Effectiveness of Bariatric Surgery vs Community Weight Management Intervention for the Treatment of Idiopathic Intracranial Hypertension: A Randomized Clinical Trial | Bariatric Surgery | JAMA Neurology | JAMA Network
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    Original Investigation
    April 26, 2021

    Effectiveness of Bariatric Surgery vs Community Weight Management Intervention for the Treatment of Idiopathic Intracranial Hypertension: A Randomized Clinical Trial

    Author Affiliations
    • 1Birmingham Neuro-Ophthalmology, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Birmingham, United Kingdom
    • 2Department of Metabolic Neurology, Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom
    • 3Department of Neurology, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Birmingham, United Kingdom
    • 4Birmingham Clinical Trials Unit, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom
    • 5Health Economics Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom
    • 6Centre for Endocrinology, Diabetes and Metabolism, Birmingham Health Partners, Birmingham, United Kingdom
    • 7Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom
    • 8Department of Neurology, Gloucestershire Hospitals NHS Foundation Trust, Gloucester, United Kingdom
    • 9Manchester University NHS Foundation Trust, Manchester Royal Eye Hospital, Manchester, United Kingdom
    • 10Department of Neurology, Royal Hallamshire Hospital, Sheffield, United Kingdom
    • 11Department of Ophthalmology, Royal Devon and Exeter NHS Foundation Trust, Exeter, United Kingdom
    • 12Nottingham Clinical Trials Unit, University of Nottingham, University Park, Nottingham, United Kingdom
    • 13Upper GI Unit and Minimally Invasive Unit, Birmingham Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom
    • 14Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, United Kingdom
    • 15Department of Endocrinology, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Birmingham, United Kingdom
    • 16Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, United Kingdom
    JAMA Neurol. Published online April 26, 2021. doi:10.1001/jamaneurol.2021.0659
    Key Points

    Question  Is bariatric surgery superior to a community weight management intervention in sustaining the weight loss necessary to achieve sustained remission among patients with idiopathic intracranial hypertension?

    Findings  In this randomized clinical trial of 66 women with idiopathic intracranial hypertension and a body mass index of 35 or higher, bariatric surgery was superior to a community weight management intervention in decreasing intracranial pressure, with continued improvement at 2 years.

    Meaning  The study’s findings indicate that, among women with idiopathic intracranial hypertension and a body mass index of 35 or higher, bariatric surgery is an effective treatment to reduce intracranial pressure and for sustained disease remission.

    Abstract

    Importance  Idiopathic intracranial hypertension (IIH) causes headaches, vision loss, and reduced quality of life. Sustained weight loss among patients with IIH is necessary to modify the disease and prevent relapse.

    Objective  To compare the effectiveness of bariatric surgery with that of a community weight management (CWM) intervention for the treatment of patients with active IIH.

    Design, Setting, and Participants  This 5-year randomized clinical trial (Idiopathic Intracranial Hypertension Weight Trial) enrolled women with active IIH and a body mass index (calculated as weight in kilograms divided by height in meters squared) of 35 or higher at 5 National Health Service hospitals in the UK between March 1, 2014, and May 25, 2017. Of 74 women assessed for eligibility, 6 did not meet study criteria and 2 declined to participate; 66 women were randomized. Data were analyzed from November 1, 2018, to May 14, 2020.

    Interventions  Bariatric surgery (n = 33) or CWM intervention (Weight Watchers) (n = 33).

    Main Outcomes and Measures  The primary outcome was change in intracranial pressure measured by lumbar puncture opening pressure at 12 months, as assessed in an intention-to-treat analysis. Secondary outcomes included lumbar puncture opening pressure at 24 months as well as visual acuity, contrast sensitivity, perimetric mean deviation, and quality of life (measured by the 36-item Short Form Health Survey) at 12 and 24 months. Because the difference in continuous outcomes between groups is presented, the null effect was at 0.

    Results  Of the 66 female participants (mean [SD] age, 32.0 [7.8] years), 64 (97.0%) remained in the clinical trial at 12 months and 54 women (81.8%) were included in the primary outcome analysis. Intracranial pressure was significantly lower in the bariatric surgery arm at 12 months (adjusted mean [SE] difference, −6.0 [1.8] cm cerebrospinal fluid [CSF]; 95% CI, −9.5 to −2.4 cm CSF; P = .001) and at 24 months (adjusted mean [SE] difference, −8.2 [2.0] cm CSF; 95% CI, −12.2 to −4.2 cm CSF; P < .001) compared with the CWM arm. In the per protocol analysis, intracranial pressure was significantly lower in the bariatric surgery arm at 12 months (adjusted mean [SE] difference, −7.2 [1.8] cm CSF; 95% CI, −10.6 to −3.7 cm CSF; P < .001) and at 24 months (adjusted mean [SE] difference, −8.7 [2.0] cm CSF; 95% CI, −12.7 to −4.8 cm CSF; P < .001). Weight was significantly lower in the bariatric surgery arm at 12 months (adjusted mean [SE] difference, −21.4 [5.4] kg; 95% CI, −32.1 to −10.7 kg; P < .001) and at 24 months (adjusted mean [SE] difference, −26.6 [5.6] kg; 95% CI, −37.5 to −15.7 kg; P < .001). Quality of life was significantly improved at 12 months (adjusted mean [SE] difference, 7.3 [3.6]; 95% CI, 0.2-14.4; P = .04) and 24 months (adjusted mean [SE] difference, 10.4 [3.8]; 95% CI, 3.0-17.9; P = .006) in the bariatric surgery arm.

    Conclusions and Relevance  In this randomized clinical trial, bariatric surgery was superior to a CWM intervention in lowering intracranial pressure. The continued improvement over the course of 2 years shows the impact of this intervention with regard to sustained disease remission.

    Trial Registration  ClinicalTrials.gov Identifier: NCT02124486

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