Kiesewetter 1997.
Study characteristics | ||
Methods | Study design: randomised, double‐blind, placebo‐controlled Method of randomisation: not stated Exclusions post randomisation: not stated Losses to follow‐up: not stated |
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Participants | Country: Germany Setting: university Number: 81 patients Age: mean 59 ± 7 years Gender: 26 M:55 F Inclusion criteria: stage I to II of Wert CVI Exclusion criteria: acute thromboses; ulcus cruris; heart insufficiency; recent venous surgery; venoactive drugs |
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Interventions | Treatment: 500 mg Buckwheat herb and 30 mg troxerutin. 2 tablets 3 × per day Control: placebo Duration: 84 days Follow‐up: 112 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: "For randomization of patients, the program was 'Rancode' of the company IDV data analysis and experimental design, Gauting, used" Comment: computerised generation of a random sequence generally accepted as a fair method of randomisation |
Allocation concealment (selection bias) | Unclear risk | Comment: no information given about methods used for allocation concealment |
Blinding (patients) | Low risk | Quote: "The same number of identical‐looking placebo tablets consisting of lactose were given" Comment: Identical placebo ensures double‐blinding |
Blinding (study researchers) | Low risk | Quote: "The same number of identical‐looking placebo tablets consisting of lactose were given" Comment: Identical placebo ensures double‐blinding |
Blinding (outcome assessment) | Low risk | Quote: "The same number of identical‐looking placebo tablets consisting of lactose were given" Comment: Identical placebo ensures double‐blinding |
Incomplete outcome data | Unclear risk | Comment: number of participants in each group described. No information provided about participants who prematurely dropped out of the study |
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 |