Findings Statement

The results of survey “Evaluation of the “Phtisio-Biofon” device employment efficacy in a complex therapy of influenza”

Saint Petersburg, 2000

List of participating researchers

1. Ì.Ê. Yerofeyeva - Candidate of Science (Medicine), Laboratory Head
2. V.V. Maksakoa - Candidate of Science (Medicine), Leading Researcher
3. L.S. Shadrin – professor, Doctor of Science (Medicine), consultant
4. L.N. Oberlander — researcher-lab assistant
5. A.A. Savostikov – Lt.Col., 1^st Category Physician, Head Medical Service
6. V.V. Vlasova – Physician (Sick ward)
7. T.F. Kovynova – Senior Sister (Sick ward)

Content

Introduction

1. The basis and purpose of the research
2. Materials and methods
3. The results and discussion
• The influenzal epidemic situation in St. Petersburg in winter 2000
• Analysis of the epidemiology observations

Conclusion

Deduction

Introduction

Grippe infection occupies a leading position among infectious diseases and continues to remain the most topical issue among the unresolved challenges of health care. It is characterized by high incidence, frequent development of severe cases and calls for pursuit of new means and methods of combating viral infections.

The basis and purpose of the research

The effect of weak fields on live cells is one of the modern avenues of research in clinical medicine. This avenue of inquiry has been developing abroad since 1951 when P. Foll first published results of his work. At present time this principle has been implemented in many designs of diagnostic and therapeutical appliances affecting the biologically active areas. The IR-therapy devices of the “Biofon” series, developed at the Government-owned enterprise “Izhevsky Mekhanichesky Zavod” is one of the kind. The operating principle of the apparatus is based on the changes induced in the electrostatic potential at the cell membranes of pathogenic microorganisms causing deterioration of their protective function, decrease of the toxins produced by the affected pathogens, which facilitates their inactivation and subsequent elimination by the human immune system. High selectivity of the device permits to inactivate and hamper the viability only of pathogenic microorganisms not affecting the human commensal flora or cells.

The purpose of the present study was examination of tolerance and efficacy of the “Biofon” apparatus in a complex therapy of influenza and acute respiratory viral infection (ARVI) of various severity.

Materials and methods

The study was conducted at the premises of a military unit sick ward where the influenza and ARVI patient were admitted. The age of the observed patients averaged 18 – 20 years. The total number of patients under observation in February-March 2000 amounted to 75 cases, 32 in the survey group and 43 in the check group. The patients in both the study and the check group received standard symptomatic treatment – antipyretics, anti-inflammatory and detoxification agents. In addition 32 patients of the study group underwent exposure treatment with the “Biofon” apparatus strictly according to the schedule, i.e. 6 24 seconds exposure sessions daily.

The exposure schedule for use of the “Biofon” apparatus is attached (see Addendum1). During the exposure the patient was located sitting or lying at 1.0 – 1.5m distance from the “Biofon” device. The following criteria were use while forming the groups: positive influenza or ARVI clinical diagnosis, early inclusion in the sick list, pronounced intoxication and catarrh symptoms – headache, high temperature, indisposition, running nose, nasal stuffiness, cough etc.

Obtaining an agreement for voluntary participation from all patients was mandatory. An individual case file was started for each patient of the check and the study group which contained personal data (family name, name, patronymic, date of birth, course, instruction class number), complaints of the patient on admission, the results of clinical examination on admission (before treatment), during treatment and in the end of treatment, use or lack of the “Biofon” exposure, accompaniment treatment, laboratory data, admission and discharge dates, final diagnosis (see Addendum 2).

The clinical examination included collection of the anamnesis data, daily examination by the attending physician, thermometry, blood and urine tests. ECG and X-ray examination were conducted in case of indications.

To look into the case etiology a small number of selected patients underwent the following laboratory tests:

serum examination, i.e. dual blood taking at the start of disease and in 14-21 days from the start with subsequent agglutination test by a standard method.

Taking nasal wash for virology immunofluorescent examination.

The appraisal of the apparatus clinical efficacy was done by the following criteria:

Average duration of institutional treatment (days)

Presence and frequency of influenzal complications

Comparative peripheral blood and urine tests

All these data obtained from the patients undergoing a complex treatment enhanced by the “Biofon” emission exposure were evaluated by comparison against the similar parameters from the patients getting standard treatment.

The “Biofon” effect tolerance was determined on the basis of the patient’s individual sensations and impersonal data.

Statistical analysis of the obtained results was performed with use of the Student’s t-test.

Results and discussion

Influenzal epidemic situation in Saint Petersburg in winter 2000

According to the influenza and ARVI incidence statistics epidemic started in St. Petersburg during the week from January 24 to January 30, 2000. The epidemic lasted 6 weeks. The incidence peak happened during the 3d week of the epidemic (February 7 – February 13, 2000), (see Table 1)

Table 1 Influenza and ARVI incidence among the ST.Petersburg population for the period December 1999 – April 2000

Weeks	Influenza and ARVI incidence (cases per 10000 population)
	Total	15 years and older
06.12-12.12	56,8	22,5
13.12-19.12	48,6	20,7
20.12-26.12	49,4	21,0
26.12-02.01	37,8	17,6
03.01-09.01	23,3	10,9
10.01-16.01	43,98	20,2
17.01-23.01	57,9	27,1
24.01-30.01	77,3	38,1
31.01-06.02	107,0	55,4
07.02-13.02	132,0	79,5
14.02-20.02	123,2	77,5
21.02-27.02	103,6	67,1
28.02-05.03	92,6	59,4
06.03-12.03	63,7	39,5
13.03-19.03	63,5	37,7
20.03-26.03	49,8	24,3
27.03-02.04	43,3	23,8
03.04-09.04	40,7	20,9
10.04-16.04	42,9	20,5
17.04-23.04	43,1	20,1

The epidemic was primarily caused by grippe virus type A (H3N2). During the St. Petersburg epidemic 12 viruses were isolated, 11 being similar to the L/Sidney/5/97 (H3N2) standard, with the remaining one determined as B type virus.

In the units similar to the one observed by ourselves a growth in influenza and ARVI incidence was noted too, the main cause also being grippe virus type A(H3N2).

This diagnosis was confirmed by the hemoagglutination test in 66,7% patients, grippe A(H1N1) in 1.4% cases and grippe B in 4.3% cases.

In the observed unit 50% patients were diagnosed (by hemoagglutination test) as having grippe A(H3N2).

Analysis of the epidemiology observations

The “Biofon” apparatus for influenza and ARVI therapy was employed in the observed unit in mid February 2000 during the epidemic rise in incidence.

No negative side effects that might be attributed to the action of the device were noted during administration of exposure sessions. The “Biofon” exposure treatment mixed well with known pharmaceutical and physical therapy methods. On the second day from the start of exposure therapy all the patients claimed a betterment in general condition, a better appetite, and a rise in kinetic tone. The majority of the influenza and ARVI patients receiving the complex treatment employing the “Biofon” apparatus noted that the disease went on easier and convalescence came sooner.

The administered “Biofon” treatment ensured decrease in the average influenza and ARVI case duration by 1.6 day (see Table 2)

Table 2 Case duration during the observation period (February – March 2000)

Observation groups	Number of patients	Disease duration (days) and number of cases									Total days on the sick leave	Average case duration (days)
			4	5	6	7	8	9	15	16
Biofon	32	1	13	9	4	2	2	1	0	0	160	5,0±0,26 ð<0,01
The check	43	0	6	8	13	8	3	3	1	1	280	6,6±0,42

Thus during employment of “Biofon” positive treatment dynamics and a quicker resolution of clinical manifestations was evident.

Effect of the “Biofon” appliance together with the symptomatic and etiotropic means permitted to reduce significantly the frequency of complications. In the check group incidence of complications was 5.5 times greater (see Table 3).

It is common knowledge that grippe is characterized by a pronounced intoxication and microcirculation disorders with lesion of various organs and systems. In this perspective the obtained positive results in employment of “Biofon” for treatment influenza and ARVI cases (including reduction of illness duration, prevention of complications) permit to regard it as an accessory means and an aid in enhancing the efficacy of treatment of diseases of viral etiology and recommend its active engagement in clinical practice especially during the periods of influenza epidemics.

Table 3 Incidence of complications in the influenza and ARVI patients

Observed group	Number of patients	Complicated course		Including
				bronchitis		quinsy		maxillitis		Intercostal neuralgia		Chronic tonsillitis
		Abs. no.	%%	Abs. no.	%%	Abs. no.	%%	Abs. no.	%%	Abs. no.	%%	Abs. no.	%%
Biofon	32	2	6,2	2	6,2	0	0	0	0	0	0	0	0
The check	43	11	25,6	3	6,9	3	6,9	2	6,2	1	3,1	2	6,2

Conclusion

The study of the clinical efficacy of the “Biofon” apparatus in a complex influenza and ARVI therapy was conducted in winter 2000 in an organized group of young persons 18-20 years old during the epidemic rise of the A(H3N2) type grippe. 75 influenza and ARVI patients were under survey 32 receiving “Biofon” exposure treatment (6-7 24 seconds-long sessions daily) in addition to the standard therapy. The remaining 43 patients receiving symptomatic treatment only comprised the check group.

The apparatus has demonstrated good tolerance in our inquiry causing no negative side effects whatsoever.

From the subjective standpoint all the patients noted feeling better after the second day of exposure to the apparatus. They demonstrated shorter sickness duration and significant drop in incidence of the complicated forms of the disease.

A pronounced positive healing effect of the “Biofon” apparatus, absence of contraindications, possibility of administering exposure to several patients simultaneously during a single session and handiness of operation permit to recommend the “IR-therapy apparatus “Biofon” for batch production and employment in the clinical practice of complex treatment of influenza and ARVI cases

Deduction

1. The “Biofon” apparatus used for influenza and ARVI treatment has promoted reduction in the case duration by 1.6 days in comparison to the cases of the check group.
2. The grippe complications among the “Biofon” exposure patients proved 5.5 times less frequent than in the check group.
3. The “Biofon’ IR-therapy apparatus is harmless, easy to use and may be recommended as a modern aid in complex institutional and out-patient treatment of influenza and ARVI.

Signed

M.K. Yerofeyeva
Candidate of Science (Medicine)
Head Test Laboratory for Innovative Viral Infections Protection Means
The Grippe Research Institute, Russian Academy of Science
V.L. Maksakova
Candidate of Science (Medicine)
Responsible Executive
Leading researcher