title: A multicenter randomized controlled trial evaluating balneotherapy in patients with advanced chronic venous insufficiency.
abstract: 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-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 - +14.3; Ctr: +6.1%; 95% CI, +3.2 - +10.4), whereas the Venous Clinical Severity Score improved significantly in the treatment group (Spa: -1.2; 95% CI, -1.6 - -0.8; Ctr: -0.6; 95% CI, -1.0 - -0.2; P = .04). A significant difference favoring spa treatment was found regarding symptoms after 1 year (Spa: -0.03; 95% CI, -0.57 - +0.51; Ctr: +0.87; 95% CI,+0.46 - +1.26; P = .009). EuroQol 5D improved in the treatment group (Spa: +0.01; 95% CI, -0.02 - +0.04) while it worsened (Ctr: -0.07; 95% CI, -0.10 - -0.04) in the control group (P < .001). A similar pattern was found for the Chronic Venous Insufficiency Questionnaire 2 scale (Spa: -2.0; 95% CI, -4.4 - +0.4; Ctr: +2.4; 95% CI, +0.2 - +4.7; P = .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.
authors.affiliation: Clinique Universitaire de Médecine Vasculaire, Pôle Pluridisciplinaire de Médecine, Centre Hospitalier Universitaire, Grenoble, France; Centre de Recherche Universitaire, La Léchère, France. Electronic address: pcarpentier@chu-grenoble.fr.
authors.forename: Patrick H
authors.initials: PH
authors.lastname: Carpentier
authors.affiliation: Clinique Universitaire de Médecine Vasculaire, Pôle Pluridisciplinaire de Médecine, Centre Hospitalier Universitaire, Grenoble, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Blaise
authors.affiliation: Clinique Universitaire de Médecine Vasculaire, Pôle Pluridisciplinaire de Médecine, Centre Hospitalier Universitaire, Grenoble, France; Centre de Recherche Universitaire, La Léchère, France.
authors.forename: Bernadette
authors.initials: B
authors.lastname: Satger
authors.affiliation: Centre d'Investigation Clinique Inserm CIC03, Centre Hospitalier Universitaire, Grenoble, France.
authors.forename: Céline
authors.initials: C
authors.lastname: Genty
authors.affiliation: Centre d'Investigation Clinique Inserm CIC03, Centre Hospitalier Universitaire, Grenoble, France.
authors.forename: Carole
authors.initials: C
authors.lastname: Rolland
authors.affiliation: Médecine Physique et Rééducation Département, Université Paul Sabatier, Toulouse, France.
authors.forename: Christian
authors.initials: C
authors.lastname: Roques
authors.affiliation: Centre d'Investigation Clinique Inserm CIC03, Centre Hospitalier Universitaire, Grenoble, France.
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Bosson
mesh_terms: D001452:Balneology; D016009:Chi-Square Distribution; D002908:Chronic Disease; D005602:France / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D007871:Leg Ulcer / Q000175:diagnosis / Q000453:epidemiology / Q000628:therapy*; D011788:Quality of Life; D012720:Severity of Illness Index; D016037:Single-Blind Method; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014689:Venous Insufficiency / Q000175:diagnosis / Q000453:epidemiology / Q000628:therapy*