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UNIVERSITY
PHILIPPINE
DEPARTMENT
OF THE PHILIPPINES
GENERAL HOSPITAL
OF OTOLARYNGOLOGY
TITLE" RandomizedClinicalTrialon the EfficacyandSafetyof
LoratadineVersusAstemizolein Allergic Rhinitis
AUTHORS: MarianoB. Caparas,MD
RomualdoA. Aragon,Jr., MD
JoseAntonio M. Santos,MD
Jesus M. Jardin,MD
CiriacoB. Gato,Jr. MD
INTRODUCTION MATERIALS AND METHODS
The management of allergic rhiaitis involves Study Design and Study Site
environmental control, pharmacologic interventions,
and allergen immunotherapy (1). In the Philippines, This double-blind randomized clinical trial was
environmental control and allergen immunotherapy conducted at the Outpatient Section of the Department
have yet to be proven effective and feasible. On the of Otorhinolaryngology, Head and Neck Surgery of
other hand, pharmacologic interventions, which entail the UP-PGH Medical Center from February to June,
the use of decongestants, antihistamines, corticoster- 1988.
oids, and cromolyn sodium, have helped patients, in
coping with acute attacks. Patient Section
Through the years, drowsiness or sedation was Seventy patients with unequivocal history of althe
most common complaint against antihistamines lergen-induced rhinitis were recruited provided that
therapy. Since 1941, many H1 antihistamines have they were more than 12 years of age and presenting
been introduced to provide antiallergic effect with with at least two of the following nasal symptoms:
minimal anticholinergic and sedative actions. One itchiness, stuffiness, discharge and sneezing affecting
oftheseis astemizole, an orally potent highly selective to a moderate degree (i.e., bothersome but not disantihistamine
administered once a day. Various clinical abling or intolerable).
studies have confirmed its efficacy and safety (2,3,4). Excluded were pregnant or lactating patients,
those with asthmas, those on allergen immunother-
Loratadine is a newer long,acting, tricyclic apy, or those receiving other anti-allergic drugs within
antihistamine with selective peripheral Hi-receptor an- the last six months. Patients with other significant
tagonist activity. Like astemizole, it is also admini- current diseases or abnormal baseline laboratory tests
stered once daily. It has an added advantage of more results, those who haveaknownidiosyncraticreaction
rapid response and various clinical trials have con- to antihistamines, and those who have taken any
firmed its efficacy and safety (5,6,7), inve f gatJonal drugs within one month prior to the
start of this study were also excluded.
This double-blind randomized clinical trial was
conducted to compare the etlicacy and safety of a Interventions
14-day course of loratadine with those Iff astem izole
given to Filipino patients with allergic rhinitis. After informed consent has been secured, the
patients were randomly allocated to receive either
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