Effectiveness of Maximum Medical Therapy in Chronic Rhinosinusitis: A Placebo Controlled Trial Study

Abstract

Background: Rhino-sinusitis is an increasing health issue affecting a large population of society. Most clinical trials studying the efficacy of macrolides in chronic rhino-sinusitis (CRS) are small and open. Prospective, randomized, and blinding trials are very few. This formed the basis of this study to design it as a double-blinded, randomized, placebo-controlled study.

Objective: To compare the efficacy of maximal medical therapy (MMT) with placebo in patients with chronic rhino-sinusitis.

Methods: The study consisted of 52 cases and 36 controls, where cases were treated by Maximal Medical Therapy and controls were treated by placebo drugs. Maximal Medical Therapy consisted of low dose, long-term (3 months) clarithromycin (250mg 1 BD × 7 days → 250mg 1 OD) and mometasone furoate nasal spray 2 puffs once daily, along with systemic decongestants, analgesics, and multi-vitamins. VAS, SF-36, and SNOT-20 have been taken for scoring of symptoms, and saccharine clearance time, nasal endoscopy, and CT scan findings are taken as signs to observe before starting the treatment and at regular intervals thereafter (3, 6, and 12 months).

Results: Maximum patients presented to us belonged to the third decade of their life (31.81%), followed by the fourth decade of their life (25%). Male to female incident ratio was 1.99:1. We used the Student‘t’ test for statistical analysis. It was observed that there was statistically significant improvement in symptom and sign score (p<0.05) after 3months of treatment and was sustained in 6 and 12 month follow-up in case group, in comparison to the control group.

Conclusion: A 3-month course of MMT is effective and sufficient in CRS.