Perfil asistencial de una pauta agrupada de inmunoterapia con extractos de pólenes absorbidos en hidróxido de aluminio / Assistential profile of a cluster immunotherapy schedule with aluminium hydroxide-absorbed pollen extracts

Fundamento: Las pautas convencionales de iniciación de inmunoterapia se utilizan ampliamente a causa de su seguridad bien conocida, pero no se ha demostrado que constituyan un procedimiento óptimo. En los últimos años se han publicado algunas experiencias que avalan la seguridad de pautas agrupadas. Objetivo: Conocer de forma práctica las ventajas asistenciales de una pauta agrupada para extractos de pólenes estandarizados biológicamente y absorbidos en hidróxido de aluminio, en las condiciones de administración controlada en unidades asistenciales de inmunoterapia. Métodos: 139 pacientes alérgicos a pólenes (Olea, gramíneas, Chenopodium, Plantago) se trataron con Pangramín Depot® (ALK-Abelló, España) mediante una pauta de 4 visitas y 10 dosis, siguiendo las recomendaciones de la EAACI en dos unidades de inmunoterapia de Andalucía. El 72 por ciento de ellos tenían rinoconjuntivitis y asma y el 28 por ciento restante sólo rinoconjuntivitis. Se perseguía alcanzar la dosis máxima recomendada por el fabricante. Resultados: Los pacientes hicieron un total de 585 visitas a las unidades de inmunoterapia y recibieron 1.433 dosis. Seis pacientes (4,3 por ciento) presentaron otras tantas reacciones locales inmediatas (0,4 por ciento de las inyecciones) y un paciente (0,7 por ciento) sufrió una reacción sistémica leve (0,07 por ciento de las dosis) consistente en exantema urticarial.Todos alcanzaron la dosis de mantenimiento propuesta por el fabricante, sin abandonos ni exclusiones. Conclusiones: La pauta analizada ahorra considerablemente visitas, es bien aceptada por los pacientes y muestra un perfil de seguridad que permite su utilización habitual. Se propone la realización de otros trabajos que investiguen su utilidad para mejorar la eficacia y conocer el mecanismo de acción (AU)

Immunotherapy with a calcium phosphate-adsorbed five-grass-pollen extract in seasonal rhinoconjunctivitis: a double-blind, placebo-controlled study.

BACKGROUND: Calcium phosphate-adsorbed allergen extracts are used for subcutaneous immunotherapy to avoid the use of aluminium adjuvants. OBJECTIVES: A double-blind, placebo-controlled study was performed in order to confirm the safety and assess the efficacy of a standardized five-grass-pollen extract adsorbed onto calcium phosphate for specific immunotherapy (IT). METHODS: Twenty-nine patients with seasonal rhinoconjunctivitis were randomized to receive either the active preparation (16 patients) or placebo (13 patients), in a 1-year study. During the increasing dose phase, an extract ranging from 0.1 IR per ml to 50 IR per ml was administered at a rate of one subcutaneous injection per week until a maintenance dose was reached. The patients were assessed by symptom diary and rescue medications during seasonal exposure and specific nasal and skin reactivity before and after IT. Immunological parameters (specific IgE and IgG4 antibodies) were assessed before, during and after IT. RESULTS: The overall symptoms score (mean AUC) was not significantly different between the IT group and the placebo group during grass-pollen exposure (49.6 vs. 56, respectively). The total medication score (mean AUC) was significantly lower in the IT group than in the placebo group (11 vs. 41, P < 0.01, Mann-Whitney U-test). The cumulative symptom/medication score was significantly lower in the IT group than in the placebo group (64.5 vs. 102.3, P < 0.05, U-test). A significant increase in nasal reactivity threshold was observed after IT in the IT group (21. 4 IR/mL before IT vs. 63.4 IR/mL after IT, P < 0.01, Wilcoxon), whereas no significant changes were observed in the placebo group (31.0 IR/mL before IT vs. 37.7 IR/mL after IT). IT induced a significant reduction in grass pollen cutaneous reactivity in the actively treated group (P < 0.001). A significant increase in serum-specific IgG4 antibody response was observed in the IT group (3.1% before IT vs. 10.1% after IT, P < 0.001). Nine patients in the IT group developed moderate immediate systemic reactions vs. two patients in the placebo group. CONCLUSION: Specific immunotherapy with calcium phosphate-adsorbed standardized grass pollen extract was safe and effective for the treatment of patients with seasonal allergic rhinoconjunctivitis.

Prophylactic and acute treatment with the homeopathic medicine, Betula 30c for birch pollen allergy: a double-blind, randomized, placebo-controlled study of consistency of VAS responses.

A study of the consistency of responses by allergic patients in repeated studies of the homeopathic remedy Betula 30c or placebo against birch pollen allergy, was made. A randomized, double-blind, placebo-controlled trial was performed including participants with a known allergy to birch pollen. Allergy symptoms were assessed on a visual analogue scale (VAS) by patients or parents each day during a 20-day period during two different pollen seasons. The work was carried out in Oslo, Norway during May 1995, 1996 and 1997. There were 51 patients ranging in age from 7 to 50y. The homeopathic remedy Betula 30c or placebo was given as tablets, both as a prophylactic agent, once a week for 4 weeks before the pollen season started, and as an acute remedy during the pollen season. The mean value of the symptom scores on the visual analogue scale, for all registration days from each patient was the main outcome. The patient groups that received either placebo or Betula 30c for two successive years showed a consistent response (r=0.75, P=0.01 and r=0.70, P=0.003, respectively). No such correlation was found in the two groups that changed remedy from one year to another (either from placebo to Betula or vice versa). Subjective assessment of allergic symptoms to birch pollen differed more from one year to another when different regimens (placebo or homeopathic) had been administered these two seasons, than when the same treatment had been given.

Pollen-specific rush immunotherapy: clinical efficacy and effects on antibody concentrations.

BACKGROUND: Studies of rush immunotherapy (RIT) with standardized extracts for the treatment of seasonal pollen allergy are few, especially for birch-pollen RIT. OBJECTIVE: The study was performed to investigate the efficacy of RIT with standardized birch- or timothy-pollen extracts. Further, the serum antibody levels were evaluated for correlation with clinical efficacy. METHODS: This open, longitudinal study included 30 allergic patients treated with RIT and 16 allergic patients serving as a control group. The therapy was continued for 3 years and blood samples were collected at regular intervals for antibody measurements using the Pharmacia CAP System. RESULTS: The RIT was generally well tolerated. An increase in the total and specific IgE concentrations during the early months of RIT was observed, followed by decreased levels. Specific IgG and IgG4 increased continuously for 2 years. The symptom and medication scores were significantly decreased, compared with preRIT, at both the first and third pollen seasons after the start of RIT treatment (P < .0001 and P < .001, respectively). The clinical improvement during RIT was significantly greater compared with the control group (P < .05). The decreased medication and the symptom improvement during the third year of RIT correlated with the relative decrease in specific IgE (rs = .52, P < .05) and with the specific IgG4 level before the start of RIT (rs= -.68, P < .01), respectively. CONCLUSIONS: Our study indicates that RIT with standardized birch- or timothypollen extracts is clinically effective and safe. Measurements of specific antibody levels during treatment may be helpful in monitoring RIT.

Preseasonal local allergoid immunotherapy to grass pollen in children: a double-blind, placebo-controlled, randomized trial.

BACKGROUND: We assessed the efficacy of preseasonal local allergoid immunotherapy in a group of children with asthma and/or rhinitis and/or rhinoconjunctivitis due to grass pollen. METHODS: We randomly assigned 24 children allergic to grass pollen to receive local allergoid immunotherapy for 3 months before the pollen season and 24 such patients to receive identically appearing placebo. The immunotherapy consisted of tablets of monomeric allergoid grass pollen allergens held in the mouth until they dissolved and then swallowed. The study was double-blind. Symptoms and medications were scored on diary cards during the pollen season. Nasal eosinophil cationic protein levels were measured by the monoclonal antibodies EG1 and EG2 outside the pollen season and at low and at high pollen concentration during the pollen season. RESULTS: The active-treatment group had a statistically significant reduction of total symptoms (P<0.05), especially bronchial symptoms (P<0.05), in comparison with the placebo group. Immunotherapy was well tolerated and compliance was good. Nasal levels of EG2 and EG1 increased significantly during the pollen season, but there was no difference between groups. EG2/EG1 increased significantly only in the placebo group during natural allergen exposure (P<0.01). CONCLUSIONS: Our results suggest that this immunotherapy is effective for the treatment of asthma due to grass pollen in children.

Beneficial effect of pollen and/or propolis on the metabolism of iron, calcium, phosphorus, and magnesium in rats with nutritional ferropenic anemia.

There has been considerable debate regarding the nutritional benefits of pollen and the propolis produced by bees, although most contributions have lacked scientific soundness. This paper describes the possible beneficial effect of their use in pharmacological products in cases of anemic syndrome. We studied the effect of these two natural products on the digestive utilization of iron, calcium, phosphorus, and magnesium, using control rats and rats with nutritional ferropenic anemia. The addition of these products to the diet produced a positive effect on weight gain; this fact could constitute a scientific basis for the application of pollen and propolis as fortifiers. They improve the digestive utilization of iron and the regeneration efficiency of hemoglobin, especially during recovery from an anemic syndrome. They also have a positive effect on phosphocalcic metabolism and maintain an appropiate level of magnesium metabolism. Furthermore, in iron-deficient rats, these natural products palliate, to a large extent, the adverse effects of iron deficiency on calcium and magnesium metabolism as a result of the improvement in the digestive utilization of these minerals.

Is homeopathic 'immunotherapy' effective? A double-blind, placebo-controlled trial with the isopathic remedy Betula 30c for patients with birch pollen allergy.

The objective of the study was to examine the effect of the homeopathic remedy Betula 30c vs. placebo for patients with birch pollen allergy. A double-blind, randomized, placebo-controlled trial was carried out. Tablets were given for 4 weeks during the birch pollen season. The setting was Oslo, Norway, May 1995. Patients were aged between 18 and 50 y; 32 patients received Betula 30c tablets and 34 patients received placebo tablets. The main outcome measure was the total score of 17 different allergy symptoms. Daily total scores were calculated, as well as differences and ratios between the run-in and the following time periods. Point estimates of the median difference between the experimental and placebo groups, with their 95% confidence intervals, were the main measure of effect. No statistically significant difference between the groups was found during the first and last period of May. However, from 8 to 18 May, a clinically interesting difference was revealed between the groups, those receiving Betula 30c having fewer and less serious symptoms. For some days these differences were statistically significant. Surprisingly, this group reported more aggravation from the tablets than did the placebo group. With a statistical power of 70% for a defined clinically interesting difference (25%), the present results indicate that treatment with Betula 30c during the pollen season deserves further attention.

No beneficial effect of isopathic prophylactic treatment for birch pollen allergy during a low-pollen season: a double-blind, placebo-controlled clinical trial of homeopathic Betula 30c.

The objective of this research was to determine if the homeopathic medicine Betula 30c is more effective than placebo at reducing symptoms of pollen allergy in patients sensitive to birch pollen. It was a double-blind, randomized, placebo-controlled trial. Tablets were given both as a prophylactic agent, once a week four weeks before the pollen season and as an acute remedy during the pollen season. The study was done in Oslo, Norway, in May 1996 and involved 73 children, adolescents and young adults from 7 to 25 y of age. Allergy-symptoms were assessed on a visual analogue scale (VAS) by patients or parents. Main outcome measure was the median (with its 95% confidence interval) of the symptom scores for all the treated patients, each day during a 10-day period. The pollen count was very low in 1996, only three days were high enough to provoke allergic symptoms. Surprisingly, the verum treated patients fared worse than the placebo group; they used more rescue medication and had higher symptom scores during these three days. Homeopaths might attribute the findings to a putative aggravation response, but the results certainly do not lend support to the usefulness of the tested prophylactic approach, under conditions of low allergen exposure.

Cytokine production by peripheral blood mononuclear cells following birch-pollen immunotherapy.

We studied the Th2/Th1 balance by short-term stimulation of peripheral blood mononuclear cells (PBMC) isolated during the pollen season from seven allergic patients treated with conventional birch-pollen immunotherapy (IT) for 18 months, eight matched allergic control patients and 10 non-atopic individuals. The PBMC were cultured for 7 days with birch-pollen extract (BPE) or tetanus toxoid (TT), and then restimulated with PHA and PMA to induce high IL-5, IL-10 and IFN-gamma production. The serum levels of birch-pollen-specific IgG and IgG4 were significantly elevated after IT treatment. The proliferative response to BPE was significantly enhanced in the allergic control group, but not in the IT-treated group, compared to the non-atopic group (P<0.05). Birch-pollen-specific IL-5 production was significantly enhanced in both the IT-treated group and the allergic control group (P<0.01-0. 05). Furthermore, both the IT-treated group and the allergic control group had a cytokine profile to BPE significantly more Th2 polarized (high IL-5/IFN-gamma ratio) than to TT (P<0.05 and P<0.01, respectively). No differences in IL-10 production between the three study groups were observed. The Th2/Th1 balance in vitro correlated with the serum concentrations of birch-pollen-specific IgE (r=0.60, P<0.05), and in the IT-treated group, also with the IgG and IgG4 levels (r=0.79, P<0.05 and r=0.86, P<0.05, respectively). We conclude that conventional birch-pollen IT does not lead to changes in the cytokine profile of the circulating pool of allergen-specific T cells during birch-pollen season. However, induction of peripheral T-cell tolerance and increased production of specific IgG and IgG4 might be part of the mechanisms of IT.

[Sublingual immunotherapy for allergic diseases].

4 patients suffering from severe pollinosis and/or allergic rhinitis, with or without asthma, were treated as follows: 30 minutes before breakfast the vaccine was dropped sublingually and retained for 2-3 minutes before being swallowed. It was a commercial preparation of allergen, diluted 50% w/v in glycerin. This stock solution was then diluted in physiological saline containing 0.05% human albumin and kept refrigerated in a dark glass bottle for up to 4 weeks. Of the first dilution which contained 10 Au/ml, 1 drop was given on day 1 and 1 drop more each day until days 5 to 17, when 5 drops were given daily. Then 1000 and then 2500 Au/ml were given sequentially in the same manner, and finally 5000 was given for up to 2 years. A maintenance dose of 3 drops of 5000 Au/ml twice weekly was then prescribed. 41 patients showed striking clinical improvement after about 6 months of treatment. A definite reduction in the use of other medications was achieved in all. Sublingual immunotherapy is practically free of unwanted side effects and easy to self-administer at home. To establish the specificity of sublingual immunotherapy, patients who had severe allergic symptoms to one pollen allergen causing symptoms in the spring and to a second in the autumn, were first immunized sublingually against a single allergen. A year later, after symptoms due to this allergen had subsided, and if symptoms caused by the second allergen had not improved, immunization against the second allergen was started. Sublingual immunotherapy acts by increasing mucosal antibodies at the site of entry of the allergen into the respiratory tract. It is a safe and practical procedure with results comparable to subcutaneous allergy injections.

New clinical data and therapeutic prospects in Cupressaceae pollen allergy.

The authors emphasize, thanks to their clinical data over the last 20 years: The steady increase of allergy to C. sempervirens pollen compared to other pollinosis and to atopy. The frequency of cross-reactivity between C. sempervirens and other pollens belonging to Cupressaceae and Taxodiaceae families, in order, in the absence of a very good standardization and of a purification of this pollen, to try to undertake a sound specific immunotherapy using the most cross-reactive pollen mixed with C. sempervirens extracts. As a matter of fact the partially purified extracts of C. japonica gave the higher incidence (91%) of cross-reactivity. Consequently, a mixture of C. sempervirens and C. japonica extracts was used since 1993 with good results in a double blind study.

[Short-term immunotherapy--a survey of current studies]. / Kurzzeit-Immuntherapie--ein Uberblick über aktuelle Ergebnisse.

Immunotherapy (IT) plays a central role in the therapy of allergic rhinitis as it was proved to be causal and preventive. IT induces humoral and cellular changes in the immune system, a reduction of symptoms and a prophylactic effect regarding a possible expansion of the allergene spectrum and of involved organ systems. Regular therapeutic schedules include allergen injections starting immediately after the pollen season and ending just before the expected beginning of a season. Additionally, perseasonal and perennial therapy schemes have been used. In all these, a phase of dose-increase is followed by an individually adjusted steady-state preservation-phase. In perseasonal and perennial scheme the injections are given during the pollen season. The preseasonal shortterm-immunotherapy is another schedule. The increase of the injected allergen-dose is made very fast (most commonly during seven weeks), so that the phase of dose-increase is shortened considerably, and a preservation-phase does not take place. This shortterm-immunotherapy has been developed for patients who consult their doctor shortly before the start of the pollen season. The preseasonal shortterm-immunotherapy has been shown to be efficient regarding allergic rhinitis caused by grass-, rye-, birch-, hazel- and alder-pollen. Clinical and experimental data of two placebo-controlled trials and one open study are presented and the role of this new immunotherapy approach is discussed.

PAT--the Preventive Allergy Treatment Study design and preliminary results.

The Preventive Allergy Treatment Study, the PAT Study, is a European multi-center study. The end-point is to show in what capacity allergen specific subcutaneous immunotherapy can reduce the outcome of asthma in children with allergic rhinoconjunctivitis sensitized to birch and/or timothy pollen. Two hundred and ten children aged from 5 to 13 years were included in the study. Children were randomized to the active treatment group receiving allergen specific immunotherapy with birch and/or timothy pollen allergen extract or to the control group receiving the optimal pharmacotherapy. Immunotherapy was given for the course of three years. Preliminary data show that immunotherapy has been effective, it has been safe and statistically significantly less children in the actively treated group had asthmatic symptoms than children in the control group. Data have not been evaluated from all centers at the moment. The study is a prospective follow-up study, the patients' data will be evaluated next time in the year 2002.

Comparison of the efficacy and safety of two preseasonal regimens of glutaraldehyde modified, tyrosine-adsorbed parietaria pollen extract over a period of three years in monosensitive patients.

The purpose of this study was to evaluate the clinical efficacy over a period of three years (1988-90) of two preseasonal dosage regimens of a Parietaria allergoid (Bencard Tyrosine Parietaria) in patients who were only sensitive to this pollen. Fifty patients were included (14 men and 36 women, age: mean, 28 years; range, 14-47 years). Twenty five patients (group A) were treated each january with the basic course of Bencard Tyrosine Parietaria. This consisted of injecting subcutaneously 0.5 ml from each of three vials, with one week between each injection. A further injection using the vial with the highest dose was given one week later. Each january and february, twenty five patients (group B) were treated with the basic course of Bencard Tyrosine Parietaria, repeating the last dose five times, with one week between each injection. Immunotherapy with a tyrosine-adsorbed Parietaria judaica allergoid is an effective method for mitigating nasal (p < 0.0001), bronchial (p < 0.005), conjunctival (p < 0.001) and palatal itching symptoms (p < 0.0001) in patients who are sensitive to this pollen. Sensitivity to Parietaria pollen, as verified by skin test and nasal challenge, decreased during immunotherapy (p < 0.001). Histamine release by peripheral blood basophils decreased during the course of the study, falling from 43.5 ng/ml to 12.3 ng/ml in group A and from 42.9 ng/ml to 10.0 ng/ml in group B; during the second and third years, IgG levels were increased one and four months after starting treatment with the extract, while this was not the case after ten months; IgE levels were also increased. Finally, overall tolerance to this immunotherapy product was good in almost all patients.

Late recall urticaria.

In the cases reported of recall urticaria, the clinical manifestations usually develop within an hour. We present the clinical case of an 11-year-old boy who, after 9 weeks of immunotherapy with pollen extracts (Phleum pratense and Festuca elatior), presented an urticarial lesion 48 to 72 h after of the injection on the opposite arm to where it had been applied and in the same place where the previous injections had been administered. This reaction continued for every injection given during the time that the immunotherapy was applied twice a week, and for the 6 weeks that it was applied once a week. Subsequently, the urticarial lesions appeared every two or three injections.

[The efficacy of flower pollen in patients with rheumatoid arthritis and concomitant diseases of the gastroduodenal and hepatobiliary systems]. / Efektyvnist' pylku kvitkovoho u khvorykh na revmatoïdnyi artryt z suputnimy zakhvoriuvanniamy hastroduodenal'noï ta hepatobiliarnoï system.

Kept under medical surveillance were 93 patients with rheumatoid arthritis (RA) of different degrees of activity, articular and visceral manifestations. Of these, 83 had apparent and latent afflictions of the gastroduodenal and hepatobiliary systems (gastritis, gastroduodenitis, peptic ulcer, cholecystitis, hepatitis). Floral pollen (FP) was used as a gastro- and hepatocytoprotectors. FP had a marked positive effect on disorders of the gastroduodenal and hepatobiliary systems and, to a lesser extent, on clinical manifestations and course of RA, as evidenced by clinical and biochemical, endoscopic, and ultrasonic investigations.

Double-blind, placebo-controlled evaluation of sublingual immunotherapy with standardized olive pollen extract in pediatric patients with allergic rhinoconjunctivitis and mild asthma due to olive pollen sensitization.

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 (Stallergènes SA) administered sublingually pre- and coseasonally from January to July for 2 consecutive years. Serial concentrations from 1 to 300 IR. were used up to the maintenance dose of 20 drops of 300 IR daily. The cumulative dose for each patient was 300 times higher than in parenteral immunotherapy, and the cumulative dose of the major allergen Ole e 1 was 8.1 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<0.04 during the first season; P<0.03 during the second season). At the pollinic peak during the second year, a lower score of conjunctivitis was recorded (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 IgG4 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.

Efficacy and safety of oral immunotherapy in respiratory allergy to Parietaria judaica pollen. A double-blind study.

Two groups of 15 patients with respiratory allergy due to the pollen of Parietaria judaica were studied; one received a treatment of oral specific hyposensitization, the other one a placebo. All of them were monosensitized and clinically matched according to age, gender, score symptoms, drug consumption, skin test and RAST, and nasal or bronchial provocation test. The pollen counts were the same during this period. The study was double-blind and lasted 2 years. The clinical tests including score symptoms, drug consumption, and nasal or bronchial provocation test, revealed a statistically significant improvement in the treated group as compared to the placebo group. No side effects were observed.

Immunotherapy with sublingual birch pollen extract. A short-term double-blind placebo study.

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 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 (T0) and after (T1) treatment. For statistics p < 0.05 was applied. At T0 there was no decisive difference in the in vitro and in vivo results between the two groups. After the treatment period (T1), actively treated patients showed a significantly higher tolerance to the birch pollen CPT (p < 0.01). 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 rhinomanometry 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.