Skip to main content
Erschienen in: Journal of Neurology 5/2011

01.05.2011 | Original Communication

A randomised controlled trial of treatment for idiopathic intracranial hypertension

verfasst von: Alexandra K. Ball, Andrew Howman, Keith Wheatley, Michael A. Burdon, Timothy Matthews, Andrew S. Jacks, Mark Lawden, Arul Sivaguru, Alexandra Furmston, Steven Howell, Basil Sharrack, M. Brendan Davies, Alexandra J. Sinclair, Carl E. Clarke

Erschienen in: Journal of Neurology | Ausgabe 5/2011

Einloggen, um Zugang zu erhalten

Abstract

The cause of idiopathic intracranial hypertension (IIH) remains unknown, and no consensus exists on how patients should be monitored and treated. Acetazolamide is a common treatment but has never been examined in a randomised controlled trial. The objectives of this pilot trial are to prospectively evaluate the use of acetazolamide, to explore various outcome measures and to inform the design of a definitive trial in IIH. Fifty patients were recruited from six centres over 23 months and randomised to receive acetazolamide (n = 25) or no acetazolamide (n = 25). Symptoms, body weight, visual function and health-related quality-of-life measures were recorded over a 12-month period. Recruited patients had typical features of mild IIH and most showed improvement, with 44% judged to have IIH in remission at the end of the trial. Difficulties with recruitment were highlighted as well as poor compliance with acetazolamide therapy (12 patients). A composite measure of IIH status was tested, and the strongest concordance with final disease status was seen with perimetry (Somers’ D = 0.66) and optic disc appearance (D = 0.59). Based on the study data, a sample size of 320 would be required to demonstrate a 20% treatment effect in a substantive trial. Clinical trials in IIH require pragmatic design to involve sufficiently large numbers of patients. Future studies should incorporate weighted composite scores to reflect the relative importance of common outcome measures in IIH.
Literatur
1.
Zurück zum Zitat Friedman DI, Jacobson DM (2002) Diagnostic criteria for idiopathic intracranial hypertension. Neurology 59:1492–1495PubMed Friedman DI, Jacobson DM (2002) Diagnostic criteria for idiopathic intracranial hypertension. Neurology 59:1492–1495PubMed
2.
Zurück zum Zitat Durcan F, Corbett J, Wall M (1988) The incidence of pseudotumor cerebri: population studies in Iowa and Louisiana. Arch Neurol 45:875–877PubMed Durcan F, Corbett J, Wall M (1988) The incidence of pseudotumor cerebri: population studies in Iowa and Louisiana. Arch Neurol 45:875–877PubMed
3.
Zurück zum Zitat Wall M, George D (1991) Idiopathic intracranial hypertension. A prospective study of 50 patients. Brain 114:155–180PubMedCrossRef Wall M, George D (1991) Idiopathic intracranial hypertension. A prospective study of 50 patients. Brain 114:155–180PubMedCrossRef
4.
Zurück zum Zitat Corbett J, Savino P, Thompson H et al (1982) Visual loss in pseudotumor cerebri. Arch Neurol 39:461–474PubMed Corbett J, Savino P, Thompson H et al (1982) Visual loss in pseudotumor cerebri. Arch Neurol 39:461–474PubMed
5.
Zurück zum Zitat Lueck C, McIlwaine G (2005) Interventions for idiopathic intracranial hypertension. Cochrane Database Syst Rev 20(3): CD003434 Lueck C, McIlwaine G (2005) Interventions for idiopathic intracranial hypertension. Cochrane Database Syst Rev 20(3): CD003434
6.
Zurück zum Zitat Rowe F, Sarkies N (1998) Assessment of visual function in idiopathic intracranial hypertension: a prospective study. Eye 12:111–118PubMed Rowe F, Sarkies N (1998) Assessment of visual function in idiopathic intracranial hypertension: a prospective study. Eye 12:111–118PubMed
7.
Zurück zum Zitat Radhakrishnan K, Thacker AK, Bohlaga NH, Maloo JC, Gerryo SE (1993) Epidemiology of idiopathic intracranial hypertension: a prospective and case-control study. J Neurol Sci 116:18–28PubMedCrossRef Radhakrishnan K, Thacker AK, Bohlaga NH, Maloo JC, Gerryo SE (1993) Epidemiology of idiopathic intracranial hypertension: a prospective and case-control study. J Neurol Sci 116:18–28PubMedCrossRef
8.
Zurück zum Zitat Newborg B (1974) Pseudotumor cerebri treated by rice reduction diet. Arch Intern Med 133:802–807PubMedCrossRef Newborg B (1974) Pseudotumor cerebri treated by rice reduction diet. Arch Intern Med 133:802–807PubMedCrossRef
9.
Zurück zum Zitat Johnson LN, Krohel GB, Madsen RW, March GA Jr (1998) The role of weight loss and acetazolamide in the treatment of idiopathic intracranial hypertension (pseudotumor cerebri). Ophthalmology 105:2313–2317PubMedCrossRef Johnson LN, Krohel GB, Madsen RW, March GA Jr (1998) The role of weight loss and acetazolamide in the treatment of idiopathic intracranial hypertension (pseudotumor cerebri). Ophthalmology 105:2313–2317PubMedCrossRef
10.
Zurück zum Zitat Amaral J, Tsiaris W, Morgan T, Thompson W (1987) Reversal of benign intracranial hypertension by surgically induced weight loss. Arch Surg 122:946–949PubMed Amaral J, Tsiaris W, Morgan T, Thompson W (1987) Reversal of benign intracranial hypertension by surgically induced weight loss. Arch Surg 122:946–949PubMed
11.
Zurück zum Zitat Rubin RC, Henderson ES, Ommaya AK, Walker MD, Rall DP (1966) The production of cerebrospinal fluid in man and its modification by acetazolamide. J Neurosurg 25:430–436PubMedCrossRef Rubin RC, Henderson ES, Ommaya AK, Walker MD, Rall DP (1966) The production of cerebrospinal fluid in man and its modification by acetazolamide. J Neurosurg 25:430–436PubMedCrossRef
12.
Zurück zum Zitat Celebisoy N, Gokcay F, Sirin H, Akyurekli O (2007) Treatment of idiopathic intracranial hypertension: topiramate vs acetazolamide, an open-label study. Acta Neurol Scand 116:322–327PubMedCrossRef Celebisoy N, Gokcay F, Sirin H, Akyurekli O (2007) Treatment of idiopathic intracranial hypertension: topiramate vs acetazolamide, an open-label study. Acta Neurol Scand 116:322–327PubMedCrossRef
13.
14.
Zurück zum Zitat Clarke CE (2004) A cure for Parkinson’s disease: can neuroprotection be proven with current trial designs? Mov Disord 19:491–498PubMedCrossRef Clarke CE (2004) A cure for Parkinson’s disease: can neuroprotection be proven with current trial designs? Mov Disord 19:491–498PubMedCrossRef
15.
Zurück zum Zitat Bruce BB, Kedar S, Van Stavern GP et al (2009) Idiopathic intracranial hypertension in men. Neurology 72:304–309PubMedCrossRef Bruce BB, Kedar S, Van Stavern GP et al (2009) Idiopathic intracranial hypertension in men. Neurology 72:304–309PubMedCrossRef
16.
Zurück zum Zitat Craig JJ, Mulholland DA, Gibson JM (2001) Idiopathic intracranial hypertension; incidence, presenting features and outcome in Northern Ireland (1991–1995). Ulster Med J 70:31–35PubMed Craig JJ, Mulholland DA, Gibson JM (2001) Idiopathic intracranial hypertension; incidence, presenting features and outcome in Northern Ireland (1991–1995). Ulster Med J 70:31–35PubMed
17.
Zurück zum Zitat Sugerman HJ, Felton WL, Salvant JB Jr et al (1999) Gastric surgery for pseudotumor cerebri associated with severe obesity. Ann Surg 229:634–642PubMedCrossRef Sugerman HJ, Felton WL, Salvant JB Jr et al (1999) Gastric surgery for pseudotumor cerebri associated with severe obesity. Ann Surg 229:634–642PubMedCrossRef
18.
Zurück zum Zitat Sinclair AJ, Burdon MA, Nightingale PG et al (2010) Low energy diet and intracranial pressure in women with idiopathic intracranial hypertension: prospective cohort study. BMJ 340:c2701CrossRef Sinclair AJ, Burdon MA, Nightingale PG et al (2010) Low energy diet and intracranial pressure in women with idiopathic intracranial hypertension: prospective cohort study. BMJ 340:c2701CrossRef
19.
Zurück zum Zitat Kleinschmidt JJ, Digre KB, Hanover R (2000) Idiopathic intracranial hypertension: relationship to depression, anxiety and quality of life. Neurology 54:319–324PubMed Kleinschmidt JJ, Digre KB, Hanover R (2000) Idiopathic intracranial hypertension: relationship to depression, anxiety and quality of life. Neurology 54:319–324PubMed
20.
Zurück zum Zitat Daniels AB, Liu GT, Volpe NJ et al (2007) Profiles of obesity, weight gain and quality of life in idiopathic intracranial hypertension (pseudotumor cerebri). Am J Opthalmol 143:635–641CrossRef Daniels AB, Liu GT, Volpe NJ et al (2007) Profiles of obesity, weight gain and quality of life in idiopathic intracranial hypertension (pseudotumor cerebri). Am J Opthalmol 143:635–641CrossRef
21.
Zurück zum Zitat Orcutt JC, Page NG, Sanders MD (1984) Factors affecting visual loss in benign intracranial hypertension. Ophthalmology 91:1303–1312PubMed Orcutt JC, Page NG, Sanders MD (1984) Factors affecting visual loss in benign intracranial hypertension. Ophthalmology 91:1303–1312PubMed
Metadaten
Titel
A randomised controlled trial of treatment for idiopathic intracranial hypertension
verfasst von
Alexandra K. Ball
Andrew Howman
Keith Wheatley
Michael A. Burdon
Timothy Matthews
Andrew S. Jacks
Mark Lawden
Arul Sivaguru
Alexandra Furmston
Steven Howell
Basil Sharrack
M. Brendan Davies
Alexandra J. Sinclair
Carl E. Clarke
Publikationsdatum
01.05.2011
Verlag
Springer-Verlag
Erschienen in
Journal of Neurology / Ausgabe 5/2011
Print ISSN: 0340-5354
Elektronische ISSN: 1432-1459
DOI
https://doi.org/10.1007/s00415-010-5861-4

Weitere Artikel der Ausgabe 5/2011

Journal of Neurology 5/2011 Zur Ausgabe

Leitlinien kompakt für die Neurologie

Mit medbee Pocketcards sicher entscheiden.

Seit 2022 gehört die medbee GmbH zum Springer Medizin Verlag

Update Neurologie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.