Laryngopharyngeal reflux (LPR) is characterized by the retrograde movement of gastric or gastroduodenal contents into the larynx and pharynx, resulting in irritation and inflammation of the upper aerodigestive tract. Unlike classical gastroesophageal reflux disease (GERD), patients with LPR may not have prominent heartburn or regurgitation. Instead, they commonly present with throat clearing, globus sensation, hoarseness, chronic cough, excessive throat mucus, dysphagia, throat irritation, and voice disturbance.¹,² LPR is an important clinical problem in otorhinolaryngology because its symptoms are often nonspecific and overlap with allergic, infectious, respiratory, and functional disorders. The condition may therefore be difficult to diagnose and monitor. The Reflux Symptom Index (RSI), a validated nine-item patient-reported questionnaire, provides a standardized method for assessing symptom severity, while the Reflux Finding Score (RFS) evaluates characteristic laryngoscopic findings associated with reflux.³,⁴ Proton pump inhibitors have traditionally formed the basis of empirical treatment for suspected LPR. PPIs suppress gastric acid production and may reduce acid-mediated mucosal injury. However, treatment response to PPI therapy is variable, and not all reflux episodes are strongly acidic. Weakly acidic or non-acidic reflux, pepsin-mediated injury, and behavioral factors may contribute to persistent symptoms despite acid suppression.⁵,⁶,⁷,⁸ Consequently, dietary and lifestyle interventions have received increasing attention. Avoidance of reflux-triggering foods, reduction of acidic and fatty food intake, modification of meal timing, weight management, avoidance of recumbency after meals, and elevation of the head end of the bed may reduce reflux burden and mucosal exposure.⁹,¹⁰,¹¹,¹²,¹³ The role of dietary therapy is particularly relevant in the Indian population, where dietary practices commonly include spicy and fried foods, tea and coffee, late-night meals, and other potential reflux-provoking dietary behaviors. A culturally appropriate dietary intervention may therefore have practical importance in routine LPR management.¹⁴,¹⁵ Previous studies have demonstrated benefits from low-acid and plant-based dietary approaches, while other studies have evaluated PPI therapy or lifestyle modification separately.⁹,¹⁶,¹⁷–¹⁹ However, direct comparison of PPI monotherapy, dietary modification alone, and combined therapy remains limited. The present study was therefore undertaken to compare the short-term effectiveness of PPI therapy alone, dietary modification alone, and their combination in patients with LPR using validated subjective and objective outcome measures. Aim To compare the efficacy of dietary modification, proton pump inhibitor therapy, and their combination in the treatment of laryngopharyngeal reflux among patients attending a tertiary care center. Objectives 1. To compare the effectiveness of PPI therapy, dietary modification, and combined therapy in reducing LPR symptoms as measured by the RSI. 2. To evaluate the effect of dietary modification alone on LPR symptoms and laryngoscopic findings. 3. To evaluate the effect of PPI therapy alone on LPR symptoms and laryngoscopic findings. 4. To compare combination therapy with either monotherapy. 5. To assess treatment adherence, patient satisfaction, and adverse events among the three treatment groups.

Study Design and Setting This was a prospective, comparative, observational study conducted in the Department of Otorhinolaryngology, Grant Government Medical College and Sir J.J. Group of Hospitals, Mumbai, Maharashtra, India. The study was conducted over an 18-month period following Institutional Ethics Committee approval. Ethical Approval The study protocol was approved by the Institutional Ethics Committee of Grant Government Medical College and Sir J.J. Group of Hospitals, Mumbai Written informed consent was obtained from all participants before enrollment. Consent was obtained in the participant's preferred language, including English, Hindi, or Marathi. Study Population Patients aged 18–65 years presenting to the Otorhinolaryngology outpatient department with symptoms suggestive of LPR were screened for eligibility. Inclusion Criteria: Patients were included if they fulfilled all of the following: • Age 18–65 years. • Either sex. • RSI score >13 at presentation. • RFS score >7 on laryngoscopic examination. • Willingness to participate and provide written informed consent. Exclusion Criteria:Patients were excluded if they had: • Previous upper gastrointestinal surgery. • Proton pump inhibitor or H2-receptor blocker use within the preceding four weeks. • Pregnancy or lactation. • Psychiatric illness or cognitive impairment affecting reliable symptom reporting. • Chronic respiratory or neurological disease affecting voice. • Refusal to provide informed consent. Sample Size :Sample size was calculated using Cohen's f for one-way analysis of variance with three independent groups, assuming a medium effect size (f=0.25), a two-sided significance level of 5%, and 80% statistical power. The minimum calculated sample size was approximately 252 participants. The actual study included 270 patients, with 90 patients allocated to each treatment group. Sampling and Group Allocation: Consecutive sampling was used. Eligible patients were sequentially allocated to one of three predefined treatment groups in a 1:1:1 ratio according to order of presentation. Group A: PPI therapy alone Group B: PPI therapy + dietary and lifestyle modification Group C: Dietary and lifestyle modification alone Because allocation was sequential rather than randomized, the study is appropriately classified as a prospective observational comparative study rather than a randomized controlled trial. Treatment Protocol Group A – PPI Therapy Patients received oral pantoprazole 40 mg twice daily for four weeks. Group B – PPI Plus Dietary Modification Patients received oral pantoprazole 40 mg twice daily for four weeks together with structured dietary and lifestyle modification. Group C – Dietary Modification Patients received structured dietary and lifestyle modification without PPI therapy. Dietary and Lifestyle Intervention The dietary intervention consisted of a structured reflux-preventive, low-acid dietary plan emphasizing vegetables, low-acid fruits, whole grains, and low-fat protein sources. Patients were advised to reduce or avoid: • Citrus fruits • Tomatoes • Caffeinated beverages • Aerated beverages • Alcohol • Spicy foods • Fried foods • Processed foods Lifestyle measures included: • Avoiding recumbency for 2–3 hours after meals • Taking smaller and more frequent meals • Elevating the head end of the bed • Weight reduction where appropriate • Avoiding tight abdominal clothing Dietary counseling was culturally adapted and provided according to the patient's preferred language. Outcome Measures Primary Outcomes • Change in RSI from baseline to four weeks. • Change in RFS from baseline to four weeks. Secondary Outcomes • Change in RSI and RFS at two weeks. • RSI reduction of ≥6 points. • RSI normalization (RSI ≤13). • RFS normalization (RFS ≤7). • Composite clinical response, defined as simultaneous RSI ≤13 and RFS ≤7. • Treatment adherence. • Patient satisfaction. • Adverse events. • Treatment discontinuation. Assessment Tools Reflux Symptom Index The RSI is a validated nine-item questionnaire assessing symptoms including hoarseness, throat clearing, excess throat mucus, dysphagia, cough, breathing difficulty, troublesome cough, globus sensation, and heartburn/chest discomfort. Each item is scored from 0 to 5, giving a maximum total score of 45. An RSI >13 was used as an inclusion criterion.³ Reflux Finding Score The RFS is an eight-item laryngoscopic scoring system with a maximum score of 26. The evaluated findings include subglottic edema, ventricular obliteration, erythema/hyperemia, vocal fold edema, diffuse laryngeal edema, posterior commissure hypertrophy, granuloma/granulation, and thick endolaryngeal mucus. An RFS >7 was used as an inclusion criterion. Laryngoscopic assessment was performed at baseline and follow-up visits. Follow-up : At each follow-up, RSI, RFS, compliance, adverse events, and patient feedback were recorded. Patients were assessed at: • Baseline • Two weeks • Four weeks Statistical Analysis: Data were entered into Microsoft Excel and analyzed using IBM SPSS Statistics version 26.0 (IBM Corporation, Armonk, New York, USA). Continuous variables were assessed using appropriate parametric or non-parametric tests. Age and height were analyzed using one-way ANOVA, while BMI, weight, and symptom duration were assessed using the Kruskal–Wallis test when appropriate. Categorical variables were compared using the chi-square test or Fisher's exact test. Changes in RSI and RFS over time were assessed using repeated-measures ANOVA. Time effects and time-by-group interaction effects were evaluated. Paired comparisons were performed using paired t-tests where appropriate. Between-group comparisons of mean reductions were performed using one-way ANOVA, followed by appropriate post-hoc testing. A two-sided p value <0.05 was considered statistically significant.

Study Population A total of 270 patients with LPR fulfilled the eligibility criteria and completed the study protocol. Participants were equally distributed among the three treatment groups, with 90 patients in each group. Table 1. Distribution of Patients According to Treatment Group Treatment group Intervention Number Percentage Group A PPI therapy only 90 33.3% Group B PPI + dietary modification 90 33.3% Group C Dietary modification only 90 33.3% Total 270 100% Baseline Demographic Characteristics: The treatment groups were therefore equal in size. The majority of patients belonged to the 26–35-year age group (36.7%), followed by the 36–45-year age group (25.9%). Female patients constituted 51.9% of the study population and male patients 48.1%. There was no statistically significant difference between the treatment groups with respect to age group or gender. The study groups were also comparable with respect to age, BMI, height, weight, and duration of symptoms. Table 2. Age and Gender Distribution Variable Group A Group B Group C Total p-value 18–25 years 14 (15.6%) 16 (17.8%) 12 (13.3%) 42 (15.6%) 0.900 26–35 years 34 (37.8%) 30 (33.3%) 35 (38.9%) 99 (36.7%) 36–45 years 23 (25.6%) 21 (23.3%) 26 (28.9%) 70 (25.9%) 46–55 years 13 (14.4%) 17 (18.9%) 10 (11.1%) 40 (14.8%) 56–65 years 6 (6.7%) 6 (6.7%) 7 (7.8%) 19 (7.0%) Female 48 (53.3%) 45 (50.0%) 47 (52.2%) 140 (51.9%) 0.901 Male 42 (46.7%) 45 (50.0%) 43 (47.8%) 130 (48.1%) Baseline Risk Factors :Daily tea/coffee intake and spicy/fried food consumption were the most frequently reported reflux-related risk factors. There were no significant differences in the distribution of these risk factors among the three groups. Overall: ● Daily tea/coffee intake: 177 patients (65.6%) ● Spicy/fried food intake: 157 patients (58.1%) ● Late-night meals/snacking: 112 patients (41.5%) ● Type A/stress-prone profile: 108 patients (40.0%) ● Current smoking: 87 patients (32.2%) Baseline Symptoms:Globus/foreign-body sensation and frequent throat clearing were the predominant symptoms. These were followed by excessive throat mucus/postnasal drip, hoarseness or voice disturbance, cough after eating or lying down, troublesome cough, and heartburn/chest discomfort. Breathing difficulty or choking episodes was relatively uncommon and was reported in 14 patients overall. The baseline symptom profile did not differ significantly between treatment groups. Baseline Laryngoscopic Findings:Posterior commissure hypertrophy was the most common laryngoscopic finding, followed by erythema/hyperemia, vocal fold edema, diffuse laryngeal edema, and thick endolaryngeal mucus. Table 3. Baseline Laryngoscopic Findings RFS component Total n (%) p-value Posterior commissure hypertrophy 178 (65.9%) 0.984 Erythema/hyperemia 171 (63.3%) 0.715 Vocal fold edema 134 (49.6%) 0.529 Diffuse laryngeal edema 116 (43.0%) 0.941 Thick endolaryngeal mucus 112 (41.5%) 0.623 Ventricular obliteration 64 (23.7%) 0.980 Subglottic edema 32 (11.9%) 0.269 Granuloma/granulation 12 (4.4%) 0.608 No baseline RFS component differed significantly between the groups. Table 4. Baseline RSI and RFS Scores Parameter Group A PPI Group B PPI + Diet Group C Diet p-value Baseline RSI 22.02 ± 3.15 22.02 ± 2.84 22.14 ± 3.00 0.951 Baseline RFS 10.54 ± 1.87 10.70 ± 1.75 10.63 ± 1.69 0.840 Baseline RSI and RFS Scores The three groups were well matched before treatment. Thus, there was no statistically significant difference in baseline symptom severity or laryngoscopic severity. Table 5. Change in RSI Scores Over Four Weeks Group Baseline RSI Mean ± SD 2-week RSI Mean ± SD 4-week RSI Mean ± SD Within-group p-value Group A – PPI 22.02 ± 3.15 17.41 ± 1.41 13.41 ± 1.34 <0.001 Group B – PPI + diet 22.02 ± 2.84 16.50 ± 1.13 11.91 ± 1.53 <0.001 Group C – Diet 22.14 ± 3.00 17.77 ± 1.90 14.24 ± 1.96 <0.001 All three treatment groups demonstrated progressive reduction in RSI from baseline to two weeks and further reduction at four weeks. Repeated-measures ANOVA demonstrated a highly significant time effect (F=1679.632, p<0.001) and a significant time-by-group interaction (F=9.101, p<0.001), indicating that the pattern of symptom improvement differed significantly according to treatment modality. Table 6. Between-group Comparison of RSI Improvement at Four Weeks Parameter Group A Group B Group C p-value RSI reduction 8.61 ± 3.63 10.11 ± 3.87 7.90 ± 3.05 <0.001 RSI percentage reduction 37.69 ± 11.44% 44.49 ± 12.65% 34.89 ± 10.90% <0.001 RSI at 4 weeks 13.41 ± 1.34 11.91 ± 1.53 14.24 ± 1.96 <0.001 The mean reduction in RSI was greatest in the combination group. Post-hoc analysis demonstrated that Group B had significantly greater RSI reduction than Group A (p=0.022) and Group C (p<0.001). The difference between Groups A and C was not statistically significant (p=0.332). Table 7. Change in RFS Scores Over Four Weeks Group Baseline RFS Mean ± SD 2-week RFS Mean ± SD 4-week RFS Mean ± SD Within-group p-value Group A – PPI 10.54 ± 1.87 8.81 ± 1.28 7.50 ± 1.37 <0.001 Group B – PPI + diet 10.70 ± 1.75 8.34 ± 1.31 6.20 ± 1.52 <0.001 Group C – Diet 10.63 ± 1.69 8.63 ± 1.10 6.89 ± 1.13 <0.001 RFS decreased significantly from baseline to two weeks and further to four weeks in all three treatment groups. Repeated-measures ANOVA demonstrated a significant overall time effect (F=789.597, p<0.001) and a significant time-by-group interaction (F=9.906, p<0.001). Table 8. Between-group Comparison of RFS Improvement at Four Weeks Parameter Group A Group B Group C p-value RFS reduction 3.04 ± 2.29 4.50 ± 2.17 3.74 ± 2.03 <0.001 RFS at 4 weeks 7.50 ± 1.37 6.20 ± 1.52 6.89 ± 1.13 <0.001 One-way ANOVA demonstrated a statistically significant difference in RFS reduction among the three groups (F=10.192, p<0.001). Tukey post-hoc testing showed: ● Group A versus Group B: mean difference −1.456, p<0.001 ● Group A versus Group C: mean difference −0.700, p=0.078 ● Group B versus Group C: mean difference 0.756, p=0.052 Thus, combination therapy produced significantly greater RFS improvement than PPI monotherapy, whereas the differences involving dietary monotherapy did not reach conventional statistical significance. Table 9. Clinically Meaningful Outcomes at Four Weeks Outcome Group A n (%) Group B n (%) Group C n (%) p-value ≥6-point RSI reduction 65 (72.2%) 70 (77.8%) 61 (67.8%) 0.321 RSI normalization (≤13) 43 (47.8%) 73 (81.1%) 22 (24.4%) <0.001 RFS normalization (≤7) 51 (56.7%) 63 (70.0%) 55 (61.1%) 0.170 Composite response (RSI ≤13 + RFS ≤7) 17 (18.9%) 46 (51.1%) 12 (13.3%) <0.001 The proportion of patients achieving at least a six-point reduction in RSI was highest in the combination group, although this difference was not statistically significant. RSI normalization was significantly more frequent in the combination group. Similarly, composite clinical response was significantly higher in Group B than in either monotherapy group. RFS normalization was numerically highest in Group B, although the difference did not reach statistical significance. Table 10. Compliance, Satisfaction, and Safety Parameter Group A Group B Group C p-value Good medication adherence 82 (91.1%) 79 (87.8%) Not applicable 0.467 Good dietary adherence Not applicable 71 (78.9%) 76 (84.4%) 0.335 Satisfied/very satisfied 58 (64.4%) 74 (82.2%) 55 (61.1%) 0.004 Any adverse event 20 (22.2%) 22 (24.4%) 6 (6.7%) 0.003 Treatment discontinuation 0 1 (1.1%) 0 1.000 Serious adverse event 0 0 0 — Good medication adherence was recorded in 82 patients (91.1%) receiving PPI monotherapy and 79 patients (87.8%) receiving combination therapy. This difference was not statistically significant (p=0.467). Good dietary adherence was reported by 71 patients (78.9%) in Group B and 76 patients (84.4%) in Group C, without a statistically significant difference (p=0.335). Patient satisfaction was significantly higher in the combination group. Adverse events were significantly more frequent in the PPI-containing groups than in the dietary modification-only group. Only one treatment discontinuation occurred, and no serious adverse event was recorded

LPR remains a challenging condition in otorhinolaryngology because of its heterogeneous presentation, multifactorial pathophysiology, and variable response to treatment. The present prospective comparative observational study evaluated three commonly used therapeutic approaches: PPI monotherapy, dietary and lifestyle modification alone, and combined PPI plus dietary modification. The principal finding was that all three treatment approaches produced significant improvement in both subjective symptoms and objective laryngoscopic findings, but the magnitude of improvement was greatest with combination therapy. The groups were comparable at baseline. There were no statistically significant differences in age, gender, BMI, symptom duration, baseline risk factors, comorbidities, baseline RSI, or baseline RFS. This baseline comparability strengthens the interpretation that the observed differences in follow-up outcomes were related, at least in part, to treatment strategy rather than major baseline imbalance. The study population was predominantly young to middle-aged adults, with the 26–35-year age group representing the largest proportion. Female participants were slightly more numerous than male participants. The distribution is consistent with the clinical observation that LPR commonly affects adults during economically productive years. Daily tea or coffee intake and spicy/fried food consumption were the most frequently reported risk factors. These findings are particularly relevant to the Indian setting, where dietary practices and meal patterns may influence reflux symptoms. The absence of significant differences between groups suggests that these behavioral factors were relatively evenly distributed at baseline. The most frequent presenting symptoms were globus sensation and throat clearing. This is consistent with the recognized clinical spectrum of LPR and emphasizes the importance of standardized symptom assessment rather than relying exclusively on classical GERD symptoms such as heartburn and regurgitation.¹,⁴ Posterior commissure hypertrophy and erythema/hyperemia were the most common baseline laryngoscopic findings. Importantly, none of the individual RFS components differed significantly between groups at baseline, supporting objective comparability before treatment. Symptomatic Response A significant reduction in RSI occurred in all three groups. The mean RSI reduction at four weeks was 8.61 points with PPI monotherapy, 10.11 points with combination therapy, and 7.90 points with dietary modification alone. The combination group therefore demonstrated the greatest symptomatic improvement. The superiority of combined therapy was statistically significant compared with both PPI monotherapy and dietary monotherapy. In contrast, the difference between PPI monotherapy and dietary modification alone was not statistically significant. These findings suggest that dietary modification may provide meaningful symptom control and that the addition of dietary intervention to PPI therapy may provide greater short-term symptomatic benefit than either intervention alone. The findings are compatible with previous literature indicating that dietary and lifestyle interventions may have an important role in LPR management.⁹,¹⁰,¹¹,¹⁷–¹⁹ Zalvan et al. demonstrated significant improvement with a predominantly plant-based Mediterranean-style diet combined with alkaline water, with outcomes comparable to conventional PPI treatment.⁹ Similarly, studies evaluating dietary approaches have emphasized the potential value of low-acid and plant-based diets in patients with LPR.¹⁰,¹⁸ Objective Laryngoscopic Response The improvement in RFS provides an important complementary finding. RFS decreased significantly in all three groups, demonstrating that dietary modification as well as pharmacological treatment was associated with improvement in laryngoscopic findings. However, the combination group had the greatest mean RFS reduction, at 4.50 points, compared with 3.04 points in the PPI-only group and 3.74 points in the dietary group. The statistically significant superiority of combination therapy over PPI monotherapy suggests that acid suppression alone may not address all factors contributing to laryngopharyngeal mucosal injury. The difference between combination therapy and dietary modification alone narrowly missed statistical significance. Similarly, dietary modification and PPI monotherapy did not differ significantly. This finding is clinically relevant because it suggests that dietary modification should not necessarily be viewed as merely an adjunct to pharmacological therapy. In selected patients, particularly those with concerns regarding prolonged pharmacological treatment, dietary modification may represent a meaningful therapeutic strategy. RSI and RFS Normalization The combination group demonstrated the highest RSI normalization rate. At four weeks, 81.1% of patients receiving combination therapy achieved an RSI ≤13, compared with 47.8% of patients receiving PPI therapy alone and 24.4% receiving dietary modification alone. The difference was highly statistically significant. The rate of RFS normalization was also numerically greatest in the combination group, although the difference did not achieve statistical significance. The discrepancy between symptomatic and laryngoscopic normalization is noteworthy. Symptoms may respond more rapidly to treatment than visible laryngeal changes, and subjective symptoms and objective findings may not always change in parallel. Composite Clinical Response The composite endpoint requiring simultaneous normalization of both RSI and RFS was achieved by 51.1% of patients in the combination group, compared with 18.9% in the PPI group and 13.3% in the dietary group. This finding is particularly important because simultaneous symptomatic and objective improvement represents a more stringent marker of treatment success than improvement in either outcome alone. The substantially greater composite response with combination therapy supports a multimodal approach to LPR management. Compliance and Patient Satisfaction Medication adherence was high in both PPI-containing groups, exceeding 87%. Dietary adherence was also relatively high, with approximately four-fifths of patients in the dietary intervention groups demonstrating good adherence. Patient satisfaction was significantly higher among patients receiving combination therapy, with 82.2% reporting that they were satisfied or very satisfied. This may reflect the greater overall improvement in both symptoms and laryngoscopic findings observed with combination treatment. Safety Adverse events were reported in 22.2% of the PPI-only group, 24.4% of the combination group, and 6.7% of the dietary-only group. The difference was statistically significant. However, the study duration was only four weeks and therefore cannot be used to draw conclusions regarding long-term PPI safety. Concerns regarding prolonged acid suppression have been discussed in the literature, but short-term findings in this study indicate that treatment discontinuation was rare and no serious adverse event occurred.²⁰,²¹ Clinical Implications The findings support a multimodal approach to LPR treatment. PPI therapy remains useful, particularly when rapid symptomatic improvement is desired. However, the superior outcomes observed with combination therapy suggest that PPI treatment may be more effective when accompanied by structured dietary and lifestyle counseling. Dietary modification alone also produced substantial improvement and may be appropriate for selected patients, especially those who prefer non-pharmacological approaches or who require reduction in medication exposure. The dietary intervention should ideally be individualized and culturally adapted. This may be particularly important in India, where dietary practices vary substantially according to region, socioeconomic circumstances, and cultural preferences. Strengths The principal strengths of the study include: 1. Prospective study design. 2. Relatively large sample size of 270 participants. 3. Equal allocation of participants across three treatment groups. 4. Use of validated RSI and RFS outcome measures. 5. Assessment of both subjective and objective outcomes. 6. Assessment at baseline, two weeks, and four weeks. 7. Evaluation of compliance, satisfaction, and adverse events. 8. Use of a structured dietary and lifestyle intervention.

All three treatment strategies—PPI therapy, dietary and lifestyle modification, and their combination—resulted in significant short-term improvement in symptoms and laryngoscopic findings among patients with laryngopharyngeal reflux. However, combination therapy with pantoprazole and structured dietary and lifestyle modification demonstrated the greatest overall benefit, with significantly greater reduction in RSI and RFS scores, the highest rate of RSI normalization, and the highest composite clinical response. Dietary modification alone also produced meaningful improvement and demonstrated outcomes that were not significantly different from PPI monotherapy for several measures. These findings support the incorporation of structured dietary and lifestyle counseling into the routine management of LPR, particularly when combined with short-term PPI therapy. Further multicenter randomized studies with longer follow-up and objective reflux monitoring are warranted to establish the long-term effectiveness of these treatment strategies.

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