Three explorative studies on the efficacy of the antihistamine mebhydroline (Omeril).

J Waitzinger, H Lenders, G Pabst, C Reh, E Ulbrich

Index: Int. J. Clin. Pharmacol. Ther. 33 , 373, (1995)

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Abstract

The efficacy of a multiple oral dose treatment with mebhydroline (Omeril coated tablets, 100 mg t.i.d.) was examined in 3 studies which were performed in a randomized, double-blind and placebo-controlled 2-way cross-over design. A second target was to investigate the suitability of different pharmacodynamic models for testing the efficacy of antihistamines. Study A involved a nasal provocation with a specific allergen in 11 symptom-free patients suffering from seasonal allergic rhinitis. In study B, a nasal provocation with histamine was investigated in 11 healthy volunteers. Study C involved a cutaneous provocation with a specific allergen in 12 symptom-free patients suffering from seasonal allergic rhinitis/atopy. The mebhydroline treatment's superiority over placebo was shown statistically at the 95% confidence level for the symptoms itchy nose in study A and for nasal congestion in study B. In study C, allergen-induced weals (planimetric measurement) and itching (visual analog scale) were significantly changed by mebhydroline. A qualitative evaluation revealed a reaction intensity that differed between the 2 treatments to a clinically relevant degree, however, without reaching significance. On the basis of the data it is expected that the clinical efficacy of mebhydroline may be further substantiated in confirmatory clinical trials which should include placebo and positive controls. The test methods used differed in their suitability for measuring the pharmacodynamic effects of antihistamines. Overall, the most clear-cut results were seen in hay fever patients using a specific allergen for provocation. The planimetric assessment of weal response should be preferred as a cutaneous model. Both AR and AARM have their clinical relevance. Based on highly significant results of a subgroup analysis there are indications in favor to AR, but momentary there is no definite conclusion in favor of or against either of the 2 methods.