Effects of dimethindene maleate nasal spray on the quality of life in seasonal allergic rhinitis.
OBJECTIVE
To determine if the H1-receptor antagonist dimethindene maleate (DMM), topically applied, is able to improve the quality of life (QoL) in patients with seasonal allergic rhinitis better than placebo.


METHODS
The study was a multi-centre, randomised, placebo-controlled, double-blinded phase III trial including 157 patients. Two parallel groups received either DMM nasal spray or placebo for 2 weeks. Patients answered 5 QoL questionnaires (Rhinoconjunctivitis QoL Questionnaire (LQ-AR), Munich Life Dimension List (MLDL), Profile of Mood States (POMS), 2 Visual Analogue Scales (VAS-QoL, VAS-GES)) on days 1, 4, 8, and 15.


RESULTS
QoL improved significantly in all scales and groups. Statistically significant differences between groups were achieved in the sub-scales LQ-AR Eye Symptoms and Daily Activities, MLDL Total, POMS Depression and Energy, VAS-QoL and VAS-General Health. All differences favoured the DMM group and were present initially but disappeared in visit 4, except MLDL Total and POMS Energy. Almost all other scores had a better tendency of DMM.


CONCLUSIONS
A significant improvement of QoL was found in both groups. Only weak differences between groups (in favour of DMM) were found. There are several reasons explaining this outcome, mainly the rainy weather during the study period (mean weather index 10-20% less sunny than in previous seasons).
Division of Plastic Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, USA.
C H
CH
Kirchhoff
B
B
Kremer
S
S
Haaf-von Below
H J
HJ
Kyrein
R
R
Mösges
D000281:Administration, Intranasal; D000293:Adolescent; D000368:Aged; D004115:Dimethindene / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006634:Histamine H1 Antagonists / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D016896:Treatment Outcome
D006634:Histamine H1 Antagonists; D004115:Dimethindene