Die klinische wirksamkeit der sublingualen und subkutanen birkenpollenallergenspezifischen immuntherapie: Eine randomisierte, plazebokontrollierte, doppelblinde double-dummy-studie
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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Die klinische wirksamkeit der sublingualen und subkutanen birkenpollenallergenspezifischen immuntherapie : Eine randomisierte, plazebokontrollierte, doppelblinde double-dummy-studie. / Khinchi, M. S.; Poulsen, L. K.; Carat, F.; André, C.; Hansen, A. B.; Malling, H. J.
I: Allergologie, Bind 27, Nr. 9, 09.2004, s. 355-366.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Die klinische wirksamkeit der sublingualen und subkutanen birkenpollenallergenspezifischen immuntherapie
T2 - Eine randomisierte, plazebokontrollierte, doppelblinde double-dummy-studie
AU - Khinchi, M. S.
AU - Poulsen, L. K.
AU - Carat, F.
AU - André, C.
AU - Hansen, A. B.
AU - Malling, H. J.
PY - 2004/9
Y1 - 2004/9
N2 - Background: Both sublingual allergen-specific immunotherapy (SLIT) and subcutaneous immunotherapy (SCIT) have a documented clinical efficacy, but only few comparative studies have been performed. Objective: To investigate the clinical efficacy of SLIT vs SCIT and secondary to compare SLIT and SCIT with placebo and to evaluate the relative clinical efficacy in relation to systemic side effects. Methods: A 3-year randomized, placebo-controlled, double-blind, double-dummy study including 71 adult birch pollen, hay fever patients treated for two consecutive years after a baseline year. Allocation to treatment groups was based on disease severity in the baseline season, gender and age. Results: Clinical efficacy was estimated in 58 patients completing the first treatment year by subtracting baseline data, and by calculating the ratio first treatment season vs baseline. SLIT diminished the median disease severity to one half and SCIT to one-third of placebo treatment. No statistically significant difference between the two groups was observed. Both for symptoms and medication scores, actively treated patients showed statistically significant and clinically relevant efficacy compared with placebo. SLIT treatment only resulted in local mild side-effects, while SCIT resulted in few serious systemic side-effects. Conclusion: Based on the limited number of patients, the clinical efficacy of SLIT was not statistically different from SCIT, and both treatments are clinically effective compared with placebo in the treatment of birch pollen rhinoconjunctivitis. The lack of significant difference between the two treatments does not indicate equivalent efficacy, but to detect minor differences necessitates investigation of larger groups. Due to the advantageous safety profile, SLIT may be favored.
AB - Background: Both sublingual allergen-specific immunotherapy (SLIT) and subcutaneous immunotherapy (SCIT) have a documented clinical efficacy, but only few comparative studies have been performed. Objective: To investigate the clinical efficacy of SLIT vs SCIT and secondary to compare SLIT and SCIT with placebo and to evaluate the relative clinical efficacy in relation to systemic side effects. Methods: A 3-year randomized, placebo-controlled, double-blind, double-dummy study including 71 adult birch pollen, hay fever patients treated for two consecutive years after a baseline year. Allocation to treatment groups was based on disease severity in the baseline season, gender and age. Results: Clinical efficacy was estimated in 58 patients completing the first treatment year by subtracting baseline data, and by calculating the ratio first treatment season vs baseline. SLIT diminished the median disease severity to one half and SCIT to one-third of placebo treatment. No statistically significant difference between the two groups was observed. Both for symptoms and medication scores, actively treated patients showed statistically significant and clinically relevant efficacy compared with placebo. SLIT treatment only resulted in local mild side-effects, while SCIT resulted in few serious systemic side-effects. Conclusion: Based on the limited number of patients, the clinical efficacy of SLIT was not statistically different from SCIT, and both treatments are clinically effective compared with placebo in the treatment of birch pollen rhinoconjunctivitis. The lack of significant difference between the two treatments does not indicate equivalent efficacy, but to detect minor differences necessitates investigation of larger groups. Due to the advantageous safety profile, SLIT may be favored.
KW - Allergen-specific immunotherapy
KW - Clinical efficacy
KW - Controlled study
KW - Randomized
KW - Rhinitis
KW - Side effects
KW - Subcutaneous
KW - Sublingual
UR - http://www.scopus.com/inward/record.url?scp=4644264065&partnerID=8YFLogxK
U2 - 10.5414/alp27355
DO - 10.5414/alp27355
M3 - Tidsskriftartikel
AN - SCOPUS:4644264065
VL - 27
SP - 355
EP - 366
JO - Allergologie
JF - Allergologie
SN - 0344-5062
IS - 9
ER -
ID: 313376659