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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
Videofilm during this Congress !
News of the I.S.M.H.News of the I.S.M.H.
http://www.med.uni-muenchen.de/ismh