Effectiveness of Bariatric Surgery vs Community Weight Management Intervention for the Treatment of Idiopathic Intracranial Hypertension: A Randomized Clinical Trial
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 communi...
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| Veröffentlicht in: | Archives of neurology (Chicago) 2021-06, Vol.78 (6), p.678-686 |
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| creator | Mollan, Susan P Mitchell, James L Ottridge, Ryan S Aguiar, Magda Yiangou, Andreas Alimajstorovic, Zerin Cartwright, David M Grech, Olivia Lavery, Gareth G Westgate, Connar S. J Vijay, Vivek Scotton, William Wakerley, Ben R Matthews, Tim D Ansons, Alec Hickman, Simon J Benzimra, James Rick, Caroline Singhal, Rishi Tahrani, Abd A Brock, Kristian Frew, Emma Sinclair, Alexandra J |
| description | 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 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. INTERVENTIONS: Bariatric surgery (n = 33) or CWM intervention (Weight Watchers) (n = 33). MAIN OUTCOMES AND MEASURES: 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. RESULTS: 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 |
| doi_str_mv | 10.1001/jamaneurol.2021.0659 |
| format | Article |
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J ; Vijay, Vivek ; Scotton, William ; Wakerley, Ben R ; Matthews, Tim D ; Ansons, Alec ; Hickman, Simon J ; Benzimra, James ; Rick, Caroline ; Singhal, Rishi ; Tahrani, Abd A ; Brock, Kristian ; Frew, Emma ; Sinclair, Alexandra J</creator><creatorcontrib>Mollan, Susan P ; Mitchell, James L ; Ottridge, Ryan S ; Aguiar, Magda ; Yiangou, Andreas ; Alimajstorovic, Zerin ; Cartwright, David M ; Grech, Olivia ; Lavery, Gareth G ; Westgate, Connar S. J ; Vijay, Vivek ; Scotton, William ; Wakerley, Ben R ; Matthews, Tim D ; Ansons, Alec ; Hickman, Simon J ; Benzimra, James ; Rick, Caroline ; Singhal, Rishi ; Tahrani, Abd A ; Brock, Kristian ; Frew, Emma ; Sinclair, Alexandra J</creatorcontrib><description>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 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. INTERVENTIONS: Bariatric surgery (n = 33) or CWM intervention (Weight Watchers) (n = 33). MAIN OUTCOMES AND MEASURES: 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. RESULTS: 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. CONCLUSIONS AND RELEVANCE: 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02124486</description><identifier>ISSN: 2168-6149</identifier><identifier>EISSN: 2168-6157</identifier><identifier>DOI: 10.1001/jamaneurol.2021.0659</identifier><identifier>PMID: 33900360</identifier><language>eng</language><publisher>United States: American Medical Association</publisher><subject>Acuity ; Adult ; Bariatric Surgery - trends ; Body mass ; Body Mass Index ; Body size ; Body weight loss ; Cerebrospinal fluid ; Clinical trials ; Comments ; Female ; Gastrointestinal surgery ; Health services ; Humans ; Hypertension ; Intervention ; Intracranial pressure ; Intracranial Pressure - physiology ; Measuring instruments ; Online First ; Original Investigation ; Patients ; Pseudotumor Cerebri - diagnosis ; Pseudotumor Cerebri - epidemiology ; Pseudotumor Cerebri - therapy ; Quality of life ; Remission ; Remission (Medicine) ; Surgery ; Treatment Outcome ; Visual acuity ; Weight control ; Weight loss ; Weight Loss - physiology ; Weight Reduction Programs - trends ; Womens health ; Young Adult</subject><ispartof>Archives of neurology (Chicago), 2021-06, Vol.78 (6), p.678-686</ispartof><rights>Copyright American Medical Association Jun 2021</rights><rights>Copyright 2021 Mollan SP et al. .</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-a358t-63e898edfbeb0d4f7a1acd0fdad587fec62f3d6e46db50526030aba96028bbcb3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://jamanetwork.com/journals/jamaneurology/articlepdf/10.1001/jamaneurol.2021.0659$$EPDF$$P50$$Gama$$H</linktopdf><linktohtml>$$Uhttps://jamanetwork.com/journals/jamaneurology/fullarticle/10.1001/jamaneurol.2021.0659$$EHTML$$P50$$Gama$$H</linktohtml><link.rule.ids>64,230,314,777,781,882,3327,27905,27906,76238,76241</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33900360$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mollan, Susan P</creatorcontrib><creatorcontrib>Mitchell, James L</creatorcontrib><creatorcontrib>Ottridge, Ryan S</creatorcontrib><creatorcontrib>Aguiar, Magda</creatorcontrib><creatorcontrib>Yiangou, Andreas</creatorcontrib><creatorcontrib>Alimajstorovic, Zerin</creatorcontrib><creatorcontrib>Cartwright, David M</creatorcontrib><creatorcontrib>Grech, Olivia</creatorcontrib><creatorcontrib>Lavery, Gareth G</creatorcontrib><creatorcontrib>Westgate, Connar S. J</creatorcontrib><creatorcontrib>Vijay, Vivek</creatorcontrib><creatorcontrib>Scotton, William</creatorcontrib><creatorcontrib>Wakerley, Ben R</creatorcontrib><creatorcontrib>Matthews, Tim D</creatorcontrib><creatorcontrib>Ansons, Alec</creatorcontrib><creatorcontrib>Hickman, Simon J</creatorcontrib><creatorcontrib>Benzimra, James</creatorcontrib><creatorcontrib>Rick, Caroline</creatorcontrib><creatorcontrib>Singhal, Rishi</creatorcontrib><creatorcontrib>Tahrani, Abd A</creatorcontrib><creatorcontrib>Brock, Kristian</creatorcontrib><creatorcontrib>Frew, Emma</creatorcontrib><creatorcontrib>Sinclair, Alexandra J</creatorcontrib><title>Effectiveness of Bariatric Surgery vs Community Weight Management Intervention for the Treatment of Idiopathic Intracranial Hypertension: A Randomized Clinical Trial</title><title>Archives of neurology (Chicago)</title><addtitle>JAMA Neurol</addtitle><description>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 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. INTERVENTIONS: Bariatric surgery (n = 33) or CWM intervention (Weight Watchers) (n = 33). MAIN OUTCOMES AND MEASURES: 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. RESULTS: 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. CONCLUSIONS AND RELEVANCE: 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02124486</description><subject>Acuity</subject><subject>Adult</subject><subject>Bariatric Surgery - trends</subject><subject>Body mass</subject><subject>Body Mass Index</subject><subject>Body size</subject><subject>Body weight loss</subject><subject>Cerebrospinal fluid</subject><subject>Clinical trials</subject><subject>Comments</subject><subject>Female</subject><subject>Gastrointestinal surgery</subject><subject>Health services</subject><subject>Humans</subject><subject>Hypertension</subject><subject>Intervention</subject><subject>Intracranial pressure</subject><subject>Intracranial Pressure - physiology</subject><subject>Measuring instruments</subject><subject>Online First</subject><subject>Original Investigation</subject><subject>Patients</subject><subject>Pseudotumor Cerebri - diagnosis</subject><subject>Pseudotumor Cerebri - epidemiology</subject><subject>Pseudotumor Cerebri - therapy</subject><subject>Quality of life</subject><subject>Remission</subject><subject>Remission (Medicine)</subject><subject>Surgery</subject><subject>Treatment Outcome</subject><subject>Visual acuity</subject><subject>Weight control</subject><subject>Weight loss</subject><subject>Weight Loss - physiology</subject><subject>Weight Reduction Programs - trends</subject><subject>Womens health</subject><subject>Young Adult</subject><issn>2168-6149</issn><issn>2168-6157</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkt2O0zAQhSMEYlfLvgBCyBI33LRM4sRJuEBaqoWttAgJiri0JvG49Sqxi-1UKu_De-LSpfz4ZizNd45mNCfLnuUwzwHyV3c4oqXJu2FeQJHPQVTtg-y8yEUzE3lVPzz9y_YsuwzhDtJrAEpePs7OOG8BuIDz7Me11tRHsyNLITCn2Vv0BqM3Pfs8-TX5PdsFtnDjOFkT9-wrmfUmsg9ocU0j2ciWNpJP-micZdp5FjfEVp4w_mony6UybotxkzwT7LH3aA0O7Ga_JR_JhqR8za7YJ7TKjeY7KbYYjDV9YlZpmuFJ9kjjEOjyvl5kX95drxY3s9uP75eLq9sZ8qqJM8GpaRtSuqMOVKlrzLFXoBWqqqnTnqLQXAkqheoqqAoBHLDDVkDRdF3f8YvszdF3O3UjqZ4O0w5y682Ifi8dGvlvx5qNXLudbKCuoYRk8PLewLtvE4UoRxN6GoZ0LTcFWVR5UxeVEG1CX_yH3rnJ27Reosrkx9tSJKo8Ur13IXjSp2FykIcoyD9RkIcoyEMUkuz534ucRL8Pn4CnRyCpT92irhtRAf8JNzDAdQ</recordid><startdate>20210601</startdate><enddate>20210601</enddate><creator>Mollan, Susan P</creator><creator>Mitchell, James L</creator><creator>Ottridge, Ryan S</creator><creator>Aguiar, Magda</creator><creator>Yiangou, Andreas</creator><creator>Alimajstorovic, Zerin</creator><creator>Cartwright, David M</creator><creator>Grech, Olivia</creator><creator>Lavery, Gareth G</creator><creator>Westgate, Connar S. J</creator><creator>Vijay, Vivek</creator><creator>Scotton, William</creator><creator>Wakerley, Ben R</creator><creator>Matthews, Tim D</creator><creator>Ansons, Alec</creator><creator>Hickman, Simon J</creator><creator>Benzimra, James</creator><creator>Rick, Caroline</creator><creator>Singhal, Rishi</creator><creator>Tahrani, Abd A</creator><creator>Brock, Kristian</creator><creator>Frew, Emma</creator><creator>Sinclair, Alexandra J</creator><general>American Medical Association</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7TK</scope><scope>7U7</scope><scope>C1K</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20210601</creationdate><title>Effectiveness of Bariatric Surgery vs Community Weight Management Intervention for the Treatment of Idiopathic Intracranial Hypertension: A Randomized Clinical Trial</title><author>Mollan, Susan P ; Mitchell, James L ; Ottridge, Ryan S ; Aguiar, Magda ; Yiangou, Andreas ; Alimajstorovic, Zerin ; Cartwright, David M ; Grech, Olivia ; Lavery, Gareth G ; Westgate, Connar S. J ; Vijay, Vivek ; Scotton, William ; Wakerley, Ben R ; Matthews, Tim D ; Ansons, Alec ; Hickman, Simon J ; Benzimra, James ; Rick, Caroline ; Singhal, Rishi ; Tahrani, Abd A ; Brock, Kristian ; Frew, Emma ; Sinclair, Alexandra J</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a358t-63e898edfbeb0d4f7a1acd0fdad587fec62f3d6e46db50526030aba96028bbcb3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Acuity</topic><topic>Adult</topic><topic>Bariatric Surgery - trends</topic><topic>Body mass</topic><topic>Body Mass Index</topic><topic>Body size</topic><topic>Body weight loss</topic><topic>Cerebrospinal fluid</topic><topic>Clinical trials</topic><topic>Comments</topic><topic>Female</topic><topic>Gastrointestinal surgery</topic><topic>Health services</topic><topic>Humans</topic><topic>Hypertension</topic><topic>Intervention</topic><topic>Intracranial pressure</topic><topic>Intracranial Pressure - physiology</topic><topic>Measuring instruments</topic><topic>Online First</topic><topic>Original Investigation</topic><topic>Patients</topic><topic>Pseudotumor Cerebri - diagnosis</topic><topic>Pseudotumor Cerebri - epidemiology</topic><topic>Pseudotumor Cerebri - therapy</topic><topic>Quality of life</topic><topic>Remission</topic><topic>Remission (Medicine)</topic><topic>Surgery</topic><topic>Treatment Outcome</topic><topic>Visual acuity</topic><topic>Weight control</topic><topic>Weight loss</topic><topic>Weight Loss - physiology</topic><topic>Weight Reduction Programs - trends</topic><topic>Womens health</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mollan, Susan P</creatorcontrib><creatorcontrib>Mitchell, James L</creatorcontrib><creatorcontrib>Ottridge, Ryan S</creatorcontrib><creatorcontrib>Aguiar, Magda</creatorcontrib><creatorcontrib>Yiangou, Andreas</creatorcontrib><creatorcontrib>Alimajstorovic, Zerin</creatorcontrib><creatorcontrib>Cartwright, David M</creatorcontrib><creatorcontrib>Grech, Olivia</creatorcontrib><creatorcontrib>Lavery, Gareth G</creatorcontrib><creatorcontrib>Westgate, Connar S. J</creatorcontrib><creatorcontrib>Vijay, Vivek</creatorcontrib><creatorcontrib>Scotton, William</creatorcontrib><creatorcontrib>Wakerley, Ben R</creatorcontrib><creatorcontrib>Matthews, Tim D</creatorcontrib><creatorcontrib>Ansons, Alec</creatorcontrib><creatorcontrib>Hickman, Simon J</creatorcontrib><creatorcontrib>Benzimra, James</creatorcontrib><creatorcontrib>Rick, Caroline</creatorcontrib><creatorcontrib>Singhal, Rishi</creatorcontrib><creatorcontrib>Tahrani, Abd A</creatorcontrib><creatorcontrib>Brock, Kristian</creatorcontrib><creatorcontrib>Frew, Emma</creatorcontrib><creatorcontrib>Sinclair, Alexandra J</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Archives of neurology (Chicago)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mollan, Susan P</au><au>Mitchell, James L</au><au>Ottridge, Ryan S</au><au>Aguiar, Magda</au><au>Yiangou, Andreas</au><au>Alimajstorovic, Zerin</au><au>Cartwright, David M</au><au>Grech, Olivia</au><au>Lavery, Gareth G</au><au>Westgate, Connar S. J</au><au>Vijay, Vivek</au><au>Scotton, William</au><au>Wakerley, Ben R</au><au>Matthews, Tim D</au><au>Ansons, Alec</au><au>Hickman, Simon J</au><au>Benzimra, James</au><au>Rick, Caroline</au><au>Singhal, Rishi</au><au>Tahrani, Abd A</au><au>Brock, Kristian</au><au>Frew, Emma</au><au>Sinclair, Alexandra J</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effectiveness of Bariatric Surgery vs Community Weight Management Intervention for the Treatment of Idiopathic Intracranial Hypertension: A Randomized Clinical Trial</atitle><jtitle>Archives of neurology (Chicago)</jtitle><addtitle>JAMA Neurol</addtitle><date>2021-06-01</date><risdate>2021</risdate><volume>78</volume><issue>6</issue><spage>678</spage><epage>686</epage><pages>678-686</pages><issn>2168-6149</issn><eissn>2168-6157</eissn><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 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. INTERVENTIONS: Bariatric surgery (n = 33) or CWM intervention (Weight Watchers) (n = 33). MAIN OUTCOMES AND MEASURES: 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. RESULTS: 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. CONCLUSIONS AND RELEVANCE: 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02124486</abstract><cop>United States</cop><pub>American Medical Association</pub><pmid>33900360</pmid><doi>10.1001/jamaneurol.2021.0659</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 2168-6149 |
| ispartof | Archives of neurology (Chicago), 2021-06, Vol.78 (6), p.678-686 |
| issn | 2168-6149 2168-6157 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_8077040 |
| source | MEDLINE; American Medical Association Journals |
| subjects | Acuity Adult Bariatric Surgery - trends Body mass Body Mass Index Body size Body weight loss Cerebrospinal fluid Clinical trials Comments Female Gastrointestinal surgery Health services Humans Hypertension Intervention Intracranial pressure Intracranial Pressure - physiology Measuring instruments Online First Original Investigation Patients Pseudotumor Cerebri - diagnosis Pseudotumor Cerebri - epidemiology Pseudotumor Cerebri - therapy Quality of life Remission Remission (Medicine) Surgery Treatment Outcome Visual acuity Weight control Weight loss Weight Loss - physiology Weight Reduction Programs - trends Womens health Young Adult |
| title | Effectiveness of Bariatric Surgery vs Community Weight Management Intervention for the Treatment of Idiopathic Intracranial Hypertension: A Randomized Clinical Trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-18T11%3A46%3A49IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Effectiveness%20of%20Bariatric%20Surgery%20vs%20Community%20Weight%20Management%20Intervention%20for%20the%20Treatment%20of%20Idiopathic%20Intracranial%20Hypertension:%20A%20Randomized%20Clinical%20Trial&rft.jtitle=Archives%20of%20neurology%20(Chicago)&rft.au=Mollan,%20Susan%20P&rft.date=2021-06-01&rft.volume=78&rft.issue=6&rft.spage=678&rft.epage=686&rft.pages=678-686&rft.issn=2168-6149&rft.eissn=2168-6157&rft_id=info:doi/10.1001/jamaneurol.2021.0659&rft_dat=%3Cproquest_pubme%3E2540773946%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2540773946&rft_id=info:pmid/33900360&rft_ama_id=2778650&rfr_iscdi=true |