Study 83

Results of an open clinical trial with (Pollen Extract) in patients with Pollinosis

Mazzi Rodolfo
Lugano, Switzerland (1986)

Aim of trial

To evaluate the effect of T60 in patients, who are allergic to flower pollen and suffering from pollinosis. The trial should provide information on the improvement concerning the symptoms (mainly Rhinitis and Conjunctivitis) and on the occurrence of adverse (allergic) reactions. The patients have been treated in 4 centers.

Principal Investigator
Dr. R. Mazzi, Locarno, CH, Center 1

Co-Investigators
Dr. G. Bolognini, Mendrisio, CH, Center 2
Dr. S. Gilardi, Locarno, CH, Center 3
Dr. T. Pani, Lugano, CH, Center 4

Sponsors
SA, Lugano, CH
Lagap SA, Lugano, CH

Dosage
1-2 sachets /day corresponding to 840mg T60 and 42mg GBX/sachet (1 sachet = 3g)

Period of treatment
March- July 1985 and 1986 respectively

Summary

T60 taken prophylactically in early spring has caused a positive respond in 66% of a collective of 45 patients suffering from pollinosis.

The patients have reported of an improvement of symptoms, especially concerning Rhinitis, Conjunctivitis and Sneeze.

Age and sex of the patients did not significantly influence the result of the treatment.

The date of start of treatment, whether March or April did not influence the results.

There seemed to be a clear dose/response relation. Patients treated with 2 sachets per day form by far the best group with only "good" or "completely disappeared" results.

No adverse reactions have been observed. Even a high dosage of T60 (up to 1.6 gram of Pollen Extract) administered per os did not cause allergies patients usually highly allergic to flower pollen.

Introduction

Contains as active ingredient a flower pollen extract, which is standardized in composition and production process (called: Pollen Extract).

During the spring of 1985 and 1986 respectively, 45 patients suffering from Pollinosis have been treated with T60 prophylactically to evaluate the effect of the drug on the symptoms of Pollinosis.

An additional aim of the trial has been to evaluate the tolerability of the T60 Pollen Extract, given per os at a high dosage to patients, known to be allergic against flower pollen.

T60 is presented in powder form in aluminum sachets and has been administered daily per os (1 or 2 sachets). Each sachet contains 3g of T60, which corresponds to 882 mg of T60 {T60 (water-soluble components): 840 mg; GBX (fat-soluble components): 42 mg}.

The patients have been treated in 4 centers in Lugano and Locarno in the southern part of Switzerland.

The trial has been carried out as an open trial. For each patient a detailed Case Record Form has been worked out and completed by the investigator(s).

Centers and Patients

The following 4 physicians participated in the trial:

The patients have been divided as follows:

Table 1: Distribution of patients according to centers, sex and age

* for 8 patients of center 1 (1985) data on age are missing

Dosage

The normal dosage has been 1 sachet of T60 per day. In center 2 however, 7 patients out of 13 have been treated with a double dose of 2 sachets daily.

Results

The results of the treatment have been evaluated in two ways:

a) Effect of the treatment on the following of pollinosis:

• Pruritis
• Sneeze
• Rhinitis
• Conjunctivitis
• Asthma

The patient had to report on each symptom whether at the end of the treatment it has:

• completely disappeared
• much improvement
• moderately improved
• remained unchanged
• deteriorated

b) General assessment of the treatment:

The patient and the physician had to judge each one separately, whether the result of the treatment has been considered as

• very good
• good
• mediocre
• non-satisfactory

Effect of T60 on the symptoms of pollinosis

Table 2: Combined results 1985/86, 45 patients (figures are number of patients)

A majority of patients reported moderate to substantial improvement for the symptoms of Sneeze, Rhinitis and Conjunctivitis.

66,6% of the patients reported a positive response for Rhinitis, 62,2% for Conjunctivitis and 60% for Sneeze.

Much improved and/or completely disappeared were: 44,4% for Rhinitis, 42,2% for Conjunctivitis and 40% for Sneeze.

Detailed data for each center are found in table 1-8 of the annex of this report.

Even though the figures suggest quite a positive result for T60, one has to consider the high placebo effect, the low number of patients and lack of statistical evaluation.

General Assessment of the treatment

Data on each patient concerning age, sex, dosage, start and end of the treatment, as well as concerning the assessment of the treatment are found in table 10-13 of the annex to this report.

The combined results of all 4 centers are shown in the following table:

Table 3: Combined results of the treatment of T60, 1985/86, 45 patients

68.9% of the patients responded positively to the drug. Good to very good response has been achieved by 53.3%. Over 15% showed a mediocre result and 31.1% did not respond at all.

Adverse Reactions

It is remarkable to notice that no adverse reactions (allergies) have been observed or reported due to the treatment with Pollen Extract. One has to recall the high dosage of Pollen Extract (corresponding to more than 10 tablets Cernilton/day) and the sensitivity of the special selected patients, who are generally allergic to flower pollen.

From the present trial can be concluded, that per os intake of Cernilton Extract up to 882 mg/day do not cause any allergic reactions.

7 patients of center 2 have been treated with 1764 mg/day and did not show adverse reactions.

Effect of the treatment in function of the genus

The following table shows that there is no substantial difference concerning the sex, except that the assessment of "very good" is rarer in the groups of women.

Table 5

Effect of treatment in function of age

Table 6

The only surprising difference is in the "mediocre" group, where under 25 years of age there is a percentage of 23.5%, but over 25 years only 5%. It seems that many of the over 25 years patients simply judge a mediocre result as "non satisfactory".

Effect of treatment in function of dosage

The results of center 2 (see table 11 of annex) clearly show a much more consistent and better result by taking 2 sachets instead of 1 per day. All 7 patients report good to very good results. Such a result has not been observed in any other group or center.

Start/end of treatment

The date of start or duration of the treatment did not influence the results.

Conclusions

Efficacy

The prophylactic intake in spring has caused a certain relief in the symptoms of patients suffering from pollinosis. Over 65% of the 45 patients reported of an improvement of their conditions at the end of the treatment, especially concerning the symptoms of Rhinitis, Conjunctivitis and Sneeze.

In this preliminary, open study no difference has been observed regarding sex and age of the patients. Also, the beginning of the treatment, whether March or April, seemed not to have any influence on the results.

However, a treatment with a double dose (2 sachets/day) definitely improved the outcome of the treatment.

The present results have not been statistically analyzed. One has to take into consideration the low number of patients and the high placebo effects, as well as the varying weather conditions.

A final conclusion concerning the efficacy of the product will need a further trial with more patients and a control group ideally the trail should be blinded.

Tolerability

The present study is however very convincing concerning the tolerability of T60. At the high dosage of 882 mg of Flower Pollen Extract there has not been observed any adverse effects, say allergies in all 38 patients receiving this dosage. Seven patients receiving 1764 mg daily did also not show any allergic reaction. Thus, the conclusion is justified, that Pollen Extract (T60) does not cause allergenicity when administered orally.

Annex

1. Data on single patients and evaluation of the therapy for each patient
2. Effect of T60 on the symptoms (Pruritis, Sneeze, Rhinitis, Conjunctivitis and Asthma) Table 1-9

Dr. R. Mazzi, Center 1

* results not recorded (eliminated from final evaluation)
** irritation of pre-existing eczema (hands); objectively doubtful.

Dr. G. Bolognini, Center 2

Dr. S. Gilardi, Center 3

Dr. T. Pani, Center 4

Table 1: Results of Center 1, 1985, 8 patients (Dr. R. Mazzi)

Table 2: Results of Center 1, 1986, 14 patients (Dr. R. Mazzi)

Table 3: Combined results of Center 1, 1985 and 1986, 22 patients(Dr. R. Mazzi)

Table 4: Results of Center 2, 1985, 6 patients (Dr. G. Bolognini)

Table 5: Results of Center 2, 1986, 7 patients (Dr. G. Bolognini)

Table 6: Combined results of Center 2, 1985 and 1986, 13 patients(Dr. G. Bolognini)

Table 7: Results of Center 3, 1986, 5 patients (Dr. S. Gilardi)

Table 8: Results of Center 4, 1986, 5 patients (Dr. T. Pani)

Table 9: Combined results of all 4 Centers 1985 and 1986, 45 patients