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

Phase

N/A

Condition

Common Cold

Gastroesophageal Reflux Disease (Gerd)

Non-ulcer Dyspepsia (Nud)

Treatment

N/A

Clinical Study ID

NCT01389401

cescsp179/04

Ages 19-72
All Genders
Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

study group:
symptoms of reflux laryngitis (Reflux Symptom Index- RSI >13) andvideolaryngoscopic 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

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

January 01, 2009

July 31, 2011

Study 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.

Connect with a study center

Otolaryngology Department of Santa Casa School of Medicine and Hospitals of SÃ£o Paulo Brazil
SÃ£o Paulo, 01222-000
Brazil
Site Not Available
Otolaryngology Department of Santa Casa School of Medicine and Hospitals of São Paulo Brazil
São Paulo, 01222-000
Brazil
Site Not Available

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