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
Secondary
|
|
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 |