Carpentier 2014.

Methods	Study design: randomised controlled trial Study grouping: parallel group Total number: 425 participants (214 in balneotherapy group and 211 control group) Start date: no details given Duration of participation: 18 months End date: no details given Method of randomisation: centralised randomisation. Blinding: participant – no; spa physician – yes; assessor outcomes – yes Power calculation: the number of participants to be included was calculated from the expected reduction in the incidence of leg ulcers. The hypothesis was based on a yearly incidence of 20% in the control group compared with 10% in the treated group, with an alpha risk of 5% and a power of 80%. 199 participants were needed for the comparison, and the authors decided to include 440 participants to allow for dropouts. Total number of participants randomised: 425 Total number of participants analysed: 390 Losses to follow‐up: 35 losses (14 in control group; 21 in spa treatment group) Number of withdrawals and reasons: control group – 11 withdrew consent, 2 dropped out, 1 early stop. Spa treatment – 19 withdrew consent, 1 dropped out, 1 early stop Unit of allocation: participants Source of funding: no details given
Participants	Setting: outpatients (second care) Country: France (multicentre) Gender: 186 men and 239 women Age (mean): 63.5 years in balneotherapy group and 65.1 years in control group Inclusion criteria: people with primary or post‐thrombotic CVI with skin changes but no active ulcer (C4a, C4b, or C5) and evidence of venous incompetence demonstrated by duplex ultrasound examination with ≥ 1 significant reflux (of > 1‐second duration in a standing position) in the superficial veins, deep veins, perforator veins, or a combination of these. Aged ≥ 18 years and willing to participate (written informed consent) in the study (to attend a 3‐week course of spa treatment in 1 of the 12 French spa resorts treating people with CVI) and to accept a follow‐up of 18 months' duration including a monthly self‐administered questionnaire and a medical examination every 6 months. Exclusion criteria: people with surgical or endovascular treatment of the venous disease planned at any time during the study period (18 months) or had been performed < 6 months prior to the inclusion visit. Spa treatment in the previous 6 months or a contraindication to spa treatment (life‐threatening disease, cardiac or renal failure, immunodeficiency, psychiatric disorders, severe difficulty walking), oedema of non‐venous origin (clinical lymphoedema, cardiac failure, hypoalbuminaemia), symptomatic neurological diseases of the lower limbs (neurogenic pain or abnormal neurological examination of the lower limbs) or significant peripheral arterial disease (ankle‐brachial index < 0.70)
Interventions	Technique: 4 balneotherapy sessions per day, 6 days per week for 3 weeks, and educational activities that were differently organised in each resort. The balneotherapy sessions included a 15‐minute walking session in a specially designed pool with tracks in semi‐deep (80 cm) cool (28 °C) water (training of muscle pump function under water compression); a 20‐minute whirlpool bath session with automatic air and water massage cycles (aimed at relaxation and mobilisation of the superficial skin volume flow); a 10‐minute bath session with customised underwater strong massaging jets (mobilisation and softening of the sclerotic subcutaneous tissues); and a 10‐minute massage session of the leg and ankle skin areas by a registered physiotherapist under a light spray shower (softening of the sclerotic subcutaneous tissues) or a 15‐minute joint mobilisation session in a deep (150 cm) warm (34 °C) pool under the supervision of a physiotherapist (improvement of ankle, and also knee and hip joint mobility for better ambulation and muscle‐pump functioning) Balneotherapy group: 3‐week spa treatment course in the spa resort closest to their home, soon after randomisation. Control group: during comparison period no treatment; followed by spa treatment after the comparison period (i.e. starting soon after day 365); Duration of follow‐up: comparison period 1 year; total duration of follow‐up: 18 months
Outcomes	Outcomes relevant for this review (collected) Disease severity signs and symptoms score (measured using VCSS; Rutherford 2000), ranging from 0 to 27 Health‐related quality of life (measured every 6 months by CIVIQ2 (Launois 1996) and EQ‐5D (Brooks 1996)) (self‐administered questionnaire) Pain (measured by VAS, range 0–10) Incidence of leg ulcer Reported outcomes Data regarding direct cost of medical and nursing cares were recorded for subsequent medico‐economic analysis, but were not analysed in the paper. All outcomes were measured every 6 months.
Identification	Authors name: Patrick H Carpentier Institution: Clinique Universitaire de Médecine Vasculaire, Pôle Pluridisciplinaire de Médecine, Centre Hospitalier Universitaire, Grenoble email: pcarpentier@chu‐grenoble.fr
Notes	The study authors confirmed this trial used a different population from the study reported in Carpentier 2009 (personal communication by email, 5 February 2019).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information about sequence generation.
Allocation concealment (selection bias)	Low risk	Central allocation
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants not blinded.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Data managers blinded to randomisation, including the final data review.
Incomplete outcome data (attrition bias) All outcomes	Low risk	All exclusions reported with reasons and by study group.
Selective reporting (reporting bias)	Low risk	All outcomes reported.
Other bias	Unclear risk	Funding by Association Française de Researche Thermale. Sessions customised according the participant's needs and capabilities by specialist spa physician.