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Original Article |
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Double-blind, placebo-controlled
study of immunotherapy with Parietaria judaica: Clinical
efficacy and tolerance |
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M. Ferrer1, E. Burches1,
A. Peláez1, A. Muñoz2, D.
Hernández2, A. Basomba2, E.
Enrique3, R. Alonso3, A. Cisteró-Bahima3,
S. Martín4, P. Rico4, B. Gandarias4 |
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1 Hospital Clínico Universitario.
Valencia, Spain
2 Hospital Universitario La Fe. Valencia, Spain
3 Institut Universitari Dexeus, UAB. Barcelona, Spain
4 Medical Department, ALK-ABELLÓ, S.A. Madrid, Spain |
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J Invest Allergol Clin Immunol
2005; Vol. 15(4): 283-292 |
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Abstract |
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Allergy to
Parietaria causes
significant
morbidity in most
Mediterranean areas.
The aim of this
study is to
investigate the
efficacy and
tolerance of
Parietaria depot
extract at 25 BU/mL
(1.5 µg/ mL Par j
1).
We performed a
multicenter double-blind,
placebo-controlled
study in rhinitic
patients with/without
asthma, sensitized
to Parietaria. 42
patients followed
20-month
immunotherapy.
Clinical efficacy
was based on symptom
and medication
scores and the
percentage of
healthy days (days
without symptoms or
medication).
Severity of
asthma/rhinitis
scales, visual
analogue scale,
evaluation of the
treatment by doctors
and patients,
immediate and
delayed cutaneous
response and quality
of life
questionnaires were
also studied.
The active group
showed a sustained
decrease in symptoms
(p = 0.008),
medication (p =
0.009) and both (p
=0.001), and an
increase in healthy
days (p = 0.001)
throughout the study,
with a threefold
increase of healthy
days and almost a
three time reduction
in medication only
after one year of
treatment. Asthma
and rhinitis
severity scales also
decreased after
immunotherapy, and
blinded clinical
evaluation by
physicians confirmed
efficacy in 85% and
77% of the active
patients. Patient’s
self-evaluation
returned similar
results. None of
these changes were
observed with
placebo.
Immediate cutaneous
response was
significantly
reduced at the
maintenance phase in
the active group and
remained reduced
throughout the study.
Late-phase response
after intradermal
testing also showed
a statistical
decrease in actively
treated patients.
Immunotherapy was
well tolerated and
every systemic
reaction reported
was mild.
In conclusion,
immunotherapy with
Parietaria 25 BU/mL
is an effective and
safe treatment for
patients with
respiratory
allergies.
Key words:
Parietaria,
immunotherapy,
rhinitis, allergens,
clinical efficacy,
tolerance. |
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