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. 2019 Aug 26;2019(8):CD013085. doi: 10.1002/14651858.CD013085.pub2

Ernst 1991.

Methods Study design: randomised controlled trial
Study grouping: parallel group
Total number: 61 participants (30 in balneotherapy group and 31 control group)
Start date: no details given
Duration of participation: 24 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: participants
Source of funding: no details given
Participants Setting: outpatients (second care)
Country: Austria
Gender: 16 men and 45 women
Age (mean): 58.1 (SD 7.4) years
Inclusion criteria: people with primary varicosity
Exclusion criteria: people with post‐traumatic or post‐thrombotic CVI, lymphoedema, hereditary vascular abnormalities, venous compression syndromes, congestive heart disease, liver and kidney diseases, malignancies, inflammatory diseases, haematological abnormalities, peripheral arterial occlusive disease.
Interventions Technique: treatment comprised intermittent cold and warm water according to Kneipp therapy (Forestier 2014), or continuous cold‐water treatments, mostly in region of lower legs up to the knees. It was carried 5 days per week and lasted about 12 minutes.
Hydrotherapy group: hydrotherapy
Control group: no hydrotherapy
Duration of follow‐up: 24 days
Cointerventions: participants already wearing compression stockings continued to do so.
Outcomes Outcomes relevant for this review (collected)
  • Oedema (measured by leg volume in millilitres in water plethysmography, by minimal ankle circumference in centimetres and by maximal calf circumference in centimetres)


Reported outcomes
  • VFT measured by light reflex rheography

  • Spontaneously related subjective symptoms


All outcomes were measured at 12 and 24 days
Identification Authors name: Edzard Ernst
Institution: Department Physical Medicine and Rehabilitation, University of Vienna
email: no details given
Notes We assumed Ernst 1991 and Ernst 1992 were separate studies but were unable to confirm this with the study authors.
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) Unclear risk Insufficient information about allocation concealment.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Participants and spa physicians not blinded.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Investigators uninformed as to which study group given participant belonged.
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 No evidence of other bias.