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

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.

Conflict of interest statement

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.

Figures

Figure 1.. CONSORT Diagram

In the bariatric surgery arm, 18 patients were assessed 2 weeks after surgery.

Figure 2.. Body Weight, Lumbar Puncture (LP) Opening Pressure, Percentage Change in Body Weight, and Percentage Change in Intracranial Pressure (ICP) by Trial Arm

Whiskers represent SEs. CSF indicates cerebrospinal fluid; CWM, community weight management.