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

Gastroesophageal Reflux Disease (GERD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01389401
• Other study ID #: cescsp179/04
• Status: Completed
• Phase: N/A
• First received: July 6, 2011
• Last updated: March 5, 2013
• Start date: January 2009
• Est. completion date: July 2011

Study information

• Verified date: March 2013
• Source: Faculdade de Ciências Médicas da Santa Casa de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 72 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Laryngitis
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease (GERD)
• Laryngitis

Intervention

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

Locations

Country	Name	City	State
Brazil	Otolaryngology Department of Santa Casa School of Medicine and Hospitals of São Paulo Brazil	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Faculdade de Ciências Médicas da Santa Casa de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Eckley CA, Michelsohn N, Rizzo LV, Tadokoro CE, Costa HO. Salivary epidermal growth factor concentration in adults with reflux laryngitis. Otolaryngol Head Neck Surg. 2004 Oct;131(4):401-6. Erratum in: Otolaryngol Head Neck Surg. 2005 Feb;132(2):344. Tadakoro, Carlos Eduardo [corrected to Tadokoro, Carlos Eduardo]. — View Citation

Eckley CA, Rios Lda S, Rizzo LV. Salivary egf concentration in adults with reflux chronic laryngitis before and after treatment: preliminary results. Braz J Otorhinolaryngol. 2007 Mar-Apr;73(2):156-60. — View Citation

Rourk RM, Namiot Z, Sarosiek J, Yu Z, McCallum RW. Impairment of salivary epidermal growth factor secretory response to esophageal mechanical and chemical stimulation in patients with reflux esophagitis. Am J Gastroenterol. 1994 Feb;89(2):237-44. — View Citation

Sarosiek J, McCallum RW. Do salivary organic components play a protective role in health and disease of the esophageal mucosa? Digestion. 1995;56 Suppl 1:32-7. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	salivary EGF concentration	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	120 days	No