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Table of Contents
ORIGINAL ARTICLE
Year : 2021  |  Volume : 11  |  Issue : 1  |  Page : 1-6

Usefulness of the reflux symptom index in laryngopharyngeal reflux


1 Department of Otorhinolaryngology, RVM Institute of Medical Sciences, Siddipet, Telangana, India
2 Department of Otorhinolaryngology, Meenakshi Medical College and Hospital, Kanchipuram, Tamil Nadu, India
3 Medi Point Clinic, Bowenpally, Secunderabad, Telangana, India

Date of Submission05-Sep-2020
Date of Acceptance13-Feb-2021
Date of Web Publication5-Jul-2021

Correspondence Address:
Saai Ram Thejas
Assistant Professor, Department of Otorhinolaryngology, RVM Institute of Medical Sciences, Laxmakkapally Village, Mulugu Mandal, Siddipet - 502 279, Telangana
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jlv.JLV_11_20

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   Abstract 


Introduction: Laryngopharyngeal reflux (LPR) is highly prevalent in the general population and its impact on health systems is growing dramatically by the day. The term reflux means back flow. The contents of the stomach flowing back into the esophagus, pharynx, and larynx because of a transient relaxation of the lower esophageal sphincter cause of a spectrum of symptoms diagnosed with LPR and gastroesophageal reflux disease. Aims and Objectives: To study in detail the symptoms caused in LPR and to ascertain if and how they hamper the routine of an individual by using the reflux symptom index (RSI). Materials and Methods: The RSI is a self-administered nine-item outcomes instrument for LPR. Ninety-one patients with clinically diagnosed LPR were taken up for this study and were issued the RSI (translated into the local language for better results) before and after treatment. Data were assessed at the end of 3 months and 6 months. Observations and Results: The tabulated data showed significant improvement in the symptomatic index after treatment. Conclusion: It can thus be concluded that RSI is still highly valid in the follow-up for patients with LPR because of it can be easily administered and gives excellent validation for accurate results.

Keywords: Antacid, gastroesophageal reflux disease, laryngopharyngeal reflux, proton-pump inhibitor, reflux symptom index


How to cite this article:
Thejas SR, Rajamohan G, Sindu M, Swarna K. Usefulness of the reflux symptom index in laryngopharyngeal reflux. J Laryngol Voice 2021;11:1-6

How to cite this URL:
Thejas SR, Rajamohan G, Sindu M, Swarna K. Usefulness of the reflux symptom index in laryngopharyngeal reflux. J Laryngol Voice [serial online] 2021 [cited 2021 Oct 18];11:1-6. Available from: https://www.laryngologyandvoice.org/text.asp?2021/11/1/1/320557




   Introduction Top


Reflux of gastroduodenal contents into the larynx because of transient relaxation of the lower esophageal sphincter may cause inflammation and symptoms resulting in chronic laryngeal signs often referred to as laryngopharyngeal reflux (LPR).[1] It is often associated with chronic cough, hoarseness, dysphonia, recurrent throat clearing, and globus pharyngeus (sensation of a lump in the throat).

Due to nonspecific symptoms, laryngoscopy is often performed to rule out malignancy and the diagnosis of LPR is considered with any signs of laryngeal inflammation.[2] The two predominant pathophysiological mechanisms for LPR are direct and indirect exposure of the larynx to injurious gastric contents. The direct exposure is due to acid, pepsin, and bile acid exposure to laryngopharyngeal mucosa. The indirect mechanism is thought to be a result of refluxate interactions with structures distal to the larynx, evoking a vagus nerve mediated response to bronchoconstriction.[3] LPR is estimated to account for 10% of all ear, nose, and throat clinic patients and 50% of patients with voice complaints.[4] However, due to the lack of gold standard testing, the prevalence of LPR can be overstated, with one meta-analysis that reviewed data from pH probe readings reporting that 10%–60% of normal subjects demonstrated reflux.[5]

LPR differs from classic gastroesophageal reflux disease (GERD) in many ways. While heartburn and regurgitation are the common symptoms of GERD, such symptoms are not present in most LPR patients.[4] LPR, on the other hand, presents with laryngeal inflammation and reflux in the upright position. LPR is the preferred term for the use in otorhinolaryngology. It is also ubiquitous and pernicious in pediatric patients. The diagnosis may be particularly difficult to make because infants and children almost never complain of heartburn or other symptoms related to reflux. Physiologic barriers against the development of reflux include the lower esophageal sphincter, esophageal peristalsis, saliva that buffers the refluxed contents and mucus covering of the stomach-esophagus-larynx-pharynx along with the upper esophageal sphincter.

Shaw et al. presented a 12-item symptom questionnaire to assess GERD, but again, it concentrates on the symptoms such as acid taste, burning, and chest pain.[6] The questionnaire from a GERD perspective and from a LPR perspective has to be different since the symptomatology's vary ever so slightly. The LPR questionnaire must focus more on the symptoms in the throat and voice as compared to the GERD questionnaire which needs to assess the condition of the esophagus with relation to the damage done by the anti-peristaltic movement.

Up until 2002, there was no validated and approved questionnaire for the diagnosis and follow-up in patients with LPR. The Reflux Symptom Index (RSI) is a self-administered nine item score sheet for the symptomatic assessment of patients with LPR. It was developed by Belafsky et al. and it has been in use ever since.[7] The RSI has its advantages in the fact that it is easy to use, inexpensive, and is easily available in print. A simple copy can be administered to the patient. Thus, this criterion-based validity has become an important tool in diagnostics.

This study deals with the relevance of the RSI in the local population whilst treating properly diagnosed patients with LPR. Diagnosis was made on the basis of RSI and laryngeal endoscopic findings. Data were accumulated and analyzed before the start of treatment and at the 3- and 6-month timelines.


   Materials and Methods Top


This study was conducted at a tertiary care center in Southern India between January 2018 and December 2019 over a period of 24 months.

Study design

Prospective study.

Inclusion criteria

  • Diagnosed LPR
  • RSI greater than or equal to 13
  • Laryngeal endoscopy revealing changes secondary to reflux
  • Age group of 18–60 years
  • Patients who give consent to treatment and procedure
  • Patients who agree to be part of the study.


Exclusion criteria

  • Patients with comorbidities
  • GERD
  • Patients unfit to take treatment or follow-up for a 6-month period
  • Age below 18 and above 60 years
  • Patients with severe disease requiring surgical intervention
  • Patients with organic laryngeal disorders.


Method of statistical analysis

All statistical analyses were performed using the SPSS Statistics 19 software for Windows (IBM Corp., Armonk, NY, USA). Samples were compared by means of a paired t-test. P < 0.05 was considered statistically significant. The confidence interval was set at 95%.

Sample size

Ninety-one (91).

Selection of patients

All the patients visiting the outpatient department of otorhinolaryngology with any sort of complaints related to difficulty in swallowing, difficulty in speech, sensation of foreign body in the throat, voice changes, and a feeling of acid in the mouth. Such patients were assessed with a laryngoscopy and the RSI instrument. RSI ≥13 was taken as significant.[7]

According to the Reflux Finding Score (RFS), the various laryngeal changes which can be seen in these patients on a laryngeal endoscopy include:[8]

  • Edema (vocal cords/subglottis)
  • Ventricular obliteration
  • Erythema/hyperemia
  • Mucus
  • Granuloma/granulation.


Procedure

After thorough counselling and acquiring proper consent, each patient was given the RSI instrument before the beginning of the treatment. If the patient was unable to understand English, the same was explained in the local language (Tamil) and a translated version of the same was given [Table 1] and [Table 2]. The risks of treatment and the necessity to continue for a particular amount of time were mentioned.
Table 1: Reflux symptom index in English 7

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Table 2: Reflux symptom index in Tamil

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The RSI instrument contains nine questions. Each question carries five points on a 0–5 severity scale wherein 0 indicates no problem and 5 indicates severe problem. Each patient was asked to fill this up without any prompting. Thus, the maximum score a patient could get was 45. Any value of ≥13 was considered significant and part of study.[7]

The treatment modality was multi-fold and each patient was asked to follow the same pattern.

Dietary modifications

  1. No eating or drinking within 3 h of bedtime
  2. Avoid over eating or reclining right after meals
  3. Avoid fried food and low-fat diet
  4. Avoid coffee, tea, chocolate, mints, and soda
  5. Avoid caffeine containing foods and beverages
  6. Avoid alcohol, especially in the evening
  7. Increase intake of water.


Lifestyle modifications

  1. Elevate head end of the bed
  2. Avoid wearing tight fitting clothes or belts
  3. Quit tobacco.


  4. Medical management


  1. Liquid Antacid – magnesium hydroxide and aluminium hydroxide (1 tablespoon after each meal and at bedtime)
  2. Proton-pump inhibitor (PPI) – Pantoprazole, 20 mg half an hour before the first and last meals of the day.


After the aforementioned therapy, patients were asked to have a follow-up once a month for the next 6 months. The RSI instrument was given to the patient at the end of 3 months and 6 months. The results were documented and tabulated. After the end of the 6-month period, patients were slowly asked to wean off on the medications and strictly follow the lifestyle changes to keep the symptoms under control.


   Observations and Results Top


Among the 91 people part of the study, 56 were male and 35 were female [Figure 1].
Figure 1: Distribution based on gender

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The average age of the study group was found to be 39.62 years. The maximum number of patients was found to be in the age bracket of 36–45 years. The youngest case reported in our study was 19 years with the oldest being 62 years [Figure 2].
Figure 2: Distribution based on age

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The average RSI score before the treatment was 23.78. Before treatment, the symptom causing the most trouble was “Heart burn, chest pain, indigestion, or stomach acid coming up” which docked at 4.109/5 and the symptom causing the least trouble was “Breathing difficulties or choking episodes” which docked at 1.637/5.

At the end of 3 months, the sensation of heart burn/acid in throat improved by about 56% and by the end of 6 months it reached to about 65%. In between the treatment, i.e., at the 3-month and 6-month intervals, the relative improvement was found to be the most in “Difficulty in swallowing food, liquids or pills” at a significant 11%.

The total score improved by about 49% after 3 months and 58% after 6 months [Table 3] and the P value was found to be significant [Table 4], [Table 5], [Table 6].
Table 3: Average reflux symptom index score at 0, 3, and 6 months' timeline

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Table 4: Paired sample correlations after 3 months

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Table 5: Paired sample correlations after 6 months

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Table 6: Paired sample statistics

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   Discussion Top


There is a difference in the symptomatology of GERD and LPR. The patterns, mechanisms, manifestations, and treatment of LPR and GERD differ and the gastroenterology model of reflux disease does not apply to LPR. LPR patients have head and neck symptoms, but heartburn is uncommon. Consequently, LPR is often called silent reflux. LPR patients have predominantly upright (day-time) reflux and normal esophageal motility; most do not have esophagitis, which is the diagnostic entity of GERD. Laryngopharyngeal epithelium is far more susceptible to reflux-related tissue injury than is the esophageal epithelium. Because of these differences, treatment algorithms for LPR and GERD vary.[9]

The RSI is a nine-item self-administered outcome instrument that accurately documents symptom improvement of patients with LPR, thus displaying excellent criterion-based validity.[7]

The questionnaire from a GERD perspective and from an LPR perspective has to be different since the symptomatology's vary ever so slightly. The LPR questionnaire must focus more on the symptoms in the throat and voice as compared to the GERD questionnaire which needs to assess the condition of the esophagus with relation to the damage done by the anti-peristaltic movement.

Symptoms of LPR improve over 2 months of therapy. The physical findings of LPR resolve more slowly than the symptoms and this continues throughout at least 6 months of treatment. The physical findings of LPR are not always associated with patient symptoms and treatment should continue for a minimum of 6 months or until complete resolution of the physical findings.[10]

The diagnosis of LPR is usually made on the basis of presenting symptoms and associated laryngeal signs. Current recommendation for the management of this group of patients is empiric therapy with twice daily proton-pump inhibitors for 2–4 months.[11] In majority of those who are unresponsive to such therapy other causes of laryngeal irritation is considered.

Although acid can be controlled by PPI therapy, all of the other damaging factors (i.e., pepsin, bile salts, bacteria, and pancreatic proteolytic enzymes) remain potentially damaging on PPI therapy and may have their damaging ability enhanced.[12]

Changing food, lifestyle, and habits will go a long way in reducing the drug intake and maintaining long-term cure. LPR still has many aspects in its etiopathogenesis, as well as treatment which need to be understood before we can achieve complete cure rates.[13] Awareness regarding LPR in the general population will also help reduce the severity with which the patients present to the primary care physician.

PPIs remain the cornerstone of treatment of LPR. The current management recommendation for this group of patients is empiric therapy with twice-daily PPIs for 1–2 months.[14]

Various studies have found that the RFS as a clinical tool for the diagnosis of LPR should be viewed with limited utility as it exhibits low inter-rater reliability.[15] Thus, it becomes all the more necessary that the RSI be assessed extensively for symptomatic betterment in the patient.

Every fifth patient who reports to their family medicine physician shows the symptoms of LPR. On primary health care levels, it is possible to establish some form of prevention, diagnostics, and therapy for LPR in accordance with suggested algorithms. Only a small number of patients require surgical procedures and do not show improvement with medical management.[16]

Researches have proved that the RSI is a quality tool in the assessment of LPR. It can be used in regular ENT practice to analyze the improvement in patients after the commencement of therapy.[17],[18]


   Conclusion Top


The diagnosis and management of LPR are tough in clinical practice since the symptoms are loosely related to GERD. Specific tools are thus needed which can aid in the assessment of improvement or deterioration of the patient after the treatment modality administered. One of those tools include the RSI which is by far the easiest to use because of its non-invasive nature, cost-effectiveness, and time-saving policy. In our study, we found that the RSI improved by about 49% after 3 months and 58% after 6 months. It can thus be concluded that the RSI is a relevant tool to assess patients with LPR in our population.

Compliance with ethical standards

We have received a written, informed consent from every patient with respect to the medication administered, procedure, and also the risks and benefits were explained in detail. Each form was thoroughly read and signed by both the patient and an attender to the patient.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
   References Top

1.
Vaezi MF, Hicks DM, Abelson TI, Richter JE. Laryngeal signs and symptoms and gastroesophageal reflux disease (GERD): A critical assessment of cause and effect association. Clin Gastroenterol Hepatol 2003;1:333-44.  Back to cited text no. 1
    
2.
Patel DA, Blanco M, Vaezi MF. Laryngopharyngeal reflux and functional laryngeal disorder: Perspective and common practice of the general gastroenterologist. Gastroenterol Hepatol (N Y) 2018;14:512-20.  Back to cited text no. 2
    
3.
Ahuja V, Yencha MW, Lassen LF. Head and neck manifestations of gastroesophageal reflux disease. Am Fam Physician 1999;60:873-80, 885-6.  Back to cited text no. 3
    
4.
Koufman JA. The otolaryngologic manifestations of gastroesophageal reflux disease (GERD): A clinical investigation of 225 patients using ambulatory 24-hour pH monitoring and an experimental investigation of the role of acid and pepsin in the development of laryngeal injury. Laryngoscope 1991;101:1-78.  Back to cited text no. 4
    
5.
Merati AL, Lim HJ, Ulualp SO, Toohill RJ. Meta-analysis of upper probe measurements in normal subjects and patients with laryngopharyngeal reflux. Ann Otol Rhinol Laryngol 2005;114:177-82.  Back to cited text no. 5
    
6.
Shaw MJ, Talley NJ, Beebe TJ, Rockwood T, Carlsson R, Adlis S, et al. Initial validation of a diagnostic questionnaire for gastroesophageal reflux disease. Am J Gastroenterol 2001;96:52-7.  Back to cited text no. 6
    
7.
Belafsky PC, Postma GN, Koufman JA. Validity and reliability of the Reflux Symptom Index (RSI). J Voice 2002;16:274-7.  Back to cited text no. 7
    
8.
Belafsky PC, Postma GN, Koufman JA. Validity and reliability of the Reflux Finding Score. Laryngoscope 2001;111:1313-7.  Back to cited text no. 8
    
9.
Koufman JA. Laryngopharyngeal reflux is different from classic gastroesophageal reflux disease. Ear Nose Throat J 2002;81:7-9.  Back to cited text no. 9
    
10.
Belafsky PC, Postma GN, Koufman JA. Laryngopharyngeal reflux symptoms improve before changes in physical findings. Laryngoscope 2001;111:979-81.  Back to cited text no. 10
    
11.
Farrokhi F, Vaezi MF. Laryngeal disorders in patients with gastroesophageal reflux disease. Minerva Gastroenterol Dietol 2007;53:181-7.  Back to cited text no. 11
    
12.
Pearson J, Parikh S, Orlando R, Johnston N, Allen J, Tinling S. Review article: Reflux and its consequences – The laryngeal, pulmonary and oesophageal manifestations. In: conference held in conjunction with the 9th international symposium on human pepsin (ISHP) Kingston-upon-Hull, UK, 21–23 April 2010. Aliment Pharmacol Ther 2011;33 Suppl 1:1-71.  Back to cited text no. 12
    
13.
Kirti YK. Reflux Finding Score (RFS) a quantitative guide for diagnosis and treatment of laryngopharyngeal reflux. Indian J Otolaryngol Head Neck Surg 2018;70:362-5.  Back to cited text no. 13
    
14.
Abou-Ismail A, Vaezi MF. Evaluation of patients with suspected laryngopharyngeal reflux: A practical approach. Curr Gastroenterol Rep 2011;13:213-8.  Back to cited text no. 14
    
15.
Keshavamurthy VB, Sadashivaooa YB, Harsham NK. Laryngopharyngeal reflux: Inter-rater reliability of reflux finding score in clinical practice. Bengal J Otolaryngol Head Neck Surg 2019;27:186-92.  Back to cited text no. 15
    
16.
Salihefendic N, Zildzic M, Cabric E. Laryngopharyngeal reflux disease-LPRD. Med Arch 2017;71:215-8.  Back to cited text no. 16
    
17.
Mesallam TA, Stemple JC, Sobeih TM, Elluru RG. Reflux symptom index versus reflux finding score. Ann Otol Rhinol Laryngol 2007;116:436-40.  Back to cited text no. 17
    
18.
Nunes HS, Pinto JA, Zavanela AR, Cavallini AF, Freitas GS, Garcia FE. Comparison between the Reflux Finding Score and the Reflux Symptom Index in the Practice of Otorhinolaryngology. Int Arch Otorhinolaryngol 2016;20:218-21.  Back to cited text no. 18
    


    Figures

  [Figure 1], [Figure 2]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]



 

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