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

Allegra 1981.

Study characteristics
Methods Study design: randomised, double‐blind, placebo‐controlled
Method of randomisation: table of random numbers
Exclusions post randomisation: none
Losses to follow‐up: none
Participants Country: Italy
Setting: hospital
Number: 80 patients
Age: not stated
Gender: not stated
Inclusion criteria: patients with postphlebitic syndrome, oedema of the lower limb, phlebolymphoedema, constitutional venous stasis, varices
Exclusion criteria: not stated
Interventions Treatment: 2 × 10 mg Centella tablets 3 × per day
Control: placebo
Duration: 30 days
Follow‐up: 30 days
Outcomes Primary
  • Symptoms ‐ heavy legs, pain, cramps, global assessment by participant and by physician measured by an ordinal scale (0 to 3)

  • Signs ‐ leg oedema, venous dilatation and skin trophism measured by an ordinal scale (0 to 3). Venous pressure measured by echo Doppler


Secondary
  • Tolerance

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The assignment of patients to one of two treatments, labelled as A or B, was made randomly using a special randomization list"
Comment: a randomisation list is generally accepted as a fair method of ensuring a random sequence
Allocation concealment (selection bias) Unclear risk Comment: no information given about methods used for allocation concealment
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: no exclusions post randomisation and no losses to follow‐up
Selective reporting Unclear risk Comment: the number of participants in both groups was described. However, a table with important characteristics was lacking; this could lower the generalisability. Adverse events, tolerability and signs of intolerance were presented
Other bias Low risk Comment: none detected