Medical tests on device “Doctor Svet”
Director, Moscow SRI of pediatrics and child surgery MH RF
Prof. A.D. Tsaregorodzev
17 July 2006
RECORDS OF MEDICAL TESTS ON
Physiotherapeutic light-emitting diode device (PL-EDD) “DOCTOR SVET”
Tests conducted on: 24.04.06-15.07.06
Test subject: Physiotherapeutic light-emitting diode device (PL-EDD) “DOCTOR SVET” (59 units).
Manufactured by: JSK “AVERS”,
Basis for test: As per records N1, dated 19.04.06, for the commission on equipment, devices and instruments used in pediatrics, obstetrics and gynecology, from Committee on New Medical Technology.
Purpose: To establish clinical efficiency of the application of the physiotherapeutic light-emitting diode device (PL-EDD) “DOCTOR SVET” in the treatment of light and moderate acute forms of ARVI in infants ages 0 – 3 years.
Clinical tests on physiotherapeutic light-emitting diode device “DOCTOR SVET” for the treatment of light and moderate acute forms of ARVI in children ages 0-3 years were conducted on 59 children (as per test records). Out of these, 23 children were between 2 months and 1 year; 24 children between 1-3 years; and 12 subjects over 3 years. 51 of the children had histories of recurrent ARVI. Clinical progress of the previous illnesses were analyzed and served as control group for comparison.
In accordance with instructions and on the basis of statistics for irradiation and safety dosage, the following method was used: children allocated into the experimental group were prescribed the use of the “DOCTOR SVET” nipple 4-5 times per day throughout the period of illness. The device is preset for the length of each physiotherapeutic session (2 minutes). Depending on the specifics of a child’s behavior, the light-emitting diode device was activated either before or after inserting the nipple into the child’s mouth.
Unlike an ordinary nipple, special care was given to the cleaning and storage of this device. After each session the device was washed under running water, rinsed with boiling water, and stored closed in a container until the next session.
GROUP 1. Children from 2 months to 1 year (23 children)
In this group, only 8 children were ill for the first time; the remaining 15 (65%) had recurrence of infection (the histories of the previous illnesses were used for comparison of efficiency). Of these, 4 children (26.7%) were treated for ARVI with antibiotics. Their previous bouts of illness persisted for a significant period – for 14 children, over 10 days (93%). The children were administered different sorts of symptomatic remedies; – nasal drops – nasivin, sofradex, protargol; different kinds of cough mixtures – from child mixtures with Althaea or root of licorice, to syrups Lazolvan, Hadelix, etc. Thus, with children 1 year age, treatment of ARVI involved the administration of more than 3-4 drugs within 7-10 days. Fever had been observed in all patients ranging from 37.5 to 38.5. The patients had temperatures for 3-5days and were given antipyretics by their parents, irrespective of the level of fever. Antipyretics used were variants of Paracetamol.
With the introduction of the proposed physiotherapeutic device, a reduced recovery period was observed – in 12 children recovery took place within 4-5 days (52.3%); and for the rest – up to 10 days. It has been observed that longer periods of recovery were registered for children with histories of allergic reactions. The same was observed with application of the device, not on the first day of appearance of symptoms of ARVI, but on the 2nd – 4th days when the illness had already developed severe catarrhal reaction.
It must also be re-emphasized that EFFICIENCY OF TREATMENT WAS SIGINIFICANTLY HIGHER WHEN USED AT THE TIME WHEN SYMPTOMS FIRST APPEARED i.e. in the period of prodromal symptoms or debut. When beginning treatment during the advanced stage, efficiency is observed but less pronounced.
Background treatment using “DOCTOR SVET” device, running nose and rhinitis symptoms were reduced by the 3rd day in 49.3% of the children; and in another 34.7% (total 19 children), by the 5th day of treatment. Within the remaining patients, recovery took 7-10 days which was still significantly shorter than treatment without the application of such physiotherapy. The temperature normalized on the 1-2 day from start of treatment in 74% of the children; which made it possible to stop antipyretic treatment after 1-2 doses of Paracetamol.
There was no observation of allergic reaction to the device and throughout treatment in any of the children. The “DOCTOR SVET” nipple was reacted to with interest by majority of the children, they tried to take it out and examine it visually. By the 2nd -3rd time, they accepted it readily. There were no problems observed with 6-month old infants, with the exception of 2 cases leading to the exclusion of those particular children from the clinical experiment. These infants, ages 3 months and 4 months were breast-fed and therefore not used to suckling on suckling nipples, spat them out each time. Therefore, in prescribing or proposing the use of this device to parents for the treatment of ARVI, it is necessary to know which type of feeding is used; and whether they are used to suckling on teats. If an infant is only breast-fed and not used to suckling on teats, it is neither advisable nor efficient to forcibly use this device for treatment. Breast feeding, in this case, remains a priority.
On the whole, in analysis of efficiency within infants of less than a year, we have observed a two fold in recovery rate. Application of physiotherapeutic treatment of specific effect reduces the severity of infection, prevents complications and reduces swelling of the mucous membranes, factors important in determining the clinical stage (blocked nose and cough – due to swelling and excessive tear-secretion).
The device is efficient, as well, in cases of frequent appearance of catarrhal symptoms and cutting of teeth. In such cases, we observed relief from pain.
GROUP 2. Children from 1- 3 years (24 children)
All children in their anamnesis had histories of ARVI, the majority of them experience 3-5 bouts, especially within the autumn-winter period. 12 of the children had their last bout just 3-4 weeks before (the onset of the present illness). With the exception of 1 child, all the others in their anamnesis were treated for ARVI with antibiotics. The period of illness (cough and rhinitis persisted) in 16 of the children was more than 10 days (70%). All the children were given Paracetamol, symptomatic drugs – different nasal drops and cough mixtures and syrups.
With the application of physiotherapeutic device “DOCTOR SVET” a faster recovery from the symptoms was observed – rhinitis ceased by the 3-5 day in 58% of the children, by this time cough significantly went down in 62.5% of the children (15). It must be noted that parents in the first days used, as well, symptomatic remedies – vasoconstrictor nasal drops, cough mixtures and massage. However, fast recovery from basic symptoms, the use of drugs did not exceed 3-5 days, which is twice shorter than in previous bouts of ARVI. Not in a single case did the need arise for antibiotic treatment.
Allergic reactions and side effects on use of the “DOCTOR SVET” nipple were not observed in even a single child. All the children suckled on it with pleasure and interest and pleaded with their parents, in several ways, to repeat the sessions. Thus, this method of treatment provoked no stress in the children, as sometimes is the case of the use of tablets or nasal drops.
GROUP 3. Children over 3 years. (12 children)
All the children, had in their history bouts of ORVI. Over the last year, prior to the present illness, only one child had been given antibiotic treatment for ARVI. However, in the 1st – 2nd years of life, all the children were treated for ARVI with antibiotics. The children were ill for 10-14 days and had temperature continuously for 1-5 days. However, the basic symptoms persisted till 10-14 days. Majority of the children had allergic reactions; all of them were in kindergarten and a third of them already had symptoms of adenoiditis. With the application of physiotherapeutic device “DOCTOR SVET” a fast recovery effect was observed – nose running significantly was reduced by the 1-3 day (75%) – 9 children; by the 3-5 day, cough ceased in 50% of the children. Children, in whom the symptoms persisted, went through recovery easier than before, because of less pronounced symptoms. We also observed that the earlier treatment is started, the higher is the efficiency. If the treatment is started at an advanced stage, parents do not notice any difference in severity between the present bout and previous ones.
Clinical tests conducted with the use of physiotherapeutic device “DOCTOR SVET” in 59 infants (2 months – 5 years) for treatment of light and moderate forms of ARVI have proved its high efficiency:
Period of basic clinical symptoms (rhinitis, cough, fever) was reduced by half in the majority of children (over 75%).
The earlier the treatment is started – at the beginning of the first symptoms of infection, - the higher the efficiency of application of the device; In this case there is possibility of a lighter course of the illness and reduction of the risk of complications. With application of the device at an advanced stage, the effect on the course of the illness is significantly less. We have observed only less expressed appearance of symptoms; which do not differ in the length of persistence, from the group of comparison.
It has been remarked that use of the device does not only reduce catarrhal reactions, but also reduces intoxication (indirect effect on multiplication of viruses and production of toxins), since we observed a clear shortening of the fever period and quick improvement in general condition and mood of the children. Parents noted, as well, an increase in appetite.
Application of the device significantly reduces the load of drugs and ensures the exclusion of antibacterial agents in treatment of moderate forms of ARVI even in infants under 1 year.
There has been no single case of allergic reaction or individual discomfort.
The device may be applied to ensure relief during cutting of teeth, characterized by catarrhal reactions.
Thus, the physiotherapeutic light-emitting diode device “DOCTOR SVET” can be recommended for the treatment of ARVI, mainly in ambulatory and outpatient basis, in maternity and children’s homes, in specialized and non-infectious wards, and in places of large numbers of infants for the prophylaxis of ARVI. The device is simple in use and easy to wash.
Supervisor of clinical experiment,
Head of department, Physiotherapy
and Recovery treatment. L.B. Ilyin, Ph.D.med Sc.
Members of experimental team Berdnikova E.K.