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

Pointel 1986.

Study characteristics
Methods Study design: randomised, double‐blind, placebo‐controlled
Method of randomisation: not stated
Exclusions post randomisation: none
Losses to follow‐up: 4 (4%)
Participants Country: France
Setting: hospital
Number: 94 patients
Age: mean 49 ± 12 years
Gender: 8 M:86 F
Inclusion criteria: CVI
Exclusion criteria: severe varicose veins requiring an elastic strip, postphlebitic patients, those with unilateral venous insufficiency, those treated with a venoactive drug before the start of the study
Interventions Treatment: Centella asiatica (TECA) 120 mg: two 30 mg capsules twice a day vs Centella asiatica (TECA) 60 mg: one 30 mg capsule twice a day
Control: placebo
Duration: 56 days
Follow‐up: 56 days
Outcomes Primary
  • Symptoms of CVI (pain, heaviness) and oedema measured by an ordinal scale (0 to 3)


Secondary
  • Venous distensibility measured by plethysmography

  • Side effects

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "The study conducted in four hospitals according to a controlled, randomized, double‐blind (double dummy) study performed on three parallel groups for eight weeks"
Comment: no method of randomisation described
Allocation concealment (selection bias) Unclear risk Comment: no methods 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: number of participants in each group described, along with inclusion and exclusion criteria and important characteristics for participants. In addition, study author reported the number of adverse events that occurred, the number of participants who withdrew prematurely and reasons for dropping out
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