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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-07-31

Brief Summary

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* 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

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Detailed Description

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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.

Conditions

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Gastroesophageal Reflux Disease (GERD) Chronic Laryngitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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reflux laryngitis group pre-treatment

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.

omeprazole

Intervention Type DRUG

omeprazole 40 mg twice a day for 16 weeks; dietary and lifestyle changes

study group - post treatment

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

omeprazole

Intervention Type DRUG

omeprazole 40 mg twice a day for 16 weeks; dietary and lifestyle changes

control group

healthy controls paired by gender and age that do not present symptoms and videolaryngoscopic signs suggestive of reflux laryngitis

omeprazole

Intervention Type DRUG

omeprazole 40 mg twice a day for 16 weeks; dietary and lifestyle changes

Interventions

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omeprazole

omeprazole 40 mg twice a day for 16 weeks; dietary and lifestyle changes

Intervention Type DRUG

Other Intervention Names

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reflux group pre-treatment reflux group post-treatment control group

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes