scholarly journals Optimization of Postoperative Intravenous Patient-Controlled Analgesia with OpioidDexmedetomidine Combinations: An Updated Meta-Analysis with Trial Sequential Analysis of Randomized Controlled Trials

2017 ◽  
Vol 7 (20;7) ◽  
pp. 569-595
Author(s):  
Fu-hai Ji
Keyword(s):  
Postoperative Pain ◽  
Adverse Events ◽  
Pain Intensity ◽  
Sequential Analysis ◽  
Meta Analysis ◽  
Trial Sequential Analysis ◽  
Controlled Trials ◽  
Patient Controlled Analgesia ◽  
Randomized Controlled ◽  
Morphine Equivalent

Background: It is still a challenge to optimize postoperative pain management. The effects of adding dexmedetomidine (DEX) to opioid-based postoperative intravenous patient-controlled analgesia (PCA) are not fully understood. Objectives: The aim of this study is to assess the efficacy and safety of opioid-DEX combinations for postoperative PCA, and a trial sequential analysis (TSA) is utilized to evaluate the robustness of the current evidence. Study Design: A systematic review and meta-analysis. Setting: Randomized controlled trials that compared opioid-DEX combinations with opioid-only for PCA in adult surgical patients. Methods: MEDLINE, EMBASE, and CENTRAL databases were searched for relevant articles. The main outcomes analyzed were postoperative pain intensity, opioid requirement, and opioid-related adverse events. The random-effects model was used to estimate mean differences (MDs) or relative risks (RRs) with 95% confidence intervals (CIs). A TSA was performed to test whether the evidence was reliable and significant. The quality of evidence for the main outcomes was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. Results: Eighteen studies involving 1,284 patients were included. The meta-analysis indicated that opioid-DEX combinations were associated with lower postoperative pain intensity (at rest: MD [24 hours] = -0.48, 95% CI [-0.75, -0.21], P = 0.0005), lower morphine-equivalent requirement (MD [0 – 24 hours] = -12.16 mg [-16.12, -8.21], P < 0.00001), and lower adverse events (nausea: RR = 0.66 [0.52, 0.83]; vomiting: RR = 0.65 [0.49, 0.87]; and pruritus: RR = 0.57 [0.40, 0.81]). For the above results, the TSA revealed that the cumulative Z-curve exceeded both the traditional boundary and the trial sequential monitoring boundary for benefit. DEX had no effect on the incidence of hypotension or bradycardia, which was also confirmed by the TSA. The GRADE level of evidence was high for postoperative nausea, moderate for pain intensity at rest at 24 hours postoperatively, morphine-equivalent requirement during 0 – 24 hours postoperatively, and postoperative vomiting, pruritus, and bradycardia, and low for postoperative hypotension. Limitations: The risk of introducing potentially significant heterogeneity exists, and this study did not evaluate the effects of DEX combined with opioids on long-term outcomes including chronic pain and patients’ satisfaction after hospital discharge. Conclusions: Postoperative PCA strategies with opioid-DEX combinations decreased postoperative pain, opioid requirement, and opioid-related adverse events. DEX is a useful adjuvant to opioid-based PCA. Key words: Dexmedetomidine, pain, postoperative analgesia, opioid, patient-controlled

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.

scholarly journals Efficacy of Oral Cryotherapy in the Prevention of Oral Mucositis Associated with Cancer Chemotherapy: Systematic Review with Meta-Analysis and Trial Sequential Analysis

2021 ◽  
Vol 28 (4) ◽  
pp. 2852-2867
Author(s):  
Ali Hatem Manfi Al-Rudayni ◽  
Divya Gopinath ◽  
Mari Kannan Maharajan ◽  
Sajesh Kalkandi Veettil ◽  
Rohit Kunnath Menon
Keyword(s):  
Bone Marrow ◽  
Bone Marrow Transplantation ◽  
Oral Mucositis ◽  
Sequential Analysis ◽  
Meta Analysis ◽  
Trial Sequential Analysis ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Solid Malignancies ◽  
Oral Cryotherapy

Background: This review aimed to evaluate the efficacy of oral cryotherapy in the prevention of chemotherapy-induced oral mucositis using meta-analysis and trial sequential analysis, as well as to assess the quality of the results by the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. Methods: A comprehensive search of three databases including Medline, Embase and Central was performed to identify randomized controlled trials that used oral cryotherapy for the prevention of chemotherapy-induced oral mucositis. The primary outcome was the incidence of oral mucositis for trials employing oral cryotherapy as the intervention for the prevention of oral mucositis. The meta-analysis was performed using the random-effects model and random errors of the meta-analyses were detected by trial sequential analysis. Results: A total of 14 RCTs with 1577 participants were included in the present meta-analysis. Patients treated with oral cryotherapy were associated with a significantly lower risk of developing oral mucositis of any grade (risk ratio (RR), 0.67 (95% CI: 0.56–0.81, p < 0.05)). Findings from the subgroup analyses showed that oral cryotherapy significantly reduced the risk of oral mucositis in patients undergoing bone marrow transplantation (RR 0.69, CI: 0.54–0.89, p < 0.05) as well as chemotherapy (RR 0.66, CI: 0.58–0.75, p < 0.05). Findings from the trial sequential analysis suggested that the evidence on oral cryotherapy as a preventive intervention for oral mucositis in patients with solid malignancies receiving conventional chemotherapy was conclusive. Conclusion: Oral cryotherapy is effective in preventing oral mucositis in patients undergoing chemotherapy for the management of solid malignancies. The use of oral cryotherapy in preventing oral mucositis in bone marrow transplantation settings showed promising efficacy, but the evidence is not conclusive and requires more high-quality randomized controlled trials.

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