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The following abstracts detail studies conducted
around the world that demonstrate the effectiveness
of oral immunotherapy.
AUSTRIA
J Investig A Allergol Clin Immunol 1998 May-Jun;8(3):165-71
Immunotherapy with sublingual birch pollen extract.
A short-term double-blind placebo study.
Horak F, Stubner P, Berger UE, Marks B, Toth J,
Jager S University ENT-Clinic, Vienna, Austria.
The aim of this double-blind placebo-controlled
study was to evaluate the efficacy and tolerability
of short-term birch pollen sublingual immunotherapy.
Forty-one patients suffering from allergic rhinoconjunctivitis
caused by Betula alba were included. Exclusion
criteria were the following: undergoing immunotherapy
within the last 2 years, contraindications to
immunotherapy, pregnancy and nursing. The treatment
schedule comprised a 28-day basic course, followed
by a 3-month maintenance treatment. The evaluation
of the parameters was performed before treatment
and 4 months after the last maintenance dose.
Skin prick test and conjunctival provocation test
(CPT) in a dilution series were carried out to
determine the threshold of the reaction. The objective
parameters used were the diameter of the skin
wheals and the lowest concentration. of the allergen
extract to induce the symptoms of itching and
reddening of the eyes. The allergic reaction in
general was 9 evaluated with the help of a 2-h
birch pollen challenge in the Vienna Challenge
Chamber (VCC): nasal flow and resistance was measured
by rhinomanometry. and nasal secretion was quantified
by weighing used handkerchiefs. Bronchial reactions
were objectified by spirometry. subjective symptoms
of the eyes. the nose and the bronchial tract
were documented by the patients via a visual analog
scale. Birch pollen specific IgE and IgG were
evaluated by monoclonal antibody enzyme immunoassay
before (TO) and after (Tl) treatment. For statistics
p < 0.05 was applied. At TO there was no decisive
difference in the in vitro and in vivo results
between the two groups. After the treatment period
(Tl) I). actively treated patients showed a significantly
higher tolerance to the birch pollen CPT (p <
0. 0 1 The skin reaction was significantly lower
than in the placebo group. Furthermore. actively
treated patients produced less than half of the
nasal secretion of placebo-treated patients during
the challenge session. The rhinomanometrv analysis
during the challenge showed significant differences
for verum and placebo in favor of the actively
treated patients (p = 0.033). There was no significant
difference in the specific IgE and IgG concentrations.
The side effects and compliance during the treatment
were comparable in both groups. In conclusion.
sublingual immunotherapy is a well tolerated and
clinically effective method of treatment.
FRANCE
Allergy 1999 May;53(5):493-8
Clinical efficacy of sublingual-swallow immunotherapy:
a double-blind,, placebo-controlled trial of a
standardized five-grass-pollen extract in rhinitis.
Clavel R, Bousquet J, Andre C Groupement d'Allergologie
et d'Immunologie Clinique du Rhone Moyer, Lyon,
France.
Sublingual-swallow immunotherapy (SLIT) using
high doses of standardized allergen extracts has
been found to be effective in reducing allergic
symptoms and medication needs. A double-blind,
placebo-controlled study was carried out in a
large number of patients to determine whether
medication needs can be reduced by SLIT. Some
136 patients with grass-pollen rhinitis with or
without mild asthma were studied. Patients received
either placebo or SLIT with a standardized grass-pollen
extract administered day with increasing doses
up to 300 IR (index of reactivity) from January
to the end of July 1994. During the grass-pollen
season, patients were instructed to use medications
as required and to visit their doctors in case
of asthma. Sumtom_medications scores were assessed
during the pollen season, and serum-specific IgG4
was measured before and at the end of SLIT. In
the SLIT group, drug consumption dropped significantly
throughout the pollen season (P < 0.02). Moreover,
at the peak of the pollen season, betamethasone
consumption was significantly reduced in the SLIT
group (P < 0.02). Only one patient in the SLIT
group had an asthma attack compared to eight patients
in the placebo group (P < 0.02). IgG4 levels increased
significantly in the SLIT group (P < 0.001) but
without correlation with symptoms. Side-effects
were comparable in both groups. This study indicates
that SLIT in grass-pollen rhinitis is well tolerated,
improves overall clinical symptoms Sublingual-swallow
immunotherapy (SLIT) using high doses of standardized
allergen extracts has been found to be effective
in reducing allergic symptoms and medication needs.
A double-blind, placebo-controlled study was carried
out in a large number of patients to determine
whether medication needs can be reduced by SLIT.
Some 136 patients with grass-pollen rhinitis with
or without mild asthma were studied. Patients
received either placebo or SLIT with a standardized
grass-pollen extract administered day with increasing
doses up to 300 IR (index of reactivity) from
January to the end of July 1994. During the grass-pollen
season, patients were instructed to use medications
as required and to visit their doctors in case
of asthma. Sumtom_medications scores were assessed
during the pollen season, and serum-specific IgG4
was measured before and at the end of SLIT. In
the SLIT group, drug consumption dropped significantly
throughout the pollen season (P < 0.02). Moreover,
at the peak of the pollen season, betamethasone
consumption was significantly reduced in the SLIT
group (P < 0.02). Only one patient in the SLIT
group had an asthma attack compared to eight patients
in the placebo group (P < 0.02). IgG4 levels increased
significantly in the SLIT group (P < 0.001) but
without correlation with symptoms. Side-effects
were comparable in both groups. This study indicates
that SLIT in grass-pollen rhinitis is well tolerated,
improves overall clinical symptoms, and reduces
drug consumption and the need for oral corticosteroids.
Allergy 1994 May,49(5):309-13
A double-blind, placebo-controlled trial by the
sublingual route of immunotherapy with a standardized
grass pollen extract.
Sabbah A, Hasoun S Le Sellin J, Andre C, Sicard
H Laboratoire d'Immunoallergologie, Centre Hospitalier
Regional et Universitaire, Fresnes, France.
Fifty-eight patients with well-documented history
of seasonal rhinoconjunctivitis caused by grass
pollens were allocated randomly on a double-blind
basis to receive either sublingual therapy with
a solution of purified, standardized allergen
preparation (Stallergenes) or a matched placebo
for 17 weeks. The assessment of the effect of
oral immunotherapy, done with drops of five-grass
allergen extract, was on the clinical symptoms
and on the medication score of the authorized
rescue treatments. The actively treated patients
had significantly (P < 0.05 to P < 0.01) fewer
symptoms of rhinitis (sneezing and rhinorrhea)
and of conjunctivitis (redness and tears) during
the pollen season than the placebo group. Consumption
of nasal solution of sodium cromoglycate and of
betamethasone and dexchlorpheniramine was significantly
less in the desensitized group (P < 0.01). Side-effects
were negligible. This study concludes that perlingual
immunotherapy with grass pollen extract in grass-pollen-sensitive
seasonal hay fever and conjunctivitis patients
is effective, easy to perform, inexpensive, and
safe.
GREECE
Allergy 1998 Jul;53(7):662-72
Double-blind, place placebo-control controlled
lied evaluation of sublingual immunotherapy with
standardized olive pollen extract in pediatric
patients with allergic rhinoconjunctivitis and
mild asthma due to olive pollen sensitization.
Vourdas D, Syrigou E, Potamianou P, Carat F, Batard
T< Andre C, Papageorgiou PS P. & A. Kyriakou Hospital,
Athens, Greece.
For evaluation of the efficacy and the safety
of specific sublingual immunotherapy with high
allergen dose, 66 children with seasonal asthma,
rhinitis, and conjunctivitis due to sensitization
to olive pollen were enrolled in a double-blind,
randomized, placebo-controlled study between October
1994 and October 1996 in Greece. Thirty-four patients
were randomly allocated to the active group, and
32 received placebo. Immunotherapy consisted of
olive-allergen extracts (Stallergenes SA) administered
sublingually pre- and coseasonally from January
to July for 2 consecutive years. Serial concentrations
from I to 300 IR were used up to the maintenance
dose of 20 drops of 300 IR day. The cumulative
dose for each patient was 300 times higher than
in parenteral immunotherapy, and the cumulative
dose of the major allergen Ole e I was 8.1 1 mg/2
years. The patients were assessed by clinical
parameters (symptom and medication scores from
patients' daily diaries) and immunologic measurements
(specific IgE, IgG4, eosinophil Cationic protein
[ECP]) were performed. The actively treated patients
had a significantly lower score for dyspnea (P<0.05)
in the actively treated patients. The analysis
of intragroup evolution showed that the total
score of rhinitis Increased significantly during
the pollinic peak in the group under placebo,
whereas there was no symptomatic peak for the
same period in the group under active treatment.
However, the difference between the groups was
not significant. The medication score did not
differ significantly between the groups. Oral
steroids were the only variables with a P value
near the significance level (P=0.06) in favor
of the actively treated group. A significant decrease
in skin reactivity was recorded in the active
group after 2 years of treatment. No significant
variation in specific IgE and 1gG4 was detected.
A significantly lower level of serum ECP was observed
at the pollinic peak in the actively treated patients
during the first pollen season (P=0.01), but this
was not confirmed the second year when the ECP
levels doubled in both groups without correlation
to the clinical findings. Tolerance was excellent
with only a few minor side-effects reported. In
conclusion, high-dose specific sublingual immunotherapy
appears to be safe and effective in improving
mild seasonal asthma and conjunctivitis linked
to olive-pollen sensitization.
ITALY
J Investig Allergol Clin Immunol 1995 Jan-Feb;5(l):25-3U
Sublingual immunotherapy in Parietaria pollen-induced
rhinitis: a double-blind study.
Troise C, Voltolini S, Canessa A, Pecora S, Negrini
AC
Department of Allergology, Ospedale San Martino,
Genova, Italy.
A double-blind. placebo-controlled study of immunotherapy
was conducted in 31 patients with allergic rhinitis
due to Panietaria pollen to evaluate the efficacy
and safety of high doses of allergen via tile
sublingual route. The patients were assessed before
and after a I 10-month period of treatment by
clinical (symptom-medication scores and specific
nasal reactivity) and immunological (total IgE,
specific, IgG and IgG4 antibodies) parameters.
High doses of Parietaria extract corresponding
to a cumulative dose of 105 BU for each patient
were administered with negligible side effects.
The actively treated patients had significantly
lower medication scores than those on placebo
(p < 0.05) when the maximum pollen count was recorded,
and at the end of the trial they showed a significant
decrease in nasal reactivity (p < 0.02) and a
significant increase in serum specific IgG4 (p
= 0.02). No differences were detected in any of
these parameters in the placebo group. Possible
explanations for the mechanisms of sublingual
immunotherapy are proposed.
Allergrol Immunopathol (Madr) 1996 Jul-Aug;24(4):
146-51
Published erratum appears in Allergol Immunopathol
(Madr) 1996 Nov-Dec 24(6) 262
Rush sublincyual immunotherapy in Parietaria Allergic
patients. Sublingual Allergic
D' Ambrosio FP, Ricciardi L, Isola S, Savi E,
Parmiani S. Puccinelli P, Musarra A
Policlinico Universitario di Messina, Scuola di
Specializzazione in AJlerszologla ed Immunologia
Clinica. Milano. Italia.
Forty patients. monosensitized to Parietaria judaica
with a clinical history of at least two years
of rhinoconjunctivitis with or without asthma,
were selected and randomly allocated in two groups.According
to an open controlled experimental plan, twenty
patients were submitted to subilligual I immunotherapy
(SLIT) with a solution of purified and biologically
standardized extract of Parietaria judaica, following
a preseasonal rush schedule. All patients, twenty
belonging to the SLIT group and 9 twenty belonging
to the control group, were allowed to take authorized
rescue drugs at need. At the end of the Parietaria
pollen season. 15 patients for each group resulted
to have compiled with the criteria of the study.
SLIT tolerance turned out to be excellent as no
side effects were noticed in the group under treatment.
No change could be detected in specific IgE and
IgG4 in either group. According to the daily symptom
and drug scores registered by each patient in
a diary card, the SLIT group showed a statistically
significant lower symptom score (p = 0.032) and
lower drug plus symptom score (p = 0.037) during
the peak pollen period (May-June 1994) in comparison
to the group treated only with symptomatic drugs.
Moreover, 13 out of 15 patients submitted to SLIT
expressed a very favourable subjective opinion
about the therapy and asked to continue the same
treatment the following season. According to our
results, the rush SLIT schedule, followed by maintenance
during the pollen season, is simple, safe and
effective for Parietaria pollen allergy and showed
an excellent compliance.
-Allergol Immunopathol (Madr) 1995 Sep-Oct,-23(5):224-30
Safety and efficacy of sublingual rush immunotherapy
with grass allergen extracts. A double blind study.
Felizinni V, Lattuada G, Parmiani S, Dall'Aglio
PP Ambulatorio di Allergologia Dovosione Medicina,
Ospedale Civile di Lanciano, Chieti, Italia.
Thirty-four patients suffering from rhinoconjunctivitis
with or without asthma due to grass pollen, were
submitted to sublingual immunotherapy according
to a double blind placebo controlled experimental
plan-, eighteen patients received the active therapy,
sixteen the placebo. A rush preseasonal treatment
schedule was followed in order to reach the maintenance
dose in 15 days with two administrations per day;
the top dose reached was then administered three
times a week until the end of the pollen season.
The symptoms and drugs related to rhinoconjunctivitis
and asthma were recorded by means of diary cards
and grass pollen counts were performed during
the season. The actively treated group showed
a reduction of symptoms of rhinoconjunctivitis
and asthma and a lower intake of drugs for the
same symptoms, all these differences resulted
to be statistically significant. No patient showed
local or systemic side effects of any relevance.
According to these results-of our study. sublingual
rush immunotherapy is clinically effective and
because of the ease of handling, the shortness
of the treatment. the absence of relevant side
effects and the high compliance of the patient
can be considered as an alternative to classic
injective immunotherapy in grass pollen allergic
patients
Allergol Immunopathol (Madr) 1993 Sep-Oct;21(5):173-8
Rush immunotherapy with sublingual administration
of grass allergen extract.
Feliziani V, marfisi RM, Parmiani S Ambulatorio
di Allergologia Divisione Medicina, Ospedale Civile
di Lanciano, Chieti, Italia.
A study of RUSH specific immunotherapy by sublingual
route has been performed. Twenty patients have
been studied suffering from rhinoconjunctivitis
a/o allergic asthma to grass pollen, divided ill
two homogeneous groups. The first group was treated
with immunotherapy, the other was used as a comparison
in open. The level of specific IgG4 specific IgE
drug consumption and the symptom score were monitored.
The symptom and drug scores recorded by the patients
during the pollen season were significantly reduced
in the group undergoing sublingual allergen administration,
thus proving the clinical efficacy of this treatment.
There has not been, however, a significant reduction
of specific NE, nor a significant increase of
specific IgG4 towards grasses. in the treated
group, monitored before and at the end of the
immunotherapy.
J Allergy Clin Immunol 1999 Aug;104(2 Pt 1):425-432
Double-blind placebo-controlled evaluation of
sublingual-swallow immunotherapy with standardized
Parietaria judaica extract in children with allergic
rhinoconjunctivitis.
La Rosa M, Ranno C, Andre C, Carat F, Tosca MA,
Canonica GW Clinical Pediatrica 1, Catania, Italy,
Stallergenes, Antony, France, and the Allergy
and Clinical Immunology Unit, Department of Internal
Medicine, Genoa, Italy.
[Record supplied by publisher]
BACKGROUND: Sublingual-swallow immunotherapy was
recently recognized in the World Health Organization
Position Paper (Allergen immunotherapy: therapeutic
vaccines for allergic diseases) "as a viable alternative
to parenteral injection therapy to treat allergic
diseases" in adults. More controlled studies were
required to assess the efficacy and safety of
this treatment in children. OBJECTIVE: This study
was carried out to assess the clinical efficacy
and safety profile of sublingual-swallow Immunotherapy
with high-dose allergen in children with allergies.
METHODS: We used a double-blind placebo-controlled
design. Forty-one children with Parietaria -induced
rhinoconjunctivitis were randomized to receive
sublingual standardized Parietaria judaica extract
(n 20) or placebo (n = 21) for 2 years. The cumulative
dose of allergen was 375 times higher than that
used in parenteral immunotherapy and the cumulative
dose of Par J I major allergen was 52.5 mg over
2 years. The main efficacy assessment criteria
were symptoms and rescue medication scores recorded
on the patients' diary cards. Secondary criteria
were changes in skin and conjunctival specific
reactivity as well as blood parameters, analyzed
after I and 2 years of immunotherapy. The safety
of the treatment was assessed by evaluating the
frequency and severity of adverse effects.
RESULTS: A significant reduction in rhinitis symptoms
was observed in the active treatment group during
the second season (P =.02), with no difference
in medication scores. A significant decrease in
skin reactivity (P =.002 after 2 years of treatment)
and an increase in the threshold dose for conjunctival
allergen provocation test (P =.02) were observed
in the active treatment group compared with the
group receiving placebo- A significant increase
in specific IgG(4 ) levels (P =.02) was also observed
in the active group. Immunotherapy was well tolerated.
CONCLUSION: Sublingual-swallow immunotherapy in
Parietaria -allergic children provided a clinical
benefit and a decreased specific reactivity to
the allergen. The safety profile of this treatment,
which constitutes an important issue, indicated
good tolerance and compliance.
NETHERLANDS
Allergol Immunopathol (Madr) 1998 Sep-Oct,26(5)234
-40
sublingual immunotherapy with a standardised grass
pollen extract; a double-blind placebo-controlled
study.
Hordijk GJ, Antvelink JB, Luwema RA University
Hospital. Utrecht- The Netherlands.
BACKGROUND- To assess the efficacy and safety
of sublingual immunotherapy in patients with allergic
rhinitis/conjunctivitis a double blind placebo
controlled study was performed. METHODS AND RESULTS
Fifty-seven (57) patients with a well-documented
history of seasonal grass pollen allergy were
evaluated in a DBPC trial over a period of 10
months (January to November 1995) with a view
to investigating the efficacy and safety of sublingual
immunotherapy with a grass pollen extract, 9,500
BU/ml. The course of treatment consisted of an
incremental phase of approximately 3 weeks followed
by a twice weekly maintenance dosage of 9,500
BU. Compared with the placebo Croup (30 patients),
the group treated with grass pollen extract (27
patients) showed a significant (p < 0.03) lower
mean severity of allergic complaints. i.e. sneezing,
and itchy nose, a watery runny nose and itching
of the eyes during the maximum pollen counts of
the season. The use of anti-allergic medication
was similar in the two groups. Both groups showed
a significant increase in grass-pollen-specific
IgG serum levels. However, the increase shown
in the patients treated with grass pollen extract
occurred earlier in the season and was significantly
(p < 0.002) higher than the increase detected
in the placebo group. Side effects were limited
to a small number of generally mild local I patients
reactions.
CONCLUSIONS. The treatment with sublingually applied
grass pollen extract in pat' suffering from allergic
rhinoconjunctivitis caused by grass pollen was
well tolerated and served to reduce the severity
of allergic complaints. without reducing the consumption
of anti-allergic medication.
SPAIN
Allergol Immunopathol (Madr) 1997 Sep-Oct;25(5):219-27
Clinical efficacy and tolerance of two year Lolium
perenne sublingual immunotherapy.
Gozalo F, Martin S, Rico P, Alvarez E, Cortes
C Allergology Unit, Hospital de Leon (Insalud),
Spain.
Last years, in spite of increasing use of sublingual
immunotherapy (SLIT), not enough clinical studies
have been published and its efficacy ought to
be documented still more. For that purpose, 54
patients suffering seasonal rhinoconjunctivitis-
with or without asthma-were allocated to either
six month preseasonal SLIT with Lolium perenne
extract (n = 35) or to a control group (n = 19).
In the following year, thirty from previously
treated patients and 12 from former control group,
received a nine-month pre-coseasonal SLIT. Skin
(SPT) and conjunctival (CPT) allergen response
were monitorized several times along the study.
Either seric antibodies or intraseasonal eosinophil
cationic protein (ECP), as symptom, medication
scores and peak nasal inspiratory flow (PNIF)
were also assessed, fifty-five adverse reactions
were recorded (0.7% doses), although only four
required treatment. No main changes in CPT, SPT
and antibodies were detected. Nevertheless, during
the first pollen season, treated patients needed
less medication than their control counterparts
(p < 0.05). In the second season, the twelve ex-control
subjects also required fewer drugs than in the
first one (p < 0.01). Moreover, the whole forty-two
treated patients showed a lesser intraseasonal
ECP than a reference set of grass-allergic individuals
(p < 0.05). We conclude that Lolium perenne SLIT
is well tolerated and induces fewer drug requirements
during pollen season, being eosinophil activation
additionally reduced.
J Invertig Allergol Clin Immunol 1994 Nov-Dec;4(6):33
05-14
Double-blind, placebo-contro lied clinical trial
of preseasonal treatment with allergenic extracts
of Olea europaea pollen administered sublingually.
Casanovas M, Guerra F, Moreno C, Miguel R, Maranon
F, Daza JC Laboratorios CBF-LETI, S.A., Madrid,
Spain.
In a double-blind, placebo-controlled, pilot clinical
trial we evaluated the clinical efficacy and safety
of immunotherapy (IT) with an extract of the pollen
of the tree Olea europaea administered sublingually.
'The parameters tested were symptom score, dose-response
bioassay of skin prick test and specific IgE and
IgG, and the absolute value at a single serum
dilution of each IgG subclass. Fifteen patients
allergic to this pollen with symptomatology of
rhinitis and/or rhinoconjunctivitis were randomly
allocated to the placebo group (6 patients) or
to the extract group (9 patients). Immunotherapy
was administered in a short: preseasonal period
of time, practically no side effects being recorded.
The group of patients treated with extract presented
a slightly lower incidence (0.05 < p < 0. 1 )
of nasal symptoms of sneezing and obstruction,
and, more importantly, developed less dyspnea
(p < 0.05) than the group treated with placebo,
suggesting that IT can act as prophylaxis for
the development of bronchial symptoms. No differences
were observed in the immunological determinations.
Differences in skin tests between the two groups
displayed a slight significance (0.05 < p < 0.
1) at the end of the trial, hence, a higher concentration
of the allergen was needed in the group treated
with extract to induce the same wheal as in the
placebo group. In both groups the size of the
wheal showed a time-dependent variation, which
was dependent on the time of the year and independent
of the type of treatment received, indicating
a significant modification in the in vivo skin
response to allergen challenge. demonstrated by
a shift in the kinetics of allergen-ligand binding
(slope) and in the magnitude of the measured response
(intercept).
TURKEY
Ann Allergy Asthma Immunol 1999 May;82(5):485-90
Comparison of the efficacy of subcutaneous and
sublingual immunotherapy in mite-sensitive patients
with rhinitis and asthma--a placebo controlled
study.
Mungan D, Misirligil Z, Gurbuz L Department of
Allergic Diseases, Faculty of Medicine, Ankara
University, Turkey.
BACKGROUND: The efficacy of therapy with sublingual
allergen extracts is unproven. BACKGROUND: The
efficacy of therapy with sublingual allergen extracts
is unproven. OBJECTIVE: To evaluate the clinical
and immunologic outcome of sublingual immunotherapy
and to compare the results with subcutaneous immunotherapy
and placebo in '16 patients with rhinitis and
asthma due to mite allergy. METHOD: Thirty-six
patients with rhinitis and asthma due to mite
allergy were randomly divided into three groups
in order to receive subcutaneous injections with
allergenic extracts, sublingual drops with solutions
of purified standardized allergen preparations,
or sublingual placebo for a period of I year.
Assessment of clinical and immunologic efficacy
included symptom and medication scores, methacholine
provocation tests, skin prick tests, and specific
IgE and IgG4 antibody concentrations. RESULTS:
Subcutaneous immunotherapy for both rhinitis and
asthma was clinically effective. Patients treated
with sublingual immunotherapy had decreased rhinitis
symptoms (P < .0 1) but no change in asthma scores.
Medication scores significantly decreased in both
actively treated groups (P < . 0 1 ) at the first
year compared with baseline. When skin prick tests
were evaluated, the subcutaneously treated group
had a significant decrease in the wheal diameter
of D. pteronyssinus (P <.01), D. farinae (P <.05),
and histamine (P < .05) while other two groups
showed no difference. There was no significant
change in methacholine PC20 values in all groups
at the end of the first year when compared with
baseline. No change in D. pteronyssinus and D.
farinae specific lgE levels were observed, however,
specific IgG4 concentrations were significantly
higher than baseline both in sublingual and subcutaneous
immunotherapy groups (P < .05) after I year immunotherapy.
No significant difference was obtained in any
of these parameters in the placebo group. CONCLUSION:
sublingual immunotherapy may be effective in patients
with allergic rhinitis. Further. we believe it
is a potential therapy for allergic asthmatic
patients. The clinical usefulness of this form
of immunotherapy (when administered to larger
study groups for a longer time) and the mechanisms
underlying its immunologic effect deserve additional
studies.
Abstract
Clin Allergy 1987 Nov; 17(6):501-13
Efficacy of grass-maize pollen immunotherapy ill
patients with seasonal hay-fever: a double-blind
study.
Van Niekerk C I I De Wet JI
Department of Paediatrics and Chi Id I Health,
University of the Orange Free State, Bloemfontein,
South Africa.
Article Number: U188136077
Abstract: Forty patients with a well-documented
history of seasonal hay fever and a positive skin-prick
test specific to grass pollen, including Bermuda
grass and maize pollen (Zea maize) were allocated
randomly oil a double-blind basis to receive either
an oral mixed grass-maize pollen extract or a
matched placebo during the 1981/1982 grass pollen
season. After 12 months the code was broken and
patients on 1, placebo were transferred to active
therapy while patients on active therapy continued
with maintenance therapy for another 12 months
during the 1982/1993 grass pollen season. The
assessment of the effect or the orally administered
grass-maize pollen extractives was on the clinical
symptoms. During the first year the patients on
active therapy had significantly fewer hay fever
symptoms during the summer months compared with
the placebo group. During the second study year,
with all patients on active therapy, both groups
had markedly milder symptoms compared with the
placebo group. Side-effects were negligible. This
study concludes that oral immunotherapy with grass-maize
pollen extract in grass pollen-sensitive seasonal
hay fever patients is safe and effective.
UNITED STATES
Abstract
Ann Allergy Asthma Immunol 1997 Jnn;78(6):573-80
Efficacy and safety of oral immunotherapy with
short ragweed extract.
Van Deusen MA. Angelini BL, Cordoro KM, Seiler
BA, Wood L, Skoner DP Children's I Hospital of
Pittsburgh Pennsylvania, USA
Article Nullifier: U19735 1439
Abstract: BACKGROUND: Oral immunothempy, if proven
safe and effective, could be an alternative to
subcutaneous immunothempy. OBJECTIVE:This pilot
study investigated the clinic and immunologic
effects of ragweed immunotherapy using a new microencapsulated,
ph -sensitive, oral delivery system. METHODS:
A double-blind, placebo-controlled trial was conducted
in 23 patients with allergic rhinitis to short
ragweed. Following a baseline nasal challenge
with ragweed allergen, oral immunotherapy with
encapsulated short ragweed extract or placebo
was administered once daily. 6 days/week. Dosed
began at 3 micrograms Amb 1 per day and were increased
by 3 micrograms every three days as tolerated,
to a maximum daily maintenance dose of 24 micrograms.
A nasal challenge was repeated 6 weeks, later,
followed by the continuation of maintenance therapy
through the natural ragweed season. Daily allergy
symptoms and relief medication ion usage was recorded.
A final nasal challenge was performed at the end
of the natural season. Short ragweed-specific
serum IgE, IgG, and IgG4 antibody levels were
measured every 2 weeks during the study. RESULTS:
Maximum tolerated doses ranged from 6 to 24 micrograms
Amb 1 per day (74% reached 24 micrograms). Adverse
events were not serious or different between the
active and placebo groups. The active group showed
increased in short ragweed-specific serum I IgG
and IgG4 antibody levels. Symptom scores during
the natural season were numerically but not statistically
lower in the active treatment group. This group
also experienced a greater reduction from baseline
in nasal reactivity as assessed by nasal challenge.
CONCLUSIONS: These pilot data suggest that the
encapsulated, pH- I-sensitive oral immunothernpy
delivery system was safe, induced a brisk serologic
response, and attenuated the symptomatic response
to both experimental and environmental ragweed
exposure.
Allergy 1986 May;41(4):271-9
Oral immunotherapy of children with rhinoconjunctivitis
due to birch pollen allergy. A double blind study.
Moller C, Dreborg S, Lanner A, Bjorksten
B
Thirty children with rhino conjunctivitis due
to birch pollinosis were treated in a double blind
manner for 10 months with enteric-coated capsules
containing either a birch pollen preparation (n
= 14) with doses up to 1.4 X 10(6) biologic units
per day or placebo (n = 16). Compared with the
placebo group the actively treated children had
less symptoms during the birch pollen season after
3 months of therapy (P = 0.035). Skin prick reactions
decreased significantly more in the active group
than in the placebo group after 10 months (P =
0.01). Conjunctival sensitivity was lower in the
active group than in the placebo group after 3
months of treatment (P = 0.0 1) but not after
10 months. Compared with the placebo group the
treated children more often increased their levels
of IgG (P = 0.007) and pre-seasonal IgE (P = 0.001)
against birch. There was a seasonal increase of
IgE antibody level against birch in the placebo
but not in the treatment group (P less than 0.
00 1). None of the treated children developed
asthma, compared with five of the untreated children.
No general reactions occurred and few side effects
were seen during the treatment period. We conclude
that in children with birch pollinosis oral immunotherapy
with high doses of a biologically potent preparation
in enteric-coated capsules is effective, easy
to perform, economic and safe.
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