This randomized, double-blind, placebo-controlled trial will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis.
Chronic laryngitis commonly manifests through symptoms including cough, hoarseness, throat clearing, foreign body sensation, throat pain, sensation of excessive phlegm, and difficulty swallowing. A significant minority also present with GERD, rhinosinusitis-induced post-nasal drainage, direct allergic effect, and smoking issues. Amitriptyline is commonly used for mental/mood problems, but is also prescribed to treat chronic laryngitis because some investigators suggest a neuropathic etiology for idiopathic chronic laryngitis. No trials have compared any treatment for chronic laryngitis to placebo and it is unknown if currently used therapies for chronic laryngitis are effective. At the baseline visit, subjects will be assigned at random to amitriptyline or placebo, which they will take for 4 weeks each. Subjects will be seen in the clinic at baseline and after 10 weeks. Improvement will be measured using standardized symptom scales, and a self-reported subjective improvement percentage.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
6
Subjects in this arm will receive pills composed of amitriptyline and Avicel (cellulose filler)
Subjects in this arm will receive pills composed only of Avicel (cellulose filler)
Boston Medical Center
Boston, Massachusetts, United States
Change in Score on Reflux Symptom Index (RSI)
The Reflux Symptom Index (RSI) is a validated questionnaire consisting of 9 statements to be ranked on a scale of 0-5 (0=no problem, 5=severe problem). RSI scores can range from 0 to 45, with higher scores correlated with more reflux symptoms.
Time frame: baseline, 8 weeks
Change in the Score on the Voice Handicap Index-10 (VHI-10)
The Voice Handicap Index-10 (VHI-10) is a 10-question scale rated from 0-4 that addresses effects on quality of life from voice disorders (0=never, 1=almost never, 2=sometimes, 3=almost always, 4=always). VHI-10 scores can range from 0 to 40, with lower scores correlated with a higher quality of life related to voice disorders.
Time frame: baseline, 8 weeks
Change in the Score on the Cough Severity Index (CSI)
The Cough Severity Index is a validated 10 item questionnaire to quantify a patient's symptoms associated with upper airway chronic cough. The 4 point Likert scale for each of the 10 items is 0 to 4 where 0 = Never, 1 = Almost never, 2 = Sometimes, 3 = Almost always, 4 = Always. Scores can range from 0 to 40 and higher scores reflect more coughing.
Time frame: baseline, 8 weeks
Change in Throat Pain or Burning
Participants will be asked to rate the severity of their "throat pain or burning" on a scale from 0 (no problem) to 5 (severe). Higher scores are correlated with more throat pain/burning.
Time frame: baseline, 8 weeks
Change in Pain When Swallowing
Participants were asked to rate their pain when swallowing on a scale of 0=none to 5= severe pain.
Time frame: baseline, 8 weeks
Subjective Improvement of Laryngitis Symptoms
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Patients will subjectively rate improvement of symptoms on an ordinal 10-point scale where 0=no improvement and 10=significant improvement.
Time frame: 8 weeks
Number of Participants Who Dropped Out of the Study Due to Side Effects
The number of patients who report they did not continue with study participation due to side effects, will be obtained from study logs.
Time frame: 8 weeks