Dear Editors,
This is in reference to a very well written article titled ‘Comparative study of the efficacy of topical steroid and antibiotic combination therapy versus oral antibiotic alone when treating acute rhinosinusitis’ by El-Hennawi et al.Reference El-Hennawi, Ahmed, Farid and Al Murtadah1 The study design is well thought of and I must commend the authors for undertaking such a novel study. However, there seem to be some flaws in the study design and I would like to highlight them.
Acute sinusitis is a common condition and a sample size of just 40 patients does not seem to be appropriate to derive a conclusion about its treatment. The sample size should be larger and more representative.
The authors compared oral amoxicillin to topical ofloxacin and steroid combination. This creates a treatment bias, as both groups received different treatments; therefore, comparing them is not correct. Moreover, no culture was performed of the nasal secretions to determine the sensitivity pattern of the organisms causing sinusitis. This creates a bias as it is possible that the organisms causing sinusitis in the ‘amoxicillin group’ may not be sensitive to it at all, which can also affect the outcome of the study.
The efficacy of ofloxacin irrigations in preventing bacterial biofilms has been reported.Reference Ezzat, Fawaz, Rabie, Hamdy and Shokry2 However, there are no reports of the efficacy of ‘topical’ ofloxacin in acute sinusitis. It is not clear how the dose of 5 drops every 8 hours has been calculated and seems to be arbitrary. Another consideration concerns the usage of ofloxacin either as topical drops or as topical irrigations.
In view of the above arguments against the present study design, I would recommend that a prospective randomised study with a larger sample size be designed before a definite conclusion is made. The investigators should culture the secretions, and divide patients into two groups that are given same antibiotic either orally or topically.
If the efficacy of topical antibiotics is established, another randomised study can be designed that has two groups: one that is given topical antibiotic alone and one given a topical antibiotic and steroid combination.
