• 제목/요약/키워드: randomized clinical trials

검색결과 984건 처리시간 0.025초

A Randomized trial to investigate the effect of Asparagus racemosus root tablet in Relieving Postmenopausal Hot Flashes

  • K.M. Hina Fatima;Mariyam Roqaiya;Nawazisha
    • 셀메드
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    • 제14권10호
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    • pp.10.1-10.6
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    • 2024
  • Background and Objectives: As per the available data, 75% peri and postmenopausal women experience hot flashes having negative effect on their quality of life. Using herbal medicines are stepping forward to alleviate hot flashes as the available hormonal medications have been reported the presence of side effects. This study was planned with the intention to investigate the effect of Asparagus racemosus root in the treatment of postmenopausal hot flashes in comparison to the placebo. Methods: This prospective patient blinded clinical trial randomly assigned 40 postmenopausal women with symptoms of hot flashes to receive either test drug (n=20) comprising Asparagus racemosus tablet of 1g in the dosage of 2 tablet thrice in a day for the duration of 60 days continuously or to receive placebo tablet prepared from roasted wheat flour in the same dosage and duration as test drug. The efficacy was determined by reduction in the frequency and intensity of hot flashes assessed by daily diary along with the improvement in quality of life assessed through Hot Flash-Related Daily Interference Scale. Statistical analysis was accomplished by student t test and Chi-square/Fisher Exact test. Results: Test drug significantly (p <0.001) reduced the intensity and frequency of hot flashes as well as improved the quality of life without showing any side effect. Discussion & Conclusion: According to Unani scriptures, the treatment is to treat the underlying cause, such as aberrant temperament and psychological and environmental issues. Unani drugs have emmenagogue, anti-inflammatory, analgesic, and neuroprotective qualities that can help alleviate premenstrual symptoms. Unani herbs such as C. sativus, Vitex, agnus castus, P. vulgare, N. Jatamansi, M. officinalis, and Z. officinalis have been clinically demonstrated to be effective in PMS. Thus, traditional knowledge authentication and conservation are vital for future research and appreciated for application in the modern day. Furthermore, randomised controlled trials, comprehensive reviews, and meta-analyses are suggested.

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

  • 채명옥;전해옥;김아린
    • 한국산학기술학회논문지
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    • 제17권3호
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    • pp.638-651
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    • 2016
  • 본 연구는 중년여성을 대상으로 한 비약물적 우울중재연구를 고찰하고 그 효과를 탐색하기 위해 수행되었다. 체계적 문헌고찰은 국내 데이터베이스인 RISS, KISS, DBPia의 온라인 검색을 통해 2006년부터 2015년 9월까지 국내 학술지에 게재된 연구 논문을 대상으로 하였으며. 자료 검색어는 중년여성과 우울, 폐경기와 우울, 갱년기와 우울로 하였다. 그 결과, 280편이 검색되었고, PICOTS-SD에 따라 최종 12편이 분석에 이용되었다. 그 중 4편은 간호학 분야 연구였고, 6편은 무작위 배정이 이루어진 무작위 대조군 실험연구였다. 비약물적 우울중재는 에어로빅 등 신체적 활동을 포함하는 형태가 4편으로 가장 많았고, 웃음요법과 단전 등 명상 각각 3편, 아로마 마사지와 상담 각각 2편, 미술요법이 1편으로 나타났고, 복합중재가 적용된 논문은 3편이었다. 중재 프로그램의 1회 적용 시간은 20분에서 120분, 중재 적용 기간은 2주에서 24주, 총 중재 회기는 8회에서 72회로 나타났고, 이들 프로그램은 우울뿐만 아니라 비만과 관련된 신체적 측면과 불안, 삶의 질, 삶의 만족도 등 사회 심리적 변수에 유의한 영향을 주는 것으로 나타났다.

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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    • 제45권2호
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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).

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

  • 이정우;공광식;김동연;고운
    • 대한통합의학회지
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    • 제9권1호
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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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    • 제45권2호
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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.

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

  • 조계화;박애란;이진주
    • Journal of Hospice and Palliative Care
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    • 제18권2호
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    • pp.136-147
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    • 2015
  • 목적: 본 연구는 통합적 완화 돌봄 중재연구가 말기 암환자의 삶의 질에 미치는 효과 크기를 분석하기 위한 메타분석 연구이다. 방법: 말기 환자와 통합적 완화 돌봄 중재 및 연구 설계를 나타내는 용어들을 병합하여 PubMed, Cochrane Library CENTRAL, LWW (Ovid), CINAHL 및 국내 데이터 베이스에서 검색하였다. 논문의 질평가는 RCT 연구인 경우 RoB 도구를 사용하였으며, Non-RCT 연구인 경우는 RoBANS를 사용하였다. 중재의 효과크기는 Stata 10 프로그램으로 메타분석 하였다. 결과: 8편의 연구가 최종선정 되었으며, 총 대상자의 수는 356명이었다. 통합적 완화 돌봄 중재는 평균 6.5주, 5.6 세션으로 이루어졌으며, 한 세션당 평균 47.8분이 소요되었다. 효과는 동질성 및 하위그룹 분석을 실시하였다. 통합적 완화 돌봄 중재의 효과는 삶의 질(ES=1.83, P=0.018, $l^2=92%$), 영적 안녕(ES=0.78, P=0.040, $l^2=0$), 우울(ES=0.86, P<0.001, $l^2=32$) 및 불안(ES=0.69, P=0.041, $l^2=71.1$)에서 효과가 있었다. 그러나 말기암환자의 통증(ES=0.365, P=0.230, $l^2=69.8$)에는 효과가 없었다. 결론: 이상의 결과로 통합적 완화 돌봄 중재는 비록 통증은 완화시키지는 못했으나 우울과 불안을 감소시키고 영적 안녕과 삶의 질을 높이는 것으로 나타나, 통합적 완화 돌봄 중재는 말기암환자의 사회심리영적 차원의 삶의 질을 증진시킬 수 있다고 본다.

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

  • 이경은;박민령;이지원;황인준;이보람;서종철;권찬영
    • 동의신경정신과학회지
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    • 제34권3호
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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
    • 대한치매학회지
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    • 제22권3호
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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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    • 제15권19호
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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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    • 제57권5호
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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.