Effectiveness of Bariatric Surgery vs Community Weight Management Intervention for the Treatment of Idiopathic Intracranial Hypertension

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 PARTICIPANTSThis 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 MEASURESThe 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. RESULTSOf 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, kg; 95% CI, −32.1 to −10.7 kg; P < .001) and at 24 months (adjusted mean [SE] difference, 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 RELEVANCEIn this randomized clinical trial, bariatric surgery was superior to a CWM intervention in lowering intracranial pressure. The continued improvement over the course of 2 year...

The Health Economic Evaluation of Bariatric Surgery Versus a Community Weight Management Intervention Analysis from the Idiopathic Intracranial Hypertension Weight Trial (IIH:WT)

“…The IIH:WT established that bariatric surgery was superior to a community weight management intervention in reduction of intracranial pressure, headache outcomes, and delivery of better quality of life in those with active IIH and a body mass index ≥35 kg/m 2 [18]. This cost-effectiveness analysis reports on the economic value of bariatric surgery and details how the initial high cost of bariatric surgery is offset by these superior gains in intracranial pressure when compared to a weight management programme over 24 months.…”

“…Bariatric surgery results in sustainable long term weight loss [24], and in the IIH:WT reduced the intracranial pressure to below that of the diagnosis level, i.e., induced remission [18]. The durability of bariatric surgery will therefore likely reduce the frequent relapses reported in IIH [5,6], which contribute to significant costly frequent hospital admissions over time [2][3][4].…”

“…The trial was registered, clinicaltrials.gov identifier: NCT02124486. The protocol and eligibility criteria [17] and the main study findings have previously been published [18].…”

“…However, prior to the IIH weight trial (IIH:WT) there was little evidence for the best method of weight loss to achieve sustained IIH remission [17]. IIH:WT showed that bariatric surgery was superior to community weight management intervention in women with active IIH and a body mass index (BMI) ≥ 35 kg/m 2 in lowering intracranial pressure, improved headache outcomes, and providing improvements in quality of life [18]. Sustained weight loss should prevent multiple relapses of the disease [5,6], which will translate into a substantial reduction in healthcare costs.…”

Incidence of idiopathic intracranial hypertension in Southern Tasmania, Australia

“…7 8 A complex interplay also exists between IIH, migraine 9 10 and other headache classifications, with over two-thirds of patients with an IIH diagnosis receiving a subsequent additional headache diagnosis, where headache persists despite treatment of IIH. 11 Management strategies include weight loss (with evidence for bariatric surgery over community weight management alone), 12 often in conjunction with carbonic anhydrase inhibitors (oral acetazolamide 13 and/ or topiramate) and in some cases, diuretics. Patients who are medically refractory or unable to tolerate these medications may need to undergo optic nerve sheath fenestration or insertion of a CSF shunt (ventriculoperitoneal or lumboperitoneal).…”