bÁlint g, ÁdÁm a, ratkÓ i, somos É, poÓr l, bÁlint p, tefner i, bender t. budapest, hungary...

25

Upload: kerry-terry

Post on 16-Jan-2016

219 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: BÁLINT G, ÁDÁM A, RATKÓ I, SOMOS É, POÓR L, BÁLINT P, TEFNER I, BENDER T. Budapest, Hungary DOUBLE BLIND STUDY ABOUT THE EFFECTIVITY OF THE THERMAL MINERAL
Page 2: BÁLINT G, ÁDÁM A, RATKÓ I, SOMOS É, POÓR L, BÁLINT P, TEFNER I, BENDER T. Budapest, Hungary DOUBLE BLIND STUDY ABOUT THE EFFECTIVITY OF THE THERMAL MINERAL

BÁLINT G, ÁDÁM A, RATKÓ I,BÁLINT G, ÁDÁM A, RATKÓ I, SOMOS É, POÓR L,SOMOS É, POÓR L,BÁLINT P, BÁLINT P, TEFNER I, BENDER TTEFNER I, BENDER T..

Budapest, HungaryBudapest, Hungary

DOUBLEDOUBLE BLIND BLIND STUDYSTUDY ABOUT THE EFFECTIVITY OF THE ABOUT THE EFFECTIVITY OF THE

THERMAL MINERAL THERMAL MINERAL WATER OF WATER OF NAGYBARACSKANAGYBARACSKA ININ PATIENT WITH PATIENT WITH KNEEKNEE

JOINTJOINT OSTEOARTHRITISOSTEOARTHRITIS

BÁLINT G, ÁDÁM A, RATKÓ I,BÁLINT G, ÁDÁM A, RATKÓ I, SOMOS É, POÓR L,SOMOS É, POÓR L,BÁLINT P, BÁLINT P, TEFNER I, BENDER TTEFNER I, BENDER T..

Budapest, HungaryBudapest, Hungary

DOUBLEDOUBLE BLIND BLIND STUDYSTUDY ABOUT THE EFFECTIVITY OF THE ABOUT THE EFFECTIVITY OF THE

THERMAL MINERAL THERMAL MINERAL WATER OF WATER OF NAGYBARACSKANAGYBARACSKA ININ PATIENT WITH PATIENT WITH KNEEKNEE

JOINTJOINT OSTEOARTHRITISOSTEOARTHRITIS

Page 3: BÁLINT G, ÁDÁM A, RATKÓ I, SOMOS É, POÓR L, BÁLINT P, TEFNER I, BENDER T. Budapest, Hungary DOUBLE BLIND STUDY ABOUT THE EFFECTIVITY OF THE THERMAL MINERAL

AIMS OF THE STUDYAIMS OF THE STUDY

TO STUDY THE EFFECT OFTO STUDY THE EFFECT OF THE THERMAL MINERAL WATER THE THERMAL MINERAL WATER OF OF NAGYBARACSKANAGYBARACSKA ON THE KNEE PAIN AND MOBILITY OF ON THE KNEE PAIN AND MOBILITY OF PATIENTS WITH MILD AND MODERATE OSTEOARTHRITIS OF PATIENTS WITH MILD AND MODERATE OSTEOARTHRITIS OF THE KNEE.THE KNEE.

AIMS OF THE STUDYAIMS OF THE STUDY

TO STUDY THE EFFECT OFTO STUDY THE EFFECT OF THE THERMAL MINERAL WATER THE THERMAL MINERAL WATER OF OF NAGYBARACSKANAGYBARACSKA ON THE KNEE PAIN AND MOBILITY OF ON THE KNEE PAIN AND MOBILITY OF PATIENTS WITH MILD AND MODERATE OSTEOARTHRITIS OF PATIENTS WITH MILD AND MODERATE OSTEOARTHRITIS OF THE KNEE.THE KNEE.

Page 4: BÁLINT G, ÁDÁM A, RATKÓ I, SOMOS É, POÓR L, BÁLINT P, TEFNER I, BENDER T. Budapest, Hungary DOUBLE BLIND STUDY ABOUT THE EFFECTIVITY OF THE THERMAL MINERAL

THE CONTENTOF THE MINERAL WATEROF NAGYBARACSKA

THE CONTENTOF THE MINERAL WATEROF NAGYBARACSKA

N2 + 531

K+ 35NH4 + 6,7Ca ++ 219Mg ++ 65Fe +++ 1,89 Mn ++ 0,08 Li + 0,46 Kations 879,00Cl - 443Br - 0,89J - 0,78F - 2,8HCO3 1.458.0NO2 -

NO3 -

Anions 1.931.00Free CO2 864.00

Total: 3.722.00

N2 + 531

K+ 35NH4 + 6,7Ca ++ 219Mg ++ 65Fe +++ 1,89 Mn ++ 0,08 Li + 0,46 Kations 879,00Cl - 443Br - 0,89J - 0,78F - 2,8HCO3 1.458.0NO2 -

NO3 -

Anions 1.931.00Free CO2 864.00

Total: 3.722.00

mg / l mg / l

Page 5: BÁLINT G, ÁDÁM A, RATKÓ I, SOMOS É, POÓR L, BÁLINT P, TEFNER I, BENDER T. Budapest, Hungary DOUBLE BLIND STUDY ABOUT THE EFFECTIVITY OF THE THERMAL MINERAL

INCLUSION CRITERIAINCLUSION CRITERIA

- - FEMALE AND MALE PATIENTS WITH THE AGE FEMALE AND MALE PATIENTS WITH THE AGE BETWEENBETWEEN 5O-755O-75 YEARSYEARS

  - - FEMALE PATIENTS IN MENOPAUSEFEMALE PATIENTS IN MENOPAUSE  - - PAIN CHARACTERISTIC OF KNEE JOINT OA FOR AT PAIN CHARACTERISTIC OF KNEE JOINT OA FOR AT

LEAST 3 MONTHSLEAST 3 MONTHS  - - FULFILLING THE ACR CRITERIA FOR OA OF THE KNEEFULFILLING THE ACR CRITERIA FOR OA OF THE KNEE  - - NOT HAVING SYSTEMATIC OR LOCAL STEROID NOT HAVING SYSTEMATIC OR LOCAL STEROID TREATMENT, ANY KIND OF PHYSIOTHERAPY TREATMENT, ANY KIND OF PHYSIOTHERAPY

(WITH THE EXCEPTION OF(WITH THE EXCEPTION OF HOME-EXCERCISES) HOME-EXCERCISES) IN THE LAST TWO MONTHIN THE LAST TWO MONTH

  - - ALL THE PATIENTS MUST HAVE A-P X-RAY FILMS OF ALL THE PATIENTS MUST HAVE A-P X-RAY FILMS OF BOTH KNEES NOT OLDER THEN ONE YEARBOTH KNEES NOT OLDER THEN ONE YEAR

INCLUSION CRITERIAINCLUSION CRITERIA

- - FEMALE AND MALE PATIENTS WITH THE AGE FEMALE AND MALE PATIENTS WITH THE AGE BETWEENBETWEEN 5O-755O-75 YEARSYEARS

  - - FEMALE PATIENTS IN MENOPAUSEFEMALE PATIENTS IN MENOPAUSE  - - PAIN CHARACTERISTIC OF KNEE JOINT OA FOR AT PAIN CHARACTERISTIC OF KNEE JOINT OA FOR AT

LEAST 3 MONTHSLEAST 3 MONTHS  - - FULFILLING THE ACR CRITERIA FOR OA OF THE KNEEFULFILLING THE ACR CRITERIA FOR OA OF THE KNEE  - - NOT HAVING SYSTEMATIC OR LOCAL STEROID NOT HAVING SYSTEMATIC OR LOCAL STEROID TREATMENT, ANY KIND OF PHYSIOTHERAPY TREATMENT, ANY KIND OF PHYSIOTHERAPY

(WITH THE EXCEPTION OF(WITH THE EXCEPTION OF HOME-EXCERCISES) HOME-EXCERCISES) IN THE LAST TWO MONTHIN THE LAST TWO MONTH

  - - ALL THE PATIENTS MUST HAVE A-P X-RAY FILMS OF ALL THE PATIENTS MUST HAVE A-P X-RAY FILMS OF BOTH KNEES NOT OLDER THEN ONE YEARBOTH KNEES NOT OLDER THEN ONE YEAR

Page 6: BÁLINT G, ÁDÁM A, RATKÓ I, SOMOS É, POÓR L, BÁLINT P, TEFNER I, BENDER T. Budapest, Hungary DOUBLE BLIND STUDY ABOUT THE EFFECTIVITY OF THE THERMAL MINERAL

EXCLUSION CRITERIAEXCLUSION CRITERIA

  

- - NOT FULFILLING THE INCLUSION CRITERIANOT FULFILLING THE INCLUSION CRITERIA-- ANY PREVIOUS KNEE JOINT OPERATIONANY PREVIOUS KNEE JOINT OPERATION- -  ANY HIP JOINT OR SPINE OPERATION WITHIN ONE YEAR BEFORE ANY HIP JOINT OR SPINE OPERATION WITHIN ONE YEAR BEFORE

THE STUDYTHE STUDY   - -  ANY TRAUMA OF ONE OF THE KNEE JOINTS WITHIN ONE YEAR ANY TRAUMA OF ONE OF THE KNEE JOINTS WITHIN ONE YEAR

BEFORE THE STUDYBEFORE THE STUDY- -  ARTHROSCOPY OF THE KNEE JOINT WITHIN 3 MONTHS BEFORE ARTHROSCOPY OF THE KNEE JOINT WITHIN 3 MONTHS BEFORE

THE STUDYTHE STUDY   - - INTRAARTICULAR HYALURONAN INJECTION WITHIN 2 MONTHS INTRAARTICULAR HYALURONAN INJECTION WITHIN 2 MONTHS

BEFORE THE STUDYBEFORE THE STUDY-- PATIENTS WITH LUMBAR RADICULOPATHYPATIENTS WITH LUMBAR RADICULOPATHY

   -- PATIENTS WITH PALPABLE BAKER CYSTPATIENTS WITH PALPABLE BAKER CYST   -- SEDIMENTATION RATE HIGHER, THEN 30 mm IN FEMALES SEDIMENTATION RATE HIGHER, THEN 30 mm IN FEMALES

AND HIGHER THEN 20 mm IN MALESAND HIGHER THEN 20 mm IN MALES   -- PATIENTS WITH SEVERE INTERNAL UROGENITAL PATIENTS WITH SEVERE INTERNAL UROGENITAL

RHEUMATOLOGICAL OR ANY OTHER DISEASES RHEUMATOLOGICAL OR ANY OTHER DISEASES CONTRAINDICATING BALNEOTHERAPYCONTRAINDICATING BALNEOTHERAPY

   - - NON-COMPLIANT, AND PSYCHO-NEUROROTIC PATIENTSNON-COMPLIANT, AND PSYCHO-NEUROROTIC PATIENTS

EXCLUSION CRITERIAEXCLUSION CRITERIA

  

- - NOT FULFILLING THE INCLUSION CRITERIANOT FULFILLING THE INCLUSION CRITERIA-- ANY PREVIOUS KNEE JOINT OPERATIONANY PREVIOUS KNEE JOINT OPERATION- -  ANY HIP JOINT OR SPINE OPERATION WITHIN ONE YEAR BEFORE ANY HIP JOINT OR SPINE OPERATION WITHIN ONE YEAR BEFORE

THE STUDYTHE STUDY   - -  ANY TRAUMA OF ONE OF THE KNEE JOINTS WITHIN ONE YEAR ANY TRAUMA OF ONE OF THE KNEE JOINTS WITHIN ONE YEAR

BEFORE THE STUDYBEFORE THE STUDY- -  ARTHROSCOPY OF THE KNEE JOINT WITHIN 3 MONTHS BEFORE ARTHROSCOPY OF THE KNEE JOINT WITHIN 3 MONTHS BEFORE

THE STUDYTHE STUDY   - - INTRAARTICULAR HYALURONAN INJECTION WITHIN 2 MONTHS INTRAARTICULAR HYALURONAN INJECTION WITHIN 2 MONTHS

BEFORE THE STUDYBEFORE THE STUDY-- PATIENTS WITH LUMBAR RADICULOPATHYPATIENTS WITH LUMBAR RADICULOPATHY

   -- PATIENTS WITH PALPABLE BAKER CYSTPATIENTS WITH PALPABLE BAKER CYST   -- SEDIMENTATION RATE HIGHER, THEN 30 mm IN FEMALES SEDIMENTATION RATE HIGHER, THEN 30 mm IN FEMALES

AND HIGHER THEN 20 mm IN MALESAND HIGHER THEN 20 mm IN MALES   -- PATIENTS WITH SEVERE INTERNAL UROGENITAL PATIENTS WITH SEVERE INTERNAL UROGENITAL

RHEUMATOLOGICAL OR ANY OTHER DISEASES RHEUMATOLOGICAL OR ANY OTHER DISEASES CONTRAINDICATING BALNEOTHERAPYCONTRAINDICATING BALNEOTHERAPY

   - - NON-COMPLIANT, AND PSYCHO-NEUROROTIC PATIENTSNON-COMPLIANT, AND PSYCHO-NEUROROTIC PATIENTS

Page 7: BÁLINT G, ÁDÁM A, RATKÓ I, SOMOS É, POÓR L, BÁLINT P, TEFNER I, BENDER T. Budapest, Hungary DOUBLE BLIND STUDY ABOUT THE EFFECTIVITY OF THE THERMAL MINERAL

ALL THE PATIENTS WERE INFORMED ABOUT THE AIM AND ALL THE PATIENTS WERE INFORMED ABOUT THE AIM AND THE DETAILS OF THE STUDY BEFORE SCREENINGS AND THE DETAILS OF THE STUDY BEFORE SCREENINGS AND ALL GAVE THEIR WRITTEN CONSENT. ALL GAVE THEIR WRITTEN CONSENT. THE STUDY WAS PERMITTED BY THE LOCALTHE STUDY WAS PERMITTED BY THE LOCAL AND AND REGIONALREGIONAL ETHICAL COMMITTEEETHICAL COMMITTEE

ALL THE PATIENTS WERE INFORMED ABOUT THE AIM AND ALL THE PATIENTS WERE INFORMED ABOUT THE AIM AND THE DETAILS OF THE STUDY BEFORE SCREENINGS AND THE DETAILS OF THE STUDY BEFORE SCREENINGS AND ALL GAVE THEIR WRITTEN CONSENT. ALL GAVE THEIR WRITTEN CONSENT. THE STUDY WAS PERMITTED BY THE LOCALTHE STUDY WAS PERMITTED BY THE LOCAL AND AND REGIONALREGIONAL ETHICAL COMMITTEEETHICAL COMMITTEE

Page 8: BÁLINT G, ÁDÁM A, RATKÓ I, SOMOS É, POÓR L, BÁLINT P, TEFNER I, BENDER T. Budapest, Hungary DOUBLE BLIND STUDY ABOUT THE EFFECTIVITY OF THE THERMAL MINERAL

COURSE OF THE STUDYCOURSE OF THE STUDY

32-32 PATIENTS SCREENED AND SELECTED FOR THE STUDY 32-32 PATIENTS SCREENED AND SELECTED FOR THE STUDY WERE RANDOMLY ALLOCATED EITHER IN THE BALNEOLOGY OR WERE RANDOMLY ALLOCATED EITHER IN THE BALNEOLOGY OR THE CONTROLL GROUPS BY ONE OF THE AUTHORS. (L.P)THE CONTROLL GROUPS BY ONE OF THE AUTHORS. (L.P)

COURSE OF THE STUDYCOURSE OF THE STUDY

32-32 PATIENTS SCREENED AND SELECTED FOR THE STUDY 32-32 PATIENTS SCREENED AND SELECTED FOR THE STUDY WERE RANDOMLY ALLOCATED EITHER IN THE BALNEOLOGY OR WERE RANDOMLY ALLOCATED EITHER IN THE BALNEOLOGY OR THE CONTROLL GROUPS BY ONE OF THE AUTHORS. (L.P)THE CONTROLL GROUPS BY ONE OF THE AUTHORS. (L.P)

Page 9: BÁLINT G, ÁDÁM A, RATKÓ I, SOMOS É, POÓR L, BÁLINT P, TEFNER I, BENDER T. Budapest, Hungary DOUBLE BLIND STUDY ABOUT THE EFFECTIVITY OF THE THERMAL MINERAL

1 . FIGUREMEAN AND SD OF THE AGE OF THE PATIENTS1 . FIGUREMEAN AND SD OF THE AGE OF THE PATIENTS

TAP WATER GROUPTAP WATER GROUP THERMAL-MINERALWATER GROUP

THERMAL-MINERALWATER GROUP

00

1010

2020

3030

4040

5050

6060

7070

8080

Page 10: BÁLINT G, ÁDÁM A, RATKÓ I, SOMOS É, POÓR L, BÁLINT P, TEFNER I, BENDER T. Budapest, Hungary DOUBLE BLIND STUDY ABOUT THE EFFECTIVITY OF THE THERMAL MINERAL

00

55

1010

1515

2020

2525

TAP WATER GROUPTAP WATER GROUP THERMAL-MINERALWATER GROUP

THERMAL-MINERALWATER GROUP

2 . FIGUREMEAN AND SD OF DURATIOM OF DISEASE2 . FIGUREMEAN AND SD OF DURATIOM OF DISEASE

Page 11: BÁLINT G, ÁDÁM A, RATKÓ I, SOMOS É, POÓR L, BÁLINT P, TEFNER I, BENDER T. Budapest, Hungary DOUBLE BLIND STUDY ABOUT THE EFFECTIVITY OF THE THERMAL MINERAL

3 . FIGUREMEAN AND SD OF TOTAL WOMAC SCORES BEFORE TREATMENT

3 . FIGUREMEAN AND SD OF TOTAL WOMAC SCORES BEFORE TREATMENT

00

55

1010

1515

2020

2525

3030

3535

4040

4545

5050

TAP WATER GROUPTAP WATER GROUP THERMAL-MINERALWATER GROUP

THERMAL-MINERALWATER GROUP

Page 12: BÁLINT G, ÁDÁM A, RATKÓ I, SOMOS É, POÓR L, BÁLINT P, TEFNER I, BENDER T. Budapest, Hungary DOUBLE BLIND STUDY ABOUT THE EFFECTIVITY OF THE THERMAL MINERAL

99

1616

1010

1717

00

22

44

66

88

1010

1212

1414

1616

1818

MALEMALE FEMALEFEMALE

TAP WATER GROUPTAP WATER GROUP

THERMAL-MINERALWATER GROUP

THERMAL-MINERALWATER GROUP

4 . FIGUREDISTRIBUTION OF GENDERS IN THE TAP WATER ANDTERMAL-MINERAL WATER GROUP

4 . FIGUREDISTRIBUTION OF GENDERS IN THE TAP WATER ANDTERMAL-MINERAL WATER GROUP

Page 13: BÁLINT G, ÁDÁM A, RATKÓ I, SOMOS É, POÓR L, BÁLINT P, TEFNER I, BENDER T. Budapest, Hungary DOUBLE BLIND STUDY ABOUT THE EFFECTIVITY OF THE THERMAL MINERAL

ALL THE ASSESSEMENTS BEFORE AND AFTER THE STUDY ALL THE ASSESSEMENTS BEFORE AND AFTER THE STUDY WERE PERFORMED BY ONE OF THE AUTHORS. (É.S.) WERE PERFORMED BY ONE OF THE AUTHORS. (É.S.)ALL THE ASSESSEMENTS BEFORE AND AFTER THE STUDY ALL THE ASSESSEMENTS BEFORE AND AFTER THE STUDY WERE PERFORMED BY ONE OF THE AUTHORS. (É.S.) WERE PERFORMED BY ONE OF THE AUTHORS. (É.S.)

Page 14: BÁLINT G, ÁDÁM A, RATKÓ I, SOMOS É, POÓR L, BÁLINT P, TEFNER I, BENDER T. Budapest, Hungary DOUBLE BLIND STUDY ABOUT THE EFFECTIVITY OF THE THERMAL MINERAL

THE STUDY GROUP RECEIVEDTHE STUDY GROUP RECEIVED  30 MINUTES INDIVIDUAL THERMAL MINERAL WATER 30 MINUTES INDIVIDUAL THERMAL MINERAL WATER TREATMENT IN TUBS, 5 TIMES A WEEK FOR 4 WEEKS.TREATMENT IN TUBS, 5 TIMES A WEEK FOR 4 WEEKS.  THE CONTROLL GROUP RECEIVEDTHE CONTROLL GROUP RECEIVED  30 MINUTES INDIVIDUAL TAP WATER TREATMENT HEATED UP 30 MINUTES INDIVIDUAL TAP WATER TREATMENT HEATED UP TO THE TEMPERATURE OF THE THERMAL WATER IN THE TO THE TEMPERATURE OF THE THERMAL WATER IN THE SAME ARRANGEMENT.SAME ARRANGEMENT.

THE STUDY GROUP RECEIVEDTHE STUDY GROUP RECEIVED  30 MINUTES INDIVIDUAL THERMAL MINERAL WATER 30 MINUTES INDIVIDUAL THERMAL MINERAL WATER TREATMENT IN TUBS, 5 TIMES A WEEK FOR 4 WEEKS.TREATMENT IN TUBS, 5 TIMES A WEEK FOR 4 WEEKS.  THE CONTROLL GROUP RECEIVEDTHE CONTROLL GROUP RECEIVED  30 MINUTES INDIVIDUAL TAP WATER TREATMENT HEATED UP 30 MINUTES INDIVIDUAL TAP WATER TREATMENT HEATED UP TO THE TEMPERATURE OF THE THERMAL WATER IN THE TO THE TEMPERATURE OF THE THERMAL WATER IN THE SAME ARRANGEMENT.SAME ARRANGEMENT.

Page 15: BÁLINT G, ÁDÁM A, RATKÓ I, SOMOS É, POÓR L, BÁLINT P, TEFNER I, BENDER T. Budapest, Hungary DOUBLE BLIND STUDY ABOUT THE EFFECTIVITY OF THE THERMAL MINERAL

THE ASSESSING PHYSICIAN (É.S)THE ASSESSING PHYSICIAN (É.S)  PERFORMEDPERFORMED DETAILED HISTORY TAKINGDETAILED HISTORY TAKING

DETAILED PHYSICAL EXAMINATIONDETAILED PHYSICAL EXAMINATION RANGE OF MOVEMENTS OF THE KNEESRANGE OF MOVEMENTS OF THE KNEESASCERTAINING THAT THE PATIENT IS FULFILLING THE ASCERTAINING THAT THE PATIENT IS FULFILLING THE INCLUSION CRITERIA AND PRESENTING NO EXCLUSION INCLUSION CRITERIA AND PRESENTING NO EXCLUSION CRITERIACRITERIA

THE ASSESSING PHYSICIAN (É.S)THE ASSESSING PHYSICIAN (É.S)  PERFORMEDPERFORMED DETAILED HISTORY TAKINGDETAILED HISTORY TAKING

DETAILED PHYSICAL EXAMINATIONDETAILED PHYSICAL EXAMINATION RANGE OF MOVEMENTS OF THE KNEESRANGE OF MOVEMENTS OF THE KNEESASCERTAINING THAT THE PATIENT IS FULFILLING THE ASCERTAINING THAT THE PATIENT IS FULFILLING THE INCLUSION CRITERIA AND PRESENTING NO EXCLUSION INCLUSION CRITERIA AND PRESENTING NO EXCLUSION CRITERIACRITERIA

Page 16: BÁLINT G, ÁDÁM A, RATKÓ I, SOMOS É, POÓR L, BÁLINT P, TEFNER I, BENDER T. Budapest, Hungary DOUBLE BLIND STUDY ABOUT THE EFFECTIVITY OF THE THERMAL MINERAL

- - ASCERTAINED THE FILLING OUT OF THE WOMAC SCOREASCERTAINED THE FILLING OUT OF THE WOMAC SCORE- - REGISTERING OF THE SIDE EFFECTSREGISTERING OF THE SIDE EFFECTS-- REGISTRATION OF THE USE OF EXTRA ANALGESICSREGISTRATION OF THE USE OF EXTRA ANALGESICS-- PHYSICIANS OPINION ABOUT THE RESULT OF THE STUDYPHYSICIANS OPINION ABOUT THE RESULT OF THE STUDY

- - ASCERTAINED THE FILLING OUT OF THE WOMAC SCOREASCERTAINED THE FILLING OUT OF THE WOMAC SCORE- - REGISTERING OF THE SIDE EFFECTSREGISTERING OF THE SIDE EFFECTS-- REGISTRATION OF THE USE OF EXTRA ANALGESICSREGISTRATION OF THE USE OF EXTRA ANALGESICS-- PHYSICIANS OPINION ABOUT THE RESULT OF THE STUDYPHYSICIANS OPINION ABOUT THE RESULT OF THE STUDY

Page 17: BÁLINT G, ÁDÁM A, RATKÓ I, SOMOS É, POÓR L, BÁLINT P, TEFNER I, BENDER T. Budapest, Hungary DOUBLE BLIND STUDY ABOUT THE EFFECTIVITY OF THE THERMAL MINERAL

ASSESSEMENTS WERE PERFORMEDASSESSEMENTS WERE PERFORMED  - - BEFORE THE STUDYBEFORE THE STUDY- - IMMEDIATELY AFTER FINISHING OF THE STUDYIMMEDIATELY AFTER FINISHING OF THE STUDY- - 3 MONTHS AFTER FINISHING THE STUDY3 MONTHS AFTER FINISHING THE STUDY

ASSESSEMENTS WERE PERFORMEDASSESSEMENTS WERE PERFORMED  - - BEFORE THE STUDYBEFORE THE STUDY- - IMMEDIATELY AFTER FINISHING OF THE STUDYIMMEDIATELY AFTER FINISHING OF THE STUDY- - 3 MONTHS AFTER FINISHING THE STUDY3 MONTHS AFTER FINISHING THE STUDY

Page 18: BÁLINT G, ÁDÁM A, RATKÓ I, SOMOS É, POÓR L, BÁLINT P, TEFNER I, BENDER T. Budapest, Hungary DOUBLE BLIND STUDY ABOUT THE EFFECTIVITY OF THE THERMAL MINERAL

THE STUDY DOCTOR (A.Á)THE STUDY DOCTOR (A.Á)   INQUIRED ABOUT THE GENERALINQUIRED ABOUT THE GENERAL STATUSSTATUS AND KNEE PAIN OF THE AND KNEE PAIN OF THE PATIENPATIENTT MEASURED PULSE RATE AND BLOOD PRESSURE MEASURED PULSE RATE AND BLOOD PRESSURE INQUIRED ABOUT SIDE EFFECTS AND USE OF EXTRA INQUIRED ABOUT SIDE EFFECTS AND USE OF EXTRA ANALGESICS DURING THE STUDY, TWICE A WEEK.ANALGESICS DURING THE STUDY, TWICE A WEEK.    NEITHER THENEITHER THE ASSESSING NOR THE RANDOMIZING, AND THE ASSESSING NOR THE RANDOMIZING, AND THE STUDY DOCTOR OR ANY PERSONS WERE AWARE OF THE TYPE STUDY DOCTOR OR ANY PERSONS WERE AWARE OF THE TYPE OF TREATMENT THE PATIENTS RECEIVED,OF TREATMENT THE PATIENTS RECEIVED, WITH EXCEPTION OF WITH EXCEPTION OF THE BALNEO-TECHNICIAN, BUT HE WAS ASKED TO KEEPTHE BALNEO-TECHNICIAN, BUT HE WAS ASKED TO KEEP IT IT IN IN SECRET.SECRET.

THE STUDY DOCTOR (A.Á)THE STUDY DOCTOR (A.Á)   INQUIRED ABOUT THE GENERALINQUIRED ABOUT THE GENERAL STATUSSTATUS AND KNEE PAIN OF THE AND KNEE PAIN OF THE PATIENPATIENTT MEASURED PULSE RATE AND BLOOD PRESSURE MEASURED PULSE RATE AND BLOOD PRESSURE INQUIRED ABOUT SIDE EFFECTS AND USE OF EXTRA INQUIRED ABOUT SIDE EFFECTS AND USE OF EXTRA ANALGESICS DURING THE STUDY, TWICE A WEEK.ANALGESICS DURING THE STUDY, TWICE A WEEK.    NEITHER THENEITHER THE ASSESSING NOR THE RANDOMIZING, AND THE ASSESSING NOR THE RANDOMIZING, AND THE STUDY DOCTOR OR ANY PERSONS WERE AWARE OF THE TYPE STUDY DOCTOR OR ANY PERSONS WERE AWARE OF THE TYPE OF TREATMENT THE PATIENTS RECEIVED,OF TREATMENT THE PATIENTS RECEIVED, WITH EXCEPTION OF WITH EXCEPTION OF THE BALNEO-TECHNICIAN, BUT HE WAS ASKED TO KEEPTHE BALNEO-TECHNICIAN, BUT HE WAS ASKED TO KEEP IT IT IN IN SECRET.SECRET.

Page 19: BÁLINT G, ÁDÁM A, RATKÓ I, SOMOS É, POÓR L, BÁLINT P, TEFNER I, BENDER T. Budapest, Hungary DOUBLE BLIND STUDY ABOUT THE EFFECTIVITY OF THE THERMAL MINERAL

RESULTSRESULTS

FROM THE THERMAL-MINERALFROM THE THERMAL-MINERAL WATER GROUPWATER GROUP 5 PATIENTS5 PATIENTS  FROM TH E TAP WATER GROUP 7 PATIENTS DID NOT FINISH THE FROM TH E TAP WATER GROUP 7 PATIENTS DID NOT FINISH THE TRIALTRIAL

RESULTSRESULTS

FROM THE THERMAL-MINERALFROM THE THERMAL-MINERAL WATER GROUPWATER GROUP 5 PATIENTS5 PATIENTS  FROM TH E TAP WATER GROUP 7 PATIENTS DID NOT FINISH THE FROM TH E TAP WATER GROUP 7 PATIENTS DID NOT FINISH THE TRIALTRIAL

Page 20: BÁLINT G, ÁDÁM A, RATKÓ I, SOMOS É, POÓR L, BÁLINT P, TEFNER I, BENDER T. Budapest, Hungary DOUBLE BLIND STUDY ABOUT THE EFFECTIVITY OF THE THERMAL MINERAL

  REASONS FOR FREASONS FOR FAALLING OUTLLING OUT  

THERMAL-MINERALTHERMAL-MINERAL TAP WATER GROUPTAP WATER GROUP WATER GROUPWATER GROUP

ACUTE FEBRILEACUTE FEBRILE CONDITION CONDITION 11

33  HYPERTENSIONHYPERTENSION 11 11  FAMILY AFFAIRSFAMILY AFFAIRS 11 22  UNKNOWNUNKNOWN 22 11

ALLTOGETHERALLTOGETHER 55 77

  REASONS FOR FREASONS FOR FAALLING OUTLLING OUT  

THERMAL-MINERALTHERMAL-MINERAL TAP WATER GROUPTAP WATER GROUP WATER GROUPWATER GROUP

ACUTE FEBRILEACUTE FEBRILE CONDITION CONDITION 11

33  HYPERTENSIONHYPERTENSION 11 11  FAMILY AFFAIRSFAMILY AFFAIRS 11 22  UNKNOWNUNKNOWN 22 11

ALLTOGETHERALLTOGETHER 55 77

Page 21: BÁLINT G, ÁDÁM A, RATKÓ I, SOMOS É, POÓR L, BÁLINT P, TEFNER I, BENDER T. Budapest, Hungary DOUBLE BLIND STUDY ABOUT THE EFFECTIVITY OF THE THERMAL MINERAL

  IN THE THERMALIN THE THERMAL MINERAL WATER GROUPMINERAL WATER GROUP 27 (10 ♂, 17 ♀)27 (10 ♂, 17 ♀)IN THE TAP WATER GROUPIN THE TAP WATER GROUP 29 ( 9 ♂, 16 ♀)29 ( 9 ♂, 16 ♀)  

PATIENTS FINISHED THE TRIAL AND THEIR RESULTS WERE PATIENTS FINISHED THE TRIAL AND THEIR RESULTS WERE ANALYSED.ANALYSED.  THE TWO GROUPS WERE COMPARABLE.THE TWO GROUPS WERE COMPARABLE.

  IN THE THERMALIN THE THERMAL MINERAL WATER GROUPMINERAL WATER GROUP 27 (10 ♂, 17 ♀)27 (10 ♂, 17 ♀)IN THE TAP WATER GROUPIN THE TAP WATER GROUP 29 ( 9 ♂, 16 ♀)29 ( 9 ♂, 16 ♀)  

PATIENTS FINISHED THE TRIAL AND THEIR RESULTS WERE PATIENTS FINISHED THE TRIAL AND THEIR RESULTS WERE ANALYSED.ANALYSED.  THE TWO GROUPS WERE COMPARABLE.THE TWO GROUPS WERE COMPARABLE.

Page 22: BÁLINT G, ÁDÁM A, RATKÓ I, SOMOS É, POÓR L, BÁLINT P, TEFNER I, BENDER T. Budapest, Hungary DOUBLE BLIND STUDY ABOUT THE EFFECTIVITY OF THE THERMAL MINERAL

0.3270.32725251.0001.00044.5444.54222.69222.69408.00408.00Walking distance afterWalking distance after

------2525--- --- 44.3944.39221.93221.93407.20407.20Walking distance in meters before treatmentWalking distance in meters before treatment

1.0001.00025250.0000.0000.660.663.323.3243.2843.28WOMAC after 3 monthWOMAC after 3 month

0.0040.00425253.2193.2190.640.643.183.1831.3631.36WOMAC afterWOMAC after

------2525------0.660.663.323.3243.2843.28WOMAC beforeWOMAC before

1.0001.0002525Z=0.000Z=0.0000.180.180.910.918.808.80WOMAC stiffness score after 3 monthWOMAC stiffness score after 3 month

0.0570.05725 25 2.0002.0000.150.150.760.768.608.60WOMAC stiffness score after treatmentWOMAC stiffness score after treatment

------2525------0.180.180.910.918.808.80WOMAC pain score before treatmentWOMAC pain score before treatment

1.0001.0002525Z=0.000Z=0.0000.220.221.081.082.80 2.80 WOMAC stiffness score after 3 monthWOMAC stiffness score after 3 month

1.0001.0002525Z=0.000Z=0.0000.220.221.081.082.802.80WOMAC stiffness score after treatmentWOMAC stiffness score after treatment

------2525------0.220.221.08 1.08 2.802.80WOMAC stiffnest score before treatmentWOMAC stiffnest score before treatment

1.0001.00025 25 0.0000.0000.550.552.752.7532.6832.68WOMAC activity score after 3 monthWOMAC activity score after 3 month

0.0290.02925252.3172.3170.58 0.58 2.90 2.90 31.36 31.36 WOMAC activity score after treatmentWOMAC activity score after treatment

------2525------0.550.552.762.7631.6831.68WOMAC activity score before treatmentWOMAC activity score before treatment

P valueP valueNNT&Z valueT&Z valueSEMSEMSDSDMeanMeanParameterParameter

TAP WATER GROUPTAP WATER GROUP

Page 23: BÁLINT G, ÁDÁM A, RATKÓ I, SOMOS É, POÓR L, BÁLINT P, TEFNER I, BENDER T. Budapest, Hungary DOUBLE BLIND STUDY ABOUT THE EFFECTIVITY OF THE THERMAL MINERAL

0.0270.0272626-2.343-2.343135.75135.75692.18692.18743.08743.08Walking distance afterWalking distance after

------2626--- --- 59.3759.37302.74302.74525.00525.00Walking distance in meters before treatmentWalking distance in meters before treatment

0.0120.01227272.7122.7120.560.562.912.9142.1142.11WOMAC after 3 monthWOMAC after 3 month

0.0000.00027275.8935.8930.610.613.183.1838.8538.85WOMAC afterWOMAC after

------2727------0.670.673.473.4743.0443.04WOMAC beforeWOMAC before

0.0050.00527273.0583.0580.200.201.041.048.378.37WOMAC stiffness score after 3 monthWOMAC stiffness score after 3 month

0.0000.00027277.2577.2570.220.221.121.127.227.22WOMAC stiffness score after treatmentWOMAC stiffness score after treatment

------2727------0.220.221.161.168.748.74WOMAC pain score before treatmentWOMAC pain score before treatment

0.1800.1802626Z=1.342Z=1.3420.140.140.750.752.52 2.52 WOMAC stiffness score after 3 monthWOMAC stiffness score after 3 month

0.1290.12926261.5681.5680.150.150.790.792.372.37WOMAC stiffness score after treatmentWOMAC stiffness score after treatment

------2626------0.180.180.93 0.93 2.632.63WOMAC stiffnest score before treatmentWOMAC stiffnest score before treatment

0.00927 27 2.8012.8010.390.392.032.0331.2231.22WOMAC activity score after 3 monthWOMAC activity score after 3 month

0.00027276.4246.4240.41 0.41 2.15 2.15 29.22 29.22 WOMAC activity score after treatmentWOMAC activity score after treatment

------2727------0.420.422.202.2031.7031.70WOMAC activity score before treatmentWOMAC activity score before treatment

P valueP valueNNT&Z valueT&Z valueSEMSEMSDSDMeanMeanParameterParameter

THERMAL-MINERAL WATER GROUPTHERMAL-MINERAL WATER GROUP

Page 24: BÁLINT G, ÁDÁM A, RATKÓ I, SOMOS É, POÓR L, BÁLINT P, TEFNER I, BENDER T. Budapest, Hungary DOUBLE BLIND STUDY ABOUT THE EFFECTIVITY OF THE THERMAL MINERAL

SUMMARYSUMMARY  THE WOMAC ACTIVITY AND TOTAL SCORE IMPROVED THE WOMAC ACTIVITY AND TOTAL SCORE IMPROVED SIGNIFICANTLY EVEN INSIGNIFICANTLY EVEN IN THE TAP WATER GROUP AT THE THE TAP WATER GROUP AT THE AND OF THE TRIAL, BUT THERE WAS NO SIGNIFICANT AND OF THE TRIAL, BUT THERE WAS NO SIGNIFICANT IMPROVEMENT AFTER 3 MONTHS COMPARED TO THE IMPROVEMENT AFTER 3 MONTHS COMPARED TO THE VALUEVALUESS MEASURED BEFORE THE TREATMENT. MEASURED BEFORE THE TREATMENT.

ALL THE WOMAC SCORES, AND ALSO THE WALKING ALL THE WOMAC SCORES, AND ALSO THE WALKING DISTANCE IMPROVED SIGNIFICANTLY IN THE THERMAL DISTANCE IMPROVED SIGNIFICANTLY IN THE THERMAL MINERALMINERAL WATER GRWATER GROOUP BOTH AT THE END OF THE UP BOTH AT THE END OF THE TREATMENT AND AFTER THREE MONTHS.TREATMENT AND AFTER THREE MONTHS.  NO CONSIDERABLE SIDE EFFECTS OCCURED, THERE WAS NO CONSIDERABLE SIDE EFFECTS OCCURED, THERE WAS NO EXTRA USE OF ANALGESICS IN EITHER GROUP.NO EXTRA USE OF ANALGESICS IN EITHER GROUP.

SUMMARYSUMMARY  THE WOMAC ACTIVITY AND TOTAL SCORE IMPROVED THE WOMAC ACTIVITY AND TOTAL SCORE IMPROVED SIGNIFICANTLY EVEN INSIGNIFICANTLY EVEN IN THE TAP WATER GROUP AT THE THE TAP WATER GROUP AT THE AND OF THE TRIAL, BUT THERE WAS NO SIGNIFICANT AND OF THE TRIAL, BUT THERE WAS NO SIGNIFICANT IMPROVEMENT AFTER 3 MONTHS COMPARED TO THE IMPROVEMENT AFTER 3 MONTHS COMPARED TO THE VALUEVALUESS MEASURED BEFORE THE TREATMENT. MEASURED BEFORE THE TREATMENT.

ALL THE WOMAC SCORES, AND ALSO THE WALKING ALL THE WOMAC SCORES, AND ALSO THE WALKING DISTANCE IMPROVED SIGNIFICANTLY IN THE THERMAL DISTANCE IMPROVED SIGNIFICANTLY IN THE THERMAL MINERALMINERAL WATER GRWATER GROOUP BOTH AT THE END OF THE UP BOTH AT THE END OF THE TREATMENT AND AFTER THREE MONTHS.TREATMENT AND AFTER THREE MONTHS.  NO CONSIDERABLE SIDE EFFECTS OCCURED, THERE WAS NO CONSIDERABLE SIDE EFFECTS OCCURED, THERE WAS NO EXTRA USE OF ANALGESICS IN EITHER GROUP.NO EXTRA USE OF ANALGESICS IN EITHER GROUP.

Page 25: BÁLINT G, ÁDÁM A, RATKÓ I, SOMOS É, POÓR L, BÁLINT P, TEFNER I, BENDER T. Budapest, Hungary DOUBLE BLIND STUDY ABOUT THE EFFECTIVITY OF THE THERMAL MINERAL