Allergic Origin Otorhinological Diseases:

A Clinical Study Utilizing ENERCEL®
Performed by:
Gedeon O. Kereszti, MD, Ph.D.
December 1996

APPLICATION OF ENERCEL® Mist , A HOMEOPATHIC NASAL SPRAY, IN CASES OF ALLERGIC ORIGIN OTORHINOLOGICAL DISEASES

Gedeon 0. Kereszti, MD, Ph.D.
Department of Otolaryngology & Audiology
Magyar Imre Hospital,
Ajka, Hungary.

The ENERCEL® line of homeopathic remedies have been invented and distributed by World Health Advanced Technologies, Ltd. All the ingredients of these combination homeopathic remedies will be found in the US Homeopathic Pharmacopoeia and have a mechanism of action similar to other homeopathic remedies.

Ingredients of the ENERCEL® Mist Homeopathic Nasal Spray as follows:

Cactus Grandifloris 4 X

Aloe Socotrina 4 X

Abis Negra 4X

Arnica 6X

Lachesis 11 X

Calcium Carbonate 6 X

Pulsatilla Vulgaris 6X

Distilled water

Alcohol (8% by volume)

Clinical trials and medical practice has indicated that the remedies help to boost the natural defense of the human body against different diseases, and assists in its self healing activity.

See and Tilles of the University of California along with Bertacchinni in his in-vitro and in-vivo experiments have shown that the activation of the T-lymphocytes are regulated and modulated after administration of ENERCEL®.

According to the International Rhinitis Management Working Group, the activated T cells have a crucial central modulatory effect in allergic inflammatory responses both in the early and late phase. In an atopic individual, B cell origin plasma cells produce IgE which sensitize the mastocytes, the crucial cells of the early phase. T helper (CD4+) cells direct the activation of the B cells. The T system is also responsible for the activation, maturation, life span and tissue migration of the eosinohilic and basophilic cells which is important in the late phase.

According to reports from Argentina, ENERCEL® Mist, as an inhalant, was successfully used for asthma and upper respiratory infections: These reports had made ENERCEL® Mist a very desirable therapeutic agent for intranasal delivery for the .N.T. Specialist, since its immune regulatory effect could be exploited for the benefit of the pediatric and adult patient population suffering from allergic origin E.N.T. diseases.

ENERCEL® Mist is a combination homeopathic solution in a nasal spray delivery form with virtually no side effects which is especially important for our pediatric patients. It was noted that in the last few decades, the allergic etiologies of different E.N.T. diseases have increased. These diseases have negligible effects to life expectancy, but have a definite negative effect in regards to quality of life. The spectrum and intensity of symptoms could increase to a level where patients will notice definite changes in their every day life and activities.

It is important in every age group to have adequate nasal functions. It is known that the nose has a crucial function in the protection of the upper and lower airways. The inspired air is warmed, moistened, and filtrated by the large surface area, richly supplied by capillaries and lymphatic vessels of the ciliated nasal mucosa. Any noxious agent-virus, bacteria, allergen -may cause rhinitis, which is by definition an inflammatory reaction of the nasal mucosa with congestion, dripping, sneezing, and itching. Perennial rhinitis, in most cases, is accompanied by obstructive bronchitis and dermal manifestations and further complications such as sinusitis and otitis is frequent.

The conventional allopathic medications chromoglycat (Taleum), the second generation antihistamines cetirizin (Zyrtec), loratidin (Claratin) and the parenteral long acting depot corticosteroids ( as for example the Depomedrol) as well as local cortisone preparations budesonid (Rhinocort), beclomethasolone (Aldecin) all have the well known non-desirable side effects.

In the late summer months of August and September, which is pollen season in our area, our E.N.T. ward had seen 82 patients at our out-patient clinic. These patients all had seasonal and perennial allergic rhinitis, all confirmed with a prick test. The age of the patients ranged from 3 to 66 years.

The number of patients under 14 years were 33 (39.3%), the number of adult patients were 49 (59.8%). Thirty-two percent (32%) of the patients had skin lesions and all patients had accompanying lower respiratory symptoms. One third (1/3) of our patients previously were already treated with other antiallergenic treatment. ENERCEL® Mist nasal spray was delivered in 2 puffs, 4 times a day to both nostrils. We have stressed to our patients that succussion /pounding the bottle at least 10 times against the palm, is absolutely necessary to achieve the full therapeutic effect, patients were instructed to blow their noses prior to application of the spray to achieve better absorption. Patients were seen 1 week and 1 month after the initiation of treatment, at which time clinical examinations were done. We also questioned the patients about their symptoms and possible side effects.

The symptoms of allergic rhinitis (congestion, itching, dripping, tearing, eye irritation) have shown significant improvement p <0.01, that was maintained throughout the treatment. Some significant improvements were found in cases of rhinitis due to atopic dermatitis, urticaria. Obstructive airway symptoms (wheezing, coughing at rest and at exhertion, shortness of breath) have improved significantly on symptomatic score index and it was maintained during the whole treatment period.

During the treatment period, 26% of the cases had concomitant diseases mostly upper and lower respiratory infections. We did not suspend giving ENERCEL® Mist in these cases and 26% of the patients received additional therapy adequate for their individual condition.

We have had an interesting observation that was not too surprising to us: We found 15 pediatric patients with serious exudates in their bilateral middle ears who have had either seasonal or perennial rhinitis. We concluded from their history, that these cases were resistant to all conventional treatments before. After treatment with ENERCEL® Mist nasal spray we have experienced dramatic improvement: less exudate was found in the middle ears, hearing has improved and at the end of the treatment their tympanogram was in normal range, that indicated a well aerated middle ear.

In the above condition, we stress the possibility of allergic origin of the middle ear disease, and the concomitant treatment with ENERCEL® Mist nasal spray yielded good results.

After continuous 1 month application of ENERCEL® Mist nasal spray, the next statements can be made:

1) After proper application of ENERCEL® Mist nasal spray in likeness to other drugs (based on the well known cocaine, Versed etc.) has perfect absorption from the nasal mucosa, as an alternative to intravenous application. In this manner local and general immuno-modulatory effect can be achieved.

2) The symptoms (congestion, sneezing, dripping, itching, tearing, and eye irritation) have improved significantly or ceased completely.

3) The result of the above finding is the positive medical and patients opinion about the effectiveness of the treatment are shown on the next slides.

4) Compared to the previously used antiallergenic agents only in 2 cases, we found same result. In the rest of the cases, the patients preferred the ENERCEL® Mist nasal spray.

The choice of the patients and parents about the continuation of the treatment as well as the comparison of the ENERCEL® Mist homeopathic nasal spray by other previous antiallergic treatment are shown on these two slides.

5) There were no side effects noted in either cases, adult or pediatric.

Summary:

In summary, we understand that we have a therapeutically effective medicament at our disposal to treat allergic origin othorhinilogical diseases. ENERCEL® Mist homoepathic nasal spray is well tolerated by adults and children alike. In contrast to conventional allopathic medications, there were no side effects reported.

* This paper was delivered on the WORLD CONGRESS OF LOCOMOTOR DISORDERS SPORTS & REHABILITATION MEDICINES, 27th, 28th and 29th December 1996. Colombo, Sri Lanka

Dr. Gedeon Kereszti, M.D., Ph.D.

Formerly Honorary Professor in Otolaryngology.Medical Faculty, University of Aden, P.D.R. Yemen. Chief; Department of Otolaryngology & Audiology, Magyar Imre Hospital, Ajka, Hungary

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