Ana Danic Hadzibegovic1,2,3, Ana Kozmar4, Irzal Hadzibegovic5,6,7,8, Drago Prgomet9,10, Davorin Danic6. 1. Clinical Department for Otorhinolaryngology and Head and Neck Surgery, University Hospital Centre Zagreb, Kišpatićeva 12, 10000, Zagreb, Croatia. ana_djanic@yahoo.com. 2. Faculty of Medicine, Josip Juraj Strossmayer University of Osijek, Osijek, Croatia. ana_djanic@yahoo.com. 3. Faculty of Dental Medicine and Health Care, Josip Juraj Strossmayer University of Osijek, Osijek, Croatia. ana_djanic@yahoo.com. 4. Department of Laboratory Diagnostics, University Hospital Center Zagreb, Zagreb, Croatia. 5. Faculty of Medicine, Josip Juraj Strossmayer University of Osijek, Osijek, Croatia. 6. Faculty of Dental Medicine and Health Care, Josip Juraj Strossmayer University of Osijek, Osijek, Croatia. 7. Department for Cardiology, University Hospital Dubrava, Zagreb, Croatia. 8. Department for Internal Medicine, University Hospital Dubrava, Zagreb, Croatia. 9. Clinical Department for Otorhinolaryngology and Head and Neck Surgery, University Hospital Centre Zagreb, Kišpatićeva 12, 10000, Zagreb, Croatia. 10. School of Medicine, University Zagreb, Zagreb, Croatia.
Abstract
PURPOSE: It has been shown that the reflux of the gastric content to the proximal oesophagus influences incidence of voice prosthesis (VP) complications in laryngectomized patients. We conducted prospective randomised study to investigate the relationship between pepsin concentration in saliva and occurrence of VP complications before and after 3 months of proton pump inhibitor (PPI) therapy. METHODS:60 laryngectomized patients with VP and 30 controls were included in the study. Saliva samples were collected in the morning and concentration of pepsin were measured by Human Pepsin (PG) ELISA kit. Thirty-Four (57%) patients reported one or more VP complication and were randomised in two groups, with and without PPI therapy, 40 mg pantoprazole per day for 3 months. RESULTS: Patients who had longer time since last VP change had higher incidence of periprosthetic and transprosthetic leakage and Candida colonisation. Pepsin was found in all saliva samples. Median saliva pepsin concentration level did not significantly differ between laryngectomized patients and control subjects, or between patients with and without VP complications, and there was no correlation between saliva pepsin concentration levels and type of VP complication. After 3 months therapy, there was no difference in median saliva pepsin level or incidence of VP complication between patients with and without PPI therapy. CONCLUSION: Although reflux was proposed to be associated with VP complications and pepsin was proven as a most sensitive and specific marker of EER, we did not find any statistically significant correlation between pepsin levels and occurrence of VP complications. A 3 months 40 mg pantoprazole therapy was ineffective in reduction of VP complications in our study group.
RCT Entities:
PURPOSE: It has been shown that the reflux of the gastric content to the proximal oesophagus influences incidence of voice prosthesis (VP) complications in laryngectomized patients. We conducted prospective randomised study to investigate the relationship between pepsin concentration in saliva and occurrence of VP complications before and after 3 months of proton pump inhibitor (PPI) therapy. METHODS: 60 laryngectomized patients with VP and 30 controls were included in the study. Saliva samples were collected in the morning and concentration of pepsin were measured by Human Pepsin (PG) ELISA kit. Thirty-Four (57%) patients reported one or more VP complication and were randomised in two groups, with and without PPI therapy, 40 mg pantoprazole per day for 3 months. RESULTS:Patients who had longer time since last VP change had higher incidence of periprosthetic and transprosthetic leakage and Candida colonisation. Pepsin was found in all saliva samples. Median saliva pepsin concentration level did not significantly differ between laryngectomized patients and control subjects, or between patients with and without VP complications, and there was no correlation between saliva pepsin concentration levels and type of VP complication. After 3 months therapy, there was no difference in median saliva pepsin level or incidence of VP complication between patients with and without PPI therapy. CONCLUSION: Although reflux was proposed to be associated with VP complications and pepsin was proven as a most sensitive and specific marker of EER, we did not find any statistically significant correlation between pepsin levels and occurrence of VP complications. A 3 months 40 mg pantoprazole therapy was ineffective in reduction of VP complications in our study group.