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Biomedical subjects

Michael F Vaezi

Publications and source records attributed to Michael F Vaezi.

At least 19 recordsLinked to original sources

Proton pump inhibitor therapy for suspected GERD-related chronic laryngitis: a meta-analysis of randomized controlled trials.

OBJECTIVE: The role of proton pump inhibitors (PPIs) in suspected GERD-related chronic laryngitis (CL) is controversial. Hence, we performed a meta-analysis of the existing randomized controlled trials (RCTs) to evaluate the efficacy of PPIs in this disorder. METHODS: Data extracted from MEDLINE (1966 to August 2005), Cochrane Controlled Trials Register (1997 to August 2005), EMBASE (1980 to August 2005), ClinicalTrials.gov website, and meetings presentations (1999-2005). Published and unpublished randomized placebo-controlled trials of PPIs in suspected GERD-related CL were selected by consensus. Random effects model was utilized with standard approaches to quality assessment, sensitivity analysis, and an exploration of heterogeneity and publication bias. The primary outcome measure was defined as the proportion of patients with >or=50% reduction in self-reported laryngeal symptoms. RESULTS: Pooled data from 8 studies (N = 344, PPI 195, placebo 149; mean age 51 yr; males 55%; study duration 8-16 wk) were analyzed. No significant quantitative heterogeneity was found among the studies (chi2= 11.22, P= 0.13). Overall, PPI therapy resulted in a nonsignificant symptom reduction compared to placebo (relative risk 1.28, 95% confidence interval 0.94-1.74). No clinical predictors of PPI response were identified on meta-regression analysis done at study level. CONCLUSIONS: PPI therapy may offer a modest, but nonsignificant, clinical benefit over placebo in suspected GERD-related CL. Validated diagnostic guidelines may facilitate the recognition of those patients most likely to respond favorably to PPI treatment.

Chronic Disease↗

Reflux-induced laryngitis (laryngopharyngeal reflux).

Gastroesophageal reflux disease (GERD) has been increasingly associated with ear, nose, and throat (ENT) signs and symptoms. This condition, often referred to as laryngopharyngeal reflux (LPR) has become increasingly prevalent. However, the cause and effect relationship between GERD and laryngeal signs or symptoms is far from established. Many patients diagnosed initially with GERD as the cause of laryngeal signs do not symptomatically or laryngoscopically respond to aggressive acid suppression and do not have abnormal esophageal acid exposure by pH monitoring. This has resulted in frustration on the part of both gastroenterologists and ENT physicians and confusion on the part of patients. The current recommendations for the management of LPR patients call for initial empiric therapy with twice daily proton-pump inhibitors (PPIs) for 2 to 4 months. In those unresponsive to such therapy, diagnostic testing with prolonged pH monitoring may be indicated. However, in the majority of such patients, the reason for lack of response to PPI therapy may be irritation of the larynx by causes other than GERD. Surgical fundoplication in this group of patients has lower efficacy than in those with typical symptoms of GERD and is reserved for those with improvement on acid-suppressive therapy.

Journal Article↗

Laryngeal cancer and gastroesophageal reflux disease: a case-control study.

PURPOSE: Gastroesophageal reflux disease (GERD) is common in patients with laryngeal cancer. However, the role of GERD in laryngeal cancer remains controversial because of poor matching and selection of inappropriate control groups in prior studies. We aimed to better understand this relationship by conducting a matched case-control study. METHODS: This study was based in a single tertiary care center over a 2-year period. Cases included all patients with a diagnosis of new laryngeal cancer presenting to the otolaryngology clinics. Two controls, derived from the internal medicine clinics, were matched to the cases on an individual basis for age (within 1 year), gender, ethnicity, and time of first visit to the institution (within 1 month). Data were extracted by chart review. Conditional logistic regression was used to assess the relationship between laryngeal cancer and GERD, tobacco, and alcohol consumption. RESULTS: A total of 96 cases were matched to 192 controls. On univariable analysis, the significant risk factors were current smoking, odds ratio (OR) 5.46 (95% confidence interval [CI], 2.59-11.50); alcohol, OR 1.97 (CI, 1.19-3.26); and GERD, OR 1.79 (CI, 1.03-3.11). On multivariable analysis, only smoking and GERD continued to be significantly associated with laryngeal cancer, OR 6.08 (CI, 2.82-13.10) and OR 2.11 (CI, 1.16-3.85), respectively. CONCLUSIONS: Smoking and GERD are significant risk factors for laryngeal cancer and may have an independent incremental risk for laryngeal carcinogenesis.

Aged↗

Surgical fundoplication in laryngopharyngeal reflux unresponsive to aggressive acid suppression: a controlled study.

BACKGROUND & AIMS: In patients with persistent laryngeal symptoms despite aggressive proton pump inhibitor therapy, gastroesophageal reflux disease (GERD) continues to be implicated. The role of surgical fundoplication as the definitive therapy for these patients is uncertain. METHODS: In this prospective concurrent controlled study, 72 patients with suspected GERD-related laryngeal symptoms received aggressive acid-suppressive therapy. Four-month symptomatic nonresponders (<50% improvement) with continued laryngeal inflammation and normalized esophageal acid exposure were offered laparoscopic Nissen fundoplication. The primary outcome was symptom improvement/resolution at 1 year after surgery. RESULTS: Twenty-five of 72 (35%) patients remained unresponsive after 4 months of acid-suppressive therapy. Ten patients (40%) underwent surgical fundoplication (median age, 54 y; men, 4) and 15 patients (60%) continued medical therapy (median age, 52; men, 4). The most common laryngeal symptoms were sore throat, hoarseness, and cough. pH studies at 3 and 12 months were normal in all patients after fundoplication (median % time pH < 4, .0% and .3%; respectively). One of 10 (10%) patients in the surgery group reported improvement of laryngeal symptoms at 1 year compared with 1 of 15 in the control group (6.7%) (P = 1.0). Treatment of causes other than GERD improved symptoms in an additional 2 of 10 (20%) patients in the surgical group, and 10 of 15 (66%) patients in the nonsurgical cohort. CONCLUSIONS: Surgical fundoplication does not improve laryngeal symptoms reliably in patients unresponsive to aggressive proton pump inhibitor therapy. The argument of low volume or intermittent reflux as the cause of persistent laryngeal symptoms needs to be replaced with evaluation and therapy for other potential non-GERD causes.

Adult↗

Should we bravo?

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Cohort Studies↗

Treatment of chronic posterior laryngitis with esomeprazole.

OBJECTIVE: To evaluate the efficacy of acid-suppressive therapy with the proton pump inhibitor esomeprazole on the signs and symptoms of chronic posterior laryngitis (CPL) in patients with suspected reflux laryngitis. STUDY DESIGN: Prospective, multicenter, randomized, parallel-group trial that compared twice-daily esomeprazole 40 mg with placebo for 16 weeks. METHODS: Eligible patients had a history of one or more CPL symptoms (throat clearing, cough, globus, sore throat, or hoarseness) and laryngoscopic signs indicating reflux laryngitis based on CPL index (CPLI) scores measured during a screening laryngoscopy. Patients were randomized to treatment if their 7-day screening diary-card recordings showed a cumulative primary symptom score of 9 or higher and they had 3 or more days with moderately severe symptoms based on a 7-point scale. Efficacy was assessed by changes in symptoms as recorded by patients and investigators and by changes in CPLI scores based on laryngoscopic examinations. RESULTS: The patients' primary CPL symptom at final visit (primary efficacy end point) was resolved in 14.7% (14/95) and 16.0% (8/50) of patients in the esomeprazole and placebo groups, respectively (P=.799). Esomeprazole and placebo were not significantly different for change from baseline to the final visit in mean total CPLI (-1.66+/-2.13 vs. -2.0+/-2.55, respectively; P=.446) or any other secondary efficacy end points based on patient diary card or investigator assessments. CONCLUSION: This study provides no evidence of a therapeutic benefit of treatment with esomeprazole 40 mg twice daily for 16 weeks compared with placebo for signs and symptoms associated with CPL.

Adult↗

Chronic laryngitis associated with gastroesophageal reflux: prospective assessment of differences in practice patterns between gastroenterologists and ENT physicians.

OBJECTIVES: Ear, nose, and throat (ENT) physicians often diagnose gastroesophageal reflux disease (GERD)-related laryngitis on the basis of symptoms and laryngeal signs; and may refer patients to gastroenterologists who contend that many such patients do not have reflux. Because of this dichotomy we designed this study to assess the practice pattern differences among ENT physicians and gastroenterologists in relation to the diagnosis and treatment of patients with GERD-related laryngitis. METHODS: Separate surveys were specifically designed for ENT physicians and gastroenterologists to assess the following: the percentage of patients diagnosed with GERD-related laryngitis, dose and duration of therapy, treatment response, and other diagnostic options in nonresponders. A total of 2000 surveys were mailed randomly to members of both the American Academy of Otolaryngology Head and Neck Surgery and the American Gastroenterological Association. RESULTS: Of the total 4,000 surveys sent, 782 (39%) ENT physicians and 565 (28%) gastroenterologists responded. Most respondents (both specialties) were private practitioners (82% and 74%, respectively). From the ENT survey, the diagnosis was most commonly suspected based on the following symptoms: globus = throat clearing > cough > hoarseness. The most useful signs were laryngeal erythema and edema reported by 70% of respondents. Seventy-four percent of ENT physicians reported they made the diagnosis more on symptoms than on laryngeal signs, and initiated therapy most often with proton pump inhibitor (PPI) once daily for 2 months. Gastroenterologists were divided on pre-therapy testing, 50% reporting testing with esophagogastro-duodenoscopy followed by pH monitoring (distal > proximal) prior to therapy, while the remaining 50% reported treating empirically with PPI twice daily for 3 months. Seventy percent of gastroenterologists reported treatment response of less than 60%, while 62% of ENT physicians reported response rate of greater than 60% (p < 0.05). CONCLUSIONS: (1) Globus and throat clearing were considered the most useful symptoms in diagnosing GERD-related laryngitis, while laryngeal erythema and edema were considered the most useful signs for diagnosis and treatment of this condition by ENT physicians. However, these symptoms and signs may represent the least specific markers for reflux. (2) Many gastroenterologists perform pre-therapy testing which has low sensitivity in GERD-related laryngitis. (3) There is a dichotomy in treatment dose, duration, and perceived patient response to therapy between the two specialists. (4) Our study highlights a need for cross communication and education between these two disciplines in understanding and treating GERD-related laryngitis better.

Anti-Ulcer Agents↗

A physiologic clinical study of achalasia: should Dor fundoplication be added to Heller myotomy?

OBJECTIVE: Myotomy for achalasia disrupts the lower esophageal sphincter, improving emptying at the expense of reflux. We hypothesized that surgical palliation of achalasia requires balancing desirable improvement in esophageal emptying with undesirable production of gastroesophageal reflux. Therefore, we objectively studied the physiologic effects of adding Dor fundoplication to Heller myotomy. METHODS: From December 1996 to June 2004, 149 patients underwent Heller myotomy; 88 (59%) had additional Dor fundoplication. The adequacy of myotomy was assessed by premyotomy to postmyotomy change in lower esophageal sphincter pressures, esophageal emptying by change in timed barium esophagram, and gastroesophageal reflux by postoperative 24-hour pH monitoring. RESULTS: For adequacy of myotomy, postmyotomy resting lower esophageal sphincter pressure was higher with (median, 18 mm Hg) than without (median, 13 mm Hg) Dor fundoplication (P = .002), as was residual lower esophageal sphincter pressure (median, 4.6 vs 1.8 mm Hg; P = .01). For esophageal emptying, postmyotomy barium height and width were similar with or without Dor fundoplication (P > .1). For gastroesophageal reflux, percentage of upright time with a pH of less than 4 was lower with (median, 0.4%) than without (median, 2.9%) Dor fundoplication (P = .005), and percentage of supine time with a pH of less than 4 was lower with (median, 0%) than without (median, 5.8%) Dor fundoplication (P = .007). CONCLUSIONS: The addition of Dor fundoplication reduces the adequacy of myotomy without impairing emptying and reduces reflux. Heller myotomy and Dor fundoplication balance emptying and reflux and therefore should be the surgical treatment of choice for achalasia.

Digestive System Surgical Procedures↗

Does diffuse esophageal spasm progress to achalasia? A prospective cohort study.

Diffuse esophageal spasm (DES) and achalasia share both clinical and manometric characteristics. Some reports support the notion of progression of DES to achalasia. However, there are currently no prospective data in support of this theory. To assess prospectively the rate of manometric progression of DES to achalasia. Manometry tracings of DES patients diagnosed between 1992 and 2003 were independently reviewed blindly and agreed on by two esophageal experts. Patients with DES who agreed to undergo repeat esophageal manometry constituted the study cohort. Follow-up manometry tracings were evaluated blindly and independently by the same two interpreters to determine the rate of manometric progression to achalasia. Predictors of manometric progression were assessed. A total of 32 patients were diagnosed with DES between 1992-2003. Twelve patients (9M/3F; median age 62 years) agreed to participate and underwent second manometry (mean +/- SD follow-up of 4.8 +/- 3.4 years). Achalasia was diagnosed on follow-up manometry in one patient (8%), seven (58%) patients continued to have DES, three (25%) had normal motility, and one (8%) had nutcracker esophagus. There were no predictors of progression to achalasia based on the initial manometry parameters. A subgroup of DES patients with initial low esophageal body amplitude developed increase in esophageal simultaneous contractions on follow-up similar to the patient who evolved to achalasia. Following were the results. 1) Progression from DES to achalasia is uncommon. 2) DES patients with low esophageal body amplitude may develop increased simultaneous contractions over time. 3) DES remains an elusive diagnosis clinically and manometrically.

Aged↗

Esophageal impedance recording: clinical utility and limitations.

Multichannel intraluminal impedance (MII) is a new technique available for the evaluation of esophageal bolus transit and reflux similar to barium swallow, but without the hazards of radiation exposure. Combined MII and pH monitoring (MII-pH) allows evaluation of the nature and pH of the refluxate and the proximal extent of a reflux event. Thus, MII-pH is useful in evaluation of nonacid reflux in patients with persistent typical or atypical symptoms of gastroesophageal reflux disease that are refractory to acid suppression therapy. Additionally, combined MII and esophageal manometry (MII-EM) affords concurrent assessment of esophageal function (bolus transit) and motility. Therefore, it provides a more complete esophageal function test than esophageal manometry alone. The few limitations of impedance monitoring include the complexity of interpreting the tracings and the lack of data in the diseased population. However, continued improvements in the software and increasing studies in different patient populations will aid in overcoming these limitations.

Electric Impedance↗

The role of pH monitoring in extraesophageal gastroesophageal reflux disease.

Gastroesophageal reflux disease (GERD) is linked to several extraesophageal disease states including laryngitis, asthma, chronic cough, and noncardiac chest pain (NCCP). Although 24-hour pH monitoring is considered the "gold standard" in the diagnosis of typical GERD, it is also increasingly used in establishing the diagnosis of GERD in patients with extraesophageal symptoms. The clinical utility of pH monitoring in this patient population, however, remains controversial. In this article, the authors examine the role of pH monitoring in laryngitis, asthma, chronic cough, and NCCP.

Asthma↗

Esophageal manometry: assessment of interpreter consistency.

BACKGROUND AND AIMS: Manometry is used widely in the evaluation of esophageal disorders. Our aim was to assess the intra- and interobserver reliability of esophageal manometry and identify potential causes for diagnostic variability. METHODS: Seventy-two esophageal manometry tracings were selected randomly from archives. Eight interpreters randomly and blindly evaluated tracings. Interpreters were divided into 3 groups: highly experienced (N = 3), moderately experienced (N = 3), and inexperienced (N = 2). Each tracing was examined for abnormalities involving the lower-esophageal sphincter (LES) and esophageal body. Interpreters rendered a single diagnosis from a list of 7 manometric diagnoses: normal, nutcracker, hypertensive LES, hypotensive LES, diffuse esophageal spasm (DES), nonspecific/ineffective esophageal motility (IEM), and achalasia. Intra- and interobserver agreements were determined and reasons for varied diagnoses were investigated. RESULTS: Overall intraobserver agreement was good (kappa = .63, P < .0001). There was no difference ( P = .9) between the highly and midexperienced interpreters (kappa = .61 and .65, respectively). Interobserver agreement for the diagnosis of achalasia and normal motility was good (kappa = .65 and .56, respectively). However, other manometric diagnoses yielded only fair interobserver agreement (kappa = .27). DES, nonspecific/ineffective esophageal motility (IEM), and hypo- and hypertensive LES diagnoses showed the least agreement. Poor adherence to established manometric criteria, misinterpretation of intrabolus pressure, and technical inadequacy were the most common sources of inconsistency in interpretations. CONCLUSIONS: Manometric diagnoses of conditions other than normal or achalasia are variable and have poor interobserver variability. Given their uncertain clinical implications, we must either redefine them or eliminate them from practice.

Adult↗

Therapy Insight: gastroesophageal reflux disease and laryngopharyngeal reflux.

Gastroesophageal reflux disease has been increasingly associated with ear, nose and throat signs and symptoms; however, the cause and effect relationship between these two clinical entities is far from established. Many patients initially diagnosed with gastroesophageal reflux disease as the cause of laryngeal signs do not respond either symptomatically or laryngoscopically to aggressive acid suppression, and do not have abnormal esophageal acid exposure as measured by pH monitoring. This has resulted in frustration on the part of both gastroenterologists and ear, nose and throat physicians, and confusion on the part of patients. This review discusses the reasons for this controversy and highlights data that attempt to clarify this complex area.

Anti-Ulcer Agents↗

Is GERD a risk factor for laryngeal cancer?

OBJECTIVE/HYPOTHESIS: The significance of gastroesophageal reflux disease (GERD) in laryngeal cancer is controversial due to disparate studies. To evaluate the overall strength of the association of GERD with laryngeal cancer, we performed meta-analysis of the original studies in literature. STUDY DESIGN: Meta-analysis. METHODS: All studies cited on Ovid Medline (1966-June 2004), EMBASE (1980-June 2004), and Cochrane database describing GERD and laryngeal cancer were eligible for inclusion. The inclusion criteria for the study included original controlled study design and a clear documentation of the reflux prevalence in cases and controls. Statistical analysis was performed by NCSS software. RESULTS: Fifteen original studies were identified. Eight studies did not have control groups, two studies did not clearly document GERD prevalence in controls, and two studies were published using the same data, one of which was included in this meta-analysis. Thus, four studies qualified for inclusion for the meta-analysis. The methodologic quality in the studies was heterogeneous, not only in the evaluation of confounding risk factors such as smoking and alcohol but also in the mode of GERD diagnosis. There was also significant heterogeneity of effect of reflux among the studies (P = .001). The pooled odds ratio on the basis of fixed-effects model was 2.86 (95% CI, 2.73-2.99), and on the basis of random-effects model was 2.37 (95% CI 1.38-4.08). CONCLUSION: Our meta-analysis suggests that GERD may be a significant risk factor for laryngeal cancer. However, given the heterogeneity of the published data, future prospective controlled studies are needed.

Confounding Factors, Epidemiologic↗

Laryngopharyngeal reflux: prospective cohort study evaluating optimal dose of proton-pump inhibitor therapy and pretherapy predictors of response.

PURPOSE: Laryngopharyngeal reflux (LPR) is frequently treated with empiric proton-pump inhibitors (PPI), but the optimal dosing and duration is unknown. We performed an open label prospective cohort study to evaluate whether twice-daily (BID) PPI is more effective than once-daily (QD) PPI for the treatment of LPR. METHODS: Patients diagnosed with LPR based on ear, nose, and throat (ENT) symptoms and laryngoscopy findings were enrolled. Questionnaire assessed demographics, ENT symptoms, symptom severity, and exposure to other potential laryngeal irritants. Esophageal manometry, ambulatory 24-hour pH monitoring, and upper gastrointestinal endoscopy were performed before initiation of therapy. Patients were consecutively assigned to three groups: BID PPI (lansoprazole 30 mg BID), BID PPI + H2 receptor antagonist (H2RA; omeprazole 20 mg BID + ranitidine 300 mg each night), or QD PPI (esomeprazole 40 mg QD). Greater than 50% primary symptom improvement from baseline defined symptom response. At 2 month follow-up, the same PPI dose was continued for responders, and PPIs were doubled for nonresponders for an additional 2 months. Repeat symptom assessment and laryngoscopy performed at 4 month follow-up. RESULTS: Eighty-five patients were enrolled (median age 49 years, interquartile range 44.0 - 65.0; 76% white; 34% male). Treatment groups were BID PPI for 30 patients, BID PPI + H2RA for 30 patients, and QD PPI for 25 patients. RESPONSE TO THERAPY: At 2 months, BID response occurred among 15 of 30 (50%) patients, BID + H2RA for 15 of 30 (50%), and QD for 7 of 25 (28%) (P = .03). No statistical difference found between the two BID PPI groups with and without H2RA. Among the QD group nonresponders, 7 of 13 (54%) achieved symptom response with additional 2 months of BID dosing. At 4 month follow-up, an additional 22% of responses were obtained from the two BID groups (43/60, 72%). The overall response rate for all three groups was 70% (54/77). PREDICTORS OF OUTCOME: Pretherapy interarytenoid mucosa and true vocal folds abnormalities were associated with twofold increase in symptom response (odds ratio 1.99 and 1.96, respectively, P = .017). CONCLUSION: BID PPI appears to be more effective than QD PPI in achieving clinical symptom response in suspected LPR. More response was achieved at 4 months compared with 2 months. Therefore, aggressive acid suppression with BID PPI for at least 4 months is warranted for treatment of LPR.

2-Pyridinylmethylsulfinylbenzimidazoles↗

Correlation between symptoms and laryngeal signs in laryngopharyngeal reflux.

OBJECTIVE/HYPOTHESIS: Laryngopharyngeal reflux (LPR) is diagnosed by the presence of laryngeal signs and symptoms. Some studies have noted that signs and symptoms may be nonspecific and may have poor correlation. However, many such studies were either observational or had short-term follow-up. Therefore, we conducted subgroup analysis of a prospective concurrent controlled study with a 1 year follow-up to study the correlation between signs and symptoms. STUDY DESIGN: Prospective study. METHODS: Seventy-two patients with suspected gastroesophageal reflux disease related laryngeal symptoms/signs received a 4 month trial of aggressive acid-suppressive therapy. Four month symptomatic nonresponders (<50% improvement) with continued laryngeal inflammation and normalized esophageal acid exposure were then offered laparoscopic Nissen fundoplication. The primary outcome was laryngeal symptom-sign correlation at 1 year postsurgery. RESULTS: Twenty-five of 72 (35%) patients remained unresponsive after 4 months of aggressive acid suppressive therapy. Ten (40%) patients agreed to undergo surgical fundoplication (mean age = 50, male = 4). The most common laryngeal symptoms were sore throat (40%), hoarseness (30%), and cough (20%), whereas the most common signs were medial arytenoid wall erythema/edema (60%), interarytenoid erythema (50%), and arytenoid complex erythema/edema (50%). At 1 year postfundoplication, laryngeal symptoms improved in only 1 of 10 (10%) patient, whereas signs improved in 8 of 10 (80%) patients. CONCLUSIONS: There appears to be poor correlation between signs and symptoms of LPR, particularly when monitoring therapeutic outcomes. In patients unresponsive to twice-daily proton-pump inhibitor therapy for 4 months, further aggressive therapy is unlikely to bring additional symptomatic benefit.

Anti-Ulcer Agents↗