Pecchi 1990.
Study characteristics | ||
Methods | Study design: randomised, double‐blind, placebo‐controlled Method of randomisation: use of alternation by order of arrival of each participant Exclusions post randomisation: none Losses to follow‐up: none |
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Participants | Country: Italy Setting: university Number: 40 patients Age: mean 48.2 ± 15.7 years Gender: 4 M:36 F Inclusion criteria: primary CVI and post‐thrombotic syndrome Exclusion criteria: postphlebitic syndrome; severe trophic lesions; no venous oedema; patients taking diuretics, corticosteroids or vasoactive drugs; elastic stockings or bandages |
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Interventions | Treatment: calcium dobesilate 1000 mg per day Control: placebo Duration: 30 days Follow‐up: 30 days |
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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: "Patients admitted to the study were randomly divided into two balanced groups treated respectively with calcium or placebo for one month..." Comment: no method of randomisation described |
Allocation concealment (selection bias) | Unclear risk | Quote: "The allocation to individual patients of either type of treatment was performed according to the access sequence number of the patient" Comment: no method of allocation concealment described |
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 | Low risk | Comment: numbers of participants in both groups described. No losses reported. No baseline characteristics of participants provided |
Selective reporting | Low risk | Comment: no 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 |