Comparison of the Therapeutic Efficacy of Antibiotic Therapy, Nasal Steroids, Isotonic Saline, and Hypertonic Saline in Patients with Acute Rhinosinusitis

Introduction

Regardless of etiology, inflammation of the mucosa lining the nasal cavity and paranasal sinuses is defined as rhinosinusitis. Rhinosinusitis is a common health problem1. Patients with symptoms lasting between 0 and 4 weeks are classified as having acute rhinosinusitis (ARS)2. In 50–70% of ARS cases, the causative microorganisms are viruses—most frequently rhinovirus, influenza, parainfluenza, coronavirus, and adenovirus3-6. The main bacterial pathogens include

Regardless of etiology, inflammation of the mucosa lining the nasal cavity and paranasal sinuses is defined as rhinosinusitis. Rhinosinusitis is a common health problem1. Patients with symptoms lasting between 0 and 4 weeks are classified as having acute rhinosinusitis (ARS)2. In 50–70% of ARS cases, the causative microorganisms are viruses—most frequently rhinovirus, influenza, parainfluenza, coronavirus, and adenovirus3-6. The main bacterial pathogens include Streptococcus pneumoniae (25–30%), Haemophilus influenzae (20–30%), and Moraxella catarrhalis (15–20%)7.

The diagnosis of ARS is clinical. In patients whose symptoms last fewer than 10 days, viral etiology is assumed, and symptomatic treatment is recommended. Intranasal steroids (NS) and isotonic saline solution (ISS) irrigation have been reported to be effective for symptomatic relief 8,9. If symptoms worsen or persist beyond 10 days, bacterial superinfection is suspected, and antibiotic therapy is added. However, recent meta-analyses have reported that antibiotic treatment may be unnecessary even in patients whose symptoms last longer than 10 days7.

Antibiotic resistance remains a major global health problem. Moreover, treatment costs impose a significant financial burden on social security systems and governments. Therefore, choosing the most cost-effective and efficient treatment is crucial. Based on these considerations, this study aimed to investigate the effects of different treatment modalities on symptom improvement in patients diagnosed with ARS.

Materials and Methods

Ethical approval was obtained from the Mustafa Kemal University Tayfur Ata Sökmen Faculty of Medicine Local Ethics Committee (approval code: 23/06/2014/121; research protocol: 2014/116).

Between September and December 2014, adult patients aged 18–60 years, who presented to the Otorhinolaryngology outpatient clinic of Mustafa Kemal University Medical Faculty Hospital, had symptoms for 10 to 21 days, and were clinically diagnosed with ARS, were included in the study. Diagnosis was based on the presence of at least two of the following symptoms: facial pain/pressure, nasal obstruction, nasal or postnasal discharge, and hyposmia/anosmia, accompanied by purulent discharge in the middle meatus and/or postnasal drainage on examination. The difference in the presence of postnasal and/or purulent discharge before and after treatment was evaluated.

Patients with systemic diseases were excluded. Additional exclusion criteria included pregnancy, inability to provide consent, allergic rhinitis, cystic fibrosis, primary ciliary dyskinesia, hypertension, immunodeficiency, diabetes mellitus, dementia, Alzheimer’s disease, cerebrovascular accident, or cardiovascular/pulmonary diseases. Pediatric patients were also excluded.

A total of 150 eligible patients were randomized into five treatment groups, with 30 patients in each group:

• Group 1: Amoxicillin–clavulanate + paracetamol

• Group 2: Intranasal steroid (NS) + paracetamol

• Group 3: Isotonic saline solution (ISS) irrigation + paracetamol

• Group 4: Hypertonic saline (HS) nasal lavage + paracetamol

• Group 5 (Control): Paracetamol only

Treatment protocols were standardized across the study groups. The antibiotic group received oral amoxicillin–clavulanate (1000 mg twice daily), while the intranasal steroid group used mometasone furoate nasal spray at a dose of 200 μg per day. Patients in the isotonic and hypertonic saline groups performed nasal irrigation twice daily using commercially available saline solutions. In all groups, paracetamol (500 mg, up to three times daily as needed) was permitted for symptomatic relief.

The VAS scoring system used in this study included multiple ARS-related symptoms. Symptoms such as nasal obstruction, nasal discharge/postnasal drip, olfactory disturbance, facial pressure or fullness, headache, fever, halitosis, cough, fatigue, dental pain, and ear pain were each evaluated individually using a 0–10 Visual Analog Scale (VAS). The VAS values reported in the study represent the summed cumulative scores derived from these individual symptom ratings rather than the score of a single symptom. Therefore, the reported VAS values may exceed the conventional 0–10 range used for individual VAS assessments.

After 10 days of treatment, patients were re-examined by an independent physician blinded to treatment allocation. Post-treatment symptoms were reassessed using the VAS. Pre- and post-treatment VAS scores were compared within and between groups.

Statistical analyses were performed using the Mann-Whitney U, Wilcoxon, and Kruskal-Wallis variance analysis tests. A p-value < 0.05 was considered statistically significant.

Results

The ages of the patients ranged from 18 to 60 years (mean: 36.10 ± 13.03). Of the participants, 78 were female (52%) and 72 were male (48%). There were no statistically significant differences among the groups with respect to age or sex distribution (p > 0.05).

Regarding treatment response, Group 1 (amoxicillin–clavulanate + paracetamol) showed a substantial reduction in mean VAS scores from 60.70 ± 12.45 pre-treatment to 24.70 ± 9.17 post-treatment. In Group 2 (NS + paracetamol), VAS scores improved from 52.10 ± 10.37 to 26.60 ± 9.95.

Figure 1. VAS scores of the groups before treatment

Table 1. Mean Pre- and Post-Treatment VAS Scores of the Groups

*Wilcoxon test

Figure 2. VAS scores of the groups after treatment

Similarly, patients in Group 3 (ISS + paracetamol) demonstrated a decrease from 54.70 ± 14.00 to 28.10 ± 13.70, and Group 4 (HS + paracetamol) showed improvement from 52.03 ± 12.46 to 30.56 ± 10.33. All four treatment groups exhibited statistically significant reductions in VAS scores (p = 0.001). In contrast, no significant change was observed in Group 5 (control), with pre- and post-treatment VAS scores of 46.36 ± 12.79 and 45.83 ± 13.35, respectively (p > 0.05) (Table 1; Figures 1 and 2).

Figure 3. Mean difference in VAS scores before and after treatment

When comparing the change in VAS scores between groups, the reduction in symptom severity was significantly greater in all treatment groups compared with the control group (p = 0.001) (Table 2, Figure 3). A 59.7% reduction in postnasal discharge symptoms and an 88.6% reduction in purulent discharge in the middle meatus were observed after total treatments. The detailed comparison of the differences in pre- and post-treatment VAS scores among the five groups is presented in Table 3.

Table 2. Mean Differences in Pre- and Post-Treatment Scores Between Groups

*Kruskal–Wallis One-Way Analysis of Variance

Table 3. Detailed comparison of the differences in pre- and post-treatment VAS scores

*Mann Whitney U test

4. Discussion

Treatment guidelines generally recommend symptomatic therapy—including analgesics and decongestants—for patients whose symptoms last fewer than 10 days, assuming a viral etiology. When symptoms worsen or persist beyond 10 days, bacterial superinfection is suspected, and antibiotics may be considered 7-9. However, several recent meta-analyses have suggested that antibiotics are often unnecessary even in prolonged cases 7,8. Studies have also demonstrated the efficacy of NS and saline irrigation in symptom relief 10.

Antibiotic resistance remains one of today’s most pressing health concerns 7-9. Moreover, the cost burden of unnecessary antibiotic use on healthcare systems underscores the importance of cost-effective management7.

Although many ARS cases are viral and may resolve without antibiotics, clinical suspicion of bacterial infection increases when symptoms persist beyond 10 days or worsen after initial improvement. In such cases, antibiotic therapy may provide additional symptomatic benefit. Therefore, appropriate patient selection remains essential to balance effective treatment and antibiotic stewardship. In this study, we aimed to evaluate the effectiveness of various treatment options in ARS patients with symptoms persisting beyond 10 days. Our findings showed that post-treatment VAS scores were significantly lower in all treatment groups compared to the control group, and significantly lower than pre-treatment values within each treatment group.

Although a previous randomized study reported that amoxicillin was not superior to placebo in ARS 11,12, that study included patients with symptoms lasting fewer than 10 days, likely of viral origin. In contrast, our study involved patients with symptoms exceeding 10 days, where bacterial etiology is more probable. Accordingly, antibiotic therapy resulted in greater symptom improvement compared with control.

Numerous studies have shown that NS are highly effective in ARS management 13,14. Potter et al. reported that NS were more effective than antibiotics, particularly in allergic rhinosinusitis15. NS exert their effect by suppressing cellular infiltration and reducing edema in the ostiomeatal complex, thereby improving sinus drainage and aeration16,17. In our study, symptom scores decreased significantly in the NS group both compared to baseline and to the control group. This symptomatic improvement in the NS group may be attributed to these mechanisms, as the reduction in mucosal inflammation and edema likely facilitated better sinus drainage and ventilation, thereby alleviating patient complaints.

Other studies have also demonstrated the benefit of ISS and HS irrigations in ARS 18,19. Saline or seawater solutions enhance mucociliary clearance by increasing humidity and may improve sinus ventilation through mild vasoconstrictive effects 20,21. However, some authors argue that highly concentrated solutions may disrupt the mucosal pH balance and cause dryness. Consistent with these proposed mechanisms, our study also demonstrated a significant reduction in symptoms in both the HS and ISS groups, suggesting that saline irrigation—regardless of tonicity—can provide meaningful clinical improvement in ARS.

Previous research has shown that children without nasopharyngeal bacterial colonization benefit significantly less from antibiotic therapy than those colonized with pathogens22, highlighting the limited value of antibiotics in certain patient subgroups. Similarly, in our study, both ISS and HS irrigation groups demonstrated significant symptom improvement compared with the control group, suggesting that non-antibiotic supportive treatments may offer substantial clinical benefit in ARS, particularly even when bacterial involvement is absent.

The inclusion of only acute, non-allergic, non-chronic rhinosinusitis cases may explain the consistent improvement observed. Considering the prevalence of ARS, its significant impact on the quality of life, and high costs, both direct and indirect, proper diagnosis and appropriate treatment avoiding unnecessary therapeutic escalation can have a significant impact on public health in its broadest sense23. Previous research indicates that general physicians are more prone to diagnostic errors than specialists when applying established ARS criteria 24, underscoring the importance of accurate diagnosis because treatment selection—particularly the decision to prescribe antibiotics—should be based on true clinical suspicion of bacterial involvement. Indeed, antibiotics have been shown to significantly reduce treatment failure in children with clinically confirmed ARS compared with placebo 25. In our study, both ISS and HS irrigation groups demonstrated significant symptom improvement compared with the control group, supporting the utility of non-antibiotic supportive therapies, especially when bacterial infection is less likely. However, it is noteworthy that the antibiotic-treated group (Group 1) showed the most pronounced reduction in symptom scores among all treatment arms. These findings suggest that while supportive treatments can provide meaningful clinical benefit, antibiotic therapy may lead to more pronounced symptom improvement in patients with suspected bacterial ARS, particularly when bacterial involvement is likely or when clinical severity warrants antimicrobial treatment. These findings collectively emphasize the need for precise diagnostic assessment to avoid unnecessary antibiotic exposure while ensuring that antibiotics are appropriately used in patients who are most likely to benefit.

The earliest laboratory indicator of bacterial ARS is an elevated C-reactive protein (CRP) level. The presence of elevated CRP levels, purulent nasal discharge, and a physician’s high or intermediate suspicion of acute bacterial sinusitis have been identified as early indicators that help confirm bacterial involvement in ARS 26. Although most cases are self-limited, these infections still have a considerable impact on patients’ daily functioning, often leading to the use of multiple medications—many of which are unnecessary and associated with adverse effects 27. In this context, our study demonstrated that while all active treatment modalities significantly reduced symptom scores, the antibiotic-treated group showed the most substantial improvement. This finding suggests that when clinical or laboratory indicators raise suspicion for bacterial sinusitis, antibiotic therapy may provide added benefit. Nevertheless, the pronounced symptom reduction observed in both the ISS and HS irrigation groups indicates that supportive treatments can provide meaningful relief even in patients with suspected bacterial sinusitis, thereby helping to reduce unnecessary medication exposure despite the presence of bacterial concern.

To our knowledge, few studies have directly compared multiple treatment modalities—including antibiotics, NS, ISS, and HS—within the same patient cohort. By evaluating these approaches in patients with symptoms persisting beyond 10 days, our study helps fill an important gap in the literature regarding optimal management strategies for suspected bacterial ARS. This study has several limitations. First, it was conducted at a single center with a relatively small sample size. Second, bacterial etiology was not microbiologically confirmed. Laboratory markers such as C-reactive protein (CRP), microbiological cultures, or molecular diagnostic tests were not performed. Instead, the diagnosis of acute rhinosinusitis was established based on clinical evaluation, including patient history and physical examination findings. Therefore, the study population should be interpreted as patients with clinically suspected ARS rather than microbiologically confirmed bacterial ARS, and the findings regarding antibiotic efficacy should be interpreted with caution. Third, only short-term outcomes were evaluated, and long-term relapse rates or sustained improvements could not be assessed. Finally, symptom severity was measured using subjective VAS scores without endoscopic or radiologic confirmation. These limitations should be taken into account when interpreting our findings. Future studies with larger, multicenter populations are needed to confirm these findings and to better define patient subgroups that benefit most from each treatment modality. Incorporating microbiological confirmation, and long-term follow-up data would further strengthen the evidence base. Additionally, comparative studies evaluating different concentrations and delivery methods of saline irrigation may provide deeper insight into the optimal supportive treatment for ARS.

5. Conclusion

In this study, all active treatment modalities—including antibiotics, intranasal steroids, and both isotonic and hypertonic saline irrigation—significantly improved symptoms of acute rhinosinusitis compared with the control group. The antibiotic-treated group was associated with a greater reduction in symptom scores in this study. However, because bacterial etiology was not microbiologically confirmed, these findings should be interpreted cautiously. Antibiotic therapy may provide additional benefit in patients with suspected bacterial ARS, whereas supportive treatments such as nasal steroids and saline irrigation can also provide meaningful symptom relief. These findings highlight the importance of accurate diagnosis and appropriate patient selection to optimize treatment outcomes while avoiding unnecessary antibiotic use.