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

Marinello 2002.

Study characteristics
Methods Study design: randomised, multi‐centre, double‐blind, placebo‐controlled
Method of randomisation: not stated
Exclusions post randomisation: none
Losses to follow‐up: 21/123 (17%)
Participants Country: Spain
Setting: hospital
Number: 143 patients
Age: mean 52.87 (range 19 to 72) years
Gender: 25 M:77 F
Inclusion criteria: CVI stage CEAP III, IV and V
Exclusion criteria: not stated
Interventions Treatment: calcium dobesilate 1000 mg per day or calcium dobesilate 2000 mg per day
Control: placebo
Duration: 84 days
Follow‐up: 84 days
Elastic stockings permitted
Outcomes Primary
  • Symptoms ‐ heaviness and pain in the legs

  • Signs ‐ transcutaneous PO2 and CO2


Secondary
  • Not stated

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "In total 143 patients 123 were randomized (41 per treatment group)"
Comment: no method of randomisation described
Allocation concealment (selection bias) Unclear risk Comment: no methods of allocation concealment described
Blinding (patients) Low risk Quote: "The placebo had the same characteristics which include active treatment. The oral administration was under the same conditions as the active treatment"
Comment: Identical placebo ensures double‐blinding
Blinding (study researchers) Low risk Quote: "The placebo had the same characteristics which include active treatment. The oral administration was under the same conditions as the active treatment"
Comment: Identical placebo ensures double‐blinding
Blinding (outcome assessment) Low risk Quote: "The placebo had the same characteristics which include active treatment. The oral administration was under the same conditions as the active treatment"
Comment: Identical placebo ensures double‐blinding
Incomplete outcome data Low risk Comment: number of participants in each group described, along with baseline characteristics. In addition, numbers and information provided about adverse events and participants who withdrew prematurely from the study
Selective reporting Low risk Comment: no published protocol identified, and no differences between outcomes reported in the methods section and those reported in the results section
Other bias Low risk Comment: none detected