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

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
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
Interventions Treatment: 500 mg Buckwheat herb and 30 mg troxerutin. 2 tablets 3 × per day
Control: placebo
Duration: 84 days
Follow‐up: 112 days
Outcomes Primary
  • Lower leg volume determined by ultrasound of the more affected leg


Secondary
  • Symptoms ‐ pain, paraesthesia, cramps, swelling, restless legs, burning feet measured by an ordinal scale (0 to 2)

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