Recurrent Allergic Disease of the Upper Respiratory Tract

ENERCEL® : A NEW HOMEOPATHIC IMMUNE ENHANCER NASAL SPRAY FOR RECURRENT ALLERGIC DISEASE OF THE UPPER RESPIRATORY TRACT:

A PRELIMINARY COMMUNIQUE

RAFAEL RUIZ IZAGUIRRE, M.D., FAAP
Principal Investigator
Pediatrician, Neonatalist, President, Clinicas Medicas Ruiz MD
San Salvador, El Salvador, Central America
October 1999

ENERCEL®, a new homeopathic immune enhancer nasal spray in recurrent allergic disease of the upper respiratory tract~ a preliminary commentary.

Upper respiratory disease and its complications are currently the number one ambulatory health problem in El Salvador.1 During recent weather disturbances, this has reached epidemic proportions. In the greater San Salvador city area, allergic and allergenic-based pathologies, plus secondary infections are between 30% to 50% of the reason to consult one of the four leading ENT specialists who practice in this city.2 A similar phenomenon has been observed in Guatemala City3 where air pollution is similar to that observed in San Salvador. In England, this disease originates 50% of outpatient consultations and when complicated, 30% of admissions.20 So, when a report by Kereszti, et al. on the ENERCEL® Mist nasal spray formulation4 and other reports on the immune response enhancing effect of the ENERCEL® Mist line of products came to our attention early in 1998, 5,6,7 we decided to review our own therapeutic approach to the problem of allergy-induced upper airways disease. After reviewing some pertinent classic reports8’9,10 on the immune response and recent epidemiological and therapeutic reports in the pathophysiology of allergic respiratory disease11,12,13 we decided to run our own clinical trial with this new homeopathic medication. Our series is planned to end with case #100, but the results obtained are so promising that we decided to submit this preliminary work for publication.

MATERIAL AND METHODS:

A total of 30 cases, ages from 8 months to 82 years were enrolled between September 1998, and May 1999. Patients or their parents were adequately informed about the new medication before the trial was started. Diagnosis was based on a referral from either a treating allergist, pneumonologist or ENT specialist, plus our own clinical evaluation. We consider that our communication with all patients or their parents was quite good, and their response to our evaluation reflects an objective view of the cases. All cases have been followed from the initiation of the therapy to the day of this writing, no less than four times. We eliminated one case after the patient did not follow instructions and refused to collaborate in other aspects. The rest of the patients (29 cases) are here described, and some additional comments on special cases are included. Given our financial limitations as well as that of the patients, WBC, eosinophil counts, nasal cultures, X-rays, and other tests were done only when clinically needed.

The protocol included a standard dose of two sprays of ENERCEL® Mist (*) in each nostril three times per day in patients above five years of age, one spray three times per day in patients between two and five years of age, and one spray twice per day for infants under two years of age. Initially or during relapses, one of the doses was given via nebulizer, diluting 0.25 cc of the medication in 5m1 of sterile water. In no instance was any other anti-allergic, bronchial relaxant or mucolytic medication used, even though that has been done with good results)14 All cases included in this report ceased other medications while they were subjects of the study with two exceptions: one in which a therapeutic program for emphysema was continued while ENERCEL® Mist was being administered, and one who self-medicated with a systemic decongestant (Sinutabs) during a mild relapse.

Among the clinical parameters followed were those usually related to allergic rhinitis, asthmatic bronchitis, hypertrophy of adenoidal tissues, aggregated infections, failing general condition and anorexic weight loss (when applicable), fever, frequency, duration and severity of relapses and the patient’s sense of well being. In all of the cases, the result was in agreement between the author and the patients or their relatives.

Results were classified by the author after re-evaluating the patient’s medical history through the time of the study, examining the patient clinically and comparing the findings subsequently. The following score was used:

(1) No results: No detectable changes during the course of treatment.

(2) Poor results: A mild positive change, but definitely at least a moderate improvement of the disease and the general condition of the patient.

(3) Good results: Definitive improvement of symptoms and relapses substantially improved.

(4) Excellent: Patient free of disease for all practical purposes and/or a general condition of normalcy attained, despite exposure to environmental conditions that otherwise would have triggered a relapse.

No “cured” status has been considered, even though at the moment of this writing, the earliest patient (age 6) has been asymptomatic for over one year despite no additional therapy being administered.

AGES CLINICAL RESULTS

No Poor Good Excellent Sub-Totals

<15 0 0 2 8 10

15-30 0 0 0 5 5

30> 1 1 8 4 14

All Cases1 1 10 17 29

3.4% 3.4% 34.5% 58.6% 100%

At a brief glance, it becomes evident that there is a strong positive influence of the medication on the course of the disease: in only 1 case (3.4%) there was not a clinically measurable effect; in another case (3.4%) the influence was poor and in the rest, an effect from good to very good (34.5%) to excellent (58.6%) effect was noted . If considered separately, each subgroup gave significant differences. In the younger age subgroup of less than 15, among the 10 cases, 2 (20%) yielded good to very good results and 8 of the 10 cases (80%) yielding excellent. Among the 5 cases in the 15 to 30 years of age group, all (100%) gave excellent results. Among the 14 patients in the “older” age group (30> years), there was one case (7.14%) that did not respond to therapy, one (7.14%) that gave poor results, 8 (57.14%) that yielded good to very good results and 4 (28.57%) giving excellent results.

Remarkably, among the first signs of improvement was the cessation of the snoring secondary to adenoidal hypertrophy. This was observed in 4 cases in the younger group; one being documented by cavum X-rays.

Also, in patients below age 30, clinical results were observed within the first week of therapy. In the younger patients (under age 5), ENERCEL® Mist, given in nebulization containing 0.25m1 of the drug, produced an almost immediate decrease in rales. This was followed by a definitive improvement of an asthmatic relapse within the following 12 to 24 hours.

In older patients, two cases are worth mentioning. The first case enrolled in the study is an 82-year-old lady with chronic emphysema who had frequent exacerbation after common colds and grippe-like acute infections, requiring frequent use of antibiotics and at least one hospitalization after secondary bronchopneumonia. After more than one year on ENERCEL® Mist at standard doses, she has been nearly asymptomatic. During this writing she suffered her only relapse, which lasted only 24 hours and receded rapidly with the usual medications. The second case was a most severe chronic emphysema, who unfortunately rejected using ENERCEL® Mist the first time it was offered to him. One year later, when his condition had deteriorated substantially, he used a protocol of three ENERCEL® Mist preparations. This was followed by a rapid improvement of his ventilation, decrease of secretion production and a better quality of life. He died one month after, during an acute respiratory failure with severe asphyxia. At the moment of his demise, his airways were clear and there was no clinical or laboratory evidence of infection.

It was interesting to find a relative predominance of males (20) to females (9) in a 2.2:1 ratio, within the 29 cases of the study. A more specific sex difference was not investigated, since we considered that these relatively few number of cases would not allow a significant result.

DISCUSSION

The current scientific trend on allergy is to consider it as secondary to an underlying deficiency, this being in the immune globulin group11,12,13 or in genetically derived lymphocyte deficiencies15. In third world countries, or even in industrial ones, air pollution frequently coexists with overcrowded housing and schools or at work. The contamination and the multiplicity of contacts so created potentializes the surfacing of immune deficiencies that otherwise would have remained subclinical.

Unfortunately, the textbook recommendation21 to avoid antibiotic abuse in mild, self-limited acute infections of the upper respiratory area, and in convalescents and asymptomatic carriers and use them only in complicated susceptible bacterial infections20 is frequently unheard of by those who in their everyday practice use the newest variety of broad spectrum antibiotics, even when it is known to hamper the ability of self defense and to render the patient susceptible to the same bacteria when it infects him or her again. The traditional therapeutic approach also usually by-passes the notion of immune deficiency, and in many instances includes steroids, a medication known to decrease immune response, and even at very small doses, to favor life-threatening viral infections16. Tonsillectomy and adenoidectomy are not devoid of bacterial consequences17 or even fatal complications20. Thus, to ignore the true origins of allergic air passageway problems and their bacterial complications with their inevitable vicious cycles in the clinical course of treating this disease becomes a possible concern.

Socio-economic issues must also be brought into perspective, when treating such a complex and potentially serious disease in underprivileged societies. In countries where the variety of medicines to treat asthma, for example, will be available as long as they will be needed, even when falling short of the ideal 22, the patient has ambulatory options and secondary or, if needed, tertiary care during a relapse. In developing countries with traditional health systems, however, this kind of approach is either not available or not affordable for the vast majority of the population, which is precisely the kind that needs it the most. In such circumstances, the availability of a simple method of preventive therapy might not be the difference between health and disease, or between productivity and dependency, but the difference between life and death.

As early as the mid-sixties, Dr. Jesus Kumate Rodriguez18, then a full time faculty member of the Hospital Infantil de Mexico, strongly anticipated the unavoidable need of an immunotherapeutic approach to recurrent bacterial infections of the GI tract, after the emerging resistance to antibiotics, mediated by the, in those days, recently discovered bacterial resistance transfer factor. We believe that here in San Salvador, thirty years later, in the area of recurrent allergically-mediated diseases of the upper respiratory tract, a similar ecology-dependent, genetically-based, therapeutically-conditioned, constellation of clinical phenomena has been created, and, evidently, this has induced antibiotic resistance1. The immunological properties of the product used in this study would explain the effects obtained.

CONCLUSIONS AND RECOMMENDATIONS:

1. The use of ENERCEL® Mist nasal spray favorably influences allergic-originated upper respiratory tract recurrent disease in 34.5% of the cases and yields excellent results in an additional 58.6% of them.

2. These results are more evident in patients below 30 years of age.

3. No results and poor results were obtained in 6.8% of the cases.

4. No adverse reactions were reported in any case.

5. The medication was found especially effective when given by nebulization.

The above considerations support our conviction that ENERCEL® Mist, a nasal spray based on a homeopathic formula, is an important therapeutic contribution in the field of allergy mediated upper respiratory tract disease. If future evidence confirms our experience with the product, it is tempting to postulate it could very well be the ideal therapeutic choice for a wide variety of airborne bacterial and viral infections, particularly those associated with allergies and/or underlying congenital or acquired immunodeficiencies.

  REFERENCES:

(1) Salud Publica on Cifra, Ministorio de Salud, Gobierno de El Salvador, 1997

(2) Vides Lemus, R. Medina E. Echegoyen, J.C. Portillo Vasquez, O. Personal Communication – May June ’98

(3) Beteta Mazariegos, C. Personal Communication

(4) Kereszti: Application of ENERCEL® Mist homeopathic nasal spray in cases of allergic origin orthorrinological diseases. Paper presented at the World Congress of Locomotor Disorders, Sports, and Rehabilitation Medicine in Colombo, Sri Lanka, Dec. 27-29, 1996

(5) See., D.M., Tilles, J.G., Immunomodulatory effects of a homeopathic agent. Amer. J Nat Med, 5 (6) July/Aug 1998

(6) Bertacchni, C. The effects of ENERCEL® treatment on aspects of quality of life in patients with advanced pancreatic cancer. Publication of the Centro Medico Buenos Aires 1992

(7) Bertacchini, C. Analysis of the mechanism of action of ENERCEL® therapeutics. Centro Medico Buenos Aires, ’91

(8) Burnet, M.F.: The mechanism of Immunity. Sci. American. 204 (1) 58-67, Jan 1961

(9) Speirs, R.S.: How cells attack antigens Sci. American, Fb. 1964

(10) Nossal, CVJ.: How cells make Antibodies Sci. American, Dec. 1964

(11) Moss, R.B.: Deficiency of IgG4 in children: Association of isolated IgG4 deficiency with recurrent respiratory tract infection. J. Peds. 120(1) 16-21, Jan. 1992

(12) Shapiro, G.G. et al.: Immunologic defects in patients with refractory sinusitis. Pediatrics 87 (3) 311-315

(13) Berthel, F. et al.: Clinical consequences and treatment of primary immunodeficiency syndromes

(14) Casper, J.T., et al.: Successful treatment with an unrelated donor bone marrow transplant in a BLS deficient patient with severe combined immune deficiency (“Bare Lymphocyte Syndrome”)) J. Peds. 123 (4) 577-579, Oct 1993

(15) (2) 262-265, Feb. 1990

(16) Eld, N.S. and Jones, V.F.: Bacterial Tracheitis as a complication of tonsillectomy and adenoidectomy, J. Peds 125 (3) 401-402, Sept. 1994

(17) Kumate Rodriguez J.: Lecture on the perspectives of immunology, Hospital Infantil de Mexico, 1996

(18) Vega, S.: Lecture on antimicrobial resistance in respiratory tract infections, SKP symposium on antibiotics, San Salvador, October, 1999

 

© 2018 Enercel | Nature Advanced - Disclaimer | Privacy Policy | Terms of Service
Top