Predictors of Outcome in an Open Label, Therapeutic Trial of High-Dose Omeprazole in Laryngitis

Department of Gastroenterology, St George Hospital, University of New South Wales, Sydney, Australia.
The American Journal of Gastroenterology (Impact Factor: 10.76). 06/2004; 99(5):777-85. DOI: 10.1111/j.1572-0241.2004.04151.x
Source: PubMed


Gastroesophageal reflux is implicated in some cases of laryngitis. There are no established predictors of response to acid suppression therapy in suspected reflux laryngitis.
In a population with laryngitis, the aim is to determine whether (a) omeprazole 20 mg tds (3 months) improves symptoms and laryngitis, and (b) the outcome in response to potent acid suppression can be predicted by esophageal and/or pharyngeal parameters during ambulatory pH monitoring or by other pretreatment variables.
From the 70 consecutive patients with laryngitis screened, 20 patients met the inclusion criteria (dysphonia >3 months; laryngoscopically demonstrated laryngitis); and 50 patients were excluded because of one or more criteria indicating alternative causes for laryngeal injury. The primary outcome measure was improvement of at least one level in a 4-point laryngitis grading at 3 months. Twenty-four-hour dual, pharyngo-esophageal pH monitoring was performed at baseline. Secondary outcomes (symptom questionnaire; computerized voice analysis) were measured at baseline, and at 6 and 12 wk.
Response rates at 6 and 12 wk were 47% and 63%, respectively. GERD symptoms (heartburn (p= 0.03) and regurgitation (p= 0.0001)) improved. However, neither baseline GERD symptoms nor endoscopic findings predicted laryngoscopic or symptomatic response. Neither baseline laryngitis grade (p= 0.46) nor esophageal acid exposure on pH testing (p= 0.3) predicted outcome. Four of 20 patients demonstrated pharyngeal regurgitation on pH testing, all four of whom responded to potent acid suppression (p= 0.2). Computerized voice measures were not predictive of outcome, although fundamental frequency (Fo) was inversely related to baseline laryngoscopic grade.
In a carefully defined population of patients with laryngitis (a) 63% have a laryngoscopic response to 3 months of potent acid suppression without significant improvement in laryngeal symptoms; (b) neither voice measures, esophageal acid exposure time, symptoms nor severity of laryngitis predict outcome; and (c) although numbers were small, all patients with a positive pharyngeal pH study responded to therapy and pharyngeal pH-metry may prove useful; (4) available evidence supports an empiric trial of high-dose proton pump inhibitors (PPI), for at least 12 wk, as the initial diagnostic step for suspected reflux laryngitis.

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    • "Patients with less severe GI symptoms (lower scores on ReQuest™-GI) showed a better response to pantoprazole treatment. Previous reports have shown that treatment outcome may be predicted by symptom severity before or shortly after commencing treatment [31–35]. Previously reported results for the total population suggest that ReQuest™ scores at baseline have some predictive ability for outcomes at Week 8, although the authors suggested that the predictive accuracy may be lower than physicians would wish [4]. "
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    ABSTRACT: Predicting response to proton pump inhibitor (PPI) treatment can aid the effective management of gastroesophageal reflux disease (GERD). The aim was to investigate the predictors of symptomatic response to pantoprazole in Asian patients with GERD; the first study of its kind in Asian patients. Asian patients with GERD symptoms (N = 209) received pantoprazole 40 mg daily for 8 weeks in a multinational, prospective, open-label study. Response was assessed using ReQuest™. Baseline and demographic factors were examined using logistic regression to determine if they were related to treatment response. Response rates were 44.3% (Week 4) and 63.6% (Week 8) in Asian patients versus 60.7% (P < 0.001) and 72.2% (P = 0.010) for the rest of the world. Higher response rates at 8 weeks occurred in patients with erosive reflux disease (ERD; 71.3%) versus those with non-erosive reflux disease (NERD) at baseline (48.5%). The presence of ERD (P = 0.0143) and lower ReQuest™-GI scores at baseline (P = 0.0222) were associated with response. Improvements in quality of life (QoL) and anxiety and depression at 4 and 8 weeks were associated with treatment response (both P < 0.0001). Patient satisfaction correlated with treatment response (P < 0.0001), and improvement in anxiety and depression (P < 0.0001) and QoL (P < 0.0001). Asian patients with GERD, especially those with NERD, may have lower response rates to PPIs than Western populations. ERD and less severe gastrointestinal symptoms may help to predict symptomatic responses to PPIs in Asian patients. Trial Registration identifier: NCT00312806.
    BMC Gastroenterology 09/2014; 14(1):156. DOI:10.1186/1471-230X-14-156 · 2.37 Impact Factor
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    • "Presence of abnormalities in the inter-arytenoid mucosa and true vocal folds were associated with a favorable response to PPI therapy (19). However, the presence of reflux symptoms or reflux findings was not a reliable predictor of good response to PPI (20, 21). In accordance with these previous reports, we could not define reliable symptoms or physical findings for prediction of response to PPI medication. "
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    ABSTRACT: The aims of this study were to determine the benefits of short-term empirical proton pump inhibitor (PPI) medication on laryngopharyngeal reflux (LPR) and to determine whether scores on the reflux symptom index (RSI) and the reflux finding score (RFS) could be combined to identify subgroups of patients that will more likely to improve with this medication. Fifty-one Korean Otolaryngology Board-certified specialists joined this prospective, multi-center, and open-label observational study. A total of 1,142 adult patients with LPR was enrolled for 12 weeks of rabeprazol medication. According to pre-treatment scores on RSI and RFS, patients were divided into 4 subgroups. RFS and RSI were measured repeatedly with a month interval along the treatment period. Changes of RSI and RFS were analyzed in an overall study cohort as well as in each subgroup. Approximately 40% (n=455) of enrolled patients were followed up until 12 weeks of PPI treatment. Significant improvement in RSI was obtained in 29%, 58%, and 75% of patients after 4, 8, and 12 weeks of PPI medication. RFS was improved in 16%, 42%, and 57% of the patients with 4, 8, and 12 weeks of PPI medication. All subgroups showed improvement regardless of their pre-treatment scores on the RSI and RFS. Even though RSI and RFS may be used as a general guideline for LPR management, pre-treatment RSI and RFS are not useful in predicting the patients' response to short-term PPI medication in the usual pattern of practice for LPR, which is mostly based on the physical evaluation and history taking.
    Clinical and Experimental Otorhinolaryngology 03/2012; 5(1):28-33. DOI:10.3342/ceo.2012.5.1.28 · 0.85 Impact Factor
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    • "Reflux disease is linked to, but is not indicative of supra-esophageal complications of reflux[2], [17]–[20] and even asymptomatic individuals exhibit occasional gastro-esophageal reflux events. This suggests the existence of a mechanism protecting the airways from gastro-esophageal reflux. "
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    ABSTRACT: Esophago-pharyngeal regurgitation is implicated in various otolaryngologic and respiratory disorders. The pathophysiological mechanisms causing regurgitation are still largely unknown. To determine the principal mechanisms behind esophago-pharyngeal regurgitation. We studied 11 patients with extra-esophageal GORD symptoms in whom esophago-pharyngeal acid regurgitation had previously been demonstrated using ambulatory, dual (pharyngo-esophageal) pH metry (>2 episodes/day using previously validated pH-metric criteria). Patients underwent continuous, 24 hr, stationary monitoring of pharyngo-esophageal manometry and dual (pharyngeal and esophageal) pH recordings. They were intubated with a 14-channel manometric assembly incorporating 2 sleeve sensors monitoring the upper and lower esophageal sphincters simultaneously. A dual pH catheter recorded pH signals 2 cm above the UES midpoint and 7 cm above the LES midpoint. A total of 32 episodes of spontaneous esophago-pharyngeal acid regurgitation were recorded. All episodes occurred in the upright posture and 91% occurred within 3 hrs post-prandium. All regurgitation events were associated with a relaxation of the UES, which were classified as transient non-swallow related relaxations in 29 (91%) and swallow-related in the remaining 3 (9%). Straining was an additional associated factor in 41% of regurgitation events, but strain alone was not sufficient to cause esophago-pharyngeal regurgitation. Some form of active UES relaxation is necessary for regurgitation to occur. The dominant mechanism underlying esophago-pharyngeal acid regurgitation is the non-swallow related, transient UES relaxation. N/A.
    PLoS ONE 07/2011; 6(7):e22630. DOI:10.1371/journal.pone.0022630 · 3.23 Impact Factor
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