OUTCOME-RESEARCH in Thermalism OUTCOME-RESEARCH in Thermalism

Nuevos retos en medicinaNuevos retos en medicinaThe New Challenge of MedicineThe New Challenge of Medicine

Helmut G. Pratzel, MD, PhD

President of the International Society of Medical Hydrology and Climatology (I.S.M.H.)

Situación y competencia térapéuticaSituación y competencia térapéutica

Sano

Agotado

Enfermedades crónicas

Enfermedades agudas

Caso de emergenciaM

éd

ico d

e f

am

ilia

Hospital

Vacaciones de salud

en spa

en spa Tra-

tamiento

Criterios de excelencia de las curas hydrotermales Criterios de excelencia de las curas hydrotermales y de los lugares del termalismo dentro de las y de los lugares del termalismo dentro de las

grandes opciones terapeuticasgrandes opciones terapeuticas

Spas and Health Resorts Rank within Health Care Systems Criteria of Efficient

Treatments

Long time experience Long time experience by many patientsby many patients

Controlled trialsControlled trialsby few patientsby few patients

¿Equivalencia de resultados clínicos?

Clinical Trial Protocol Clinical Trial Protocol by the Guidelines for Good Clinical Practice (GCP) of by the Guidelines for Good Clinical Practice (GCP) of

the European Communitythe 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 VariablePrimary 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.

Los métodos siguentes están Los métodos siguentes están permitidospermitidos

Comparación clinicaComparación de los gastos antes y despues

del tratamientoComparación del tiempo sin trabajo

Tiempo sin trabajoTiempo sin trabajoControlled trialControlled trial in Bad Wörishofen 1991-1994 in Bad Wörishofen 1991-1994

Non-working days

5,53

3,55

2,42,58

3,41

4,24

1,921,67

1,26 1,15

1,53

1,91

Initial End 3 months later 6 months later 9 months later 12 months later0

1

2

3

4

5

6

Out-patient In-patient Treatment

Pelka et al. 1995

n=115n=115

n=248n=248

ControlledControlled DoubleDouble--BlindBlind TrialsTrials

Placebo-controlled trials in spa treatment are not required and are ethically suspicious.

Comparison of different treatments or different dosage without changing the normal basic complex strategy could be realised.

Trials with mono therapies have no relevance to balneotherapeutic practise

Double-blind-control equipmentDouble-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-ReaderThe Barcode-Reader

Tres grados de la investigación son Tres grados de la investigación son importantesimportantes

Efecto del tratamiento médico durante la curaResultados médicos y socio-médicos a largo

plazo Diferencia entre los gastos y el efecto

MeasurementMeasurement of pressure painof pressure pain thresholdthreshold

Pressure 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

Pressure pain threshold by Sulphur bath seriesPressure pain threshold by Sulphur bath series

Period of inspectionPeriod of inspection Period of inspectionPeriod of inspection

kg/cmkg/cm22 kg/cmkg/cm22

2 weeks later

3 weeks later later

3,33,33,33,3

3,03,03,03,0

2,72,72,72,7

2,42,42,42,4

2,12,12,12,1

1,81,81,81,8

SulphurSulphur WaterWater

TapTap WaterWater

1 week later

Pressure pain thresholdPressure pain thresholdby Radon baths seriesby 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

-25-20-15-10

-505

10152025

end oftreatment

3 month later 6 month later

Subjective pain feelingSubjective pain feelingRheumatoide Arthritis (Radon trial Bad Brambach 1997)Rheumatoide Arthritis (Radon trial Bad Brambach 1997)

1st value1st valueCO2CO2

Radon+ CO2Radon+ CO2

mm VAS

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

Differences to 1st value and 95%-Confidence interval

Imp

rove

men

t

Moving test by KeitelMoving 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 KeitelMoving Test by KeitelRheumatoide Arthritis (Radon trial Bad Brambach Rheumatoide Arthritis (Radon trial Bad Brambach

19971997))

-8

-6

-4

-2

0

2

4

6

8

end oftreatment

3 month later 6 month later

CO2CO2

Radon+CO2Radon+CO2

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

SktDifferenzen zum Ausgangswert und 95%-Konfidenzintervall

Imp

rove

men

t

1st value1st value

Measurement of Patient Outcome - MOPOMeasurement of Patient Outcome - MOPO Physical handicap and psychosocial Consequences by Rheumatoid ArthritisPhysical 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 Measurement of Patient Outcome (MOPO)(MOPO)Rheumatoide Arthritis (Radon trial Bad Brambach 1997)Rheumatoide Arthritis (Radon trial Bad Brambach 1997)

-0,8

-0,6

-0,4

-0,2

0

0,2

0,4

0,6

0,8

3 month later 6 month later

Radon+CO2Radon+CO2

CO2CO2

Differenzen zum Ausgangswert und 95%-Konfidenzintervall

Skt

N = 29/30 N = 29/30

Imp

rove

men

t

1st value1st value

Structural AssessmentsStructural AssessmentsMusculoskeletalMusculoskeletal

upper extremity DASHlower extremity WOMACBack NASSmore Regions HAQ

Sangha O et.al. Rheumatol 56:322-333, 1997

Disease AssessmentsDisease 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 für Morbus Bechterew BASFI für Morbus Bechterew (Ankylosing Spondylitis)(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 für Morbus Bechterew BASFI für Morbus Bechterew (Ankylosing Spondylitis)(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

BASFI für Morbus BechterewBASFI für Morbus Bechterew((Bath Ankylosing Spondylitis Functional Index)Bath Ankylosing Spondylitis Functional Index)

Easy Unimportant

Each question 11 positions !

Ruof J et al, Z. Rheumatol 58:218-225 (1999)

Mineral water for bathingMineral water for bathingMineral water for bathingMineral water for bathingChemical quality can be used only in bath tubs

– Without any disinfections of water– With minimal concentrations of following substances

H2S > 10 mg/l Radon > 1 kBq/l CO2 > 1 g/l Brine 10-150 g/l (Dermatitis low – Psoriasis high)

In pools only physical quality can be used– With disinfections (chlorine)– Temperature must be more than 30 °C

IndicationsIndications Sulphured water in bath tubs in rheumatology Radon water in bath tubs and Radon-gas-baths or Radon-mines CO2 water in bath tubs and CO2-gas-baths

Brine water in bath tubs Brine water in pools for kinesitherapy Thermo-neutral baths (35 °C) Cold baths (<32 °C) Cold-warm changing baths Hot baths (>39 °C)

IndicationsIndicationsSulphured-Water in bath tubs in RheumatologySulphured-Water in bath tubs in Rheumatology

Degenerative joint disease Extra-articular rheumatism Chronic articular rheumatism Posttraumatic lesions Postoperative therapies

IndicationsIndicationsRadon-Water in bath tubs and Radon-Gas-baths or Radon-Water in bath tubs and Radon-Gas-baths or

Radon-minesRadon-mines

Ankylosing spondylitis Degenerative joint disease Spondylarthrosis Myofascial soft tissue syndrome Ovarian hypofunction Allergic bronchial Asthma

IndicationsIndicationsCOCO22-Water in bath tubs and CO-Water in bath tubs and CO22-Gas-baths-Gas-baths

Disorder of microcirculation of the skin Trophic ulcera of the skin, venous ulcera Decubitus Peripheral arterial occlusive disease in any stage Functional disorder of vascularity Polyneuropathy (Malum perforans) Cerebral disorders of microcirculation Arterial hypertension Algodystrophy (M. Sudeck)

IndicationsIndicationsBrine-Water in bath tubsBrine-Water in bath tubs

Psoriasis vulgaris

+ UV-B-irradiation

Neurodermitis

+ UV-A-irradiation

IndicationsIndicationsBrine-Water in pools for kinesitherapyBrine-Water in pools for kinesitherapy

Degenerative joint diseaseSpondylarthrosisOsteoporosisPosttraumatic and postoperative

state

Bath effectsBath effectsIndications thermoneutral baths (35 °C) Indications thermoneutral baths (35 °C)

Relaxation of muscles and exoneration of joints– Rheumatic Diseases

Relaxation effect by sympathicolysis, suppression of stress hormones and muscle relaxation– Psycho-vegetative syndrome– Psycho-physical overloading– Convalescence

Bath effectsBath effectsIndications thermoneutral baths (35 °C) Indications thermoneutral baths (35 °C)

Dehydration by increase of capillary re-absorption and diuresis– Rheumatic diseases– Posttraumatic und postoperative state– Oedema

Training vegetative-hormonal functions like blood volume, blood pressure and electrolyte regulation– Convalescence– Disorder of heart-circulation-regulation– Psycho-vegetative syndrome

Bath effectsBath effectsIndications cold baths (<32 °C)Indications cold baths (<32 °C)

Thermic stimuli for training of vascular regulation– Functional disorders of vascularity– Phlebopathies– Heart-circulation disorders

Thermic stimuli for training to inure– Infect prophylaxis

Bath effects Bath effects Indications cold-warm changing bathsIndications cold-warm changing baths

Thermic stimuli for training of vegetative-hormonal functions– Convalescence– Psycho-vegetative syndrome– Disorder of heart-circulation-regulation– Metabolic disorders

Bath effects Bath effects Indications hot baths (>39 °C)Indications hot baths (>39 °C)

Muscle relaxationIncrease of distensibility of connective tissue

structures Analgesic Antiphlogistic by hyperthermia

– Rheumatic diseases– Chronic-inflammatory diseases of the urogenital

system– Posttraumatic und postoperative state

Risks of bathingRisks of bathing

By immerse:increased cardiac preload result in a decompensation riskPrecaution by disorders of heart rhythm and Angina pectoris

By get out:Collapse riskPrecaution by venous diseases andorthostatic irregularity

During bathing:Loading of respiratory and lung function Precaution by respiratory insufficiency

Controles de calidad (DIN ISO 9001ff)Controles de calidad (DIN ISO 9001ff)

de la ejecución de los métodos terapéuticos

de los remedios naturales usados

de la prescripción

de los resultados terapéuticos

Quality of Health Resort MedicineQuality of Health Resort Medicine

• Quality control of

•Mineral waters

•Air and climate

•Treatment strategies

• Quality assurance by

•Technical systems

•Protection of resources

•Definition of performance standards

ConclusiónConclusiónPacientes con enfermedades crónicas

dependen de los ofrecimientos de las estaciones balnearias

En Europa no conocemos métodos mejores para esos pacientes

End of End of SlidesSlides

International Congress on International Congress on Natural Spa Therapy of the Natural Spa Therapy of the

I.S.M.H.I.S.M.H.

Dead Sea Israel21-24 November, 2001

Contact: dorit@ofakim.co.il

34th WORLD CONGRESS of the 34th WORLD CONGRESS of the I.S.M.H.I.S.M.H.

Budapest-Heviz (Hungary)14-19 October, 2002

Contact: http://www.ismh2002.hu

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