Real-World Data on the Use of Hypertonic Saline Nasal Spray in ENT Practice

Abstract

Hypertonic saline solutions are in broad medicinal use for treatment of various disorders of nose and paranasal sinuses. This trial aimed at the evaluation of safety and efficacy of a hypertonic saline nasal spray within the scope of routine care in an otorhinolaryngological outpatient setting. One hundred and thirty-six patients were included into this uncontrolled clinical trial and received 2.7% saline solution nasal spray. Symptoms and clinical signs were documented on an ordinal scale of 0–4 during initial and final examination, and both individual symptoms and the sum of symptom scores (clinical sum score) were assessed. Participating patients and physicians furthermore evaluated the clinical benefit of the therapy. Clinical sum score decreased from 13.63 ± 6.65 to 7.85 ± 6.79 (p < 0.001) between initial and final examination, and significant improvements were observed for 10 out of 12 individual symptoms. A clinical benefit was attributed to hypertonic saline treatment by both patients and physicians in more than 50% of the documented cases. Seventy percent of the patients noticed improvement of nasal breathing, and 50% of the patients considered hypertonic saline an alternative to the use of α-sympathomimetics. One adverse event (epistaxis) was reported, whereas 95% of the patients rated the treatment as flawless. Eleven pregnant women and one nursing mother participated in the trial without the occurrence of any negative effect on mother and child. This study substantiates the safe and efficacious use of hypertonic saline nasal spray. Reduction in use of classical decongestants constitutes a valuable and safe therapeutic option for patients for whom use of these drugs is contraindicated.Clinical Trial Register: DRKS-ID: DRKS00010825