Koscielnny 1996.
Study characteristics | ||
Methods | Study design: randomised, double‐blind, placebo‐controlled Method of randomisation: not stated Exclusions post randomisation: none Losses to follow‐up: 6/77 (8%) |
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Participants | Country: Germany Setting: university Number: 94 patients selected; 67 randomised Age: 'adults' Gender: not stated Inclusion criteria: CVI stage I to II Widmer Exclusion criteria: not stated |
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Interventions | Treatment: Buckwheat herb tea 3 × 1.8 g per day Control: placebo tea 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) | Unclear risk | Quote: "After a placebo period of two weeks, patients were randomly assigned to active treatment or a placebo group" Comment: no information about methods of randomisation provided |
Allocation concealment (selection bias) | Unclear risk | Comment: no information about methods of allocation concealment provided |
Blinding (patients) | Low risk | Quote: "Placebo is with taste and appearance indistinguishable from the treatment" Comment: Identical placebo ensures double‐blinding |
Blinding (study researchers) | Low risk | Quote: "Placebo is with taste and appearance indistinguishable from the treatment" Comment: Identical placebo ensures double‐blinding |
Blinding (outcome assessment) | Low risk | Quote: "Placebo is with taste and appearance indistinguishable from the treatment" Comment: Identical placebo ensures double‐blinding |
Incomplete outcome data | Low risk | Comment: number of participants in both placebo and treatment groups described, along with the most important participant characteristics, numbers of participants who dropped out prematurely, reasons for drop‐out, influence of drop‐outs and information on compliance |
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 |