The Therapeutic Effect of Balneotherapy: Evaluation of the Evidence from Randomised Controlled Trials

M. E. Falagas; E. Zarkadoulia; P. I. Rafailidis

Disclosures

Int J Clin Pract. 2009;63(7):1068-1084. 

In This Article

Methods

We searched the PubMed, Scopus and Cochrane library (the period examined was 1950-2006) for RCTs, examining the effect of balneotherapy (both as a solitary approach and in the context of spa) on various diseases. The following search terms were used: 'balneotherapy', 'spa', 'skin diseases', 'disease', 'disorders', 'respiratory', 'cardiovascular', 'rheumatic', 'gynaecology', 'allergic', 'gastrointestinal' in various combinations. Our review, from the methodological standpoint, did not seek to look into a specific disease, but to retrieve the data from the literature regarding the effect of balneotherapy (if any) in human disease in general.

Study Selection Criteria

Included studies were RCTs, comparing the effectiveness of balneotherapy vs. therapeutic modalities, not comprising balneotherapy for the treatment of rheumatic, cardiovascular, gynaecological, allergic, gastrointestinal. RCTs written in other languages than English, German, Italian and French were excluded from this systematic review. We excluded studies regarding the effect of hydrotherapy (generally employing tap water). We also excluded studies regarding thalassotherapy only when the temperature was below the defined for balneotherapy (balneotherapy was not a separate treatment arm in these studies) or studies examining the effect of balneotherapy when applied once a week or examining the effect of balneotherapy in patients with ≥ 2 concurrent diagnoses, studies reporting on the use of thermal water with a temperature lower than 34 °C or interim analyses of the same research group (not included to avoid reporting of duplicate data) or a dropout rate of > 15% of the patients in one of the comparator arms or application of one of the comparators for a period of time with over 1 month difference or the conduct of the RCT in over two different geographical areas while concurrently they recruited a trial group with < 50 per site (25 patients and 25 controls per site) or technical errors in allocation.

For the enrolment of patients in the trials considered for inclusion in this systematic review, a diagnosis of the disease should be based primarily on established clinical criteria, whether or not further supported by radiological or other laboratory criteria.

Data Extraction

Two reviewers (PIR and EZ) independently evaluated all retrieved articles, on the basis of title and abstract, for eligibility and for inclusion in the systematic review. We also reviewed the references of the relevant articles in our attempt to identify additional publications of potential interest. Full-text papers of possibly relevant articles were further reviewed. Selected articles for inclusion in this review are presented in Table 1, on the basis of first author and year of the relevant publication. Data referring to the characteristics of each trial were extracted, including geographical area (country) and thermal water composition, especially regarding the temperature and electrolyte composition of the thermal water, type of study, number of randomised patients and their category of disease (Table 1), treatment arms and the time of the assessments, the methods employed for the evaluation of the different outcomes and findings of the study regarding the outcomes (Table 2). Any differences in the extracted data between the two reviewers were resolved in the meetings of all authors.

Outcomes

The primary comparison studied in this review, included balneotherapy vs. other therapeutic modalities in the treatment of various diseases. The primary effectiveness outcome of this review was clinical success, comprising substantial improvement of symptoms by clinical criteria and assessment tools related to the specific disease, of the patients. The time of determination of the primary effectiveness outcome was the time of the assessment of the primary clinical efficacy endpoint, which was used in each trial.

Validity Assessment

A review of the quality of each RCT included in our meta-analysis was performed by using the Oxford Quality Scale (OQS), which examines whether there is randomisation, blinding and information on withdrawals from the study, and evaluates the appropriateness of randomisation and blinding, if present.[6] One point was awarded for the presence of each of the former three criteria, whereas the latter two criteria could be awarded the values of -1 (inappropriate), 0 (no data) and +1 (appropriate). Thus, the maximum score for a study was five, and a score higher than two points denotes a good quality RCT according to this methodology. The reviewers calculated the score of each study independently. In addition, we proceeded to use the Oxford Pain Validity Scale (OPVS),[7] which takes into account blinding (score range 0-6), size of the group trials (score range 0-3), pre hoc desirable outcomes (score range 0-2), baseline level of pain/outcomes and internal sensitivity (score range 0-1) and data analysis consisting of definitions of outcomes, data presentation, statistical testing and handling of dropouts (score range 0-4) (Table 1).

Data Analysis and Statistical Methods

Statistical analyses were not performed, as the studies were assessed as clinically heterogeneous. The outcomes examined in these studies were variable as would be expected when assessing the effect of balneotherapy in various diseases, and outcomes examined in at least five of the RCTs were assessed.

Comments

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