Birmingham Neuro-Ophthalmology, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Birmingham, United Kingdom.
Department of Metabolic Neurology, Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom.
JAMA Neurol. 2021 Jun 1;78(6):678-686. doi: 10.1001/jamaneurol.2021.0659.
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.
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.
Bariatric surgery (n = 33) or CWM intervention (Weight Watchers) (n = 33).
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.
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.
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.
ClinicalTrials.gov Identifier: NCT02124486.
重要性：特发性颅内高压（IIH）可引起头痛、视力丧失和生活质量下降。IIH 患者需要持续减肥，以改变疾病并预防复发。
目的：比较减重手术与社区体重管理（CWM）干预对活跃 IIH 患者的治疗效果。
设计、地点和参与者：这是一项为期 5 年的随机临床试验（特发性颅内高压体重试验），在英国的 5 家国民保健服务医院招募了 74 名患有活跃 IIH 且体重指数（BMI，体重以千克为单位除以身高以米为单位的平方）为 35 或更高的女性，这些患者于 2014 年 3 月 1 日至 2017 年 5 月 25 日之间进行评估。其中 6 名女性不符合研究标准，2 名女性拒绝参加，66 名女性被随机分组。数据于 2018 年 11 月 1 日至 2020 年 5 月 14 日进行分析。
干预措施：减重手术（n=33）或 CWM 干预（Weight Watchers）（n=33）。
主要结果和测量：主要结局是通过腰椎穿刺开放压在 12 个月时测量的颅内压变化，这是一项意向治疗分析。次要结局包括在 24 个月时的腰椎穿刺开放压以及在 12 个月和 24 个月时的视力、对比敏感度、视野平均偏差和生活质量（通过 36 项简短健康调查进行衡量）。由于呈现了组间连续结果的差异，因此零效应为 0。
结果：66 名女性参与者（平均[SD]年龄，32.0[7.8]岁）中，64 名（97.0%）在 12 个月时仍留在临床试验中，54 名女性（81.8%）纳入主要结局分析。在 12 个月和 24 个月时，减重手术组的颅内压明显低于 CWM 组（调整后的平均[SE]差异，-6.0[1.8]cm 脑脊液[CSF]；95%CI，-9.5 至-2.4 cm CSF；P=0.001）。在符合方案分析中，在 12 个月时（调整后的平均[SE]差异，-7.2[1.8]cm CSF；95%CI，-10.6 至-3.7 cm CSF；P<0.001）和 24 个月时（调整后的平均[SE]差异，-8.7[2.0]cm CSF；95%CI，-12.7 至-4.8 cm CSF；P<0.001），减重手术组的颅内压也明显更低。在 12 个月时（调整后的平均[SE]差异，-21.4[5.4]kg；95%CI，-32.1 至-10.7 kg；P<0.001）和 24 个月时（调整后的平均[SE]差异，-26.6[5.6]kg；95%CI，-37.5 至-15.7 kg；P<0.001），减重手术组的体重明显更低。在 12 个月（调整后的平均[SE]差异，7.3[3.6]；95%CI，0.2-14.4；P=0.04）和 24 个月（调整后的平均[SE]差异，10.4[3.8]；95%CI，3.0-17.9；P=0.006）时，减重手术组的生活质量也明显改善。
结论和相关性：在这项随机临床试验中，减重手术在降低颅内压方面优于社区体重管理干预。2 年内持续改善表明，这种干预措施对持续缓解疾病有影响。
试验注册：ClinicalTrials.gov 标识符：NCT02124486。
