PREVENTION OF POST-OPERATIVE THROMBOEMBOLISM BY NEGATIVE AIR IONIZATION IN A DOUBLE-BLIND STUDY
E
MERIMSKY*
Y.I. LITMANOVITCH**
F.G. SULMAN***
* Department of Urology, Ichilov University
Hospital, Tel Aviv,
** Vascular Clinic, Hadassah University Hospital
and Medical Centre, Tel Aviv,
*** Bioclimatology Unit of the Rothschild-Hadassah
University Medical Centre, Jerusalem, Israel
This research was made possible by a
generous grant from Mr. and Mrs. Herman Lane N.Y. and the
Felton International Inc. N.Y.
ABSTRACT. - A new method for avoiding
post-operative thromboembolism has been tried, employing
negative air ionization around the clock for an average period
of 10 days during which 228 patients were hospitalized after
major urologic surgery. The patients stayed in two rooms, 5 x
5m in size in which 4 ionizing apparatuses each had been
installed. This allowed every patient to lie at a distance of
2m from a "Modulion"R ionizer emitting an average of 1 x 104
negative ions/cm3 air. In the six control rooms, 1,232
post-operative cases were hospitalized without ionization.
Other treatment in all rooms was identical, avoiding
anticoagulants.
In the 228 post-operative patients
exposed to negative air ionization there occurred only one
case of thromboembolism during an observation period of 28
months (0.04%), whereas in the 1,232 patients in the six
control rooms there were 12 (1%) cases of thromboembolism
which were then given standard treatment with anticoagulants:
3 of them died. The percentage of post-operative
thromboembolism (1%) corresponded well to the average number
of thromboembolism encountered in the rest of the hospital and
to other hospitals in the country which did not use air
ionization. Thus it appears that negative ionization can
replace the risky prophylactic use of anticoagulants after
operations.
INTRODUCTION
Deep venous thrombosis (DVT) and
pulmonary embolism (PE) have become an increasingly important
cause of disability and death during the last 50 years,
especially in hospitalized patients (Kakkar, 1977a). Their
importance to our society has to be judged by their incidence
and effect on mortality and morbidity. Fatal embolism has been
estimated at more than 20,000 cases annually in England and
Wales (Kakkar, 1977b) and 50,000 cases annually in the United
States (Hume et al., 1970). Pharmacological methods are quite
effective in preventing deep vein thrombosis and pulmonary
embolism, but fatal cases can still happen, according to
different author, varying between 0.09 and 3% and even 15% in
non fatal cases (Brown, 1977, Kass et al., 1978, Kakkar et
al., 1975, Williams, 1971). Apart from the immediate risk to
life, one must also consider the late sequels of this disease
- the postphlebitic syndrome (phleboedema, chronic venous
insufficiency, varicose veins, ulceration and induration) -
which represent on equally distressing situation (Kurz et al,
1978). The urgency of the physician's concern with
thromboembolism clearly lies in his inability to diagnose the
condition accurately at an early stage when treatment can be
effective. In almost half the patients, the thrombotic process
is clinically silent, or the diversity of its symptoms is open
to misinterpretation, Thus, fatal embolism may be the first
symptom of DVT and PE.
It should be stressed at the outset that
thrombosis is often the result of multiple factors, such as
blood changes which predispose to thrombosis or trigger
thrombus formation, i.e. alterations in the properties of
platelets and of the components of the coagulation and
fibrinolytic systems, furthermore, changes in the vessel wall
are directly redated to coagulation and fibrinolysis, mainly
platelet adhesiveness and aggregation. Processes associated
with tissue damage (operation, burns, fractures, cancer)
leading to an increased platelet adhesiveness or increased
platelet coagulant activity, or both, initiate the formation
of platelet thrombi. Certain patients such as those undergoing
open prostatectomy or total hip replacement, are a high risk
for thromboembolism and cannot be protected by prophylactic
heparinisation (West et al., 1979). The final outcome in such
cases is determined by the balance between thrombogenic and
fibrolytic mechanisms, vascular injury and reactions of the
platelets being the main contributory causes of thrombosis
(Nilsson, 1977).
Patients with pulmonary embolism often
have reduced arterial oxygen tension and this has been found
to be the most consistent non specific laboratory finding. In
the present study we have therefore tried to overcome the
problem of reduced arterial oxygen tensions and doubtful
prophylaxis by exposing post-operative patients to permanent
negative air ionization which has been shown to activate
oxygen tension and to convey a negative charge on the platelet
membrane - thus preventing platelet aggregation (Sulman,
1976).
MATERIAL
AND METHODS
Air Ionization
IONISING APPARATUS. - Negative ions were
generated by the Modulion (R) of Amcor-Amron (Herzliya,
Israel) which contains four ionising needles, each with a -
5,000 V charge (Fig.1). They produce corona discharges each
emitting 2.5 x 1011 ions/s/mm3. As a Modulion can be used at a
distance of 1-2m, the actual ion density reaching a patient is
2.5 x 105 - 2.5 x 104 ions/cm3/s. The apparatus'
specifications are: 220/240 V, 50/60Hz. A control neon light
built into the on/off switch flashes to indicate working
conditions. The electrical field is 5,000 V DC, and the short
circuit at ionization needles lower than 0.1mA. The 4 needles
can be touched without receiving any unpleasant electrical
discharge as the short circuit current on the high voltage
side is limited to more 0.1mA. Power consumption is 2 W only.
Dimensions: length - 14.5cm, width - 9.5cm and height - 7.5cm.
Production of ozone and nitrous oxides is reduced to a
minimum; at a distance of 10cm they could not be traced by
10/a Draeger Detection Tubes. Electrically charged aerosols
have not been encountered. The casing of the Modulion is
grounded which guarantees a stable and continuous ion flux.
Design is according to international and European safety
standards (VDE, SEV, IEC).
Normal Effects of Air Ions
Air ions are taken up by the respiratory
tract and part of them reach the lungs. As they are mostly
ionized oxygen and water aerosols they are taken up by the
erythrocytes and thrombocytes at the alveole site together
with normal oxygen and water. Positive air ions release
serotonin from the thrombocytes (Tal et al., 1976),
negative-ones counter this effect (Sulman et al., 1975), and,
moreover, can inhibit platelet aggregation (Sulman,
1980).
Additional Effects of Air Ionization
A. Anti-Pollutant Effect
The room subjected to negative air
ionization profited from a low bacterial count which amounted
to 70% less than in control room (Sulman et al.,
1974).
B. Anti-Serotonin Effect
Patients in the ionized rooms profited
from the absence of weather-borne serotonin release with all
its adverse sufferings (Sulman et al., 1977).
C. Dust Precipitation
The ionized rooms were freed from dust by
the ionising apparatuses (Sulman et al., 1974). The was an
advantage to the patients, yet it needed special arrangement
in the immediate vicinity of the apparatuses which had to be
protected by special paper on which the precipitated dust
settled. The paper sheets were changed whenever required. In
addition, the small apparatuses were mounted on a black
rod.
Subjects and Design
The ionising apparatuses were installed
in two rooms of the ward; the other six rooms contained dummy
apparatuses. The patients, nurses and assistants of the ward
were not aware of the trial and regarded the apparatuses as
"electrical air conditioners". In each of the two ionized
rooms 5 patients after major urologic surgery were
accommodated (Table 2). the average stay of a patient in one
of the ionized rooms was 10 days. During 28 months, 228
patients had profited from the negative air ionization, each
one exposed to it 24 hours around the clock at a distance of
about 2m. Ventilation of the two rooms was allowed at the
customary level of the hospital.
In an earlier paper we showed that
permanent ionization does not produce any harmful effect on
well-being, routine blood and urine tests, EEG or ECG (Sulman
et al., 1978). During the 28 months of observation 1,232
control patients after major urological operations had
similarly spent an average of 10 days in six non-ionized rooms
of the ward with dummy ionizer's. There was also an unintended
"cross over" trial because, in the meantime, the ward was
completely refurbished, which necessitated transfer of the
"ionized" patients to other "ionized" rooms for 3
weeks.
To allow a clean assessment of the
anti-thromboembolism effect, none of the patients in the ward
received any prophylactic drug treatment which was only given
when a case of thromboembolism appeared. Patients got up as a
rule two days after the operation. During hospitalization
regular blood and urine tests were used to supervise the
patients' health and impending thromboembolism.
The "double blind" trial went on for 28
months, and is continuing now as an open trial. There was
1,460 admissions to the ward in that period, of which 228 were
put at random into the two "ionized" room, 202 males and 26
females. Ages of the male patients varied from 14 to 88 years,
ages of the female ones - from 29 - 75 years (Table
1).
The diagnosis and operations of the 228
patients in the "ionized" rooms are summarized in Table
2.
RESULTS
In the six non-ionized rooms there
occurred during the 28 months of observation, 5 cases of deep
vein thrombosis, 4 cases of pulmonary embolism and 3 cases of
fatal pulmonary embolism, i.e. 12 cases of thromboembolism out
of 1,460 admissions = 1% (Table 3).
In the ionized rooms there was only one
case of deep vein thrombosis in a woman aged 67 who had
undergone multiple operations on her right kidney and was
hospitalized for 67 days. Her thrombosis was slight and lasted
only a few days. Thus thromboembolism in the two "ionized
rooms" amounted to 0.04% (P ,0.005).
Selected case histories
It would be interesting to note some
exceptional cases which strengthened the case for the
"ionized" rooms.
A woman, aged 50, arrived in our
"non-ionized" ward after a gynecological operation and
developed a deep vein thrombosis. She was then put in an
"ionized" room. the thrombosis subsided and, in spite of
further operations, there was no recurrence.
A man, aged 68, with a history of
recurrent pulmonary embolism in the past was put in an
"ionized" room and was operated on his prostate. There was not
thrombosis or any sign of pulmonary embolism.
A man, aged 68, was admitted to the
cardiac ward because of paroxysmal tachycardia. He was
transferred to us for prostatectomy and put into an "ionized"
room. He was discharged on the tenth post-operative day in
good condition. The following day he was readmitted to the
intensive care unit and died there of myocardial
infarction.
DISCUSSION
As post-operative thromboembolism is
mainly due to platelet aggregation, the mechanism of its
prevention should be sought in the negative charge conveyed to
the blood platelets by negative air ionization, since
negatively charged particles do not tend to agglomerate
(Sulman, 1980). Likewise, it has been claimed that the
glucoproteids which cost the cell membranes of all blood cells
prevent agglomeration by virtue of their negative
charge.
Thromboembolism may appear in man like an
epidemic on special days. It affects patients after operations
especially in urologic and orthopaedic departments, or those
suffering from varicose veins, phlebectasias, heart infarcts,
cardiac insufficiency, arteriectasias, arterial occlusion and
polycythyemia vera. Its correlation to weather changes has
often been described (Feiman, 1965). Our research has shown
that positive air ionization indeed provokes neurohormonal
changes, especially serotonin release, which may precipitate
thromboembolism (Sulman, 1977).
Recently we have extended these studies
to atmospheric (electro-magnetic waves), showing that they
affect serotonin release just like air ionization (Sulman et
al., 1977). Thus it appears that the "epidemic" occurrence of
thromboembolism on days of high positive electric air charges
is produced by incoming weather fonts. It is a phenomenon
which can be avoided by collaboration between surgeons and
meteorologists. In South Germany, operations are not carried
out on Foehn days because of the risk of thromboembolism
caused by Foehn ionizations and sferics. Combating the menace
by suitable neutralization of the ambient air is presently
being studied by us, as negative electrical D.C. field
combined with negative ionization may provide the cure. The
problem aroused much interest in Germany when E. Rehn (1970)
published his observations on the abolition of thromboembolism
in an area (Kahlenberg) rich in negative ions and the return
of thromboembolism in his modern hospital in Freiburg when the
air was deprived of its ionization (Kahlenberg Factor). Rehn's
observations did not receive the attention they deserved
because they were published in the German language. 20
The fact that negative air ionization
over 3-6 hours did not influence blood chemical components is
noteworthy, however more study should be devoted to this
finding using negative ionization for 24 hours, a period which
has been shown by us to be free of harmful side effects
(Sulman et al., 1978). Russian investigators cited in a NASA
report (1966) claimed that negative air ions may cause a
decrease in elevated blood cholesterol - a finding not yet
closely studied.
The fact that negative air ionization
prevents thromboembolism cannot be denied, yet its exact
mechanism needs more research on membrane reactions which has
now been inaugurated.
REFERENCES
BROWSE, K.L. (1977): The prevention of
depp vein thrombosis and pulmonary embolism by pharmacological
methods. Triangle, 16:29-32.
FREIMAN, D.G., SUYEMOTO, J. and WESSLER,
S. (1965): Frequency of pulmonary thromboembolism in man. New
Engl.J.Med., 272:1278-1280.
HUME, M., SEVITT, S. and THOMAS, D.P.
(1970): Venous thrombosis and pulmonary embolism. Harvard
Union Press Cambridge, Mass. p.3
KAKKAR, V.V. (1977a): Prevention of fatal
post-operative pulmonary embolism. Triangle, 16:63-67.
KAKKAR, V.V. (1977b): Diagnosis of deep
vein thrombosis and pulmonary embolism. Triangle
16:1-9.
KAKKAR, V.V., CORRIGAN, T.P. and POSSARD,
D.P. (1975): Prevention of fatal post-operative pulmonary
embolism by low doses of heparin. Lancet. 2:45-51.
KASS, E.J., SONDA, P., GERSHON, C. and
FISCHER, C.P. (1978): The use of prophylactic low dose heparin
in T.U.R. of the prostate. J.Urol., 120:186-187.
MURZ, W., WITTLINGER, G., LITMANOVITCH,
Y.I., ROMANOFF, H., PFEIFER, Y., TAL, E. and SULMAN, P.G.
(1978): Effect of manual lymph drainage massage on urinary
excretion of neurohormones and minerals in chronic lymphedema.
Angiology, 29:764-772.
NILSON, I.M. (1977): Coagulation,
fibrinolysis and venous thrombosis. Triangle,
16:19-27.
REHN, E. (1970): Die Blutgerinnung und
ihre Stoerungen - der Kahlenberg Faktor, W. Spitzner Pharm
Publ. Ettlingen 1970, ppp 1-10.
SULMAN, F.G. (1976): Health, weather and
climate. Monograph, Karger Publ. Basel, 160 pp.
SULMAN, F.G. (1980): The effect of air
ionization, electric fields, atmospherics and other electric
phenomena on man and animal. Monograph, Ch. C. Thomas Publ.
Springfield III. 400 pp.
SULMAN, F.G., LEVY, D., PFEIFER, Y.,
SUPERSTINE, E. and TAL, E. (1975): Effect of the sharav and
bora on urinary neurohormone excretion in 500
weather-sensitive females. Int.J.Biometeor.,
19:202-209.
SULMAN, F.G., PFEIFER, Y., SHALITA, B. and
TAL, E. (1974): Air Sterilisation: influence of negative
ionization on bacterial counts on agar plates exposed to air.
Int.Res.Comm.Syst., 2:1452.
SULMAN, F.G., PFEIFER, Y., LEVY, D.,
LUNKAN, L. and SUPERSTINE, E. (1977): Human sensitivity and
atmospheric electricity. Israel Meteorological Research
Papers, Steinitz Memorial Volume, 1:42-63.
SULMAN, F.G., LEVY, D., LUNKAN, L.,
PFEIFER, Y. and TAL, E. (1978): Absence of harmful effects of
protracted negative air ionization. Internat.J.Biometeor.,
22:53
TAL, E., PFEIFER, Y. and SULMAN, F.G.
(1976): Effect of air ionization on blood serotonin in vitro.
Experientia, 32:326-327.
WEST, B., GARRISON, R.N. and FLINT, L.M.
Jr. (1979): Effects of concurrent seosis with clinically
significant pulmonary embolic disease. Am.J.Surg.,
137:358-361.
WILLIAMS, H.T. (1971): Prevention of
post-operative deep vein thrombosis with preoperative
subcutaneous heparin. Lancet, 2:950-952.
Table 1: Number, sex and age of 228 patients
hospitalized in ionized rooms during 28
months.
|
|
| Age-Years |
Male |
Female |
| Under 50 |
14 |
3 |
| 50-60 |
25 |
8 |
| 60-70 |
79 |
13 |
| 70-80 |
72 |
2 |
| Over 80 |
12 |
0 |
| Total |
202 |
26 | |
|
| Table
2: Diagnosis of 228 patients hospitalized in Ionized rooms
during 28 months. |
| Diagnosis and Operation |
15 |
10 |
| Pyelo-uretro-lithotomy |
4 |
7 |
| Nephrectomy |
17 |
4 |
| Bladder Tumor |
0 |
3 |
| Stress incontinence |
127 |
0 |
| Prostatectomy |
39 |
2 |
| Miscellaneous |
|
|
| Total |
202 |
26 | |
|
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