Objectives To systematically review the efficacy of interventions for Meniere's disease (MD) to report clinical implications of the results and to identify areas for future valuable research.... Show moreObjectives To systematically review the efficacy of interventions for Meniere's disease (MD) to report clinical implications of the results and to identify areas for future valuable research. Methods In line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Abstracts (PRISMA-A) guideline, a systematic online database search was conducted in which MEDLINE (PubMed), Embase (Ovid) and CENTRAL (Cochrane Library) were searched until May 2021 in order to search for the efficacy of treatment was analysed in a systematic review. Systematic reviews (SRs) on treatments for MD were screened for eligible interventions. From these SRs, we included placebo randomised controlled trials (RCTs). A separate search was conducted to identify RCTs on treatment modalities that were systematically reviewed yet published after the conduction of these SRs. The primary outcome was control of vertigo as defined by the American guideline as published in 1995. The PRISMA-A and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to appraise and evaluate the certainty of evidence. Results We found five SRs from which 19 RCTs were extracted. Five RCTs were added by the separate search resulting in a total of 25 RCTs (n=1248) which evaluated the efficacy of betahistine dihydrochloride, intratympanic injections with gentamicin or steroids, endolymphatic sac surgery and pressure pulse therapy. Evidence on the efficacy of interventions for patients with MD is generally of low certainty. Betahistine (48 mg per day and 144 mg per day) and positive pressure therapy probably do not reduce MD symptoms when compared with placebo. Intratympanic injection with gentamicin or steroids, or treatment with endolymphatic surgery may reduce symptoms in MD when compared with placebo. Conclusions A definite effective and well-tolerated therapy for MD has yet to be discovered and information on the natural course of disease is one of the biggest flaws in current research. PROSPERO registration number CRD4201502424. Show less
In the European Union (EU), the delivery of health services is a national responsibility but there are concerted actions between member states to protect public health. Approval of pharmaceutical... Show moreIn the European Union (EU), the delivery of health services is a national responsibility but there are concerted actions between member states to protect public health. Approval of pharmaceutical products is the responsibility of the European Medicines Agency, while authorising the placing on the market of medical devices is decentralised to independent 'conformity assessment' organisations called notified bodies. The first legal basis for an EU system of evaluating medical devices and approving their market access was the Medical Device Directive, from the 1990s. Uncertainties about clinical evidence requirements, among other reasons, led to the EU Medical Device Regulation (2017/745) that has applied since May 2021. It provides general principles for clinical investigations but few methodological details-which challenges responsible authorities to set appropriate balances between regulation and innovation, pre-and post-market studies, and clinical trials and real-world evidence. Scientific experts should advise on methods and standards for assessing and approving new high-risk devices, and safety, efficacy, and transparency of evidence should be paramount. The European Commission recently awarded a Horizon 2020 grant to a consortium led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, that will review methodologies of clinical investigations, advise on study designs, and develop recommendations for aggregating clinical data from registries and other real-world sources. The CORE-MD project (Coordinating Research and Evidence for Medical Devices) will run until March 2024. Here, we describe how it may contribute to the development of regulatory science in Europe. Show less
Background and Objectives: Adverse drug reactions on sexual functioning (sADRs) may seriously decrease a person's quality of life. A multitude of diseases and drugs are known risk factors for... Show moreBackground and Objectives: Adverse drug reactions on sexual functioning (sADRs) may seriously decrease a person's quality of life. A multitude of diseases and drugs are known risk factors for sexual dysfunction.To inform patients better about these potential effects, more insight is needed on the estimated number of patients at high risk for sADRs and their characteristics.Methods: This cross-sectional study estimated the number of patients in the Netherlands who were dispensed drugs with a potential very high risk (>10%) or high risk (1-10%) for sADRs as registered in the Summary of Product Characteristics, the official drug information text in Europe.Results: In April 2019, 2.06% of the inhabitants of the Netherlands received drugs with >10% risk for sADRs and 7.76% with 1-10% risk.The majority of these patients had at least one additional risk factor for decreased sexual function such as high age or depression. Almost half of the patients were identified with two or more morbidities influencing sexual functioning. Paroxetine, sertraline and spironolactone were the most dispensed drugs with a potential >10% risk for sADRs. One-third of their first dispenses were not followed by a second dispense, with a higher risk of discontinuation for a decreasing number of morbidities.Conclusion: About 1 in 11 inhabitants of the Netherlands was dispensed a drug with a potential high risk for sADRs, often with other risk factors for sexual complaints. Further research is needed whether these users actually experience sADRs, to understand its impact on multimorbid patients and to provide alternatives if needed. Show less
