Medical Hydrology and Balneology: Environmental Aspects

Methodological comments on balneotherapy
actual medical benefit assessment
Roques CF (1)
(1) AFRETH Scientific Committee President. Paris. France
cf.roques@gmail.com
Introduction and Objectives
Balneotherapy is a complex, non-pharmacological intervention, whose actual
medical benefit has to be established by the Evidence Based Medicine’s processes.
EBM needs conclusive clinical trials: well designed clinical trials statistically
significant for the main endpoint.
Materials and Methods
A “clinical trial” must have a clinical main endpoint (= directly perceptible by
the patient). The number of patients to enroll (usually a difficult issue) has to be
previously calculated according to the main endpoint modification score. An Intention
To Treat statistical analysis will be performed using appropriate statistical tests.
The criteria of importance are crucial to establish the relevance of the main endpoint
modifications. Criteria of importance as Minimum Clinically Important Improvement,
Minimum Detectable Change, Responder (or non responder) scores,
Patient Acceptable State, critical values etc. have to be used whenever existing.
Results
Randomisation, well appropriated for drugs assessment, can be a controversial
issue for complex interventions assessment. Peculiar randomisation designs can be
useful (Zelen, cluster randomisation, …), preference trials but also alternative
designs to randomization have to be discussed such as observational studies of
cohorts matched using propensity scores. Blind assessment of the patients is also an
important issue. The duration of the follow-up must be appropriate to the condition
treated but also acceptable for the patient. The different interventions (treatment
tested and control treatment) have to be defined and standardised. The patients’
follow-up needs to give information about lost patients, changes of study arm,
patients’ withdrawals, … . The adverse events have to be reported and described in
the paper. Whenever possible and necessary, the trial would be a multicentre one,
testing the different waters used for the investigated condition. A preliminary feasibility
study can be useful to approach the effect size of the treatment ; its usefulness
to predict capacity to enroll the patients is more controversial.
Conclusions
The conformity to ethical national regulations has to be validated by an ethic
committee; the trial will be registered before the beginning of the patients’ inclu-
Balnea
2012, núm. 6, 81-82
81
ISBN: 978-84-669-1887-0
978-84-669-3482-4