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

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%)
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
Interventions Treatment: Buckwheat herb tea 3 × 1.8 g per day
Control: placebo tea
Duration: 84 days
Follow‐up: 112 days
Outcomes Primary
  • Oedema, by reduction of leg volume

  • Symptoms ‐ tenseness, heaviness, swelling, pain, paraesthesia, cramps, burning feet, restless legs, itching


Secondary
  • Side effects

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