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

Educational Objective
To investigate whether bariatric surgery is superior to a community weight management intervention in sustaining the weight loss necessary to achieve sustained remission in patients with idiopathic intracranial hypertension (IIH).
1 Credit CME
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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Article Information

Accepted for Publication: January 29, 2021.

Published Online: April 26, 2021. doi:10.1001/jamaneurol.2021.0659

Correction: This article was corrected on May 24, 2021, to fix errors in Figure 2.

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2021 Mollan SP et al. JAMA Neurology.

Corresponding Author: Alexandra J. Sinclair, PhD, Department of Metabolic Neurology, Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham B15 2TT, United Kingdom (a.b.sinclair@bham.ac.uk).

Author Contributions: Ms Mollan and Mr Mitchell contributed equally to this study. Drs Brock and Sinclair had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Lavery, Matthews, Singhal, Frew, Sinclair.

Acquisition, analysis, or interpretation of data: Mollan, Mitchell, Ottridge, Aguiar, Yiangou, Alimajstorovic, Cartwright, Grech, Westgate, Vijay, Scotton, Wakerley, Matthews, Ansons, Hickman, Benzimra, Rick, Singhal, Tahrani, Brock, Frew, Sinclair.

Drafting of the manuscript: Mollan, Mitchell, Aguiar, Grech, Lavery, Singhal, Tahrani, Frew, Sinclair.

Critical revision of the manuscript for important intellectual content: Mollan, Mitchell, Ottridge, Aguiar, Yiangou, Alimajstorovic, Cartwright, Lavery, Westgate, Vijay, Scotton, Wakerley, Matthews, Ansons, Hickman, Benzimra, Rick, Singhal, Tahrani, Brock, Frew, Sinclair.

Statistical analysis: Mitchell, Aguiar, Alimajstorovic, Cartwright, Scotton, Tahrani, Brock, Frew.

Obtained funding: Singhal, Sinclair.

Administrative, technical, or material support: Mitchell, Ottridge, Yiangou, Grech, Lavery, Westgate, Benzimra, Rick, Singhal, Tahrani, Frew, Sinclair.

Supervision: Mollan, Lavery, Tahrani, Frew, Sinclair.

Conflict of Interest Disclosures: Dr Mollan reported receiving personal fees from Allergan, Chiesi Farmaceutici, Heidelberg Engineering, Invex Therapeutics, Neurodiem, Novartis, Roche, Santen Pharmaceutical, and Santhera Pharmaceuticals outside the submitted work. Dr Mitchell reported receiving grants from the National Institute of Health Research during the conduct of the study and grants from the UK Ministry of Defence outside the submitted work. Ms Grech reported receiving funding through a Brain Research UK PhD studentship during the conduct of the study and consulting fees from Invex Therapeutics outside the submitted work. Dr Lavery reported receiving funding through a Wellcome Trust Senior Fellowship during the conduct of the study. Dr Wakerley reported receiving personal fees from Invex Therapeutics outside the submitted work. Dr Matthews reported serving on the advisory board of AbbVie outside the submitted work. Dr Tahrani reported receiving grants from Novo Nordisk and Sanofi; personal fees from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly and Company, Janssen Pharmaceuticals, Merck Sharp & Dohme, Napp Pharmaceuticals, Novo Nordisk, and Sanofi; and nonfinancial support from Aptiva, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly and Company, Impeto Medical, Merck Sharp & Dohme, Napp Pharmaceuticals, Novo Nordisk, and ResMed outside the submitted work. Dr Brock reported owning equity in AstraZeneca and GlaxoSmithKline, receiving personal fees from Eli Lilly and Company and Invex Therapeutics, and receiving reimbursement from Merck & Co and Roche outside the submitted work. Dr Frew reported receiving grants from the Birmingham City Council (United Kingdom) and the National Institute of Health Research outside the submitted work. Dr Sinclair reported receiving grants from the Medical Research Council of the United Kingdom and funding through a Sir Jules Thorn Award for Biomedical Science during the conduct of the study. No other disclosures were reported.

Funding/Support: This clinical trial was funded by grant NIHR-CS-011-028 (clinician scientist fellowship) from the National Institute for Health Research (Dr Sinclair) and grant MR/K015184/1 from the Medical Research Council of the United Kingdom (Dr Sinclair).

Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Data Sharing Statement: See Supplement 3.

Disclaimer: The views expressed in this article are those of the authors and not necessarily those of the UK National Health Service, the National Institute for Health Research, or the UK Department of Health and Social Care.

Additional Contributions: The Birmingham Clinical Trials Unit provided clinical trial coordination and data management. Natalie J Ives, BSc(Hons), MSc, (Birmingham Clinical Trials Unit) contributed to the study design, statistical protocol development, and statistical analysis planning (with compensation); Smitaa Patel, BSc, Msc (Birmingham Clinical Trials Unit), contributed to the interim analyses and statistical analysis planning (with compensation); and Rebecca L Woolley, BSc(Hons), MSc (Birmingham Clinical Trials Unit), contributed to the statistical protocol development, interim analyses, and statistical analysis planning (with compensation). Other members of the bariatric surgery pathway at Birmingham Heartlands Hospital included Paul Super, MBChB, and Markos Daskalakis, PhD, who served as consulting bariatric surgeons (without compensation); Sally Abbott, MRes, who served as the specialist bariatric dietician (without compensation); and Natasha Robinson, who served as the bariatric pathway coordinator (without compensation). Rab Mollan, MD, and Richard Blanch, PhD, of University Hospitals Birmingham and the University of Birmingham provided critical review of the manuscript (without compensation). We thank staff at the National Institute for Health Research Clinical Research Network and the Wellcome Trust Clinical Research Facilities, where this clinical trial was performed.

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