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Research Article | Volume 11 Issue 4 (April, 2025) | Pages 732 - 738
A Longitudinal Study between the Effects of Anti-Infective and Anti-Reflux Pharmacotherapy in Patients with Chronic Pharyngitis
 ,
 ,
1
Associate Professor, MBBS, MS – ENT, Department of Otorhinolaryngology, Murshidabad Medical College Hospital 73, Station Rd, Raninagar, Gora Bazar, Berhampore, West Bengal 742101
2
Senior Resident, MBBS, MS – ENT, Department of Otorhinolaryngology, Murshidabad Medical College Hospital 73, Station Rd, Raninagar, Gora Bazar, Berhampore, West Bengal 742101
3
Assistant Professor, MBBS DPM MS ENT, Department of Otorhinolaryngology, Murshidabad Medical College Hospital 73, Station Rd, Raninagar, Gora Bazar, Berhampore, West Bengal 742101
Under a Creative Commons license
Open Access
Received
March 20, 2025
Revised
April 5, 2025
Accepted
April 19, 2025
Published
April 30, 2025
Abstract

Background: Chronic Pharyngitis (ICD 10 J31.2) is a chronic inflammatory condition of the pharynx. Pathologically, it is characterized by hypertrophy of mucosa, seromucinous glands, sub epithelial lymphoid follicles and even the muscular coat of the pharynx .Pharyngeal pain without an obvious explanation is chronic nonspecific pharyngitis. Aims: To determine the treatment efficacy between appropriate anti-biotics and anti-reflux medication in the management of Chronic Pharyngitis and to determine the etiopathological role of infection vs. LPR in Chronic Pharyngitis. Materials and method: The present study was a single centered, hospital based longitudinal analytical study. This study was conducted from April 2021 March 2022 at ENT OPD, Midnapore medical college and hospital. 200 patients were included in this study. Result: In Group-A, the mean Reflux Symptom Index Post – treatment (mean± s.d.) of patients was 22.7344±2.6055. In Group-B, the mean Reflux Symptom Index Post – treatment (mean± s.d.) of patients was 28.5032±2.8087. Distribution of mean Reflux Symptom Index Post - treatment with Group was statistically significant (p<0.0001). Conclusion: We concluded that Chronic Pharyngitis is more often due to long standing irritation at the laryngopharynx due to acidic and non-acid reflux from the esophagus. It has been found that chronic and recurrent cases of pharyngitis often develop resistance to antibiotics and that antibiotics have limited role, especially in culture negative pharyngitis and Non-specific Chronic Pharyngitis. Thus it is expected that anti-reflux pharmacotherapy will be more effective than anti-biotics.

Keywords
INTRODUCTION

Chronic Pharyngitis (ICD 10 J31.2) is a chronic inflammatory condition of the pharynx. Pathologically, it is characterized by hypertrophy of mucosa, seromucinous glands, sub epithelial lymphoid follicles and even the muscular coat of the pharynx [1] .Pharyngeal pain without an obvious explanation is chronic nonspecific pharyngitis.[2]

 

Sore throat due to pharyngitis is a common presentation in ENT clinics. Most of which are caused by Viruses and others by Group A beta hemolytic Streptococci (GABHS). Illness is self-limiting in immunocompetent adults. The preferred antibiotic of choice is penicillin or erythromycin in patients allergic to penicillin. However, inadvertent use of antibiotics to treat sore throat will lead to resistance; this will limit the usage of higher antibiotics for complicated cases.[3]

 

Laryngopharyngeal reflux is defined as the retrograde flow of stomach content to the larynx and pharynx whereby this material comes in contact with the upper aero-digestive tract [4]. LPR may be related to the pathogenesis of chronic nonspecific pharyngitis

The larynx is party lined by areas of very delicate squamous epithelium and respiratory epithelium, both of which are less resilient than the oesophageal mucosa. Tissue damage is thought to be caused by activated pepsin, and can occur rapidly after exposure times as brief as 30 seconds 3 times per week [5]. LPR events often occur more commonly in the upright than supine position. Reflux episodes may involve significant volumes of liquid gastric contents, particularly in the lower esophagus, but in the laryngopharynx may be mainly gaseous, containing a fine aerosol of droplets [6]. Such episodes may be triggered by transient lower esophageal sphincter relaxations. Irritation of the distal oesophagus 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 [7],[8].

 

Proton pump inhibitors (PPIs) are in common usage for treatment of LPR [9], particularly as part of a combined management strategy including diet and lifestyle advice. In LPR the effect of PPI is indirect by raising gastric pH to reduce activation of pepsin by cleavage of pepsinogen. As mucosal damage can occur with short-lived reflux episodes, 24-hour coverage is necessary, and twice daily dosage is needed to achieve. PPIs are given 30 minutes before breakfast and evening meal. A treatment trial of at least 2 3 months is required. A total treatment time of approximately 6 months has been advocated for responders, and with the recognition of acid rebound if PPI therapy is discontinued abruptly, tapered withdrawal may be more appropriate [10]. Although the most accurate diagnostic test is 24 hour esophageal pH monitoring, it is expensive, invasive and also is not easy to use in clinics; so there is a need for a simple method for scanning suspicious patients. Belafsky et al. [11] reported that reflux finding score (RFS) and reflux symptoms index (RSI) can be used to document the physical findings and the severity of LPR simply economically and noninvasively. Thus, they tried to investigate LPR in adult patients with chronic nonspecific pharyngitis by using RFS and RSI. To determine the treatment efficacy between appropriate anti-biotics and anti-reflux medication in the management of Chronic Pharyngitis and to determine the etiopathological role of infection vs. LPR in Chronic Pharyngitis.

MATERIALS AND METHODS

Study design: A single cantered, hospital based longitudinal analytical study

 

Study setting: Tertiary care medical college in predominantly tribal area of West Bengal.

 

Place of study: ENT OPD, Murshidabad medical college and hospital.

 

Period of study: Twelve months (April 2023 - March 2024).

Study population: Study was conducted on all eligible patients visiting the ENT OPD fulfilling the inclusion criteria.

 

Sample size: 200 approximately.

  • Group – A: Anti-infective Therapy Group
  • Group – B: Anti-reflux Therapy Group

Case control required or not: Only diagnosed cases of Chronic Pharyngitis.

 

Inclusion criteria:

  • Patients suffering from symptoms of chronic pharyngitis, chronic throat irritation, chronic cough, globus sensation, cervical dysphagia, and intermittent hoarseness.
  • Symptoms should have continued more than 3 months.
  • Age 18 60 years

 

Exclusion criteria:

  • Patients who had organic causes such as acute infection, nasal obstruction, rhinitis, sinusitis or tumorous lesions on history taking and physical examination were excluded
  • Patients with acute pharyngitis
  • Patients who have specific contra-indications for the intended pharmacotherapy
  • Patients who will not be available for long term (approx. 6months) follow up
  • Psychologically unstable patients.
  • Patient is chronic history of vocal abuse due to occupation or any other cause.
  • Any other plausible explanation for Chronic Pharyngitis

 

Data collection and interpretation:

Data was collected using a self-administered pre-tested nine-item Reflux Symptom Index (RSI), and an 8-item clinical severity scale based on findings during fiberoptic laryngoscopy called reflux finding score (RFS).

 

 

Study tools:

  • Case report form.
  • Consent form signed by study subjects.
  • Rigid Fiberoptic laryngoscope (70°).

 

Statistical Analysis:

For statistical analysis, data were initially entered into a Microsoft Excel spreadsheet and then analyzed using SPSS (version 27.0; SPSS Inc., Chicago, IL, USA) and GraphPad Prism (version 5). Numerical variables were summarized using means and standard deviations, while categorical variables were described with counts and percentages. Two-sample t-tests, which compare the means of independent or unpaired samples, were used to assess differences between groups. Paired t-tests, which account for the correlation between paired observations, offer greater power than unpaired tests. Chi-square tests (χ² tests) were employed to evaluate hypotheses where the sampling distribution of the test statistic follows a chi-squared distribution under the null hypothesis; Pearson's chi-squared test is often referred to simply as the chi-squared test. For comparisons of unpaired proportions, either the chi-square test or Fisher’s exact test was used, depending on the context. To perform t-tests, the relevant formulae for test statistics, which either exactly follow or closely approximate a t-distribution under the null hypothesis, were applied, with specific degrees of freedom indicated for each test. P-values were determined from Student's t-distribution tables. A p-value ≤ 0.05 was considered statistically significant, leading to the rejection of the null hypothesis in favour of the alternative hypothesis.

RESULTS

Table: 1. Demographic parameters: Group

 

 

Group-A

Group-B

Total

p-value

Age in group (years)

 

Frequency

Percentage

Frequency

Percentage

Frequency

Percentage

 

≤40

22

22.0

26

26.0

48

24.0

0.4317

41-50

25

25.0

24

24.0

49

24.5

51-60

36

36.0

38

38.0

64

32.0

≥61

17

17.0

12

12.0

29

14.5

Total

100

100

100

100

200

100

Religion

Hindu

38

38.0

38

38.0

76

38.0

0.9868

Muslim

36

36.0

23

23.0

59

29.5

Sikh

26

26.0

39

39.0

65

32.5

Total

100

100

100

100

200

100

Sex

Female

22

22.0

78

78.0

100

50.0

0.7254

Male

78

78.0

22

22.0

100

50.0

Total

100

100

100

100

200

100

 

Table: 2. Association between Addictions: Group

Addiction

Group-A

Group-B

Total

p-value

Frequency

Percentage

Frequency

Percentage

Frequency

Percentage

Alcohol

15

15.0

14

14.0

29

29.0

0.8042

Betel leaf

16

16.0

17

17.0

33

33.0

Guthkha

22

22.0

20

20.0

42

42.0

Smoking

18

18.0

22

22.0

40

40.0

No

29

29.0

27

27.0

56

56.0

TOTAL

100

100

100

100

200

100

 

   

Table: 3. Distribution of mean Reflux Symptom Index Pre-treatment and Post - treatment: Group

 

 

Number

Mean

SD

Minimum

Maximum

Median

p-value

Reflux Symptom Index Pre-treatment

Group-A

100

32.8061

4.0264

28

40

34

0.9021

Group-B

100

32.7226

4.0001

28

40

34

Reflux Symptom Index Post - treatment

Group-A

100

22.7344

2.6055

16

28

24

<0.0001

Group-B

100

28.5032

2.8087

24

34

30

In Group-A, 22 (22.0%) patients were ≤40years of age, 25 (25.0%) patients were 41-50years of age, 36 (36.0%) patient were 51-60 years of age and 17 (17.0%) patients were ≥61years of age. In Group-B, 26 (26.0%) patients were ≤40years of age, 24 (24.0%) patients were 41-50years of age, 38 (38.0%) patient were 51-60 years of age and 12 (12.0%) patients were ≥61years of age. Association of Age in group with Group was not statistically significant (p=0.4317). In Group-A, 38 (38.0%) patients were Hindu, 36 (36.0%) patients were Muslim, and 26 (26.0%) patients were Sikh. In Group-B, 38 (38.0%) patients were Hindu, 23 (23.0%) patients were Muslim and 39 (39.0%) patients were Sikh. Association of Religion with Group was not statistically significant (p=0.9868). In Group-A, 22 (22.0%) patients were Female, 78 (78.0%) patients were Male.  In Group-B, 78 (78.0%) patients were Female, 22 (22.0%) patients were Male.  Association of Sex with Group was not statistically significant (p=0.7254).

In Group-A, 15 (15.0%) patients had Alcoholic, 16 (16.0%) patients had Betel leaf addicted 22 (22.0%) patients had Guthkha addicted and 18 (18.0%) patients had Smoker. In Group-B, 14 (14.0%) patients had Alcoholic, 17 (17.0%) patients had Betel leaf addicted 20 (20.0%) patients had Guthkha addicted and 22 (22.0%) patients had Smoker. Association of Addiction with Group was not statistically significant (p=0.8042).

 

In Group-A, the mean Reflux Symptom Index Pre-treatment (mean± s.d.) of patients was 32.8061±4.0264. In Group-B, the mean Reflux Symptom Index Pre-treatment (mean± s.d.) of patients was 32.7226±4.0001. Distribution of mean Reflux Symptom Index Pre-treatment with Group was not statistically significant (p=0.9021). In Group-A, the mean Reflux Symptom Index Post – treatment (mean± s.d.) of patients was 22.7344±2.6055. In Group-B, the mean Reflux Symptom Index Post – treatment (mean± s.d.) of patients was 28.5032±2.8087. Distribution of mean Reflux Symptom Index Post - treatment with Group was statistically significant (p<0.0001).

DISCUSSION

The present study was a single centered, hospital based longitudinal analytical study. This study was conducted from April 2021 March 2022 at ENT OPD, Midnapore medical college and hospital. 200 patients were included in this study.

 

Campagnolo AM et al [12](2014) found that laryngopharyngeal reflux (LPR) occurs when gastric contents pass the upper esophageal sphincter, causing symptoms such as hoarseness, sore throat, coughing, excess throat mucus, and globus.

 

In this study, demographic variables such as age, religion, and sex were analyzed across two patient groups (Group-A and Group-B). The age distribution between the two groups showed no significant difference (p=0.4317), with similar proportions of patients across various age ranges, suggesting that age may not be a distinguishing factor between the groups. Likewise, the distribution of religion did not significantly vary between the two groups (p=0.9868), as both groups exhibited similar percentages of Hindus, Muslims, and Sikhs. Regarding sex, the distribution was opposite in the two groups, with Group-A having a predominance of males (78%) and Group-B having a predominance of females (78%), but this difference was also not statistically significant (p=0.7254). These findings suggest that the examined demographic factors—age, religion, and sex—do not significantly differentiate between the two groups, implying that other factors may play a more substantial role in any observed differences between them. Further research should focus on exploring other potential variables that could influence outcomes in these groups.

 

The analysis of addiction patterns in both groups revealed no significant difference between Group-A and Group-B (p=0.8042). In Group-A, 15% of patients were alcoholics, 16% were addicted to betel leaf, 22% were addicted to gutkha, and 18% were smokers. Similarly, in Group-B, the addiction rates were 14% for alcohol, 17% for betel leaf, 20% for gutkha, and 22% for smoking. These findings suggest that addiction to substances such as alcohol, betel leaf, gutkha, and tobacco is relatively similar across the two groups, indicating that these addiction-related factors may not be a distinguishing characteristic between them. The lack of statistical significance in addiction patterns suggests that other clinical or socio-demographic variables might be more influential in differentiating between the groups. Further investigation into the specific impact of addiction on health outcomes in these populations is warranted.

 

Watson MG et al [13] (2011) found that laryngopharyngeal reflux is commonly encountered in UK ENT clinics. This paper describes the diagnosis and management of this condition in a district general hospital setting. Invasive investigations are usually reserved for cases which are diagnostically difficult, who do not respond well to medical treatment or where antireflux surgery is contemplated. New techniques which are less invasive are described. Symptoms should be documented using the Reflux Symptom Index at each visit. Standard medical treatment is described.

 

Lieder A et al [14] (2011) laryngopharyngeal reflux is a manifestation of extraoesophageal gastro-oesophageal reflux disease. Its proposed mechanisms of injury include direct contact of the larynx with low pH irritant stomach contents and vagally mediated reflex responses in response to exposure to low pH in the distal oesophagus.

 

Campagnolo AM et al [15] (2014) found that laryngopharyngeal reflux (LPR) is a highly prevalent disease and commonly encountered in the otolaryngologist's office. To review the literature on the diagnosis and treatment of LPR. LPR is associated with symptoms of laryngeal irritation such as throat clearing, coughing, and hoarseness.

The pre-treatment Reflux Symptom Index (RSI) scores in both Group-A (32.8061±4.0264) and Group-B (32.7226±4.0001) were similar, with no statistically significant difference (p=0.9021). This indicates that both groups had comparable baseline reflux symptom severity before treatment. The lack of significant disparity suggests that any subsequent treatment effects are unlikely to be influenced by initial symptom severity. Thus, the groups were well-matched in terms of pre-treatment RSI.

 

Dettmar PW et al [16](2018) found that pepsin is a biomarker for reflux disease and a major etiological factor in laryngopharyngeal reflux (LPR). Do chronic pharyngitis patients have significant concentrations of pepsin present in saliva samples indicating the presence of reflux disease? Thirty-two patients with chronic pharyngitis symptoms and laryngoscopy findings from the reflux finding score (RFS), indicating chronic pharyngitis, were recruited from an Ear, Nose and Throat (ENT) department. A total of 96 patient saliva samples were analysed for the presence of pepsin. Reflux questionnaires assessed the symptoms of reflux [reflux symptom index (RSI), RFS, and reflux disease questionnaire (RDQ)] and, the non-invasive reflux diagnostic device PeptestTM was used to determine the concentration of pepsin present in the patient’s saliva samples.

 

The post-treatment Reflux Symptom Index (RSI) scores showed a significant difference between Group-A (22.7344±2.6055) and Group-B (28.5032±2.8087), with Group-A demonstrating a greater reduction in symptoms (p<0.0001). This indicates that Group-A experienced a more substantial improvement in reflux symptoms following treatment. The significant difference suggests that the treatment intervention in Group-A was more effective in alleviating symptoms compared to Group-B. Further investigation is needed to explore the factors contributing to this disparity in treatment outcomes.

CONCLUSION

We concluded that Chronic Pharyngitis is more often due to long standing irritation at the laryngopharynx due to acidic and non-acid reflux from the esophagus. It has been found that chronic and recurrent cases of pharyngitis often develop resistance to antibiotics and that antibiotics have limited role, especially in culture negative pharyngitis and Non-specific Chronic Pharyngitis. Thus it is expected that anti-reflux pharmacotherapy will be more effective than anti-biotics.

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