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The Effect of Balneotherapy on Knee Osteoarthritis

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					      The Effects of
  Balneotherapy on Knee
      Osteoarthritis
           Prof.Dr. Arif Dönmez
İstanbul University, İstanbul Medical Faculty,
     Department of Medical Ecology and
             Hydroclimatology


    III. Hungarian-Turkish Balneological Symposium
                     1 APRIL 2005
The Effects of Balneotherapy on
Knee Osteoarthritis
 Knee OA and disability
 EULAR Recommendations 2003 : an
  evidence based approach to the
  management of knee osteoarthritis
 Balneotherapy studies on knee
  osteoarthritis
 Problems in balneotherapy studies
 Mechanisms of action
 Efficacy of balneotherapy in OA
 Proposals for high quality studies
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                 Balneological Symposium
Knee OA and disability
   As an estimation, 10 % of people older than 55
    years have disabling knee symptoms
           ~25 % of them are severely disabled
   According to WHO report on global burden of
    disease, knee OA is likely to be one of the most
    important global cause of disability in the society
           Fourth most important in women and eighth most
            important in men
      Peat G, Mc Carney R, Croft P. Knee pain and osteoarthritis in older adults: a review of community
                                 burden and current use of health care. Ann Rheum Dis 2001;60:91–7
        Murray CJL, Lopez AD. The global burden of disease. Geneva: World Health Organization, 1997




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                                          Balneological Symposium
EULAR Recommendations 2003
Non-pharmacological                     Pharmacological                   Intraarticular            Surgical
Education                               Paracetamol                       Corticosteroid            Arthroscopy
Exercise                                NSAIDs
Insoles                                 Opioid analgesics                 Hyaluronic acid           Osteotomy
Orthotic devices                        Sex hormones
Weight Loss                             SYSADOA                           Tidal irrigation          Uni-compartmental
Laser                                   Psychotropic drugs                                          knee replacement
Spa                                     Topical NSAIDs
Telephone                               Topical capsaicin                                           Total knee
Vitamins / Minerals                                                                                 replacement
Pulsed EMF
Ultrasound
TENS
Acupuncture
Nutrients
Herbal remedies
Jordan K M, Arden N K, Doherty M et al. EULAR Recommendations 2003: an evidence based approach to the management of
knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic
Trials (ESCISIT) Ann Rheum Dis 2003;62:1145–1155.
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                                                   Balneological Symposium
Evidence : Categories
Category Evidence provided from:

     1A     Meta-analysis of RCTs

     1B     At least one RCT

     2A     At least one controlled study without randomization

     2B     At least one quasi-experimental study

            Descriptive studies such as comparative, correlation
      3
            or case-control studies
            Expert committee reports or opinions and/or clinical
      4
            experience of respected authorities
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                               Balneological Symposium
The strength of recommendation is
based on
 the level of evidence
 the effect size of the intervention
 the side effect profile
 the applicability of the evidence to the
  population of interest
 practicality of delivery
 economic considerations




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                   Balneological Symposium
      Strength of recommendation and
            the level of evidence
Category Directly based on

      A     category 1 evidence

            category 2 evidence
      B     OR
            extrapolated recommendation from category 1 evidence
            category 3 evidence
      C     OR
            extrapolated recommendation from category 1 or 2 evidence
            category 4 evidence
      D     OR
            extrapolated recommendation from category 2 or 3 evidence



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                             Balneological Symposium
Balneotherapy studies on knee
osteoarthritis
 Observational studies (OSs)
 Controlled Clinical Trials (CCTs)
 Randomized Controlled Clinical Trials
  (RCCTs)




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Observational studies
Selected References
1.   Dönmez A, Karagülle Z, Turan M: Balneotherapie mit Akratoterme
     bei Gonartrose. Zeitschrift Naturamed 1995;7-20-3
2.   Forestier R.Magnitude and duration of the effects of two spa
     therapy courses on knee and hip osteoarthritis: an open
     prospective study in 51 consecutive patients. Joint Bone Spine
     2000;67(4):296-304.
3.   Guillemin F, Virion JM, Escudier P et al. Effect on osteoarthritis of
     spa therapy at Bourbonne-les-Bains. Joint Bone Spine 2001 ; 68 :
     499-503
4.   Fioravanti A, Valenti M, Altobelli E et al. Clinical efficacy and cost-
     effectiveness evidence of spa therapy in osteoarthritis. The results
     of "Naiade" Italian Project. Panminerva Med.2003 Sep;45(3):211-
     7.
5.   Yılmaz B, Goktepe SA, Alaca R et al.Comparison of a generic and
     a disease specific quality of life scale to assess a comprehensive
     spa therapy program for knee osteoarthritis. Joint Bone Spine.
     2004 Nov;71(6):563-6.


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Results of Observational studies
 Pain  1,2,3,4
 Lequesne Knee Index score               1,2

 Walking distance  2
 Flexion range  2
 Quality of life  3,5
 Drug consumption  4




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                Balneological Symposium
Controlled Clinical Trials
Selected References
1.   Wigler I, Elkayam O, Paran D, Yaron M. Spa
     therapy for gonartrosis: prospective study.
     Rheumatol Int 1995;15:65-68.
2.   Flusser D, Abu-Shakra M, Friger M, et al.Therapy
     With Mud Compresses for Knee Osteoarthritis
     Comparison of Natural Mud Preparations With
     Mineral-Depleted Mud. J Clin Rheumatol
     2002;8:197–203
3.   Odabaşı E, Karagülle MZ, Karagülle M et al.
     Comparison of two traditional spa therapy
     regimens in patients with knee osteoarthritis; an
     exploratory study. Phys Med Rehab Kuror
     2002;12:337-341
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                        Balneological Symposium
Results of CCTs
      Wigler I, Elkayam O, Paran D, Yaron M. Spa
       therapy for gonartrosis: prospective study.
       Rheumatol Int 1995;15:65-68.
       Mineral water bath and mud pack combination is
       bettter than:
           Mineral water bath + rinsed mud pack
           Tap water bath + rinsed mud pack




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                              Balneological Symposium
Results of CCTs
      Flusser D, Abu-Shakra M, Friger M, et al.
       Therapy With Mud Compresses for Knee
       Osteoarthritis Comparison of Natural Mud
       Preparations With Mineral-Depleted Mud. J Clin
       Rheumatol 2002;8:197–203
       Mineral mud compresses are far effective than
       mineral-depleted mud compresses




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                          Balneological Symposium
Results of CCTs
      Odabaşı E, Karagülle MZ, Karagülle M et al.
       Comparison of two traditional spa therapy
       regimens in patients with knee osteoarthritis; an
       exploratory study. Phys Med Rehab Kuror
       2002;12:337-341
       Thermal water bath and peloid pack combination is
       better than twice-a-day thermal water bath
       application



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                         Balneological Symposium
Randomized Controlled Trials
Selected References I
      Balneotherapy group vs. Tap water group
1.   Szucs L, Ratko I, Lesko T et al. Double-blind trial on the
     effectiveness of the Puspokladany thermal water on
     arthrosis of the knee-joints. J R Soc Health 1989; 109:7–9
2.   Kovács I, Bender T. The therapeutic effects of Cserkeszölö
     thermal water in osteoarthritis of the knee: a double
     blind,controlled, follow-up study Rheumatol Int (2002) 21:
     218–221
3.   Balint G, Ádam A, Ratko I et al. Double blind study about
     the effectivity of the thermal mineral water of
     Nagybaracska in patient with knee joint
     osteoarthritis.2.Turkish-Hungarian Balneological Workshop,
     Pamukkale, Turkey 16-18 September 2004



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                           Balneological Symposium
Randomized Controlled Trials
Selected References II
Balneotherapy group vs. Outpatient medical care group
1.   Nguyen M , Revel M, Dougados M. Prolonged effects of 2 week therapy in
     a spa resort on lumbar spine, knee and hip osteoarthritis: Follow-up after
     5 months. A randomized controlled trial. British Journal of
     Rheumatology1997:36;77-81
2.   Tishler M Rosenberg O, Levy O et al. The effect of balneotherapy on
     osteoarthritis. Is an intermittent regimen effective? Eur J Intern Med 2004
     15(2): 93-96
3.   Uysal B, Dönmez A, Karagülle MZ et al. Wirksamkeit der Balneotherapie
     bei Patienten mit Gonarthrose im Kurort Gönen: eine randomisierte
     kontrollierte Studie. 5.Deutsch-Türkischer Kongress für Balneologie und
     Medizinische Klimatologie 27-28 Juni 2003

            Balneotherapy and control groups stayed at the
                              same area
1.   Sukenik S, Flusser D, Codish S. Balneotherapy at the Dead Sea
     area for knee osteoarthritis IMAJ 1999;1:83-85



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Systematic Review of RCTs
      Brosseau L, Macleay L, Robinson V. Efficiacy of
       balneotherapy for osteoarthritis f the knee; a
       systematic review. Physical Therapy Reviews.
       2002;7:209-222
       “ The results of this review suggest that
       balneotherapy can be effective on a short-term basis
       for measures of pain severity and function as well as
       for improved ROM and timed stair climbing.”



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                          Balneological Symposium
Problems in balneotherapy studies
   Type of treatment
           mud pack, sulphur bath, radon and carbon dioxide bath,
            Dead Sea bath salts, NaCl baths salts, and mineral
            water bath
   Treatment characteristics
           duration of study, frequency, number of treatments,
            duration of treatment, temperature
   Setting
           in the sea, hospital, home
   Constituents of the treatment agent
           Na, Ca, K, Cl…
   Individual who prepared bath
           patient, medical staff
     Brosseau L, Macleay L, Robınson V. Efficacy of balneotherapy for osteoarthritis of the
                 knee: a systematic review. Physical Therapy Reviews 2002; 7: 209–222

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                                     Balneological Symposium
Problems in balneotherapy studies
   Verhagen AP, de Vet HCW, de Bie RA et al. Balneotherapy
    for rheumatoid arthritis and osteoarthritis (Cochrane
    Review) In: The Cochrane Library, Issue 2, 2002. Oxford:
    Update Software.
    “… the positive findings reported in most trials. However the
    scientific evidence is weak
           the poor methodological quality,
           the absence of an adequate statistical analysis,
           the absence of most essential outcome measures (pain, quality of life)
    Therefore, the noted "positive findings" should be viewed with
    caution.”


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                                     Balneological Symposium
Mechanisms of action
   A combination of mechanical, thermal and chemical effects
           Heat
                Analgesia
                Anti inflammatory effect
                Muscle tonus decrease
                Peripheral vasodilatation
                ß-endorphin level
                Gate-control theory
           Buoyancy and hydrostatic pressure
                affect muscle tone,
                joint mobility
                pain intensity by decreasing joint load
           Mineral water chemical implications
   Environmental change
   Non-competitive atmosphere
   Absence of work duties

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                                      Balneological Symposium
Efficacy of balneotherapy in OA - I
TNF α  *                                          TNF α ***
IL-1  **                                          IL-1  ***
                                                   IGF-1  ***
CRP  *,**
Haptoglobulin  *,**
  *   Tütüncü ZN,Turan M, Barut A: Changes in TNF α plasma levels in
      osteoarthritic patients under balneotherapy with acratotermal water.
      Phys Rehab Kur Med 1996;6:80-82
  ** Turan M :Wirkungen der Balneotherapie auf die Akute-Phase-Reaction.
      IV.Deutsch-Türkischer Ärtzekongress Balneologie und Klimatologie,
      İzmir,Türkie 2000, Kongressbuch: 39-41
  *** Bellometti S, Giannini S, Sartori L, Crepaldi G: Cytokine levels in
      osteoarthrosis patients undergoing mud bath therapy. Int J Clin
      Pharmacol Res. 1997;17(4):149-53
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                               Balneological Symposium
Efficacy of balneotherapy in OA - II
   Beta endorphine 
    Kubota K, Kurabayashi H, Tamura K, et al (1992) A
    transient rise in plasma beta-endorphin after a traditional
    47 degrees C hot-spring bath in Kusatsu-spa, Japan. Life
    Sci. 51(24):1877-80.
   Beta endorphine (60%) , (30%) , (10%) 
    Yurtkuran M, Ulus H, Irdesel J (1993) The effect of
    balneotherapy on plasma beta endorphine level in patient
    with osteoarthritis. Phys Rehab Kur Med 3:130-132




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                           Balneological Symposium
Proposals for high quality studies
   Standardization
           application method, medium, environment. …
 Proper/Current outcome measures
 Appropriate sampling
           representative number of patients
 Intent-to-treat analysis
 Randomization
 Blinded studies
           single, double
   Placebo controlled studies
8/26/2011                    III. Hungarian – Turkish    23
                             Balneological Symposium
            THANK YOU



8/26/2011     III. Hungarian – Turkish   24
              Balneological Symposium

				
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