Effectiveness of Bariatric Surgery vs Community Weight Management Intervention for the Treatment of Idiopathic Intracranial Hypertension: A Randomized Clinical Trial.
Effectiveness of Bariatric Surgery vs Community Weight Management Intervention for the Treatment of Idiopathic Intracranial Hypertension: A Randomized Clinical Trial.
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DOI：
10.1001/jamaneurol.2021.0659
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发表时间：
2021-06-01
期刊：
影响因子：
29
通讯作者：
Sinclair AJ
中科院分区：
文献类型：
--
作者：
Mollan SP;Mitchell JL;Ottridge RS;Aguiar M;Yiangou A;Alimajstorovic Z;Cartwright DM;Grech O;Lavery GG;Westgate CSJ;Vijay V;Scotton W;Wakerley BR;Matthews TD;Ansons A;Hickman SJ;Benzimra J;Rick C;Singhal R;Tahrani AA;Brock K;Frew E;Sinclair AJ
在维持特发性颅内高压患者达到持续缓解所必需的体重减轻方面，减肥手术是否上级社区体重管理干预？在这项随机临床试验中，66名患有特发性颅内高压且体重指数为35或更高的女性，减肥手术在降低颅内压方面上级社区体重管理干预，2年后持续改善。该研究的结果表明，在患有特发性颅内高压和体重指数为35或更高的女性中，减肥手术是降低颅内压和持续缓解疾病的有效治疗方法。特发性颅内高压（IIH）会导致头痛、视力下降和生活质量下降。IIH患者的持续体重减轻对于改善疾病和预防复发是必要的。比较减肥手术与社区体重管理（CWM）干预治疗活动性IIH患者的有效性。这项为期5年的随机临床试验（特发性颅内高血压体重试验）招募了2014年3月1日至2017年5月25日期间在英国5家国民健康服务医院的活动性IIH和体重指数（以千克为单位的体重除以以米为单位的身高）为35或更高的女性。在74名接受资格评估的女性中，6名不符合研究标准，2名拒绝参与; 66名女性被随机分组。分析了2018年11月1日至2020年5月14日的数据。减肥手术（n = 33）或CWM干预（Weight Watchers）（n = 33）。主要结局是12个月时通过腰椎穿刺开口压测量的颅内压变化，如意向治疗分析中所评估的。次要结局包括24个月时的腰椎穿刺开口压以及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项简表健康调查测量）。由于显示了组间连续结局的差异，因此零效应为0。在66名女性受试者（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%）被纳入主要结局分析。在12个月时，减肥手术组的颅内压显著降低（校正的平均值[SE]差异，-6.0 [1.8] cm脑脊液[CSF]; 95% CI，-9.5至-2.4 cm CSF; P = .001）和24个月时（校正的平均值[SE]差异，−8.2 [2.0] cm CSF; 95% CI，−12.2至−4.2 cm CSF; P < .001）与CWM组相比。在符合方案分析中，在12个月时，减肥手术组的颅内压显著降低（校正的平均值[SE]差异，-7.2 [1.8] cm CSF; 95% CI，-10.6至-3.7 cm CSF; P < .001）和24个月时（校正后的平均值[SE]差异，-8.7 [2.0] cm CSF; 95% CI，-12.7至-4.8 cm CSF; P < .001）。减肥手术组在12个月（校正后平均值[SE]差异，−21.4 [5.4] kg; 95%CI，−32.1至−10.7 kg; P < .001）和24个月（校正后平均值[SE]差异，−26.6 [5.6] kg; 95%CI，−37.5至−15.7 kg; P < .001）时体重显著较低。12个月时生活质量显著改善（校正平均值[SE]差异，7.3 [3.6]; 95% CI，0.2-14.4; P = 0.04）和24个月（校正均值[SE]差异，10.4 [3.8]; 95% CI，3.0-17.9;在这项随机临床试验中，减肥手术在降低颅内压方面优于CWM干预上级。在2年的过程中持续改善显示了这种干预对持续疾病缓解的影响。ClinicalTrials.gov 标识符：NCT 02124486这项随机临床试验比较了减肥手术与社区体重管理干预治疗特发性颅内高压患者的疗效。
Is bariatric surgery superior to a community weight management intervention in sustaining the weight loss necessary to achieve sustained remission among patients with idiopathic intracranial hypertension? In this randomized clinical trial of 66 women with idiopathic intracranial hypertension and a body mass index of 35 or higher, bariatric surgery was superior to a community weight management intervention in decreasing intracranial pressure, with continued improvement at 2 years. The study’s findings indicate that, among women with idiopathic intracranial hypertension and a body mass index of 35 or higher, bariatric surgery is an effective treatment to reduce intracranial pressure and for sustained disease remission. 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. 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 This randomized clinical trial examines the efficacy of bariatric surgery compared with a community weight management intervention for the treatment of patients with idiopathic intracranial hypertension.
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影响因子：
2.9
作者：
Mollan, Susan;Hemmings, Krystal;Sinclair, Alexandra J.
通讯作者：
Sinclair, Alexandra J.
影响因子：
9.9
作者：
Ko, M. W.;Chang, S. C.;Liu, G. T.
通讯作者：
Liu, G. T.
影响因子：
7.2
作者：
Ware, JE;Gandek, B
通讯作者：
Gandek, B
影响因子：
9.9
作者：
Friedman, Deborah I;Liu, Grant T;Digre, Kathleen B
通讯作者：
Digre, Kathleen B
DOI：
10.1111/obr.12647
发表时间：
2018-04
期刊：
Obesity reviews : an official journal of the International Association for the Study of Obesity
影响因子：
--
作者：
Chang SH;Freeman NLB;Lee JA;Stoll CRT;Calhoun AJ;Eagon JC;Colditz GA
通讯作者：
Colditz GA