Evidence in Balneology – the current situation Christoph Gutenbrunner

Evidence in Balneology – the current situation

Christoph Gutenbrunner

Christoph Gutenbrunner, MD, PhD, Professor Department for Physical Medicine and RehabilitationInstitute for Balneology and Medical ClimatologyHanover Medical SchoolD-30625 Hannovergutenbrunner.christoph@mh-hannover.de

Evidence in Balneology – the current situation Christoph Gutenbrunner 17th European Congress on PRMVenice, May 23 -26, 2010

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

Introduction: aims and problems

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 of single 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

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

Balneology: the problem of definitions

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

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

Meta-analysis in Balneology

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

Proposal for definitions

Use of terms

Wälde & Guten-brunner 2009

(unpublished)

Systematic approach to classify studies in Balneology

Structure of Sciences: clinical sciences

Biosciences, Physiology

Society

Basic Sciences Applied Sciences Clinical Sciences

Social Sciences, Epidemiology

Rehabilitation system sciences

Biomedical Sciences,

Technology

Clinical Sciences

Stucki G, Grimby G: J Rehabil Med 2007; 39: 293-298, modified

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

Example 1: cardiovascular risk factor profile

Parameter p-value ( T1-T2) p-value ( T1-T3)

Overall effect p = 0,000*) p = 0,020*)

BMI [kg/m2] p = 0,000**) p = 0,021**)

Apolipoprotein B [mg/dl] p = 0,015**) p = 0,008**)

Fasting insulin [mg/dl] p = 0,035**) p = 0,034**)

Fibrinogen [mg/dl] p = 0,950**) p = 0,215**)

Mean arterial blood pressure [mmHg] p = 0,002**) p = 0,101**)

p<0,05

[mg/dl]

Change of Apolipo-protein B

control group (n=82)

study group (n=71)

T1-T2 T1-T3T1-T2 T1-T3

Effect size

Gutenbrunner et al.: Phys Med Rehab Kuror 2001; 12: 272-283

Example 1: cardiovascular risk factor profile

Example 3: Fibromyalgia

0 1 2 3 4 5 6 7 8 9 10 11 12 13

p<0,05p<0,05

Treatment period

p<0,001

FibromyalgiaImpactQuestionnaire (FIQ)

[Score]

Thermal pool baths (n=16)

No baths (n=13)(Dönmez et al. 2005)

Months after start of treatment

Example 4: Low Back Pain

0 1 2 3 4

p<0,01

Treatment period

p<0,01

VisualAnalogueScale(Pain)(Patients with cLBP)

[Score]

Mineral water baths (n=30)

Tap water baths (n=30)Balogh et al. 2005)

Months after start of treatment

Example 5: Psoriasis

Brockow T et al.; J Altern Compl Med 2007; 13: 725-732

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

Example 6: Anxiety disorder

Dubois et al.: www,afreth.fr

RCT with 237 patients with

anxiety

◦ cure thermale: n=120

◦ anxiolytic drug

(Paroxetine): n=117

follow-up: 24 months(Dubois et al. 2009; www. afreth.fr)

Example 6: Anxiety disorder

Meta-analyses and systematic reviews

Meta-analysis

Pittler et al., Rheumatol 2006 published online

Pool-Exercise in Fibromyalgia

Gowans SE, deHueck A: Pool exercise for individuals with fibromyalgia. Curr Opin Rheumatol. 2007 Mar; 19(2): 168-73Purpose 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. […]

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 evaluatedFalagas et al., Int J Clin Pract, 2009; 63 (7): 1068–1084

Results: ◦ in 17 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

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

Thank you for your attention

Christoph Gutenbrunner, MD, PhD, Professor Department for Physical Medicine and RehabilitationInstitute for Balneology and Medical ClimatologyHanover Medical SchoolD-30625 Hannovergutenbrunner.christoph@mh-hannover.de

Evidence in Balneology – the current situation Christoph Gutenbrunner

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