Efficacy of Long-Term Low Dose Macrolide Therapy in Preventing Early Recurrence of Nasal Polyps After Endoscopic Sinus Surgery

Fatima Jinnah Medical University

Status: Completed

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Treatments: Procedure: clarithromycin 250 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT07316959

260/proposal-ENT/ERC

Details and patient eligibility

About

This randomized controlled trial evaluated the effectiveness of long-term, low-dose clarithromycin (250 mg/day) in reducing symptoms, improving endoscopic and radiologic scores, and preventing early recurrence of nasal polyps after endoscopic sinus surgery. Conducted at the ENT Department of Sir Ganga Ram Hospital, Lahore, the study included patients aged 15-75 undergoing surgery for nasal polyps. Group A received clarithromycin for three months in addition to standard therapy, while Group B received standard therapy alone. Patients treated with clarithromycin showed significantly greater improvements in SNOT, Lund-Kennedy, and Lund-Mackay scores at 8 and 12 weeks compared to controls (p<0.05). Polyp recurrence at three months was also lower in the macrolide group (12%) than in the non-macrolide group (32%).

Overall, low-dose clarithromycin was found to be safe and effective in enhancing postoperative outcomes and reducing early recurrence of nasal polyps after endoscopic sinus surgery.

Enrollment: 100 patients

Sex: All

Ages: 15 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Male and female patients aged 15 to 75 years

Clinical diagnosis of nasal polyps

Underwent endoscopic sinus surgery

Willing and able to provide informed consent Exclusion Criteria

Current or recent use of antibiotics or macrolide therapy

History of multiple facial fractures

Presence of neurological disorders

Presence of psychiatric or psychological disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Group A

Experimental group

Description:

Received Macrolide (clarithromycin 250 mg) once day in addition to their usual prescription

Treatment:

Procedure: clarithromycin 250 mg

Group B

Active Comparator group

Description:

Patients in Group B received only their routine prescribed postoperative medications following surgery (no macrolide therapy).

Treatment:

Procedure: clarithromycin 250 mg