PRP Injections for the Treatment of Knee Osteoarthritis: A Meta-Analysis of Randomized Controlled Trials

Objective To evaluate effectiveness, in terms of patient-reported outcome measures, of platelet-rich plasma (PRP) injections for knee osteoarthritis compared to placebo and other intraarticular treatments. Design PubMed, Cochrane Library, Scopus, Embase, Web of Science, as well as the gray literature were searched on January 17, 2020. Randomized controlled trials (RCTs) comparing PRP injections with placebo or other injectable treatments, in any language, on humans, were included. Risk of bias was assessed following the Cochrane guidelines; quality of evidence was graded using the GRADE guidelines. Results Thirty-four RCTs, including 1403 knees in PRP groups and 1426 in control groups, were selected. WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score favored PRP, with a statistically and clinically significant difference versus placebo at 12-month follow-up ( P = 0.02) and versus HA (hyaluronic acid) at 6-month ( P < 0.001) and 12-month ( P < 0.001) follow-ups. A clinically significant difference favoring PRP versus steroids was documented for VAS (Visual Analogue Scale) pain ( P < 0.001), KOOS (Knee Injury and Osteoarthritis Outcome Score) pain ( P < 0.001), function in daily activities ( P = 0.001), and quality of life ( P < 0.001) at 6-month follow-up. However, superiority of PRP did not reach the minimal clinically important difference for all outcomes, and quality of evidence was low. Conclusions The effect of platelet concentrates goes beyond its mere placebo effect, and PRP injections provide better results than other injectable options. This benefit increases over time, being not significant at earlier follow-ups but becoming clinically significant after 6 to 12 months. However, although substantial, the improvement remains partial and supported by low level of evidence. This finding urges further research to confirm benefits and identify the best formulation and indications for PRP injections in knee OA.

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Protein Supplementation Under Resistance Training Conditions in Elderly Patients with Sarcopenia: A Meta-analysis of Randomized Controlled Trials

10.21203/rs.3.rs-152067/v1 ◽

2021 ◽

Author(s):

Rui Cheng ◽

Xiao-long Ye ◽

Xu-jun Qin ◽

Yi Wan ◽

Meng Xu

Keyword(s):

Elderly Patients ◽

Randomized Controlled Trials ◽

Meta Analysis ◽

Protein Supplementation ◽

Cochrane Library ◽

Controlled Trials ◽

Quality Of Evidence ◽

Randomized Controlled ◽

Significant Difference

Abstract Background: The efficacy of interventions for elderly patients with sarcopenia has received increasing attention. Exercise and nutrition have been recognized as effective treatments for sarcopenia in many studies. However, evidence-based support from relevant studies is still lacking. Methods: The PubMed, Embase, Cochrane Library, VIP, CNKI, and SinoMed databases were searched. The basis for the diagnosis of sarcopenia, general condition of the subjects, duration and methods of exercise/nutritional therapy, outcome indicators, and quality of evidence were evaluated, and a meta-analysis of differences in treatment outcomes between the groups from baseline to the end of each study was conducted. Results: A total of 1860 papers were screened, including six randomized controlled trials, and the effects of protein intervention under exercise conditions on muscle mass, strength, and function in elderly patients with sarcopenia were investigated. The results showed that protein supplementation under resistance exercise conditions had the following effects on elderly patients with sarcopenia: there was a significant difference in knee flexion and extension strength (p = 0.02), grip strength (p = 0.02), fat mass (p = 0.04), and normal pace and pace (p = 0.0008 and p = 0.0010, respectively) between the intervention group and baseline data.Conclusion: The meta-analysis revealed some positive effects of protein intervention treatment under exercise conditions on elderly patients with sarcopenia. However, the quality of evidence is low. High-quality randomized controlled trials should be conducted in the future to provide a better clinical basis. Keywords: Sarcopenia, Exercise, Proteins

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Physical therapy interventions for older people with vertigo, dizziness and balance disorders addressing mobility and participation: a systematic review

10.21203/rs.3.rs-19855/v3 ◽

2020 ◽

Author(s):

Verena Regauer ◽

Eva Seckler ◽

Martin Müller ◽

Petra Bauer

Keyword(s):

Physical Therapy ◽

Randomized Controlled Trials ◽

Outcome Measures ◽

Cochrane Library ◽

Controlled Trials ◽

Balance Disorders ◽

Quality Of Evidence ◽

Randomized Controlled ◽

Therapy Interventions

Abstract Background: Vertigo, dizziness and balance disorders (VDB) are among the most relevant contributors to the burden of disability among older adults living in the community and associated with immobility, limitations of activities of daily living and decreased participation. The aim of this study was to identify the quality of evidence of physical therapy interventions that address mobility and participation in older patients with VDB and to characterize the used primary and secondary outcomes. Methods: A systematic search via MEDLINE (PubMed), Cochrane Library, CINAHL, PEDro, forward citation tracing and hand search was conducted initially in 11/2017 and updated in 7/2019. We included individual and cluster-randomized controlled trials and trials with quasi-experimental design, published between 2007 and 2017/2019 and including individuals ≥ 65 years with VDB. Physical therapy and related interventions were reviewed with no restrictions to outcome measurement. Screening of titles, abstracts and full texts, data extraction and critical appraisal was conducted by two independent researchers. The included studies were heterogeneous in terms of interventions and outcome measures. Therefore, a narrative synthesis was conducted. Results: A total of 20 randomized and 2 non-randomized controlled trials with 1,876 patients met the inclusion criteria. The included studies were heterogeneous in terms of complexity of interventions, outcome measures and methodological quality. Vestibular rehabilitation (VR) was examined in twelve studies, computer-assisted VR (CAVR) in five, Tai Chi as VR (TCVR) in three, canal repositioning manoeuvres (CRM) in one and manual therapy (MT) in one study. Mixed effects were found regarding body structure/function and activities/participation. Quality of life and/or falls were assessed, with no differences between groups. VR is with moderate quality of evidence superior to usual care to improve balance, mobility and symptoms. Conclusion: To treat older individuals with VDB, VR in any variation and in addition to CRMs seems to be effective. High-quality randomized trials need to be conducted to inform clinical decision making.

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LITERATURE SEARCHING FOR RANDOMIZED CONTROLLED TRIALS USED IN COCHRANE REVIEWS: RAPID VERSUS EXHAUSTIVE SEARCHES

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462303000552 ◽

2003 ◽

Vol 19 (4) ◽

pp. 591-603 ◽

Cited By ~ 621

Author(s):

Pamela Royle ◽

Ruairidh Milne

Keyword(s):

Randomized Controlled Trials ◽

Allocation Concealment ◽

Cochrane Library ◽

Controlled Trials ◽

Randomized Controlled ◽

Cochrane Reviews ◽

Literature Searches ◽

Significant Difference ◽

The Cochrane Library

Objectives:To analyze sources searched in Cochrane reviews, to determine the proportion of trials included in reviews that are indexed in major databases, and to compare the quality of these trials with those from other sources.Methods:All new systematic reviews in the Cochrane Library, Issue1 2001, that were restricted to randomized controlled trials (RCTs) or quasi-RCTs were selected. The sources searched in the reviews were recorded, and the trials included were checked to see whether they were indexed in four major databases. Trials not indexed were checked to determine how they could be identified. The quality of trials found in major databases was compared with those found from other sources.Results:The range in the number of databases searched per review ranged between one and twenty-seven. The proportion of the trials in the four databases were Cochrane Controlled Trials Register=78.5%, MEDLINE=68.8%, Embase=65.0%, and Science/Social Sciences Citation Index=60.7%. Searching another twenty-six databases after Cochrane Controlled Trials Register (CCTR), MEDLINE, and Embase only found 2.4% additional trials. There was no significant difference between trials found in the CCTR, MEDLINE, and Embase compared with other trials, with respect to adequate allocation concealment or sample size.Conclusions:There was a large variation between reviews in the exhaustiveness of the literature searches. CCTR was the single best source of RCTs. Additional database searching retrieved only a small percentage of extra trials. Contacting authors and manufacturers to find unpublished trials appeared to be a more effective method of obtaining the additional better quality trials.

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Physical therapy interventions for older people with vertigo, dizziness and balance disorders addressing mobility and participation: a systematic review

10.21203/rs.3.rs-19855/v2 ◽

2020 ◽

Author(s):

Verena Regauer ◽

Eva Seckler ◽

Martin Müller ◽

Petra Bauer

Keyword(s):

Physical Therapy ◽

Randomized Controlled Trials ◽

Outcome Measures ◽

Cochrane Library ◽

Controlled Trials ◽

Balance Disorders ◽

Quality Of Evidence ◽

Randomized Controlled ◽

Therapy Interventions

Abstract Background: Vertigo, dizziness and balance disorders (VDB) are among the most relevant contributors to the burden of disability among older adults living in the community and associated with immobility, limitations of activities of daily living and decreased participation. The aim of this study was to identify the quality of evidence of physical therapy interventions that address mobility and participation in older patients with VDB and to characterize the used primary and secondary outcomes.Methods: A systematic search via MEDLINE (PubMed), Cochrane Library, CINAHL, PEDro, forward citation tracing and hand search was conducted initially in 11/2017 and updated in 7/2019. We included individual and cluster-randomized controlled trials and trials with quasi-experimental design, published between 2007 and 2017/2019 and including individuals ≥ 65 years with VDB. Physical therapy and related interventions were reviewed with no restrictions to outcome measurement. Screening of titles, abstracts and full texts, data extraction and critical appraisal was conducted by two independent researchers. The included studies were heterogeneous in terms of interventions and outcome measures. Therefore, a narrative synthesis was conducted.Results: A total of 20 randomized and 2 non-randomized controlled trials with 1,876 patients met the inclusion criteria. The included studies were heterogeneous in terms of complexity of interventions, outcome measures and methodological quality. Vestibular rehabilitation (VR) was examined in twelve studies, computer-assisted VR (CAVR) in five, Tai Chi as VR (TCVR) in three, canal repositioning manoeuvres (CRM) in one and manual therapy (MT) in one study. Mixed effects were found regarding body structure/function and activities/participation. Quality of life and/or falls were assessed, with no differences between groups. VR is with moderate quality of evidence superior to usual care to improve balance, mobility and symptoms.Conclusion: To treat older individuals with VDB, VR in any variation and in addition to CRMs seems to be effective. High-quality randomized trials need to be conducted to inform clinical decision making.Trial Registration: PROSPERO 2017 CRD42017080291.

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Physical therapy interventions for older people with vertigo, dizziness and balance disorders addressing mobility and participation: a systematic review

10.21203/rs.3.rs-19855/v1 ◽

2020 ◽

Author(s):

Verena Regauer ◽

Eva Seckler ◽

Martin Müller ◽

Petra Bauer

Keyword(s):

Physical Therapy ◽

Randomized Controlled Trials ◽

Outcome Measures ◽

Cochrane Library ◽

Controlled Trials ◽

Balance Disorders ◽

Quality Of Evidence ◽

Randomized Controlled ◽

Therapy Interventions

Abstract Background Vertigo, dizziness and balance disorders (VDB) are among the most relevant contributors to the burden of disability among older adults living in the community and associated with immobility, limitations of activities of daily living and decreased participation. The aim of this study was to identify the quality of evidence of physical therapy interventions that address mobility and participation in older patients with VDB and to characterize the used primary and secondary outcomes. Methods A systematic search via MEDLINE (PubMed), Cochrane Library, CINAHL, PEDro, forward citation tracing and hand search was conducted initially in 11/2017 and updated in 7/2019. We included individual and cluster-randomized controlled trials and trials with quasi-experimental design, published between 2007 and 2017/2019 and including individuals ≥ 65 years with VDB. Physical therapy and related interventions were reviewed with no restrictions to outcome measurement. Screening of titles, abstracts and full texts, data extraction and critical appraisal was conducted by two independent researchers. The included studies were heterogeneous in terms of interventions and outcome measures. Therefore, a narrative synthesis was conducted. Results A total of 20 randomized and 2 non-randomized controlled trials with 1,876 patients met the inclusion criteria. The included studies were heterogeneous in terms of complexity of interventions, outcome measures and methodological quality. Vestibular rehabilitation (VR) was examined in twelve studies, computer-assisted VR (CAVR) in five, Tai Chi as VR (TCVR) in three, canal repositioning manoeuvres (CRM) in one and manual therapy (MT) in one study. Mixed effects were found regarding body structure/function and activities/participation. Quality of life and/or falls were assessed, with no differences between groups. VR is with moderate quality of evidence superior to usual care to improve balance, mobility and symptoms. Conclusion To treat older individuals with VDB, VR in any variation and in addition to CRMs seems to be effective. High-quality randomized trials need to be conducted to inform clinical decision making.

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Physical therapy interventions for older people with vertigo, dizziness and balance disorders addressing mobility and participation: a systematic review

BMC Geriatrics ◽

10.1186/s12877-020-01899-9 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Verena Regauer ◽

Eva Seckler ◽

Martin Müller ◽

Petra Bauer

Keyword(s):

Physical Therapy ◽

Randomized Controlled Trials ◽

Outcome Measures ◽

Cochrane Library ◽

Controlled Trials ◽

Balance Disorders ◽

Quality Of Evidence ◽

Randomized Controlled ◽

Therapy Interventions

Abstract Background Vertigo, dizziness and balance disorders (VDB) are among the most relevant contributors to the burden of disability among older adults living in the community and associated with immobility, limitations of activities of daily living and decreased participation. The aim of this study was to identify the quality of evidence of physical therapy interventions that address mobility and participation in older patients with VDB and to characterize the used primary and secondary outcomes. Methods A systematic search via MEDLINE (PubMed), Cochrane Library, CINAHL, PEDro, forward citation tracing and hand search was conducted initially in 11/2017 and updated in 7/2019. We included individual and cluster-randomized controlled trials and trials with quasi-experimental design, published between 2007 and 2017/2019 and including individuals ≥65 years with VDB. Physical therapy and related interventions were reviewed with no restrictions to outcome measurement. Screening of titles, abstracts and full texts, data extraction and critical appraisal was conducted by two independent researchers. The included studies were heterogeneous in terms of interventions and outcome measures. Therefore, a narrative synthesis was conducted. Results A total of 20 randomized and 2 non-randomized controlled trials with 1876 patients met the inclusion criteria. The included studies were heterogeneous in terms of complexity of interventions, outcome measures and methodological quality. Vestibular rehabilitation (VR) was examined in twelve studies, computer-assisted VR (CAVR) in five, Tai Chi as VR (TCVR) in three, canal repositioning manoeuvres (CRM) in one and manual therapy (MT) in one study. Mixed effects were found regarding body structure/function and activities/participation. Quality of life and/or falls were assessed, with no differences between groups. VR is with moderate quality of evidence superior to usual care to improve balance, mobility and symptoms. Conclusion To treat older individuals with VDB, VR in any variation and in addition to CRMs seems to be effective. High-quality randomized trials need to be conducted to inform clinical decision making. Trial registration PROSPERO 2017 CRD42017080291.

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Dynamic Stabilization of Syndesmosis Injuries Reduces Complications and Reoperations as Compared With Screw Fixation: A Meta-analysis of Randomized Controlled Trials

The American Journal of Sports Medicine ◽

10.1177/0363546519849909 ◽

2019 ◽

Vol 48 (4) ◽

pp. 1000-1013 ◽

Cited By ~ 5

Author(s):

Alberto Grassi ◽

Kristian Samuelsson ◽

Pieter D’Hooghe ◽

Matteo Romagnoli ◽

Massimiliano Mosca ◽

...

Keyword(s):

Randomized Controlled Trials ◽

Screw Fixation ◽

Meta Analysis ◽

Controlled Trials ◽

Cochrane Central Register ◽

Quality Of Evidence ◽

Dynamic Fixation ◽

Randomized Controlled

Background: Several devices for obtaining dynamic fixation of the syndesmosis have been introduced in recent years, but their efficacy has been tested in only a few randomized controlled trials (RCTs), without demonstrating any clear benefit over the traditional static fixation with screws. Purpose: To perform a level 1 meta-analysis of RCTs to investigate the complications, subjective outcomes, and functional results after dynamic or static fixation of acute syndesmotic injuries. Study Design: Meta-analysis of RCTs. Methods: A systematic literature search was performed of the Medline/PubMed, Cochrane Central Register of Controlled Trials, and Embase electronic databases, as well as ClinicalTrials.gov for unpublished studies. Eligible studies were RCTs comparing dynamic fixation and static fixation of acute syndesmosis injuries. A meta-analysis was performed, while bias and quality of evidence were rated according to the Cochrane Database questionnaire and the Grading of Recommendations Assessment, Development and Evaluation guidelines. Results: Dynamic fixation had a significantly reduced relative risk (RR = 0.55, P = .003) of complications—in particular, the presence of inadequate reduction at the final follow-up (RR = 0.36, P = .0008) and the clinical diagnosis of recurrent diastasis or instability (RR = 0.10, P = .03). The effect was more evident when compared with permanent screws (RR = 0.10, P = .0001). The reoperation rate was similar between the groups (RR = 0.64, P = .07); however, the overall risk was reduced after dynamic fixation as compared with static fixation with permanent screws (RR = 0.24, P = .007). The American Orthopaedic Foot & Ankle Society score was significantly higher among patients treated with dynamic fixation—6.06 points higher ( P = .005) at 3 months, 5.21 points ( P = .03) at 12 months, and 8.60 points ( P < .00001) at 24 months—while the Olerud-Molander score was similar. The visual analog scale for pain score was reduced at 6 months (–0.73 points, P = .003) and 12 months (–0.52 points, P = .005), and ankle range of motion increased by 4.36° ( P = .03) with dynamic fixation. The overall quality of evidence ranged from “moderate” to “very low,” owing to a substantial risk of bias, heterogeneity, indirectness of outcome reporting, and evaluation of a limited number of patients. Conclusion: The dynamic fixation of syndesmotic injuries was able to reduce the number of complications and improve clinical outcomes as compared with static screw fixation—especially malreduction and clinical instability or diastasis—at a follow-up of 2 years. A lower risk of reoperation was found with dynamic fixation as compared with static fixation with permanent screws. However, the lack of patients or personnel blinding, treatment heterogeneity, small samples, and short follow-up limit the overall quality of this evidence.

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Effectiveness of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Meta-analysis of Randomized Controlled Clinical Trials

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967120973284 ◽

2021 ◽

Vol 9 (3) ◽

pp. 232596712097328

Author(s):

Liu-yan Nie ◽

Kun Zhao ◽

Jiaqi Ruan ◽

Jing Xue

Keyword(s):

Pain Relief ◽

Knee Osteoarthritis ◽

Randomized Controlled Trials ◽

Platelet Rich Plasma ◽

Meta Analysis ◽

Indirect Comparison ◽

Cochrane Library ◽

Controlled Trials ◽

Randomized Controlled ◽

Significant Difference

Background: The effectiveness of platelet-rich plasma (PRP) injections for knee osteoarthritis and the effects of leukocyte-poor PRP (LP-PRP) versus leukocyte-rich PRP (LR-PRP) are still controversial. Purpose: To assess the effectiveness of different PRP injections through a direct and indirect meta-analysis of randomized controlled trials. Study Design: Systematic review; Level of evidence, 1. Methods: A systematic literature search of electronic databases (PubMed, Cochrane Library, and EMBASE) was performed to locate randomized controlled trials published through March 2019 that compared PRP with control treatment. A random-effects meta-analysis was conducted to synthesize the evidence, and meta-regression analyses were conducted to determine the influence of trial characteristics. An indirect comparison was performed to assess the effects of LP-PRP and LR-PRP compared with hyaluronic acid (HA). Results: A total of 21 trials were included. A clinically important benefit for pain relief was seen for intra-articular PRP compared with intra-articular saline (standardized mean difference [SMD] = –1.38 [95% CI, –2.07 to –0.70]; P < .0001; I 2 = 37%) and corticosteroid solution injection (SMD = –2.47 [95% CI, –3.34 to –1.61]; P < .00001; I 2 = 47%). As a result of heterogeneity ( I 2 = 89%), there was no conclusive effect compared with HA, even though the pooling effect provided clinically relevant pain relief (SMD = –0.59 [95% CI, –0.97 to –0.21]; P = .003). Indirect meta-analysis showed that there was no significant difference between LR-PRP and LP-PRP. Conclusion: PRP injections are beneficial for pain relief and functional improvement in knee osteoarthritis. Larger, randomized high-quality studies are needed to compare the effects of LP-PRP and LR-PRP.

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Effect of Biocompatible Peritoneal Dialysis Solution on Residual Renal Function: A Systematic Review of Randomized Controlled Trials

Peritoneal Dialysis International ◽

10.3747/pdi.2012.00331 ◽

2014 ◽

Vol 34 (7) ◽

pp. 724-731 ◽

Cited By ~ 22

Author(s):

Eun-Young Seo ◽

Sook Hee An ◽

Jang-Hee Cho ◽

Hae Sun Suh ◽

Sun-Hee Park ◽

...

Keyword(s):

Systematic Review ◽

Renal Function ◽

Peritoneal Dialysis ◽

Randomized Controlled Trials ◽

Residual Renal Function ◽

Cochrane Library ◽

Controlled Trials ◽

Randomized Controlled ◽

Significant Difference

Introduction Residual renal function (RRF) plays an important role in outcome of peritoneal dialysis (PD) including mortality. It is, therefore, important to provide a strategy for the preservation of RRF. The objective of this study was to evaluate relative protective effects of new glucose-based multicompartmental PD solution (PDS), which is well known to be more biocompatible than glucose-based conventional PDS, on RRF compared to conventional PDS by performing a systematic review (SR) of randomized controlled trials. Methods We searched studies presented up to January 2014 in MEDLINE, EMBASE, the COCHRANE library, and local databases. Three independent reviewers reviewed and extracted prespecified data from each study. The random effects model, a more conservative analysis model, was used to combine trials and to perform stratified analyses based on the duration of follow-up. Study quality was assessed using the Cochrane Handbook for risk of bias. Eleven articles with 1,034 patients were identified for the SR. Results The heterogeneity of the studies under 12 months was very high, and the heterogeneity decreased substantially when we stratified studies by the duration of follow-up. The mean difference of the studies after 12 months was 0.46 mL/min/1.73 m2 (95% confidence interval = 0.25 to + 0.67). Conclusion New PDS showed the effect to preserve and improve RRF for long-term use compared to conventional PDS, even though it did not show a significant difference to preserve RRF for short-term use.

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Efficacy and Safety of Non-Steroidal Anti-Androgens in Patients with Metastatic Prostate Cancer: Meta-Analysis of Randomized Controlled Trials

Reviews on Recent Clinical Trials ◽

10.2174/1574887114666191105152404 ◽

2020 ◽

Vol 15 (1) ◽

pp. 34-47 ◽

Cited By ~ 1

Author(s):

Muhammed Rashid ◽

Madhan Ramesh ◽

K. Shamshavali ◽

Amit Dang ◽

Himanshu Patel ◽

...

Keyword(s):

Prostate Cancer ◽

Adverse Events ◽

Randomized Controlled Trials ◽

Quality Assessment ◽

Cochrane Library ◽

Control Group ◽

Controlled Trials ◽

Efficacy And Safety ◽

Randomized Controlled ◽

Significant Difference

Background: Prostate cancer (PCa) is the sixth primary cause of cancer death. However, conflicts are present about the efficacy and safety of Non-steroidal anti-androgens (NSAA) for its treatment. The aim of this study was to assess the efficacy and safety of NSAAs versus any comparator for the treatment of advanced or metastatic PCa (mPCa). Methodology: MEDLINE and the Cochrane Library were searched. References of included studies and clinicaltrials.gov were also searched for relevant studies. Only English language studies after 1990 were considered for review. Randomized controlled trials (RCTs) examining the efficacy and safety of NSAAs as compared with any other comparator including surgery or chemotherapy in mPCa patients were included. The outcomes include efficacy, safety and the tolerability of the treatment. The Cochrane Risk of Bias Assessment Tool was used for quality assessment. Two authors were independently involved in the selection, extraction and quality assessment of included studies and disagreements were resolved by discussion or by consulting a third reviewer. Results: Fifty-eight out of 1307 non-duplicate RCTs with 29154 patients were considered for the review. NSAA showed significantly better progression-free survival [PFS] (Hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.46-0.78; P=0.0001), time to distant metastasis or death [TTD] (HR, 0.80; 95% CI 0.73-0.91; p<0.0001), objective response (Odds ratio [OR], 1.64; 95% CI 1.06-2.54; P=0.03) and clinical benefits (OR, 1.33; 95% CI 1.08-1.63; P=0.006) as compared to the control group. There was no significant difference observed between the groups in terms of overall survival (HR, 0.95; 95%CI, 0.87-1.03; P=0.18) and time to progression (HR, 0.93; 95% CI 0.77-1.11; P=0.43). Treatment-related adverse events were more with the NSAA group, but the discontinuation due to lack of efficacy reason was 43% significantly lesser than the control group in patients with mPCa. Rest of the outcomes were appeared to be non-significant. Conclusion: Treatment with NSAA was appeared to be better efficacious with respect to PFS, TTD, and response rate with considerable adverse events when compared to the control group in patients with metastatic PCa.

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