• Title/Summary/Keyword: randomized clinical trials

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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.

A Systematic Review of Non-pharmacological Intervention for Depression in Korean Middle-aged Women (한국 중년여성의 비약물적 우울중재연구: 체계적 문헌고찰)

  • Chae, Myung-Ock;Jeon, Hae Ok;Kim, Ahrin
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.17 no.3
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    • pp.638-651
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    • 2016
  • The purpose of this study was to review the literature and examine the effects on non-pharmacological depression intervention for middle-aged women in Korea. This systematic review analyzed the literature from 2006 to September, 2015. The existing literature was searched in the electronic databases in RISS, KISS and DBPia using the following key words: middle-aged women and depression, menopause and depression, climacterium and depression. Two hundred eighty studies were found through the database. According to PICOTS-SD, twelve studies were included for analysis. Among the twelve studies, four studies were conducted in the nursing field. Six studies were randomized controlled trials. Aerobic exercise, laughter therapy, meditation, aroma massage, counseling and art therapy were performed as non-pharmacological interventions for depression in Korean middle-aged women. The length of each session ranged from 20 to 120 minutes. The intervention period varied from 2 to 24 weeks, and the total number of the interventions ranged from 8 to 72 times. They influenced not only depression, but also physical aspects that are associated with obesity and psychosocial variables, such as anxiety, quality of life, life satisfaction, etc.

Effect of Korea red ginseng on nonalcoholic fatty liver disease: an association of gut microbiota with liver function

  • Hong, Ji Taek;Lee, Min-Jung;Yoon, Sang Jun;Shin, Seok Pyo;Bang, Chang Seok;Baik, Gwang Ho;Kim, Dong Joon;Youn, Gi Soo;Shin, Min Jea;Ham, Young Lim;Suk, Ki Tae;Kim, Bong-Soo
    • Journal of Ginseng Research
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    • v.45 no.2
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    • pp.316-324
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    • 2021
  • Background: Korea Red Ginseng (KRG) has been used as remedies with hepato-protective effects in liver-related condition. Microbiota related gut-liver axis plays key roles in the pathogenesis of chronic liver disease. We evaluated the effect of KRG on gut-liver axis in patients with nonalcoholic statohepatitis by the modulation of gut-microbiota. Methods: A total of 94 patients (KRG: 45 and placebo: 49) were prospectively randomized to receive KRG (2,000 mg/day, ginsenoside Rg1+Rb1+Rg3 4.5mg/g) or placebo during 30 days. Liver function test, cytokeraton 18, and fatigue score were measured. Gut microbiota was analyzed by MiSeq systems based on 16S rRNA genes. Results: In KRG group, the mean levels (before vs. after) of aspartate aminotransferase (53 ± 19 vs. 45 ± 23 IU/L), alanine aminotransferase (75 ± 40 vs. 64 ± 39 IU/L) and fatigue score (33 ± 13 vs. 26 ± 13) were improved (p < 0.05). In placebo group, only fatigue score (34 ± 13 vs. 31 ± 15) was ameliorated (p < 0.05). The changes of phyla were not statistically significant on both groups. In KRG group, increased abundance of Lactobacillus was related with improved alanine aminotransferase level and increased abundance of Clostridium and Intestinibacter was associated with no improvement after KRG supplementation. In placebo group, increased abundance of Lachnospiraceae could be related with aggravation of liver enzyme (p < 0.05). Conclusion: KRG effectively improved liver enzymes and fatigue score by modulating gut-microbiota in patients with fatty liver disease. Further studies are needed to understand the mechanism of improvement of nonalcoholic steatohepatitis. ClnicalTrials.gov: NCT03945123 (www.ClinicalTrials.gov).

Effects of Manual Therapy on Musculoskeletal Diseases : A Meta-Analysis (근육뼈대계 질환에 대한 도수치료의 효과: 메타분석)

  • Lee, Jeong-Woo;Gong, Gwang-Sik;Kim, Dong-Yeon;Koh, Un
    • Journal of The Korean Society of Integrative Medicine
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    • v.9 no.1
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    • pp.203-217
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    • 2021
  • Purpose: The purpose of this meta-analysis was to examine the high-level evidence of the effects of manual therapy on musculoskeletal diseases. Methods: Domestic databases were searched for studies that conducted clinical trials associated with manual therapy on chronic musculoskeletal diseases. A total of 591 studies published between 2005 and 2018 were identified, with 18 studies satisfying the inclusion data. The studies were classified according to patient, intervention, comparison, and outcome (PICO). The search outcomes were items associated with pain and physical function. The 18 studies included in the study were evaluated by using the R meta-analysis (version 4.0). The quality of 18 randomized control trials was evaluated by using the Cochrane risk of bias (ROB). The effect sizes were computed as the corrected standardized mean difference (SMD). Subgroup and meta-regression analyses were also used. Egger's regression test was carried out in order to analyze the publication bias. Cumulative meta-analysis and sensitivity analysis were also conducted in order to analyze the data error. Results: The following factors showed the large effect size of manual therapy on chronic musculoskeletal diseases: pain (Hedges's g = 2.66; 95% CI = 1.47 ~ 3.85), and physical function (Hedges's g = 2.15; 95% CI: 1.22 ~ 3.08). The subgroup analysis only showed a statistical difference in the type of manual therapy (pain) and outcome (physical function). No statistically significant difference was found in the meta-regression analysis. Publication bias was found in the data, but the results of the trim-and-fill method showed that such bias did not largely affect the obtained data. Furthermore, there were no data errors in the cumulative meta-analysis and sensitivity analysis. Conclusion: This study provides evidence for the effectiveness of manual therapy on chronic musculoskeletal diseases in pain and physical function. Subgroup analysis suggests that only the type of manual therapy for pain and the type of outcome for physical function differed in effect size.

New techniques for wound management: A systematic review of their role in the management of chronic wounds

  • Bekara, Farid;Vitse, Julian;Fluieraru, Sergiu;Masson, Raphael;De Runz, Antoine;Georgescu, Vera;Bressy, Guillaume;Labbe, Jean Louis;Chaput, Benoit;Herlin, Christian
    • Archives of Plastic Surgery
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    • v.45 no.2
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    • pp.102-110
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    • 2018
  • Debridement is a crucial component of wound management. Recent technologies such as hydrosurgery (Versajet), ultrasound therapy (the MIST therapy device), or plasma-mediated bipolar radio-frequency ablation therapy (Coblation) seem to represent interesting alternatives for wound debridement. The purpose of this systematic review was to describe, evaluate, and compare these three recently developed methods for the management of chronic wounds. In January 2016, an electronic database search was conducted of MEDLINE, PubMed Central, and Embase for articles concerning these three innovative methods for the management of chronic wounds. A total of 389 references were identified by our search strategy, and 15 articles were included. We extracted data regarding the number and age of patients, indications, operating time, number of procedures, costs, wound healing time, decrease in exudation, perioperative blood loss, bacterial load, and the occurrence of complications. The 15 articles included studies that involved 563 patients who underwent hydrosurgery (7 studies), ultrasound therapy (6 studies), or Coblation (2 studies). Six randomized controlled trials were included that compared the use of a scalpel or curette to hydrosurgery (2 studies) or ultrasound therapy (6 studies). Hydrosurgery, in addition to being a very precise and selective tool, allows significantly faster debridement. Ultrasound therapy provides a significant reduction of exudation, and improves the wound healing time. No comparative study dedicated to Coblation was identified. Despite the obvious clinical interest of the topic, our review of the current literature revealed a lack of prospective randomized studies comparing these devices with each other or with standard techniques, particularly for Coblation and hydrosurgery.

Effects of Integrated Palliative Care Intervention on Quality of Life in Terminal Cancer Patients: A Meta-analysis (통합적 완화 돌봄 중재가 말기암환자의 삶의 질에 미치는 효과: 메타분석)

  • Jo, Kae Hwa;Park, Ae Ran;Lee, Jin Ju
    • Journal of Hospice and Palliative Care
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    • v.18 no.2
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    • pp.136-147
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    • 2015
  • Purpose: This study was conducted to evaluate the effects of integrated palliative care intervention on quality of life in terminally ill patients. Methods: A comprehensive literature search was performed via PubMed, Cochrane Library CENTRAL, LWW (Ovid), CINAHL and several Korean databases. The main search strategy was to combine terms indicating palliative care intervention, presence of terminal illness and study design. Methodological quality was assessed using Cochrane's Risk of Bias for randomized studies and Risk of Bias Assessment tool for non-randomized studies. Data were analyzed by the Stata 10 program. Results: Eight clinical trials met the inclusion criteria with a total of 356 participants. Integrated palliative care interventions were administered for a mean of 6.5 weeks, 5.6 sessions and an average of 47.8 minutes per session. Effect sizes were heterogeneous, and subgroup analysis was done. Integrated palliative care interventions had a significant effect on quality of life (ES=1.83, P=0.018, $l^2=92%$), spiritual well-being (ES=0.78, P=0.040, $l^2=0$), depression (ES=0.86, P<0.001, $l^2=32$) and anxiety (ES=0.69, P=0.041, $l^2=71.1$). But integrated palliative care interventions had no significant effect on pain (ES=0.365, P=0.230, $l^2=69.8$). Conclusion: Results support findings that integrated palliative care interventions were helpful in lessening depression and anxiety and improving quality of life and spiritual well-being, however, the interventions did not assist pain management in terminal cancer patients. These findings suggest that various integrated palliative care interventions can assist terminal cancer patients with better quality of life in the socio-psycho-spiritual dimension.

Effectiveness of Auricular Blood-letting Therapy for Headaches: A Systematic Review and Meta-Analysis (두통에 대한 이혈 방혈요법의 유효성 분석: 체계적 문헌고찰 및 메타분석)

  • Kyoungeun Lee;Min-Ryeong Park;Ji-Won Lee;In-Jun Hwang;Boram Lee;Jong Cheol Seo;Chan-Young Kwon
    • Journal of Oriental Neuropsychiatry
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    • v.34 no.3
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    • pp.259-274
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    • 2023
  • Objectives: The purpose of this study was to provide clinical evidence to support the use of auricular blood-letting therapy (ABT) for headaches. Methods: Studies were identified by a comprehensive search of five databases. Randomized controlled trials (RCTs) that investigated the effects of the ABT for headaches were included. Two authors independently extracted the data and assessed the methodological quality of the included studies using Cochrane's risk-of-bias tool. If two or more studies reported the same outcome, a meta-analysis was performed. Meta-analysis results for dichotomous variables are expressed as risk ratios (RRs) and 95% confidence intervals (CIs). Results: A total of eight RCTs were included in this review. The total effective rate (TER) was the most commonly used outcome measurement. Among the eight RCTs, five were included in the metaanalysis. The TER was not statistically significantly different in the ABT group compared to the medication group (two studies, n=55, RR=1.24, 95% CI: 0.78 to 1.96, p=0.36, I2 =86%). However, the TER of the combined ABT and medication group was significantly different compared to the medication alone group (four studies, n=159, RR=1.23, 95% CI: 1.12 to 1.35, p<0.0001, I2 = 0%). Pain and mental health-related outcomes in the combined ABT and medication group were significantly different from the control groups. The methodological quality of the included RCTs was generally low. Conclusions: ABT combined with medication may be effective for treating headaches. However, the number of studies included was small, so the results were insufficient, and statistically significant effects were not confirmed for a single implementation of ABT. Thus, well-designed further studies based on the findings of this study are recommended.

Effects of GV1001 on Language Dysfunction in Patients With Moderate-to-Severe Alzheimer's Disease: Post Hoc Analysis of Severe Impairment Battery Subscales

  • Hyuk Sung Kwon;Seong-Ho Koh;Seong Hye Choi;Jee Hyang Jeong;Hae Ri Na;Chan Nyoung Lee;YoungSoon Yang;Ae Young Lee;Jae-Hong Lee;Kyung Won Park;Hyun Jeong Han;Byeong C. Kim;Jinse Park;Jee-Young Lee;Kyu-Yong Lee;Sangjae Kim
    • Dementia and Neurocognitive Disorders
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    • v.22 no.3
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    • pp.100-108
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    • 2023
  • Background and Purpose: The efficacy and safety of GV1001 have been demonstrated in patients with moderate-to-severe Alzheimer's disease (AD). In this study, we aimed to further demonstrate the effectiveness of GV1001 using subscales of the Severe Impairment Battery (SIB), which is a validated measure to assess cognitive function in patients with moderate-to-severe AD. Methods: We performed a post hoc analysis of data from a 6 month, multicenter, phase 2, randomized, double-blind, placebo-controlled trial with GV1001 (ClinicalTrials.gov, NCT03184467). Patients were randomized to receive either GV1001 or a placebo for 24 weeks. In the current study, nine subscales of SIB-social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction, and orientation to name-were compared between the treatment (GV1001 1.12 mg) and placebo groups at weeks 12 and 24. The safety endpoints for these patients were also determined based on adverse events. Results: In addition to the considerable beneficial effect of GV1001 on the SIB total score, GV1001 1.12 mg showed the most significant effect on language function at 24 weeks compared to placebo in both the full analysis set (FAS) and per-protocol set (PPS) (p=0.017 and p=0.011, respectively). The rate of adverse events did not differ significantly between the 2 groups. Conclusions: Patients with moderate-to-severe AD receiving GV1001 had greater language benefits than those receiving placebo, as measured using the SIB language subscale.

Efficacy and Toxicity of Anti-VEGF Agents in Patients with Castration-Resistant Prostate Cancer: a Meta-analysis of Prospective Clinical Studies

  • Qi, Wei-Xiang;Fu, Shen;Zhang, Qing;Guo, Xiao-Mao
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.19
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    • pp.8177-8182
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    • 2014
  • Background: Blocking angiogenesis by targeting vascular endothelial growth factor (VEGF) signaling pathway to inhibit tumor growth has proven to be successful in treating a variety of different metastatic tumor types, including kidney, colon, ovarian, and lung cancers, but its role in castration-resistant prostate cancer (CRPC) is still unknown. We here aimed to determine the efficacy and toxicities of anti-VEGF agents in patients with CRPC. Materials and Methods: The databases of PubMed, Web of Science and abstracts presented at the American Society of Clinical Oncology up to March 31, 2014 were searched for relevant articles. Pooled estimates of the objective response rate (ORR) and prostate-specific antigen (PSA) response rate (decline ${\geq}50%$) were calculated using the Comprehensive Meta-Analysis (version 2.2.064) software. Median weighted progression-free survival (PFS) and overall survival (OS) time for anti-VEGF monotherapy and anti-VEGF-based doublets were compared by two-sided Student's t test. Results: A total of 3,841 patients from 19 prospective studies (4 randomized controlled trials and 15 prospective nonrandomized cohort studies) were included for analysis. The pooled ORR was 12.4% with a higher response rate of 26.4% (95%CI, 13.6-44.9%) for anti-VEGF-based combinations vs. 6.7% (95%CI, 3.5-12.7%) for anti-VEGF alone (p=0.004). Similarly, the pooled PSA response rate was 32.4% with a higher PSA response rate of 52.8% (95%CI: 40.2-65.1%) for anti-VEGF-based combinations vs. 7.3% (95%CI, 3.6-14.2%) for anti-VEGF alone (p<0.001). Median PFS and OS were 6.9 and 22.1 months with weighted median PFS of 5.6 vs. 6.9 months (p<0.001) and weighted median OS of 13.1 vs. 22.1 months (p<0.001) for anti-VEGF monotherapy vs. anti-VEGF-based doublets. Conclusions: With available evidence, this pooled analysis indicates that anti-VEGF monotherapy has a modest effect in patients with CRPC, and clinical benefits gained from anti-VEGF-based doublets appear greater than anti-VEGF monotherapy.

Comparative Analysis of Endovascular Stroke Therapy Using Urokinase, Penumbra System and Retrievable (Solitare) Stent

  • Choi, Jae-Hyung;Park, Hyun-Seok;Kim, Dae-Hyun;Cha, Jae-Kwan;Huh, Jae-Taeck;Kang, Myongjin
    • Journal of Korean Neurosurgical Society
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    • v.57 no.5
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    • pp.342-349
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    • 2015
  • Background : Higher reperfusion rates have been established with endovascular treatment for acute ischemic stroke patients. There are limited data on the comparative performance of mechanical thrombectomy devices. This study aimed to analyse the efficacy and safety of the stent retriever device (Solitaire stent) by comparing procedure time, angiographic outcome, complication rate and long term clinical outcome with previous chemical thrombolysis and mechanical thrombectomy using penumbra system. Method : A retrospective single-center analysis was undertaken of all consecutive patients who underwent chemical thrombolysis and mechanical thrombectomy using Penumbra or Solitaire stent retriever from March 2009 to March 2014. Baseline characteristics, rate of successful recanalization (modified Thrombolysis in Cerebral Infarction score 2b-3), symptomatic intracerebral hemorrhage, procedure time, mortality and independent functional outcomes ($mRS{\leq}2$) at 3 month were compared across the three method. Results : Our cohort included 164 patients, mechanical thrombectomy using stent retriever device had a significant impact on recanalization rate and functional independence at 3 months. In unadjusted analysis mechanical thrombectomy using Solitaire stent retriever showed higher recanalization rate than Penumbra system and chemical thrombolysis (75% vs. 64.2% vs. 49.4%, p=0.03) and higher rate of functional independence at 3 month (53.1% vs. 37.7% vs. 35.4%, p=0.213). In view of the interrelationships between all predictors of variables associated with a good clinical outcome, when the chemical thrombolysis was used as a reference, in multiple logistic regression analysis, the use of Solitaire stent retriever showed higher odds of independent functional outcome [odds ratio (OR) 2.62, 95% confidence interval (CI) 0.96-7.17; p=0.061] in comparison with penumbra system (OR 1.57, 95% CI 0.63-3.90; p=0.331). Conclusion : Our initial data suggest that mechanical thrombectomy using stent retriever is superior to the mechanical thrombectomy using penumbra system and conventional chemical thrombolysis in achieving higher rates of reperfusion and better outcomes. Randomized clinical trials are needed to establish the actual benefit to specific patient populations.