI-SF) at 3 and 6 months after surgery between the groups. Results: Fifty eight patients completed the study. At 24 hours postoperatively, total opioid consumption was significantly less in group E than in group P (285.0 ± 92.0, 95% confidence interval [CI]: 250.1 to 320.0 vs. 223.2 ± 83.4, 95% CI: 191.5 to 254.9, P = 0.005). Intraoperative and cumulative PCA fentanyl consumption at 3, 6, 9, and 24 hours were also less in group E than in group P (P = 0.004, P = 0.048, P = 0.020, P = 0.036, and P < 0.001, respectively). Patient satisfaction was higher in group E (6.9 ± 1.8 vs. 7.8 ± 1.4, P = 0.042). The incidences of PONV was similar. Conclusions: The ESPB decreased postoperative opioid consumption and increased patient satisfaction without significant complications after IBR with a tissue expander after mastectomy.

뇌졸중 후 경련성 편마비의 침치료에 대한 최신 임상 연구 동향 - CAJ 검색을 중심으로 (Review of Clinical Research about Acupuncture for Spastic Hmiplegia after Stroke - Research on China Academic Journal)

  • 조명재;김다혜;김선우;박철우;김영광;장혜연;김민욱
    • 동의생리병리학회지
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    • 제35권1호
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    • pp.28-35
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    • 2021
  • To analyze the clinical efficacy of acupuncture for spastic hemiplegia after stroke, this study was accomplished by considering Randomized Controlled Trials. We searched for papers that performed acupuncture for spastic hemiplegia after stroke in the China Academic Journal of the China National Knowledge Infrastructure, from January 1, 2017 to June 30, 2020. In total, 23 reports were included in this review. There are 18 studies conducted with more than 50 subjects and less than 100 subjects. The largest number of treatment was 20 times. 28days(4weeks) was the largest number of treatment period, which accounted 10 studies. The most frequently used evaluation index was The Fugl-Meyer Assessment(FMA) and Clinical Efficacy, each used 21 times and 17 times. The most frequently used acupuncture point was LI3, which was used 13 times. The retention time was 30 minutes and 11 studies were conducted. Western medicine treatment was the most common control group in 15 studies. Most of studies showed result of the intervention group was statistically significant, compared with the control group. These results suggest that acupuncture for spastic hemiplegia after stroke was effective and it was statistically more significant than the control group. However, it is difficult to confirm a conclusion, because the quality of most of studies was low.

소아 식욕부진에 대한 이공산(異功散) 치료의 효과 : 체계적 문헌고찰 및 메타분석 (Effects of Yigong-san for the Treatment of Anorexia in Children: A Systematic Review and Meta-Analysis)

  • 이보람;하다정;허태영;박상은;이선행;장규태
    • 대한한방내과학회지
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    • 제43권4호
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    • pp.542-558
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    • 2022
  • Objectives: The purpose of this study was to assess the effect of Yigong-san on anorexia in children by conducting a systematic review and meta-analysis of randomized controlled trials (RCTs). Methods: Eleven electronic databases were searched on May 30, 2022 to collect relevant studies. All studies published up to the search date were considered. RCTs reporting the effect of Yigong-san on the treatment of anorexia in children were included. The primary outcome was an improvement in clinical anorexia symptoms after treatment. In this meta-analysis, continuous and binary outcomes were assessed, and the data were presented as the mean difference and risk ratio with their 95% confidence intervals. The risk of bias was assessed using the Cochrane Collaboration's risk of bias tool. Results: A total of nine studies were included in this systematic review. The treatment group (Yigong-san only or Yigong-san plus conventional treatment) showed a statistically significant effect compared to the control group (conventional treatment only) in total effective rate (Yigong-san only: RR 1.26, 95% CI 1.17, 1.36, I2=0%; Yigong-san plus conventional treatment: RR 1.32, 95% CI 1.18, 1.47, I2=0%), clinical symptoms, some of the anthropometric outcomes, and biological markers related to appetite and growth in children with anorexia. No serious adverse events related to Yigong-san were reported. Conclusions: Yigong-san showed statistically significant effects as a treatment for anorexia in children. However, the number of studies included in the meta-analysis was insufficient, and the herbs contained in the Yigong-san used in the included studies were not standardized. Future research should focus on the implementation of methodologically robust clinical research.

당귀작약산이 정상인의 총경동맥 탄력도에 미치는 영향 : 무작위대조군 교차시험 (Effects of Dangui-jakyak-san on Common Carotid Artery Elasticity in Healthy Subjects ; A Randomized controlled crossover study)

  • 김수현;서유나;배인후;조기호;문상관;정우상;권승원;진철
    • 대한중풍순환신경학회지
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    • 제21권1호
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    • pp.21-32
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    • 2020
  • ■ Objectives 당귀작약산 단회 복용으로 정상인의 총경동맥 탄력도에 미치는 영향을 평가하고자 하였다. ■ Methods 본 연구는 정상인 남성을 대상으로 한 전향적 무작위 대조군 교차시험연구다. 모든 대상자들은 임의로 당귀작약산 복용군과 비복용군인 대조군으로 나누어졌다. 1주일 간격으로 총 2회 방문하며, 첫 번째 방문 시에 당귀작약산 복용군은 당귀작약산 1포(2.5g)과 물을 제공받고, 대조군은 물만 제공받아 복용하였다. 두 번째 방문 시 첫 번째 방문과 반대로 당귀작약산을 복용했던 복용군은 물만 제공받고, 물만 복용했던 피험자들은 당귀작약산 1포와 물을 제공받았다. 물은 100 cc로 매번 동일하게 제공되었다. 모든 대상자들은 복용 직전과 복용 2시간, 4시간 후에 총경동맥 탄력도, 혈압, 총경동맥 내막-중막 두께와 맥박수를 측정하였다. ■ Results 총 20명의 정상인 남성이 모집되었으며, 시간에 따라 당귀작약산 복용 후의 총경동맥 탄력도가 대조군에 비하여 유의하게 상승한 것이 확인되었다. 내막-중막 두께, 혈압 및 맥압, 맥박은 유의한 변화가 나타나지 않았다. ■ Conclusion 당귀작약산의 단회 복용으로 총경동맥 탄력도가 즉시 개선되는 것을 확인하였고, 이로써 당귀작약산이 동맥 경직도 완화 및 탄성의 개선에 영향을 미친다는 것을 알 수 있었다.

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Effect of Bi-/Unilateral Masticatory Training on Memory and Concentration - Assessor-blind, Cross-over, Randomized Controlled Clinical Trial

  • Bae, Jun-hyeong;Kim, Hyungsuk;Kang, Do Young;Kim, Hyeji;Kim, Jongyeon;Kim, Koh-Woon;Cho, Jae-Heung;Song, Mi-yeon;Chung, Won-Seok
    • 대한한의학회지
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    • 제43권2호
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    • pp.61-74
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    • 2022
  • Objectives: This study aimed to explore the short-term effects of bilateral masticatory training using an intraoral device on memory and concentration, which is an advanced form of Gochi, compared to the unilateral form with gum. Methods: Thirty young healthy participants (age, 16-30 years) were screened and randomly assigned to one of two sequences in a crossover design. The participants assigned to sequence A (n=15) performed bilateral mastication using an intraoral device with a total of 300 taps, followed by unilateral mastication using gum with the same number of repetitions and frequency, separated by a 7-day washout period. A reverse order was used for sequence B. The primary and secondary outcomes were the digit span test result and the symbol digit modality test and the word list recall results, respectively, which were conducted before and after each intervention. Results: Symbol digit modality test scores increased by 12.03±8.33 with bilateral mastication, which was significantly higher than that obtained with chewing gum (5.17 points;95% confidence interval: 0.99, 9.34; p<0.05). Changes in the digit span test and word list recall scores were not significantly different between the two groups. In the digit span test forward, symbol digit modality test, and word list recall test, bilateral mastication was not inferior to unilateral mastication in improving memory and concentration. Conclusions: Bilateral masticatory exercises using an intraoral device are not inferior to unilateral mastication with gum for improving memory in healthy young individuals. Further research is needed to determine the efficacy of bilateral masticatory training on cognitive function.

Comparison of the effectiveness of extensor muscle strengthening exercise by itself, exercise with polydeoxyribonucleotide injection, and exercise with extracorporeal shockwave therapy in lateral epicondylitis: a randomized controlled trial

  • Shim, Bum Jin;Seo, Eun-Min;Hwang, Jung-Taek;Kim, Do-Young;Yang, Jae-Shin;Seo, Su-Jung;Hong, Myung Sun
    • Clinics in Shoulder and Elbow
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    • 제24권4호
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    • pp.231-238
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    • 2021
  • Background: Extensor muscle strengthening exercises with counterforce braces (EX) is a conventional conservative treatment for lateral epicondylitis (LE) of the elbow. In addition, polydeoxyribonucleotide (PDRN) or extracorporeal shockwave therapy (ESWT) has been recently used for LE. Methods: Sixty-three patients with chronic LE participated in this study and randomly allocated in three groups (G1: EX, G2: EX+PDRN injection, and G3: EX+ESWT). All of the three groups were taught to perform EX at the first out-patient department (OPD) visit. Group 2 was injected with 3 mL PDRN (5.625 mg/3 mL), while group 3 received ESWT at the first OPD visit. Visual analog scale pain score, Mayo elbow performance score (MEPS), and ultrasonographic examination were checked before, 6 weeks, and 12 weeks after the treatments. Results: Overall functional scores and ultrasonographic findings in all three groups improved after treatment. The mean MEPS in group 2 improved more than groups 1 and 3 at 6 weeks (G1, 56.9>62.4; G2, 54.3>65.0; G3, 55.7>62.6), and more than group 1 at 12 weeks (G1, 56.9>67.9; G2, 54.3>73.6). The mean common extensor tendon depth (CETD) on ultrasonography in group 2 increased more than groups 1 and 3 at 6 and 12 weeks (6 weeks: G1, 0.385>0.386; G2, 0.332>0.392; G3, 0.334>0.357; 12 weeks: G1, 0.385>0.409; G2, 0.332>0.438; G3, 0.334>0.405 [cm]). Conclusions: PDRN injections combined with EX exhibited a greater improvement in mean MEPS and mean CETD compared to EX only or EX combined with ESWT for LE within the 12 weeks follow-up.

집속초음파 치료의 한의 임상 활용에 대한 고찰 (Clinical Application of Focused Ultrasound in Korean Medicine)

  • 최유민;이마음;허나연;이은희;최혁용;서형식;황의형;장인수
    • Korean Journal of Acupuncture
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    • 제40권3호
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    • pp.79-89
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    • 2023
  • Objectives : The purpose of this study is to investigate various application methods of focused ultrasound and apply them to clinical use in Korean medicine. Methods : Search was performed using the search engines of electronic databases, including PubMed, ScienceDirect, Cumulative Index to Nursing and Allied Health Literature (CINAHL), ScienceON, Oriental Medicine Advanced Searching Integrated System (OASIS), China National Knowledge Infrastructure (CNKI), Wanfang Data, Japan Science Technology Information Aggregator, Electronic (J-STAGE) and Citation Information by NII (CiNii), from inception to July 2023 without language limitation. Inclusion criteria were clinical studies including randomized controlled trials (RCTs), and animal experimental studies related with focused ultrasound treatments for acupoints or meridian sinews. Results : Total 17 papers, 7 for RCT, 6 for in vivo animal studies, and other experimental studies, were finally selected. Indications used in studies were shoulder pain, back pain, chronic back pain, and degenerative knee arthritis. In experimental studies, studies on animal models of hypoxic ischemic brain damage and hyperlipidemia were also conducted. As for the acupoints, LR3, LI4, and ST36 were used in clinical studies and, in animal experimental studies, GV20, KI1, and ST36 were used. As for the dose, 4 studies below 3 W/cm2 and 3 studies in the range of 0.625 to 5 W/cm2 in clinical studies, and all studies did not exceed 5 W/cm2. In animal experimental studies, 0.5 W/cm2, 2 W/cm2, 7.5 WW/cm2, 15 W/cm2, 10~20 W/cm2 were used. In all three studies describing the penetration depth during irradiation, it was less than 1 cm. Conclusions : We suggest that focused ultrasound is an appropriate treatment tool for stimulating the acupoints to transfer heat energy. Future studies with rigorous and well-designed RCTs for various diseases will be required to ascertain the focused ultrasound stimulate acupoints or meridian sinews.

한랭 두드러기에 대한 한약 치료: 체계적 문헌 고찰 및 메타분석 (Herbal Medicine Treatment for Cold Urticaria: A Systematic Review and Meta-Analysis)

  • 김혜나;오정화;윤화정
    • 한방안이비인후피부과학회지
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    • 제36권4호
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    • pp.122-144
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    • 2023
  • Objectives : The purpose of this study is to evaluate the effects of herbal medicine treatment in patients with cold urticaria. Methods : We searched randomized controlled trials(RCTs) reporting the effects of herbal medicine for cold urticaria through domestic and international databases from their inception to September 2023. The results were summarized in tables. We assessed the risk of bias in included RCTs through Cochrane risk of bias tool and the data synthesis was conducted through RevMan version 5.4. Results : A total of 12 RCTs were included in this review and all trials compared herbal medicine alone treatment(treatment group) with western medicine alone treatment(control group). The total effective rate(TER) of treatment group was statistically higher than that of control group(RR: 1.49, 95% CI: 1.38 to 1.62, p<0.00001, I2=65%). On the other hand, when comparing except for 1 trial with different evaluation period, the TER of treatment group was statistically higher than that of control group and heterogeneity was very low(RR: 1.36, 95% CI: 1.26 to 1.47, p<0.00001, I2=0%). And when comparing 8 trials using the total symptom score(TSS) change index as an indicator of TER, the TER of treatment group was statistically higher than that of control group and heterogeneity was very low(RR: 1.38, 95% CI: 1.26 to 1.51, p<0.00001, I2=0%). The treatment group showed more statistically significant decrease compared to the control group in TSS(MD: -2.51, 95% CI: -2.63 to -2.40, p<0.00001, I2=99%). The relapse rate of treatment group was statistically lower than that of control group(RR: 0.19, 95% CI: 0.10 to 0.40, p<0.00001, I2=0%). Mild adverse events such as sleepiness, dizziness were reported in control group and gastric discomfort was reported in treatment group. In the risk of bias assessment, many cases were evaluated as 'Unclear risk'. Conclusions : This review found that herbal medicine alone treatment could more effective and safe than western medicine alone treatment for cold urticaria. But further well-designed researches are needed because of heterogeneity between trials and the quality of the included trials.

Neuroimaging Assessment of the Therapeutic Mechanism of Acupuncture and Bee Venom Acupuncture in Patients with Idiopathic Parkinson's Disease: A Double-blind Randomized Controlled Trial

  • Young-Eun Lee;Seung-Yeon Cho;Han-Gyul Lee;Seungwon Kwon;Woo-Sang Jung;Sang-Kwan Moon;Jung-Mi Park;Chang-Nam Ko;Seong-Uk Park
    • 대한한의학회지
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    • 제44권4호
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    • pp.104-120
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    • 2023
  • Objectives: The purpose of this study was to explore the therapeutic mechanism of acupuncture and bee venom acupuncture (BVA) in patients with idiopathic Parkinson's disease (IPD) using positron emission tomography (PET) and arterial spin labeling (ASL). Methods: Patients with IPD who received a stable dose of anti-parkinsonian medication for at least 4 weeks were recruited and randomly divided into one of two groups: treatment and control. The treatment group (11 subjects) received acupuncture and BVA at acupoints, and the control group (9 subjects) received sham acupuncture and normal saline injections at non-acupoints, twice per week for 12 weeks. The patients were examined using PET and ASL at baseline and after the 12-week treatment. In addition, age- and sex-matched healthy subjects without neurological symptoms and history were recruited to compare ASL data of patients with IPD. Results: PET results revealed that striatal dopamine transporter binding increased in each group after 12 weeks. Although the change was larger in the treatment group, the difference was not statistically significant. In ASL results, the treatment group exhibited hyperperfusion in specific regions compared with the healthy control group. After 12 weeks' intervention, hyperperfusion regions were recovered only in the treatment group. In contrast, significant changes were not found in hyperperfusion regions in the control group after 12 weeks. Conclusions: Our findings suggest that the therapeutic mechanisms of acupuncture and BVA in IPD are different from placebo and operate by altering dopamine availability and recovering hyperactivity in cerebral blood flow.

패 추출물이 제2형 당뇨병 환자의 혈당 및 항산화 체계에 미치는 영향 (Effects of Ishige okamurae Extract Supplement on Blood Glucose and Antioxidant Systems in Type 2 Diabetic Patients)

  • 강연주;김학주;한지숙
    • 한국식품영양과학회지
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    • 제40권12호
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    • pp.1726-1733
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    • 2011
  • 본 연구는 패추출물 섭취를 통해 제 2형 당뇨병 환자의 혈당, 혈중지질 및 항산화 체계 개선에 있어서 패추출물의 효능을 규명하고자 하였다. 동결건조 한 패추출물을 200 mg 캡슐로 만들어 제 2형 당뇨환자에게 아침과 저녁 식전에 4캡슐씩 하루 8캡슐(1600 mg)을 10주간 섭취하도록 하였다. 위약군은 동량의 corn starch를 실험군과 동일하게 제조한 후 같은 방법으로 섭취하게 하였고, 이중맹검법을 사용하였다. 실험대상자는 총 46명이며 실험군 24명, 위약군 22명으로 구성되었으며, 두 군의 일반적 특성 및 생활습관은 유의적 차이가 없었다. 패추출물 섭취군에서 공복혈당은 10주간 섭취 후 $136.50{\pm}31.96$ mg/dL에서 $130.90{\pm}29.88$ mg/dL로 감소하였으나 유의적인 차이를 보이지 않았다. 당화혈색소는 $7.34{\pm}0.78%$에서 $6.82{\pm}0.98%$로 유의적(p<0.01)으로 감소하였다. 특히 당화혈색소가 8% 미만인 저당화혈색소 군에서 유의적으로(p<0.05) 감소하는 것으로 나타났다. 인슐린저 항성은 패추출물군의 경우 $2.77{\pm}0.49$ mmol/L에서 $2.19{\pm}0.62$ mmol/L로 감소하였으나 유의성이 없었으며 위약군도 유의한 변화가 없었다. 패추출물의 섭취가 10주간 이루어지면서 혈청지질의 변화는 유의하지 않았으나 HDL-콜레스테롤 경우 위약군에서 감소한 반면 패추출물군에서는 $41.14{\pm}7.86$ mg/dL에서 $46.82{\pm}5.69$ mg/dL로 증가하였다. LDL-콜레스테롤은 $115.43{\pm}27.47$ mg/dL에서 $108.73{\pm}22.36$ mg/dL로 감소하였으나 유의한 변화는 없었다. 지질과산화물 농도는 패추출물 섭취군에서 $6.83{\pm}1.05$ nmol/MDA에서 $5.72{\pm}1.28$ nmol/MDA로 그 함량이 감소되었고, superoxide dismutase, glutathione peroxidase, catalase와 같은 항산화 효소계의 활성은 위약군에 비하여 패추출물 섭취군에서 증가하였으나 유의적인 차이를 보이지 않았다. 간기능 지표인 AST, ALT, ${\gamma}$-GTP와 신장 기능 지표인 BUN, creatinine에서 유의적인 차이 없이 정상범위를 나타내었다. 이상의 연구 결과 한국인 제2형 당뇨병 환자에서 패추출물의 섭취는 지난 2~3개월간의 평균 혈당관리 상태를 파악할 수 있는 지표인 당화혈색소 감소에 효과적인 것으로 나타났으며, 패추출물 복용 후에도 간 및 신장기능이 정상으로 확인되었으므로 패추출물은 당뇨병 환자들의 평균 혈당관리에 도움을 줄 수 있을 것으로 사료된다.