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

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

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

Abstract and Background

Abstract

Study Design: Systematic review.
Summary of Background Data: There is widespread popular belief that balneotherapy is effective in the treatment of various ailments.
Methods: We searched PubMed (1950-2006), Scopus and Cochrane library for randomised controlled trials (RCTs), examining the clinical effect of balneotherapy (both as a solitary approach and in the context of spa) on various diseases.
Results: A total of 203 potentially relevant articles were identified. In all, 29 RCTs were further evaluated; 22 of them (75.8%) investigated the use of balneotherapy in rheumatological diseases and eight osteoarthritis, six fibromyalgia, four ankylosing spondylitis, four rheumatoid arthritis and three RCTs (10.3%) in other musculoskeletal system diseases (chronic low back pain). In addition, three relevant studies focused on psoriasis and one on Parkinson's disease. A total of 1720 patients with rheumatological and other musculoskeletal diseases were evaluated in these studies. Balneotherapy did result in more pain improvement (statistically different) in patients with rheumatological diseases and chronic low back pain in comparison to the control group in 17 (68%) of the 25 RCTs examined. In the remaining eight studies, pain was improved in the balneotherapy treatment arm, but this improvement was statistically not different than that of the comparator treatment arm(s). This beneficial effect lasted for different periods of time: 10 days in one study, 2 weeks in one study, 3 weeks in one study, 12 weeks in 2 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.
Conclusion: The available data suggest that balneotherapy may be truly associated with improvement in several rheumatological diseases. However, existing research is not sufficiently strong to draw firm conclusions.

Background

There is widespread popular belief that balneotherapy is effective in the treatment of various diseases. Balneotherapy is defined as the use of baths containing thermal mineral waters from natural springs at a temperature of at least 20 °C and with a mineral content of at least 1 g/l.^[1] More so, it is more common that the temperature of the thermal water is approximately 34°. Balneotherapy has been used not only in the ancient years in the treatment of various illnesses but also in modern times.

Under the broad term balneotherapy (in contrast to the strict definition given above), various treatment methods are included: Dead Sea salt or mineral baths, sulphur baths, radon-carbon dioxide baths.^[2,3] Balneotherapy is either provided as the solitary component of the therapeutic approach or in the context of spa therapy. Spa therapy additionally to balneotherapy employs various modalities such as physiotherapy, and even the change in environment and lifestyle per se may contribute to the changes seen in patient outcome measurements, i.e. the therapeutic result may not be attributed to the balneotherapy alone. Thus, while some researchers have regarded balneotherapy and spas as more or less interchangeable terms,^[4] others disagree.^[5] More so one has to acknowledge that the composition of the mineral water differs in its content in cations and anions, and thus assessing which is the specific therapeutic component is difficult. We sought to review the existing evidence regarding randomised controlled trials (RCTs), examining the clinical effects of balneotherapy.

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Abstract and Background
Methods
Results
Discussion
References

Table 1. Characteristics of Relevant Studies
References	Geographical area and thermal water composition	Type of study	Oxford Quality Scale	Oxford Pain Validity Scale	Study population	Category of disease
Leaute-Labreze et al.^[18]	A*: Salies de Béarn, France TW: Naturally saline thermal water (250 g/l of Na⁺) with a high Mg²⁺ content (980 mg/l)	Randomised controlled	3	13	67 patients	Psoriasis
Cantarini et al.^[19]	A*: Levico Terme (Trento, Italy) TW: 38 °C rich in Fe²⁺ and H₂AsO₃	Randomised singled blind controlled	3	11	74 patients	Knee osteoarthritis
Ardic et al.^[20]	A*: Denizli, Turkey TW: Na⁺, Ca²⁺, Mg²⁺, HCO₃ ^-, SO₄ ^2- and Cl^-	Randomised prospective	3	7	24 patients	Fibromyalgia
Altan et al.^[21]	A*: Bursa, Turkey TW: 39 °C spa water rich in HCO₃ ^-, SO₄ ^2-, Na⁺, Ca²⁺	Randomised prospective	3	11	60 patients	Ankylosing spondylitis
Yurtkuran et al.^[22]	A*: Bursa, Turkey TW: 37 °C rich in CaCO₃ SO₄ ^2-, Na⁺, Ca²⁺, K⁺, free CO₂	Randomised placebo controlled	5	14	52 patients	Knee osteoarthritis
Balint et al.^[23]	A*: Nagybaracsa, Hungary TW: > 25 °C in winter, rich in Na⁺, Ca²⁺, K⁺, HCO^3- and Cl^-	Randomised double blind	4	15	64 patients	Knee osteoarthritis
Balogh et al.^[24]	A*: Kehidakustány, Hungary TW: 36 °C with 143 mg/l of cations, 450 mg/l anions, 118 mg/l free carbonic acid and 37 mg/l metasilicic acid	Randomised single blind controlled	4	12	60 patients	Low back pain
Codish et al.^[25]	A*: Dead Sea, Israel TW: 36 °C to 37 °C sulphur mineral pool	Randomised single-blind controlled study	3	10	28 patients	Ankylosing spondylitis
Dönmez et al.^[26]	A^†: Izmir, Turkey TW: 36 °C ± 1 °C contains primarily Na⁺, Cl^-, HCO₃ ^-, F^- M: classical massage	Randomised controlled	3	10	29 patients	Fibromyalgia
Yurtkuran et al.^[27]	A*: Bursa, Turkey TW: 80 °C spring water allowed to cool to 37 °C rich in HCO₃ ^-, SO₄ ^2-, Na⁺, Ca²⁺	Randomised single-blinded study	3	11	61 patients	Ankylosing spondylitis
Dawe et al.^[28]	A*: Photobiology unit, Dundee, UK TW: 37 °C Dead Sea salt	Randomised observer- blinded study	3	12	60 patients	Psoriasis
Altan et al.^[29]	A*: Bursa, Turkey TW: 37 °C rich in HCO₃ ^-, SO₄ ^2-, Na⁺, Ca²⁺	Randomised controlled trial	3	11	46 patients	Fibromyalgia
Kovacs and Bender^[30]	A*: Csekeszölo, Hungary TW: 69 °C allowed to cool to 36 °C with 1675 mg/l solute content comprised primarily of NaHCO₃, silicic acid and F^-	Double blind controlled	5	14	70 patients	Osteoarthritis
van Tubergen et al.^[31]	A^†: Bad Hofgastein, Austria and Spa resort at Arcen, The Netherlands TW: NA	Randomised controlled trial	3	13	120 patients	Ankylosing spondylitis
Brefel-Courbon^[32]	A^†: Ussat les bains, Ariege area, France TW: ND	Randomised prospective cross-over controlled study	3	10	31 patients	Parkinson's disease
Evcik et al.^[33]	A*: Afyon, Turkey TW: 36 °C to 60 °C contains primarily Na⁺, HCO₃ ^-, SO₄ ^-2	Randomised prospective	2	8	42 patients	Fibromyalgia
Neumann et al.^[34]	A*: Dead sea, Israel TW: 37 °C sulphur pool	Randomised prospective	3	11	48 patients	Fibromyalgia
Buskila et al.^[35]	A*: Dead Sea, Israel TW: 37 °C with 2000 mg/l of sulphur from spring water on the northern shore of the/Dead Sea	Randomised controlled	3	11	48 patients	Fibromyalgia
Halevy et al.^[36]	A*: Dead Sea, Israel TW: 35 °C Dead Sea bath salt (primarily MgCl₂, KCl, CaCl₂, NaCl, bromine and rubidium)	Double-blind controlled trial	4	13	23 patients	Psoriasis
Franke et al.^[37]	A*: Bad Brambach, Germany TW: radon 1.3 kBq/l, CO₂ 1.6 g/l	Randomised sham controlled study	5	15	60 patients	Rheumatoid arthritis
Sukenik et al.^[38]	A*: Dead Sea, Israel TW: 37 °C sulphur mineral pool	Randomised controlled	3	10	40 patients	Osteoarthritis
Constant et al.^[39]	A*: Vittel, France TW: 36 °C with either 510 mg/l total mineral or 1585 mg/l mineral including sulphate, chloride and sodium	Randomised controlled	5	16	224 patients	Low back pain
Nguyen et al.^[40]	A^†: Vichy, France TW: ND	Randomised controlled	3	13	188 patients	Osteoarthritis (lumbar spine, knee and hip)
Wigler et al.^[41]	A*: Tiberias spa hotel, Israel TW: 38 °C rich in NaCl, Sulphate, Ca²⁺, zinc and cobalt	Prospective double blind	4	13	33 patients	Osteoarthritis
Sukenik et al.^[42]	A*: Dead Sea area, Israel TW: 37 °C sulphur baths	Randomised controlled	3	10	36 patients	Rheumatoid arthritis
Konrad et al.^[43]	A*: Budapest, Hungary TW: 37 °C rich in sodium, magnesium, calcium, chloride, sulphur, bicarbonate	Randomised controlled	3	11	158 patients	Low back pain
Elkayam et al.^[44]	A*: Tiberias spa hotel, Israel TW: 38 °C rich in NaCl, sulphate, Ca²⁺, zinc and cobalt	Randomised Prospective	3	11	41 patients	Rheumatoid arthritis
Sukenik et al.^[45]	A*: Dead Sea area, Israel TW: 37 °C sulphur baths	Randomised controlled	2	10	40 patients	Rheumatoid arthritis
Szucs et al.^[46]	A*: Puspokladany, Budapest, Hungary TW: Alkalic hydrocarbonated chloride, iodine water	Double blind, placebo controlled	4	12	62 patients	Osteoarthritis of the knee

*Same therapeutic area (same place) for comparators (i.e. no confounding associated with the 'atmosphere' pertaining to the spa location).
^†Not the same therapeutic area for the comparators (confounding because of the atmosphere cannot be excluded). A, geographical area, TW, thermal water composition.

Table 2. Outcomes of RCTs Examining the Effect of Balneotherapy
References	Treatment arms	Outcomes examined	Outcome analysis
Leaute-Labreze et al.^[18]	Group I (n = 22): spa water alone Group II (n = 21): UV-B 311 alone Group III (n = 24): spa water and UV-B The 3 groups were treated on a daily basis 5 days a week for a total of 21 days Assessment: baseline, 1 week, 2 weeks, 3 weeks and 1 year later M: for all groups moisturisers and emollients	Psoriasis area and severity index > 10	Change in PASI was -29% for group I and -64% and -55% for groups II and III respectively (p < 0.001 for the comparison between group I vs. groups II and III) Combined saline spa water and UVB therapy had no sparing effect on UVB dosages. No long-term benefit was evident 1 year after the treatments
Cantarini et al.^[19]	Group I (n = 30): spa water alone Group II (n = 24): short wave diathermy Group III (n = 20): regular ambulatory care The 3 groups were treated for a total of 21 days Assessment: baseline, 3 weeks and 12 weeks later M: for all groups usual pharmacological and non-pharmacological treatment	Pain using a Visual Analogue Scale (pVAS), Lequesne index of severity, Arthritis impact measurement scale (AIMS), analgesic intake, overall assessment of efficacy by the patients	At 3 weeks: significant reduction in pain in group I and II (p < 0.01) while significant worsening in group III. Significant difference between group III and groups I and II At 12 weeks: group I showed significant additional improvement in pain reduction (compared with baseline) (p < 0.01) while group II showed statistically significant worsening (p < 0.01). Statistically significant difference between group I and the other groups (p < 0.01). Analgesic consumption significantly decreased in group I in comparison to groups II and III (p < 0.01). Decrease in Lequesne's index score (p < 0.01) and significant improvement in AIMS (p < 0.01) present only in group I
Ardiç et al.^[20]	Group I (n = 12): thermal water Group II (n = 9): none (daily activities only) Group III: (n = 10) age matched healthy women Patients in group I had treatment 20 min a day, 5 days a week, for a total duration of three weeks Assessment: baseline and after therapy M: no additional	Pain using VAS, tenderness measurement, algometric score, Fibromyalgia Impact Questionnaire (FIQ), Beck's depression index (BDI), full blood count, erythrocyte sedimentation rate, C-reactive protein, rheumatoid factor, IL-1, LTB₄, prostaglandin E₂	At the end of treatment period: significantly different alterations in pain intensity (p < 0.001), count of tenderness points (0.01), BDI (p < 0.001), FIQ (p < 0.05), serum PGE₂ levels (p < 0.001) between groups I and II in favour of group I
Altan et al.^[21]	Group I (n = 30): balneotherapy on an outpatients basis in a therapeutic pool containing spa water at 39 °C for 30 min. In addition, they followed a home exercise programme Group II (n = 30): home exercise programme Assessment: baseline, 3 weeks and 24 weeks M: no additional	Pain using a Visual Analogue Scale Morning stiffness using a four-point scale, Disease activity: bath Ankylosing spondylitis disease activity index activity (BASDAI), Functional capacity: bath Ankylosing Spondylitis functional index (BASFI) and the Dougados Functional Index Spinal mobility: Occiput-wall distance, chest expansion, modified Shober test and fingertip-fibula head distance Life quality score: Nottingham Health Profile (NHP), NHP-pain, NHP-physical activity, NHP-tiredness, NHP-social isolation, NHP-emotional reaction	Comparison of the groups showed significantly superior results for group I patients for parameters of BASDAI (p < 0.01), NHP-Total score (p < 0.01), NHP-pain score (p < 0.01), NHP-Tiredness score (p < 0.01), NHP-Physical activity score (p < 0.05), NHP-Sleep score (p < 0.05) and the physician's and patient's global evaluation (p < 0.05) at 3 weeks, but only for the parameters of patient's global evaluation (p < 0.050 and the modified Shoeber's test (p < 0.05) at 24 weeks
Yurtkuran et al.^[22]	Group I (n = 27): treatment with 37 °C Spa water (balneotherapy group) Group II (n = 25): treatment in the same pool with 37 °C tap water Patients in both groups had treatment 20 min a day, 5 days a week, for a total duration of 2 weeks Assessment: baseline, 2 weeks and 12 weeks M: for all groups home-based exercise programme	Primary outcomes: pain on movement: Visual Analogue Scale (pVAS) Fifty-foot walking time Active knee flexion degree (AFD), tenderness score (TS), quadriceps muscle strength Secondary outcomes: Western Ontario and McMaster Universities osteoarthritis index (WOMAC) Quality of Life: Nottingham Health Profile (NHP)	Better improvement in group I for pVAS (p = 0.015) at the 2nd week and for TS (p = 0.002) and NHP-Pain Score at the 12th week (p = 0.02) when compared with group II
Balint et al.^[23]	Group I (n = 32): thermal mineral water Group II (n = 32): non-spa resort village Both groups received 30 min sessions of bathing 5 days a week for four consecutive weeks Assessment: immediately before and at the end of the trial M: for all groups regular exercises	Western Ontario and McMaster Osteoarthritis (WOMAC) indices	The WOMAC activity, pain, and total scores improved significantly in the thermal mineral-water- treated group and in the tap water group after treatment (at 4 weeks). However, the improvement at the 3 months follow up was only evident in group I regarding the following outcomes: WOMAC activity score (p = 0.009), WOMAC pain score (0.005), WOMAC total score (p = 0.012)
Balogh et al.^[24]	Group I (n = 30): baths in reduced sulphurous water Group II (n = 30): baths in modified tap water of matching colour and odour Assessment: at baseline, after balneotherapy/hydrotherapy and at the end of the 3-month follow-up period M: no additional	VAS Modified Onswestry index, mobility of the spine, antalgic posture, tenderness of the paravertebral muscles, dose requirements for analgesics, efficacy assessed by the patients and the physicians	Group I: improvement of pain (as reflected by the VAS (p < 0.01), and mitigation of the muscle spasm (p < 0.1), alleviation of local tenderness, enhanced flexion-extension and rotation of the spine, improvement in Shoeber's index (all with a p < 0.01). All these changes were evident at the 3-month follow-up period as well. Group II: Only temporary improvement of the VAS score (p < 0.01)
Codish et al.^[25]	Group I (n = 14): balneotherapy and exposure to climatic conditions of Dead Sea Group II (n = 14): fresh pool water and exposure to climatic conditions of Dead Sea Assessment: baseline, 2 weeks, 1 month after end of therapy, 3 months after end of therapy M: no additional	Bath AS disease activity index (BASDAI) VAS for pain VAS for spinal movement, SF-36 questionnaire	BASDAI and pain VAS: Significant improvement in both Group I (p = 0.002) and Group II (p = 0.002) with no difference between the two groups Vas for limitations of movement: significant improvement in both group I (p = 0.011) and group II (p = 0.011) with no difference between the two groups Quality of life (assessed by SF-36) significantly improved in terms of pain amelioration in Group I
Dönmez et al.^[26]	Group I (n = 16):.thermal pool baths for 2 weeks (at 36 ± 1 °C for 20 min) every day (except Sunday), and pressured shower with thermal water (at 37 °C for 15 min) or classical massage (15 min) every other day alternatively Group II (n = 14): medical treatment and/or daily exercises Assessment: baseline, 2nd week and at the 1st, 3rd, 6th and 9th months after the spa therapy M: classical massage for group I	Primary outcomes: pain (using a 10 cm Visual Analogue Scale) and point pressure threshold with a dolorimeter, total number of tender points (ACR 1990 classification criteria) and Fibromyalgia Impact Questionnaire (FIQ) Secondary outcomes: Fibromyalgia-related symptoms namely sleep problems, fatigue, gastrointestinal symptoms and anxiety Beck Depression inventory	Pain: less severe up to 9 months in the spa arm as compared with baseline (p < 0.05). In group II, lower pain measurement was found in the assessments at 6 and 9 months (p < 0.05) Pain was less in group I in comparison to group II at 1 month (p = 0.045) Tender point counts: significantly decreased in group I in comparison to group II (p = 0.037) at the 1st month after therapy FIQ: Patients in the spa therapy arm showed significant improvements in follow-up evaluations of the FIQ up to the 9th month (p < 0.05) compared with baseline while no significant improvement was observed in the control group. At 6 months, the FIQ score was in favour of group I (p = 0.014) in comparison to group II. Spa group was superior to the control group in terms of patients global evaluation and fatigue in the second week of assessment
Yurtkuran et al.^[27]	Group I (n = 21): balneotherapy Group II (n = 20): Balneotherapy plus NSAID Group III (n = 20): NSAID Assessment: baseline, 3 weeks and 6 months after the spa therapy M: for all groups respiratory and postural exercises	Morning pain and nocturnal pain (VAS), morning stiffness duration, ESR, global well-being of the patient, occiput-wall distance, chest expansion, finger to floor distance, Shoeber's test and functional index	There was statistically significant improvement in all of the variables (including morning and nocturnal pain) of Group I, Group II and Group III at the end of treatment as well as 6 months after the treatment except for ESR, and finger to floor distance. In Group I and II, the 6-month changes included improvement in Shoeber's test (p < 0.01 and p < 0.05 respectively) and global well-being (p < 0.05 and p < 0.05 respectively). Comparison of the 6-month changes in Group I and Group II was almost similar for all the parameters. Group II was superior to Group I for the 6-month improvements observed in morning stiffness duration (p < 0.05). Group I was superior to Group II for the 6-month improvement in chest expansion (p < 0.05). Group I was superior to Group III in all variables (p < 0.05) except for ESR. Group II was better than Group III except for Schoeber's test and ESR (p < 0.05). Differences were found in the Functional Index comparisons between group I and III and group II and III (p < 0.01)
Dawe et al.^[28]	Group I: Dead Sea salt balneotherapy plus narrowband ultraviolet B Group II: narrowband ultraviolet B M no additional	Primary outcome: area under the psoriasis severity-time curves Secondary outcomes: Scaling, Erythema and Induration score	The mean area under the psoriasis severity-time curves was not detectably lower in group I than in group II (p = 0.099). The psoriasis severity score fell slightly more in group I than in group II (p = 0.019). No difference in time to relapse between the two groups
Altan et al.^[29]	Group I (n = 25): balneotherapy plus pool-based exercise Group II (n = 25): balneotherapy only Assessment: pretreatment (0), 12 and 24 weeks M: no additional	Pain (VAS and 5-point scale), Fatigue (VAS and 5-point scale), morning stiffness, sleep, number of tender points, algometric score, myalgic score, FIQ, Patient's global evaluation, physician's global evaluation, chair test, Beck depression inventory	Group I: improvement in all parameters except for the chair test at both 12 and 24 weeks (p = 0.01) Group II: improvement in all parameters except for the chair test and Beck depression inventory (p = 0.01) Comparison between group I and group II showed an improved Beck depression inventory at 12 weeks (p < 0.01) and at 24 weeks (p < 0.05) for group I
Kovacs and Bender^[30]	Group I (n = 31) : active treatment was performed by bathing the painful knee in thermal water cooled to 36 °C for 30 min daily Group II (n = 27): A mixture of tap water and thermal water (also 36 °C) of negligible mineral content were used to obtain a placebo preparation, with colour and odour matching those of the active preparation Daily balneotherapy sessions were administered over 15 days Assessment: baseline, at the 15-day treatment period and 3 months later M: no additional	Pain intensity (VAS), initial pain using a scoring system (none 1, mild 2, moderate 3, severe 4), range of motion during flexion and extension of the knee, using a goniometer, stair climbing (the time needed to ascend and then descend 20 steps was measured), tenderness on palpation (by pressing the medial epicondyle) and tenderness rated using the scoring system for initial pain, patient's subjective rating of therapeutic effect, physician's opinion on the therapeutic effect, overall ambulatory capability	Pain intensity: immediately upon concluding the 15-day course, the improvement using a Visual Analogue Scale was statistically significant in group I and II (p < 0.0001). Three months later this improvement persisted only in the group I. Range of motion: increase was significant after treatment and at 3 months later in group I, whereas no improvement could be ascertained in group II. Stair climbing performance: at 3 months varied reciprocally between the two groups (better in group I). Tenderness on palpation: was alleviated significantly by treatment with thermal water (p < 0.0001) but it remained unchanged in the control group at the 15-day assessment. Tenderness on palpation was improved at 3 months after treatment both in group I (p = 0.0072) and II (p = 0.0036). Nevertheless, the difference was no longer detectable 3 months later Patient's Subjective rating: significant improvement immediately after treatment in both groups. Paradoxically, 3 months later this improvement was present only in group II. Physician's opinion: significant improvement only in group I after 15 days. After 3 months, there was no difference between the two groups.
van Tubergen^[31]	Group I (n = 40): treated in a spa resort in Bad Hofgastein for 3 weeks Group II (n = 40): spa resort in Arcen, Netherlands for 3 weeks Group III (n = 40): control group stayed at home. Weekly group therapy for another 37 weeks consisting of physical exercises, sports and hydrotherapy. Total study period: 40 weeks Assessment: 2 weeks prior to intervention and at 4, 16, 28 and 40 weeks after spa therapy M: for groups I and II every other day sauna, hydrotherapy, sports. Additionally, daily walking as well as 1 h daily group physical exercises for groups I and II	Primary outcomes: functional ability measured by Bath Ankylosing Spondylitis Function Index (BASFI)-patient's global well-being (VAS), pain intensity (VAS), morning stiffness Results of the primary outcomes were expressed in a Pooled Index of Change (PIC) Secondary outcomes: BASDAI, Health assessment questionnaire for spondyloarthropathies, night pain (VAS), quality of life measured by ASQol (ankylosing spondylitis quality of life questionnaire), intake of non-steroidal anti-inflammatory drugs	The between-group difference for BASFI-AUC was 1% for group I vs. controls (p = 0.001) and 0.6% for group II vs. controls (0.02) Analysis of variance showed a statistically significant time-effect (p < 0.001) and time-by-treatment interaction (p = 0.004) indicating that the 3 groups differed over time with respect to the course of the PIC. 4 weeks after start of spa therapy the mean difference in PIC between group I and controls was 0.l49 (p = 0.004) and between group II and controls was 0.46 (p = 0.005). At 16 weeks, the difference between group I and controls was 0.63(p = 0.002) and between group II and controls was 0.34 (p = 0.086). At 28 and 40 weeks, more improvement was found for group I compared with controls (p = 0.062) but not for group II compared with controls Ankylosing Spondylitis Quality of Life was improved at 40 weeks for group I vs. the controls (p < 0.05)
Brefel-Courbon et al.^[32]	Group I (n = 16): 20-week spa period with thermal water (3 weeks spa and usual drug therapy for 17 weeks) and then 20-week non-spa period Group II (n = 15): 20-week non-spa period and then 20-week spa period (3 week spa and usual drug therapy for 17 weeks) Assessment: at baseline at 4 weeks and 20 weeks M: For the spa-period of both groups drinking mineral water, showers, underwater massage, physiotherapy, speech and relaxation therapies	Primary outcomes: quality of life scales (PDQ-39 and SF-36) Secondary outcomes: Motor scale (UPDRS), psychological questionnaire (GHQ-28)	At week 4: Group I showed significant improvements in several dimensions of PDQ-39 (p < 0.05) and SF-36 (p < 0.05), part IV of the UPDRS (p < 0.05) and GHQ-28 (p < 0.05). At week 20, no difference in any parameter was found The mean direct medical cost over the 20 weeks in the spa period was slightly reduced in comparison of that of the non-spa period (p < 0.05)
Evcik et al.^[33]	Group I (n = 20): 20-min bathing once a day and 5 times per week Group II (n = 20): control group Assessment: baseline, after therapy and at 6 months M: no additional	Number of tender points, VAS for pain, Beck's depression index (BDI), FIQ for functional capacity	Group I: after 3 weeks statistically significant differences compared with group II in the number of tender points, VAS for pain, BDI, FIQ (p < 0.001). At the end of 6 months, there was still a significant improvement in the number of tender points (p < 0.001), VAS and FIQ values (p < 0.05) in group I in comparison to group II
Neumann et al.^[34]	Group I (n = 24): balneotherapy Group II (n = 24): control (no balneotherapy) Assessment: baseline, 10 days, 1 month, 3 months M: for both groups similar degree of activity	QoL (SF-36), psychological well-being and Fibromyalgia-related symptoms	QoL: At 10-days: Improved components of the physical (p = 0.019) and mental components (p = 0.036) of the QoL in groups I and II At 3 months, functioning status improved only in group I (p = 0.05) Psychological well-being: lower levels of anxiety (p < 0.001) and depression (p < 0.001) in group I. In group II improvement occurred but did not last. Fibromyalgia-related symptoms: Pain (p = 0.0002) and fatigue p = 0.0006) improved in both groups I and II, although the beneficial effect was more pronounced in group I
Buskila et al.^[35]	Group I (n = 24): sulphur baths Group II (n = 24) control group Assessment: baseline, after therapy and at 6 months M: no additional	VAS to evaluate pain, anxiety, depression, fatigue, morning stiffness and global well-being, Fibromyalgia Impact Questionnaire (FIQ), Functional Disability Index (FDI) point count, Tenderness assessment	Point count was improved in group I in comparison to group II (p = 0.037). Physical functioning and tenderness improved moderately in both groups. With the exception of the tenderness threshold, the improvement was especially notable in group I and it persisted even after 3 months. Relief in the severity of symptoms such as pain, fatigue, stiffness and anxiety was reported in both groups. However, pain VAS was improved more in group I than in group II (p = 0.017)
Hallevy et al.^[36]	Group I (n = 12): Dead Sea bath salt Group II (n = 11): common salt Group III (n = 13): healthy volunteers Assessment: baseline and at 3 weeks M: no additional	Psoriasis Area and Severity Index (PASI)	The number of patients with a % PASI reduction ≥ 25 was higher in patients treated with Dead Sea bath salt (Group I) vs those treated with common salt (Group II) although not statistically significant (58% vs 36%)
Franke et al.^[37]	Group I (n = 30): baths with natural spring water containing radon and carbon dioxide Group II (n = 30): artificially produced carbon dioxide of the same carbon dioxide concentration Assessment: baseline, completion of therapy, 3 months, 6 months M: for all groups exercises/physiotherapy, classical massage, hydrogalvanic baths, occupational therapy	Pain intensity, Keitel functional index, Arthritis impact measurement scale (AIMS), ESR, CRP, pain frequency and morning stiffness	Pain intensity and AIMS after 6 months: Marked between group differences (pain intensity -16.9% (95% CI: -27.6 to -6.2) i.e., improvement in Group I vs. Group II (p = 0.04 and p = 0.01 respectively)
Sukenik et al.^[38]	Group I (n = 10): bathing in sulphur bath Group II (n = 10) : bathing in the Dead Sea Group III (n = 10): sulphur bath and bathing in the Dead sea Group IV (n = 10): control group Assessment: baseline, 2 weeks, 1 month, 3 months M: same degree of activity	Lequesne index, patient assessment of knee pain, assessment of the range of movement for each knee, soft tissue swelling, effusions and crepitus	Lequesne index: significant improvement at the end of the treatment period in groups I, II and III, but not in group IV. This improvement continued for up to 3 months in group I (p < 0.05), group II (p < 0.05) and group III (p < 0.05) Patient's assessment: significant improvement that lasted for 1 month only in group III (p < 0.01) No significant improvement in any of the other parameters assessed
Constant et al.^[39]	Group I (n = 62): spa therapy with low total mineral content thermal water plus mud packs plus usual drug therapy for 6 times a week for 3 weeks Group II (n = 63): spa therapy with high total mineral thermal water content plus mud packs plus usual drug therapy for 6 times a week for 3 weeks Group III (n = 94): control group only usual drug therapy Assessment: Baseline, 3 weeks, 3 months M: 20 min massage under flowing water for groups I and II	Duke Health profile, finger floor distance, Schoeber index, pain, patient's evaluation, disability questionnaire	There were no statistically significant differences between the two treatment groups and between treatment subgroup and controls at baseline. At 3 weeks and 3 months, health status had improved in each treatment subgroup, but there were no statistically significant differences between them. There were no statistically significant differences between the treatment and control groups at baseline except for the mental health and depression scores, which were significantly higher in the control group (p = 0.02). At 3 weeks and 3 months, considered together patients health status improved significantly in the treatment group compared with the control group. Significant improvement severe noted in measures of the physical health (p = 0.011) and mental health (p = 0.033), anxiety (p = 0.001) and depression (0.0001), pain duration (< 0.0001), pain intensity (< 0.0001) and functional disability (< 0.0001)
Nguyen et al.^[40]	Group I (n = 91): treatment group (spa therapy for 21 days) Group II (n = 97): control group Assessment: Baseline and at 3 and 24 weeks thereafter M: rest, spring water and medical attention for group I	NSAID total consumption, analgesic total consumption, Pain (100 mm VAS, Main and Waddell score index, Le-quesne's hip index, Lequesne's knee index, finger-floor distance for lumbar spine osteoarthritis, buttock to heel distance for knee osteoarthritis, intermalleolar distance for hip osteoarthritis	NSAID consumption during 24 weeks: lower in Group I (p = 0.008) Analgesic consumption during 24 weeks: lower in group I (p = 0.01) Improvement of pain at 4 and 24 weeks: better in group I vs. group II (p < 0.001) Quality of life at 4 and 24 weeks: better in group I vs. group II (p < 0.0001)
Wigler et al.^[41]	Group I (n = 11): daily mineral water baths and hot native mineral mudpacks applied on the knees Group II (n = 12): daily mineral water baths and rinsed mineral-free mudpacks applied on the knees every second day Group III (n = 10), control group had daily tap water baths and mineral-free mudpacks applied on the knees every second day Treatment period: 2 weeks for all groups. Duration of baths and mudpack application was 20 min respectively Assessment: 3 days before arrival at the spa (week 0), 1 week after beginning treatment (week 1), at the completion of treatment (week 2) and at 3, 8, 12, 16 and 20 weeks from the start of treatment M: no additional	Functional impairment using the index of severity of OA of the knee (ISK), pain intensity using a Visual Analogue Scale (VAS) 10 cm in length, night pain using the severity rate scale (SRS), pain on passive motion (SRS scale), tenderness of palpation (SRS scale), patient assessment of disease severity, physician assessment of disease severity and daily analgesic drug consumption	Severity of knee OA (ISK): improvement (p < 0.05) was achieved in group I after 1 week and was sustained until week 16. In group II, the reduction in ISK values was short and not significant. In group III, a reduction was observed at weeks 8 and 12, but it was transient and disappeared in the next follow up Improvement of pain intensity did not reach statistical significance in any group. Night pain was significantly reduced only in group I (p < 0.05) after 1 week of treatment and was maintained until week 20. Tenderness of palpation and pain on passive motion did not improve significantly in any of the 3 groups Improvement in patient and physician assessment of disease severity was found in both group I and the control group (p < 0.05), and it was sustained until week 20 for group I and until week 16 for the control group. Significant decrease in analgesic consumption was found only in group I and group III and was sustained until week 12 (p < 0.05)
Sukenik et al.^[42]	Group I (n = 9): daily baths at the Dead Sea Group II (n = 9): daily sulphur baths Group III (n = 10): combination of daily bathing in the Dead Sea and daily sulphur baths Group IV (n = 8): control group Assessment: baseline, day 12, 1 month, 3 months M: For all groups similar degree of activity	Duration of morning stiffness, 15 min walk time, right and left hand grip strength using a standard recorder, activities of daily living, patient assessment of disease severity, number of active joints, number of effused joints, Ritchie index	Morning stiffness: significant reduction in the duration was observed in groups I, II and III (p < 0.05). This improvement was maintained for 3 months in group III only (p < 0.05) 15-m walk time: At 3 months significant improvement in group III (p < 0.01) only. Hand grip strength: statistically significant improvement in groups I, II and III at 1 month (p < 0.05). At 3 months improvement seen only in group I (p < 0.01). Activities of daily living: statistically significant at 3 months in groups I and III only (p < 0.05) Patient self-assessment: best results in group I and III but even in these groups the improvement did not last more than 1 month (p < 0.05). Number of active joints and Ritchie index: improvements were seen in groups I, II (p < 0.01) at 3 months Number of effused joints: at 3 months reduced only in group III (p < 0.05)
Konrad et al.^[43]	Group I (n = 35): balneotherapy Group II (n = 44): underwater traction bath Group III (n = 26): underwater massage Group IV (n = 53): control group Each group was treated for 4 weeks Assessment: baseline, 4 weeks, 1 year M: no additional	Pain score (VAS), number of analgesic tablets taken during the 24 h immediately preceding the assessment Straight leg rising angle in each leg measured with a goniometer, flexion/extension/lateral flexion of the lumbar spine measured with a goniometer	At 4 weeks: analgesic tablets consumption was less by more than 50% in groups I, II and III but not in the group IV (p < 0.01). At no time was there any difference in analgesic consumption between the treated groups. Reduction of pain scores for groups I, II and III (p < 0.01) At 1 year: analgesic tablets consumption was less by more than 50% in the treated groups (I, II, III) but not in the control group (p < 0.01)
Elkayam et al.^[44]	RA patients: Group I (n = 19): daily mineral water baths at 38 °C for 20 min and mud packs applied on affected joints every second day for 20 min Group II (n = 22): only daily tap water baths, at 38 °C for 20 min Patients continued to receive their medications Assessment: 3 days before arrival at the spa (week 0), at the end of treatment, and at 4, 8, and 12 weeks from the start of treatment M: no additional	For RA patients: duration of morning stiffness (in min), 15 m walk time, right and left hand grip strength using a single standard recorder (mm Hg), the Ritchie index, and patient and physician assessment of the severity of disease according to a specific scale. Also, laboratory variables: complete blood count (CBC) and (ESR) at each visit, and rheumatoid factors (RF) at week 0 and 12	RA patients: group I showed improvement in grip strength (p < 0.05), which was maintained for 3 months. Both groups had a temporary improvement in Ritchie index, observed 2 weeks after the end of treatment and sustained until week 8 after treatment (p < 0.05). Improvement in patient and physician assessment of disease severity was found in both group I and II and was sustained for 2 weeks after the completion of treatment (p < 0.05). No improvement was noticed in morning stiffness, 15 m walk time and laboratory variables of disease activity in either group
Sukenik et al.^[45]	Group I (n = 10): daily mud packs for 2 weeks Group II (n = 10): daily hot sulphur baths for 2 weeks Group III (n = 10): mud packs and sulphur baths for 2 weeks Group IV (n = 10): control group for 2 weeks Assessment: baseline, 1 week, 2 weeks, 1 month, 3 months M: same degree of activity	Morning stiffness, 15-m walk time, hand grip, circumference of proximal interphalangeal joints, activities of daily living, patient assessment of disease severity, number of active joints and Ritchie index	Duration of morning stiffness: improvement at 3 months in group II (p < 0.05) and IV (p < 0.01) 15-m walk time and hand grip at 1 month: improvement in group I (p < 0.05), group II (p < 0.05) and group III (p < 0.01) Circumference of proximal interphalangeal joints: at 3-months improvement (decrease) in group I (p < 0.01), group II (p < 0.05), and group IV (p < 0.05). Activities of daily living: improvement in group I and IV at 3 months (p < 0.05). Patient assessment of disease severity: at 3-months improvement in group I (p < 0.01), group II (p < 0.05), and group III (P < 0.05). Number of active joints: At 3-months improvement (decrease) in group I (p < 0.01), group II (p < 0.05), and group III (p < 0.05) and Ritchie index: at 3-months improvement (decrease) in group I (p < 0.01), group II (p < 0.01), group III (p < 0.05) and group IV (p < 0.05)
Szucs et al.^[46]	Group I: daily 20-min treatments in 36 °C baths, altogether in 18 occasions with the exception of Sundays. The thermal group received undiluted thermal water Group II received 36 °C tap water Assessment: baseline, on 8th day, and 1-2 days after concluding the treatment on the 18th day M: no additional	Pain at rest, pain at movement, pressure sensitivity (Ritchie method)	Pain at movement and knee-joints pressure sensitivity were reduced (p < 0.05) by the 18th day in group I compared with group II

n, number of patients; As, assessment; M, other (non-pharmacological) therapeutic modalities employed; RCTs, randomised controlled trials; NSAID, non-steroidal anti-inflammatory drugs.

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