TNX-102 SL is a new sublingual tablet formulation of cyclobenzaprine (CBP) for rapid transmucosal absorption. We aimed to evaluate the efficacy and safety of TNX-102 SL in improving pain and sleep quality in patients with fibromyalgia (FM). Searches were conducted in Embase, PubMed, Cochrane Library, and Web of Science databases. The primary endpoint was the reduction in daily diary pain score. Secondary outcomes included Fibromyalgia Impact Questionnaire (FIQ-R) Function and Symptoms, daily diary sleep score, and adverse effects. Four studies met eligibility criteria and a random-effect meta-analysis was performed to combine data. The analyses of 1,993 patients yielded statistically significant differences in the TNX-102 SL group versus the control group on daily diary pain intensity (SMD = -0.25; 95% CI [-0.34, -0.16]; p < 0.001), FIQ-R Function (SMD = -0.18; 95% CI [-0.35, -0.02]; p = 0.028), FIQ-R Symptoms (SMD = -0.23; 95% CI [-0.33, -0.13]; p < 0.001) and sleep daily diary (SMD = -0.21; 95% CI [-0.32, -0.11]; p < 0.001). Sedation, oral hypoaesthesia, and paresthesia were TNX102-SL's most common adverse effects. Pooled data show TNX-102 SL significantly reduces pain, improves sleep quality, and enhances quality of life in FM patients. www.crd.york.ac.uk/prospero identifier is CRD42024588069.
BACKGROUND AND OBJECTIVES: Bypass surgery is an important option for treating complex intracranial aneurysms (IAs) and Moyamoya disease (MMD), particularly when conventional approaches are insufficient. However, the literature remains heterogeneous, with important limitations in reporting quality that hinder reproducibility and comparability. We aimed to evaluate the current evidence and propose a reporting guideline to improve transparency and methodological rigor. METHODS: We searched PubMed, Embase, and Web of Science databases. Eligible studies were observational or randomized studies reporting clinical and/or surgical outcomes of bypass for IAs or MMD, including a sample size of ≥3 patients, and published in English between January 1, 2000, and January 1, 2025. Assessment focused on key domains: (1) Assessment of reported baseline characteristics; (2) assessment and reporting on imaging methods and pathology characteristics; (3) reporting on pivotal concept definitions; (4) reporting on neurosurgeon(s) and staff characteristics; (5) reporting on the anesthetic protocol; (6) reporting on vascular procedure details; (7) reporting on antiaggregant and anticoagulation protocol; (8) assessing and reporting on clinical and surgical outcomes, besides adverse events; (9) reporting on retreatment details; and (10) funding and conflicts of interest declarations. RESULTS: Thirty studies were included. Our assessment revealed substantial reporting gaps across all domains pertinent to bypass. A bypass reporting guideline was developed and organized into 10 domains, featuring a pragmatic checklist composed of one common domain and disease-specific sections for IA and MMD. The guideline emphasizes detailed technical reporting, graft patency assessment and verification, perioperative antithrombotic management, and standardized clinical and radiological outcome measures. CONCLUSION: This systematic review on bypass surgery for IA and MMD identified substantial methodological and reporting limitations that compromise evidence quality and comparability. The proposed reporting guideline provides a structured framework to address these gaps, enhancing transparency, reproducibility, and standardization, with the potential to strengthen the evidence base and improve patient care.
Glioblastoma is an aggressive brain tumor with median survival under 2 years despite standard therapy. At recurrence, treatment options are limited, and regorafenib has emerged as a promising option. A systematic search was conducted through Pubmed, Cochrane Library, Embase, and Web of Science for studies on regorafenib in adult recurrent glioblastoma, and a single-arm meta-analysis with random-effects model was performed to pool the data. Across ten studies (724 patients), median overall survival (OS) was 7.2 months and median progression-free survival (PFS) was 2.6 months, with a 12-month OS of 22.5% and a 6-month PFS of 14.9%. Disease control rate (DCR) was 36.1%, including stable disease (SD) of 26.6% and a partial response of 8.5%; progressive disease occurred in 60.9%, and grade 3-4 adverse events in 31.4%. Meta-regression suggested MGMT methylation was associated with improved OS, PFS, DCR, and SD, while male sex was associated with better OS and SD. Overall, regorafenib demonstrated a predictable safety profile in recurrent glioblastoma, with outcomes potentially improved in male patients with MGMT-methylated tumors.