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

Results

We identified initially 203 potentially relevant articles and out of it 174 articles were excluded (Figure 1). Finally, 29 RCTs regarding balneotherapy in various medical fields were analysed (Addendum). In Table 1 and Table 2 , we present the characteristics and outcomes, respectively, of the selected and reviewed trials. The majority of the RCTs [25 out of 29 (89.6%)] pertained to the use of balneotherapy in rheumatological and other musculoskeletal diseases: eight in osteoarthritis, six in fibromyalgia, four in ankylosing spondylitis, four of them regarding in rheumatoid arthritis and three regarding chronic low back pain. A total of 1720 patients were evaluated in these studies. Four studies were also found from other medical fields, specifically, three in psoriasis and one in Parkinson's disease. Nine of the 29 RCTs were performed in Israel (Dead Sea area), seven in Turkey, five in Hungary, four in France, one in Italy, one in the UK, one in Germany and one in Austria/Netherlands.

Figure 1.

Flow diagram of the reviewed articles.

Balneotherapy did result in more clinical improvement (as assessed by various indices) in patients with rheumatological/musculoskeletal diseases in comparison to the control group in the 25 RCTs examined ( Table 1 and Table 2 ). This positive effect did not always refer to the same outcome measurement characteristic and lasted for different periods of time (follow-up periods were different in the RCTs). Pain was the most common outcome examined in these 25 RCTs investigating the role of balneotherapy in rheumatological/musculoskeletal diseases. Pain was improved (with statistical difference) in the treatment arm of balneotherapy more than in the comparator treatment arm in 17 (68%) of the 25 RCTs ( Table 1 and Table 2 ).[19,20,21,22,23,26,27,30,31,33,34,35,37,39,40,41,46] In another eight studies,[24,25,29,38,42,43,44,45] pain was improved in the balneotherapy treatment arm, but this improvement was statistically not different than that of the comparator treatment arm(s). Specifically, the beneficial effect lasted for 10 days in one study, 2 weeks in one study, 3 weeks in one study, 12 weeks in two studies, 3 months in 11 studies, 16-20 weeks in one study, 24 weeks in three studies, 6 months in three studies, 40 weeks in one study and 1 year in one study.

Morning stiffness was among the outcomes in eight RCTs:[21,27,29,35,37,42,44,45] in one RCT, statistically significant improvement was present at the end of treatment;[27] in seven of them, improvement was noted[21,29,35,37,42,44,45] in all comparator arms.

The number of tender points and the Fibromyalgia Impact Questionnaire (FIQ) were outcomes examined in common in five[20,26,29,33,35] of the six RCTs investigating the role of balneotherapy in fibromyalgia. In three of five of these RCTs,[20,26,33] more improvement (statistically significant) was noted regarding the number of tender points and the FIQ in the balneotherapy treatment arm than in the comparator. This improvement lasted from 3 weeks[20] up to 6 months.[26,33] In the remaining two studies,[29,33] improvement was noted in both comparators.

Analgesic consumption was the outcome in five RCTs;[19,24,40,41,43] in two of them[19,40] analgesic consumption was decreased in the balneotherapy arm in comparison to the comparator, in the other two studies[41,43] improvement occurred in both comparators, while in one study no improvement was noted in either of the comparators.[24]

The Arthritis Impact Measurement Scale was the outcome in two RCTs[19,37] and was improved more (statistically significant) in the balneotherapy treatment arm. Quality of Life was assessed in four RCTs[25,31,32,34] and found to be improved with statistical difference in all of them at the last follow up.

A sum of 25 of the 29 RCTs (86.2%) did refer to the same therapeutic area (identical location) for the comparator groups. In four of the RCTs as shown in Table 1 , there was difference in the location of the therapeutic intervention. Regarding the three RCTs examining the role of balneotherapy in psoriasis, no statistical differences could be observed regarding the skin lesions.

We proceeded to a subset analysis of the studies with the highest methodological scores on the OQS and the OPVS. Nine of the studies had an OQS score of ≥ 4[22,23,24,30,36,37,39,41,46] and in these studies patient blinding was performed by the use of water with same physical characteristics (i.e. temperature, colour and odour) in the comparator arms. The same plus another four studies[18,28,31,40] had an OPVS score of ≥ 12. In total, 10 of the 13 studies that scored higher on the OQS and OPVS referred to rheumatological/musculoskeletal disease while three to psoriasis. An analysis of these 13 studies which scored higher showed: the six studies regarding osteoarthritis showed at least one favourable outcome significantly different over the control group [pain using a Visual Analogue Scale (pVAS) at 2 weeks, Nottingham Health Profile pain score and tenderness score at 12 weeks][22], Western Ontario and McMaster activity, pain and total scores at 3 months,[23] pVAS at 3 months,[30] non-steroidal anti-inflammatory drugs and analgesic consumption during 24 weeks, improvement of pain and quality of life at 24 weeks,[40] night pain at 20 weeks and severity of knee osteoarthritis at 16 weeks,[41] pain at movement, pressure sensitivity at end of treatment (~3 weeks).[46] One study regarding rheumatoid arthritis[37] showed significantly improved pain intensity and Arthritis Impact Measurement Scale over the control group at 6 months, and one study regarding ankylosing spondylitis[31] showed a significantly improved Pooled Index of Change (a combined measure of primary outcomes) over the control group at 40 weeks. Two studies regarding low back pain[24,39] showed a favourable outcome (one of them[39] over the control group at 3 months in physical health and mental health, anxiety and depression, pain duration, pain intensity and functional disability). Three of these studies reported on psoriasis, two[28,36] showed a favourable outcome (non-significant difference over the control) and one showed no effect.[18]

Five of the 29 studies made a distinction between primary and secondary outcomes.[22,26,28,31,32] Three among them achieved a higher OQS and OPVS; two of these studies examining patients with osteoarthritis and rheumatoid arthritis[22,31] showed a significant difference of a primary outcome over the control group.

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