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Therapy for Acute Nonpurulent Rhinosinusitis With Cineole: Results of a Double‐Blind, Randomized, Placebo‐Controlled Trial
Author(s) -
Kehrl Wolfgang,
Sonnemann Uwe,
Dethlefsen Uwe
Publication year - 2004
Publication title -
the laryngoscope
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.181
H-Index - 148
eISSN - 1531-4995
pISSN - 0023-852X
DOI - 10.1097/00005537-200404000-00027
Subject(s) - medicine , placebo , randomized controlled trial , population , sinusitis , clinical endpoint , anesthesia , surgery , alternative medicine , environmental health , pathology
Objectives/Hypothesis Nonpurulent rhinosinusitis can be treated successfully with cineole. Study Design Prospective, randomized, double‐blinded, placebo‐controlled study. Methods We compared efficacy and safety of cineole capsules with placebo capsules in 152 patients with acute rhinosinusitis (76 patients in each treatment group). The dosage of the active ingredient was two 100‐mg capsules of cineole three times daily. The primary end point was the reduction of a defined symptoms‐sum‐score based on symptoms and signs comparing baseline therapy difference from the beginning to the end of the 7‐day treatment. Results All randomly selected patients were assigned to the intention‐to‐treat‐population. At the beginning, the mean symptoms‐sum‐score was 15.6 in both treatment groups. The mean values for the symptoms‐sum‐scores in the cineole group were 6.9 ± 2.9 after 4 days and 3.0 ± 2.8 after 7 days, and in the placebo group, 12.2 ± 2.5 after 4 days and 9.2 ± 3.0 after 7 days. The differences between both groups were clinically relevant and statistically significant after 4 and 7 days. The result for the primary end point was validated by the amelioration of the following secondary end points: headache on bending, frontal headache, sensitivity of pressure points of trigeminal nerve, impairment of general condition, nasal obstruction, and rhinological secretion. Mild side effects, possibly associated with medication, were observed in two patients as heartburn and exanthema after treatment with cineole. Conclusion In patients with acute nonpurulent rhinosinusitis, timely treatment with cineole is effective and safe before antibiotics are indicated.