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Butterbur Extract Appears as Effective as Fexofenadine In Allergic Rhinitis: Presented at EAACI

By Michael Smith


AMSTERDAM, THE NETHERLANDS -- June 14, 2004 -- An herbal extract from the leaves of the butterbur plant is at least as effective as is fexofenadine in relieving the symptoms of intermittent allergic rhinitis, say researchers.

In a poster session at the 23rd Congress of the European Academy of Allergology and Clinical Immunotherapy (EAACI), Andreas Schapowal, MD, PhD, of Landquart, Switzerland, the study's principal investigator, said that
because the extract is non-sedating, it may be an alternative for patients who can't tolerate the soporific effect of antihistamines.

The drug – formally known as Ze339 -- "has now been subjected to a series of stringent trials" and deserves to be considered an alternative to traditional anti-histamine therapy, Dr. Schapowal explained.

Earlier studies, both blinded and controlled, had shown Ze339 was not inferior to cetirizine and was superior to placebo, he said. Dr. Schapowal and his colleagues designed a prospective, double-blind, double-dummy randomized trial with a placebo control to compare Ze339 with fexofenadine.

The target of the study was the change in symptoms from baseline to end point. Four main symptoms – rhinorrhea, sneezing, itchy nose, and itchy or watery eyes – were recorded.

As expected, the 107 patients in the placebo group saw little or no improvement in their symptoms. But, patients getting either of the active treatment drugs saw all 4 symptoms improve by more than 35% – a result that is highly statistically significant, at the P =.001 confidence level.

Both drugs began working quickly -- day 1 for fexofenadine and day 2 for butterbur, results showed.

In nature, the butterbur plant contains liver-toxic alkaloids, but the variety used to make this extract has very low levels and they are removed during preparation, Dr. Schapowal said.

The researchers did not observe any serious adverse effects in this study, including elevations of liver enzymes.

Ze339 "is well-tolerated by patients," he concluded.


243 - Randomised, double blind, double-dummy, prospective clinical investigation of the efficacy and tolerability of Zeller butterbur extract Ze 339 versus

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