Carpentier 2009.

Methods	Study design: randomised controlled trial Study grouping: parallel group Total number: 59 participants (29 in balneotherapy group and 30 control group) Start date: no details given Duration of participation: 15 months End date: no details given Method of randomisation: centralised randomisation was performed after the inclusion visit, and its result kept hidden from the investigators. Blinding: participants – no; spa physician – yes; outcome assessors – yes Power calculation: calculated the number of participants required as 20 in each group (using a bilateral test, with α = 0.05, β = 0.15). This hypothesis was based on poorly documented potential outcomes (worsening by 15% of the pigmentation in the control group vs 5% in the treated group, with a 10% standard deviation). The authors decided to include 60 participants in order to accommodate potential problems of underestimation of variability and possible dropouts. Losses to follow‐up: 4 withdrew soon after randomisation and refused the follow‐up. 1 late refusal (woman from the treatment group because of personal difficulties in the organisation of her stay in the spa resort). The 3 others came from participants from the control group: 1 for an unexplained personal reason; 1 because of the onset of family problems and 1 because he expected an immediate spa treatment and did not accept the result of the randomisation. Unit of allocation: participants Source of funding: no details given
Participants	Setting: outpatients (second care) Country: France Gender: 19 men and 40 women Age: mean age 59.3 years in balneotherapy group and 62.5 years in control group Inclusion criteria: people with primary or post‐thrombotic CVI with skin changes but no active ulcer (C4 or C5), and the evidence of a venous incompetence demonstrated by ultrasound duplex examination with at least a significant reflux (> 1‐second duration in standing position) in the superficial, deep, perforator veins, or a combination of these. Aged ≥18 years, living in Grenoble area and willing to participate (written informed consent) in the study (to perform a 3‐week course of spa treatment of in La Léchère resort and a follow‐up of 15 months' duration including a weekly self‐administered questionnaire and a medical examination every 3 months). Exclusion criteria: prior spa treatment course, if a surgical or endovascular treatment of the venous disease was planned for the study time course or had been performed < 6 months prior to the inclusion visit. People with contraindication of spa treatment (life‐threatening disease, cardiac or renal failure, immunodeficiency, psychiatric disorders, strong limitation of ambulation), 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 < 0.90).
Interventions	Technique: 4 balneotherapy sessions per day, 6 days per week for 3 weeks. During the stay, the participant also participated in 2 or 3 × 90‐minute educational workshops performed according to a previously published method. Balneotherapy group: 3‐week spa treatment course in La Léchère 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: 15 months Cointerventions: during the whole study time course, participants of both groups remained attended by their usual physicians, who provided them with any care they thought useful for their participants.
Outcomes	Outcomes relevant for this review (collected) Health‐related quality of life (measured every 3 months by CIVIQ2 self‐administered questionnaire; Launois 1996) Pain (measured by VAS, range 0–10) Incidence of leg ulcer Skin pigmentation change (assessed by skin chromametry at the level of the medial malleolar region: pigmentation index and erythema index) Reported outcomes Data regarding direct cost of medical and nursing cares were recorded for subsequent medico‐economic analysis, but were not analysed in the study paper. All outcomes were measured every 6 months, except pain, which was measured every 5 weeks.
Identification	Authors name: Patrick H Carpentier Institution: Clinique Universitaire de Médecine Vasculaire, Pôle Pluridisciplinaire de Médecine, Centre Hospitalier Universitaire de Grenoble, and the Centre de Recherche Universitaire de la Léchère. email: patrick.carpentier@ujf‐grenoble.fr
Notes	The study authors confirmed this trial used a different population from the study reported in Carpentier 2014 (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 (results kept hidden from investigator).
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 management performed blindly, including a final blind review regarding protocol deviations and missing data.
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	No evidence of other bias.