Efficacy and safety of the topical use of intranasal cinnamon bark extract in seasonal allergic rhinitis patients: A double-blind placebo-controlled pilot study

Abstract

The present study was aimed at the evaluation of the efficacy and safety of an intranasal spray of a type-A proanthocynidine polyphenol based standardized hydroalcoholic extract of Cinnamonum zylanicum bark (TAPP-CZ) in seasonal allergic rhinitis (AR) patients using a double-blind placebo-controlled parallel design. TAPP-CZ (nasal spray, 100μg/100μL in each nostril, twice a day) with matching placebo were administered for 4-weeks to 40 randomized patients (20 each in TAPP-CZ and placebo groups) who suffered from severe AR. The efficacy outcome measure scores were obtained from Juniper rhinoconjunctivitis quality of life questionnaire (RQLQ) instrument, nasal symptom scores (NSS), total NSS (TNSS), Work Productivity and Activities Impairment–Allergy Specific (WPAI–AS) instrument at baseline, end of 4-week treatment, and after 4-weeks of follow-up period. The safety outcome measures included pulmonary function tests (spirometry), vital signs, hematology, biochemistry, urinalysis parameters and adverse event (AE) monitoring at baseline and end of 4-week treatment. At the end of 4-week treatment of TAPP-CZ nasal spray showed statistically and clinically significant improvement for overall RQLQ and four of its individual domain scores (namely activities, emotional, nasal symptoms, and eye symptoms), TNSS and NSS. Work productivity was significantly improved on 4-weeks of treatment by TAPP-CZ nasal spray as compared with placebo. TAPP-CZ was found to have excellent safety and tolerability profile with no serious AEs. In conclusion, TAPP-CZ nasal spray was found to be a useful treatment in management of acute seasonal AR patients.