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 WATER OF NAGYBARACSKA IN PATIENT WITH KNEE JOINT OSTEOARTHRITIS

3. AIMS OF THE STUDY TO STUDY THE EFFECT OF THE THERMAL MINERAL WATER OF NAGYBARACSKA ON THE KNEE PAIN AND MOBILITY OF PATIENTS WITH MILD AND MODERATE OSTEOARTHRITIS OF THE KNEE.

4. THE CONTENT OF THE MINERAL WATER OF NAGYBARACSKA THE CONTENT OF THE MINERAL WATER OF NAGYBARACSKA N 2 + 531 K + 35 NH 4 + 6,7 Ca ++ 219 Mg ++ 65 Fe +++ 1,89 Mn ++ 0,08 Li + 0,46 Kations879,00 Cl - 443 Br - 0,89 J - 0,78 F - 2,8 HCO 3 1.458.0 NO 2 - NO 3 - Anions 1.931.00 Free CO 2 864.00 Total: 3.722.00 N 2 + 531 K + 35 NH 4 + 6,7 Ca ++ 219 Mg ++ 65 Fe +++ 1,89 Mn ++ 0,08 Li + 0,46 Kations879,00 Cl - 443 Br - 0,89 J - 0,78 F - 2,8 HCO 3 1.458.0 NO 2 - NO 3 - Anions 1.931.00 Free CO 2 864.00 Total: 3.722.00 mg / l

5. INCLUSION CRITERIA - FEMALE AND MALE PATIENTS WITH THE AGE BETWEEN 5O-75 YEARS - FEMALE PATIENTS IN MENOPAUSE - PAIN CHARACTERISTIC OF KNEE JOINT OA FOR AT LEAST 3 MONTHS - FULFILLING THE ACR CRITERIA FOR OA OF THE KNEE - NOT HAVING SYSTEMATIC OR LOCAL STEROID TREATMENT, ANY KIND OF PHYSIOTHERAPY (WITH THE EXCEPTION OF HOME-EXCERCISES) IN THE LAST TWO MONTH - ALL THE PATIENTS MUST HAVE A-P X-RAY FILMS OF BOTH KNEES NOT OLDER THEN ONE YEAR

6. EXCLUSION CRITERIA - NOT FULFILLING THE INCLUSION CRITERIA -ANY PREVIOUS KNEE JOINT OPERATION - ANY HIP JOINT OR SPINE OPERATION WITHIN ONE YEAR BEFORE THE STUDY - ANY TRAUMA OF ONE OF THE KNEE JOINTS WITHIN ONE YEAR BEFORE THE STUDY - ARTHROSCOPY OF THE KNEE JOINT WITHIN 3 MONTHS BEFORE THE STUDY - INTRAARTICULAR HYALURONAN INJECTION WITHIN 2 MONTHS BEFORE THE STUDY - PATIENTS WITH LUMBAR RADICULOPATHY - PATIENTS WITH PALPABLE BAKER CYST - SEDIMENTATION RATE HIGHER, THEN 30 mm IN FEMALES AND HIGHER THEN 20 mm IN MALES - PATIENTS WITH SEVERE INTERNAL UROGENITAL RHEUMATOLOGICAL OR ANY OTHER DISEASES CONTRAINDICATING BALNEOTHERAPY - NON-COMPLIANT, AND PSYCHO-NEUROROTIC PATIENTS

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

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

9. 1. FIGURE MEAN AND SD OF THE AGE OF THE PATIENTS 1. FIGURE MEAN AND SD OF THE AGE OF THE PATIENTS TAP WATER GROUP THERMAL-MINERAL WATER GROUP THERMAL-MINERAL WATER GROUP 0 0 10 20 30 40 50 60 70 80

10. 0 0 5 5 10 15 20 25 TAP WATER GROUP THERMAL-MINERAL WATER GROUP THERMAL-MINERAL WATER GROUP 2. FIGURE MEAN AND SD OF DURATIOM OF DISEASE 2. FIGURE MEAN AND SD OF DURATIOM OF DISEASE

11. 3. FIGURE MEAN AND SD OF TOTAL WOMAC SCORES BEFORE TREATMENT 3. FIGURE MEAN AND SD OF TOTAL WOMAC SCORES BEFORE TREATMENT 0 0 5 5 10 15 20 25 30 35 40 45 50 TAP WATER GROUP THERMAL-MINERAL WATER GROUP THERMAL-MINERAL WATER GROUP

12. 9 9 16 10 17 0 0 2 2 4 4 6 6 8 8 10 12 14 16 18 MALE FEMALE TAP WATER GROUP THERMAL-MINERAL WATER GROUP THERMAL-MINERAL WATER GROUP 4. FIGURE DISTRIBUTION OF GENDERS IN THE TAP WATER AND TERMAL-MINERAL WATER GROUP 4. FIGURE DISTRIBUTION OF GENDERS IN THE TAP WATER AND TERMAL-MINERAL WATER GROUP

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

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

15. THE ASSESSING PHYSICIAN (É.S) PERFORMEDDETAILED HISTORY TAKING DETAILED PHYSICAL EXAMINATION RANGE OF MOVEMENTS OF THE KNEES ASCERTAINING THAT THE PATIENT IS FULFILLING THE INCLUSION CRITERIA AND PRESENTING NO EXCLUSION CRITERIA

16. - ASCERTAINED THE FILLING OUT OF THE WOMAC SCORE - REGISTERING OF THE SIDE EFFECTS - REGISTRATION OF THE USE OF EXTRA ANALGESICS - PHYSICIANS OPINION ABOUT THE RESULT OF THE STUDY

17. ASSESSEMENTS WERE PERFORMED - BEFORE THE STUDY - IMMEDIATELY AFTER FINISHING OF THE STUDY - 3 MONTHS AFTER FINISHING THE STUDY

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

19. RESULTS FROM THE THERMAL-MINERAL WATER GROUP 5 PATIENTS FROM TH E TAP WATER GROUP 7 PATIENTS DID NOT FINISH THE TRIAL

20. REASONS FOR FALLING OUT THERMAL-MINERALTAP WATER GROUP WATER GROUP ACUTE FEBRILE CONDITION1 3 HYPERTENSION1 1 FAMILY AFFAIRS1 2 UNKNOWN2 1 ALLTOGETHER5 7 REASONS FOR FALLING OUT THERMAL-MINERALTAP WATER GROUP WATER GROUP ACUTE FEBRILE CONDITION1 3 HYPERTENSION1 1 FAMILY AFFAIRS1 2 UNKNOWN2 1 ALLTOGETHER5 7

21. IN THE THERMAL MINERAL WATER GROUP 27 (10 ♂, 17 ♀) IN THE TAP WATER GROUP29 ( 9 ♂, 16 ♀) PATIENTS FINISHED THE TRIAL AND THEIR RESULTS WERE ANALYSED. THE TWO GROUPS WERE COMPARABLE. IN THE THERMAL MINERAL WATER GROUP 27 (10 ♂, 17 ♀) IN THE TAP WATER GROUP29 ( 9 ♂, 16 ♀) PATIENTS FINISHED THE TRIAL AND THEIR RESULTS WERE ANALYSED. THE TWO GROUPS WERE COMPARABLE.

22. TAP WATER GROUP

23. THERMAL-MINERAL WATER GROUP

24. SUMMARY THE WOMAC ACTIVITY AND TOTAL SCORE IMPROVED SIGNIFICANTLY EVEN IN THE TAP WATER GROUP AT THE AND OF THE TRIAL, BUT THERE WAS NO SIGNIFICANT IMPROVEMENT AFTER 3 MONTHS COMPARED TO THE VALUES MEASURED BEFORE THE TREATMENT. ALL THE WOMAC SCORES, AND ALSO THE WALKING DISTANCE IMPROVED SIGNIFICANTLY IN THE THERMAL MINERAL WATER GROUP BOTH AT THE END OF THE TREATMENT AND AFTER THREE MONTHS. NO CONSIDERABLE SIDE EFFECTS OCCURED, THERE WAS NO EXTRA USE OF ANALGESICS IN EITHER GROUP.