Habanera Journal of Medical Sciences 2014; 13 (3): 425-436

CLINICAL AND PATHOLOGICAL SCIENCES

Faculty of Medical Sciences "General Calixto García" Research Center on Longevity, Aging and Health

Effect of Biomodulin T on upper respiratory infections and polypharmacy in

the elderly

Biomoduline T effect in upper respiratory infections and geriatric patients'

polypharmacy

Marlene García Orihuela I Vladimir Capdevila II, René Suárez Martínez III,
Liliam Rodríguez Rivera IV, Inés Castro González V

I Second Degree Specialist in Gerontology and Geriatrics. Second Degree Specialist in Pharmacology. MsC. Satisfactory
longevity. Assistant Professor. Faculty of Medical Sciences "General Calixto García". e.mail: mgo@infomed.sld.cu

II First Degree Specialist in Normal and Pathological Physiology, First Degree Specialist in Comprehensive General
Medicine. Research Center on Longevity, Aging and Health. e.mail: vladimir.capdevila@infomed.sld.cu

III Doctor of Science. Second Degree Specialist in Biostatistics. Second Degree Specialist in Occupational Medicine. Full
Professor and Consultant. Faculty of Medical Sciences "General Calixto García". e.mail: resumar@infomed.sld.cu

IV Second Degree Specialist in Gerontology and Geriatrics. MSc. Aging and Health. Assistant teacher. Research Center on
Longevity, Aging and Health. e.mail: cesaryalejandro@hotmail.com

V First Degree Specialist in Pharmacology. Assistant Professor. ICBP "Victoria de Girón". e.mail: icastro@giron.sld.cu

SUMMARY

Introduction: Biomodulin T (BM T) is a natural medicine composed of thymus hormones of a polypeptide nature, obtained by
an original procedure, which has an immunomodulatory effect, characterized by the induction of the differentiation of T
lymphocytes and lacks toxicity, without producing alterations in organs and tissues or negative interference in the functions of
fundamental systems.

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Objective: to evaluate the effect of Biomodulin T in homeopathic presentation in upper respiratory infections and
polypharmacy in the elderly.
Material and methods: A randomized, open Phase II Controlled Clinical Trial was conducted at the Longevity, Aging and
Health Research Center during the period from 2008 to 2009. 100 subjects were included, giving their informed consent. The
patients were divided into two groups of equal size; one received the study treatment and the other the control treatment. The
main response variable was the incidence of upper respiratory infections, during and after treatment. The Epidat version 3.1
statistical package was used.

Results: The age group between 70 and 79 years was representative for 41.3% in cases and 49.0% in controls, as well as
the female sex (54.4% and 53.1%, respectively), the Flu prevalence decreased at the end of treatment to 45.7% in the case
group and to 39.8% in the control group; medication consumption was lower at the end of each stage, where 5 medications
were consumed by only 19.6% of the cases and 16.3% of the controls.

Conclusions: Biomodulin T in pharmaceutical presentation had a good therapeutic effect in the reduction and severity of
upper respiratory infections, and managed to decrease hospital admissions for this cause and polypharmacy.

Keywords: clinical trial, upper respiratory infections, Biomodulin T, polypharmacy.

ABSTRACT

Introduction: Biomoduline T (BM T) is a natural medication composed by Thyroid hormones that are natural polypeptides.
These hormones are obtained by an original method that has an immunomodulator effect, characterized by the induction of the
differentiation of T lymphocytes, the lack of toxicity, not producing neither alterations in organs or tissues, nor negative
interference in the functions of the fundamental systems.

Objective: aging and Health with the aim of evaluating the effect of homeopathic presentation of Biomoduline T in upper
respiratory infections and the polypharmacy in geriatric patients.

Material and Method: a controlled open and randomized clinical trial, phase II was performed during 2008 and 2009 at the
Research Center on Longevity. One hundred patients previously given their informed consent were included in the trial. They
were divided into two groups; one received the study treatment and the other the control treatment. The primary response in
patients following the control treatment was the incidence and severity of respiratory infection during and after the treatment.
The statistical package version 3.1 Epidat was used.

Results: the age average was between 70 and 79 years old, 41.3% in the cases and 49.0% in the controls. The female sex
predominated in both groups, (54.4% and
53.1% respectively). The flu prevalence decreased at the end of the treatment to
45.7% in the cases group and to 39.8% in the control group. There were fewer drugs intake at the end of each stage.
Only five medications were taken by the
19.6% of the cases and the 16.3% of the controls.
Conclusions: the pharmaceutical presentation of Biomoduline T had a good therapeutic effect in the reduction of
upper respiratory infections, decreasing hospital admissions for this cause, and drugs intake.

Key words: clinical trial, upper respiratory infections, Biomoduline T, polypharmacy.

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INTRODUCTION

During the last decades, the progressive increase of the elderly throughout the world has been evident, this demographic
explosion has a significant impact on the economic and social planning of any country, and Cuba is not exempt from this. The
high morbidity that characterizes this population group represents a great demand and overload for health services. one

As a consequence of aging, a dysfunction of the immune system occurs, a phenomenon known as immunosenescence; 2 This
immunological deterioration is largely responsible for many diseases and for the diminished defense capacity against
aggressive agents, which conditions predisposition to infectious processes.

The thymus has the special function of ensuring the acquisition of the maturity and immunocompetence traits of T
lymphocytes from multipotential cells originating in the bone marrow and is involved in the production and maturation of
lymphocytes rather than in immune surveillance itself. It is the primary site at which T lymphocytes differentiate and
become functionally competent. The mass of this gland remains intact until the age of 15 and decreases rapidly after
sexual maturation. From the age of 45 to 50, the lymphoid mass of the human thymus is only 15% of its maximum size. 3

At ages over 60 years, it is not possible to detect thymic hormone remains in any normal individual, so there is a progressive
decrease in the ability to generate competent T lymphocytes, a fact that from the 70s accelerates due to a decrease of the
ability to generate mitosis of these lymphocytes, less activity of cooperating CD4s, greater activity of CD8 suppressors, less
activity of cytotoxic CD8s, less capacity of B lymphocytes to produce antibodies and actually respond to external antigens, also
there is an increase in the production of auto-antibodies (antithyroglobulins, parietal cells, smooth muscle), an increase in the
production of circulating immunocomplexes and a lower capacity to produce T-cell growth factor. 4

The above explained justifies the greater tendency to autoimmune, oncological diseases, malnutrition, prolonged periods of
convalescence and, above all, a higher prevalence of infections in the elderly; Within them, respiratory diseases are of special
interest due to their high morbidity and mortality, contributing to polypharmacy. 5 ( higher consumption of antitussives,
mucolytics, antimicrobials), high incidence of hospital admissions for adverse drug reactions and high costs. 6

Faced with the risks that deterioration of immune function means for the elderly, many interventions have been proposed in
order to improve it, such is the probable influence of drugs with immunomodulatory function. 7

Biomodulin T (BM T) is a natural medicine composed of thymus hormones of a polypeptide nature, obtained by an original
procedure, 8 which has an immunomodulatory effect, characterized by induction of T lymphocyte differentiation and lacks
toxicity, 9 it does not produce alterations in the organs and tissues or negative interference in the functions of the fundamental
systems.

In 1994, in our country, a randomized controlled clinical trial was carried out in geriatric patients with chronic obstructive
pulmonary disease, in which

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evaluated the efficacy of BM T in parenteral presentation, which showed that the drug is an effective immunomodulator in
Geriatrics. 10

Taking into account the potential therapeutic value of this medicine in the prevention of infections in the elderly, the clear
advantages with respect to the injectable presentation, the wide use of homeopathy in multiple pathologies eleven and finally the
fact of knowing that the most important activity in primary health care is the primary prevention of infections to decrease
morbidity and mortality and maintain or improve the quality of life in the elderly is that we decided to carry out the present
study, where evaluates the therapeutic effect of BM T in homeopathic presentation by the sublingual route in geriatric patients
with repeated upper respiratory infections, which will allow optimizing the therapy in this population group and obtaining social
and economic benefits.

OBJECTIVE

To evaluate the effect of Biomodulin T in homeopathic presentation in upper respiratory infections and
polypharmacy in the elderly.

MATERIAL AND METHODS

A controlled, randomized, monocentric, open-label, Phase II therapeutic clinical trial was conducted and an experimental
parallel group design was used. The study universe consisted of patients graduated from the

Research Center on Longevity, Aging and Health (CITED) with a history of recurrent upper respiratory infections and with
follow-up in the Geriatrics outpatient clinic, in the period from 2008 to 2009.

100 patients were included, who were divided into two groups of equal size:

Group A ( Cases): Patients treated with homeopathic BM T sublingually.

B Group ( Controls): Patients treated with injectable BM T intramuscularly.

The fact that the drugs had a different presentation and route of administration made it impossible to conceal the
study.

Treatment scheme: BMT (homeopathic presentation) was administered 10 drops sublingually, twice daily for 3 months.

The BMT (injectable presentation) was administered 1 vial of 3ml (3mg) intramuscularly during 5 weeks of treatment,
distributed as follows:

First three weeks: 3 mg per day, intramuscularly, daily from Monday to Saturday (total 18 mg weekly). Last two weeks: 3 mg
per day, intramuscularly, every other day (total 9 mg weekly).

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During the treatment period, patients continued to use the medications indicated for the control of their underlying
illnesses, none of these elderly patients used drugs with an effect on immunity. 12

Compliance control: A clinical evaluation was carried out in the first consultation, at the end of the treatment and 3 months
after it.

The results were captured in a Data Collection Notebook.

The main response variable was the incidence, frequency, and severity of upper respiratory infections before and after
treatment, which was measured through the occurrence of the flu, determining whether or not this influenced the need for
hospital admissions.

Criteria for individual assessment of response

It was considered improved: When the total number of upper respiratory infections decreased to one or none without the need
for hospital admission in the course of treatment and in the 3 months following treatment.

It was considered not improved : When the previous criterion was not met.

Statistical analysis plan: A sample of 50 patients was obtained for each group. The epidat statistical package version 3.1 was
used for this purpose. Differences between groups were made with ANOVA of Reason F or Kruskal Wallis, Chi square, which
with an alpha 0.05 allowed us to reject or not the hypothesis. All the information was processed with the SPSS statistical
system, version

13.0.

RESULTS AND DISCUSSION

As can be seen in Table 1, the ages were concentrated in three decadal groups, although the last one had to be opened to
include a case older than the upper bound of the decadal intervals; for this reason, we subjected a test of equal means by
means of a t for independent samples, which allowed us to verify our initial presumption that the groups included for each
sex in the Cases group, had an average age similar (Mas = 73.7 years versus Fem = 73.2 years), which could be verified with
the statistic used at an alpha level of 0.05 (t = -0.549; p = 0.586). In this group, the contribution of each sex did not show
great differences either, since in both they did not deviate from 50.0% by more than five percentage points.

In general, the 70-79 group stood out, which grouped the majority of the cases in this stratum (41.3%), with the presence of
older patients being less (26.1%). It was for this reason that a test of homogeneity was consistent with the previous
approaches (x 2 = 0.194; p = 0.908) NS.

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The Controls stratum only lost one patient throughout the study. In this group there was a certain tendency for the male sex to
have a slightly higher age (Mas = 76.7 years versus Fem = 73.3 years), without the criterion of t for two independent samples
being able to reject the hypothesis of nullity of means similar or close, in the universe of origin (t = -1,464; p = 0.150) NS. We
also appreciate a discreet superior contribution of female cases (More = 46.9% versus Fem = 53.1%), without this being
significant, as verified with a homogeneity test, which could not be rejected either (x 2 = 0.1514; p = 0.469) at this sample size
and it was also coincidental the fact that in this group, the age range that registered the highest proportion of cases was
70-79, which included almost half of the patients (49.0% ).

The homogeneity of our study sample shows the optimal design to be used, in which 2 groups were compared under identical
conditions, in order to fulfill one of the basic pillars on which a Controlled Clinical Trial must be carried out (the concurrent
comparison). , which allows guaranteeing the validity of the results and avoiding bias. 13

International Studies 14 state that the majority of patients suffering from chronic obstructive pulmonary disease with frequent
decompensations are in the age group over 65 years, similar results were obtained in our study.

Analyzing the therapeutic effect of BM T in the sense of whether or not it was able to reduce the level of presence of upper
respiratory disorders, an aspect that we show in Table 2, where we specifically refer to the evolution of the

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influenza prevalence at the beginning and end of treatment in each group. For this, we used a paired contrast before and
after, using the McNemar statistic, which in the Cases group allowed us to reject the null hypothesis that the final prevalence
would not decrease (x 2 McNemar = 13.47; p = 0.000024), an aspect that was intuited when observing that the initial
prevalence reached 82.6% of the patients, while in the end in this group, it fell to 45.7%. Something similar happened in the
Controls group, which also significantly decreased its prevalence, going from 75.5% to 39.8%. The calculated McNemar
corroborated the significance of the change (x 2 McNemar = 13.14; p = 0.000029).

BM T both in conventional presentation and in homeopathic presentation had the desired therapeutic effect fifteen to achieve the
goal of reducing recurrence of influenza in the studied patients, an event that may be favored given the decline in age-related
thymus-dependent immunity, which affects delayed hypersensitivity and resistance to bacteria and viruses, due to
fundamentally to the intrinsic defects in the peripheral population of these lymphoid cells, responsible for causing a decrease
in lymphokines that stimulate alveolar macrophages in their bactericidal activity.

The prevalence of hospitalizations for influenza according to groups and stages is presented in Table 3, where we appreciate
that in the Cases group it went from 2.2 per 100 patients at the beginning to 0.0 at the end, that is, there was a decrease which
was statistically significant, according to the Wilcoxon non-parametric criterion (Z = 2,186; p = 0.0288). The Control group did
not present cases of influenza admission at the beginning or at the end.

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In the elderly there is an increase in the number of hospitalizations that are longer and more serious compared to young
people, admission is usually a fairly traumatic event for geriatric patients, very often they occur due to decompensation of
chronic entities. such as chronic obstructive pulmonary disease (COPD) or acute diseases. 16 These hospital admissions
have enormous significance from the economic and social point of view for Health Systems, due to the high rates of
morbidity and mortality, which entails enormous health, social and personal expenses, and require a multidisciplinary
approach and the implementation in practice of effective respiratory infection prevention programs, which must be
formulated in Primary Care. 17

Similar results to this investigation have been obtained in meta-analysis, where a decrease in the risk of death or hospital
admission in immunocompromised elderly over 65 years who had been immunized with pneumococcal vaccine, in the
prevention of respiratory diseases, has been revealed. . 18

The multiplicity of drugs consumed at the beginning and at the end was compared in Stratified Table 4 and its corresponding
graph (Graph). Polypharmacy was evidenced, since the majority of patients consumed 3 to 5 drugs in each stage and group. In
the end, there was a certain displacement towards the most favorable categories in both groups, an aspect that could be
statistically verified in the control group (paired t = 2,530; p = 0.007), while the most unfavorable categories, that is, those who
consumed four or five drugs (Cases in the category of 5 drugs from 25.1 to 19.6%) and in Controls from 22.4 to 16.3%).

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The associated graph reveals the concentration towards the three drugs.

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The number of drugs consumed decreased in both groups at the end of treatment, which is justified by the decrease in the
occurrence of infectious processes, demonstrating the relationship between comorbidity and polypharmacy. 19

It should be noted that currently many flu processes of viral etiology are interpreted as bacterial, irrationally imposing
antimicrobial therapy, 20.21 which translates into greater deterioration of immunity, appearance of supra-infection phenomena and
adverse drug reactions. 22 Medicine-related problems are responsible for approximately 25% of hospital admissions for elderly
patients. 2. 3

CONCLUSIONS

The female sex predominated in both groups and the average age was 73 years, the Biomodulin T in pharmaceutical
presentation showed a good therapeutic effect in reducing upper respiratory infections and managed to decrease the need
for hospital admissions for this cause. The study medication did not show significant differences with respect to the control
medication in reducing recurrences due to respiratory infections and there was a decrease in the consumption of
medications at the end of treatment in both study groups.

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Received: November 1, 2013 Accepted: May 8,

2014

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