Skip to main content
. 2020 Nov 3;2020(11):CD003229. doi: 10.1002/14651858.CD003229.pub4

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%)
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
Interventions Treatment: Buckwheat herb tea (rutoside) 270 mg per day
Control: placebo
Duration: 90 days
Follow‐up: 112 days
Outcomes Primary
  • Signs ‐ oedema, lower leg volume of more seriously affected leg by a Gutmann volumeter and ultrasound


Secondary
  • Symptoms ‐ tenseness, heaviness, swelling by an ordinal scale (0, 1, 2). Pain, paraesthesia, cramps, burning feet, restless legs by an ordinal scale (0, 0.5, 1)

    • Side effects

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