To Determine the Prevalence of Laryngopharyngeal Reflux in Patients of Various Throat Disorders and to Evaluate the Efficacy of Anti-reflux Therapy

Abstract

To study the prevalence of Laryngopharyngeal reflux in individuals having throat complaints by applying the Reflux Symptom Index and Reflux finding score as a prognostic tool after anti reflux therapy. Materials and Methods: A Cross-sectional study of 75 patients of age 18 years and above with clinical diagnosis of Laryngopharyngeal reflux was conducted in ENT. Cases were examined with detailed history and thorough examination with indirect laryngoscopy and Hopkins 70 degree endoscope. Symptoms and findings of patients were assessed by Belafsky Reflux Symptom Index and Reflux Finding Score. Patients presenting Belafsky Reflux Symptom Index > 13 and also Reflux Finding Score > 7 were classified as having Laryngopharyngeal reflux. After 6 weeks of treatment, patients were reassessed and Reflux Symptom Index and Reflux finding score were calculated. Results: The mean age of the study subjects was 37.12 ± 12.39 years. Most common symptom reported based on RSI questionnaire was excessive throat mucus (81.33%) followed by clearing of throat (75%) and coughing on lying down and heartburn. Based on the Laryngoscopy, about 57.33% had thick endolarygeal mucus, 56% had diffuse erythema, 45.33% had granulations and 29.33% had subglottic edema. Based on the reflux symptom scores, we found 53.33% and 80% of patients based on reflux findings score to have Laryngopharyngeal Reflux. The mean Reflux Symptom Index scores were 16.25 ± 5.53 and 10.73 ± 4.40 and also the mean Reflux Finding scores were 13.81 ± 2.42 and 6.61 ± 2.16 respectively before and after the treatment which was statistically significant.

Introduction

Laryngopharyngeal reflux (LPR) is defined as the retrograde flow of the stomach contents in the larynx and pharynx, where it comes in contact with the upper aero digestive tract [1]. Laryngeal abnormalities may be caused either by direct injury or damage by a secondary mechanism [2–6]. Direct injury occurs when acid and pepsin comes into contact with laryngeal mucosa, resulting in mucosal damage [7–9]. Irritation of the distal esophagus by acid may cause a reflux mediated by the vagus nerve, resulting in chronic cough and throat clearing which may in turn produce traumatic injury to laryngeal mucosa [10, 11]. It has been reported in 10% of patients presenting to otolaryngologist’s clinics and more than 50% of patients with hoarseness have reflux related disease [12]. GERD is accompanied by acidity and heartburn (retrosternal burning), which is rarely encountered in LPR patients [13]. In GERD, reflux and acidity typically occur during the night (nocturnal refluxers). In LPR, reflux typically occurs during the day (daytime refluxers) [13]. LPR symptoms occur when patients are in an upright position whereas GERD reflux occurs while patients are lying down. LPR patients commonly present tissue damage of the laryngopharyngeal epithelium [13]. LPR is associated with a failure of the upper sphincters, which allows the acid to move up to the throat and even into the nose or middle ears.

A study performed by Johnston et al. confirmed LPR patients had a decreased carbonic anhydrase level in the vocal fold epithelium. E-cadherin levels were absent in 37% of LPR specimens as well. This implied that the larynges lack a key transmembrane cell surface molecule that potentially helps in epithelial defence, making it more susceptible to injury from reflux [14].

In this study, the prevalence of Laryngopharyngeal Reflux is determined and the outcome of pre and post anti reflux treatment is evaluated.

Materials and Methods

The inclusion criteria is as follows: Patient of the age > and equal to 18 years, regardless of gender, who are willing to participate in study having clinical diagnosis of laryngopharyngeal reflux who have attended ENT OPD.

Exclusion criteria:

• Patients with associated diseases like respiratory and gastrointestinal malignancies.

• Patients who had radiation therapy of head and neck or gastrointestinal tract

• Patients who had undergone gastroesophageal surgery

• Patients who used H2 blockers or proton pump inhibitors in previous 1 month.

• Past or present smoker and excessive alcohol consumption

• Chronic cough attributable to known chronic pulmonary or tracheobronchial disease.

• Voice misuse and over use (excessive voice use) especially in professional voice users (singer, teachers) whose voice is integral to earning his/her livelihood.

• Patients who have vocal cord pathologies, causing hoarseness of voice -

1. Acute and chronic laryngitis

2. Functional dysphonia

3. Benign and malignant tumors (vocal cord polyp, vocal cord cyst, vocal cord nodule, reinke’s edema, laryngeal papillomatosis)

4. Neurogenic factors such as vocal cord paralysis

• Patients who had tracheal intubation in the previous 1 year

• Patients who used inhaled corticosteroids

• Patients who had cervical spine injury or maxilla-mandibular fractures

Data Collection

All patients with throat complaints of hoarseness of voice, excessive mucus, dry cough, difficulty in swallowing will be examined with a detailed history followed by a complete thorough examination with stress being on indirect laryngoscopy and Hopkins endoscopy with 70 degree endoscope. Symptoms and findings of patients will be assessed by using Belafsky Reflux Finding Score (RFS) and Reflux Symptom Index (RSI). Patients presenting Belafsky Reflux Symptom Index (RSI) > 13 and also Reflux Finding Score > 7 are classified as having Laryngo pharyngeal reflux. The empirical treatment consists of Proton pump inhibitor that is Tab Rabeprazole 20 mg twice daily for 6 weeks is given. After 6 weeks of treatment, patients will be assessed by Laryngoscopy, Reflux Symptom Index and Reflux finding score will be calculated.

Data Analysis and Statistical Analysis

A study conducted by Raffi B et al. 90 inferred that in their study, 52% of the subjects included had RSI ≥ 13. Considering this prevalence, with 95% confidence interval and 12.5% absolute error the minimum sample size calculated was 65.

For our convenience, the sample size of 75 was included in the study. All the data was collected and entered in Microsoft Excel. The data was analysed using Epi info version 7.2. The qualitative data was expressed in terms of percentages and to test the difference between two proportions chi square or fisher’s exact test has been used. The quantative data was expressed in terms of mean and standard deviation. To test the difference between the two means student t test was used. All the analysis was 2 tailed and the significance level was set at 0.05.

Pseudosulcus in a Case of Laryngopharyngeal Reflux

Posterior Commissure Hypertrophy

Results

The mean age of the study subjects was 37.12 ± 12.39 years. Majority of the subjects were in the range of 21–30 years and 41–50 years in our study. Majority of our study subjects were males in our study with male: female ratio of 1.20:1.

The most common symptom reported based on RSI questionnaire in our study was excessive throat mucus/post nasal drip (81.33%) followed by clearing of throat (75%) and coughing on lying down and heartburn.

Distribution of Study Subjects Based on RSI Symptoms

Based on the Laryngoscopy, diffuse laryngeal edema was mild in 14.67%, moderate in 50.67% and severe in 34.67% patients. About 56% of the patients had diffuse erythema and 44% had erythema in arytenoids only. About 45.33% of the patients had granuloma/ granulations during Laryngoscopy. Posterior commissure hypertrophy was mild in 64% cases, moderate in 30.67% cases and severe in 5.33% cases. Based on the Laryngoscopy, diffuse laryngeal edema was mild in 14.67%, moderate in 50.67% and severe in 34.67% patients. None of them had obstructing laryngeal edema.About 56% of the patients had diffuse erythema and 44% had erythema in arytenoids only.About 25.33% of cases had complete ventricular obliteration and 74.67% had partial obliteration. In our study, 34.67% had mild vocal edema, 38.67% had moderate vocal edema, 25.33% had severe vocal edema and 1.33% had polypoid. Among 75 cases, 29.33% had subglottic edema. Thick endolarygeal mucus was present in 57.33% of the cases.

Distribution of Study Subjects Based on Laryngeal Findings

Based on the reflux symptom scores, we found 53.33% of the patients to have LPR. The mean RSI scores were 16.25 ± 5.53 with a minimum of 10 and maximum of 28. We found 80% of the total sample to have LPR based on reflux findings score. The mean RFS scores were 13.81 ± 2.42 with a minimum of 11 and maximum of 20. The mean RSI scores were 16.25 ± 5.53 and 10.73 ± 4.40 respectively before and after the treatment and this difference was statistically significant. The mean RFS scores were 13.81 ± 2.42 and 6.61 ± 2.16 respectively before and after the treatment and this difference was statistically significant.

Box and Whisker plot showing the comparison of RSI scores before and after treatment

Box and Whisker plot showing the comparison of RFS scores before and after treatment

Discussion

De Bortoli N et al. [15] describes the characteristics of LPR in their study. The mean age of the study subjects was 51.5 ± 12.7 years in their study. The mean age of the study subjects in their study was 48 years with minimum of 20 years and maximum of 70 years. Patigaroo SA et al. [16] evaluated the use of proton pump inhibiters in treating LPR in patients attended their setup. Ezzeldin H et al. [17] conducted a study to evaluate the effect of proton pump inhibiters and voice therapy on reflux related laryngeal disorders. They were divided into two groups on the basis of the type of treatment. Group ‘A’ received treatment in the form of combination of PPI together with VT and group ‘B’ received only PPI. The mean age of the study subjects was 47.9 years with minimum of 23 years and maximum of 70 years.

De Bortoli N et al. [15] describes the characteristics of LPR in their study. Twenty-five out of 41 patients also had typical GERD symptoms (heartburn and/or regurgitation). Based on the GIS questionnaire, sore throat or hoarseness that is related heartburn or reflux was the most common symptom reported followed by burning sensation in the chest in their study. Rafii B et al. [18] describes the characteristics of LPR in their study. The most common symptom reported was hoarseness (100%) followed by throat clearing (71%) and mucus secretions (62%) in their study. Park JH et al. [19] studied the clinical characteristics, larygoscopic findings and the effect of PPI in patients with laryngeal symptoms with GERD. Sixty patients (37.5%) reported classical GERD symptoms such as heartburn and/or acid regurgitation.

De Bortoli N et al. [15] describes the characteristics of LPR in their study. The most frequent laryngoscopic findings were posterior laryngeal hyperemia (38/41), linear indentation in the medial edge of the vocal fold (31/41), vocal fold nodules (6/41) and diffuse infraglottic oedema (25/41). Elmonem MA et al. [20] conducted a study to evaluate the prevalence of LPR among GERD patients. They found oedema of cricoarytenoid folds 5 patients (11.90), oedema of posterior portion of vocal cord 4 patients (9.52%) and erythema of interarytenoid mucosa 8 patients (19.05). Park JH et al. [19] studied the clinical characteristics, larygoscopic findings and the effect of PPI in patients with laryngeal symptoms with GERD. Sixty nine percent (69%) of patients (95/138) showed abnormal laryngoscopic findings such as laryngeal edema/hyperemia, vocal cord swelling/hyperemia, arytenoids swelling/hyperemia, vocal cord nodule, vocal cord polyp, post-glottic swelling/hyperemia, etc. Endoscopically, 41.9% (39/93) showed normal endoscopic findings and 49.5% (46/93) showed minimal changes. 8.6% (8/93) of patients showed erosive reflux disease.

Park W et al. [21] conducted a prospective cohort study to evaluate the effect of PPI therapy and pre therapy predictors for response for LPR patients. Significant laryngeal improvements were found in more responders as compared with non responders in posterior cricoid wall (P = 0.005), arytenoids complex (P = 0.004), and true vocal fold (P = 0.001) abnormalities.

Conclusion

The mean age of the study subjects was 37.12 ± 12.39 years with male predominant. Based on RSI scores we found 53.33% had LPR and based on RFS we found 80% of the patients having LPR. There was a significant improvement in the symptoms and larygoscopic findings of the patients with LPR on follow up.

Funding

Not applicable.

Availability of Data and Materials

All the data and materials used in the study is available.

Code availability

Not applicable.

Declarations

Conflicts of interest

The authors report no conflict of interest.

Consent to Participate

All the procedures were explained to the participants and informed consent was taken from all participants of the study.

Consent for Publication

The consent for publication of the study is granted.

Ethical Approval

The study was conducted adhering to the guidelines of the Ethics Approval Committee of the Institute.