Treatment of obesity with intragastric injection of botulinum toxin. Is it worth the pinch? An overview of systematic reviews and meta-analysis.

BACKGROUND AND AIMS: Αvaialble evidence regarding the effectiveness of intragastric injection of botulinum toxin in reducing anthropometric indices of subjects with obesity is conflicting. We evaluated the existing evidence and perform a meta-analysis to assess the efficacy of intragastric botulinum toxin in treating obesity. METHODS: We identified published systematic reviews evaluating the efficacy of intragastric injection of botulinum toxin in patients with overweight or obesity and additionally performed a systematic literature search to retrieve randomized controlled trials on this topic. A random-effects meta-analysis was performed to synthesize the existing studies. RESULTS: A total of four systematic reviews were included in our overview of systematic reviews and six randomized controlled trials were included in our meta-analysis. Compared to placebo, intragastric injection of botulinum toxin was ineffective in reducing body weight and body mass index after the application of the Knapp-Hartung adjustment (MD = -2.41 kg, 95%CI = -5.21 to 0.38, I2 =59% and MD = -1.43 kg/m2, 95%CI = -3.04 to 0.18, I2 =62%, respectively). Moreover, treatment with intragastric injection with botulinum toxin was not superior to placebo in decreasing waist and hip circumference. CONCLUSIONS: Based on the available evidence, intragastric injection with botulinum toxin is an ineffective procedure in reducing body weight and body mass index when the Knapp-Hartung method was applied.

Supporting Active Pharmacovigilance via IT Tools in the Clinical Setting and Beyond: Regulatory and Management Aspects.

Information Technology (IT) could have a prominent role towards the "Active Pharmacovigilance" (AP) paradigm by facilitating the analysis of potential Adverse Drug Reactions (ADRs). PVClinical project aims to build an IT platform enabling the investigation of potential ADRs in the clinical environment and beyond. In this paper, we outline the respective EU regulatory framework and the related Business Processes (BPs), elaborated based on input from clinicians and PV experts as part of the project's "user requirements analysis" phase, highlighting their potential pivotal role in the design of IT tools aiming to support AP.