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

Languillat 1988.

Study characteristics
Methods Study design: randomised, double‐blind, placebo‐controlled
Method of randomisation: not stated
Exclusions post randomisation: none
Losses to follow‐up: none
Participants Country: France
Setting: hospital
Number: 20 patients
Age: 20 and 65 years
Gender: 1 M:19 F
Inclusion criteria: symptomatic CVI and oedema
Exclusion criteria: previous venous sclerosis; surgery or elastic support; trophic disturbances; ulcers or permanent oedema; cardiac, renal, hepatic insufficiency or arterial disease; Raynaud's phenomenon; lymphoedema; pregnancy; venoactive drugs; any significant change in patient lifestyle or work
Interventions Treatment: extract Ruscus aculeatus 450 mg plus hesperidin 450 mg plus ascorbic acid 300 mg per 12 hours
Control: placebo
Duration: 28 days
Follow‐up: 42 days
Outcomes Primary
  • Venous circulatory velocity measured by Xenon 133


Secondary
  • Symptoms ‐ heavy legs, pain, paraesthesias, cramp, restlessness, swelling measured by a semiquantitative scale (0 to 3)

  • Overall assessment by investigator

  • Safety

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "This was a double‐blind placebo‐controlled trial with two groups of patients treated in parallel"
Comment: no method of randomisation described
Allocation concealment (selection bias) Unclear risk Comment: no method of allocation concealment described
Blinding (patients) Low risk Quote: "The double‐blind nature of the trial was guaranteed by the strictly identical appearance of treatment units (capsules) as well as their packaging (bottles and bags of treatment kits)"
Comment: Identical placebo ensures double‐blinding
Blinding (study researchers) Low risk Quote: "The double‐blind nature of the trial was guaranteed by the strictly identical appearance of treatment units (capsules) as well as their packaging (bottles and bags of treatment kits)"
Comment: Identical placebo ensures double‐blinding
Blinding (outcome assessment) Low risk Quote: "The double‐blind nature of the trial was guaranteed by the strictly identical appearance of treatment units (capsules) as well as their packaging (bottles and bags of treatment kits)"
Comment: Identical placebo ensures double‐blinding
Incomplete outcome data Low risk Comment: number of participants in each group described, along with the most important baseline characteristics. No losses reported
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