Predictors of outcome in an open label, therapeutic trial of high-dose omeprazole in laryngitis
ABSTRACT 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.
- SourceAvailable from: Peter Bytzer
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- "Other outcome measures have included changes in lifestyle factors related to refl ux, changes in the SF-36 generic quality of life questionnaire and changes in voice quality as assessed by a computerized voice analysis (Steward et al 2004; Williams et al 2004). "
ABSTRACT: There is a lack of consistent guidelines and consensus for the diagnosis of laryngopharyngeal reflux (LPR). A therapeutic trial with a proton pump inhibitor (PPI) has been suggested to identify patients with LPR. This review focuses on the current difficulties in diagnosing the disease and examines the evidence for the effectiveness of PPI therapy in suspected reflux-related laryngeal symptoms. Additionally, mode of action, safety, and tolerability of PPIs are described. A total of 7 placebo-controlled trials were identified and included in the review. All studies evaluated the effect of a PPI on symptoms and objective laryngoscopic findings in suspected LPR. Data from these trials show that PPI therapy is no more effective than placebo in producing symptom relief in patients suspected of LPR. Symptoms, laryngoscopic findings, or abnormal findings on pH monitoring will not predict response to PPI therapy. High placebo response levels suggest a much more complex and multifactorial pathophysiology of LPR than simple acid reflux. Further studies are needed to characterize subgroups of patients with reflux-associated laryngeal symptoms that might benefit from treatment with PPI. Future studies should use validated patient reported outcome measures with endpoints that represent a predefined clinically meaningful change in symptom scores.Therapeutics and Clinical Risk Management 03/2008; 4(1):225-33. · 1.47 Impact Factor
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- "The open-labeled studies in LPR have shown response rates ranging from 47% to 90% using PPIs (Kamel et al, 1994; Wo et al, 1997; Williams et al, 2004; Park et al, 2005). A cohort study using high-dose omeprazole therapy (20 mg three times a day) showed a response rate of 47% and 63% at 6 and 12 weeks post-therapy, respectively (Williams et al, 2004). A recent uncontrolled study of patients with suspected LPR found an overall response rate of 70% after 4 months of Extra-esophageal manifestations of gastroesophageal reflux F Farrokhi and MF Vaezi twice-daily PPI therapy. "
ABSTRACT: Gastroesophageal reflux disease (GERD) is a common medical condition affecting approximately 35-40% of the adult population in the western world. The role of GERD in causing extra-esophageal symptoms including laryngitis, asthma, cough, chest pain, and dental erosions is increasingly recognized with renewed interest among gastroenterologists and other specialists. Direct injury by mucosal contact, and vagally mediated reflex from distal esophageal acid exposure are the two possible mechanisms by which reflux-related extra-esophageal tissue injuries may occur. Several investigational techniques may be used to diagnose gastroesophageal reflux; however, because of the poor sensitivity of endoscopy and pH monitoring, and the poor specificity of laryngoscopy, empiric therapy with proton-pump inhibitors (PPI) is now considered the initial diagnostic step in patients suspected of having GERD-related symptoms. In those who improve with such therapy, it is likely that GERD may be the cause of the extra-esophageal presentation. In those who are unresponsive to such therapy, other diagnostic testing such as impedance/pH monitoring may be reasonable in order to exclude continued acid or weakly acid reflux. However, PPI-unresponsive patients usually have causes other than GERD for the extra-esophageal symptoms and signs.Oral Diseases 08/2007; 13(4):349-59. DOI:10.1111/j.1601-0825.2007.01380.x · 2.40 Impact Factor
Article: 入院患者のサルモネラ保菌率およびその分離のための増菌培地の比較[Show abstract] [Hide abstract]
ABSTRACT: サルモネラ分離に際してRappaport培地,strontium chlorideブイヨン,strontium seleniteブイヨンおよびselenite Fブイヨンの4種の増菌培地を用い,その成績を比較した.その結果,Rappaport培地にstrontium seleniteブイヨンを併用すると,サルモネラの各種類の分離に最も満足すべき成績がえられた.これらの培地を用いて,下痢を全く伴わない患者,胃腸炎あるいはチフス性疾患の患者3,325名についてサルモネラ保菌率を検査した.その結果,22の血清型に属する189株のサルモネラを分離した.検出率は5.6%である.その血清型は,食中毒の原因と推定されたものから,チフス性疾患の原因菌に至るさまぎまの型が含まれていたが,最も多く分離されたのはS. derbyとS. anatumであった.また,Clonorchis sinensisに感染していた患者は,他の腸寄生虫感染者あるいは非感染者より高率にサルモネラを保有していた The efficiencies of Rappaport medium, strontium chloride, strontium selenite and selenite F broths for enrichment in the isolation of salmonellas from human stools were compared. The study showed that Rappaport medium when used in conjunction with strontium selenite broth gave the most satisfactory result, because they covered the isolation of a wider range of salmonellas. With these media, the carriage rate of Salmonella serotypes of 3,325 hospital patients who were admitted without complaints of diarrhoea or gastroenteritis or enteric fever, were tested. The result revealed that 5.6% of them carried Salmonella serotypes ranging from those that may produce food-poisoning to those which are causal agents of enteric fever. Moreover, patients who were infected with the liver-fluke, Clonorchis sinensis, had a higher carriage rate than those who were infected with other intestinal parasites or non-infected