The Idiopathic Intracranial Hypertension Weight Trial (IIH:WT) (ClinicalTrials.gov Identifier: NCT02124486) will evaluate the effectiveness of bariatric surgery to lower intracranial pressure (ICP) and reduce idiopathic intracranial hypertension (IIH) symptoms among obese patients, according to the IIH:WT protocol published in BMJ Open.
According to the investigators, there are currently no known treatment strategies for IIH that offer long-term benefit. Considering that this condition is often associated with obesity, weight loss may be a crucial approach. Many patients who do lose enough weight to experience a benefit often have difficulty sustaining weight loss, which subsequently leads to the recurrence of symptoms.
The randomized, multicenter, open-label clinical trial is currently underway to determine the effects of bariatric treatment in IIH participants with a body mass index >35 kg/m2 (n=64). Investigators plan to randomly assign subjects 1:1 to either bariatric surgery or dietary intervention during a 5-year period.
To determine the effects of these 2 strategies, researchers will assess ICP symptoms at 1 year, 2 years, and again at 5 years. Secondary outcomes include symptoms of IIH, papilledema, headache, cost-effectiveness of treatment, visual function, and quality of life.
A proposed limitation associated with this trial is its small sample size, which may not provide sufficient evidence to inform clinical decision making. Additionally, the lack of other similar trials in the available literature reduces the ability to verify results ultimately obtained in the IIH:WT.
Despite the trial’s proposed weaknesses, the investigators believe the findings generated from the IIH:WT may spur “changes in clinical practice and [have an] impact on IIH treatment guidance.”
Ottridge R, Mollan SP, Botfield H, et al. Randomised controlled trial of bariatric surgery versus a community weight loss programme for the sustained treatment of idiopathic intracranial hypertension: the Idiopathic Intracranial Hypertension Weight Trial (IIH:WT) protocol. BMJ Open. 2017;7:e017426.