Efficacy of Clarithromycin Versus Methylprednisolone in the Treatment of Non-Eosinophilic and Eosinophilic Nasal Polyposis: A Randomized Controlled Trial

Abstract

Objective: To compare the efficacy of Clarithromycin versus Methylprednisolone in the treatment of non-eosinophilic and eosinophilic nasal polyposis.

Methods:

            Study Design: Randomized controlled trial

            Setting:           Tertiary Government Training Hospital

Subjects:         Forty two patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) were grouped into non-eosinophilic and eosinophilic groups after biopsy determination of eosinophil count. Both groups were further randomized into a treatment arm given Clarithromycin (CLA) 500 mg/ day and another arm given Methylprednisolone (METH) 32 mg/ day tapering to 8 mg/ day for 15 days. All participants underwent pre– and post–treatment evaluation via anterior rhinoscopy, Sino-Nasal Outcome Test (SNOT-22) and Endoscopic Appearance (EA) Scoring. Data were encoded and subjected to statistical analysis using Mann-Whitney U test.

Results: For the 9 participants in the non-eosinophilic group, 4 were given CLA and 5 were given METH. The CLA arm showed significant improvement in SNOT-22 scores by the 15^th day (p= .007). The METH arm did not demonstrate significant improvement by the 7^th (p= .44) or 15^th day (p= .22). Comparison of the improvement in SNOT-22 scores between the two arms showed that on both 7^th and 15^th days, CLA outperformed METH (p= .026 and p= .004, respectively). For the EA scoring, both the CLA and METH groups significantly improved by the 7^th (p= .027 and p= 0.017, respectively), and 15^th day (p= .013 and p= .027, respectively). Comparison of the improvement in EA scores between the two arms showed significant difference on the 15^th day (p= .01), with the CLA performing better than METH. Overall, the results suggest that the CLA arm performed significantly better than the METH arm in the treatment of non-eosinophilic patients.

          Of the 33 eosinophilic patients, 17 were given CLA and 16 were given METH. The CLA arm showed significant improvement in SNOT-22 scores by the 15^th day (p < .001), while the METH arm on both 7^th (p= .033) and 15^th day (p< .001). Comparison of the improvement in SNOT-22 results between the two arms showed no significant differences (7^th day p= .494; 15^th day p= .587). For the EA scoring, both treatment groups showed significant improvement by the 7^th and 15^th day (p< .001). Comparison of the improvement in EA scores between the two arms showed significant differences (p< .001) on both 7^th and 15^th day, suggesting that METH was more effective than CLA. Overall, the results showed that both CLA and METH were effective in the treatment of eosinophilic nasal polyps. However, METH was significantly better than CLA in terms of superior EA scores.

Conclusion: In terms of improving symptoms and well-being, as well as decreasing nasal polyp size and reducing discharge and edema as reflected in superior SNOT-22 and EA scores, Clarithromycin was significantly more effective than Methylprednisolone in the treatment of non-eosinophilic nasal polyps. While both Clarithromycin and Methylprednisolone were shown to be effective in the treatment of eosinophilic nasal polyps, Methylprednisolone was significantly better than Clarithromycin in terms of superior EA scores. A biopsy for tissue eosinophil cell count prior to treatment is recommended to establish the predominant inflammatory cell in nasal polyps in order to provide appropriate targeted treatment, i.e. Clarithromycin for non-eosinophilic nasal polyps and Methylprednisolone for eosinophilic polyps.

Keywords: macrolides, clarithromycin, methylprednisolone, nasal polyps, eosinophils