BACKGROUND: Apart from compression therapy, physical therapy has scarcely been evaluated in the treatment of chronic venous disorders (CVDs). Spa treatment is a popular way to administer physical therapy for CVDs in France, but its efficacy has not yet been assessed in a large trial. The objective was to assess the efficacy of spa therapy for patients with advanced CVD (CEAP clinical classes C4 to C5). METHODS: This was a single-blind (treatment concealed to the investigators) randomized, multicenter, controlled trial (French spa resorts). Inclusion criteria were primary or post-thrombotic CVD with skin changes but no active ulcer (C4a, C4b, or C5). The treated group had the usual 3-week spa treatment course soon after randomization; the control group had spa treatment after the 1-year comparison period. All patients continued their usual medical care including wearing compression stockings. Treatment consisted of four balneotherapy sessions per day for 6 days a week. Follow-up was performed at 6, 12 and 18 months by independent blinded investigators. The main outcome criterion was the incidence of leg ulcers at 12 months. Secondary criteria were a modified version of the Venous Clinical Severity Score, a visual analog scale for leg symptoms, and the Chronic Venous Insufficiency Questionnaire 2 and EuroQol 5D quality-of-life autoquestionnaires. RESULTS: Four hundred twenty-five subjects were enrolled: 214 in the treatment group (Spa) and 211 in the control group (Ctr); they were similar at baseline regarding their demographic characteristics, the severity of the CVD, and the outcome variables. At 1 year, the incidence of leg ulcers was not statistically different (Spa +9.3%, 95% confidence interval (CI) +5.6 to +14.3; Ctr +6.1%, 95% CI +3.2 to +10.4), whereas the Venous Clinical Severity Score improved significantly in the treatment group (Spa -1.2, 95% CI -1.6 to -0.8; Ctr -0.6, 95% CI -1.0 to -0.2; p = 0.04). A significant difference favoring spa treatment was found regarding symptoms after 1 year (Spa -0.03, 95% CI -0.57 to +0.51; Ctr +0.87, 95% CI +0.46 to +1.26; p = 0.009). EuroQol 5D improved in the treatment group (Spa +0.01, 95% CI -0.02 to +0.04) while it worsened (Ctr -0.07, 95% CI -0.10 to -0.04) in the control group (p < 0.001). A similar pattern was found for the Chronic Venous Insufficiency Questionnaire 2 scale (Spa -2.0, 95% CI -4.4 to +0.4; Ctr +2.4, 95% CI +0.2 to +4.7; p = 0.008). The control patients showed similar improvements in clinical severity, symptoms, and quality of life after their own spa treatment (day 547). CONCLUSIONS: In this study, the incidence of leg ulcers was not reduced after a 3-week spa therapy course. Nevertheless, our study demonstrates that spa therapy provides a significant and substantial improvement in clinical status, symptoms, and quality of life of patients with advanced venous insufficiency for at least 1 year.

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