A double-blind comparison of terfenadine and mequitazine in the symptomatic treatment of acute pollinosis.

This study was a double-blind, parallel group comparison of terfenadine (TRF) 60 mg b.i.d. and mequitazine (MQZ) 5 mg b.i.d. for 7 days in the symptomatic treatment of acute pollinosis. The trial took place in the same geographic area and during the same pollen season (May-July 85), to ensure homogeneity of the study population. The fourteen investigators participating in this multicentre trial recruited 141 patients (69 TRF; 72 MQZ) suffering from well-documented pollinosis, mainly hay fever and sometimes allergy to tree pollens. Symptoms (nasal itching, sneezing, rhinorrhoea, obstruction, conjunctivitis) and possible somnolence were rated daily using a 4-point rating-scale of 0 to 3 by the patient on a diary card. Assessment of over-all efficacy and tolerability - focusing on atropinic side-effects - was made at the end of the seven-days treatment period by the physician, after reviewing the diary card and questioning the patient. The means score profile of each symptom for the study period was similar with the two treatments. Both had a fast onset of action with the regression of the total symptoms' score being already significant at day 1. Over-all assessment of efficacy at day 7 showed no significant difference between the two treatments. The daily somnolence scores however showed a clear and significant difference between the two drugs: the frequency of moderate to marked somnolence from day 2 to 7 was around 15% with MQZ and around 5% on days 2 to 5 and 0% on days 6 and 7 with TRF, the difference being significant on days 2, 5, 6 and 7.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes