A placebo-controlled evaluation of butterbur and fexofenadine on objective and subjective outcomes in perennial allergic rhinitis

Abstract

Rationale We performed a placebo-controlled evaluation of the effects of butterbur (BB) and fexofenadine (FEX) on subjective and objective outcomes in patients with perennial allergic rhinitis (PAR). Methods 16 patients with PAR and house dust mite sensitization were randomized in double-blind, double-dummy, cross-over fashion to receive for 1 week either BB 50mg bid, FEX 180mg qd and placebo (PL) qd, or PL bid. The peak nasal inspiratory flow (PNIF) response to nasal adenosine monophosphate (AMP) challenge (single 400mg/ml dose) was measured over a 60-minute period after challenge, and domiciliary total nasal symptom score (DTNSS) was recorded. Results Pre-challenge values for mean (± SEM) PNIF (l/min) were not significantly different comparing all groups; BB (138 ± 8), FEX (140 ± 9), and PL (138 ± 8). The maximum % PNIF fall from baseline after nasal AMP challenge was significantly attenuated (p<0.05) vs. PL (46 ± 3), with BB (34 ± 3) and FEX (39 ± 3). The area under the 60-minute time-response curve (%.min) was also significantly attenuated (p<0.05) vs. PL (1734 ± 156), with BB (1052 ± 258) and FEX (1194 ± 161). There was also a significant reduction (p<0.05) in DTNSS with BB (1.8 ± 0.4) and FEX (1.8 ± 0.4), vs. PL (2.8 ± 0.5). There were no significant differences between BB and FEX for any outcomes. Conclusion BB and FEX, in comparison to PL, were equally effective in attenuating the nasal response to AMP and in improving nasal symptoms, highlighting a potential role for BB in the treatment of allergic rhinitis.