Medical research in Balkan Spas; a way ahead for scientific progress Müfit Zeki Karagülle MD, PhD Istanbul, Turkey

Balneotherapy/Spa therapy in Balkan countries one of the oldest forms of therapy “traditional” still popular and widely used has been considered mainstream taught in medical schools included in health care systems reimbursed by health insurance systems

Balneotherapy/Spa therapy often argued whether it is supported by good evidence

Effectiveness relates to whether a (spa) treatment works in practice

“Medical” Clinical Research Design Ratings Research that is descriptive, anecdotal or authoritative; Research without intervention, with results that may be used in future studies; Research not involving a control group or randomization but with an evaluation; Research involving a systematic study with control groups but without randomisation; Research involving a systematic study with a randomized control group.

Tradition/Experience hierarchy of evidence

RCT (Randomized Controlled Trial); “Golden Standart” The highest quality study to check/test a ‘spa treatment or a spa therapy package'

RCT (Randomized Controlled Trial) Flowchart of four phases (enrollment, intervention allocation, follow-up, and data analysis) of a parallel randomized trial of two groups, modified from the CONSORT (Consolidated Standards of Reporting Trials) 2010 Statement

A recent example of an RCT from Balkans This prospective, randomized, observer-blind (controlled) study was carried out at PRM and Balneology Institute „Mlječanica“,

Meta- analysis

Istanbul University, Istanbul Medical Faculty, Department of Medical Ecology and Hydroclimatology

Searching methodology The databases searched: PubMed, Web of Science, Scophus and ClincalTrials.gov, USA. search terms ‘balneotherapy’, ‘balneology’, ‘spa therapy’, ‘spa treatment’, ‘pain’ ‘low back pain’ and ‘RCT’. from July 2005 until 31 December

Characeteristics of reviewed RCTs Author, (year) treatment, country Journal Jadad quality score Journal impact factor Balogh et al. (2005) Balneotherapy, Hungary ForschendeKomplementärmedizin/Research in Complementary Medicine 11,279 Leibetseder et al. (2007) Spa therapy, Austria ForschendeKomplementärmedizin/Research in Complementary Medicine 01,279 Demirel et al. (2008) Spa therapy, Turkey Journal of Back and Musculoskeletal Rehabilitation20,613 Kulisch et al. (2009) Spa therapy, Hungary Journal of Rehabilitation Medicine52,134 Doğan et al. (2011) Spa therapy, Turkey Southern Medical Journal10,915 Kesiktaş et al. (2012) Spa therapy, Turkey Rheumatology International32,214 Tefner et al. (2012) Balneotherapy, Hungary Rheumatology International32,214 Gremeaux et al. (2013) Spa therapy, France Joint Bone Spine22,748

Categories of evidence Ann Rheum Dis 2003;62; adapted from the classification of the United States Agency for Health Care Policy and Research. CategoryEvidence from: 1AMeta-analysis and systematic reviews of RCTs 1BAt least one RCT 2AAt least one controlled study without randomisation 2BAt least one quasi-experimental study 3 Descriptive studies, such as comparative, correlation or case-control studies 4 Expert committee reports or opinions and/or clinical experience of respected

Treatment and rehabilitation of rheumatic diseases in Balkan spas DiseaseEvidence Osteoarthritis1A Fibromyalgia1A Chronic low back pain 1A Ankylosing Spondylitis 1B Rheumatoid arthritis 1B

Skin Respiratory Circulatory Digestive Nervous system Cancer nutritional and metabolic disorders mental disorders diseases of the ear endocrine diseases female genital diseases nutritional deficiencies

Hydrotherapy and Physical Therapy Hospital of Ministry of Health, Yoncalı, Turkey

BalkanSpa Institute Manifesto in Belgrade February 2015

BalkanSpa Treatment & Medical Research Center BalkanSpa Health & Wellness Summit BalkanSpa Education & Training Academy BalkanSpa Quality & Promotion Awards BalkanSpa Institute

BalkanSpa Treatment & Medical Research Center Clinical and Experimental Medical Research in Balkan spas Prevention, Treatment and Rehabilitation concepts and programs in Balkan Spas Natural Healing Factors/Assets in Balkans Specific / Authentic Balkan Spa Treatments Classification/Standards and good clinical paractice in BalkanSpas Team leader; Prof. Dr. Müfit Zeki KARAGÜLLE (Turkey)

BalkanSpa Treatment & Medical Research Center Advisory Board Member Centers Research Grants

BalkanSpa Treatment & Medical Research Center Nominating BalkanSpa Treatment & Medical Research Centers in each Balkan Country Networking and collaboration with Balkan Balneological Resorts, Institutes, Hospitals, Establishments and Organizations

BalkanSpa Treatment & Medical Research Center Asistance to plan, design and conduct basic and clinical medical studies and trials Asistance to present, report and publish the research results Assistance to review and analyze the already exisiting evidence

BalkanSpa Treatment & Medical Research Center Organizing meetings to share and discuss the research methodology and issues and topics

High-quality, RCTs (randomized, controlled trials) High-quality, RCTs (randomized, controlled trials) Clinical trials with biological markers’ measurements Clinical trials with biological markers’ measurements Balneological studies on cell cultures Balneological studies on cell cultures Experimental studies with animal models Experimental studies with animal models