1. EFFICACY OF SPA THERAPY IN RHEUMATOID ARTHRITIS-A RANDOMISED CONTROLLED CLINICAL STUDY Mine Karagülle Department of Medical Ecology and Hydroclimatology Istanbul University, Istanbul Medical Faculty Istanbul, Turkey

2. Objective routine outpatient care with conventional drug therapy for RA addition of a inpatient spa therapy to routine care additional benefits in short and long- term?

3. Subjects 50 patients with active RA diagnosed according to the 1987 revised ACR criteria from outpatient musculoskeletal polyclinic of the Department Medical Ecology and Hydroclimatology of Istanbul Medical Faculty of Istanbul University

4. Study Design Prospective Randomised Controlled Assessor masked Per-protocol analyse

5. spa therapy group (n:15) Two weeks stay at Tuzla Spa Hotel in Istanbul Balneotherapy daily thermomineral water baths 36-37ºC 20 minute in thermal pool total 12 baths

6. spa therapy group (n:15) Drinking local mineral water Rest Close contact with attending physician Two sessions of open discussion with patients (one hour each) aimed to improve their knowledge on Rheumatoid arthritis

7. Routine therapy group (n:22) Conventional drug therapy DMARDs (all patients) NSAIDs (most patients) At Outpatient Musculoskeletal Polyclinic of the Department Medical Ecology and Hydroclimatology

8. Outcome measures Patient’s assessment of pain (VAS) Patient’s assessment of disease activity (VAS) Health Assessment Questionnaire (Turkish version) Tender and swollen joint counts CRP and ESR Physician’s assessment of disease activity (VAS) WHO/ILAR Core set Pain Patient global assessment Physical disability Swollen joints Tender joints Acute phase reactants Physician global assessment Radiographs of joints

9. Assessment time points At baseline just after spa therapy (at 2 week) follow-up 3 month 6 month 12 month

10. Swollen Joint Significant reductions of swollen joint counts in both groups at all measurements Significantly greater reduction at swollen joint count in spa therapy group than the routin group after spa therapy course (p:0. 04, paired t- test) no significant differences at other assessments between the two groups x x P:0,04

11. Tender joint  Significant reductions of tender joint counts in both groups at all measurements  no significant differences at other assessments between the two groups

12. Patient’s assessments Patient’s global assessments improved significantly in both groups Spa therapy group showed significant superiority over routine therapy group in patient’s assessments at 2 weeks 6 and 12 months X X X X P<0,05

13. Physician’s assessments  Physician’s global assessments improved significantly in both groups  Spa therapy group showed significant superiority over routine therapy group in physician’s assessments at 3, 6 and 12 months X X X X P: 0,05 P<0,005

14. Pain scores (VAS) VAS scores for patient’s pain decreased significantly in both groups, this decrease was significantly greater in spa group compared to routine group at all time points

15. HAQ HAQ scores significantly improved in both therapy groups (not at 2 weeks in routine group) Improvement in HAQ scores of spa group was superior at all assessment time points

16. CRP Results: CRP levels showed non-significant changes at all measurements Exception was a significant reduction in spa group at 2 week X X P<0,02

17. ESR Results:  ESR levels showed non-significant changes at all measurements

18. Conclusions Inpatient spa therapy for two weeks added to routine outpatient care of patients with active RA has beneficial effects on disease activity in short and long term This kind of spa therapy should be considered as a useful treatment modality in the management of patients with active RA