Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 2005; 10: 271–4
One of the major public health concerns is chronic low back pain.1–5 In the UK, for instance, low back pain is the largest single cause of absence from work and responsible for 12.5% of all sick days.6 Among patients who suffer from chronic low back pain complementary therapies are popular treatment options.7 Two such treatment options are balneotherapy and spa therapy, which are, at least in part, reimbursed by many European health insurance systems. Balneotherapy is defined as baths using thermal mineral waters at temperatures of at least 20 °C and a mineral content of at least 1 g per litre of water from natural springs. Spa therapy additionally employs physiotherapeutic interventions at a spa resort.8,9 In some countries, such as the UK and the USA, these treatments are viewed as complementary. Elsewhere, they have traditionally been considered mainstream, e.g. Germany, Italy and Hungary. Balneo- and spa therapies are associated with considerable costs and it is therefore reasonable to question if they are supported by good evidence. The objective of this assessment was to evaluate the evidence of the effectiveness of spa therapy for treating chronic low back pain.
The databases Medline, Embase, Cochrane Central and Amed were searched from their respective inceptions until April 2005. Hand-searches included bibliographies of all retrieved articles. There were no restrictions regarding the language of publication. Studies were included if they were described as randomised trials testing spa therapy for treating patients with chronic low back pain. Trials reported in duplicate were excluded. Methodological quality was evaluated using the system developed by Jadad et al.10 The primary endpoint was defined as the mean change of pain measured on the 100 mm VAS compared with baseline, which was used to assess intergroup differences. Standard meta-analysis software (RevMan 4.2.8, Update Software Ltd, Oxford, UK) was used to calculate means and 95% CI. Summary estimates of the treatment effect were calculated using a random effects model and the chi-square test for heterogeneity was performed.
After assessing their abstracts, 8 potentially relevant papers were retrieved for further evaluation.11–18 No unpublished studies were identified. Five publications did not meet the inclusion criteria and were excluded.11–15 Three other trials16–18 could be included and provided data that were suitable for statistical pooling (Table 1).
Table 1. RCTs of spa therapy for chronic low back pain
| First author [reference], year | Design, quality score | Intervention | Water mineralisation, constituents | Duration | Control | n randomised/n analysed | Main outcome measures | Intergroup differences | Concomitant treatment |
|---|---|---|---|---|---|---|---|---|---|
| Spa therapy | |||||||||
| Guillemin [16] 1994 | Two parallel groups, 2 | 15-min high-pressure water massage at 36° C water temperature | < 500 mg/l, mainly sulphate, sodium | Daily for 6 days, weekly for 3 weeks | Waiting list | 104/102 | 100 mm pain VAS | P < 0.0001 for all main outcome measures | None |
| Series of 3-min water massages with varying pressures and temperatures (31 to 36° C) | Schober score | ||||||||
| Waddel index | |||||||||
| Constant [17] 1995 | Two parallel groups, 3 | 10-min bath at 36° C with underwater flow | 8073 mg/l, mainly bicarbonate, sodium | Daily for 6 days, weekly for 3 weeks | Waiting list | 126/121 | 100 mm pain VAS | P < 0.0001 and P = 0.38, respectively | Routine drug treatment |
| 20-min local mud application at 45° C | Schober score | ||||||||
| 2.5-min high-pressure shower at 36° C with a massage device and regulated pulse flow | |||||||||
| Constant [18] 1998 | Two parallel groups, 2 | 10-min bath at 36° C with underwater flow | 510 mg/l | One and two daily for 6 days, weekly for 3 weeks | Waiting list | 224/219 | 100 mm pain VAS | P < 0.0001, P = 0.22 and P < 0.05, respectively | Routine drug treatment |
| 15-min local mud application at 45° C | Three every other day for 3 weeks | Schober score | |||||||
| 20-min massage under flowing water at 36° C | Quality of life |
Quality score: maximum 5
Spa therapy was tested in three RCTs. In all studies pain was assessed using 100 mm VAS. The meta-analysis suggests significant differences in favour of spa therapy compared with waiting list control groups (weighted mean difference: −26.6, 95% CI −20.4 to −32.8, n = 442). Results for the Schober index suggest no significant intergroup differences (weighted mean difference: 3.6 mm, 95% CI −2.7 to 9.8, n = 442). In all three trials there was no mention of adverse events.
The meta-analysis suggests a significant differential effect in favour of spa therapy for reducing chronic low back pain. However, the volume of the evidence is small and included only three RCTs assessing 454 patients.
This paucity of evidence from RCTs is in stark contrast to the popularity among patient populations and to the expenditure by health insurances on spa therapeutic interventions. The findings of our meta-analysis support data from previous systematic reviews, which identified the need for further studies some 7 years ago.19 Methodological difficulties in assessing these complex interventions, particularly the design of an adequate sham- or placebo-control group and the expenses involved, may be some of the reasons for the small number of studies carried out so far. Nonetheless, good quality trials are possible, as indicated by the Jadad scores (Table 1) and it is hoped that our findings will encourage further systematic research. Future studies should be randomised and careful attention should be paid to the concealment of treatment allocation, as was done in all studies on spa therapy. Adequate sample sizes should be assessed, ideally administering similar regimens under similar conditions. The design of the control group requires careful attention to minimise bias, particularly when subjective outcome measures are assessed, such as pain. In contrast to other opinions,20 we believe that balneo- and spa therapies are examples of complex interventions where delineating specific from non-specific effects is possible and required.
Trials are also needed to investigate the more fundamental question of whether spa treatments administered at a spa resort are more beneficial than the same treatments administered in a non-residential setting at home. These differences are at the heart of spa therapy and are associated with considerable costs. At present, there is no convincing evidence that spa therapy with treatments administered at a spa resort is more effective than the same treatment regimen administered at home.19 Thus, a situation exists whereby some encouraging evidence suggests that spa therapy is effective for low back pain, while it is unclear whether these treatments have to be administered at a spa resort, as an integral part of spa therapy or can be administered at home with the same therapeutic effect.
In some countries, such as Germany, the spa sector has suffered through political decisions to cut back on reimbursing such treatments (‘Kur’) through national health insurance systems. This move was motivated by financial considerations but the paucity of compelling data on specific effectiveness and cost-effectiveness also played a crucial role. Considering the potential role of spa therapy as evidenced by this meta-analysis it is disappointing that more clinical trials have not been initiated. Table 1 shows that since 1998 no RCTs of spa therapy for low back pain have been carried out. As always, the burden of demonstrating the value of a medical intervention lies on the shoulders of those who claim that it works.
In conclusion, these findings show that there is some encouraging evidence to suggest that spa therapy is effective for treating chronic low back pain. However, these data are by no means compelling and rigorous large-scale trials need to be carried out to verify these findings.
