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Open Access 
F u l l  L e n g t h  A r t i c l e  

Comparison of Ciprofloxacin and Amoxicillin/Clavulanic Acid in the 

Treatment of Chronic Rhinosinusitis 
 

Zaimal Shahan 1, Ghulam Saqulain 2, Jawwad Ahmed 3 
1 Post-graduate trainee, 2 Surgeon & Head of Department of ENT, 3 Associate Surgeon  

(Department of ENT, Capital Hospital, CDA, Islamabad, Pakistan) 

 

A B S T R A C T  

Objective: To compare ciprofloxacin with amoxicillin/ clavulanic acid in the treatment of chronic rhinosinusitis (CRS) in 

terms of frequency of improvement in symptom score. 

Patients and Methods: This randomized control trial was conducted at Department of Otorhinolaryngology, Capital 

Hospital Islamabad, from March 2015 to March 2016. Study population included 190 cases of Chronic Rhino Sinusitis 

(CRS) of either gender, aged 18 to 50 years and excluding confounders, divided in two groups. Group A received 

Ciprofloxacin 500 mg BD and Group B received Amoxicillin/ clavulanic acid 625 mg TDS for 10 days. Symptom score 

was recorded at start of treatment and finally at 16th week. Data analysis was done by SPSS 17.0. Chi Square was used 

to compare improvement of two groups. P-value ≤ 0.05 was considered significant. 

Results: The sample population comprised of 190 cases of CRS aged 18 to 50 years with mean and standard deviation 

of 31.85 ± 10.07 years. Improvement in symptom score was in the range of 1 - 28, with mean and standard deviation of 

10.52 ± 3.94. Male population was 54.7% (104/190) while females 45.3% (86/190). A significant association of treatment 

group on symptom score having p-value = 0.001 was found. Ciprofloxacin group showed higher improvement (90.53%) 

compared to Amoxicillin/ clavulanic acid group (71.58%). 

Conclusion: Ciprofloxacin showed significantly better results than Amoxicillin/ clavulanic acid in the treatment of CRS in 

terms of frequency of improvement in symptom score. 

Key words: Amoxicillin/ clavulanic acid, Chronic Rhinosinusitis, Ciprofloxacin, Symptoms Score 

Author`s Contribution 
1 Conception, synthesis, planning of research 
and manuscript writing Interpretation and 
discussion 
2-3 Data analysis, interpretation and 
manuscript writing,  Active participation in 
data collection. 

Address of Correspondence 

Ghulam Saqulain 
Email: ghulam_saqulain@yahoo.com 

Article info. 

Received:  January 22, 2017 
Accepted:  July 10, 2018 

Cite this article. Shahan Z, Saqulain G, Ahmed J. Comparison of Ciprofloxacin and 
Amoxicillin/Clavulanic Acid in the treatment of Chronic Rhinosinusitis. JIMDC.2018; 7(4): 

 

Funding Source: Nil 
Conflict of Interest: Nil 

I n t r o d u c t i o n  
 

Multidisciplinary expert panels have defined Chronic 

rhinosinusitis (CRS), as inflammatory disease of 

sinonasal mucosa lasting 12 weeks or longer including 

objective evidence of mucosal inflammation, despite 

attempts at medical management.1,2 The signs/ symptoms 

of CRS are taken as diagnostic criteria, which include two 

or more symptoms, of which one should be either 

blockage of nose/ obstruction, congestion or discharge 

(anterior/ posterior), + facial pain or pressure and + loss/ 

reduction of smell.3 This should also include either 

endoscopic signs including mucopurulent discharge 

and/or nasal polyps, and/or oedema in middle meatus. In 

leu of endoscopic signs mucosal changes within the 

ostiomeatal complex and/or sinuses on CT Scanning is 

also acceptable.3 Prevalence of CRS varies significantly, 

2% to 16% in the United states 4,5 and 7% to 27% in 

O R I G I N A L  A R T I C L E  



 

                           122 J I M D C   2 0 1 7  122 

European, south Africa and Caribbean Region.6-8 CRS is 

typically diagnosed among young or middle-aged 9 with 

mean age of 39 years with women disproportionately 

affected 4,8 and it also results in loss of work days.10 

Aim of treatment is to maintain nasal patency, reduce 

inflammation and eliminate pathogens. The pathogenesis 

is uncertain, however polymicrobial biofilms can 

contribute.11-13 Therefore, antibiotics are indicated.13 In a 

local study cephalosporin (cefuroxime) was found to be 

more frequently prescribed than amoxicillin in treatment of 

CRS.14 However, treatment also includes antihistamines, 

analgesics, decongestants, corticosteroids and mucolytic 

with antihistamines being commonly prescribed.14 Nasal 

septal deviations are commonly seen in CRS 15 so are 

nasal polyps16, therefore surgery is reserved for such 

cases and when abscess is revealed on CT and if it 

shows clinical deterioration.13 CT may also be helpful in 

the diagnosis of fungal infection involving paranasal 

sinuses.17 

Antibiotics are used against common isolates including 

staphylococcus aureus and anaerobes, including beta 

lactam producing organisms, pseudomonas aeruginosa 

and facultative Gram-negative rods. Therefore, the 

spectrum of antibiotic should include these organisms.18 A 

number of antibiotics are used in CRS especially in acute 

exacerbations including amoxicillin and clavulanic acid 

combinations and fluoroquinolones. In a local study 

efficacy for resolution of signs and symptoms of CRS with 

both Amoxicillin-Clavulanate and Levofloxacin was found 

similar 19, however, no local study is available comparing 

the efficacy of Amoxicillin-Clavulanate and quinolones for 

CRS. 

The objective of this study was to compare Ciprofloxacin 

with Amoxicillin/ clavulanic acid in the treatment of chronic 

rhinosinusitis (CRS) in terms of frequency of improvement 

in symptom score. 

P a t i e n t s  a n d  M e t h o d s  

This randomized control trial was conducted at the ENT 

department, Capital Hospital Islamabad, from March 2015 

to March 2016, after approval from the institutional ethical 

committee. Other ethical issues were taken into account. 

Presence of female attendant in cases of females being 

examined was made mandatory. The sample size was 

190 cases calculated with 5% level of significance, 80% 

power of test, and anticipated population proportion of 

83.3% in Group A and 67.6% in Group B with minimum 

sample size of 95 in each group. Non-probability 

consecutive sampling technique was used. All the 

diagnosed cases of CRS who consented for the study 

were included in the study. These included cases of both 

genders aged 18 to 50 years. Cases which could act as 

confounders, were excluded from the study. These 

included cases with previous sinus surgery/FESS, or 

nasal lavage within a week of presentation; cases with 

allergic rhinitis, allergy to test drugs, fungal sinusitis, nasal 

deformities and nasal polyposis. Moreover, cases who 

used antibiotics within the last one week before 

presentation, those with chronic use of steroids or 

immunosuppressive cases with co morbidities, and 

pregnant females were also excluded from the study. 

Patients with CRS fulfilling the selection criteria were 

selected from ENT outpatient’s department of Capital 

Hospital. Informed consent was taken and patients were 

randomly divided into two groups (Group A and Group B), 

by balloting. Patients were diagnosed as CRS clinically by 

the research supervisor. This included nasoendoscopy 

and where required CT scanning was performed. 

Performa was filled by the patient and symptom score 

calculated by the researcher. All 13 symptoms (Major 

Symptoms: nasal obstruction, post nasal discharge, nasal 

discharge, facial pain or pressure, hyposmia / anosmia, 

nasal congestion, headache; Minor Symptoms: halitosis, 

fever, fatigue, dental pain, cough, ear pain or fullness) 

were scored. Each symptom was scored on the following 

scale: 

None = No Symptom           = 0 

Mild = Symptom occurs in/ or continues for less than 6 

hours.           = 1 

Moderate = Symptom recurs in/ or continues for 6 to 12 

hours.           = 2 

Severe = Symptom recurs in/ or continues for more than 

12 hours      = 3 

As, all 13 symptoms were scored the maximum score was 

39 (13 x 3). 

Group A patients were given Ciprofloxacin 500 mg twice 

daily and Group B cases were given Amoxicillin/ 

clavulanic acid 625 mg thrice daily. Treatment was 

instituted for 10 days. Patients in both groups were also 

instituted Xylometazoline nasal spray, Tab. Loratadine  



 

                           123 J I M D C   2 0 1 7  123 

10mg once daily and saline nasal douches thrice daily. 

Symptom score was recorded at first visit and final 

outcome was measured at 16th week. Follow up was 

ensured by taking contact number and address. Data 

collected included Medical Record number, age, sex and 

contact detail and sinus score at first visit and at 16th 

week.  

The Data collected was recorded, organized and 

analyzed on SPSS 17.0. Qualitative variables like gender 

were measured in terms of frequency and percentage. 

Quantitative variables like age and symptom score were 

measured in terms of mean and standard deviation. Chi 

Square was used to compare improvement of two groups. 

P ≤ 0.05 was significant. Effect modifier like age and 

gender were controlled by stratification. Post stratification 

Chi Square was applied. 

R e s u l t s  

Among the 190 patients included in the study, 104 

(54.7%) were males while 86 (45.3%) were females with a 

male to female ratio of 1.2:1. The patient age range was 

from 18 to 50 years with mean and standard deviation of 

the age as 31.85 ± 10.07. The range of improvement in 

symptom score following treatment ranged from 1-28, with 

mean and standard deviation of 10.52 ± 3.94. Among 

males, a significant association was found between 

treatment group and improvement in symptom score, with 

p-value of 0.002 while no significant association between 

treatment group and improvement in symptom score was 

found in females with p-value of 0.118. In < 35 years of 

age group, significant association was found between 

treatment group and improvement in symptom score with 

p-value 0.003 while no significant association was found 

in patients > 35 years of age group, between treatment 

group and improvement in symptom score with p-value 

0.095 (table 1).  

Overall, the treatment group has shown significant 

association on symptom score having p-value = 0.001. It 

was noted that after instituting 10 days’ treatment and 

recording the symptom score on 16th week, Ciprofloxacin 

group showed more improvement [n = 86 (90.53%)] 

compared to Amoxicillin/ clavulanic acid group [n=68 

(71.58%)] as shown in (Table 2). 

Table.2: Comparison of improvement in both Groups 

(n = 190) 

Treatment 

Group 

Improvement Total P-

value Yes No 

Ciprofloxacin 

treatment 

86 

(90.53%) 

9 

(9.47%) 

95 0.001 

Amoxicillin 

treatment 

68 

(71.58%) 

27 

(28.42%) 

95 

Total 154 36 190  

Table.1: Stratification of gender and age 

Stratification Treatment Group Improvement Total P-value 

Yes No 

Male  

(n=104) 

Group A: Ciprofloxacin 49 (90.74%) 5 (9.26%) 54 0.002 

Group B: Amoxicillin/Clavulanic Acid 33 (66%) 17 (34%) 50 

Total 82 22 104 

Female 

 (n=86) 

Group A: Ciprofloxacin 37 (90.24%) 4 (9.76%) 41 0.118 

Group B: Amoxicillin/Clavulanic Acid 35 (77.78%) 10 (22.22%) 45 

Total 72 14 86 

< 35 Years 

(n= 118) 

Group A: Ciprofloxacin 55 (91.67%) 5 (8.33%) 60 0.003 

Group B: Amoxicillin/Clavulanic Acid 41 (70.69%) 17 (29.31%) 58 

Total 96 22 118 

>35 Years 

(n = 72) 

Group A: Ciprofloxacin 31 (88.57%) 4 (11.43%) 35 0.095 

Group B: Amoxicillin/Clavulanic Acid 27 (72.97%) 10 (27.03%) 37 

Total 58 14 72 



 

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D i s c u s s i o n  

Since CRS is an inflammatory disease of sinonasal 

mucosa lasting 12 weeks or longer 1,2, the aim of 

treatment in CRS include steps to eliminate infection, 

reduce sinonasal inflammation, and maintain patency of 

sinonasal passage to facilitate drainage. Management of 

precipitating risk factors is also recommended 20, in 

addition to antibiotics for the short-term treatment of CRS 

with exacerbations.3 A number of antibiotics are in use. 

Amoxicllin/ clavulanic acid combinations have increased 

effectiveness against B-Lactamase producing bacteria.21 

Also, fluoroquinolones including ciprofloxacin have good 

activity against most of Gram -ve and Gram +ve 

organisms.22 A number of studies comparing different 

drugs for the treatment of CRS have been documented.23-

25 Namyslowski et al,24 compared Cefuroxime axetil with 

amoxicillin/ clavulanic acid with no significant difference in 

clinical response and bacterial eradication. Zaman et al., 

in a local study found that in context with resolution of 

signs and symptoms of CRS efficacy of both Amoxicillin-

Clavulanate and Levofloxacin was similar.19 Legent F et 

al., compared the Ciprofloxacin with Amoxicllin/ clavulanic 

acid in terms of cure rate with assessment done on 40th 

day 23. In slight contrast, the objective of our research was 

to compare Ciprofloxacin with Amoxicillin/ clavulanic acid 

in the treatment of chronic rhinosinusitis (CRS) in terms of 

frequency of improvement in symptom score at 16th week. 

For this we conducted a randomized control trial in which 

one hundred and ninety patients of CRS were included 

which fulfilled the selection criteria by using, non-

probability consecutive sampling. These included patients 

aged 18 years to 50 years, with mean and standard 

deviation of the age as 31.85 ± 10.07 years. In our study 

males were 104/190 (54.7%) while females were 86/190 

(45.3%). The minimum symptom score was 1 and 

maximum score was 28 with mean and standard deviation 

as 10.52 ± 3.94.  

Several organisms (both aerobes and anaerobes) 

associated with chronic rhinosinusitis have been isolated, 

26,27 which strengthens the role of antibiotics. Role of 

amoxicillin/ clavulanic acid 2,24, ofloxacin, and 

erythromycin 25 is there. Piromchai P et al., concluded in a 

small study to support the use of systemic antibiotics for 

the curative treatment of chronic rhinosinusitis in adults 

and there is limited evidence in support of use of 

antibiotics and that further good quality trials, with large 

sample sizes, are needed to evaluate the use of 

antibiotics in chronic rhinosinusitis.28 However, due to 

emerging resistance ciprofloxacin is proving to have a 

pivotal role in treatment,23 but not many studies have 

been conducted to prove its role. 

Legent F.et al.23 reported in their study that after 9 days’ 

treatment, nasal discharge disappeared in 71/118 (60.2%) 

patients of the ciprofloxacin group and in 69/123 (56.1%) 

of those in the amoxycillin/clavulanic acid group. The 

clinical cure and bacteriological eradication rates were 

58.6% versus 51.2% and 88.9% versus 90.5% for 

ciprofloxacin and amoxycillin/clavulanic acid, respectively. 

These differences were not significant, however, amongst 

patients who had a positive initial culture and who were 

evaluated 40 days after treatment. Ciprofloxacin 

recipients had a significantly higher cure rate than those 

treated with amoxycillin/clavulanic acid (83.3% vs. 67.6%, 

p = 0.043). Our treatment groups have shown significant 

association of symptom score with p-value of 0.006. After 

instituting 10 days’ treatment and recording symptom 

score at 16th week, Ciprofloxacin group revealed a higher 

improvement (90.53%) in symptom score compared to 

Amoxicillin/ clavulanic acid group (71.58%). Thus 

Ciprofloxacin has shown to be a better antibiotic, in terms 

of improvement, in symptom score. However, more 

studies need to be conducted to further strengthen its role 

in CRS. 

C o n c l u s i o n  

Ciprofloxacin shows significantly better results than 

Amoxicillin/ clavulanic acid in the treatment of Chronic 

Rhinosinusitis, in terms of improvement in symptom 

score. Also treatment group was significantly associated 

with improvement in symptom score in males and in less 

than 35 years of age group. 

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