Comparison of Voice Therapy and Antireflex Therapy in LPR

Comparison of Voice Therapy and Antireflex Therapy in the Treatment of Laryngopharyngeal Reflux-related Hoarseness: A Prospective Randomized Control Trial

This study will be a prospective, randomized, unblinded but controlled trial. Patients presenting to the Otolaryngology clinic who are diagnosed with laryngopharyngeal reflux disorder related dysphonia and meet inclusion criteria will be eligible to enroll in the study. Subjects will be randomized to one of three treatment arms, voice therapy, anti-reflux therapy, or a combination of voice therapy and anti-reflux therapy. Reflux symptom index (RSI) scores, reflux finding scores (RFS), voice handicap index-10 (VHI-10) scores, and consensus auditory perceptual evaluation-voice (CAPE-V) scores will be compared prior to initiation of therapy as well as at 1, 2, and 3 months following initiation of treatment.

Study Overview

• Status: Withdrawn
• Conditions: Laryngopharyngeal Reflux
• Intervention / Treatment: Behavioral: Voice therapy; Drug: Omeprazole, Lansoprazole, Esomeprazole, Rantidine; Other: Combination of anti-reflux medication and voice therapy

Detailed Description

Hoarseness is one of the most common presenting complaints in otolaryngology. The differential diagnosis for hoarseness is board, but a large percentage has been attributed to laryngopharyngeal reflux (LPR). LPR refers to the symptomatic effects of regurgitated gastric contents into the pharynx and larynx.1-3 1,2 Although dual-probe 24 hour pH monitoring is the gold standard in the diagnosis of LPR, it is not always performed due to inconvenience and cost. Patients are commonly treated based on history and physical examination findings alone. The literature on the efficacy of anti-reflux therapy and LPR is controversial. Karkos et al performed a systematic review on the use of empiric treatment of proton pump inhibitors (PPI) in patients suspected of having LPR and found no statistically significant difference between patients treated with PPI and those treated with placebo in reference to symptom severity or frequency of presumed reflux events. 2 Commonly patients are started on empiric therapy with anti-reflux medications and lifestyle modifications. Laryngoscopy is performed on all patients presenting with dysphonia. While a variety of findings have been characterized as consistent with reflux a study performed by Hicks et al, found that 86% of normal volunteers had findings consistent with reflux on flexible laryngoscopy.5 This calls into question the sensitivity and specificity of laryngoscopy in the diagnosis of LPR. Park et al performed a study comparing the effectiveness of anti-reflux therapy alone versus a combination of voice therapy with PPI in the treatment of presumed LPR-related dysphonia, and found combination therapy to be superior to anti-reflux therapy alone. 3 Because there are no studies comparing voice therapy directly with anti-reflux therapy, one cannot determine whether the improvements are due to augmentation of anti-reflux therapy with voice therapy, or if voice therapy alone is superior in the treatment of LPR-related dysphonia. There are currently no studies comparing the effectiveness of voice therapy alone, anti-reflux therapy alone, and combination therapy. Patients who present with dysphonia may be over treated with anti-reflux medications. These medications are not without side effects. It is hypothesized that a subset of patients who are thought to have reflux related dysphonia are misusing their voice and can be successfully treated with voice therapy alone. This study will be a prospective, randomized, unblinded but controlled trial. Patients presenting to the Otolaryngology clinic who are diagnosed with LPR-related dysphonia who meet inclusion criteria will be eligible to enroll in the study and will be randomized to one of the three treatment arms. Reflux symptom index (RSI) scores, reflux finding scores (RFS), voice handicap index-10 (VHI-10) scores, and consensus auditory perceptual evaluation-voice (CAPE-V) scores will be compared prior to initiation of therapy as well as at 1, 2, and 3 months following initiation of treatment.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple Otolaryngology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years of age and older
• Hoarseness
• Reflux symptom index score >13
• Reflux finding score >7
• English speaking

Exclusion Criteria:

• Evidence of other laryngeal pathology
• Esophageal dysmotility
• Gastroesophageal reflux
• Currently on anti-reflux medications
• Presence of a neurologic condition
• Active smoking
• Currently pregnant
• Individuals unable to consent for themselves
• Recent upper respiratory infection lasting more than 1 month
• Prior treatment for laryngopharyngeal reflux.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Voice therapy; Evaluation is completed over two, one-hour sessions. Once the evaluation is complete, the subject will begin weekly, individual voice therapy for 55 minute sessions per week with a second year graduate student under the direct supervision of the clinical faculty member.Treatment sessions will include a counseling component and an active exercise program.	Behavioral: Voice therapy; Evaluation is completed over two, one-hour sessions. Once the evaluation is complete, the subject will begin weekly, individual voice therapy for 55 minute sessions per week with a second year graduate student under the direct supervision of the clinical faculty member.Treatment sessions will include a counseling component and an active exercise program.
Active Comparator: Antireflux medication; Intervention includes treatment with one of the following: Omeprazole- Dose range oral, 20mg once a day, up to 40mg twice a day; Lansoprazole-Dose range 15mg per day- 30mg twice a day; Esomeprazole- Dose range oral, 20mg once a day, up to 40mg twice a day; Rantidine-Dose range: 150 mg twice a day or 300 mg once a day.; Rantidine may be used in combination with any of the above	Drug: Omeprazole, Lansoprazole, Esomeprazole, Rantidine; 1.Omeprazole- Dose range oral, 20mg once a day, up to 40mg twice a day 2.Lansoprazole-Dose range 15mg per day- 30mg twice a day 3.Esomeprazole- Dose range oral, 20mg once a day, up to 40mg twice a day 4.Rantidine-Dose range: 150 mg twice a day or 300 mg
Experimental: Voice therapy and Anti-reflux therapy; Subjects will receive both anti-reflux medication as detailed above and voice therapy as detailed above.	Other: Combination of anti-reflux medication and voice therapy; Subjects will receive both anti-reflux medication as detailed above and voice therapy as detailed above.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of pre and post treatment voice outcomes in LPR-related dysphonia based on pre and post treatment CAPE-V Scores	Voice outcomes in patients with LPR related dysphonia treated with voice therapy, anti-reflux therapy, or a combination will be compared based on consensus auditory perceptual evaluation-voice scores	3 months
Comparison of treatment outcomes in laryngeal reflux findings based on RFS scores	Reflux finding scores based on laryngoscopy findings will be obtained at the beginning of the study and after treatment. Subjects treated with voice therapy, anti-reflux medication, or a combination will be compared.	3 months
Comparison of treatment outcomes in laryngeal reflux symptoms based on RSI scores	Reflux symptom index is a questionnaire subjects will fill out before the study and after treatment. Subjects treated with voice therapy, anti-reflux medication, or a combination will be compared.	3 months

Collaborators and Investigators

• Sponsor: Temple University
• Investigators: Principal Investigator: Nausheen Jamal, MD, Temple Hospital faculty member

Publications and helpful links

General Publications

• Fusconi M, De Virgilio A, Conte M, Colicchio MG, Gallo A, Greco A, Ralli G, de Vincentiis M. The importance of the number of reflux episodes in the diagnosis of laryngopharyngeal reflux disease. Otolaryngol Head Neck Surg. 2013 Feb;148(2):261-6. doi: 10.1177/0194599812466534. Epub 2012 Nov 2.
• Hicks DM, Ours TM, Abelson TI, Vaezi MF, Richter JE. The prevalence of hypopharynx findings associated with gastroesophageal reflux in normal volunteers. J Voice. 2002 Dec;16(4):564-79. doi: 10.1016/s0892-1997(02)00132-7.
• Koufman JA, Aviv JE, Casiano RR, Shaw GY. Laryngopharyngeal reflux: position statement of the committee on speech, voice, and swallowing disorders of the American Academy of Otolaryngology-Head and Neck Surgery. Otolaryngol Head Neck Surg. 2002 Jul;127(1):32-5. doi: 10.1067/mhn.2002.125760. No abstract available.
• Karkos PD, Wilson JA. Empiric treatment of laryngopharyngeal reflux with proton pump inhibitors: a systematic review. Laryngoscope. 2006 Jan;116(1):144-8. doi: 10.1097/01.mlg.0000191463.67692.36.
• Park JO, Shim MR, Hwang YS, Cho KJ, Joo YH, Cho JH, Nam IC, Kim MS, Sun DI. Combination of voice therapy and antireflux therapy rapidly recovers voice-related symptoms in laryngopharyngeal reflux patients. Otolaryngol Head Neck Surg. 2012 Jan;146(1):92-7. doi: 10.1177/0194599811422014. Epub 2011 Sep 9.

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: August 6, 2015
• First Submitted That Met QC Criteria: August 19, 2015
• First Posted (Estimate): August 21, 2015

Study Record Updates

• Last Update Posted (Actual): May 18, 2018
• Last Update Submitted That Met QC Criteria: May 15, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Laryngeal Diseases; Gastroesophageal Reflux; Laryngopharyngeal Reflux; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole; Omeprazole; Esomeprazole
• Other Study ID Numbers: 22455

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data will be shared with participants at the completion of the 3 month study period

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No