Evidence in Balneology – the current situation Christoph Gutenbrunner

1. Evidence in Balneology – the current situationChristophGutenbrunner Christoph Gutenbrunner, MD, PhD, Professor Department for Physical Medicine and Rehabilitation Institute for Balneology and Medical Climatology Hanover Medical School D-30625 Hannover gutenbrunner.christoph@mh-hannover.de

2. Overview  Introduction: aims and problems  Balneology – the problem of definitions  Systematic approach to classify studies in Balneology  Examples for randomized and non-randomized controlled studies in Balneology and Health Resort Medicine◦ cardiovascular risk factors ◦muskuloskeletal diseases ◦ psoriasis  Meta-analyses any systematic reviews Conclusion

3. Introduction: aims and problems

4. Aims  look for published data on the evidence of balneotherapy in health conditions including both: ◦ serial intervention of single treatment modality◦ complex health resort treatments excluding:◦ effects ofsingle interventions on symptoms look for meta-analyses on these effects but not: looking for evidence of efficacy of involvement of PRM specialists into health resort treatments

5. Problems  To show the efficacy of a specialty in general (e.g. PRM) or a field or sub-field (e.g. Balneology) may be an illusion◦ are surgeons efficient? ◦ is drug treatment efficient? Clinical evidence can only be proven of ◦ one agent ◦ one way of application and◦ one health condition Most therapeutic agents in balneology cannot be proven in double-blind studies Balneotherapy mostly is used in comprehensive concepts Internationally agreed definitions in Balneology are still lacking

6. Balneology: the problem of definitions

7. Balneotherapy: modalities  Substances, e.g.:◦Mineral waters (Na, Ca, Mg, Cl, SO4, H2S, CO2, trace elements)◦gases (CO2, H2S, Rn) ◦peloids (mud, peat, fango and others) Modes of application, e.g.: ◦ bathing ◦drinking◦inhalation Dosage, e.g.: ◦ single use◦series◦combination

8. Lack of uniform definitions  The term “Hydrotherapy” is not defined consistently all over the world, e.g. ◦UK: exercise in pools ◦Germany: treatments according to Kneipp and related applications of water Related terms are: ◦balneotherapy, crénotherapy◦ physiotherapy ◦ naturopathy The lack of consistent definition is a significant barrier for research especially for meta-analyses in the field of hydrotherapy and balneotherapy

9. Meta-analysis in Balneology

10. Possible Solution  To better understand the problem on terms:◦differentiate between object and term◦Accept scientific language (English) and translate to national languages Agree on definitions and English terms: ◦ a proposal will be published soon◦use uniform keywords along these definitions Reflect the question asked: ◦ evidence of efficacy of a specific modality (therapeutic substance and mode of application): clinical trials, metananlyses◦ or: efficacy of balneology in general: health care research

11. Proposal for definitions

12. Use of terms Wälde & Guten-brunner 2009 (unpublished)

13. Systematic approach to classify studies in Balneology

14. Structure of Sciences: clinical sciences Society Social Sciences, Epidemiology Rehabilitation system sciences Clinical Sciences Biomedical Sciences, Technology Biosciences, Physiology Stucki G, Grimby G: J Rehabil Med 2007; 39: 293-298, modified Cell Basic Sciences Applied Sciences Clinical Sciences

15. Examples for randomized and non-randomized controlled studies in Balneology and Health Resort Medicine

16. Example 1: cardiovascular risk factor profile

17. Example 1: cardiovascular risk factor profile Gutenbrunner et al.: Phys Med Rehab Kuror 2001; 12: 272-283

18. Example 3: Fibromyalgia

19. Example 4: Low Back Pain

20. Example 5: Psoriasis Methods: ◦160 patients with PASI of >10 (4 German spa centers) ◦ randomly allocated to UVB + sodium chloride bath (25% - 27%) or UVB only 3 a week until remission (PASI < 5) or for a maximum of 6 weeks ◦ outcome definition: reduction of PASI >= 50% Results: ◦Participants allocated to HC-SSW-UVB attained to a statistically significantly higher rate of PASI-50 than patients allocated to UVB only (86% vs. 54%; p < 0.001)◦number needed to treat: 3.1 (95% confidence interval, 2.1-6.0)◦Postintervention analysis: no clear persisting effect. Conclusion: The study indicates that HC-SSW-UVB are superior to routine UVB at the end of a 6-week treatment course Brockow T et al.; J Altern ComplMed 2007; 13: 725-732

21. Example 6: Anxiety disorder Dubois et al.: www,afreth.fr

22. Example 6: Anxiety disorder  RCT with 237 patients with anxiety ◦ cure thermale: n=120 ◦ anxiolyticdrug (Paroxetine): n=117  follow-up: 24 months (Dubois et al. 2009; www. afreth.fr)

23. Meta-analyses and systematic reviews

24. Meta-analysis Pittler et al., Rheumatol 2006 published online

25. Pool-Exercise in Fibromyalgia Gowans SE, deHueck A: Pool exercise for individuals with fibromyalgia. Curr Opin Rheumatol. 2007 Mar; 19(2): 168-73 Purpose of the Review: […] Recently, there have been a number of randomized controlled trials that evaluate the benefits of pool exercise for fibromyalgia. This review will integrate the results of eight pool exercise studies that have been published in the last 7 years. Recent Findings: Pool exercise has been evaluated against sedentary control groups, land-based exercise and immersion in a warm, mineralized pool. Pool exercise has been shown to be as effective as land-based exercise and may have greater benefits with respect to mood and sleep duration. Based on follow-up studies, exercise-induced improvements in physical function, pain and mood may persist for up to 2 years. […] Summary: Pool exercise can be an effective intervention for individuals with fibromyalgia. […]

26. Review: Therapeutic effect of Balneology

27. Review: Therapeutic effect of Balneology  Study design: Systematic review  Search: ◦ PubMed Scopus & Cochrane library (1950–2006),◦RCTs ◦clinical effects of Balneotherapy (both as a solitary approach and in the context of spa)◦various diseases Results: ◦203 potentially relevant articles; 29 RCTs evaluated: - N=22 (75.8%) rheumatological diseases (8 osteoarthritis, 6 fibromyalgia, 4 ankylosing spondylitis, 4 rheumatoid arthritis) - N=3 (10.3%) other musculoskeletal diseases (cLBP)◦1,720 patients with musculoskeletal diseases were evaluated Falagas et al., Int J Clin Pract, 2009; 63 (7): 1068–1084

28. Review: Therapeutic effect of Balneology  Results: ◦in17 studies (68%)Balneotherapy did result in more pain improvement in patients with rheumatological diseases and chronic low back pain as compared to the controls ◦in 8 studies, pain was improved in the Balneotherapy treatment arm, but this improvement was statistically not different than that of the Controls ◦the beneficial effect lasted for different periods of time: 10 days (1) 2 weeks (1), 3 weeks (1), 12 weeks (2), 3 months (11), 16–20 weeks (1), 24 weeks (3), 6 months (3) 40 weeks (1), 1 year (1) Conclusion: The available data suggest that Balneotherapy may be truly associated with improvement in several rheumatological diseases. However, existing research is not sufficiently strong to draw firm conclusions. Falagas et al., Int J Clin Pract, 2009; 63 (7): 1068–1084

29. Conclusion

30. Conclusion  To prove efficacy of Balneology as a whole is a question of health care research (not of clinical trials)  Studies can prove efficacy of one modality or concept in a specific health condition only  Internationally agreed definitions in Balneology are needed and should be used Some clinical trials exist showing efficacy, e.g.◦ cardiovascular risk factor profile ◦muscolo-skeletal diseases ◦psoriasis ◦psyciatric disorders  Some meta-analyses and systematic reviews are available now  More randomized controlled studies are needed

31. Thank you for your attention Christoph Gutenbrunner, MD, PhD, Professor Department for Physical Medicine and Rehabilitation Institute for Balneology and Medical Climatology Hanover Medical School D-30625 Hannover gutenbrunner.christoph@mh-hannover.de