A multicenter randomized controlled trial evaluating balneotherapy in patients with advanced chronic venous insufficiency Patrick H. Carpentier, MD,

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Presentation transcript:

A multicenter randomized controlled trial evaluating balneotherapy in patients with advanced chronic venous insufficiency Patrick H. Carpentier, MD, Sophie Blaise, MD, Bernadette Satger, MD, Céline Genty, MSc, Carole Rolland, MSc, Christian Roques, MD, Jean-Luc Bosson, MD, PhD Journal of Vascular Surgery Volume 59, Issue 2, Pages 447-454.e1 (February 2014) DOI: 10.1016/j.jvs.2013.08.002 Copyright © 2014 Society for Vascular Surgery Terms and Conditions

Fig 1 Pseudo cross-over design of the study. The comparison concerns the first year (ie, 1 year after treatment for the treatment group, vs 1 year after randomization but before spa treatment for the control group). CIVIQ2, Chronic Venous Insufficiency Questionnaire 2; EQ5D, EuroQol 5D; VCSS, Venous Clinical Severity Score. Journal of Vascular Surgery 2014 59, 447-454.e1DOI: (10.1016/j.jvs.2013.08.002) Copyright © 2014 Society for Vascular Surgery Terms and Conditions

Fig 2 Study flow chart. CVDs, Chronic venous disorders. Journal of Vascular Surgery 2014 59, 447-454.e1DOI: (10.1016/j.jvs.2013.08.002) Copyright © 2014 Society for Vascular Surgery Terms and Conditions

Fig 3 Time course of variations in the Venous Clinical Severity Score (modified VCSS) (mean ± standard error of the mean) (solid lines = comparative period; dotted lines = follow-up) At *: P < .05 for the difference with M0. At the end of 1 year, the improvement in VCSS was significantly greater in treated patients than in controls. After 1 year, the control patients were given the spa treatment and their VCSS scores caught up with those of the other group. Journal of Vascular Surgery 2014 59, 447-454.e1DOI: (10.1016/j.jvs.2013.08.002) Copyright © 2014 Society for Vascular Surgery Terms and Conditions

Fig 4 Time course of variations in leg symptoms as assessed by monthly visual analog scale (VAS) (mean ± standard error of the mean) (solid lines = comparative period; dotted lines = follow-up). At **: P < .01 for the difference with M0. After spa therapy, the treated group soon experienced a reduction in leg symptoms, which reached a maximum at 4 to 6 months. The difference with the control group remained substantial and highly significant for the entire year. After month 12 and their own spa treatment, the control patients also showed a dramatic improvement in their symptoms. Journal of Vascular Surgery 2014 59, 447-454.e1DOI: (10.1016/j.jvs.2013.08.002) Copyright © 2014 Society for Vascular Surgery Terms and Conditions

Fig 5 Time course of variations in the venous-related quality-of-life scale Chronic Venous Insufficiency Questionnaire 2 [CIVIQ2] (mean ± standard error of the mean). Higher scores are related to larger changes in quality of life (solid lines = comparative period; dotted lines = follow-up). At **: P < .01 for the difference with M0. In spite of seasonal variations (the spa treatment is performed mostly during summer months), the treated group showed a substantial and significant improvement vs the control group, with the difference remaining significant at month 12. Again, after the control patients were given spa treatment, their CIVIQ2 scale reached the same level as the other group. Journal of Vascular Surgery 2014 59, 447-454.e1DOI: (10.1016/j.jvs.2013.08.002) Copyright © 2014 Society for Vascular Surgery Terms and Conditions

Fig 6 Time course of variations in the four components of the Chronic Venous Insufficiency Questionnaire 2 (CIVIQ2) scale (solid lines = comparative period; dotted lines = follow-up). At *: P < .05; and at **: P < .01 for the differences with M0. All four subscales of the CIVIQ2 quality-of-life instrument, related to psychological (A), physical (B), pain (C), and social (D) components, were significantly improved in the treated group compared to the controls, with similar time course patterns. Journal of Vascular Surgery 2014 59, 447-454.e1DOI: (10.1016/j.jvs.2013.08.002) Copyright © 2014 Society for Vascular Surgery Terms and Conditions

Fig 7 Time course of variations in the generic quality-of-life index EuroQol 5D (solid lines = comparative period; dotted lines = follow-up). At **: P < .01 for the difference with M0. The most important variations are seen in the control group, which deteriorates over time, showing a significant difference with the treated group at month 12, but improves after their own spa treatment. Journal of Vascular Surgery 2014 59, 447-454.e1DOI: (10.1016/j.jvs.2013.08.002) Copyright © 2014 Society for Vascular Surgery Terms and Conditions