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. 2020 Nov 3;2020(11):CD003229. doi: 10.1002/14651858.CD003229.pub4

Klüken 1971.

Study characteristics
Methods Study design: randomised, double‐blind, placebo‐controlled
Method of randomisation: not stated
Exclusions post randomisation: not stated
Losses to follow‐up: not stated
Participants Country: Germany
Setting: hospital
Number: 60 patients
Age: 'adults'
Gender: not stated
Inclusion criteria: CVI (varicoses or post‐thrombotic syndrome)
Exclusion criteria: not stated
Interventions Treatment: troxerutin 75 mg and coumarin 15 mg per day
Control: placebo
Duration: 21 days
Follow‐up: 21 days
Outcomes Primary
  • Symptoms ‐ pain, tension measured by a qualitative scale

    • Oedema ‐ circumference of calf and ankle


Secondary
  • Not stated

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Double‐blind, randomized, placebo‐controlled. In two parallel groups"
Comment: information about methods of randomisation not provided
Allocation concealment (selection bias) Unclear risk Comment: no information about methods of allocation concealment provided
Blinding (patients) Unclear risk Comment: no information given about methods used for blinding
Blinding (study researchers) Unclear risk Comment: no information given about methods used for blinding
Blinding (outcome assessment) Unclear risk Comment: no information given about methods used for blinding
Incomplete outcome data Unclear risk Comment: number of participants in each group described. No information provided about the number of participants who dropped out of the study prematurely or the number who experienced adverse events
Selective reporting Unclear risk Comment: no published protocol identified. No outcomes reported in the methods section
Other bias Low risk Comment: none detected