Ménière's Disease Treatment: a Patient-Centered Systematic Review
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Review Audiology Neurotology Audiol Neurotol 2015;20:153–165 Published online: March 31, 2015 DOI: 10.1159/000375393 Ménière’s Disease Treatment: A Patient-Centered Systematic Review a c b Mariateresa Tassinari Daniele Mandrioli Nadia Gaggioli a, d Paolo Roberti di Sarsina a b Charity Association for Person-Centered Medicine-Moral Entity, Bologna , and Charity Association Ménière’s c Disease Patients Together (AMMI), Bologna , Cesare Maltoni Cancer Research Center, Ramazzini Institute, d Bentivoglio , Bologna , and Observatory and Methods for Health, Department of Sociology and Social Research, University of Milano-Bicocca, Milan , Italy Key Words Introduction Ménière’s disease · Idiopathic endolymphatic hydrops · Person-centred healthcare and medicine paradigm Ménière’s disease (idiopathic endolymphatic hydrops) is a disorder of the inner ear that can affect hearing and balance to a varying degree. It is characterized by episodes Abstract of vertigo, low-pitched tinnitus, and hearing loss. The Ménière’s disease is a disorder of the inner ear affecting hear- hearing loss is fluctuating rather than permanent, mean- ing and balance to a varying degree. It is characterized by ing that it comes and goes, alternating between ears for episodes of vertigo, low-pitched tinnitus, and hearing loss. some time, and then it becomes permanent with no re- There is currently no gold standard treatment for Ménière’s turn to normal function. The disease is named after the disease. We conducted a systematic search of the Cochrane French physician Prosper Ménière [Baloh, 2001] who in Database, as a high-quality source of evidence-based thera- two articles published in 1861 [Menière, 1861; Ménière, pies, for reviews on the efficacy of etiological therapy or on 1861] first reported that vertigo was caused by inner ear Ménière’s disease or its symptoms. Following recent positive disorders. Although celebrated public characters from experiences reported by other research teams, we decided the past probably suffered from this disease, most notably to involve a patients’ representative in the assessment and Charles Darwin [Hayman, 2009], Vincent Van Gogh analysis of the evidence retrieved in the literature in order to [Arenberg et al., 1990], and Marilyn Monroe [Stephens achieve a more patient-centered evaluation of the therapies. and Mudry, 2012], this syndrome had attracted little at- Evidence confirms that an effective treatment of Ménière’s tention. There have been never-ending controversies on disease is still missing, but recent discoveries on the micro- the etiopathology of the disease and there is still a lack of vascular etiology of Ménière’s disease may be assimilated by effective therapeutic approaches after more than 150 new evidence-based therapeutic approaches. years since the discovery of the syndrome: according to © 2015 S. Karger AG, Basel the NHS ‘there is no single treatment for Ménière’s dis- ease, mainly because the exact cause is still unknown’ (http://www.nhs.uk/Conditions/Menieres-disease/ © 2015 S. Karger AG, Basel Paolo Roberti di Sarsina, MD 1420–3030/15/0203–0153$39.50/0 Charity for Person Centred Medicine-Moral Entity Registered Office: Via San Vitale 40/3a E-Mail [email protected] IT–40125 Bologna (Italy) www.karger.com/aud E-Mail medicinacentratasullapersona @ medicinacentratasullapersona.org Downloaded by: Karolinska Institutet, University Library 130.237.122.245 - 3/31/2015 9:27:08 AM Pages/Treatment.aspx). The typical clinical triad of symp- and Djalilian, 2002; Rauch et al., 1995; Tomiyama, 2003] toms (recurrent vertigo, fluctuating sensorineural hear- and iatrogenic factors [Katahira et al., 2013; Pirodda et al., ing loss, and tinnitus) is often pathognomonic, and diag- 2011; Takumida et al., 2008], and even psychological fac- nosis is based on criteria established in 1995 by the tors [Eagger et al., 1992]. None of these candidates seems American Academy of Otolaryngology – Head and Neck to be necessary and sufficient to cause the disease. Fre- Foundation [Katsarkas, 1996]. Symptoms that may be quently, Ménière’s disease is associated with other degen- unilateral or bilateral [Clemmens and Ruckenstein, 2012] erative diseases such as multiple sclerosis [Bovo et al., are caused by endolymphatic hydrops of the inner ear, 2010; Spencer et al., 2002], Alzheimer’s disease, autoim- while 75% of the patients with unilateral symptoms still mune thyroiditis [Fattori et al., 2008], hyperinsulinemia present with bilateral endolymphatic hydrops [Pyykko et [D’Avila and Lavinsky, 2005; Kirtane et al., 1984], mi- al., 2013]. A glycerol dehydration test and electroco- graine [Ibekwe et al., 2008], and Cogan syndrome [Gasp- chleography are the main diagnostic tests in current prac- arovic et al., 2011; Haynes et al., 1980]. tice, while vestibular evoked myogenic potentials may be Different therapies were proposed, some of them ef- used for disease staging. Imaging techniques are not spe- fective in certain patients or for certain symptoms, but cific enough to make alone the diagnosis of Ménière’s dis- the results are generally highly heterogeneous in the ease, although they may be necessary to exclude other pa- treated population. Because of these heterogeneous re- thologies. Recently developed 3D MRI protocols can de- sponses, it is extremely complicated for the Ménière’s lineate the perilymphatic/endolymphatic spaces of the disease patient and for the physician to integrate and inner ear and aid diagnosis [Vassiliou et al., 2011]. The reach optimal care and treatment. Moreover, treatment reported prevalence rates for Ménière’s syndrome range should be tailored specifically and dynamically on the from 3.5 per 100,000 to 513 per 100,000. A recent study different symptoms and needs which the patients expe- using health claims, including data from more than 60 rience chronically (for example, tinnitus) or irregularly million individuals in the US, found a prevalence of 190 (for example, ‘drop attacks’, also known as otolithic cri- per 100,000 with a female:male ratio of 1.89: 1 [Alexander sis of Tumarkin). In this review, we summarize the and Harris, 2010]. The prevalence of Ménière’s disease in state-of-the-art of the etiologic treatments for Ménière’s Northern European countries seems markedly high: ap- disease and symptomatic treatments of vertigo and tin- proximately 430 cases per million are reported in Finland nitus according to the most recent evidence-based eval- [Kotimaki et al., 1999] and 460 cases per million in Sweden uations through systematic reviews by the Cochrane [Stahle et al., 1978]. The prevalence of Ménière’s syn- Group. We decided to include only Cochrane System- drome increases with increasing age. In Italy, an inci- atic Reviews because of their high methodological qual- dence of 8.2 per million per year was estimated, but this ity [Jorgensen et al., 2006] and common and transpar- is probably an underestimation [Celestino and Ralli, ent criteria [Higgins and Green, 2011], although the un- 1991]. Therefore, Ménière’s disease should be considered derreporting of adverse events in the studies included in as a ‘rare disease’ according to both the EU (http://ec.eu- these reviews remains a major limiting factor when it ropa.eu/health/ph_information/documents/ comes to translating the findings of these reviews to pa- ev20040705_rd05_en.pdf) and the US (http://www.gpo. tient-centered decision making (this is a common prob- gov/fdsys/pkg/PLAW-107publ280/html/PLAW- lem for all systematic reviews of interventions, not only 107publ280.htm) definitions, which report incidences for Cochrane Reviews) [Zorzela et al., 2014]. New ther- lower than 1 per 2,000 or less than 200,000 cases, respec- apeutic options, recent etiological research findings, tively. The pathophysiology of the disease was, and still is, and possible methodological improvements to over- a matter of debate [Pfaltz, 1986], and many causal factors come the current limits in the assessment and integra- for Ménière’s disease have been investigated: genetic fac- tion of the evidence on Ménière’s disease or syndrome tors [Fung et al., 2002; Semaan and Megerian, 2010] and will be addressed in our discussion. In light of the posi- hereditary factors [Hietikko et al., 2013], vascular [Ya- tive effects recently reported by other authors [Gartlehner magata et al., 1964] and environmental factors [Calabrese and Flamm, 2013] of engaging consumer and patient et al., 2010; Colletti et al., 2011; Hess et al., 1991; Roland representatives in systematic reviews of the literature et al., 2000; Vassiliou et al., 2011; Wienke and Janke, and patient-centered evaluations, we asked N.G., presi- 2007], infections [DiBerardino et al., 2007; Miller et al., dent of the Italian Ménière Disease Patients Association 2010], immunologic [Bovo et al., 2010; Derebery and Ber- (AMMI) [Gaggioli, 2013], to actively participate in all liner, 2010; Krzeska-Malinowska et al., 2002; Paparella the stages of the review process. 154 Audiol Neurotol 2015;20:153–165 Tassinari/Mandrioli/Gaggioli/ DOI: 10.1159/000375393 Roberti di Sarsina Downloaded by: Karolinska Institutet, University Library 130.237.122.245 - 3/31/2015 9:27:08 AM Methods tahistine, and endolymphatic sac surgery [Burgess and Kundu, 2006; James and Burton, 2001; Pullens et al., We searched the Cochrane Database of Systematic Reviews in 2013]. Three of these reviews included only randomized the Cochrane Library for any reviews with ‘Ménière’ or ‘idiopath- ic endolymphatic hydrops’ and with ‘tinnitus’ or ‘vertigo’ in the controlled