Inhaled Triamcinolone With Proton Pump Inhibitor for Treatment of Vocal Process Granulomas: A Series of 67 Granulomas
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Annats nfOrnlngy. tihinnhgy A Ltiryngohgy 119(5);?2.'>-330.
© 2010 Annuls Piiblinhirig Company, All righls reserved.
Inhaled Triamcinolone With Proton Pump Inhibitor for Treatment
of Vocal Process Granulomas: A Series of 67 Granulomas
Alexander T. Hillel, MD; Li-Mei Lin, MD; Robin Samlan. MS;
Heather Starmer, MA; Kevin Leahy, MD, PhD; Paul W. Flint, MD
Objectives: We sought to analyze the outcomes of vocal process granulomas treated with proton pump inhibitors and
inhaled triamcinolone acetonide.
Methods: We reviewed the medical records of patients wilh a diagnosis of contact granuloma or vocal prcKcss granuloma
between IW? and 2ÜU8. Data included age. gender, intubation history, reflux history, lesion location, previous treatment
mcthiKls. treatment course, and recurrence. Ali patients were treated with daily or twice-daily protein pump inhibitors and
inhaled triamcinolone acetonide (300 |ig 3 times a day).
Kesultii: Sixty-seven granulomas were diagnosed In 54 patients: 13 bilateral and 41 unilateral. Twenty patients, includ-
ing all II women, had a recent history of intubation. Sixty-two granulomas in 50 patients were treated wilh iriamcinolonc
and a proton pump inhibitor. Ofthe 57 granulomas that completed treatment. 5 (9%) did not respond (mean Inl low-up,
5(1 weeks; range. 30.3 lo 78.3 weeks). 13 (22'7r) partially responded (mean fol!ovv-up, 11 weeks; range. ?> to 30 weeks),
and 40 (69'ií ) completely responded (mean follow-up. 21 weeks; range. 5.9 to 84.6 weeks). Three cases had recurrence:
2 nonrespondcrs and I complete responder. One patient developed oral thrush.
Conclusions: In this study, vocal process granulomas occurred more frequently in men. whereas women developed gran-
ulomas only after intubation. The anii-inflammalory action of inhaled triamcinolone combined with antirellux proton
pump inhibitors successfully treats most vocal process granulomas with low rates of side effects and recurrence.
Key Words: gasiroesophageal retlux. hyr>erfunctional voice abuse, inhaled steroid, proton pump inhibitor, speech ther-
apy, vocal process granuloma.
INTRODUCTION logic mechanism and recognized that men were
more commonly affected.^ Other etiologic factors
Vocal process granulomas of the larynx are rela-
were identified, including direct trauma from intu-
tively uncommon benign lesions emanating over
bation injury leading to a granuloma in a woman in
the vocal process. Common synonyms include con-
1932."^ New and Devine'' substantiated this finding
tact granuloma, laryngeal granuloma, and pyogcnic
with a larger case series of 9 postintubation contact
granuloma, among others, with vocal process granu-
ulcer granulomas. In 1968. Cherry and Margulies'*
loma gaining favor as an inclusive term identifying
published a report using an acid-barium swallow
the anatomic location in contrast to more narrowly
study to associate gastroesophagopharyngeal reflux
defined pathophysiologic or etiologic descriptions.'
with granuloma formation. Delahunty and Cherry^
Vocal process granulomas are commonly associat-
conoborated their clinical suspicion in Ihe labora-
ed with laryngopharyngeal reflux disease, intuba-
tory by demonstrating granuloma formation in dogs
tion trauma, and vocal abuse. However, tradition-
whose laryngés were exposed to acid, compared
al therapy with antiretlux regimens, voice therapy,
with no granuloma formation in controls. Sub.se-
and/or surgical excision has demonstrated variable
quent clinical studies supported the eftect of reflux
success.
in the pathogenesis of vocal process granuloma.**'"
Chevalier Jackson- was the tlrst to report "con- In a small study comparing 26 patients with con-
tact ulcers" along the posterior glottis in 1928. With tact granuloma with 19 healthy controls, Ylitalo and
his son. Chevalier L. Jackson, Jackson surmi.sed the Ramel"^ demonstrated that pharyngeal reflux events
mechanical action of abusive phonation as an etio- were significantly more common in the experimen-
From the Departments of Otoiaryngology-Head and Neck Surgery (Hillel. Samlan. Slarmer. Leahy, Flint) and Neurosurgery (Lin).
Johns Hopkins University School of Medicine. Baltimore. Maryland.
Presented at Ihe mecling of the American Broncho-Esophagological Association. Phoenix. Arizona. May 28-29. 2009.
Correspondence : Paul W. Flint. MD. Dept of Otolaryngology-Head and Neck Surgery. Oregon Health and Science University. 3181
SW Sam Jackson Park Rd. Portland, OR 97239-3011.
325
326 HUtel et al. Inhaled Triamcinolone for Vocal Process Granulomas
tal group. tween 1995 and 2008. The retrospective review of
patient records was exempted by the Johns Hopkins
Identification of causal factors is important in the
treatment of vocal process granulomas. Treatment Medicine Institutional Review Board {JHM-IRB X
options include voice therapy, antiretlux therapy, 04-06-25-0le). The diagnosis was made by rigid or
surgical removal, botulinum toxin injections, and fiexible videostrobolaryngoscopy in an outpatient
steroid therapy. Although voice therapy is useful in clinic setting. Data collected included age, gender,
the management of vocal process granuloma, dis- occupation, intubation history, history of gastro-
agreement remains regarding its timing, method, and esophageal or laryngopharyngeal refiux symptoms
effectiveness. Peacher and Holinger" reported suc- or signs, lesion location, previous treatment meth-
cess with vocal reeducation in contrast to voice rest. ods, treatment course, and recurrence.
Similarly. Bloch et al'^ reported a 71% success rate After diagnosis, all patients were treated with a
in the use of conventional voice therapy for disease PPI either daily or twice daily and with inhaled tri-
resolution. However, Ward et al'-^ suggested that the amcinolone acetonide (300 |ag 3 times a day). Pa-
effectiveness of voice therapy was secondary to that tients were started on a 6- to-8-week trial, with fur-
of antireflux therapy, which was emphasized as the ther medical therapy based on repeat examination
most important treatment method. Aggressive an- and videostrobolaryngoscopy. Follow-up evalua-
tirefiux management of laryngeal granuloma is a tions took place every 6 to 12 weeks until recov-
well-documented approach.'-*'"* In 1999, Roh et al''* ery. Failure of treatment was defined as no improve-
reported success with topical inhaled steroids as the ment in signs or symptoms following 2 courses of
principal therapy for vocal process granuloma. Al- therapy. Time to partial recovery, time to complete
though surgical intervention represents a treatment recovery, and time of treatment were measured in
option, it is associated with a high rate of recurrence weeks. Recurrences and contralateral lesions that
and is generally indicated for airway obstruction, di- formed during the treatment trial were recorded.
agnostic biopsy, and granulomas that are nonrespon- Other treatment methods, including voice therapy,
sive to conservative management.*^"^ Perioperative botulinum toxin injection, steroid injection, and sys-
steroid injection and postoperative systemic corti- temic steroid treatment, were also recorded. Patients
costeroids have been proposed as adjuvant thera- in whom medical therapy failed, who needed a bi-
py I4,i5 Additionally, botulinum toxin injections are opsy, or who had an obstructive granuloma were ad-
a more recent treatment option that has been shown vised to undergo surgery.
to aid the resolution of vocal process granuloma in
poor surgical candidates whose cases were unre- Completion of treatment was defined as comple-
sponsive to conservative medical management.'^ tion of at least one 6- to-8-week course of medical
therapy with follow-up. Resolution of vocal process
granulomas was determined by modification of the
Despite the spectrum of management strategies,
grading system of Emami et al.''^ Cases with com-
vocal process granulomas continue to be difficult
plete resolution of symptoms and no identifiable le-
to eradicate and demonstrate a propensity for rapid
sion were defined as "completely resolved." Cases
return. Although management strategies have been
with discoloration, including erythema, without a
proposed, a universally accepted approach to man-
lesion were defined as "completely resolved." Cas-
aging granulomas is lacking.** Since the 1999 publi-
es that had improvement in symptoms, as well as
cation of Roh et al'-''on the success of inhaled budes-
a reduction in the size of the granuloma, and any
onide for contact granuloma, topical steroid therapy
lingering lesion, including ulcération, were defined
has not been mentioned in the literature as a treat-
as "partially resolved." Cases that demonstrated no
ment regimen. The purpose of this investigation was
symptomatic improvement or a worsening of symp-
to analyze the effectiveness of the combination of in-
toms were defined as "nonresponsive" to treatment.
haled triamcinolone acetonide and proton pump in-
hibitors (PPIs) in the treatment of vocal process gran- Statistical analyses were performed with Med-
uloma. In this case series, the success of the combi- Calc 3000 (Foundation Internet Services. Pittsburgh,
nation medical therapy was measured by partial and Pennsylvania). We applied a X" test to the location of
complete resolution of the granulomas, as well as by unilateral lesions, the association of intubation trau-
medical failure that required surgical excision. tna with gender, and the associatit>n of vocal abuse
with gender. Values for p were determined with y}
METHODS tests; values less than 0.05 were considered signifi-
cant.
The medical records of patients with a diagnosis
of contact granuloma or vocal process granuloma RESULTS
were reviewed at a tertiary care medical center be- Overall, 67 granulomas were diagnosed in 54
Hillel et al. Inhaled Triamcinolone for Vocal Process Granulomas 327
PRESENTATION OF SYMPTOMS
Patients
Vocal Symptom No. %
Idiopathic k abuse Hoarseness 39 72
37% 1I Cough
Sore throat
19
17
35
31
1i Foreign body sensation
Dysphagia
6
6
11
lt
r Globus sensation
Sensation of increased mueus
5
4
10
7
Intubation Ear pain 4 7
Vocal fatigue 3 5
rauma.
Fig 1. Frequency of causes of mechanical trauma. Hemoptysis 2 4
patients. Forty-three men and 11 women were in- associated with granuloma formation in men (p <
cluded, with an average age of 54.4 years and an 0.001). The frequencies of presenting symptotns are
average follow-up of 45.9 weeks (range. 3 to 362.7 presented in the Table.
weeks). Seven patients were professional voice us-
ers. Forty-one patients had unilateral lesions (76%), Twenty-seven patients had previously been treat-
and 13 patients had bilateral disease (24%). A con- ed with PPIs alone, either daily or twice daily, atid
tralateral granuloma in 4 patients developed after had not completely responded. Seventeen patients
initiation of therapy for the principal lesion. Of pa- previously underwent surgery (12 had tnore than
tients with unilateral vocal process granulomas, 32 1 procedure) with recurrence of the vocal process
(78%) had left-sided and 9 (22%) had right-sided granuloina. Other previous treatment included voice
lesions (p < 0.001 ). One patient was noted to have a therapy in 1 patient, inhaled steroids in 3 patients,
eontralateral ulcer that did not develop into a granu- systemic steroids in 5 patients, steroid injection in I
loma. Twenty patients, including all 11 women, had patient, and botulinum toxin injection in I patient.
a recent history of intubation. Intubation trauma was Sixty-two granulomas in 50 patients were treat-
associated with granuloma formation in women (p ed with the combination of inhaled triamcinolone
< 0.001). The 17 patients whose date of intubation and PPIs. Forty-seven patients with 58 vocal pro-
was known averaged 13.1 weeks to the diagnosis cess granulomas completed treatment for a mean
of vocal process granuloma. This cohort was intu- of 43.8 weeks (range, 3 to 84.6 weeks). Of those
bated an average of 4.8 days, with 7 patients intu- 47 patients. 16 also underwent voice therapy. In the
bated for less than 1 day. primarily for an operative cohort with complete treatment. 5 granulomas (9%)
procedure. Thirty-two ofthe patients were identified did not respond after a mean treattiient course of 50
with a history of reflux (Fig I ). Fifteen patients were weeks (range. 30.3 to 78.3 weeks). Thirteen granu-
documented voice abusers (Fig 2); voice abuse was lomas (22%) partially responded after a mean thera-
py eourse of 11 weeks (range. 3 to 30 weeks), and 40
No reflux (69%) completely responded after a mean therapy
course of 21 weeks (range. 5.9 to 84.6 weeks). Tem-
porally, complete or partial recovery was seen at 2,
4. and 6 months in 29%. 66%. and 79%. respective-
ly (Fig 3). Three patients undetwent sutgical exci-
sion: I for biopsy and 2 others in whom conserva-
tive therapy failed (after 17 and 42 weeks). There
were 3 recurrences; 2 in nonresponders after sutgery
19 20 and 1 in a complete responder. One patient devel-
oped oral thrush.
70%
73% ^ 1 DISCUSSION
37% The epidemiology, presentation, and causes of
vocal process granuloma in this study substantiate
Vocal abuse Intubation Idiopathic
previous published results. A greater number of men
Fig 2. Percentage of patients with history of reflux (light were aflected by vocal process granuloriia (by a 4:1
column) overall and in each category of mechanical trau-
ma. (Total number ol' patients in each category is listed ratio). This is likely due to the greater prevalence
above each column.) of vocal abuse in men, a result seen in this study."^
•r
328 Hillel et al. Inhaled Triamcinolone for Vocal Process Granulomas
Fig 3. Videostrobüscüpic images depict A) original granuloma and its respotise to therapy at B) 2 iiuniths.
C) 4 months, and D) 6 months.
Interestingly, the granulomas of all 11 women in This result is supported by other studies that have
this cohort followed recent intubation, an associa- demonstrated a left-sided preponderance of vocal
tion that supports previous reports that women are fold granulomas.'^•^'•22 j ^ i s phenomenon could
more likely to sustain vocal process granuloma frotn be related to intubation technique and the tendency
intubation-related or surgical trauma."*"^** McFerran for right-handed placement of an endotracheal tube
et al'** suggested that the thinner mucosa in smaller to cause the tube to come into contact with the left
laryngés makes women vulnerable to trau ma-relat- vocal process. However, only 19 ofthe 54 patients
ed granuloma. In all patients included in this study, were intubated. of whom 8 developed simultaneous
hoarseness represented the most common present- bilateral granulomas, 9 developed left-sided gran-
ing symptom, seen in 72% of patients. Voice abuse ulomas, and 2 had right-sided lesions. Therefore,
(28%). intubation trauma (35%). and laryngopha- the left-to-right ratio of intubation-related unilater-
ryngeal reflux (59%) represented the 3 principal fac- al contact granulomas is not substantially different
tors in the development of contact granuloma. Intu- from the overall ratio and likely does not explain the
bation trauma was significantly associated with de- preponderance of left-sided lesions.
velopment of granuloma in women, whereas vocal
abuse was significantly associated with granuloma The presumptive pathophysiologic process of vo-
formation in men. These findings are suggestive of cal process granuloma begins with trauma to the tnu-
potential causes in men and women; however, this cosa overlying the vocal process secondary to voice
study was not designed to analyze causality. abuse, intubation injury, other trauma, and/or over-
exposure to acid reflux.*^ This creates the ulcération
In patients with unilateral granuloma, there was commonly seen on histologie specimens along with
a significantly greater number of left-sided lesions subepithelial capillary proliferation and a mixed in-
(32) than right-sided lesions (9; p < 0.001). This flammatory infiltrate."^ Continued chemical expo-
was significantly different from expected outcomes. sure combined with mechanical trauma likely prop-
Hillel et al. Inhaled Triamcinolone fi}r Vocal Process Granulomas 329
agates constant inflammation and exposure of the rates of resolution with medical therapy.-*^
caiiilaginous process, resulting in underlying peri- Our investigation applied the inhaled topical .ste-
chondritis. epithelial hypeqjlasia, and proliferation roid triamcinolone to PPI therapy for combined med-
of granulation tissue.**-'**-^'* Fibrosis may also be ical treatment of vocal process granulomas resulting
seen on hi.stologic analysis.'** from various causes. Triamcinolone was used be-
The failure of surgical excision may be explained cause it has a greater ratio of local anti-inflammatory
by its failure to address the principal causes of vo- effect to systemic absorption than does budesonide
cal process granuloma. Recurrence rates following and it has an excellent long-term safety profile up to
surgical excision range from 25% to 92%.^-^^-^^ A 12 months.-'*"-''Our therapy regimen evolved during
large subset of patients in this study {17) entered this the course of this study, thereby causing variations
study secondary to recurrent granuloma following in PPI regimens and the use of voice therapy. The
surgery. Once placed on inhaled triamcinolone and current treatment regimen is a PPI twice daily with
a m, 2 (12%) partially responded and 13 (76%) inhaled triamcinolone 3 times daily for 6 to 8 weeks,
completely responded — rates similar to the overall augmented with voice therapy when appropriate. On
results. Only 3 patients in this study underwent sur- foilow-up. if there is partial orno resolution, we rec-
gical excision following initiation of medical thera- ommend continuation of tlicrapy for another 6 to 8
py: I for biopsy and 2 others in whom conservative weeks. After resolution of the granuloma, we dis-
therapy failed. The small number of patients who re- continue the inhaled triamcinoionc and taper the PPI
quired surgery further demonstrates the efficacy of over the next 2 to 3 months, after which patients fol-
combination medical therapy for treatment of vocal low up on an as-needed basis. We recommend this
process granuloma. treatment regimen because it addresses multiple fac-
tors involved in the pathogenesis of vocal process
Although antiretlux and voice therapy have dem- granulomas, with the PPI diminishing the chemical
onstrated some success in treatment of contact gran- insult from acid reflux and the topical triamcinolone
uloma, the disease often recurs. In a retrospective reducing the local inflammatory response from me-
review of 120 patients with contact granuloma, Yli- chanical and chemical trauma.
lato and Lindestad'^' concluded that voice therapy
did not significantly shorten healing time compared In a subset of 23 patients with vocal process gran-
to an untreated cohort. Havas et al^ demonstrated ulomas or ulcers. Emami et al'"* demonstrated an
excellent results for granulomas treated with antire- 87% rate of recovery following treatment with PPIs
Oux medications, lifestyle modifications, and voice alone. No time to resolution was mentioned in their
therapy, but still had 4 of 39 conservatively treated report.'"* Wani and Woodson'^" reported that all 18
patients ultimately require gastric fundoplication to patients treated with PPIs for vocal process granulo-
manage their gastroesophageal reflux and resolve mas responded to treatment; however, 2 of 4 partial
their granuloma. Even in highly motivated patients, responders required surgical excision, resulting in
maintaining good vocal hygiene may decrease me- an 88% rate of recovery. The average time to com-
chanical impact and laryngopharyngeal reflux; how- plete resolution was 10.4 months. Our results dem-
ever, it may not be enough to completely resolve the onstrated a 917f overall response rate with a mean
vocal process inflammation. Reduction of healing resolution time of 4.3 months. Seventy-nine percent
time and treatment of refractory granulomas rep- of patients responded by 6 months, with complete
resent the principal basis for an additional medical recovery achieved in almost half of this coht)rt by
mechanism to facilitate decreased local inflamma- 4 months and in two thirds by I year. Further dem-
tion. onstrating the success of this regimen, only 2 pa-
Inhaled steroids have a successful record in re- tients required surgical excision after failed com-
ducing local intlammation. Budesonide,beclometh- bined medical therapy, a comparatively low rate of
asone, and triamcinolone have been used to treat na-
sal polyposis, allergic rhinitis, asthma, and chronic The 1 patient in whom oral candidiasis developed
obstructive pulmonary disease.^'^-'' In 1999, Roh et during use of inhaled triamcinolone was success-
al'** applied the inhaled topical steroid budesonide fully treated with a 2-week course of topical nysta-
to the treatment of vocal process granuloma. The au- tin while the triamcinolone regimen was continued.
thors demonstrated resolution of 19 of 20 intubation The rate of 1.9% in this cohort is consistent with the
granulomas within 12 months. The only side effect incidence of candidiasis in the use of inhaled triam-
seen with inhaled budesonide in this cohort was a cinolone in the asthma patient population (2.4%).-''
10%' rate of oral moniliasis.'^ Although these out- Although oral candidiasis was an infrequent side ef-
comes were highly favorable. Roh et al'-'' solely in- fect in this study, care may be indicated in treating
cluded intubation granulomas, which have very high immunosuppressed individuals with inhaled triam-
330 Hiltel et at. Inhaled Triamcinolone for Vocal Process Granulomas
cinolone. use. Although difficult to organize and complete, a
prospective multi-institutional study would poten-
The retrospective nature of this study, its small tially include a greater number of patients that could
number of patients, and the lack of a case control yield significant results on the benefits of combined
limit its conclusions. The retrospective method re- medical therapy for the treatment of vocal process
sulted in a varied treatment protocol with a nonuni- granulomas.
form PPI dosage schedule and duration and nonuni-
form follow-up times. Furthermore, less than one In this study, vocal process granulotiias occurred
third of patients in this study received voice therapy more frequently in men, whereas women developed
for their granuloma, including only 8 of 15 patients granulomas only after intubation. The significantly
identified as vocal abusers. A greater number of pa- greater presence of left-sided granulomas supports
tients receiving voice therapy would optimize con- other investigators'findings, but lacks a clear cause,
servative multimcthod treatment for vocal process and is worthy of further investigation. The outcomes
granuloma. Finally, in 27 patients who pre.sented presented in this study support the therapeutic effi-
with PPI therapy already initiated, the inhaled ste- cacy of inhaled triamcinolone combined with antire-
roid was added to the regimen. Complete and par- tlux PPIs for treatment of vocal process granulomas
tial responses in this group suggest that a beneficial with few side effects, a low recurrence rate, and no
response may be achieved with the steroid alone; need for surgical excision. Inhaled topical steroids
however, this study did not assess inhaled steroid provide a direct anti-inflammatory mechanism to
alone versus inhaled steroid with PPI. Future studies the laryngeal mucosa and represent a complementa-
are necessary to study inhaled topical steroids' ef- ry therapy to PPI and voice therapy to improve treat-
fect on vocal process granulomas controlled for PPI ment of vocal proeess granuloma.
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