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OUTCOME-RESEARCH in Thermalism<br />

Nuevos retos en medicina<br />

The New Challenge of Medicine<br />

Helmut G. Pratzel, MD, PhD<br />

President of the International Society of Medical Hydrology and Climatology<br />

(I.S.M.H.)


Situación n y competencia térapéutica<br />

• Sano<br />

• Agotado<br />

• Enfermedades crónicas<br />

• Enfermedades agudas<br />

• Caso de emergencia<br />

Médico de familia<br />

Vacaciones<br />

de salud<br />

en<br />

spa<br />

Hospital<br />

en spa<br />

Tratamiento


Criterios de excelencia de las curas hydrotermales<br />

y de los lugares del termalismo dentro de las<br />

grandes opciones terapeuticas<br />

Spas and Health Resorts Rank within<br />

Health Care Systems Criteria of<br />

Efficient Treatments


¿Equivalencia de resultados clínicos?<br />

Long time experience<br />

by many patients<br />

Controlled trials<br />

by few patients


Clinical Trial Protocol<br />

by the Guidelines for Good Clinical Practice (GCP) of<br />

the European Community<br />

• Trial objectives and purpose<br />

• Trial design<br />

• Randomisation, Blinding<br />

• Selection and withdrawal of<br />

subjects<br />

• inclusion and exclusion<br />

criteria<br />

• Treatment of subjects and control<br />

medication<br />

• Assessment of efficacy<br />

• Assessment of safety<br />

• Control of side effects and<br />

interactions<br />

• Control of Compliance<br />

• Statistics<br />

• Direct Access to Source<br />

Data/Documents<br />

• Quality control and Quality<br />

Assurance Procedures<br />

• Ethics


Primary Efficacy Variable<br />

• Only validated parameters should be used.<br />

• Only one efficacy parameter is to defined.<br />

• Endpoints used to determine efficacy should<br />

be clearly specified.<br />

• Multiple parameters should be assembled to<br />

one score parameter.<br />

• An efficacy threshold is to defined.


Los métodos m<br />

siguentes están<br />

permitidos<br />

• Comparación clinica<br />

• Comparación de los gastos antes y despues<br />

del tratamiento<br />

• Comparación del tiempo sin trabajo


Tiempo sin trabajo<br />

Controlled trial in Bad Wörishofen W<br />

1991-1994<br />

1994<br />

Non-working days<br />

5,53<br />

Out-patient<br />

In-patient Treatment<br />

6<br />

4,24<br />

5<br />

4<br />

3,55<br />

2,4<br />

2,58<br />

3,41<br />

n=115 n=115<br />

3<br />

2<br />

1<br />

1,92<br />

1,67<br />

1,26<br />

1,15<br />

1,53<br />

1,91<br />

n=248 n=248<br />

0<br />

Initial End 3 months later 6 months later 9 months later 12 months later<br />

Pelka et al. 1995


Controlled Double-Blind<br />

Trials<br />

• Placebo-controlled trials in spa treatment are<br />

not required and are ethically suspicious.<br />

• Comparison of different treatments or different<br />

dosage without changing the normal basic<br />

complex strategy could be realised.<br />

• Trials with mono therapies have no relevance to<br />

balneotherapeutic practise


Double-blind<br />

blind-control equipment<br />

Electronic<br />

control with<br />

bar-co<strong>der</strong>ea<strong>der</strong><br />

Tap-water line<br />

Magnetic<br />

valves<br />

Bar-co<strong>der</strong>ea<strong>der</strong><br />

Radon-water line<br />

Bath -tub<br />

Technical room<br />

Bathroom


The Barcode-Rea<strong>der</strong>


Tres grados de la investigación n son<br />

importantes<br />

• Efecto del tratamiento médico durante la cura<br />

• Resultados médicos y socio-médicos a largo<br />

plazo<br />

• Diferencia entre los gastos y el efecto


Measurement of pressure pain threshold<br />

Pressure Areas<br />

1. M. levator scapulae<br />

2. M. supraspinatus<br />

3. M. teres minor<br />

4. M. deltoideus<br />

5. M. glutaeus maximus<br />

6. M. glutaeus medius<br />

7. M. bizeps femoris<br />

8. M. semimembranosus


Pressure pain threshold<br />

by Sulphur bath series<br />

kg/cm 2<br />

1,8<br />

2,1<br />

2,4<br />

2,7<br />

1 week later<br />

2 weeks later<br />

Sulphur Water<br />

Tap Water<br />

3,0<br />

3 weeks later<br />

3,3<br />

Period of inspection


Pressure pain threshold<br />

by Radon baths series<br />

kg/cm 2 After 1 week<br />

3,0<br />

End of Treatment<br />

2,8<br />

2,6<br />

2,4<br />

2,2<br />

2,0<br />

Ende <strong>der</strong> Behandlung<br />

After 2 weeks<br />

After 3 weeks<br />

After 2 month<br />

Period of inspection<br />

After 4 month<br />

RADON WATER<br />

TAP WATER


Subjective pain feeling<br />

Rheumatoide Arthritis (Radon trial Bad Brambach 1997)<br />

mm VAS<br />

1st value<br />

25<br />

20<br />

15<br />

10<br />

5<br />

0<br />

-5<br />

-10<br />

-15<br />

-20<br />

-25<br />

Differences to 1st value<br />

and 95%-Confidence interval<br />

N = 30 N = 30/27<br />

end of<br />

treatment<br />

N = 28/30<br />

3 month later 6 month later<br />

CO 2<br />

Radon+ CO 2<br />

Improvement


Moving test by Keitel<br />

• To bend the fingers<br />

• Motility of hand joins and<br />

arms<br />

• Stand up from lying<br />

• Active straddle of legs from<br />

lying<br />

• Stand up from a stool<br />

• Standing on toes and heel<br />

• Knee-crooking<br />

• Standing on one foot<br />

• Outside Rotation of the hit join<br />

• Mobility of legs and feet<br />

• Walking<br />

• Climbing stairs


Moving Test by Keitel<br />

Rheumatoide Arthritis (Radon trial Bad Brambach<br />

1997)<br />

Skt<br />

Differenzen zum Ausgangswert<br />

und 95%-Konfidenzintervall<br />

1st value<br />

8<br />

6<br />

4<br />

2<br />

0<br />

-2<br />

-4<br />

-6<br />

-8<br />

N = 30 N = 28/30 N = 30/29<br />

end of<br />

treatment<br />

3 month later 6 month later<br />

Radon+CO 2<br />

CO 2<br />

Improvement


Measurement of Patient Outcome - MOPO<br />

Physical handicap and psychosocial Consequences by Rheumatoid Arthritis<br />

Assessment included:<br />

• Mobility<br />

• Physical activity<br />

• Skill<br />

• Activities at home<br />

• Activities in daily life<br />

• Social activities<br />

• Pain<br />

• Depression<br />

• Anxiety


(MOPO)<br />

Measurement of Patient Outcome (MOPO)<br />

Rheumatoide Arthritis (Radon trial Bad Brambach 1997)<br />

Differenzen zum Ausgangswert<br />

und 95%-Konfidenzintervall<br />

1st value<br />

Skt<br />

0,8<br />

0,6<br />

0,4<br />

0,2<br />

0<br />

-0,2<br />

-0,4<br />

-0,6<br />

-0,8<br />

N = 29/30 N = 29/30<br />

3 month later 6 month later<br />

Radon+CO 2<br />

CO 2<br />

Improvement


Structural Assessments<br />

Musculoskeletal<br />

• upper extremity<br />

• lower extremity<br />

• Back<br />

• more Regions<br />

DASH<br />

WOMAC<br />

NASS<br />

HAQ<br />

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


Disease Assessments<br />

• Rheumatoide A.<br />

• Bechterew<br />

• Narrow spinal channel<br />

• Osteoarthrosis<br />

HAQ<br />

BASFI<br />

LSS-Inst.<br />

WOMAC<br />

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


BASFI für f r Morbus Bechterew<br />

(Ankylosing Spondylitis)<br />

• Ohne Hilfe und Hilfsmittel Socken und Strümpfe anziehen<br />

• Ohne Hilfe von <strong>der</strong> Hüfte aus nach vorn beugen um einen<br />

Kugelschreiber vom Boden aufzuheben<br />

• Ohne Hilfe etwas von einem Regal nehmen<br />

• Von einem Wohnzimmerstuhl ohne Armlehne aufstehen ohne<br />

dabei die Hände o<strong>der</strong> eine an<strong>der</strong>e Hilfe zu benutzen<br />

• Ohne Hilfe vom Boden aufstehen, wenn Sie auf dem Rücken<br />

liegen<br />

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


BASFI für f r Morbus Bechterew<br />

(Ankylosing Spondylitis)<br />

• Ohne Schmerzen 10 Minuten stehen ohne sich anzulehnen<br />

• Ohne Benutzung eines Gelän<strong>der</strong>s o<strong>der</strong> Gehhilfen 12-15<br />

Treppenstufen steigen. 1 Fuß pro Stufe<br />

• Über die Schulter schauen ohne dabei den Körper abzudrehen.<br />

• Körperlich anstrengende Tätigkeiten verrichten (z.B.<br />

krankengymnastische Übungen, Gartenarbeit o<strong>der</strong> Sport)<br />

• Zu Hause o<strong>der</strong> bei <strong>der</strong> Arbeit den ganzen Tag aktiv sein.<br />

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


BASFI für f r Morbus Bechterew<br />

(Bath Ankylosing Spondylitis Functional Index)<br />

Easy<br />

Unimportant<br />

Each question 11 positions !<br />

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


Mineral water for bathing<br />

• Chemical quality can be used only in bath tubs<br />

– Without any disinfections of water<br />

– With minimal concentrations of following substances<br />

• H 2 S > 10 mg/l<br />

• Radon > 1 kBq/l<br />

• CO 2 > 1 g/l<br />

• Brine 10-150 g/l (Dermatitis low – Psoriasis high)<br />

• In pools only physical quality can be used<br />

– With disinfections (chlorine)<br />

– Temperature must be more than 30 °C


Indications<br />

• Sulphured water in bath tubs in rheumatology<br />

• Radon water in bath tubs and Radon-gas-baths or Radon-mines<br />

• CO 2 water in bath tubs and CO 2 -gas-baths<br />

• Brine water in bath tubs<br />

• Brine water in pools for kinesitherapy<br />

• Thermo-neutral baths (35 °C)<br />

• Cold baths (39 °C)


Indications<br />

Sulphured-Water in bath tubs in Rheumatology<br />

• Degenerative joint disease<br />

• Extra-articular rheumatism<br />

• Chronic articular rheumatism<br />

• Posttraumatic lesions<br />

• Postoperative therapies


Indications<br />

Radon-Water in bath tubs and Radon-Gas<br />

Gas-baths or<br />

Radon-mines<br />

• Ankylosing spondylitis<br />

• Degenerative joint disease<br />

• Spondylarthrosis<br />

• Myofascial soft tissue syndrome<br />

• Ovarian hypofunction<br />

• Allergic bronchial Asthma


Indications<br />

CO 2 -Water in bath tubs and CO 2 -Gas-baths<br />

• Disor<strong>der</strong> of microcirculation of the skin<br />

• Trophic ulcera of the skin, venous ulcera<br />

• Decubitus<br />

• Peripheral arterial occlusive disease in any stage<br />

• Functional disor<strong>der</strong> of vascularity<br />

• Polyneuropathy (Malum perforans)<br />

• Cerebral disor<strong>der</strong>s of microcirculation<br />

• Arterial hypertension<br />

• Algodystrophy (M. Sudeck)


Indications<br />

Brine-Water in bath tubs<br />

• Psoriasis vulgaris<br />

+ UV-B-irradiation<br />

• Neuro<strong>der</strong>mitis<br />

+ UV-A-irradiation


Indications<br />

Brine-Water in pools for kinesitherapy<br />

• Degenerative joint disease<br />

• Spondylarthrosis<br />

• Osteoporosis<br />

• Posttraumatic and postoperative<br />

state


Bath effects<br />

Indications thermoneutral baths (35 °C)<br />

• Relaxation of muscles and exoneration of joints<br />

– Rheumatic Diseases<br />

• Relaxation effect by sympathicolysis, suppression of<br />

stress hormones and muscle relaxation<br />

– Psycho-vegetative syndrome<br />

– Psycho-physical overloading<br />

– Convalescence


Bath effects<br />

Indications thermoneutral baths (35 °C)<br />

• Dehydration by increase of capillary reabsorption<br />

and diuresis<br />

– Rheumatic diseases<br />

– Posttraumatic und postoperative state<br />

– Oedema<br />

• Training vegetative-hormonal functions like<br />

blood volume, blood pressure and<br />

electrolyte regulation<br />

– Convalescence<br />

– Disor<strong>der</strong> of heart-circulation-regulation<br />

– Psycho-vegetative syndrome


Bath effects<br />

Indications cold baths (


Bath effects<br />

Indications cold-warm changing baths<br />

• Thermic stimuli for training of vegetativehormonal<br />

functions<br />

– Convalescence<br />

– Psycho-vegetative syndrome<br />

– Disor<strong>der</strong> of heart-circulation-regulation<br />

– Metabolic disor<strong>der</strong>s


Bath effects<br />

Indications hot baths (>39 °C)<br />

• Muscle relaxation<br />

• Increase of distensibility of connective tissue<br />

structures<br />

• Analgesic<br />

• Antiphlogistic by hyperthermia<br />

– Rheumatic diseases<br />

– Chronic-inflammatory diseases of the urogenital<br />

system<br />

– Posttraumatic und postoperative state


Risks of bathing<br />

• By immerse:<br />

increased cardiac preload result in a decompensation risk<br />

Precaution by disor<strong>der</strong>s of heart rhythm and Angina pectoris<br />

• By get out:<br />

Collapse risk<br />

Precaution by venous diseases and<br />

orthostatic irregularity<br />

• During bathing:<br />

Loading of respiratory and lung function<br />

Precaution by respiratory insufficiency


Controles de calidad (DIN ISO 9001ff)<br />

de la prescripción<br />

de los remedios<br />

naturales usados<br />

de la ejecución de los<br />

métodos terapéuticos<br />

de los resultados<br />

terapéuticos


Quality of Health Resort Medicine<br />

• Quality control of<br />

•Mineral waters<br />

•Air and climate<br />

•Treatment strategies<br />

• Quality assurance by<br />

•Technical systems<br />

•Protection of resources<br />

•Definition of performance standards


Conclusión<br />

• Pacientes con enfermedades crónicas<br />

dependen de los ofrecimientos de las<br />

estaciones balnearias<br />

• En Europa no conocemos métodos mejores<br />

para esos pacientes


International Congress on<br />

Natural Spa Therapy of the<br />

I.S.M.H.<br />

Dead Sea Israel<br />

21-24 November, 2001<br />

Contact: dorit@ofakim.co.il


34th WORLD CONGRESS of the<br />

I.S.M.H.<br />

Budapest-Heviz (Hungary)<br />

14-19 October, 2002<br />

Contact: http://www.ismh2002.hu<br />

Videofilm during this Congress !


News of the I.S.M.H.<br />

http://www.med.uni-muenchen.de/ismh

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