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Study of steroid effects on graft and inner ear outcomes in tympanoplasty: Randomized controlled trial.

Abstract

More studies are needed to investigate the side effects of steroids in tympanoplasty, owing to the paucity of such studies in the literature. This randomized, controlled clinical trial included 59 patients with chronic otitis media who underwent tympanoplasty and were randomized after surgery to a systemic steroid or no steroid treatment. Patients were randomized into two groups. Perforation size, graft outcome, and complications such as tinnitus and hearing loss were compared between the two groups. Postsurgical steroid injection had no effect on graft outcome (p = 0.927) or tinnitus fp = 0.478). Tympanic membrane perforation (p = 0.92), plaque size (p = 0.94), bleeding amount (p = 0.38), and mucosal status (p = 0.96) during surgery had no effect on graft outcome after the tympanoplasty. In conclusion, administration of steroids after tympanoplasty failed to improve outcome and may put the patient at risk of side effects.

Introduction

Chronic otitis media is characterized by an irreversible tympanic perforation associated with chronic inflammation of the middle ear, and it is the most important cause of hearing loss in developing countries. (1,2) Tympanoplasty is indicated to rehabilitate hearing and to treat chronic infection. (3) The various modern surgical approaches to tympanoplasty include endomeatal, endaural, and postauricular routes. (3-5) Inner ear complications such as sensorineural hearing loss, trauma to the inner ear, and tinnitus have been reported with these surgeries. (6-9) Surgical technique is considered the main factor in determining success, but the influence of steroid-containing agents is unknown. (10)

Steroids have been effective in the treatment of some inner ear pathologies, such as noise-induced and sudden sensorineural hearing loss. (11,12) Animal studies suggest possible inhibition of neovascularization by steroids that can result in delayed wound re-epithelialization; (13,14) however, the clinical information on the effects of short-term corticosteroid administration on the healing of differentiated tissue like tympanic membrane is limited.

Due to the possible complications of steroid agents and the absence of clear evidence of their efficacy in tympanoplasty, we performed this study to assess the influence of corticosteroids on tympanoplasty outcomes.

Patients and methods

This randomized, controlled clinical trial included patients who underwent tympanoplasty at the Otolaryngology Clinic of Amir-A'lam Hospital in 2013 and 2014. All the surgeons in the study were board members and were experienced in tympanoplasty. Examiners and audiologists were blinded to the randomization.

After taking histories, doing physical examinations, and performing additive tests such as audiometry, we enrolled patients with chronic otitis media (COM) who were candidates for tympanoplasty. We excluded patients with cholesteatoma, severe damages to ossicles, history of ear surgery, active infection, total tympanic membrane loss, and age >75 years.

The final dataset included 59 patients who were randomly divided into two groups: one group of 29 patients who received dexamethasone (8 mg twice in a 12-hour interval) after surgery and a second group of 30 patients who did not receive dexamethasone. Other interventions (i.e., surgical techniques, use of a prophylactic antibiotic, and administration of preoperative steroid injection) were the same in both groups.

Patients' demographics (age, medical and surgical history, medication history, and disease duration) were obtained through questionnaires. Data on complications such as tinnitus, hearing loss, and graft condition were collected.

Patients were examined twice before surgery and once at month 3 after surgery. Perforation and plaque size were documented before the surgery as the number of quadrants involved (table 1). Hearing was assessed via audiometry (pure-tone audiometry, speech audiometry, and tympanometry), and the graft condition was assessed by microscopic otoscopy.

Data were analyzed using SPSS (v. 20) software. For the quantitative and qualitative comparison between the two groups, the t test and chi-square test, respectively, were used. The confidence interval was set at 95%, and p values <0.05 were considered statistically significant.

Results

Of the 59 total patients, 31 (52.5%) were female and 28 (47.5%) were male. Patients' ages ranged from 10 to 77 years (average: 40.78) (table 2). No significant difference existed between the two groups in the findings on physical examination before surgery or in the patients' demographics.

Bleeding volume and mucosal status during the operation were also investigated. Patients were divided into three subgroups based on bleeding volume: 47.5% had no bleeding, 27.1% had moderate bleeding, and 25.4% had severe bleeding. The extent of bleeding was defined according to the surgeons' judgment: bleeding was considered moderate when it was not problematic for the procedure and severe when it was obscuring surgeons' vision and some measures needed to be taken. Regarding mucosal status, 74.6% had normal mucosal status, 23.7% had edematous mucus, and 1.7% had polypoid mucosal status.

The graft was intact in 55 (93.2%) patients after tympanoplasty. The graft failed in 4 (6.8%) patients, 2 of whom had received a steroid injection before the surgery and 2 of whom did not receive a steroid. Steroid injection had no effect on the graft result after the tympanoplasty in this study (p = 0.927).

A total of 33 (55.9%) patients had tinnitus before the surgery; the tinnitus continued in 5 patients after tympanoplasty and was absent in 28 patients after surgery. In addition, 4 patients who did not have tinnitus before surgery had this complaint after the surgery. No significant effect of steroid injection on tinnitus was observed (p = 0.478) (table 3).

Postsurgical vertigo was also evaluated: 47 patients (79.7%) had no vertigo, 11 (18.6%) had dizziness, and 1 (1.7%) had true vertigo postsurgically. No significant relationship between steroid use and postsurgery vertigo was present (p = 0.531). A post hoc evaluation found no significant effect of perforation and plaque size on graft outcome (p = 0.92 and p = 0.94, respectively) (table 1).

As seen in table 1,50% of the lost grafts belonged to the patients in the subgroup with no bleeding and 50% to the group with moderate bleeding during the operation. No patients with severe bleeding had graft failure. The volume of bleeding had no effect on the tympanoplasty graft outcome (p = 0.38).

Mucosal status during the surgery had no significant effect on graft outcome (p = 0.96) (table 1).

Discussion

The complications of tympanoplasty include graft failure and conductive hearing loss. Postoperative steroids have been used to reduce complications to the inner ear. Considering the various side effects associated with steroids and the paucity of data in the literature on the effects of steroids on tympanoplasty outcomes, we assessed the effects of steroid use on graft outcome and hearing in 59 patients with COM.

In 2007, Starkweather and Friedman conducted a study to evaluate the effect of ciprofloxacin 0.3% and dexamethasone 0.1% on graft healing during tympanoplasty. (14) According to their study, healing of the tympanic membrane occurred in 95.3%, and the mean time to healing was 49 days. Sobol et al found an overall rate of healing of 95% and a time to healing of 30 to 60 days with the use of dexamethasone, indicating no effect on graft outcome or healing time. (15)

In 2007, Hebda et al evaluated the effects of the ciprofloxacin-dexamethasone (CDX) combination in 30 rats after myringotomy. (16) After 14 days, the healing rates were 100% in the non-CDX group and 89% in the CDX group, which improved to 100% at day 28. This result indicated no difference in overall healing between the two groups, but that healing was slower in the CDX group.

In our study, the graft failed in 4 patients, 2 of whom had received a steroid injection before surgery and 2 of whom had not. Hence, our study also shows no differences in graft outcome. However, we cannot draw conclusions about the time to healing with the use of postoperative steroid injection because we evaluated graft outcome after 3 months.

House et al conducted a study to determine the safety of using a suspension of polymyxin B, neomycin, and hydrocortisone (PNH) in tympanoplasty.17 In each surgery, the gelatin sponge saturated with PNH suspension was placed in the middle ear, and bone-conduction thresholds were measured at 500, 1,000, 2,000, and 4,000 Hz before and after the surgery. A slight improvement (average: -0.545 dB) in all frequencies except 4,000 Hz (+0.560 dB) was observed. In our study, the average bone-conduction changes were significantly different between the two groups (p = 0.02). Evaluation of the bone-conduction changes at each frequency separately showed a meaningful difference at 500 and 2,000 Hz, (p = 0.056 and p = 0.052, respectively) but not at the other frequencies.

Riechelmann et al designed a study to evaluate the effects of perioperative glucocorticoid during stapes surgery on postoperative complications. (18) In 95 patients who underwent stapedotomy, postoperative bone-conduction thresholds, sensorineural hearing loss, vertigo, and tinnitus were compared between patients who received prednisolone and controls. Prednisolone recipients showed no improvement in hearing and had vertigo at more frequencies. (18) This finding supports the lack of efficacy of steroids on vertigo and tinnitus found in our study.

Conclusion

The present study showed no beneficial effect of steroid administration in patients undergoing tympanoplasty. Routine steroid administration in these patients appears to have no benefit while exposing patients to the risk of the side effects of steroids.

References

(1.) Maharjan M, Kafle P, Bista M, et al. Observation of hearing loss in patients with chronic suppurative otitis media tubotympanic type. Kathmandu Univ Med J (KUMJ) 2009;7(28):397-401.

(2.) Roland PS. Chronic suppurative otitis media: A clinical overview. Ear Nose Throat J 2002;81(8 Suppl 1):8-10.

(3.) Sergi B, Galli J, De Corso E, et al. Overlay versus underlay myringoplasty: Report of outcomes considering closure of perforation and hearing function. Acta Otorhinolaryngol Ital 2011;31(6):366-71.

(4.) Olusesi AD, Opaluwah E, Hassan SB. Subjective and objective outcomes of tympanoplasty surgery at National Hospital Abuja, Nigeria 2005-2009. Eur Arch Otorhinolaryngol 2011;268(3):36772.

(5.) Zollner F. The principles of plastic surgery of the soundconducting apparatus. J Laryngol Otol 1955;69(10):637-52.

(6.) Briggs RJ, Luxford WM. Chronic ear surgery: A historical review. Am J Otol 1994;15(4):558-67.

(7.) Indorewala S, Pagare R, Aboojiwala S, Barpande S. Dimensional stability of the free fascia grafts: A human study. Laryngoscope 2004;114(3):543-7.

(8.) Kazikdas KC, Onal K, Boyraz I, Karabulut E. Palisade cartilage tympanoplasty for management of subtotal perforations: A comparison with the temporalis fascia technique. Eur Arch Otorhinolaryngol 2007;264(9):985-9.

(9.) Mauri M, Lubianca Neto JF, Fuchs SC. Evaluation of inlay butterfly cartilage tympanoplasty: A randomized clinical trial. Laryngoscope 2001 ; 111 (8): 1479-85.

(10.) Sheehy JL, Glasscock ME 3rd. Tympanic membrane grafting with temporalis fascia. Arch Otolaryngol 1967;86(4):391-402.

(11.) Oishi N, Schacht J. Emerging treatments for noise-induced hearing loss. Expert Opin Emerg Drugs 2011;16(2):235-45.

(12.) Wilson WR, Byl FM, Laird N. The efficacy of steroids in the treatment of idiopathic sudden hearing loss. A double-blind clinical study. Arch Otolaryngol 1980;106(12):772-6.

(13.) Brauchle M, Fassler R, Werner S. Suppression of keratinocyte growth factor expression by glucocorticoids in vitro and during wound healing. J Invest Dermatol 1995;105(4):579-84.

(14.) Starkweather A, Friedman RA. Effect of ciprodex on graft healing in tympanoplasty. Adv Ther 2007;24(2):427-35.

(15.) Sobol SE, Keswani S, Parvadia JK, et al. Effect of corticosteroidantibiotic agents on granulation tissue in a murine model. Arch Otolaryngol Head Neck Surg 2005;131(4):330-5.

(16.) Hebda PA, Yuksel S, Dohar JE. Effects of ciprofloxacin dexamethasone on myringotomy wound healing. Laryngoscope 2007;117(3):522-8.

(17.) House JR 3rd, House LK. Ototoxicity of polymyxin B, neomycin, and hydrocortisone suspension in tympanoplasty surgery. Otolaryngol Head Neck Surg 2014;150(2):282-4.

(18.) Riechelmann H, Tholen M, Keck T, Rettinger G. Perioperative glucocorticoid treatment does not influence early post-laser stapedotomy hearing thresholds. Am J Otol 2000;21(6):809-12.

Ali Kouhi, MD; Sasan Dabiri, MD; Amin Amali, MD; Nasrin Yazdani, MD; Mahboubeh Baroodabi, MD; Taha Kouchakinejad, MD; Alireza Mohseni, MD

From the Otorhinolaryngology Research Center, Department of Otolaryngology, Head and Neck Surgery, Amir-A'lam Hospital, Tehran University of Medical Sciences, Iran.

Correspondingauthor: Ali Kouhi, MD, Otorhinolaryngology Research Center, Amir-A'lam Hospital, North Sa'adi Ave., Tehran, Iran. Email: a-kouhi@tums.ac.ir

Funding/support: This study was supported by a grant from the Tehran University of Medical Sciences (grant number: 92-03-48-23363).
Table 1. Comparison of preoperative and intraoperative physical
findings with graft outcome

                                          Graft outcome
                          No. Patients
                                          Intact (n, %)

Perforation size

  1 of 4 TM quadrants          17           16(94.1%)
  2 of 4 TM quadrants          28           27 (96.4%)
  3 of 4 TM quadrants          12           11 (91.7%)
  4 of 4 TM quadrants          2             1 (50%)
Plaque Size
  No plaque                    41           38 (92.7%)
  1 of 4 TM quadrants          10            9 (90%)
  2 of 4 TM quadrants          6             6(100%)
  3 of 4 TM quadrants          1             1 (100%)
  4 of 4 TM quadrants          1             1 (100%)
Bleeding volume
  No bleeding                  28           26 (92.9%)
  Moderate                     16           14(87.5%)
  Massive                      15            15(100%)
Mucosal status
  Normal                       44           41 (93.2%)
  Edematous                    14           13(92.9%)
  Polypoid                     1             1 (100%)

                         Graft outcome    p Value *

                         Failure (n, %)      0.92

Perforation size

  1 of 4 TM quadrants       1 (5.9%)
  2 of 4 TM quadrants       1 (3.6%)
  3 of 4 TM quadrants       1 (8.3%)
  4 of 4 TM quadrants       1 (50%)
Plaque Size                                  0.94
  No plaque                 3 (7.3%)
  1 of 4 TM quadrants       1 (10%)
  2 of 4 TM quadrants        0 (0%)
  3 of 4 TM quadrants        0 (0%)
  4 of 4 TM quadrants        0 (0%)
Bleeding volume                              0.38
  No bleeding               2(7.1%)
  Moderate                 2 (12.5%)
  Massive                    0 (0%)
Mucosal status                               0.96
  Normal                    3 (6.8%)
  Edematous                 1 (7.1%)
  Polypoid                   0 (0%)

* Effect on graft outcome. Key: TM = tympanic membrane.

Table 2. Patient demographics

                        Steroid injection
                 Yes (n = 29)      No (n = 30)    Total    p Value

Mean age (yr)        38.61            42.80       40.47     0.274
Sex (M:F)            13:16            15:15       28:31     0.446

Table 3. Comparison of outcome parameters in patients with
steroid and without steroid injection

                                            No. patients

Graft outcome                                    59
  Fail                                           4
  Intact                                         55
BC changes
  Mean ([+ or -] SD)                             29
ABG changes
  Mean ([+ or -] SD)                             29
BC Changes
  250 Hz (Mean [+ or -] SD)
  500 Hz (Mean [+ or -] SD)
  1,000 Hz (Mean [+ or -] SD)
  2,000 Hz (Mean [+ or -] SD)
  4,000 Hz (Mean [+ or -] SD)
Tinnitus
  Had tinnitus before surgery,                   28
  healed after surgery
  No tinnitus before and after surgery           22
  Had tinnitus before surgery, did               5
  not heal after surgery
  No tinnitus before surgery, complained         4
  of tinnitus after surgery
Vertigo
  No vertigo                                     47
  Dizziness                                      11
  True vertigo                                   1

                                            With steroid

Graft outcome                                29 (49.2%)
  Fail                                        2 (50%)
  Intact                                     27(49.1%)
BC changes
  Mean ([+ or -] SD)                        -0.12 (0.26)
ABG changes
  Mean ([+ or -] SD)                        8.53 (2.18)
BC Changes
  250 Hz (Mean [+ or -] SD)                 0.00 (0.24)
  500 Hz (Mean [+ or -] SD)                 0.00 (0.24)
  1,000 Hz (Mean [+ or -] SD)               -0.17(0.30)
  2,000 Hz (Mean [+ or -] SD)               -0.34 (0.23)
  4,000 Hz (Mean [+ or -] SD)               -0.51 (0.37)
Tinnitus
  Had tinnitus before surgery,               12(42.9%)
  healed after surgery
  No tinnitus before and after surgery       13(59.1%)
  Had tinnitus before surgery, did            3 (60%)
  not heal after surgery
  No tinnitus before surgery, complained      1 (25%)
  of tinnitus after surgery
Vertigo
  No vertigo                                 22 (46.8%)
  Dizziness                                  6 (54.5%)
  True vertigo                                1 (100%)

                                           Without steroid    p Value

Graft outcome                                 30 (50.8%)
  Fail                                         2 (50%)         0.927
  Intact                                      28 (50.9%)
BC changes
  Mean ([+ or -] SD)                         -1.12(0.31)        0.02
ABG changes
  Mean ([+ or -] SD)                         13.08 (1.97)      >0.05
BC Changes
  250 Hz (Mean [+ or -] SD)                   0.33(0.41)       0.494
  500 Hz (Mean [+ or -] SD)                  -1.0 (0.44)       0.056
  1,000 Hz (Mean [+ or -] SD)                -0.50 (0.27)      0.428
  2,000 Hz (Mean [+ or -] SD)                -1.8 (0.69)       0.052
  4,000 Hz (Mean [+ or -] SD)                -0.16(0.61)       0.630
Tinnitus                                                       0.478
  Had tinnitus before surgery,                16 (57.1%)
  healed after surgery
  No tinnitus before and after surgery        9 (40.9%)
  Had tinnitus before surgery, did             2 (40%)
  not heal after surgery
  No tinnitus before surgery, complained       3 (75%)
  of tinnitus after surgery
Vertigo                                                        0.531
  No vertigo                                  25 (53.2%)
  Dizziness                                   5 (45.5%)
  True vertigo                                  0 (0%)

Key: ABG = air-bone gap; BC = bone conduction; SD = standard deviation.
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Title Annotation:ORIGINAL ARTICLE
Author:Kouhi, Ali; Dabiri, Sasan; Amali, Amin; Yazdani, Nasrin; Baroodabi, Mahboubeh; Kouchakinejad, Taha;
Publication:Ear, Nose and Throat Journal
Article Type:Report
Date:Jun 1, 2018
Words:2758
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