scholarly journals A Systematic Review and Meta-Analysis of Immune-Related Adverse Events of Anti-PD-1 Drugs in Randomized Controlled Trials

2020 ◽  
Vol 19 ◽  
pp. 153303382096745
Author(s):  
Yukun Wang ◽  
Dejiu Kong ◽  
Chaokun Wang ◽  
Jing Chen ◽  
Jing Li ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Control Group ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Targeted Drugs ◽  
Randomized Controlled

Objective: We aimed to evaluate immune-related adverse events occurring in clinical trials of anti-programmed cell death 1 (PD-1) drugs, compared with control treatments, including chemotherapy, targeted drugs, or placebo. Further we compared the occurrence of immune -related events in patients treated with different anti-PD-1 drugs. Data Sources: Randomized controlled trial (RCT) data were sourced from PubMed, Embase, and the Cochrane Central Register of Controlled Trials combined with https://clinicaltrials.gov . Methods: Randomized controlled trial of anti-PD-1 drugs compared with control treatments published between January 1, 1970 and March 1,2019, were searched and data on trial patient characteristics, and adverse events extracted, reviewed, and subjected to meta-analysis. Results: Eighteen Randomized controlled trials were included in our study. The Randomized controlled trials compared nivolumab (n = 12), pembrolizumab (n = 6), with chemotherapy (n = 13), targeted drugs (n = 2), or placebo (n = 3). Compared with the control group, the risk of any immune-related adverse events in patients treated with anti-PD-1 drugs was increased (RR, 2.65; 95% confidence interval, 1.84–3.83; P < 0.00001). Of the immune-related adverse events, the risk rates of pneumonitis (risk ratio, 2.10; 95% CI, 0.85-5.18), colitis (2.96;1.62-5.38), hypophysitis(4.79;1.54-14.89), hypothyroidism(7.87;5.36-11.57), hyperthyroidism (7.03;4.35-11.34), rash (1.58;0.98-2.54), pruritus (2.28; 1.38-3.76), and hepatitis (9.31;2.18-39.85) were increased by anti-PD-1 drugs. Further, the risk of immune-related adverse events was similar for patients treated with pembrolizumab and nivolumab ( P = 0.14). Conclusions: In addition to previously reported organ-specific immune-related adverse events, we found that the risk of hyperthyroidism was also increased, in anit-PD-1-treated patients, relative to control treatments. The risk of total immune-related adverse events, was similar for pembrolizumab and nivolumab.

scholarly journals The efficacy and safety of intrathecal bupivacaine alone versus bupivacaine combined with magnesium sulfate in adults using spinal anesthesia: a meta-analysis of randomized controlled trials

2020 ◽  
Author(s):  
Mi-Zhou Wang ◽  
Rui Dong ◽  
Li-Na Jia ◽  
Deng-Bin Ai ◽  
Jian-Hua Zhang
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Magnesium Sulfate ◽  
Motor Block ◽  
Meta Analysis ◽  
Sensory Block ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Rescue Analgesia ◽  
Randomized Controlled

Abstract Background: Several studies have investigated the effects of intrathecal magnesium sulfate as an adjuvant for bupivacaine; however, their conclusions are inconsistent. Therefore, it is necessary to conduct a meta-analysis on this topic.Methods We searched Pubmed, EMBASE (OvidSP) and Cochrane Central Register of Controlled Trials (CENTRAL) for randomized controlled trials (RCTs) comparing the effect of intrathecal bupivacaine combined with magnesium sulfate versus bupivacaine alone in adults using spinal anesthesia.Results Eighteen studies that met our inclusion criteria were included in our analysis. We found that the addition of intrathecal magnesium sulfate to bupivacaine provided a longer duration of analgesia (SMD 0.99; 95% CI [0.45, 1.52], P = 0.0003, I2 = 93%), prolonged the duration of sensory block (MD=106.69; 95% CI, 60.93-152.45; P<0.00001), delayed the onset of sensory block (SMD 1.20; 95% CI [0.65, 1.75], P =<0.0001, I2 = 91%) and motor block (SMD 1.46; 95% CI [0.23, 2.69], P =0.02, I2 = 96%), decreased the requirement for rescue analgesia (SMD -0.81; 95% CI [-1.06, -0.56], P < 0.00001, I2 = 11%). For duration of motor block, and incidence of postoperative adverse events (such as nausea and vomiting, hypotension, bradycardia, pruritus, shivering and neurological deficit), no statistically differences were observed between the 2 groups.Conclusions Our meta-analysis demonstrated that intrathecal magnesium sulfate combined with bupivacaine prolongs the dusration of analgesia, without an impact on the adverse events. However, the quality of evidence was very low when using GRADE to assess it. Given adverse effects before use, more high-quality trials with large samples are required before magnesium sulfate is routinely used as a intrathecal adjunct.

scholarly journals Comparative Efficacy of Pharmacological and Nonpharmacological Interventions for Acne Vulgaris: A Network Meta-Analysis

2020 ◽  
Vol 11 ◽  
Author(s):  
Qingyang Shi ◽  
Lizi Tan ◽  
Zhe Chen ◽  
Long Ge ◽  
Xiaoyan Zhang ◽  
...  
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Physical Symptoms ◽  
Current Evidence ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Comparative Efficacy ◽  
Inflammatory Lesions ◽  
Randomized Controlled

Acne has several effects on physical symptoms, but the main impacts are on the quality of life, which can be improved by treatment. There are several acne treatments but less evidence comparing their relative efficacy. Thus, we assessed the comparative efficacy of pharmacological and nonpharmacological interventions for acne. We searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials from inception to April 2019, to include randomized controlled trials for acne that compared topical antibiotics (TA), benzoyl peroxide (BPO), topical retinoids (TR), oral antibiotics (OA), lasers, light devices including LED device (LED), photodynamic therapy (PDT), and intense pulsed light, chemical peels (CP), miscellaneous therapies or complementary and alternative medicine (MTCAM), or their combinations. We performed Bayesian network meta-analysis with random effects for all treatments compared with placebo and each other. Mean differences (MDs) of lesions count and risk ratios of adverse events with their 95% credible intervals (CrIs) were calculated, and all interventions were ranked by the Surface Under the Cumulative Ranking (SUCRA) values. Additional frequentist additive network meta-analysis was performed to detect the robustness of results and potential interaction effects. Sensitivity analyses were carried out with different priors, and metaregression was to adjust for nine potential effect modifiers. In the result, seventy-three randomized controlled trials (27,745 patients with mild to moderate acne), comparing 30 grouped intervention categories, were included with low to moderate risk of bias. For adverse effects, OA had more risk in combination treatment with others. For noninflammatory lesions reduction, seventeen interventions had significant differences comparing with placebo and three interventions (TR+BPO: MD = −21.89, 95%CrI [−28.97, −14.76]; TR+BPO+MTCAM: −22.48 [−34.13, −10.70]; TA+BPO+CP: −20.63 [−33.97, −7.13]) were superior to others with 94, 94, and 91% SUCRA values, respectively. For inflammatory lesions reduction, nineteen interventions were significantly better than placebo, and three interventions (TR+BPO: MD = −12.13, 95%CrI [−18.41, −5.80]; TR+BPO+MTCAM: −13.21 [−.39, −3.04]; LED: −11.30 [−18.34, −4.42]) were superior to others (SUCRA: 81, 81, and 77%, respectively). In summary of noninflammatory and inflammatory lesions results, TR+BPO and TA+BPO were the best options compared to others. The frequentist model showed similar results as above. In summary, current evidence supports the suggestion that TR+BPO and TA+BPO are the best options for mild to moderate acne. LED is another option for inflammatory lesions when drug resistance occurs. All the combinations involved with OA showed more risk of adverse events than others. However, the evidence of this study should be cautiously used due to the limitations.

scholarly journals Does pregabalin effectively and safely relieve postoperative pain in patients undergoing pulmonary resections?

2019 ◽  
Vol 29 (4) ◽  
pp. 555-560 ◽  
Author(s):  
Shuangjiang Li ◽  
Wenbiao Zhang ◽  
Shan Cheng ◽  
Yongjiang Li
Keyword(s):  
Randomized Controlled Trial ◽  
Postoperative Pain ◽  
Randomized Controlled Trials ◽  
Controlled Trial ◽  
Perioperative Period ◽  
Control Group ◽  
Controlled Trials ◽  
Clinical Question ◽  
Randomized Controlled ◽  
Study Type

Summary A best evidence topic in thoracic surgery was written according to a structured protocol. The question addressed was whether pregabalin could effectively and safely reduce postoperative pain in patients undergoing pulmonary resections. Altogether 23 papers were found using the reported search, of which 6 randomized controlled trials represented the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. Five of 6 randomized controlled trials demonstrated that the application of oral pregabalin during the perioperative period could effectively reduce postoperative pain after pulmonary resections without compromising patients’ safety. One randomized controlled trial reported no difference in the postoperative pain levels between the pregabalin group and the control group. The rates of adverse effects were generally found to be decreased in patients who received pregabalin compared to the patients who received routine analgesia, although 2 studies reported significantly higher incidences of mild drowsiness and dizziness among the pregabalin-treated patients. Currently available evidence supports that the perioperative administration of pregabalin can effectively and safely relieve postoperative pain for patients undergoing pulmonary resections.

scholarly journals Liver-related safety assessment of green tea extracts in humans: a systematic review of randomized controlled trials

2016 ◽  
Vol 70 (11) ◽  
pp. 1221-1229 ◽  
Author(s):  
T Isomura ◽  
S Suzuki ◽  
H Origasa ◽  
A Hosono ◽  
M Suzuki ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Green Tea ◽  
Case Reports ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Randomized Controlled

Abstract There remain liver-related safety concerns, regarding potential hepatotoxicity in humans, induced by green tea intake, despite being supposedly beneficial. Although many randomized controlled trials (RCTs) of green tea extracts have been reported in the literature, the systematic reviews published to date were only based on subjective assessment of case reports. To more objectively examine the liver-related safety of green tea intake, we conducted a systematic review of published RCTs. A systematic literature search was conducted using three databases (PubMed, EMBASE and Cochrane Central Register of Controlled Trials) in December 2013 to identify RCTs of green tea extracts. Data on liver-related adverse events, including laboratory test abnormalities, were abstracted from the identified articles. Methodological quality of RCTs was assessed. After excluding duplicates, 561 titles and abstracts and 119 full-text articles were screened, and finally 34 trials were identified. Of these, liver-related adverse events were reported in four trials; these adverse events involved seven subjects (eight events) in the green tea intervention group and one subject (one event) in the control group. The summary odds ratio, estimated using a meta-analysis method for sparse event data, for intervention compared with placebo was 2.1 (95% confidence interval: 0.5–9.8). The few events reported in both groups were elevations of liver enzymes. Most were mild, and no serious liver-related adverse events were reported. Results of this review, although not conclusive, suggest that liver-related adverse events after intake of green tea extracts are expected to be rare.

scholarly journals Efficacy of web-based self-management interventions for depressive symptoms: a meta-analysis of randomized controlled trials

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yue Pang ◽  
Xin Zhang ◽  
Ruitong Gao ◽  
Linqi Xu ◽  
Meidi Shen ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Self Management ◽  
Control Group ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Web Based ◽  
Randomized Controlled ◽  
Management Interventions

Abstract Background The incidence of depression is increasing worldwide. Depression can lead to poor physical health and even suicide. However, in high-income countries, only about 50% of the people with depression receive appropriate therapy, and the detection rate of depression in low- and middle-income countries is relatively lower. Web-based self-management enables remote treatment and solves the problem of insufficient psychological treatment resources. Many past studies have evaluated the effectiveness of web-based self-management of depression, but there has been no synthesis of evidence. Therefore, this study conducted a meta-analysis of the effectiveness of web-based self-management for depressive symptoms. Method Six electronic databases (Cochrane Central Register of Controlled Trials, PubMed, Web of Science, Embase, CINAHL, and PsycINFO) were searched in September 2020. All literature referring to the effects of web-based self-management on depression were shortlisted by performing the medical subject headings (MeSH) search combined with a text word search. Results A total of 18 eligible randomized controlled trials were identified, and the results from 3055 participants were consolidated. The web-based self-management group exhibited a greater reduction in depressive symptoms than the control group (g = − 0.46; 95% CI: 0.62,0.30), and there was no evidence of publication bias. Subgroup analysis revealed that patients with moderate-to-severe depression benefited from web-based self-management interventions. In terms of interventions, those based on cognitive behavioral therapy (CBT) were highly effective. We noted that the longer the intervention time, the better was the improvement in the status of depression. Furthermore, it was established that participants who communicated with therapists and showed greater adherence to the intervention experienced significant improvement in their symptoms. The results of the intervention group were better than those of the waiting-list, treatment-as-usual, and online psychoeducation groups. Conclusions Web-based self-management is a promising therapy for depression. Future research should aim to refine these aspects of the intervention to achieve a beneficial impact.

scholarly journals The Effects of Exercise on BDNF Levels in Adolescents: A Systematic Review with Meta-Analysis

2020 ◽  
Vol 17 (17) ◽  
pp. 6056
Author(s):  
Kesley Pablo Morais de Azevedo ◽  
Victor Hugo de Oliveira ◽  
Gidyenne Christine Bandeira Silva de Medeiros ◽  
Ádala Nayana de Sousa Mata ◽  
Daniel Ángel García ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Control Group ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Exercise Programs ◽  
Randomized Controlled ◽  
Central Register ◽  
Before And After

The aim of this study was to analyze the evidence available in the literature about the effects of exercise on brain-derived neurotrophic factor levels in adolescents. The literature searches were conducted in PubMed, Embase, Scopus, ScienceDirect, Web of Science, SportDiscus, the Cochrane Central Register of Controlled Trials (CENTRAL) and CINAHL. Randomized controlled trials and non-randomized controlled trials performed with adolescents (10–19 years) who underwent different exercise programs and who evaluated BDNF levels before and after the intervention were included. We included six studies, four RCTs and two non-RCTs in the systematic review with a total of 407 adolescents. In two randomized trials and one non-RCT, the intervention groups showed significant improvements in BDNF levels compared with the control group. The results presented in the meta-analysis indicate that despite the positive effect in favor of the intervention, there were no significant differences (standardized mean difference 0.28 ng/mL, 95% confidence interval −0.28 to 0.85; p = 0.32, I² = 0%). The results presented in our review indicate that aerobic exercise programs practiced in moderate- or high-intensity are promising strategies to increase BDNF levels in adolescents. However, further studies are required to support this finding.

scholarly journals Hydroxychloroquine in COVID-19: an updated systematic review and meta-analysis

2020 ◽  
Author(s):  
Jose Chacko ◽  
Gagan Brar ◽  
Robert Premkumar
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Observational Studies ◽  
Meta Analysis ◽  
Chest Ct ◽  
Control Group ◽  
Controlled Trials ◽  
Rt Pcr ◽  
Randomized Controlled ◽  
Negative Conversion

Abstract Background Hydroxychloroquine is being administered among patients with COVID 19 infection in many healthcare systems across the world, considering its in vitro effect against the SARS CoV 2 virus. In spite of several observational studies and a few randomized controlled trials, the effect of hydroxychloroquine on patients with COVID 19 infection remains unclear. We undertook this systematic review with meta-analysis to evaluate the efficacy and safety of hydroxychloroquine among patients with COVID 19 infection. Methods We searched PubMed, Embase, the Cochrane Library, Web of Science, medRxiv, and other relevant resources until August 1, 2020. We included randomized controlled trials and observational studies in which hydroxychloroquine was administered and compared to a control group. Data were extracted, and quality assessment of the studies was carried out. We evaluated symptomatic progression, mortality, viral clearance, evolution of changes on chest CT imaging, and adverse events. A fixed or random-effects model was used depending on outcome heterogeneity. Results We included 23 studies, including seven randomized controlled trials and 16 observational studies. Among these, 11,029 patients received hydroxychloroquine alone or in combination, while 12063 did not. Mortality was reported at different points in time. The overall mortality was not significantly different among patients who received hydroxychloroquine compared to the control group (OR: 0.94, 95% CI: 0.72 to 1.22; p = 0.63). Clinical worsening did not differ between patients who received hydroxychloroquine compared to those who did not (OR 0.93, 95% CI: 0.57 to 1.52; p = 0.77). Negative conversion, assessed by RT PCR, did not differ significantly between the hydroxychloroquine and the control groups (OR: 0.67, CI: 0.21 to 2.11; p = 0.49). The evolution of changes on chest CT imaging was reported only in two studies; a more pronounced improvement was observed with the use of hydroxychloroquine compared to standard care (OR: 2.68, CI: 1.1 to 6.55; P = 0.03). The incidence of adverse events was significantly higher with hydroxychloroquine (OR: 5.95, CI: 2.56 to 13.83; p < 0.00001). Conclusions Our meta analysis does not suggest improvement in mortality, clinical progression, or negative conversion by RT PCR among patients with COVID-19 infection who are treated with hydroxychloroquine. There was a significantly higher incidence of adverse events with hydroxychloroquine use. Keywords COVID 19, SARS COV 2, hydroxychloroquine, meta analysis

Comparison of Icodextrin and Glucose Solutions for Long Dwell Exchange in Peritoneal Dialysis: A Meta-Analysis of Randomized Controlled Trials

2011 ◽  
Vol 31 (2) ◽  
pp. 179-188 ◽  
Author(s):  
Hualin Qi ◽  
Chen Xu ◽  
Haidong Yan ◽  
Jun Ma
Keyword(s):  
Renal Function ◽  
Peritoneal Dialysis ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Standard Form ◽  
Residual Renal Function ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Randomized Controlled

BackgroundIcodextrin is widely used in peritoneal dialysis (PD); however, the safety and efficacy of icodextrin are unclear. In the present study, we performed a systematic review of randomized controlled trials (RCTs) that compared icodextrin and glucose for the once-daily long dwell in PD.MethodsElectronic searches were performed in MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials to select all eligible studies. Eligible studies, as determined by consensus using predefined criteria, were reviewed, and data were extracted onto a standard form.ResultsIn the 9 RCTs that were identified, patients using icodextrin were found to have much greater net ultrafiltration (UF) and a lower incidence of negative net UF compared to patients using 1.5%, 2.5%, and 4.25% glucose solutions. Additionally, icodextrin has a markedly increased UF efficiency ratio and peritoneal clearance of creatinine and urea nitrogen, but residual renal function was not different from patients using glucose solutions for PD. No significant differences were observed between icodextrin and glucose groups with respect to risk of mortality, peritonitis, and total adverse events. Although rashes occurred significantly more often in icodextrin groups, few differences were noted between icodextrin and glucose groups when withdrawal rates secondary to adverse events were compared.ConclusionsThis meta-analysis suggests that icodextrin provides patients with greater fluid removal and small solute clearance and does not cause any damage to residual renal function. Icodextrin is particularly appropriate for use in patients with high peritoneal transport status.

scholarly journals Ganglioside-monosialic acid (GM1) for prevention of chemotherapy-induced peripheral neuropathy: a meta-analysis with trial sequential analysis

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Shaoyong Wu ◽  
Xiaohui Bai ◽  
Caixia Guo ◽  
Zhimei Huang ◽  
Handong Ouyang ◽  
...  
Keyword(s):  
Peripheral Neuropathy ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Sequential Analysis ◽  
Meta Analysis ◽  
Trial Sequential Analysis ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Clinical Issue ◽  
Randomized Controlled

Abstract Background Chemotherapy-induced peripheral neuropathy (CIPN) is a dose-limiting side effect that largely remains an unresolved clinical issue, leading to long-term morbidity. This meta-analysis aimed to evaluate the efficacy and safety of Ganglioside-monosialic acid (GM1) in preventing CIPN. Methods Systematic literature searches of PubMed, Web of Science, Embase, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov were performed to identify randomized controlled trials and cohort studies that evaluated the efficacy of GM1 for preventing CIPN. Conventional meta-analysis with a random-effects model and trial sequential analysis (TSA) were performed. Results A total of five studies involving 868 participants were included. The results showed that GM1 did not reduce the overall incidence of grade ≥ 2 CIPN when the common terminology criteria for adverse events (CTCAE) was used (OR 0.34, 95% CI 0.34–1.11). Subgroup analyses showed that GM1 could not reduce the risk of CTCAE grade ≥ 2 CIPN (OR 0.63, 95% CI 0.35–1.13) and neurotoxicity criteria of Debiopharm (DEB-NTC) grade ≥ 2 CIPN (OR 0.25, 95% CI 0.01–7.10) in oxaliplatin-treated patients, despite that GM1 was associated with a reduced risk of CTCAE grade ≥ 2 CIPN in the taxane subgroup of one study (OR 0.003, 95% CI 0.00–0.05). These results were confirmed by the sub-analysis of randomized controlled trials (RCTs). In TSA, the z-curve for the taxane subgroup crossed the upper trial sequential monitoring boundary (TSMB) but do not reach the required information size (RIS). The z-curves for the oxaliplatin subgroup remained in the nonsignificant area and did not reach the RIS. Further, GM1 did not influence the rate of response to chemotherapy and CTCAE grade ≥ 2 adverse events such as fatigue, nausea, diarrhea, and rash. Conclusions GM1 seemed to be well-tolerated and did not influence the anti-cancer effects of chemotherapeutic agents. Although the data did not confirm the effectiveness of GM1 in preventing oxaliplatin-induced peripheral neuropathy, GM1 might be able to prevent taxane-induced peripheral neuropathy. More studies are required in different ethnic populations receiving taxane-based chemotherapy to confirm these findings.

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

2020 ◽  
Vol 15 (1) ◽  
pp. 34-47 ◽  
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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