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ultrasonic dust mite controller

Scientific Documentation: Clinical Trials

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B. Double blind placebo controlled trial performed at the Pediatrician and Allergy Department of Macedonio Melloni Hospital in Milan, Italy

The study has been presented at the 5TH Congress of the Italian Society of Pediatric Allergology and Immunology at Riva del Garda, Italy. April 1 – 4 2003.
Briefly, 40 patients have been enrolled and later splitted into 2 groups.

40 devices have been distributed to the patients. 20 devices were properly working
while the remaining 20, even if identical to the other ones, were not working.

The distribution of patients and devices into the two groups has occurred according to a random scheme, so to design and perform a double blind placebo controlled trial.

The patients (range: 4 to 15.5 years old) were allergic to mites and suffering from
asthma. Each patient has received a diary for reporting symptoms and the related
data have been analysed from a statistical point of view at the end of the study.

The attached original paper lets to see the details concerning the inclusion criteria, the clinical monitoring, the therapies, the results of the study.

Regarding trial’s results, it has been observed that at the end of the study (at 4th month) the difference in score symptoms between the two groups was in favour of
the use of the electronic device. The difference was significant from a statistical
point of view concerning rhinorrea, nocturnal cough, nasal obstruction, sneezes.

Both Italian original paper and the translation into English are here attached.

information available as pdf

CLINIC EFFICACY OF A DEVICE OF ULTRASONIC REVULSION IN THE THERAPY CONNECTED TO CHILDREN WITH PERSISTENT ASTHMA DUE TO ALLERGY TO ACARI

Abstract

Introduction

The House dust mite allergy represents the most frequent cause of first breathing sensitivity in children under 6 years and one of the main reasons till 18 years. In the field of the allergy to dust mites, after the specific immunotherapy (SIT), at the moment the most effective way to prevent and/or lessen the severity of this disease is reducing the house dust mite allergen levels by environmental reclamation. For this reason the application of devices of revulsion based on the use of ultrasounds has been recently proposed, but there are no scientific proves of it s efficacy in paediatrics. We intend evaluate is efficacy, in terms of subjective symptomatology in children with intermittent asthma or mild persistent, allergic to dust mites.

Materials and Methods

Fourty Children (27M. 13F, average age 4 -15.5 Years), of our allergologic surgery who corresponded to the criteria of inclusion/exclusion, have become part of a prospectic, randomized, double blind studt of an expected 6 month length, having received undistinguishable devices, working or disactivated. The devices have been supplied by Kem-o-Tek Italia s.s.l., Caronno Pertusella (MI). Daily clinic diaries, returned at monthly checks, revealed the number of episodes of dyspnoea, wheezing, nasal obstruction, itchiness, rhinorrea, sneezes, night and exercise induced cough. Every check included also an examination of the clinical status, compliance to the protocol, the taken therapy, the right-filling in of returned diary, handing over the new diary, efficacy and integrity of the device. The collected data have been submitted to statistic analysis by student test.

Result

The survey has been suspended at the fourth month having reached a significant statistics. All the patients have completed the survey. The first month of the treatment did’nt show any significant statistics differences. In the second month significant differences related to 4/8 syptoms( nasal obstruction, sneezes, itchines and rhinorrea) have been revealed. Only two symptoms (nasal obstruction and wheezing) were different between the 2 groups in the third month, while in the fourth all the symptoms excpt dyspnoea displayed relevant statistics values. The whole evaluation of the 4 months revealed a significant reduction of the subject symptomatology concerning wheezing, nasal obstruction, sneezes, rhinorrea and night cough. The mirror like check by counting the days without symptomatology confirmed what had been found.

Conclusion

The results demonstrate the clinical efficacy of this ultrasonic device, but we can’t tie up the results, even if it can be perceived by intuition, to the reduction of the house dust mite allergen level, as a direct measurement hasn’t been conducted. Besides the reduction of the number of mites has been introduced in a previous work by another author. The most relevant benefits are connected to rhinorrea, nasal obstruction, sneezes, night cough and wheezing, with a lighter effect on the reduction of other symptoms such as itchiness, exercise induced cough and dyspnoea. The efficacy grows day by day. The results look promising and it would be interesting to extend the evaluation to a wider paediatric population, including the measurement of the dust mite allergen levels. The acceptance of the device by the patients has been good and no collateral effect has been reported.

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