Introducing a Novel Combination Therapy with Macrolides for the Treatment of Chronic Rhinosinusitis: A Randomized Controlled Trial

BACKGROUND: Macrolides have shown beneficial effects in the treatment of chronic rhinosinusitis (CRS). This study aimed to compare the effect of azithromycin and clarithromycin in combination with conventional therapies for the treatment of CRS. METHODS: This single-blind randomized controlled trial was conducted during 2018-2019 at the Otorhinolaryngology Clinic of Shahid Mohammadi Hospital, Bandar Abbas, Iran. Out of 102 selected patients, 90 were included in the analysis. Patients were selected through convenience sampling and randomly assigned to two equal groups. In addition to conventional therapies (nasal irrigation, betamethasone injection, oxymetazoline and fluticasone spray, guaifenesin syrup, and steam inhalation), the patients in the clarithromycin group received clarithromycin 500 mg tablets twice daily for four weeks. The other group received azithromycin 500 mg tablets daily for four weeks. Patients’ symptoms were evaluated pre- and post-intervention, and the Lund-Mackay (LM) scoring system was used for the staging of CRS based on computed tomography scan findings. Data were analyzed using SPSS software, and P<0.05 was considered statistically significant. RESULTS: Patients in both groups were comparable in terms of age and sex. Complete resolution of symptoms was significantly higher in the azithromycin group than the clarithromycin group (71.1% vs. 24.4%, P<0.001). Baseline LM scores did not differ significantly between the groups (P=0.120). However, post-intervention, LM scores reduced considerably in both groups, but the change was significantly higher in the azithromycin group (P<0.001). CONCLUSION: In combination with conventional therapies for CRS in adults, a four-week course of treatment with azithromycin is more effective than clarithromycin. Trial Registration Number: IRCT20201209049661N1.