Efficacy Of Long-Term Low Dose Macrolide Therapy In Preventing Early Recurrence Of Nasal Polyps After Endoscopic Sinus Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change in symptom and disease severity scores
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 15 Years to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group A
Received Macrolide (clarithromycin 250 mg) once day in addition to their usual prescription
Intervention: clarithromycin 250 mg (Procedure)
Group B
Patients in Group B received only their routine prescribed postoperative medications following surgery (no macrolide therapy).
Intervention: clarithromycin 250 mg (Procedure)
Outcomes
Primary Outcomes
Change in symptom and disease severity scores
Time Frame: 3 months
(Change in Sinonasal Outcome Test-22 (SNOT-22) , Lund-Kennedy score, and Lund-Mackay score) from baseline to 12 weeks after endoscopic sinus surgery.
Secondary Outcomes
No secondary outcomes reported