Salivary Epidermal Growth Factor (EGF) Concentration Before and After Treatment of Reflux Laryngitis

Completed

• Conditions: Gastroesophageal Reflux Disease (GERD); Chronic Laryngitis
• Interventions: Drug: omeprazole

• Registration Number: NCT01389401
• Lead Sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo

Brief Summary

* Saliva plays a key role in the homeostasis of the digestive tract

* The reflux of gastroesophageal contents may cause damage to the esophageal, laryngeal and pharyngeal mucosas

* There seems to be no correlation between the severity of reflux episodes and the intensity of inflammatory changes, suggesting individual protective mechanisms to refluxate exposure

* Inorganic and Organic Salivary changes have been associated to Gastroesophageal Reflux Disease (GERD) and its supraesophageal manifestations, especially reflux laryngitis (Laryngopharyngeal Reflux- LPR)

* Decreased salivary Epidermal Growth factor (EGF) concentrations have been found in patients with GERD and LPR, but it is unclear if these are primary or secondary to the disease.

* Hypothesis: The decreased salivary EGF concentrations in patients with reflux laryngitis is primary and therefore would not change after treatment and control of the disease

Detailed Description

Background \& Aims: Gastroesophageal Reflux Disease (GERD) is known to affect the upper airways and may cause a variety of inflammatory changes in the pharynx and larynx. The pathophysiology of the supraesophageal forms of GERD is widely unknown. Studies have suggested decreased salivary epidermal growth factor (EGF) concentrations in patients with reflux esophagitis and laryngitis. It is however unclear if these abnormalities are primary or secondary. The aim of the current cohort study was to compare salivary EGF concentrations in adults with reflux laryngitis before and after treatment and control of the disease to that of healthy individuals. Methods: Twenty-one patients with reflux laryngitis were studied prospectively at a tertiary teaching hospital. Spontaneous whole saliva was sampled before and after a 16-week course of full dose proton pump inhibitor (PPI) twice daily and compared to that of 13 healthy controls. Salivary EGF concentrations were established using a commercially available Elisa kit.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2011-01
• Study Completion: 2011-07
• Study First Submitted: 2011-07-06
• Study First Submitted QC: 2011-07-07
• Study First Posted: 2011-07-08
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-05
• Last Update Posted: 2013-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• study group:

  • symptoms of reflux laryngitis (Reflux Symptom Index- RSI >13) and videolaryngoscopic signs (Reflux Finding Score - RFS >7),
  • positive 24 hour double probe esophageal PH monitoring;

• control group:

  • Reflux Symptom Index (RSI)<13
  • Reflux Finding Score (RFS) < 7

Exclusion Criteria

• tobacco, alcohol or other inhaled drug use;
• chronic or acute rhinosinusitis;
• prior history of surgery to the digestive tract or salivary glands;
• prior or current diagnosis of head and neck or digestive tract tumors;
• chronic use of drugs known to alter salivary flow and irritate the larynx, such as, diuretics, anticonvulsants, antihistamines, and inhaled steroids

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
reflux laryngitis group pre-treatment	omeprazole	adults with clinical suspicion of Reflux Laryngitis confirmed by 24-hour double probe esophageal monitoring who have not made use of any treatment in the past 15 days.
study group - post treatment	omeprazole	adults with reflux laryngitis after 16 weeks of treatment with proton pump inhibitor (omeprazole 40 mg twice a day)and dietary/lifestyle changes that present improvement in symptoms and video laryngoscopic signs of chronic laryngitis
control group	omeprazole	healthy controls paired by gender and age that do not present symptoms and videolaryngoscopic signs suggestive of reflux laryngitis

Primary Outcome Measures

Name	Time	Method
salivary EGF concentration	120 days	salivary Epidermal Growth Factor (EGF) concentrations were determined with commercially available ELISA kit from whole saliva sampled before and after treatment in study group and in healthy controls

Trial Locations

Locations (1)

Otolaryngology Department of Santa Casa School of Medicine and Hospitals of São Paulo Brazil; 🇧🇷 São Paulo, Brazil