• Title/Summary/Keyword: RCTs Review

Search Result 501, Processing Time 0.028 seconds

Efficacy and Cardiovascular Safety of Romosozumab: A Meta-analysis and Systematic Review (Romosozumab의 효과 및 심혈관계 안전성: 체계적 문헌고찰 및 메타분석)

  • Seo-Yong Choi;Jeong-Min Kim;Sang-Hyeon Oh;Seunghyun Cheon;Jee-Eun Chung
    • Korean Journal of Clinical Pharmacy
    • /
    • v.33 no.2
    • /
    • pp.128-134
    • /
    • 2023
  • Background: This systematic review and meta-analysis aimed to evaluate the efficacy and cardiovascular safety of romosozumab compared with placebo. Methods: Randomized controlled trials (RCTs) were searched from Medline, EMBASE, Cochrane Central, and Web of Science until July 2022. Primary outcomes included the change in bone mineral density (BMD) from baseline at month 6. The secondary outcomes were the change of bone turnover markers (N-terminal propeptide of type 1 procollagen (P1NP); C-terminal telopeptide of type 1 collagen (CTX)) from baseline at month 3, and the incidence of cardiovascular adverse events for the total follow-up period. Results: A total of 7 RCTs on 8,370patients were included. Romosozumab showed better effects in improving BMD in both lumbar spine and femoral neck at month 6 (standardized mean difference, SMD 2.20 [95% CI: 1.89-2.52], SMD 0.63 [95% CI: 0.41-0.86]). In contrast to placebo, romosozumab significantly increased PINP levels and reduced CTX levels at month 3 (SMD 0.93 [95% CI: 0.65-1.22], SMD -1.03 [95% CI: -1.23~ -0.82]. However, there was no significant difference in the composite incidence of cardiovascular adverse events and major adverse cardiovascular events (OR 1.16 [95% CI: 0.82-1.65], OR 1.08 [95% CI: 0.75-1.56]). Conclusion: This analysis showed that romosozumab significantly improved BMD compared to placebo and was beneficial for change in bone turnover markers. There is no significant difference in the incidence of cardiovascular adverse events compared to placebo.

Trends in Clinical Research on Herbal Medicine Treatment in Pediatric Asthma - Focusing on Randomized Controlled Clinical Trials in Traditional Chinese Medicine (소아 천식의 한약 치료에 대한 임상연구 동향 - 중의학 무작위 대조군 임상시험을 중심으로)

  • Seo Lin;Jang Subi;Choi Bom;Choi Bom;Cheon Jin Hong
    • The Journal of Pediatrics of Korean Medicine
    • /
    • v.37 no.4
    • /
    • pp.70-90
    • /
    • 2023
  • Objective This study analyzed randomized clinical trials (RCTs) on pediatric asthma using traditional Chinese medicine (TCM) to determine its efficacy and safety. Methods We searched electronic databases in English, Chinese, Japanese, and Korean and evaluated 35 articles published up to December 28, 2022. Based on data from the literature, we analyzed treatments, results, composition of herbal medicine, frequency of medicinal herbs, and decoction. Results TCM for pediatric asthma was compared to supportive therapy, inhaled corticosteroids, and standardized treatments. Of the 35 studies, 32 showed that TCM treatments were effective in alleviating asthma symptoms. Furthermore, TCM treatment was considered safe compared to common asthma treatments. Among the TCM treatments for pediatric asthma, the most frequent decoctions were Gamisaganmahwangtang (加味射干麻黃湯) and Saganmahwangtang (射干麻黃湯). Ephedra Herba (麻黄), Armeniacae Semen (杏仁), Asiasari Radix et Rhizoma (細辛), Belamcandae Rhizoma (射干) were herbs that were frequently used for asthma in TCM decoctions. Conclusion This review showed that TCM is effective in treating pediatric asthma. More clinical RCTs are needed to confirm the efficacy and safety of TCM treatment.

The Effects of Blackcurrant and Raspberry Consumption on Blood Pressure: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

  • Ali Nikparast;Fatemeh Sheikhhossein;Mohammad Reza Amini;Sogand Tavakoli;Azita Hekmatdoost
    • Clinical Nutrition Research
    • /
    • v.12 no.1
    • /
    • pp.54-64
    • /
    • 2023
  • A systematic review and meta-analysis were designed to summarize studies conducted on the effects of raspberry and blackcurrant consumption on blood pressure (BP). Eligible studies were detected by searching numerous five online databases including PubMed, Scopus, Web of Science, Cochrane Library, and Google Scholar, until December 17, 2022. We pooled the mean difference and its 95% confidence interval (CI) by applying a random-effects model. Overall, the impact of raspberry and blackcurrant on BP was reported in ten randomized controlled trials (RCTs) (420 subjects). Pooled analysis of six clinical trials revealed that raspberry consumption has no significant reduction in systolic blood pressure (SBP) (weighted mean differences [WMDs], -1.42; 95% CI, -3.27 to 0.87; p = 0.224) and diastolic blood pressure (DBP) (WMD, -0.53; 95% CI, -1.77 to 0.71; p = 0.401), in comparison with placebo. Moreover, pooled analysis of four clinical trials indicated that blackcurrant consumption did not reduce SBP (WMD, -1.46; 95% CI, -6.62 to 3.7; p = 0.579), and DBP (WMD, -2.09; 95% CI, -4.38 to 0.20; p = 0.07). Raspberry and blackcurrant consumption elicited no significant reductions in BP. More accurate RCTs are required to clarify the impact of raspberry and blackcurrant intake on BP.

Absorbable versus Nonabsorbable Sutures for Facial Skin Closure: A Systematic Review and Meta-analysis of Clinical and Aesthetic Outcomes

  • Kashish Malhotra;Sophie Bondje;Alexandros Sklavounos;Hatan Mortada;Ankur Khajuria
    • Archives of Plastic Surgery
    • /
    • v.51 no.4
    • /
    • pp.386-396
    • /
    • 2024
  • When repairing facial wounds, it is crucial to possess a thorough understanding of suitable suture materials and their evidence base. The absence of high-quality and comprehensive systematic reviews poses challenges in making informed decisions. In this study, we conducted a review of the existing literature and assessed the quality of the current evidence pertaining to the clinical, aesthetic, and patient-reported outcomes associated with absorbable and nonabsorbable sutures for facial skin closure. The study was registered on Prospective Register of Systematic Reviews. We conducted searches on Embase, Ovid, and PubMed/MEDLINE databases. Only randomized controlled trials (RCTs) were eligible for inclusion in this study. Additionally, the risk of bias in the randomized studies was assessed using Cochrane's Risk of Bias Tool. The study included a total of nine RCTs involving 804 participants with facial injuries. Among these injuries, absorbable sutures were utilized in 50.2% (403 injuries), while nonabsorbable sutures were employed in 49.8% (401 injuries). The analysis of cosmesis scales revealed no statistically significant difference between absorbable and nonabsorbable sutures regarding infections (p = 0.72), visual analog scale (p = 0.69), wound dehiscence (p = 0.08), and scarring (p = 0.46). The quality of the included studies was determined to have a low risk of bias. Absorbable sutures can be considered a suitable alternative to nonabsorbable sutures, as they demonstrate comparable aesthetic and clinical outcomes. Future high-quality studies with a level I evidence design and cost-effectiveness analysis are necessary to enhance clinician–patient shared decision-making and optimize the selection of suture materials. Level of evidence is I, risk/prognostic study.

The Effects of Magnesium Supplementation on Serum Magnesium and Calcium Concentration in Patients With Type 2 Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

  • Mohammad Zamani;Neda Haghighat
    • Clinical Nutrition Research
    • /
    • v.11 no.2
    • /
    • pp.133-145
    • /
    • 2022
  • The aim of this systematic review and meta-analysis was to summarize all the existing randomized controlled trials (RCTs) evidence and to evaluate the effects of magnesium supplementation on serum magnesium, calcium and urinary magnesium concentrations in patients with type 2 diabetes compared with the control. Two independent authors systematically searched online databases including Embase, Scopus, PubMed, and Web of Science from inception until 30th January 2022. RCTs complying with the inclusion criteria were included in this meta-analysis. The heterogeneity among the included studies was assessed using Cochrane's Q test and I-square (I2) statistic. Data were pooled using a random-effects model and weighted mean difference (WMD) was considered as the overall effect size. Sixteen trials were included in this meta-analysis. Serum magnesium (mean difference, 0.15 mg/dL; 95% confidence interval [CI], 0.06 to 0.23; p = 0.001) and urinary magnesium (WMD, 1.99 mg/dL; 95% CI, 0.36 to 3.62; p = 0.017) concentrations were significantly increased after magnesium supplementation when compared with the control group. However, magnesium supplementation did not have any significant effect on serum calcium (WMD, -0.09 mg/dL; 95% CI, -0.27 to 0.08; p = 0.294) level when compared with the control group. This meta-analysis demonstrated that magnesium supplementation significantly increased Serum magnesium levels which may have played an indirect role in improved clinical symptoms in patients with type 2 diabetes.

Moxibustion for Benign Prostatic Hyperplasia: A Systematic Review and Meta-analysis (전립선 비대증에 대한 뜸치료의 효과 : 체계적 문헌고찰과 메타분석)

  • Bae, Go-eun;Lee, Seung-hwan;Hong, Jin-woo;Lee, In;Kim, So-yeon;Choi, Jun-young;Han, Chang-woo;Yun, Young-ju;Park, Seong-ha;Kwon, Jung-nam
    • The Journal of Internal Korean Medicine
    • /
    • v.39 no.3
    • /
    • pp.372-388
    • /
    • 2018
  • Objective: This study evaluates the effectiveness and safety of moxibustion for benign prostatic hyperplasia (BPH). Methods: Using the keywords "benign prostatic hyperplasia", "benign prostatic hypertrophy", "benign prostatic enlargement", "prostatic hyperplasia", and "moxibustion", we searched papers in numerous databases, including National Discovery for Science Leaders (NDSL), Korean Traditional Knowledge Portal (KTKP), Oriental Medicine Advanced Searching Integrated System (OASIS), Research Information Sharing Service (RISS), PubMed, Embase, and CENTRAL. The search range included randomized controlled trials (RCTs). Papers not matched with inclusion criteria were excluded. The methodological quality of each RCT was assessed using the Cochrane risk-of-bias tool. Where appropriate, meta-analyses were performed. Results: Initially, 77 studies were found. Of these, 11 duplicate studies were removed and 27 were excluded following title and abstract screening. After the remaining 39 papers were scanned, 13 RCTs were selected and analyzed. Among these 13 RCTs, five compared moxibustion therapy and oral medication, seven compared moxibustion plus acupuncture therapy and oral medication, and one compared moxibustion plus acupuncture therapy and sham-moxibustion. The meta-analysis showed positive results for the use of moxibustion therapy in terms of International Prostate Symptom Score (IPSS), Quality Of Life (QOL), Maximum Flow Rate (Qmax), Prostate Volume (PV), and the efficacy rate. The meta-analysis showed positive results for the use of moxibustion plus acupuncture therapy in terms of IPSS, QOL, and the efficacy rate. Conclusions: This meta-analysis of clinical trials suggests that moxibustion is effective intreating BPH patients. The results of this study could be applied to clinical treatment of BPH. However, additional large-scale clinical researches should be conducted.

Herbal Medicine (Cheonwangbosim-Dan, Tianwangbuxin-Pellet) for Insomnia Disorder: A Systematic Review and Meta-Analysis of Randomized Controlled Trials (불면장애에 대한 천왕보심단의 체계적 문헌 고찰 및 메타분석 연구)

  • Sakong, Jong-Won;Kim, Dong-Hee;Ha, Ji-Won;Cho, Yun-Song;Kim, Bo-Kyung
    • Journal of Oriental Neuropsychiatry
    • /
    • v.29 no.4
    • /
    • pp.267-280
    • /
    • 2018
  • Objectives: The objective of this study was to provide clinical evidence to support the use of a herbal medicine (Cheonwangbosim-Dan/Tianwangbuxin-Pellet (TWBXP)) for insomnia. Methods: Randomized controlled trials that verified effects of Herbal Medicine (Cheonwangbosim-Dan, Tianwangbuxin-Pellet) treating primary insomnia were carried out. A literature search of English, Chinese, Korean databases was also performed. The selected literature were assessed by Risk of Bias (RoB). Results: The total number of selected trials was 13 RCTs. Among the 13 RCTs, 10 were meta-analyzed. The Chinese Classification of Mental Disorders-3 (CCMD-3) was frequently used as the diagnostic criteria for interventions during the analysis of the use of herbal medicine (Cheonwangbosim-Dan/Tianwangbuxin-Pellet) for management of primary insomnia. As for outcome measurement, the effective rate was used. From the Meta-analysis of the studies, it was established that the insomnia cure effective rate in the TWBXP group was higher than that in the Western Medicine (WM) group (RR: 1.15, 95% CI: 1.07 to 1.24, p<0.0001, $I^2=33%$). Also, the effective rate in the TWBXP+ACU group was significantly different compared to the WM group (RR: 1.32, 95% CI: 1.13 to 1.54, p=0.0004, $I^2=0%$). The quality of the selected RCTs was low. Conclusions: Herbal medicine (Cheonwangbosim-Dan/Tianwangbuxin-Pellet) is effective for treating primary insomnia. It is worth noting that this studies were of relatively poor quality. The sample sizes were also small. Therefore, further investigations into the diagnosis and treatment of insomnia are warranted.

Optimized Image-Based Surrogate Endpoints in Targeted Therapies for Glioblastoma: A Systematic Review and Meta-Analysis of Phase III Randomized Controlled Trials

  • Chong Hyun Suh;Ho Sung Kim;Seung Chai Jung;Choong Gon Choi;Sang Joon Kim;Kyung Won Kim
    • Korean Journal of Radiology
    • /
    • v.21 no.4
    • /
    • pp.471-482
    • /
    • 2020
  • Objective: We aimed to determine the optimized image-based surrogate endpoints (IBSEs) in targeted therapies for glioblastoma through a systematic review and meta-analysis of phase III randomized controlled trials (RCTs). Materials and Methods: A systematic search of OVID-MEDLINE and EMBASE for phase III RCTs on glioblastoma was performed in December 2017. Data on overall survival (OS) and IBSEs, including progression-free survival (PFS), 6-month PFS (6moPFS), 12-month PFS (12moPFS), median PFS, and objective response rate (ORR) were extracted. Weighted linear regression analysis for the hazard ratio for OS and the hazard ratios or odds ratios for IBSEs was performed. The associations between IBSEs and OS were evaluated. Subgroup analyses according to disease stage (newly diagnosed glioblastoma versus recurrent glioblastoma), types of test treatment, and types of response assessment criteria were performed. Results: Twenty-three phase III RCTs published between 2000 and 2017, including 8387 patients, met the inclusion criteria. OS showed strong correlations with PFS (standardized β coefficient [R] = 0.719), 6moPFS (R = 0.647), and 12moPFS (R = 0.638). OS showed no correlations with median PFS and ORR. In subgroup analysis according to types of therapies, PFS showed the highest correlations with OS in targeted therapies for cell cycle pathways (R = 0.913) and growth factor receptors and their downstream pathways (R = 0.962). 12moPFS showed the highest correlation with OS in antiangiogenic therapy (R = 0.821). The response assessment in neuro-oncology criteria provided higher correlation coefficients between OS and IBSEs than the Macdonald criteria. Conclusion: Overall, PFS is an optimized IBSE in targeted therapies for glioblastoma; however, 12moPFS is optimal in antiangiogenic therapy.

The Effect of Herbal Medicine for Adenomyosis patients: A Systematic Review (자궁선근증에 대한 한약의 효과 : 체계적 문헌 고찰)

  • Jung, Jae-Woong;Yoon, Young-Jin
    • The Journal of Korean Obstetrics and Gynecology
    • /
    • v.32 no.4
    • /
    • pp.87-101
    • /
    • 2019
  • Objectives: The purpose of this study is to investigate the effect of herbal medicine during the Western medicine therapy in adenomyosis. Methods: The author searched 5 electronic databases and search keywords were 'Adenomyosis' and 'Herbal Medicine'. We included randomized controlled clinical trials (RCTs) using herbal medicine therapy combined Western medicine for adenomyosis patients. Results: The author selected 12 studies. The systematic review of the 12 trials indicated that herbal medicine therapy integrated Western medicine therapy was more effective than Western medicine therapy alone. Conclusions: The herbal medicine therapy combined Western medicine for adenomyosis patients seems to improve pain relief and improvement of illness from this research. However, this result should be taken cautiously by unclear risk of bias. More clinical research will be needed to standardize the results of this study through herbal medicine.

Effectiveness of Cognitive Behavioral Therapy Techniques for Control of Pain in Lung Cancer Patients: An Integrated Review

  • Phianmongkhol, Yupin;Thongubon, Kannika;Woottiluk, Pakapan
    • Asian Pacific Journal of Cancer Prevention
    • /
    • v.16 no.14
    • /
    • pp.6033-6038
    • /
    • 2015
  • Background: Experience of lung cancer includes negative impacts on both physical and psychological health. Pain is one of the negative experiences of lung cancer. Cognitive behavioral therapy techniques are often recommended as treatments for lung cancer pain. The objective of this review was to synthesize the evidence on the effectiveness of cognitive behavioral therapy techniques in treating lung cancer pain. This review considered studies that included lung cancer patients who were required to 1) be at least 18 years old; 2) speak and read English or Thai; 3) have a life expectancy of at least two months; 4) experience daily cancer pain requiring an opioid medication; 5) have a positive response to opioid medication; 6) have "average or usual" pain between 4 and 7 on a scale of 0-10 for the day before the clinic visit or for a typical day; and 7) able to participate in a pain evaluation and treatment program. This review considered studies to examine interventions for use in treatment of pain in lung cancer patients, including: biofeedback, cognitive/attentional distraction, imagery, hypnosis, and meditation. Any randomized controlled trials (RCTs) that examined cognitive behavioral therapy techniques for pain specifically in lung cancer patients were included. In the absence of RCTs, quasi-experimental designs were reviewed for possible conclusion in a narrative summary. Outcome measures were pain intensity before and after cognitive behavioural therapy techniques. The search strategy aimed to find both published and unpublished literature. A three-step search was utilised by using identified keywords and text term. An initial limited search of MEDLINE and CINAHL was undertaken followed by analysis of the text words contained in the title and abstract, and of the index terms used to describe the article. A second search using all the identified keywords and index terms was then undertaken across all included databases. Thirdly, the reference list of all identified reports and articles were searched for additional studies. Searches were conducted during January 1991- March 2014 limited to English and Thai languages with no date restriction. Materials and Methods: All studies that met the inclusion criteria were assessed for methodological quality by three reviewers using a standardized critical appraisal tool from the Joanna Briggs Institute (JBI). Three reviewers extracted data independently, using a standardized data extraction tool from the Joanna Briggs Institute (JBI). Ideally for quantitative data meta-analysis was to be conducted where all results were subject to double data entry. Odds ratios (for categorical data) and weighted mean differences (for continuous data) and their 95% confidence intervals were to be calculated for analysis and heterogeneity was to be assessed using the standard Chi-square. Where statistical pooling was not possible the finding were be presented in narrative form. Results: There were no studies located that met the inclusion requirements of this review. There were also no text and opinion pieces that were specific to cognitive behavioral therapy techniques pain and lung cancer patients.Conclusions: There is currently no evidence available to determine the effectiveness of cognitive behavioural therapy techniques for pain in lung cancer patients.