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.)

Radonbalneology

Prof. Dr.med. habil. Dr.rer.nat. Helmut G. PratzelPresident of the International Society of Medical Hydrology and Climatology

(I.S.M.H.)

Prof. Dr.med. habil. Dr.rer.nat. Helmut G. PratzelPresident of the International Society of Medical Hydrology and Climatology

(I.S.M.H.)

Quality limits for medical bath watersQuality limits for medical bath waters

• Chemical effects can be used in bath tubs if – no disinfection

– Concentration in tub is• 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

Which elements in spring waters are effective in bath therapy?

Which elements in spring waters are effective in bath therapy?

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

IndicationsRadon-Water in bath tubs and Radon-Gas-baths or Radon-mines

• 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 inclusion and exclusion criteria

Treatment of subjects and control medication

Assessment of efficacy

Assessment of safety

Control of side effects and interactions

Control of Compliance

Statistics

Direct Access to Source Data/Documents

Quality control and Quality Assurance Procedures

Ethics

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)

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 scapulae1. M. levator scapulae2. M. supraspinatus2. M. supraspinatus3. M. teres minor3. M. teres minor4. M. deltoideus4. M. deltoideus5. M. glutaeus maximus5. M. glutaeus maximus6. M. glutaeus medius6. M. glutaeus medius7. M. bizeps femoris7. M. bizeps femoris8. M. semimembranosus8. M. semimembranosus

Double-blind-control equipment

Electronic control with bar-code-reader

Technical room Bathroom

Tap-water line

Radon-water line

Bath-tub

Magnetic valves

Bar-code-reader

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

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 thresholdby Radon baths series

Ende der Behandlung

Period of inspection

kg/cm2

After 1 week

After 2 weeks

After 3 weeks

After 2 monthAfter 4 month

2,0

2,2

2,4

2,6

2,8

3,0

RADON WATERRADON WATER

TAP WATERTAP WATER

End of End of TreatmentTreatment

Pressure Pain Threshold 3000 Bq/L Rn Schlema 1993

-0.1

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9kg/qcm

Control

Radonp=0,0007p=0,028

Period of evaluation

after 1st week

after 2nd week

after 3rd week

Follow upafter 2 months

Follow up after 4 months

Pressure Pain Threshold and subjective feeling of pain

0.5

1

1.5

2 0

10

20

30

40

50

60

70

80

90

VAS

VAS

VAS

VAS VAS

VAS

beforeafter 1 week

after 2 weeks

after 3 weeks

after 4 months

PPT general pressure pain threshold VAS subjective pain feeling

3 baths

3 baths

3 baths

3 kBq/L

Follow-up period

after 2 months

PPT

PPT

PPT

PPT

PPT

PPT

Subjective feeling of pain

0%

20%

40%

60%

80%

100%

Initi

al

1 w

eek

2 w

eeks

3 w

eeks

2 m

onth

4 m

onth

very bad

bad

moderate

w ell

very w ell 0%

20%

40%

60%

80%

100%

Initi

al

1 w

eek

2 w

eeks

3 w

eeks

2 m

onth

4 m

onth

very bad

bad

moderate

w ell

very w ell

Water Radon

Pain on movement

0%

20%

40%

60%

80%

100%

Initi

al

1 w

eek

2 w

eeks

3 w

eeks

2 m

onth

4 m

onth

strong

moderate

low

no0%

20%

40%

60%

80%

100%

Initi

al

1 w

eek

2 w

eeks

3 w

eeks

2 m

onth

4 m

onth

strong

moderate

low

no

Water Radon

Pain at rest

0%

20%

40%

60%

80%

100%

Initial 1 w eek 2w eeks

3w eeks

2 month4 month

strong

moderate

low

no

0%

20%

40%

60%

80%

100%

Initial 1 w eek 2w eeks

3w eeks

2month

4month

strong

moderate

low

no

Water Radon

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

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

-0.1

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9kg/qcm

p=0,0141

Control

Radon

Period of evaluation

after 1st week

after 2nd week

after 3rd week

Follow upafter 2 months

Follow up after 4 months

1

1.5

2

2.5

1

1.5

2

Pressure Pain Threshold (mean and max)

MAX

MAX

MAX

MAX

MAX MAX

before after 1 week after 2 weeks after 3 weeks after 2 monthsafter

4 months

PPT general pressure pain threshold MAX maximum pressure pain threshold

3 baths

3 baths

3 baths

0,8 kBq/L

PPT

PPT

PPT

PPT

PPT PPT

Follow-up period

1

1.5

2

2.5 0

10

20

30

40

50

60

70

Pressure Pain Threshold and Subjective feeling of painPressure Pain Threshold and Subjective feeling of pain

VAS

VAS

VAS

VAS VAS

VAS

before

after 1 week

after 2 weeks

after 3 weeks

after 2 months

after 4 months

PPT

PPT general pressure pain threshold VAS subjective pain feeling

3 baths3 baths 3 baths

0,8 kBq/L

Follow-up period

PPT

PPT

PPT

PPT

PPT

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 ThresholdBad Steben 1997

1,5

2

2,5

Period of evaluation

kg

/cm

2

400 Bq/l Rn + 1 g/l CO2

800 Bq/l Rn

before

after 1 week

after 2 weeks

after 3 weeks

after 4 months

Follow-up period

after 2 months

25

30

35

40

45

50

Period of evaluation

mm

VA

S

400 Bq/l Rn + 1 g/l CO2

800 Bq/l Rn

Subjective Feeling of Pain Bad Steben 1997

before

after 1 week

after 2 weeks

after 3 weeks

after 4 months

Follow-up period

after 2 months

Maximum Pressure Pain Threshold Bad Steben 1997

1,5

2

2,5

1 2 3 4 5 6

Period of evaluation

kg

/cm

2

400 Bq/l Rn + 1 g/l CO2

800 Bq/l Rn

before

after 1 week

after 2 weeks

after 3 weeks

after 4 months

Follow-up period

after 2 months

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

-25

-15

-5

5

15

25

end oftreatment

3 monthlater

6 monthlater

Subjective pain feelingRheumatoide Arthritis (Radon trial Bad Brambach 1997)

1st value1st valueCO2CO2

Radon + CO2Radon + CO2

mm VAS

N = 30 N = 30/27 N = 28/30

Differences to 1st value and 95%-Confidence interval

Imp

rove

men

t

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-crookingStanding on one footOutside Rotation of the hit joinMobility of legs and feet Walking Climbing stairs

Moving Test by KeitelRheumatoide Arthritis (Radon trial Bad Brambach 1997)

-8-6-4-202468

end oftreatment

3 monthlater

6 monthlater

Radon+CO2Radon+CO2

N = 30 N = 28/30 N = 30/29

SktDifferenzen zum Ausgangswert und 95%-Konfidenzintervall

Imp

rove

men

t

1st value1st value

CO2CO2

Measurement of Patient Outcome – MOPO (AIMS –questionaire)

Physical handicap and psychosocial Consequences by Rheumatoid Arthritis

• Mobility• Physical activity• Skill• Activities at home• Activities in daily life• Social activities• Pain• Depression• Anxiety

Assessment included:

Measurement of Patient Outcome (MOPO)Rheumatoide Arthritis (Radon trial Bad Brambach 1997)

-0,8-0,6-0,4-0,2

00,20,40,60,8

3 month later 6 month later

Radon+CO2Radon+CO2

Differenzen zum Ausgangswert und 95%-Konfidenzintervall

Skt

N = 29/30 N = 29/30

Imp

rove

men

t

1st value1st value

CO2CO2

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

bei Entl.

nach 3 Mon.

nach 6 Mon.

nach 9 Mon.

nach 12 Mon.

0 0,2 0,4 0,6 0,8 10-0,2

mit Radon

ohne Radon

Spondylitis Ankylosans (Studie Lind-Albrecht)Spondylitis Ankylosans (Studie Lind-Albrecht)

Relat. NSAIDS-use after Radon mine treatment Bad Kreuznach

bei Entl.

nach 3 Mon.

nach 6 Mon.

nach 9 Mon.

nach 12 Mon.

0 0,2 0,4 0,6 0,8 10-0,2-0,4

mit Radon

ohne Radon

Spondylitis Ankylosans (Studie Lind-Albrecht)Spondylitis Ankylosans (Studie Lind-Albrecht)

Meta-AnalyseForest-Plot

treatment control

Die Permeabilität der HautResorption für Gase und Flüssigkeiten durch 2 m2 Haut

L/h10

1

0,1

0,01N2

He Ar H2

H2SO2

CO2Rn

mL/h

100

10

1

n-Pentanoln-Butanol

Wasseriso-Butanol

Ethanol

DMSO

0,0001

0,001

0,01

0,1

1

10

100

1000µl Lösung/cm2/h

Cortison

Corticosteron

Indomethacine

Salicylic acid

Hydrocortison

Heparin

Acetylsalicylic acidDMSO

Progesteron

Testosteron

Estron

Methylsalicylat

JodideSulfate

Strontium

CobaltSilver

Pertechnetate

ArsenicBromide

Ferrum II

Selenite

Chromium IIIFerrum III

CadmiumCaesiumCalciumChloridePotassium

Sodium

Phenylmercuryborate

MethanolWater

H2S

RadonCO2

Permeability of skin Skin clearance for solutions in water

Permeability of skin Skin clearance for solutions in water

Water EthanolPropanolCampher

CamphenHeptanolOctanol

How Dosis can be calculated by Skin-Clearance?

Dosis = Skin-Clearance x Area x Concentration x TimeDosis = Skin-Clearance x Area x Concentration x Time

Dosis limit is the amount on the SkinDosis limit is the amount on the Skin

Skin-Clearance is realized by optimal Penetration situation( Bath, wet Skin, Okklusion

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

Effect of temperature (Q10. = 1,1-1,4) but skin temperature only low variable

Blood level and time of bathing

Badedauer

Fließgleichgewichterreichtnicht erreicht

Calculation about Radon-kinetic

Skin-Clearance = 200 µl/cm2 h-1

Concentration in bath = 3 kBq/lArea of skin = 2 m2

Absorption rate = 200 x 3 x 2/100 = 12 kBq/h

Skin-Clearance = 200 µl/cm2 h-1

Concentration in bath = 3 kBq/lArea of skin = 2 m2

Absorption rate = 200 x 3 x 2/100 = 12 kBq/h

Distribution volum = 20 l bei 80 kg KGElimination constant = 20 h-1

Blood level in steady state= 12 kBq/h / (20 l x 20 h-1) = 0,030 kBq/lBlood 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

Distribution volum = 20 l bei 80 kg KGElimination constant = 20 h-1

Blood level in steady state= 12 kBq/h / (20 l x 20 h-1) = 0,030 kBq/lBlood 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

PoloniumBismutumPlumbum

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.

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)

Dosis of skin

Dosis of kidneys

Dosis of other organs

natürliche Dosisleistung

Maximum

Zeit in Stunden

Bath period 20 minutes

Risk by radon skin-dosis of ca. 1 mSv per cure treatment is lesser than risk by

long use of medicaments..

Trial in radon treatment should be used in future research by the following disease assessments

• Rheumatoide A. HAQ

• Bechterew BASFI

• Narrow spinal channel LSS-Inst.

• Osteoarthrosis 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, sham-controlled study and follow-up. Rheumatology 2000:39:894-902

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, sham-controlled 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

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