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%) |
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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 |
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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 |
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Outcomes | Primary
Secondary
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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 |