Ihme 1996.
Study characteristics | ||
Methods | Study design: randomised, double‐blind, placebo‐controlled Method of randomisation: Rancode computer software Exclusions post randomisation: none Losses to follow‐up: 11/77 (14%) |
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Participants | Country: Germany Setting: hospital Number: 77 patients Age: mean 57.3 ± 9.6 years active group; mean 59.8 ± 7.3 years placebo group Gender: 24 M:53 F Inclusion criteria: CVI stages I and II (oedema, symptoms, stem varicosis, post‐thrombotic syndrome, valvular insufficiency of the deep veins) Exclusion criteria: varicosis with surgical indication; active or healed ulcus cruris; acute thrombosis or venous inflammation; oedema due to cardiac or renal insufficiency; treatment with a diuretic, dihydroergotamine or any other drugs for venous therapy; other severe disorder |
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Interventions | Treatment: Buckwheat herb tea (rutoside) 270 mg per day Control: placebo Duration: 90 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: "The randomisation was carried out by Rancode computer software (IDV Gauting, Germany)" Comment: Randomisation seems like a fair method to ensure a random sequence of participants |
Allocation concealment (selection bias) | Unclear risk | Comment: no methods of allocation concealment described |
Blinding (patients) | Low risk | Quote: "A blinded taste test with pharmacists demonstrated that the teas were similar in taste and appearance and hard to distinguish" Comment: Identical placebo ensures double‐blinding |
Blinding (study researchers) | Low risk | Quote: "A blinded taste test with pharmacists demonstrated that the teas were similar in taste and appearance and hard to distinguish" Comment: Identical placebo ensures double‐blinding |
Blinding (outcome assessment) | Low risk | Quote: "A blinded taste test with pharmacists demonstrated that the teas were similar in taste and appearance and hard to distinguish" Comment: Identical placebo ensures double‐blinding |
Incomplete outcome data | Low risk | Comment: number of participants in each group described. Number of drop‐outs and reasons for dropping out of the trial described. ITT analysis conducted |
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 |