From the Birmingham Neuro-Ophthalmology (S.P.M.), University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital; Metabolic Neurology (J.L.M., A.Y., Z.A., K.A.M., A.J.S.), Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham; Department of Neurology (J.L.M., A.Y., A.J.S.), University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital; Centre for Endocrinology (J.L.M., A.Y., A.A.T., A.J.S.), Diabetes and Metabolism, Birmingham Health Partners; Birmingham Clinical Trials Unit (R.S.O.); Institute of Metabolism and Systems Research (Z.A., D.M.C., A.A.T., A.J.S.), College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom; Department of Neurology (S.J.H.), Royal Hallamshire Hospital, Sheffield, United Kingdom; Upper GI Unit and Minimally Invasive Unit (R.S.), Birmingham Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham; Institute of Cancer and Genomic Sciences (R.S.), University of Birmingham; Department of Endocrinology (A.A.T.), University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital; Health Economics Unit (E.F.), Institute of Applied Health Research, University of Birmingham; and Cancer Research UK Clinical Trials Unit (K.B.), University of Birmingham, Birmingham, United Kingdom.
Neurology. 2022 Sep 13;99(11):e1090-e1099. doi: 10.1212/WNL.0000000000200839. Epub 2022 Jul 5.
The idiopathic intracranial hypertension randomized controlled weight trial (IIH:WT) established that weight loss through bariatric surgery significantly reduced intracranial pressure when compared with a community weight management intervention. This substudy aimed to evaluate the amount of weight loss required to reduce intracranial pressure and to explore the effect of different bariatric surgical approaches.
IIH:WT was a multicenter randomized controlled trial. Adult women with active idiopathic intracranial hypertension and a body mass index ≥35 kg/m were randomized to bariatric surgery or a community weight management intervention (1:1). This per-protocol analysis evaluated the relationship between intracranial pressure, weight loss, and the weight loss methods. A linear hierarchical regression model was used to fit the trial outcomes, adjusted for time, treatment arm, and weight.
Sixty-six women were included, of whom 23 had received bariatric surgery by 12 months; the mean age was 31 (SD 8.7) years in the bariatric surgery group and 33.2 (SD 7.4) years in the dietary group. Baseline weight and intracranial pressure were similar in both groups with a mean weight of 119.5 (SD 24.1) and 117.9 (SD 19.5) kg and mean lumbar puncture opening pressure of 34.4 (SD 6.3) and 34.9 (SD 5.3) cmCSF in the bariatric surgery and dietary groups, respectively. Weight loss was significantly associated with reduction in intracranial pressure (R = 0.4734, ≤ 0.0001). Twenty-four percentage of weight loss (weight loss of 13.3 kg [SD 1.76]) was associated with disease remission (intracranial pressure [ICP] ≤ 25 cmCSF). Roux-en-Y gastric bypass achieved greater, more rapid, and sustained ICP reduction compared with other methods.
The greater the weight loss, the greater the reduction in ICP was documented. Twenty four percentage of weight loss was associated with disease remission. Such magnitude of weight loss was unlikely to be achieved without bariatric surgery, and hence, consideration of referral to a bariatric surgery program early for those with active idiopathic intracranial hypertension may be appropriate.
ClinicalTrials.gov Identifier: NCT02124486; ISRCTN registry number ISRCTN40152829; doi.org/10.1186/ISRCTN40152829.
This study provides Class II evidence that weight loss after bariatric surgery results in reduction in intracranial pressure in adult women with idiopathic intracranial hypertension. This study is Class II because of the use of a per-protocol analysis.
特发性颅内高压随机对照减重试验(IIH:WT)表明,与社区减重管理干预相比,减重手术显著降低颅内压。本亚研究旨在评估降低颅内压所需的减重幅度,并探讨不同减重手术方法的效果。
IIH:WT 是一项多中心随机对照试验。纳入患有活动期特发性颅内高压且体重指数≥35kg/m²的成年女性,按 1:1 随机分为减重手术组或社区减重管理干预组。本方案分析评估了颅内压、体重减轻与减重方法之间的关系。采用线性分层回归模型拟合试验结果,调整时间、治疗臂和体重。
共纳入 66 名女性,其中 23 名在 12 个月时接受了减重手术;减重手术组的平均年龄为 31(8.7)岁,饮食组为 33.2(7.4)岁。两组基线体重和颅内压相似,分别为 119.5(24.1)kg 和 117.9(19.5)kg,以及 34.4(6.3)cmCSF 和 34.9(5.3)cmCSF。减重手术组与饮食组的颅内压分别为 34.4(6.3)cmCSF 和 34.9(5.3)cmCSF。体重减轻与颅内压降低显著相关(R=0.4734,P≤0.0001)。体重减轻 24%(减重 13.3kg[1.76])与疾病缓解(颅内压[ICP]≤25cmCSF)相关。与其他方法相比,Roux-en-Y 胃旁路手术实现了更大、更快速和更持续的 ICP 降低。
记录到体重减轻幅度越大,颅内压降低幅度越大。体重减轻 24%与疾病缓解相关。没有减重手术,不太可能实现如此大幅度的体重减轻,因此,对于患有特发性颅内高压的患者,早期考虑转介至减重手术项目可能是合适的。
ClinicalTrials.gov 标识符:NCT02124486;ISRCTN 注册号 ISRCTN40152829;doi.org/10.1186/ISRCTN40152829。
本研究提供了 II 级证据,表明减重手术后的体重减轻可导致成年女性特发性颅内高压患者颅内压降低。本研究为 II 级,因为采用了方案分析。