Zucarelli 1987.
| Study characteristics | ||
| Methods | Study design: randomised, double‐blind, placebo‐controlled Method of randomisation: throwing dice Exclusions post randomisation: none Losses to follow‐up: 25/149 (16%) |
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| Participants | Country: France Setting: outpatients Number: 149 patients Age: mean 33 ± 9.4 years active treatment; mean 32 ± 8 years placebo Gender: 149 F Inclusion criteria: CVI stage I (functional symptoms and oedema) Participants allowed to wear elastic support Exclusion criteria: chronic venous with trophic alterations; varices; phlebitis; postphlebitic syndrome; lymphoedema; arteriopathy; pregnancy; other phlebotonics; anti‐inflammatories; diuretics; anti‐platelet or vasculo‐protector treatments |
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| Interventions | Treatment: coumarin 10.5 mg per day plus troxerutin 1050 mg per day Control: placebo Duration: 90 days Follow‐up: 90 days |
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| Outcomes | Primary
Secondary
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "The methodology used was that of a controlled trial against placebo in double‐blind perspective with the drawing of lots to constitute two parallel groups" Comment: Drawing of lots seems like a fair method of generating an adequate sequence |
| Allocation concealment (selection bias) | Unclear risk | Comment: no methods of allocation concealment described |
| Blinding (patients) | Low risk | Quote: "Ampules of placebo, which are in all respects comparable to those of the active..." Comment: Identical placebo ensures double‐blinding |
| Blinding (study researchers) | Low risk | Quote: "Ampules of placebo, which are in all respects comparable to those of the active..." Comment: Identical placebo ensures double‐blinding |
| Blinding (outcome assessment) | Low risk | Quote: "Ampules of placebo, which are in all respects comparable to those of the active..." Comment: Identical placebo ensures double‐blinding |
| Incomplete outcome data | Low risk | Comment: number of participants in each group described, along with inclusion and exclusion criteria and the most important characteristics. In addition, tolerance, adverse events and participants who dropped out prematurely described |
| 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 |
BMI: body mass index CEAP classification (clinical signs (C), aetiology (E), anatomical distribution (A) and physiological conditions (P) of CVI) CIVIQ: Chronic Venous Insufficiency International Questionnaire CT: clinical trial CVD: cardiovascular disease CVI: chronic venous insufficiency DVT: deep vein thrombosis EuroQoL: Descriptive system of health‐related quality of life states FLQA: Freiburg Life Quality Assessment h: hour ITT: intention‐to‐treat LRR: light reflection rheography MPL: most pathological leg NSAIDs: non‐steroidal anti‐inflammatories QoL: quality of life tid: 3 times a day VAS: visual analogue scale WDV: water displacement volumetry