LAUSR

Editor Kirkham et al.1 concluded in their review of the current evidence for magnetic sphincter augmentation (MSA) that it is ‘being used despite a lack of robust evidence for its effectiveness’. We disagree. Their study was designed to summarize and appraise the reporting of studies of MSA in relation to the Idea, Development, Exploration, Assessment, Longterm Study Framework for Devices (IDEAL-D), which was published after MSA was introduced and not to analyse outcomes. This requires a formal metaanalysis of the MSA evidence base which currently includes cohort studies, larger safety cohorts, a device registry and an RCT showing efficacy over proton pump inhibitor therapy2. Indeed, the majority of IDEAL-D has been followed during the introduction of MSA. A recent meta-analysis compared MSA with fundoplication and concluded that they achieved equivalent symptom and acid reflux control but that MSA caused less gas bloat. Clearly, an RCT comparing MSA with fundoplication is desirable and would make an important contribution to the evidence base for MSA3. Sadly, an application to the MRC in 2012 for such a study was declined. However, the safety of MSA has been established from recent large registry studies of 1000 and nearly 10 000 patients, reporting erosion rates of 0⋅1 and 0⋅3 per cent4,5. Imperfect reporting of other outcomes does not discount these data. A fair and comprehensive review of the literature suggests that MSA is both safe and effective, notwithstanding the need for an RCT to compare the efficacy of MSA versus standard fundoplication to add to the existing ‘real-world’ evidence.