scholarly journals Opioid-Free Anesthesia Benefit–Risk Balance: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2021 ◽  
Vol 10 (10) ◽  
pp. 2069
Author(s):  
Arthur Salomé ◽  
Hakim Harkouk ◽  
Dominique Fletcher ◽  
Valeria Martinez
Keyword(s):  
Side Effects ◽  
Adverse Effects ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Opioid Use ◽  
Randomized Controlled ◽  
Pain Scores ◽  
Lower Pain ◽  
Clinically Significant

Opioid-free anesthesia (OFA) is used in surgery to avoid opioid-related side effects. However, uncertainty exists in the balance between OFA benefits and risks. We searched for randomized controlled trials (RCTs) comparing OFA to opioid-based anesthesia (OBA) in five international databases. The co-primary outcomes were postoperative acute pain and morphine consumption at 2, 24, and 48 h. The secondary outcomes were the incidence of postoperative chronic pain, hemodynamic tolerance, severe adverse effects, opioid-related adverse effects, and specific adverse effects related to substitution drugs. Overall, 33 RCTs including 2209 participants were assessed. At 2 h, the OFA groups had lower pain scores at rest MD (0.75 (−1.18; −0.32)), which did not definitively reach MCID. Less morphine was required in the OFA groups at 2 and 24 h, but with very small reductions: 1.61 mg (−2.69; −0.53) and −1.73 mg (p < 0.05), respectively, both not reaching MCID. The reduction in PONV in the OFA group in the PACU presented an RR of 0.46 (0.38, 0.56) and an RR of 0.34 (0.21; 0.56), respectively. Less sedation and shivering were observed in the OFA groups with an SMD of −0.81 (−1.05; −0.58) and an RR of 0.48 (0.33; 0.70), respectively. Quantitative analysis did not reveal differences between the hemodynamic outcomes, although severe side effects have been identified in the literature. No clinically significant benefits were observed with OFA in terms of pain and opioid use after surgery. A clear benefit of OFA use was observed with respect to a reduction in PONV. However, more data on the safe use of OFAs should be collected and caution should be taken in the development of OFA.

Risk of infectious, hematological, and gastrointestinal side effects in patients treatedwith ibrutinib: A systematic review and meta-analysis of randomized controlled trials.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18265-e18265
Author(s):  
Myo Zaw ◽  
Kyaw Zin Thein ◽  
Aung Tun ◽  
Lukman Tijani ◽  
Elizabeth Guevara
Keyword(s):  
Systematic Review ◽  
Side Effects ◽  
Adverse Effects ◽  
Randomized Controlled Trials ◽  
Chemokine Receptors ◽  
Meta Analysis ◽  
Controlled Trials ◽  
High Grade ◽  
Randomized Controlled ◽  
Gastrointestinal Side Effects

e18265 Background: Bruton’s tyrosine kinase (BTK) is essential for signaling of B-cell and chemokine receptors. Ibrutinib targets BTK and has become frontier in many hematologic malignancies. We undertook systematic review and pooled analysis of randomized controlled trials (RCTs) to determine infectious, hematological and gastrointestinal risks associated with ibrutinib. Methods: We performed a comprehensive literature search using MEDLINE, EMBASE databases and meeting abstracts through December 31, 2016. The RCTs that mention infectious, hematological and gastrointestinal side effects as adverse effects were incorporated in the analysis. Mantel-Haenszel method was used to calculate the estimated pooled risk ratio with 95% confidence interval (CI). Results: Four RCTs with a total of 1505 patients were eligible for the analysis. Studies compared Ibrutinib (I) vs ofatumumab, I vs chlorambucil, I+ bendamustine (B)+ rituximab (R) vs placebo + B+ R and I vs temsirolimus were included in the analysis. The relative risks (RR) of all-grade side effects were as follows: infection, 1.34 (95% CI: 1.04 – 1.74; p = 0.02); pneumonia, 1.16 (95% CI: 0.82–1.66; p = 0.38); anemia, 0.77 (95% CI: 0.64 – 0.93; p = 0.007); neutropenia, 0.99 (95% CI: 0.87 – 1.14; p = 0.98); thrombocytopenia, 0.86 (95% CI: 0.71 – 1.04; p = 0.12); diarrhea, 1.74 (95% CI: 1.48 – 2.05; p < 0.0001); nausea, 0.94 (95% CI: 0.80 – 1.10; p = 0.45); and vomiting, 0.98 (95% CI 0.74 – 1.30; p = 0.93). The RR of high-grade adverse effects were as follows: febrile neutropenia, 1.32 (95% CI: 0.84 – 2.08; p = 0.21); infection, 1.20 (95% CI: 0.73 – 1.98; p = 0.45); pneumonia, 1.22 (95% CI: 0.76–1.95; p = 0.39); anemia, 0.48 (95% CI: 0.33 – 0.71; p < 0.0001); neutropenia, 0.99 (95% CI: 0.86 – 1.15; p = 0.94); thrombocytopenia, 0.61 (95% CI: 0.47 – 0.81; p = 0.001); diarrhea, 1.72 (95% CI: 0.88 – 3.34;p = 0.10); nausea, 2.56 (95% CI: 0.59 – 10.99; p = 0.20); and vomiting, 0.42 (95% CI 0.11 – 1.63; p = 0.21). Conclusions: Ibrutinib increased the risk of all-grade diarrhea and infection whereas the risks of all-grade anemia, high-grade anemia and thrombocytopenia were significantly lower in the study arm, favoring ibrutinib.

scholarly journals Fluoxetine in the Management of Major Depressive Disorder in Children and Adolescents: A Meta-Analysis of Randomized Controlled Trials

2020 ◽  
pp. 001857872092538
Author(s):  
Ayman Antoun Reyad ◽  
Kiran Plaha ◽  
Eriny Girgis ◽  
Raafat Mishriky
Keyword(s):  
Major Depressive Disorder ◽  
Side Effects ◽  
Depressive Disorder ◽  
Randomized Controlled Trials ◽  
Children And Adolescents ◽  
Meta Analysis ◽  
Mean Difference ◽  
Controlled Trials ◽  
Major Depressive ◽  
Randomized Controlled

Background: Fluoxetine is a serotonin-specific reuptake inhibitor antidepressant and is the only approved pharmacological treatment for major depressive disorder (MDD) in children and adolescent. Methods: We searched the published randomized controlled-trials to review fluoxetine efficacy and tolerability using the databases PubMed, EudraCT, ClinicalTrials.gov, and Cochrane Central Register of Controlled Trials for fluoxetine role in managing MDD in children and adolescents. A meta-analysis was conducted using the identified 7 clinical trials to assess efficacy using the outcomes: Children's Depression Rating Scale–Revised (CDRS-R), Clinical Global Impressions–Severity of Illness (CGI-S) and Clinical Global Impressions–Improvement (CGI-I) response rate. The risk of discontinuation due to adverse effects and common side effects were examined. Results: The mean difference in change from baseline for CDRS-R was −2.72 (95% confidence interval [CI], −3.96, −1.48) favoring fluoxetine treatment ( P < .001). Similarly, mean difference for CGI-S was −0.21 (95% CI, −0.36, −0.06). The risk ratio (RR) of discontinuing due to adverse events was 0.98 (95% CI, 0.54, 1.83), with RR for headache side effects 1.34 (95% CI, 1.03, 1.74) and rash 2.6 (95% CI, 1.32, 5.14). Conclusion: Fluoxetine demonstrates significant improvements in symptom intensity control in young patients suffering from MDD and is considered well tolerated with similar rates of trials discontinuation; however, fluoxetine was associated with a higher risk of headache and rash side effects. These findings will guide psychiatrists and pharmacists in their clinical role for supporting the care of young mental health patients.

scholarly journals Gastrointestinal Adverse Effects of Short-Term Aspirin Use: A Meta-Analysis of Published Randomized Controlled Trials

Drugs in R&D ◽  
2013 ◽  
Vol 13 (1) ◽  
pp. 9-16 ◽  
Author(s):  
John A. Baron ◽  
Stephen Senn ◽  
Michael Voelker ◽  
Angel Lanas ◽  
Irene Laurora ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Short Term ◽  
Randomized Controlled

Risk of hematological toxicities and febrile neutropenia in patients with hormone receptor-positive HER2-negative metastatic breast cancer treated with CDK 4/6 inhibitors: A systematic review and meta-analysis of randomized controlled trials.

2017 ◽  
Vol 35 (31_suppl) ◽  
pp. 207-207
Author(s):  
Myo Zaw ◽  
Kyaw Zin Thein ◽  
Aung Tun ◽  
Myat M. Han ◽  
Saba Radhi ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Effects ◽  
Febrile Neutropenia ◽  
Randomized Controlled Trials ◽  
Financial Burden ◽  
Meta Analysis ◽  
Neutropenic Fever ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
The Impact

207 Background: Majority of breast cancers express the estrogen receptor or progesterone receptor. CDK4/6 signaling plays a role in endocrine therapy resistance and the benefit of inhibition of these pathways has been proven in studies. Yet the impact of these agents on hematological toxicities and febrile neutropenia is a considerable safety concern. Hence, we performed a systematic review and meta-analysis of randomized controlled trials (RCT). Methods: MEDLINE, EMBASE databases and meeting abstracts from inception through June 2017 were queried. RCTs that mention anemia, thrombocytopenia, leukopenia, neutropenia and neutropenic fever as adverse effects were incorporated in the analysis. Mantel-Haenszel method was used to calculate the estimated pooled risk ratio with 95% confidence interval (CI). Random effects model was applied. Results: Five RCTs (four phase 3 and one phase 2 studies) with a total of 2671 patients were eligible for analysis. The study arm used palbociclib-letrozole, palbociclib-fulvestrant, ribociclib-letrozole and abemaciclib-fulvestrant while the control arm utilized placebo in combination with letrozole or fulvestrant. The relative risks (RR) of all-grade side effects were as follows: anemia, 3.77 (95% CI: 2.47 – 5.75, p < 0.0001); thrombocytopenia, 9.69 (95% CI: 4.26 – 22.04, p < 0.0001); leukopenia, 11.68 (95% CI: 8.19–16.65; p < 0.0001); and neutropenia, 14.09 (95% CI: 10.73–18.49; p < 0.0001). The RR of high-grade adverse effects were as follows: anemia, 2.66 (95% CI: 1.29 – 5.45, p = 0.008); thrombocytopenia, 7.08 (95% CI: 1.95 – 25.74, p = 0.003); leukopenia, 33.58 (95% CI: 14.49–77.77; p < 0.0001); and neutropenia, 40.33 (95% CI: 19.34–84.10; p < 0.001). The pooled risk of neutropenic fever was statistically significant at 4.26 (95% CI: 1.11–16.26; p = 0.034). Conclusions: CDK 4/6 inhibitors based regimen significantly contributed to all hematological toxicities as well as febrile neutropenia. These toxicities affect patients’ quality of life, add financial burden and may lead to drug dosing inconsistencies.

scholarly journals Hepatotoxicity of Nonsteroidal Anti-Inflammatory Drugs: A Systematic Review of Randomized Controlled Trials

2018 ◽  
Vol 2018 ◽  
pp. 1-13 ◽  
Author(s):  
Pajaree Sriuttha ◽  
Buntitabhon Sirichanchuen ◽  
Unchalee Permsuwan
Keyword(s):  
Side Effects ◽  
Randomized Controlled Trials ◽  
Cochrane Library ◽  
Bibliographic Databases ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Inflammatory Drugs ◽  
Anti Inflammatory ◽  
Clinically Significant ◽  
The Cochrane Library

Background. Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most widely used medication in several countries, including Thailand. NSAIDs have been associated with hepatic side effects; however, the frequency of these side effects is uncertain. Aim of the Review. To systematically review published literature on randomized, controlled trials that assessed the risk of clinically significant hepatotoxicity associated with NSAIDs. Methods. Searches of bibliographic databases EMBASE, PubMed, and the Cochrane Library were conducted up to July 30, 2016, to identify randomized controlled trials of ibuprofen, naproxen, diclofenac, piroxicam, meloxicam, mefenamic acid, indomethacin, celecoxib, and etoricoxib in adults with any disease that provide information on hepatotoxicity outcomes. Results. Among the 698 studies, 18 studies met the selection criteria. However, only 8 studies regarding three NSAIDs (celecoxib, etoricoxib, and diclofenac) demonstrated clinically significant hepatotoxic evidence based on hepatotoxicity justification criteria. Of all the hepatotoxicity events found from the above-mentioned three NSAIDs, diclofenac had the highest proportion, which ranged from 0.015 to 4.3 (×10−2), followed by celecoxib, which ranged from 0.13 to 0.38 (×10−2), and etoricoxib, which ranged from 0.005 to 0.930 (×10−2). Conclusion. Diclofenac had higher rates of hepatotoxic evidence compared to other NSAIDs. Hepatotoxic evidence is mostly demonstrated as aminotransferase elevation, while liver-related hospitalization or discontinuation was very low.

scholarly journals A Systematic Review and Meta-Analysis of Randomized Controlled Trials Comparing the Safety of Dapagliflozin in Type 1 Diabetes Patients

2020 ◽  
Author(s):  
Sumanta Saha ◽  
Sujata Saha
Keyword(s):  
Systematic Review ◽  
Type 1 Diabetes ◽  
Side Effects ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Random Effect ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Randomized Controlled

Background and Purpose: The dapagliflozin’s safety profile in insulin-treated adult type-1 diabetes mellites (T1DM) patients remains poorly explored. Therefore, this systematic review and meta-analysis compared the risk of all-cause side effects, study discontinuation of participants due to side effects, urinary tract infection (UTI), diabetic ketoacidosis, and hypoglycemia between dapagliflozin 10 mg and dapagliflozin 5 mg, dapagliflozin 10 mg and placebo, and dapagliflozin 5 mg and placebo.Materials and Methods: Parallel-arm randomized controlled trials juxtaposing the above outcomes between the afore-mentioned interventions were eligible for inclusion in this study and were searched in PubMed, Embase, and Scopus. Utilizing the Cochrane tool, the risk of bias was assessed in the recruited trials. Finally, by random-effect meta-analysis, each outcome was compared among the above interventions, and the risk ratio was estimated.Results: Four trials of varying length (1-52 weeks) sourcing data from almost 1760 participants from about 32 nations were reviewed. Overall, the trials had a low or unclear risk of bias, and only one was at a high risk of bias.  Compared to the placebo, the risk of side effects was higher in those treated with dapagliflozin 5 mg (RR=1.10; 95% CI=1.02-1.18; p=0.014; I2=0%). UTI risk was less with the 10mg dapagliflozin than its lower dose (RR=0.50; 95% CI=0.32-0.79; p-value=0.003; I2=0%). All the remaining comparisons were statistically not significantly different between the juxtaposed intervention pairs.Conclusion: In contrast to placebo, dapagliflozin 5mg increased the risk of overall adversities in insulin-treated type-1 diabetes, and dapagliflozin 10 mg had a reduced risk of UTI than its 5mg preparation.

scholarly journals Preoperative Oral Gabapentin in the Management of Postoperative Catheter-Related Bladder Discomfort in Adults: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 8 ◽  
Author(s):  
Yu-Ting Wang ◽  
Chong Xiao ◽  
Hong Liu ◽  
Xi Fu ◽  
Yi-Feng Ren ◽  
...  
Keyword(s):  
Systematic Review ◽  
Side Effects ◽  
Postoperative Pain ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Surgical Patients ◽  
Controlled Trials ◽  
Assessment Development ◽  
Randomized Controlled ◽  
Short Time

Objective: To evaluate the efficacy and safety of preoperative oral gabapentin in preventing postoperative Catheter-Related Bladder Discomfort (CRBD) in surgical patients.Methods: Randomized controlled trials in which gabapentin was used for the prevention of CRBD in surgical patients with transurethral catheterization were evaluated. The primary outcome was the incidence of moderate-to-severe CRBD at 0, 1, 2, and 6 h after surgery, and secondary outcomes included the incidence of any grade CRBD, postoperative pain, and adverse events. Pooled risk ratios (RRs) and mean difference (MD), 95% confidence intervals (CIs), and P values were estimated using fixed and random effects statistical models. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach was used to rate the levels of certainty for key results.Results: A total of 6 randomized controlled trials involving 679 participants were included in the meta-analysis. Gabapentin significantly reduced the risk of moderate-to-severe CRBD at 0, 1, 2, and 6 h (0 h: RR = 0.19, 95% CI: 0.11 to 0.31, p &lt; 0.00001; 1 h: RR = 0.40, 95% CI: 0.25 to 0.66, p &lt; 0.001; 2 h: RR = 0.38, 95% CI: 0.26 to 0.56, p &lt; 0.00001; 6 h: RR = 0.20, 95% CI: 0.11 to 0.38, p &lt; 0.00001). The overall incidence of CRBD at 1 h showed no statistical difference between the two groups (RR = 0.55, 95% CI: 0.30 to 1.00, p = 0.05). The risk of CRBD was significantly reduced in the gabapentin group at 0, 2, and 6 h after surgery (0 h: RR = 0.59, 95% CI: 0.46 to 0.74, p &lt; 0.0001; 2 h: RR = 0.62, 95% CI: 0.51 to 0.75, p &lt; 0.00001; 6 h: RR = 0.66, 95% CI: 0.52 to 0.83, p &lt; 0.001). In addition, gabapentin was associated with low postoperative pain intensity without significant side effects.Conclusion: Preoperative oral gabapentin as an adjunct to surgery is effective in decreasing the risk and severity of CRBD over a short time after surgery, and it can decrease postoperative pain without significant side effects. Overall, the level of certainty was moderate to low.Systematic Review Registration:https://www.crd.york.ac.uk/prospero/#recordDetails, identifier: CRD42021228171.

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