Stefanini 1996.

Methods	Study design: randomised controlled trial Study grouping: parallel group Total number: 55 participants (20 in melilotus officinalis group, 15 in balneotherapy group and 20 melilotus officinalis plus balneotherapy group) Start date: no details given Duration of participation: 15 days End date: no details given Methods of randomisation: no details given Blinding: mentioned "double‐blind" Power calculation: no details given Losses to follow‐up: no details given Unit of allocation: individuals Source of funding: no details given
Participants	Setting: outpatients (second care) Country: Italy Gender: 4 men and 51 women Age (mean): 55 years Inclusion criteria: people with CVI Exclusion criteria: no details provided
Interventions	Technique: 1 bath per day with hypertonic alkaline saline‐sulphonated water for 15 days, at a temperature of 36.5 °C. The ozonated water was obtained by bubbling ozonated air under pressure in water. Melilotus officinalis group:melilotus officinalis 200 mg per day Balneotherapy group: bath with hypertonic alkaline saline‐sulphonated water Balneotherapy plus melilotus officinalis group:melilotus officinalis 200 mg per day plus bath with hypertonic alkaline saline‐sulphonated water Duration of follow‐up: 15 days
Outcomes	Outcomes relevant for this review (collected) Pain Oedema Reported outcomes Hyperthermia Paraesthesia Sensation of weight Nocturnal cramps Used a scale with score of 0–3 to quantify results.
Identification	Author's name: L Stefanini Institution: Direzione Sanitaria Terme di Montecatini email: no details provided
Notes	For this study, we used the data from the melilotus officinalis group and balneotherapy group only.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information about sequence generation process.
Allocation concealment (selection bias)	Unclear risk	No details given.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and spa physician not blinded.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No details given.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No details given.
Selective reporting (reporting bias)	Low risk	All outcomes reported.
Other bias	Unclear risk	Study sponsored by Sanitary Direction of Terme di Montecatini.

CEAP: chronic venous insufficiency classification (clinical manifestations (C), aetiological factors (E), anatomical distribution (A) and pathophysiological findings (P)); CIVIQ2: Chronic Venous Disease Quality of life questionnaire; CVI: chronic venous insufficiency; EQ‐5D: Euro quality of life five dimensions; PASS: Patient Acceptable Symptom State; SF‐36: 36‐item Short Form; VAS: visual analogue scale; VCSS : Venous Chronic Severity Score; VFT: venous filling time.