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Thermes and Veines: A multicenter randomized controlled trial evaluating balneotherapy in patients with advanced chronic venous insufficiency
Balneotherapy / Annals of Physical and Rehabilitation Medicine 57S (2014) e159–e162 CO83-003-e
CO83-005-e
Thermes and Veines: A multicenter randomized controlled trial evaluating balneotherapy in patients with advanced chronic venous insufficiency
Long-term improved quality of life by a 2-week group physical and educational intervention shortly after breast cancer chemotherapy completion. Results of the “Programme of Accompanying women after breast Cancer treatment completion in Thermal resorts” (PACTHE)
P. Carpentier ∗ , B. Satger Service de médecine vasculaire, CIC–CHU de Grenoble, Grenoble, France ∗ Corresponding author. Keywords: Balneotherapy; Rehabilitation; Chronic venous disease; Quality of life Objective.– To assess the efficacy of spa therapy for patients with advanced primary or post-thrombotic CVD. Methods.– A single-blind randomized, multicenter, controlled trial. Inclusion criteria were CVD with skin changes but no ulcer (CEAP: C4a, C4b, or C5). The treated group had a 3-week spa treatment soon after randomization. All patients continued their usual care including compression stockings. Follow-up was performed at 6, 12 and 18 months. The main endpoint was the incidence of leg ulcers at 12 months. Secondary endpoints were VCSS (Venous Clinical Severity Score), VAS for leg symptoms, CIVIQ2 and EuroQol 5D questionnaires. Results.– In total, 425 patients were enrolled: 214 in the Spa and 211 in the control groups. At 1 year, the incidence of leg ulcers was not statistically different. The VCSS improved significantly in the treatment group; a significant difference favouring spa treatment was found regarding symptoms; Euro Qol 5D improved in the treatment group worsened in the control group. A similar pattern was found for the Chronic Venous Insufficiency Questionnaire 2. Conclusions.– The incidence of leg ulcers was not reduced but spa therapy provided a significant improvement in clinical status, symptoms, and quality of life of patients with advanced CVD http://dx.doi.org/10.1016/j.rehab.2014.03.581 CO83-004-e
Maathermes a randomised multicenter control trial assessing the one-year effectiveness of a 3-week balneotherapy program for the treatment of overweight or obesity Hanh a,∗ ,
Blin b ,
T. O. C.F. a HAT, Paris, France b AFRETH, Paris, France ∗ Corresponding author.
Roques b
Keywords: Balneotherapy; Overweight; Obesity Objective.– To assess the one-year effectiveness on weight loss of a 3-week balneotherapy program (BT). Methods.– A Zelen double consent randomised controlled trial to compare one-year BMI loss between a 3-week BT program versus usual care (UC) for overweight or obese patients (BMI: 27–35 kg/m2 ), associated or not with a dietary motivational interview (DMI) during the follow up, using a 2–2 factorial design. Main analysis was a per protocol analysis comparing patients attending BT to patients managed by UC, matched on sex, overweight or obese status, DMI randomisation and a propensity score to attend BT or to be managed by UC. Results.– From the 257 patients who completed the follow-up, 70 patients of each group could be matched. Mean BMI loss was 1.91 kg/m2 [95%CI: 1.46; 2.35] for the BT patients and 0.20 kg/m2 [−0.24; 0.64] for the UC patients (P < 0.001), corresponding to a significant BT benefit of 1.71 kg/m2 [1.08; 2.33]. There was no significant effect of DMI and no interaction with BT or UC. No adverse reaction was observed for patients attending BT. Conclusion.– A 3-week BT program provides a significant one-year benefit over the usual GP dietary advice for overweight and obese patients. http://dx.doi.org/10.1016/j.rehab.2014.03.582
e161
F. Kwiatkowski ∗ , Y. Bignon , A. Léger-Enreille Centre Jean Perrin, CHU de Clermont-Ferrand, Clermont-Ferrand, France ∗ Corresponding author. Keywords: Balneotherapy; Cancer; Rehabilitation Background.– Quality of life (QoL) after breast cancer is nowadays a major challenge, depression symptoms are frequent after treatment, return to activity has to be favoured; radio-chemotherapy has side effects like weight gain and fatigue. Objective.– To test a particular intervention with hydrothermal cares, physical training and dietary education. Methods.– In total, 251 non-metastatic patients in complete remission were included after chemotherapy in a prospective randomised multicenter trial testing a 2-week intervention in SPA centres (group physical training, dietary education and balneotherapy). QoL was evaluated with SF36, anxiety and depression with HAD. Anthropometric measures and QoL evaluations were obtained before randomisation and every 6 months during 3 years. Results.– Two hundred and twenty patients were evaluable at 1 year. Intervention increased significantly SF36 at 6, 12 and 24 months. Effect size (ES) was 0.63. Anxiety score was shortly minored by intervention (ES: –0.24) and depression score more durably (ES: –0.45) at 6, 12 and 24 months. The weight control and level of physical activity were significantly improved, health goods consumption was significantly reduced, return yo work favoured at 12 month in the intervention group. Conclusion.– This 2-week group intervention influenced QoL of breast cancer patients treated by chemotherapy. http://dx.doi.org/10.1016/j.rehab.2014.03.583 CO83-006-e
Stop-tag a multicenter randomised control trial comparing balneotherapy versus paroxetine in the treatment of generalized anxiety disorder O. Dubois Établissement thermal, Saujon, Charente-Maritime, France Keywords: Balneotherapy; General anxiety disorder; Anti-depressant drugs; Stress related-disorders Background.– Preliminary studies suggested that balneotherapy (BT) is an effective and well-tolerated treatment for generalized anxiety disorder (GAD). Objective.– To assess the efficacy of BT in GAD delivered in in 4 spa resorts. Methods.– We compared BT to paroxetine in terms of efficacy and safety in a randomized multicentre study lasting 8 weeks. Patients meeting the diagnostic criteria of GAD (DSM-IV) were recruited. Assessments were conducted using the Hamilton Rating Scale for Anxiety (HAM-A) and other scales, by a specifically trained and independent physician. The main endpoint was the change in the total HAM-A score between baseline and week 8. Results.– A total of 237 outpatients were enrolled in four centres; 117 were assigned randomly to BT and 120 to paroxetine. The mean change in HAM-A scores showed an improvement in both groups with a significant advantage of BT compared to paroxetine (−12.0 vs −8.7; P < 0.001). Remission (19% vs 7%) and sustained response (51% vs 28%) rates were significantly higher in the BT group.
CO83-005-e
Thermes and Veines: A multicenter randomized controlled trial evaluating balneotherapy in patients with advanced chronic venous insufficiency
Long-term improved quality of life by a 2-week group physical and educational intervention shortly after breast cancer chemotherapy completion. Results of the “Programme of Accompanying women after breast Cancer treatment completion in Thermal resorts” (PACTHE)
P. Carpentier ∗ , B. Satger Service de médecine vasculaire, CIC–CHU de Grenoble, Grenoble, France ∗ Corresponding author. Keywords: Balneotherapy; Rehabilitation; Chronic venous disease; Quality of life Objective.– To assess the efficacy of spa therapy for patients with advanced primary or post-thrombotic CVD. Methods.– A single-blind randomized, multicenter, controlled trial. Inclusion criteria were CVD with skin changes but no ulcer (CEAP: C4a, C4b, or C5). The treated group had a 3-week spa treatment soon after randomization. All patients continued their usual care including compression stockings. Follow-up was performed at 6, 12 and 18 months. The main endpoint was the incidence of leg ulcers at 12 months. Secondary endpoints were VCSS (Venous Clinical Severity Score), VAS for leg symptoms, CIVIQ2 and EuroQol 5D questionnaires. Results.– In total, 425 patients were enrolled: 214 in the Spa and 211 in the control groups. At 1 year, the incidence of leg ulcers was not statistically different. The VCSS improved significantly in the treatment group; a significant difference favouring spa treatment was found regarding symptoms; Euro Qol 5D improved in the treatment group worsened in the control group. A similar pattern was found for the Chronic Venous Insufficiency Questionnaire 2. Conclusions.– The incidence of leg ulcers was not reduced but spa therapy provided a significant improvement in clinical status, symptoms, and quality of life of patients with advanced CVD http://dx.doi.org/10.1016/j.rehab.2014.03.581 CO83-004-e
Maathermes a randomised multicenter control trial assessing the one-year effectiveness of a 3-week balneotherapy program for the treatment of overweight or obesity Hanh a,∗ ,
Blin b ,
T. O. C.F. a HAT, Paris, France b AFRETH, Paris, France ∗ Corresponding author.
Roques b
Keywords: Balneotherapy; Overweight; Obesity Objective.– To assess the one-year effectiveness on weight loss of a 3-week balneotherapy program (BT). Methods.– A Zelen double consent randomised controlled trial to compare one-year BMI loss between a 3-week BT program versus usual care (UC) for overweight or obese patients (BMI: 27–35 kg/m2 ), associated or not with a dietary motivational interview (DMI) during the follow up, using a 2–2 factorial design. Main analysis was a per protocol analysis comparing patients attending BT to patients managed by UC, matched on sex, overweight or obese status, DMI randomisation and a propensity score to attend BT or to be managed by UC. Results.– From the 257 patients who completed the follow-up, 70 patients of each group could be matched. Mean BMI loss was 1.91 kg/m2 [95%CI: 1.46; 2.35] for the BT patients and 0.20 kg/m2 [−0.24; 0.64] for the UC patients (P < 0.001), corresponding to a significant BT benefit of 1.71 kg/m2 [1.08; 2.33]. There was no significant effect of DMI and no interaction with BT or UC. No adverse reaction was observed for patients attending BT. Conclusion.– A 3-week BT program provides a significant one-year benefit over the usual GP dietary advice for overweight and obese patients. http://dx.doi.org/10.1016/j.rehab.2014.03.582
e161
F. Kwiatkowski ∗ , Y. Bignon , A. Léger-Enreille Centre Jean Perrin, CHU de Clermont-Ferrand, Clermont-Ferrand, France ∗ Corresponding author. Keywords: Balneotherapy; Cancer; Rehabilitation Background.– Quality of life (QoL) after breast cancer is nowadays a major challenge, depression symptoms are frequent after treatment, return to activity has to be favoured; radio-chemotherapy has side effects like weight gain and fatigue. Objective.– To test a particular intervention with hydrothermal cares, physical training and dietary education. Methods.– In total, 251 non-metastatic patients in complete remission were included after chemotherapy in a prospective randomised multicenter trial testing a 2-week intervention in SPA centres (group physical training, dietary education and balneotherapy). QoL was evaluated with SF36, anxiety and depression with HAD. Anthropometric measures and QoL evaluations were obtained before randomisation and every 6 months during 3 years. Results.– Two hundred and twenty patients were evaluable at 1 year. Intervention increased significantly SF36 at 6, 12 and 24 months. Effect size (ES) was 0.63. Anxiety score was shortly minored by intervention (ES: –0.24) and depression score more durably (ES: –0.45) at 6, 12 and 24 months. The weight control and level of physical activity were significantly improved, health goods consumption was significantly reduced, return yo work favoured at 12 month in the intervention group. Conclusion.– This 2-week group intervention influenced QoL of breast cancer patients treated by chemotherapy. http://dx.doi.org/10.1016/j.rehab.2014.03.583 CO83-006-e
Stop-tag a multicenter randomised control trial comparing balneotherapy versus paroxetine in the treatment of generalized anxiety disorder O. Dubois Établissement thermal, Saujon, Charente-Maritime, France Keywords: Balneotherapy; General anxiety disorder; Anti-depressant drugs; Stress related-disorders Background.– Preliminary studies suggested that balneotherapy (BT) is an effective and well-tolerated treatment for generalized anxiety disorder (GAD). Objective.– To assess the efficacy of BT in GAD delivered in in 4 spa resorts. Methods.– We compared BT to paroxetine in terms of efficacy and safety in a randomized multicentre study lasting 8 weeks. Patients meeting the diagnostic criteria of GAD (DSM-IV) were recruited. Assessments were conducted using the Hamilton Rating Scale for Anxiety (HAM-A) and other scales, by a specifically trained and independent physician. The main endpoint was the change in the total HAM-A score between baseline and week 8. Results.– A total of 237 outpatients were enrolled in four centres; 117 were assigned randomly to BT and 120 to paroxetine. The mean change in HAM-A scores showed an improvement in both groups with a significant advantage of BT compared to paroxetine (−12.0 vs −8.7; P < 0.001). Remission (19% vs 7%) and sustained response (51% vs 28%) rates were significantly higher in the BT group.