Bacterial Lysates Add-On Therapy to Reduce Postoperative Recurrence in Nasal Polyps

Area of Science:

• Otorhinolaryngology
• Immunology
• Pharmacology

Background:

• Nasal polyps (NPs) are associated with chronic rhinosinusitis (CRS), leading to significant morbidity.
• Polyp recurrence (PR) after endoscopic sinus surgery (ESS) remains a clinical challenge.
• The role of immunomodulators in preventing PR is an area of active research.

Purpose of the Study:

• To evaluate the efficacy of OM-85, an immunostimulant, in reducing polyp recurrence (PR) post-ESS.
• To assess the impact of OM-85 on patient-reported outcome measures (PROMs) and endoscopic sinus scores.
• To investigate potential immune system modulation by OM-85.

Main Methods:

• A single-center, randomized, prospective study involving 100 patients undergoing ESS.
• Patients were randomized to receive either add-on OM-85 or a control treatment.
• Primary outcome was the PR rate at 12 months; secondary outcomes included PROMs, Lund-Kennedy (L-K) and Lund-Mackay (L-M) scores, and complete blood count (CBC).

Main Results:

• The PR rate was significantly lower in the OM-85 group (8.82%) compared to the control group (27.91%, p=0.036).
• OM-85 treatment led to significant improvements in nasal obstruction, olfactory dysfunction, and mucopurulent discharge at 6 and 12 months.
• Significant improvements were observed in L-K and SNOT-22 scores, alongside elevated white blood cell counts and lymphocyte percentages in the OM-85 group.

Conclusions:

• Adjuvant OM-85 therapy demonstrates potential in reducing postoperative polyp recurrence (PR).
• OM-85 improves sinonasal symptoms and endoscopic outcomes, possibly through enhanced systemic immune function.
• Pre-operative Lund-Mackay (L-M) score and hyposmia are significant predictors of PR.