Intratympanic Steroid Therapy Educational Objectives Faculty

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					Volume 45, Issue 02                                                                                                       January 21, 2012

                                                          STEROID THERAPY
Intratympanic Steroid Therapy                                             tion and morphology; reduce hearing loss in meningitis (ac-
                                                                          cording to Cochrane analysis); prevent loss of spiral ganglion
David S. Haynes, MD, Clinical Associate Professor, Depart-                neurons; modulate sodium/potassium in endolymph; regulate
ment of Otolaryngology, Department of Hearing and Speech                  RNA transcriptional factors; ototoxicity (possibly outliers)
Sciences, Vanderbilt Bill Wilkerson Center for Otolaryngol-             Treatment with systemic steroids: Wilson et al (1980) — double-
ogy and Communication Sciences, Vanderbilt University                     blind, placebo-controlled trial showed benefit with steroids; will
Medical Center, Nashville, TN                                             not be repeated due to ethics of entering patients into placebo
                                                                          arm; several papers show no benefit of steroids for sudden SNHL;
Use of steroids: systemic therapy for sudden sensorineural hear-          Conlin and Parnes (2007) — meta-analysis of 2 randomized, pla-
  ing loss (SNHL); intratympanic therapy for SNHL and ver-                cebo-controlled trials examining benefits of steroids to treat sud-
  tigo; hearing preservation; surgery for cochlear implants               den SNHL; found no benefit
  (systemic and intratympanic); possibly for all otologic surgery       Intratympanic steroid therapy: same meaning — transtym-
Idiopathic sudden SNHL: definition by Wilson et al (1980) —                  panic therapy; middle ear perfusion; inner ear perfusion;
  decline in hearing over 3 days affecting 3 frequencies by                administration —intratympanic injection; MicroWick (off mar-
  30 dB with no identifiable etiology; disproportionate interest            ket); microcatheter; intraoperative irrigation; hydrogel; nanopar-
  in sudden SNHL (2,000 articles since 1966); reversible hear-               ticles; methods—3 separate injections 10 min apart; never inject;
  ing loss; local expertise required; high degree of patient frus-           1 injection at completion
  tration; little evidence to suggest viral infection, bacterial          Hydrogel: poly(D,L-lactic-co-glycolic acid) polymer; injected
  infection, vascular occlusion, or vasculitis as sole etiology              as liquid; gels at body temperature and releases embedded
Diagnosis: hearing test; magnetic resonance imaging (MRI); no                medication in controlled mechanism; study — patients with
  blood tests unless fluctuating or bilateral hearing loss                   Meniere disease; high perilymph level maintained at high
Proposed therapies: no double-blind, placebo-controlled trials               (220 mg/mL) concentration
  support use; shotgun therapy — in the past, patients given all          Methods of intracochlear delivery: coated electrode and os-
  available treatments at once due to multiple possible etiologies           motic pumps; egress pathways connected to reservoir
  and limited time to treat; old (1994) regimen included steroids,        Issues with injection: loss via eustachian tube; unknown whether
  carbogen inhalation, oral papaverine (Papacon, Para-Time                   absorbed systemically; highly absorbed in mucosa; unknown
  S.R., Pavabid Plateau), aspirin, and hydrochlorothiazide triam-            whether vehicle should be highly viscous or less viscous;
  terene (Dyazide, Maxzide, Maxzide-25); no longer used                      would product with higher viscosity maintain round window
Natural history: recovery rates for untreated patients, 31% to 65%;          contact better; round window adhesions; concentration gradi-
  for treated patients, 35% to 89%; reasons for wide range —                 ent needed to maintain therapeutic effect; ototoxicity of preser-
  inconsistent definition of sudden SNHL; wide range of time                 vatives in vehicles; cochlear pharmacokinetics
  frames; inconsistent definitions of “success” and “failure”             Debates: when to give; how to give; which steroid to use; how
Standard initial treatment: methylprednisolone (Medrol, Medrol               often; concentration; whether to give for sudden SNHL
  Dosepak, MethylPREDNISolone Dose Pack)—entire pack con-                 History: Itoh et al (1991) — first report on use of intratympanic
  tains 105 mg of drug; probably not enough; adequate dose un-               steroids for inner ear disease; Silverstein et al (1996) — first re-
  known; methylprednisolone acetate (DepoMedrol) injection—                  port on intratympanic steroids for sudden SNHL
  highest available dose, 100 mg prednisone equivalent; common           Timing: 3 choices — 1) at onset of systemic therapy; 2) as sal-
  dose—60 to 80 mg prednisone tapered over 10 days to 2 wk; larger           vage if treatment with systemic therapy fails; 3) intratym-
  doses of methylprednisolone given for sudden visual loss                   panic steroids only (speaker does not recommend)
Legal issues: inform patient of risks for avascular necrosis of hip,      Dosing schedule: single day; weekly; multiple weeks with self-
  peptic ulcer, hyperglycemia, cataracts; standard of care— physi-           administered drops; implantable pumps (taken off market)
  cian who does not give steroids may have violated standard of         Literature review: low numbers of patients; different steroid types
  care, but physician also at risk if steroids given and complication        and concentrations; most salvage; 0% to 100% improved; criteria
  occurs; legal term meaning that if action not taken physician has          for reporting improvement modest; twice number of studies for
  violated standard of care and therefore committed malpractice              sudden SNHL than Meniere disease; most did not have controls;
Actions of steroids on cochlea: receptors in inner ear; decrease             only 1 double-blind study; many did not use standard definition
  inflammation; improve blood flow; protect against ischemia            Speaker’s data: excluded patients with Meniere disease or fluc-
  and noise-induced hearing loss; increase stria vascularis func-         tuating hearing loss; 40 patients who failed despite treatment

                   Educational Objectives                                                     Faculty Disclosure
 The goal of this program is to improve the management of patients      In adherence to ACCME Standards for Commercial Support, Au-
 with sudden sensorineural hearing loss (SNHL) and patients with        dio-Digest requires all faculty and members of the planning com-
 chronic rhinosinusitis (CRS) with polyps. After hearing and assimi-    mittee to disclose relevant financial relationships within the past 12
 lating this program, the clinician will be better able to:             months that might create any personal conflicts of interest. Any
      1. Discuss the reasons for the wide range of reported im-         identified conflicts were resolved to ensure that this educational ac-
          provement of sudden SNHL with and without treatment.          tivity promotes quality in health care and not a proprietary business
      2. Review the actions of steroids on the cochlea.                 or commercial interest. For this program, the following has been
      3. Treat sudden SNHL with systemic and intratympanic ste-         disclosed: Dr. Haynes is a consultant for Advanced Bionics, Ans-
          roids.                                                        pach, Carl Zeiss, Cochlear Limited,and MED-EL. Dr. Murr is a
                                                                        consultant for and owns stock in Intersect ENT . The planning
      4. Review the literature on topical (spray and irrigation) and
                                                                        committee reported nothing to discose. In their lectures, Drs.
          systemic steroids to treat nasal polyposis.
                                                                        Haynes and Murr present information that is related to the off-label
      5. Treat patients with CRS and nasal polyposis using depos-       or investigational use of a therapy, product, or device.
          ited steroid delivery methods.
                                           AUDIO-DIGEST OTOLARYNGOLOGY 45:02

 for 1 wk with systemic therapy; intratympanic injection with              (CRS) with polyps and had sufficient data to include in meta-
 24 mg dexamethasone crystals in saline (mixed fresh every                  analysis; showed that intranasal steroids decrease polyp size;
 day); 40% showed any improvement; using criteria of 20 dB                  believed to result in improvement in nasal obstruction; study —
 improvement or 20% improvement in word understanding                       trend toward improvement in symptoms of cystic fibrosis (eg,
 scores, 27% improved; improvement in pure tone average, 16                nasal polyp obstruction) with topical steroid; Jankowski et al
 dB; average improvement in speech scores, 40%; 39% im-                    (2009) — fluticasone propionate aerosolized nasal spray, 200 µg
 proved if treated within 6 wk; 26% improved if treated be-                 twice daily (double Food and Drug Administration [FDA]-ap-
 tween 2 and 6 wk of symptom onset; few late recoveries;                    proved dose) compared to placebo at 1 mo, after 2 mo, and at 6
 success range using criteria from previous articles, 12% to                mo; within 2 mo of onset of nasal polyposis fluticasone at 200
 60%; demonstrates need for standardization                                 µg twice daily more effective than placebo alone, based on nasal
Conclusions: dramatic late recoveries uncommon; literature                  rhinometry (ie, peak nasal expiratory flow) and patient-centered
 supports various definitions of success; clinical benefit of in-           questionnaire; no significant difference between twice daily and
 tratympanic steroids difficult to prove; clinical use continues;           once daily when measured to end point; conclusion — can use
 newer data suggest giving early probably better; emerging                  200 µg once daily dose for long-term maintenance
 technologies for drug delivery                                           Topical irrigation: budesonide inhalation (Pulmicort Respules);
                       Questions and Answers                                not FDA approved; use through mucosal atomizer device or
                                                                            mixed into standard saline spray; Kanowitz et al (2008) —
How would speaker treat self for sudden SNHL? systemic ste-
  roids; never proven that site of lesion in cochlea; possibly in           good effect based on mucosal scale and patient questionnaire;
  cochlear nerve or intracranial; some pathology in vestibular              decreased amount of oral steroids required to keep steroid-de-
  nerve (vestibular neuronitis) and facial nerve (Bell palsy);              pendent patients comfortable; Sachanandani et al (2009) —
  would take single-dose, high concentration (24 mg/mL) intra-              budesonide inhalation did not appear to cause suppression of
  tympanic steroids, probably early; by waiting for failure of              adrenal-pituitary axis
  systemic steroids, may miss therapeutic window                          Systemic steroids: Cochrane database study — 3 randomized
Initial testing for autoimmune disease: speaker does not use blood          controlled studies; 166 patients; moderate to poor quality;
  tests; use trial of steroids to determine if patient has autoimmune       suggested short-term benefit of oral steroids in patients with
  hearing loss; autoimmune testing does not change decision about           multiple nasal polyps; parameters — endoscopic scale of
  whether to give steroids or how long to give them                         polyp size; symptom questionnaires; quality of life
Oral steroids in addition to intratympanic steroid injection?             Direct injection of steroids: Becker et al (2007)— 1500 injections
  yes                                                                       in 358 patients who had medical treatment, medical treatment and
Outcomes of study by Rauch showing no difference between                    injection, medical treatment and surgery, or medical treatment, in-
  oral and intratympanic steroids: showed probably no bene-                 jection, and surgery; 26 surgical complications; 1 complication
  fit to giving intratympanic steroids, despite most articles               from injection (transient diplopia); used 0.5 to 1 mL in 50:50 mix-
  showing some benefit                                                      ture of triamcinolone acetonide suspension (Aristospan Injection,
Stratification of data into mild, moderate, and profound                    Clinacort, Ken-Jec 40, Kenalog-10, Kenalog-40) with lidocaine
  SNHL: did not separate                                                    (not FDA approved); appeared to decrease frequency of surgery; no
Elevated glucose levels in diabetic patients given intratym-                evidence presented to directly relate to efficacy
  panic steroids alone? yes; dexamethasone highly absorbed in                                Deposited Steroid Delivery
  mucosa; during administration some enters eustachian tube;              Carboxymethylcellulose (CMC): type of dressing foam; has plate-
  unknown if dexamethasone in saline passes through stomach                   let aggregation; normally mixed with 8 mL sterile water; possi-
  into intestines and absorbed                                                ble to mix with 8 mL triamcinolone acetonide; 40 mg/mL
Treating moderate hearing loss: same treatment for all patients               triamcinolone (total dose, 160 mg per side); use as nasal dress-
  with sudden change in hearing, regardless of degree                         ing; advantages — excellent delivery localization; higher dose
Standard time for patient to remain lying down after intra-                   than currently available commercially; no patient compliance
  tympanic steroid injection? no standard; speaker leaves pa-                 required; avoid side effects of systemic steroid
  tient a few minutes                                                       Pletcher and Goldberg (2010): 8 patients with CRS and persis-
Need for more data: papers seem to support use of intratym-                   tent nasal polyposis despite functional endoscopic sinus sur-
  panic steroids, but still not clear                                         gery (FESS); all patients failed aggressive postoperative
                                                                              steroid regimens; ceased saline irrigations for 48 hr; CMC
New Methods for Steroid Delivery in Sinus Disease                             and triamcinolone improved scores on Sino-Nasal Outcome
Andrew H. Murr, MD, Professor and Vice Chair, and                             Test-20 (SNOT 20) at 1 wk and 1 mo; correlated with scores
Roger Boles, MD Endowed Chair In Otolaryngology Edu-                          on Perioperative Sinus Endoscopy (POSE) scale; scores on
cation, Department of Otolaryngology–Head and Neck                            visual analog scale (VAS) better at 1 wk than 1 mo;
Surgery, University of California, San Francisco, School                      limitations — subjective nature of endoscopic scoring scale;
                                                                              possible that CMC foam alone beneficial
of Medicine; Chief of Otolaryngology–Head and Neck                          Potential benefits: may obviate need for oral steroid delivery in
Surgery, San Francisco General Hospital                                       postoperative period; greater convenience for patient; ability to
Background: sinusitis — affects 16% of adults in United                      use in office
  States; 5 days work or school missed per year; costs $1500            Bioabsorbable steroid-eluting stent: background — FESS cen-
  per patient; annual medication costs, $1200 per patient;                    tered around reversibility of mucosal disease, preserving as
  250,000 ethmoidectomies performed each year; sinusitis can                  much mucosa as possible; atraumatic surgical technique that
  occur with or without nasal polyps; can diagnose nasal polyps               requires careful postoperative evaluation; causes of FESS
  in office with endoscope or computed tomography (CT)                        failure — recurrent inflammation and polyps; adhesions and
Treatment of nasal polyps: antibiotics; antifungals; corticoste-              synechiae; middle turbinate lateralization; stenosis of surgically
  roids; antileukotrienes; antihistamines; mast cell stabilizers; para-       created ostia; to prevent complications — packing; stents;
  sympathetic blockade drugs; surgery; corticosteroid delivery —              sponges; gels; medications to control inflammation
  topical (spray and irrigation); systemic; direct injection                Stent: spring-like design; absorbable stent made from polylactide-
Topical spray: Joe et al (2008) — of 1200 articles reviewed, 6               co-glycolide; infused with mometasone furoate (370 g); mo-
  pertained to use of topical steroids for chronic rhinosinusitis             metasone 100 µg per day FDA-approved for allergic rhinitis; 200
                                                 AUDIO-DIGEST OTOLARYNGOLOGY 45:02
     µg per day approved for polyps; placement— ethmoid cavity;                      Results: safety — no systemic steroid absorption; no suppression
     stent inserted with applicator device; mechanical function                        of adrenal-pituitary axis; statistically significant reduction in
     (opens middle meatus) and steroid delivery function                               inflammation at days 21, 28, and 45; middle turbinate position
   Study: prospective, multicenter, randomized, double-blind,                          not statistically significant; adhesion and polypoid change bet-
     controlled study; patients undergoing FESS for CRS with                           ter on steroid side; steroid dissolved by 1 mo
     and without nasal polyps; primary or revision surgery; stent                    Benefit of steroid elution: animal studies — adhesion rate without
     with steroid placed on one side and without steroid on other                      steroid, 21%; with steroid, 5%; historical comparison —21%
     side; intravenous steroids given perioperatively; no postop-                      to 25% adhesion rate with packing; benefits — avoid systemic
     erative steroids until day 30; course of antibiotics given; sa-                   side effects; more direct application of steroid; can decrease
     line spray permitted; minimum Lund-Mackay score, 6; all                           polyps and inflammation
     patients underwent bilateral ethmoidectomy

                                                                   Acknowledgements
Dr. Haynes was recorded at Chicago Laryngological and Otological Society, held December 6, 2010, in Chicago, IL, and sponsored by
Chicago Laryngological and Otological Society. Dr. Murr was recorded at UCSF Otolaryngology Update 2011, held November 10-12,
2011, in San Francisco, CA, and sponsored by the University of California, San Francisco, School of Medicine, Office of Continuing
Medical Education. Information about upcoming events from the University of California, San Francisco, School of Medicine can be
found at medschool2.ucsf.edu/medicaleducation. The Audio-Digest Foundation thanks the speakers and the sponsors for their cooper-
ation in the production of this program.
                        Suggested Reading                                          uronic acid ester nasal dressing (Merogel) on intranasal wound heal-
                                                                                   ing after functional endoscopic sinus surgery. Otolaryngol Head Neck
Becker SS et al: Steroid injection for sinonasal polyps: the University
                                                                                   Surg. 2003;128(6):862-9; Pletcher SD, Goldberg AN: Treatment of
of Virginia experience. Am J Rhinol. 2007;21(1):64-9; Beer H et al:                recurrent sinonasal polyposis with steroid-infused carboxymethylcel-
Topical nasal steroids for treating nasal polyposis in people with cystic          lulose foam. Am J Rhinol Allergy. 2010;24(6):451-3; Pondugula SR
fibrosis. Cochrane Database Syst Rev. 2011(5):CD008253; Brouwer                    et al: Glucocorticoid regulation of genes in the amiloride-sensitive so-
MC et al: Corticosteroids for acute bacterial meningitis. Cochrane                 dium transport pathway by semicircular canal duct epithelium of neo-
Database Syst Rev. 2010(9):CD004405; Chen CY et al: Oral steroid                   natal rat. Physiol Genomics. 2006;24(2):114-23; Rauch SD et al:
treatment of sudden sensorineural hearing loss: a ten year retrospec-              Oral vs intratympanic corticosteroid therapy for idiopathic sud-
tive analysis. Otol Neurotol. 2003;24(5):728-33; Conlin AE, Parnes                 den sensorineural hearing loss: a randomized trial. JAMA.
LS: Treatment of sudden sensorineural hearing loss: II. A Meta-anal-               2011;305(20):2071-9; Sachanandani NS et al: The effect of nasally
ysis. Arch Otolaryngol Head Neck Surg. 2007;133(6):582-6; De                       administered budesonide respules on adrenal cortex function in pa-
Bosscher K et al: The interplay between the glucocorticoid receptor                tients with chronic rhinosinusitis. Arch Otolaryngol Head Neck Surg.
and nuclear factor-kappaB or activator protein-1: molecular mecha-                 2009;135(3):303-7; Silverstein H et al: Intratympanic steroid treat-
nisms for gene repression. Endocr Rev. 2003;24(4):488-522; Fuse T                  ment of inner ear disease and tinnitus (preliminary report). Ear Nose
et al: Short-term outcome and prognosis of acute low-tone sensori-                 Throat J. 1996;75(8):468-71; Slattery WH et al: Oral steroid regi-
neural hearing loss by administration of steroid. ORL J Otorhinolar-               mens for idiopathic sudden sensorineural hearing loss. Otolaryngol
yngol Relat Spec. 2002;64(1):6-10; Haynes DS et al: Intratympanic                  Head Neck Surg. 2005;132(1):5-10; Tabuchi K et al: Glucocorti-
dexamethasone for sudden sensorineural hearing loss after failure of               coids and dehydroepiandrosterone sulfate ameliorate ischemia-in-
systemic therapy. Laryngoscope. 2007;117(1):3-15; Itoh A, Sakata                   duced injury of the cochlea. Hear Res. 2003;180(1-2):51-6; Wilson
E: Treatment of vestibular disorders. Acta Otolaryngol Suppl.                      WR et al: The efficacy of steroids in the treatment of idiopathic sud-
1991;481:617-23; Jankowski R et al: Long-term study of fluticasone                 den hearing loss. A double-blind clinical study. Arch Otolaryngol.
propionate aqueous nasal spray in acute and maintenance therapy of                 1980;106(12):772-6; Wormald PJ et al: A prospective single-blind
nasal polyposis. Allergy. 2009;64(6):944-50; Joe SA et al: A system-               randomized controlled study of use of hyaluronic acid nasal packs in
atic review of the use of intranasal steroids in the treatment of chronic          patients after endoscopic sinus surgery. Am J Rhinol. 2006;20(1):7-10;
rhinosinusitis. Otolaryngol Head Neck Surg. 2008;139(3):340-7;                     Worsoe L et al: Systemic steroid reduces long-term hearing
Kanowitz SJ et al: Topical budesonide via mucosal atomization de-                  loss in experimental pneumococcal meningitis. Laryngoscope.
vice in refractory postoperative chronic rhinosinusitis. Otolaryngol               2010;120(9):1872-9; Zadeh MH et al: Diagnosis and treatment of
Head Neck Surg. 2008;139(1):131-6; Martinez-Devesa P, Patiar S:                    sudden-onset sensorineural hearing loss: a study of 51 patients. Oto-
Oral steroids for nasal polyps. Cochrane Database Syst Rev.                        laryngol Head Neck Surg. 2003;128(1):92-8.
2011(7):CD005232; Miller RS et al: The clinical effects of hyal-

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                                       AUDIO-DIGEST OTOLARYNGOLOGY 45:02

                                                       STEROID THERAPY
                                To test online, go to www.audiodigest.org and sign in to online services.
           To submit a test form by mail or fax, complete Pretest section before listening and Posttest section after listening.
   1. Which of the following diagnostic tests should be performed for a patient who presents with sudden unilateral,
      nonfluctuating sensorineural hearing loss (SNHL)?
      1. Complete blood count
      2. Audiography
      3. Magnetic resonance imaging
      4. Computed tomography
        (A) 1, 2                      (B) 1, 2, 3                 (C) 2, 3                     (D) 2, 3, 4
   2. Which of the following therapies for sudden SNHL continues to be used?
       (A) Carbogen inhalation                           (C) Hydrochlorothiazide triamterene
       (B) Oral papaverine                               (D) None of the above
   3. The use of systemic steroids for treating sudden SNHL is almost universally supported in the literature.
        (A) True                                           (B) False
   4. Which of the following is known about intratympanic steroid therapy for sudden SNHL?
       (A) The steroid is absorbed in the mucosa
       (B) The steroid is absorbed systemically
       (C) Using a delivery vehicle with high viscosity is better at maintaining round window contact
       (D) It is most effective when given after systemic steroid therapy for 1 wk has failed
   5. In a literature review of studies on intratympanic steroid therapy for sudden SNHL, the percentage of patients
      shown to improve ranged from:
        (A) 0% to 100%                   (B) 12% to 60%               (C) 35% to 89%            (D) 50% to 90%
   6. Intratympanic steroid therapy is appropriate for patients with sudden SNHL that is:
        (A) Profound
        (B) Moderate or profound
        (C) Mild, moderate, or profound
   7. Use of which of the following was shown in one study to decrease the amount of oral steroids required to keep
      steroid-dependent patients with chronic rhinosinusitis (CRS) comfortable?
         (A) Fluticasone propionate nasal spray              (C) Beclomethasone dipropionate nasal spray
         (B) Budesonide inhalation                           (D) Triamcinolone acetonide as direct injection
   8. In a study of 1500 direct steroid injections in 358 patients with CRS and polyps who had medical treatment,
      medical treatment and injection, medical treatment and surgery, or medical treatment, injection, and surgery, how
      many complications were associated with injections?
        (A) 1                           (B) 12                        (C) 26                    (D) 35
   9. Carboxymethylcellulose mixed with which drug is used for deposited steroid delivery for CRS with polyps?
        (A) Fluticasone propionate                       (C) Dexamethasone
        (B) Mometasone furoate                           (D) Triamcinolone acetonide
 10. In a study of patients undergoing functional endoscopic sinus surgery for CRS, use of the bioabsorbable steroid-
     eluting stent resulted in all the following, except:
       (A) Reduction in inflammation                       (C) Polypoid change
       (B) Fewer adhesions compared to control             (D) Prevention of middle turbinate lateralization

Answers to Audio-Digest Otolaryngology Volume 45, Issue 01: 1-D, 2-B, 3-B, 4-A, 5-D, 6-C, 7-D, 8-C, 9-D, 10-D



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