Transcript Radonbalneologie

Radonbalneology
Prof. Dr.med. habil. Dr.rer.nat. Helmut G. Pratzel
President of the International Society of Medical Hydrology and Climatology
(I.S.M.H.)
Quality limits for medical bath waters
• Chemical effects can be used in bath tubs if
Which
elements
in
spring
waters
– no disinfection
areineffective
in bath therapy?
– Concentration
tub is
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H2S > 10 mg/l
Radon > 1 kBq/l
CO2 > 1 g/l
Brine 10-150 g/l
• Physical effects can be used in pools if
– water is disinfected
– temperature >30 °C
Radon Units
1 Mache Unit = 3,64 x 10-10 Ci/l
1 Ci = 3,7 x 1010 Bq
1 Mache Unit = 13,468 Bq/l
Spas using
Radonwater
Russian Radon Spas
Belochurika (Altai) 4-16 nCi/l
Dzchey-Ogus, Issyk-Kul (Kirgisia) 30- 125 nCi/l
Nowosibirsk (Sibiria) 4-670 nCi/l
Pjatigorsk (North Kaukasus) 18-330 nCi/l
Chmelnik (Ukraine) 2-97 nCi/l
Zhal-Tubo (Georgia) 2,5-33 nCi/l
250 Sanatoria with artificial Radon
Indications
Radon-Water in bath tubs and Radon-Gas-baths or Radon-mines
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Ankylosing spondylitis
Degenerative joint disease
Spondylarthrosis
Myofascial soft tissue syndrome
Ovarian hypofunction
Allergic bronchial Asthma
Clinical Trial Protocol
by the Guidelines for Good Clinical Practice (GCP) of the
European Community
 Trial objectives and purpose
 Trial design
 Randomisation, Blinding
 Selection and withdrawal of
subjects
 Assessment of safety
 Control of side effects and interactions
 Control of Compliance
 Statistics
 Direct Access to Source
Data/Documents
 inclusion and exclusion criteria Quality control and Quality Assurance
Procedures
 Treatment of subjects and control
 Ethics
medication
 Assessment of efficacy
Primary Efficacy Variable
• Only validated parameters should be used.
• Only one efficacy parameter is to defined.
• Endpoints used to determine efficacy should be clearly
specified.
• Multiple parameters should be assembled to one score
parameter.
• An efficacy threshold is to defined.
Controlled Double-Blind Trials on Radon
 Pratzel , Legler, Aurand, Baumann, Franke: Phys Rehab
Kur Med 3 (1993) 76-82
 Lind-Albrecht 1994
 Heisig, Klein, Pratzel 1997
 Reiner, Vulpe, Pratzel 1998
 Skorepa, Klein, Pratzel 1999
 Keil, Klein, Pratzel (not finished)
Pressure Pain Threshold
Test areas
1. M. levator scapulae
2. M. supraspinatus
3. M. teres minor
4. M. deltoideus
5. M. glutaeus maximus
6. M. glutaeus medius
7. M. bizeps femoris
8. M. semimembranosus
Double-blind-control equipment
Electronic control
with bar-codereader
Magnetic
valves
Bar-codereader
Tap-water line
Radon-water line
Bath-tub
Technical room
Bathroom
The Barcode-Reader
Pratzel, Legler, Baumann: Analgesic Efficacy of Radon
baths in case of spondylosis with cervical pain
Subject: 23 + 23 patients 45-65 y
Verum: Radon baths 3000 Bq/l
Control: Water baths
Treatment: 9 baths 36 °C during 3 weeks
Design: ambulant, massage and gymnastics
Follow-up: 2 and 4 months
Result: difference in follow-up period p<0,001
Pressure pain threshold
by Radon baths series
kg/cm2
End of Treatment
3,0
2,8
After 4 month
2,6
2,4
2,2
2,0
After 2 month
After 1 week
Ende der Behandlung
After 2 weeks
After 3 weeks
Period of inspection
RADON WATER
TAP WATER
Pressure Pain Threshold 3000 Bq/L Rn
Schlema 1993
kg/qcm
0.9
Follow up
after 4 months
Follow up
after 2 months
0.8
0.7
Radon
after 3rd week
0.6
0.5
after 2nd week
p=0,028
p=0,0007
0.4
0.3
after 1st week
0.2
Control
0.1
0
-0.1
Period of evaluation
Pressure Pain Threshold and
subjective feeling of pain
2
Follow-up period
3 baths
3 baths
VAS
PPT
PPT
VAS
0
10
20
VAS
3 baths
1.5
30
VAS
PPT
40
VAS
PPT
50
PPT
1
PPT
60
VAS
70
80
0.5
before
after 1
week
after 2
weeks
PPT general pressure pain threshold
after 3
weeks
after 2
months
after 4
months
VAS subjective pain feeling
90
3 kBq/L
Subjective feeling of pain
Water
Radon
100%
100%
80%
80%
very bad
60%
bad
very bad
60%
bad
40%
moderate
40%
moderate
20%
w ell
20%
w ell
4 month
2 month
3 w eeks
2 w eeks
very w ell
1 w eek
0%
Initial
4 month
2 month
3 w eeks
2 w eeks
1 w eek
very w ell
Initial
0%
Pain on movement
Water
Radon
100%
100%
80%
80%
60%
strong
60%
strong
40%
moderate
40%
moderate
4 month
2 month
no
3 w eeks
0%
2 w eeks
4 month
2 month
3 w eeks
2 w eeks
1 w eek
Initial
0%
no
1 w eek
20%
low
20%
Initial
low
Pain at rest
Water
Radon
100%
100%
80%
80%
strong
60%
strong
60%
moderate
40%
20%
moderate
low
40%
low
no
20%
no
0%
0%
Initial 1 w eek
2
3 2 month4 month
w eeks w eeks
Initial 1 w eek
2
3
2
4
w eeks w eeks month month
Heisig: Analgetic effect of Radon baths in
degenerative joint disease and spondylarthrosis
Subject: 25 + 27 patients 28-74 y
Verum: Radon baths 800 Bq/l
Control: Water baths
Treatment: 8 baths 36 °C during 3 weeks
Design: ambulant, mono-therapy
Follow-up: 2 and 4 months
Result: difference in follow-up period p<0,05
Change of Pressure Pain Threshold
Bad Steben 1995
kg/qcm
Follow up
after 4 months
0.9
Follow up
after 2 months
after 3rd week
0.8
0.7
Radon
0.6
after 2nd week
0.5
p=0,0141
0.4
0.3
after 1st week
0.2
Control
0.1
0
-0.1
Period of evaluation
Pressure Pain Threshold
(mean and max)
Follow-up period
2.5
2
3 baths
3 baths
PPT
PPT
3 baths
MAX
PPT
MAX
0,8 kBq/L
2
MAX
PPT
1.5
PPT
PPT
MAX
1.5
MAX
MAX
1
before
after 1 week after 2 weeks after 3 weeks after 2 months
PPT general pressure pain threshold
after
4 months
MAX maximum pressure pain threshold
1
Pressure Pain Threshold and
Subjective feeling of pain
Follow-up period
2.5
3 baths
3 baths
10
3 baths
VAS
PPT
PPT
VAS
2
0
PPT
VAS
VAS
20
VAS
30
PPT
PPT
40
1.5
PPT
VAS
50
60
1
before
after 1
week
after 2
weeks
PPT general pressure pain threshold
after 3
weeks
after 2
months
after 4
months
VAS subjective pain feeling
70
0,8 kBq/L
Skorepa: Effect of CO2 in Radon baths treatment in
degenerative joint disease and spondylarthrosis
Subject: 35 + 33 patients 22-73 y
Verum: Radon 400 Bq/l and CO2 1 kg/l
Control: Radon baths 800 Bq/l
Treatment: 8 baths 36 °C during 3 weeks
Design: ambulant, mono-therapy
Result: no difference: CO2 increase radon effect
Pressure Pain Threshold
Bad Steben 1997
Follow-up period
2,5
after 3
weeks
after 2
weeks
kg/cm
2
after 1
week
2
before
1,5
Period of evaluation
after 2
months
after 4
months
400 Bq/l Rn + 1 g/l CO2
800 Bq/l Rn
Subjective Feeling of Pain
Bad Steben 1997
before
50
Follow-up period
mm VAS
45
40
35
after 1
week
after 2
months
after 2
weeks
after 3
weeks
30
25
Period of evaluation
after 4
months
400 Bq/l Rn + 1 g/l CO2
800 Bq/l Rn
Maximum Pressure Pain Threshold
Bad Steben 1997
Follow-up period
2,5
after 3
weeks
after 2
months
after 4
months
kg/cm
2
after 2
weeks
after 1
week
2
before
1,5
1
2
3
4
Period of evaluation
5
6
400 Bq/l Rn + 1 g/l CO2
800 Bq/l Rn
Franke, Reiner, Pratzel, Franke, Resch: Long-term efficacy of radon
spa therapy in rheumatoid arthritis – a randomized, sham-controlled
study and follow-up. Rheumatology 2000:39:894-902
Subject: 30 + 30 RA patients <75 y
Verum: natural radon 1,3 kBq/l and CO2 1,6 kg/l
Control: artificial CO2 1,6 kg/l
Application: 15 baths 35 °C during 4 weeks
Follow up: 3 and 6 month after end of treatment
Result: relevant difference in follow-up period
Subjective pain feeling
Rheumatoide Arthritis (Radon trial Bad Brambach 1997)
mm VAS 25
Differences to 1st value
and 95%-Confidence interval
1st value
CO2
5
-5
-15
Radon + CO2
-25
N = 30
N = 30/27
end of
treatment
3 month
later
N = 28/30
6 month
later
Improvement
15
Moving test by Keitel
• To bend the fingers
• Motility of hand joins and
arms
• Stand up from lying
• Active straddle of legs from
lying
• Stand up from a stool
Standing on toes and heel
Knee-crooking
Standing on one foot
Outside Rotation of the hit join
Mobility of legs and feet
Walking
Climbing stairs
Moving Test by Keitel
Skt 8
Differenzen zum Ausgangswert
6
und 95%-Konfidenzintervall
4
2
0
1st value
-2
-4
-6
-8
Radon+CO2
CO2
N = 30
end of
treatment
N = 28/30
3 month
later
N = 30/29
6 month
later
Improvement
Rheumatoide Arthritis (Radon trial Bad Brambach 1997)
Measurement of Patient Outcome – MOPO
(AIMS –questionaire)
Physical handicap and psychosocial Consequences by Rheumatoid Arthritis
Assessment included: •
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Mobility
Physical activity
Skill
Activities at home
Activities in daily life
Social activities
Pain
Depression
Anxiety
Measurement of Patient Outcome (MOPO)
Rheumatoide Arthritis (Radon trial Bad Brambach 1997)
Differenzen zum Ausgangswert
und 95%-Konfidenzintervall
1st value
0,6
0,4
0,2
0
-0,2
-0,4
-0,6
-0,8
Radon+CO2
CO2
N = 29/30
N = 29/30
3 month later
6 month later
Improvement
Skt 0,8
Lind-Albrecht: Treatment of ankylosing
spondylitis in radon mine Bad Kreuznach
Subject: 144 + 118 SA patients, randomized
Verum: 10 x 1 hour radon mine
Control: no mine
Application: 4 weeks
Follow up: 3, 6, 9, 12 month after end of treatment
Result: relevant difference in follow-up period
Relat. Pain after Radon mine treatment
Bad Kreuznach
Spondylitis Ankylosans (Studie Lind-Albrecht)
bei Entl.
nach 3 Mon.
nach 6 Mon.
nach 9 Mon.
mit Radon
nach 12 Mon.
ohne Radon
-0,2
0
0,2
0,4
0,6
0,8
1
Relat. NSAIDS-use after Radon mine treatment
Bad Kreuznach
Spondylitis Ankylosans (Studie Lind-Albrecht)
bei Entl.
nach 3 Mon.
nach 6 Mon.
nach 9 Mon.
mit Radon
nach 12 Mon.
ohne Radon
-0,4
-0,2
0
0,2
0,4
0,6
0,8
1
MetaAnalyse
Forest-Plot
treatment
control
Die Permeabilität der Haut
Resorption für Gase und Flüssigkeiten durch 2 m2 Haut
L/h
mL/h
10
1
CO2
Rn
100
10
0,1
H2S
O2
He Ar H2
N2
0,01
n-Pentanol
n-Butanol
Wasser
iso-Butanol
Ethanol
DMSO
1
Permeability of skin
Skin clearance for solutions in water
µl Lösung/cm2/h
1000
100
10
Water
CO2
Radon
Octanol
Heptanol
Camphen
H2S
Water
Phenylmercuryborate
Campher
Propanol
Ethanol
Methanol
Sodium
Ferrum II
Strontium
Potassium
Chloride
Calcium
Caesium
Cadmium
Arsenic
Bromide
Pertechnetate
Cobalt
Silver
Sulfate
Jodide
1
0,1
0,01
Methylsalicylat
0,001
Ferrum III
Chromium III
0,0001
Selenite
Estron
Progesteron
Testosteron
DMSO
Acetylsalicylic acid
Heparin
Corticosteron
Indomethacine
Salicylic acid Cortison
Hydrocortison
Dosis = Skin-Clearance x Area x Concentration x Time
How Dosis can be calculated by
Skin-Clearance?
Dosis limit is the amount on the Skin
Skin-Clearance is realized by optimal Penetration situation
( Bath, wet Skin, Okklusion
Effect of temperature
(Q10. = 1,1-1,4) but skin temperature only low variable
Blood level and time of bathing
Badedauer
Fließgleichgewicht
erreicht
nicht erreicht
Calculation about Radon-kinetic
Skin-Clearance = 200 µl/cm2 h-1
Concentration in bath = 3 kBq/l
Area of skin = 2 m2
Absorption rate = 200 x 3 x 2/100 = 12 kBq/h
Distribution volum = 20 l bei 80 kg KG
Elimination constant = 20 h-1
Blood level in steady state= 12 kBq/h / (20 l x 20 h-1) = 0,030 kBq/l
Blood level after 10 min-bath = 0,030 x (1-e-20 h-1 x 10 min) = 0,029 kBq/l
Concentration in bath water : Blood level = 100 : 1
Radon-222 Dissolution
Polonium
Bismutum
Plumbum
The main effect of radon
Radon and the
dissolution
products penetrate
into the horny
layer.
Alpha-radiation
from the horny
layer is effective in
the stratum
spinosum.
Dissolution
products cannnot
penetrate into the
living tissue.
Langerhans Cells of the skin
Effect of Alpha-Radiation
on Langerhans Cells
Dosis by use of Radon-baths
(Radon concentration 1,5 kBq/L; 37 °C)
Bath period 20 minutes
Dosis of skin
Risk by radon skin-dosis of ca. 1 mSv
of kidneys
per cure treatment Dosis
is lesser
than risk by
long use of medicaments..
Dosis of other organs
Maximum
natürliche Dosisleistung
Zeit in Stunden
Trial in radon treatment should be used in future
research by the following disease assessments
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•
Rheumatoide A.
Bechterew
Narrow spinal channel
Osteoarthrosis
HAQ
BASFI
LSS-Inst.
WOMAC
German translation by Sangha O et.al. Rheumatol 56:322-333, 1997
BASFI for Ankylosing Spondylitis
• Ohne Hilfe und Hilfsmittel Socken und Strümpfe
anziehen
• Ohne Hilfe von der Hüfte aus nach vorn beugen um
einen Kugelschreiber vom Boden aufzuheben
• Ohne Hilfe etwas von einem Regal nehmen
• Von einem Wohnzimmerstuhl ohne Armlehne aufstehen
ohne dabei die Hände oder eine andere Hilfe zu benutzen
• Ohne Hilfe vom Boden aufstehen, wenn Sie auf dem
Rücken liegen
German translation by Sangha O et.al. Rheumatol 56:322-333, 1997
BASFI for Ankylosing Spondylitis
• Ohne Schmerzen 10 Minuten stehen ohne sich
anzulehnen
• Ohne Benutzung eines Geländers oder Gehhilfen 12-15
Treppenstufen steigen. 1 Fuß pro Stufe
• Über die Schulter schauen ohne dabei den Körper
abzudrehen.
• Körperlich anstrengende Tätigkeiten verrichten (z.B.
krankengymnastische Übungen, Gartenarbeit oder Sport)
• Zu Hause oder bei der Arbeit den ganzen Tag aktiv sein.
German translation by Sangha O et.al. Rheumatol 56:322-333, 1997
Literature of Radonbalneology
Pratzel, Deetjen: Radon in der Kurortmedizin, I.S.M.H. Verlag
1997, ISBN 3-9804437-2-8
Pratzel: Application of Pressure Algometry in Balneology for
Evaluation of Physical Therapeutic Modalities and Drug Effects.
Journal of Musculoskeletal Pain:1998:6:111-137
Deetjen, Falkenbach: Radon und Gesundheit, Peter Lang
Verlag 1999, ISBN 3-631-35532-7
Franke, Reiner, Pratzel, Franke, Resch: Long-term efficacy of
radon spa therapy in rheumatoid arthritis – a randomized, shamcontrolled study and follow-up. Rheumatology 2000:39:894-902
The following power point-files
Perkutane Resorption und Balneologie (German)
Kneipp-Therapie (German)
Radonbalneology (English)
Health Tourism and Medical Treatment - two parts in Health Resorts (English)
Las nuevas investigaciones en termalismo y los nuevos retos medicos (Spanish)
can be downloaded from the web side of the International Society of
Medical Hydrology and Climatology:
http://www.med.uni-muenchen.de/ismh
End of Slides