• Title/Summary/Keyword: Randomized controlled trials

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Prothrombin Complex Concentrate versus Fresh Frozen Plasma in Adult Patients Undergoing Cardiac Surgery: A Systematic Review and Meta-Analysis

  • Patricia Viana;Jessica Hoffmann Relvas;Marina Persson;Thamiris Dias Delfino Cabral;Jorge Eduardo Persson;Jessica Sales de Oliveira;Paulo Bonow;Camila Veronica Souza Freire;Sara Amaral
    • Journal of Chest Surgery
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    • v.57 no.1
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    • pp.25-35
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    • 2024
  • Background: Prothrombin complex concentrate (PCC) and fresh frozen plasma (FFP) are commonly used to manage bleeding in patients during cardiac surgery. However, the relative efficacy and safety of these 2 strategies remain uncertain. Methods: MEDLINE, Embase, and Cochrane were searched for studies comparing PCC and FFP in patients who underwent cardiac surgery complicated by bleeding. Review Manager (RevMan) ver. 5.4 (Nordic Cochrane Centre, The Cochrane Collaboration) was used for statistical analysis. Binary and continuous outcomes were compared using pooled risk ratios and mean differences, respectively. The meta-analysis protocol was registered in the International Prospective Register of Systematic Reviews under protocol number CRD42022379144. Results: We included 8 studies with 1,500 patients, of whom 613 (40.9%) received PCC. The mean follow-up period ranged from 28 to 90 days. The PCC group had significantly lower chest tube drainage at 24 hours (mean difference [MD], -148.50 mL; 95% CI, -253.02 to -43.99 mL; p=0.005; I2 =42%). Fewer units of red blood cells (RBCs) were transfused within the first 24 hours (MD, -1.02 units; 95% CI, -1.81 to -0.24 units; p=0.01; I2 =56%), and fewer patients required RBC transfusion within the first 24 hours (risk ratio, 0.85; 95% CI, 0.78-0.93; p<0.007; I2 =45%) in the PCC group. There were no statistically significant differences in secondary outcomes. Nonetheless, a subgroup analysis of randomized controlled trials failed to corroborate the results obtained from the main analysis. Conclusion: Our findings suggest that PCC can be effective, without increased adverse events, when compared with FFP in patients undergoing cardiac surgery complicated by bleeding.

Exercise and adults with hemophilia: a systematic review and meta-analysis (성인 혈우병 환자와 운동: 체계적 문헌고찰과 메타분석)

  • Doo Young Kim;Mi Yang Jeon;Young Eun;Da In Jeong
    • Journal of Korean Biological Nursing Science
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    • v.26 no.1
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    • pp.1-15
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    • 2024
  • Purpose: This study aimed to evaluate the effectiveness of exercise in patients with hemophilia. Methods: We carried out a systematic review and meta-analysis in accordance with the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) guidelines. A literature search was conducted of published randomized controlled trials for exercise interventions from January 1, 2014 to March 15, 2023. To estimate the size of the effects of exercise, a meta-analysis was performed using the R package "meta." Results: Five databases were searched to obtain articles published in Korean or English. Of 1,150 articles reviewed, 13 were included in the systematic review and 9 in the meta-analysis. The risk of bias was assessed using RoB 2.0. The overall effect sizes of exercise interventions, calculated as the standardized mean difference, were -0.11 (95% confidence interval [CI] = -1.41 to -1.20) for pain, -2.13 (95% CI = -3.33 to -0.93) for joint health, 9.96 (95% CI = 7.51 to 12.28) for physical activity, and 0.59 (95% CI = -0.39 to -1.56) for quality of life. Conclusion: These findings suggest that exercise is useful for improving the joint health and physical activity of patients with hemophilia. Thus, it is necessary to develop and apply exercise interventions for patients with hemophilia to reduce their pain and improve their quality of life.

A Delphi Study of Korean Medicine for Anorexia in Children for Clinical Practice Guidelines (소아 식욕부진의 한의표준임상진료지침 개발을 위한 델파이 연구)

  • Bang Miran;Lee Sun Haeng;Chang Gyu Tae
    • The Journal of Pediatrics of Korean Medicine
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    • v.38 no.2
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    • pp.21-31
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    • 2024
  • Objectives This study aimed to develop consensus-based recommendations for establishing standard clinical practice guidelines for pediatric anorexia through the utilization of a Delphi study. Methods We analyzed existing randomized controlled trials for pediatric anorexia treatment using the Delphi method-a structured process for achieving consensus among a panel of experts. A questionnaire was distributed among a select panel of nine specialists in the field. Results The initial Delphi round led to consensus on 30 distinct recommendations; however, consensus was not reached for 19 other recommendations, prompting a second Delphi round. In the subsequent round, adjustments were made based on feedback from the initial round, and deliberations were held on recommendations that previously lacked consensus. Following these adjustments, consensus was achieved on all recommendations. Additionally, a third Delphi iteration was conducted to address three specific queries that required amendment due to a reevaluation of the evidence levels of certain recommendations. In total, three Delphi rounds were carried out to produce informed recommendations related to the diagnosis, treatment, and general management of anorexia. Conclusions This investigation successfully generated evidence-based recommendations for the diagnosis and treatment of pediatric anorexia. The recommendations encompassed various practices, including herbal medicine, acupuncture, moxibustion, cupping, and Chuna manual therapy, which can be integrated into clinical settings.

Effect of Hwanggigyejiomul-tang on Postoperative Breast Cancer-related Lymphedema (BCRL): A Systematic Review and Meta-analysis (수술 후 발생한 유방암 연관 림프 부종(BCRL)에 대한 황기계지오물탕(黃芪桂枝五物湯)의 효과 : 체계적 문헌 고찰 및 메타 분석)

  • Yeong-seo Lee;Ye-seul Kim;Young-kyun Kim;Kyoung-min Kim
    • The Journal of Internal Korean Medicine
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    • v.45 no.1
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    • pp.31-54
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    • 2024
  • Objectives: This study assessed the effectiveness of Hwanggigyejiomul-tang for postoperative breast cancer-related lymphedema (BCRL) by a systematic review and meta-analysis of randomized controlled trials (RCTs). Methods: A search was conducted using keywords such as "breast cancer", "lymphedema", "edema", "Huangqi Guizhi Wuwu decoction", "Huangqi Guizhi Wuwu tang", and "Hwanggigyejiomul tang" in 10 databases (PubMed, Cochrane, ScienceDirect, CNKI, CiNii, RISS, KISS, ScienceON, OASIS, DBpia) on February 11, 2024. There were no limits on the publication period and language, and the quality of the studies was evaluated using Cochrane's risk of bias tool. A meta-analysis was performed based on the outcome measurements, such as total effective rate (TER), increase in shoulder joint mobility (flexion, extension, abduction, adduction), Fugl-Meyer assessment (FMA), and visual analog scale (VAS) using Review Manager Web. Results: Eleven RCTs were selected. The treatment group (Hwanggigyejiomul-tang-gagambang or hapbang with control group intervention) showed a more statistically significant effect compared with the control group (physical therapy or western medicine) in TER (upper limb circumference change), TER (upper limb edema grade change), increase in flexion angle, increase in extension angle, increase in adduction angle, FMA, and VAS. Conclusions: Hwanggigyejiomul-tang is effective in treating postoperative BCRL. However, because of the low quality of the included studies, more clinical studies are required to increase the possibility of clinical use.

Effectiveness of Electroacupuncture for Managing Urinary Retention Post Lumbar Spine Surgery: a retrospective single-cohort study

  • Phuong Dong Tran;Quoc Dung Nguyen;Thanh Duc Ngo
    • Journal of Pharmacopuncture
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    • v.27 no.2
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    • pp.123-130
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    • 2024
  • Objectives: Post-operative urinary retention (POUR) is a frequent complication following surgical procedures, characterized by an acute inability to void, leading to additional complications and extended hospitalization. Acupuncture has been shown to be effective in facilitating spontaneous urination and alleviating anxiety in patients experiencing poor urination. The present study aims to evaluate the effectiveness of electroacupuncture in the management of POUR in patients who have undergone lumbar spine surgery. Methods: This retrospective study conducted at the National Hospital of Acupuncture in Vietnam and reviewed the medical records of patients over 18 years old who underwent lumbar spine surgery and were diagnosed with POUR between January to December 2019. Electroacupuncture was administered at five specific acupuncture points: Qugu (CV2), Zhongji (CV3), Zhibian (BL54), Pangguanshu (BL28), and Kunlun (BL60). This study monitored key parameters related to the effectiveness of the acupuncture treatment, including the number of acupuncture treatment sessions required until a patient was successfully treated was recorded, with a maximum of three acupuncture treatment sessions per patient, the time elapsed until urination following the treatment (minutes), and urinary bladder volume before and after treatment (mL). Results: The study demonstrated a 93.3% success rate in treating POUR with electroacupuncture. A significant reduction in post-void residual volume was noted, and patients could void within 30 minutes post-treatment. No significant differences in treatment effectiveness were observed across difference genders and age groups. Conclusion: Electroacupuncture proved to be a highly effective treatment for POUR in patients post-lumbar spine surgery, with a rapid response time and substantial reduction in PVR. However, the retrospective nature of the study and single-center focus limit its generalizability. Future research incorporating randomized controlled trials or multi-center observational studies are recommended to validate these findings and explore the potential of acupuncture in POUR management on a broader scale.

Comparison of Various Joint Decompression Techniques in Septic Arthritis of the Hip in Children: A Systematic Review and Meta-Analysis

  • Sitanshu Barik;Vikash Raj;Sant Guru Prasad;Richa;Varun Garg;Vivek Singh
    • Hip & pelvis
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    • v.35 no.2
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    • pp.73-87
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    • 2023
  • The aim of this review is to conduct an analysis of existing literature on outcomes of application of various methods of joint decompression in management of septic arthritis of the hip in children. A search of literature in PubMed, Embase, and Google Scholar was conducted for identification of studies reporting on the outcomes of intervention for septic arthritis of the hip in children. Of the 17 articles selected, four were comparative studies; two of these were randomized controlled trials while the rest were single arm studies. Statistical difference was observed between the proportion of excellent clinical and radiological outcomes in arthrotomy (90%, 95% confidence interval [CI] 81-98%; 89%, 95% CI 80-98%), arthroscopy (95%, 95% CI 91-100%; 95%, 95% CI 90-99%), and arthrocentesis (98%, 95% CI 97-100%; 99%, 95% CI 97-100%), respectively. The highest overall rate of additional unplanned procedures was observed in the arthrocentesis group (24/207, 11.6%). Patients who underwent arthrocentesis had a statistically greater chance of excellent clinical and radiological outcomes, although the highest level of need for additional unplanned surgical intervention was observed in the arthrocentesis group, followed by the arthroscopy group and the arthrotomy group. Future conduct of a prospective multi-centric study focusing on the developed and developing world, along with acquisition of data. such as delay of treatment and severity of disease will enable assessment of the efficacy of one technique over the other by surgeons worldwide.

Effects of Fasting versus Non-Fasting on Emetic Complications in Radiological Examinations Using Intravascular Non-Ionic Iodinated Contrast Media: A Systematic Review and Meta-Analysis

  • Hyewon Choi;Hyunsook Hong;Min Jae Cha;Soon Ho Yoon
    • Korean Journal of Radiology
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    • v.24 no.10
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    • pp.996-1005
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    • 2023
  • Objective: To compare the incidence of aspiration pneumonia, nausea, and vomiting after intravascular administration of nonionic iodinated contrast media (ICM) between patients who fasted before contrast injection and those who did not. Materials and Methods: Ovid-MEDLINE and Embase databases were searched from their inception dates until September 2022 to identify original articles that met the following criteria: 1) randomized controlled trials or observational studies, 2) separate reports of the incidence of aspiration pneumonia, nausea, and vomiting after intravascular injection of non-ionic ICM, and 3) inclusion of patients undergoing radiological examinations without fasting. A bivariate beta-binomial model was used to compare the risk difference in adverse events between fasting and non-fasting groups. The I2 statistic was used to assess heterogeneity across the studies. Results: Ten studies, encompassing 308013 patients (non-fasting, 158442), were included in this meta-analysis. No cases of aspiration pneumonia were reported. The pooled incidence of nausea was 4.6% (95% confidence interval [CI]: 1.4%, 7.8%) in the fasting group and 4.6% (95% CI: 1.1%, 8.1%) in the non-fasting group. The pooled incidence of vomiting was 2.1% (95% CI: 0.0%, 4.2%) in the fasting group and 2.5% (95% CI: 0.7%, 4.2%) in the non-fasting group. The risk difference (incidence in the non-fasting group-incidence in the fasting group) in the incidence of nausea and vomiting was 0.0% (95% CI: -4.7%, 4.7%) and 0.4% (95% CI: -2.3%, 3.1%), respectively. Heterogeneity between the studies was low (I2 = 0%-13.5%). Conclusion: Lack of fasting before intravascular administration of non-ionic ICM for radiological examinations did not increase the risk of emetic complications significantly. This finding suggests that hospitals can relax fasting policies without compromising patient safety.

Hybrid argon plasma coagulation in Barrett's esophagus: a systematic review and meta-analysis

  • Sagar N. Shah;Nabil El Hage Chehade;Amirali Tavangar;Alyssa Choi;Marc Monachese;Kenneth J. Chang;Jason B. Samarasena
    • Clinical Endoscopy
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    • v.56 no.1
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    • pp.38-49
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    • 2023
  • Background/Aims: Patients with Barrett's esophagus are at increased risk of developing esophageal adenocarcinoma. Endoscopic therapies aim to eradicate dysplastic and metaplastic tissues. Hybrid argon plasma coagulation (hybrid-APC) utilizes submucosal fluid injection to create a protective cushion prior to ablation that shields the submucosa from injury. We performed a pooled meta-analysis to evaluate the safety and efficacy of hybrid-APC. Methods: We conducted a systematic search of major electronic databases in April 2022. Studies that included patients with dysplastic and non-dysplastic Barrett's esophagus undergoing treatment with hybrid-APC were eligible for inclusion. Outcome measures included complete remission of intestinal metaplasia (CR-IM), stricture formation, serious adverse events, and number of sessions necessary to achieve CR-IM. Results: Overall pooled CR-IM rate for patients undergoing hybrid-APC was 90.8% (95% confidence interval [CI], 0.872-0.939; I2=0%). Pooled stricture rate was 2.0% (95% CI, 0.005-0.042; I2=0%). Overall serious adverse event rate was 2.7% (95% CI, 0.007-0.055; I2=0%). Conclusions: Results of the current meta-analysis suggest that hybrid-APC is associated with high rates of CR-IM and a favorable safety profile. Interpretation of these results is limited by the inclusion of retrospective cohort and case series data. Randomized controlled trials that standardize treatment and outcome evaluation protocols are necessary to understand how this treatment option is comparable to the current standards of care.

Effects of Omega-3 Fatty Acid Supplementation on Skeletal Muscle Mass and Strength in Adults: A Systematic Review

  • Gi Kyoung Moon;So Young Bu
    • Clinical Nutrition Research
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    • v.12 no.4
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    • pp.304-319
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    • 2023
  • Previous studies have suggested that omega-3 polyunsaturated fatty acids, predominantly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), have several health benefits. However, their effect on changes in skeletal muscle mass and strength has not been established, owing to differences in study designs. This systematic review aimed to investigate the recent evidence regarding the role of dietary EPA and DHA in muscle mass changes and their association with muscle strength. Databases including PubMed and Google Scholar were searched for randomized controlled trials and single-arm interventions that investigated the effects of omega-3 fatty acids on skeletal muscle mass, strength, and body composition in adults aged 18 years and older. A total of 18,521 studies were retrieved from the databases and manual searches; 21 studies were quality assessed, and the findings were summarized. Studies were categorized into 3 main categories according to the type of omega-3 fatty acid supplementation: pure compounds such as oil tablets, formulated forms with protein, leucine, and vitamin D, and ingredients added to enteral nutrition support products. Overall, the majority of the study results appeared to indicate that omega-3 fatty acids are beneficial for muscle health. However, meta-analysis was not conducted because of the heterogeneity of the study participants, evaluation method of muscle indices, and intervention periods among the studies. High-quality studies are required to validate our conclusions. However, this systematic review of the effects of EPA and DHA on skeletal muscle and body composition provides evidence that can be applied in both clinical and industrial settings.

Postoperative analgesic effects of the quadratus lumborum block in pediatric patients: a systematic review and meta-analysis

  • Insun Park;Jae Hyon Park;Hyun-Jung Shin;Hyo-Seok Na;Bon-Wook Koo;Jung-Hee Ryu;Ah-Young Oh
    • The Korean Journal of Pain
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    • v.37 no.1
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    • pp.59-72
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    • 2024
  • Background: This study assessed the postoperative analgesic efficacy and safety of the quadratus lumborum block (QLB) in pediatric patients. Methods: Electronic databases were searched for studies comparing the QLB to conventional analgesic techniques in pediatric patients. The primary outcome was the need for rescue analgesia 12 and 24 hours after surgery. Secondary outcomes covered the Face-Legs-Activity-Cry-Consolability Scale (FLACC) scores at various time points; parental satisfaction; time to the first rescue analgesia; hospitalization time; block execution time; block failure rates, and adverse events. Results: Sixteen randomized controlled trials were analyzed involving 1,061 patients. The QLB significantly reduced the need for rescue analgesia both at 12 and 24 hours after surgery (12 hours, relative risk [RR]: 0.45; 95% confidence interval [CI]: 0.01, 0.88; 24 hours, RR: 0.51; 95% CI: 0.31, 0.70). In case of 24 hours after surgery, type 1 QLB significantly reduced the need for rescue analgesia (RR: 0.56; 95% CI: 0.36, 0.76). The QLB also exhibited lower FLACC scores at 1 hour (standardized mean difference [SMD]: -0.87; 95% CI: -1.56, -0.18) and 6 hours (SMD: -1.27; 95% CI: -2.33, -0.21) following surgery when compared to non-QLB. Among QLBs, type 2 QLB significantly extended the time until the first rescue analgesia (SMD: 1.25; 95% CI: 0.84, 1.67). No significant differences were observed in terms of parental satisfaction, hospitalization time, block execution time, block failure, or adverse events between QLB and non-QLB groups. Conclusions: The QLB provides non-inferior analgesic efficacy and safety to conventional methods in pediatric patients.