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

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
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
Interventions Treatment: calcium dobesilate 1000 mg per day
Control: placebo
Duration: 30 days
Follow‐up: 30 days
Outcomes Primary
  • Symptoms ‐ pain, cramps, heaviness, pruritus, swelling and paraesthesia measured by a semiquantitative scale (0 to 4)

  • Signs ‐ oedema measured by plethysmographic parameters and circumference of ankle; varicoses in the legs measured by a semiquantitative scale (0 to 4)


Secondary
  • Not stated

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